gem_id
stringlengths 31
34
| gem_parent_id
stringlengths 31
34
| source
stringlengths 1k
5.71k
| target
stringlengths 219
4.42k
| doi
stringlengths 25
30
| references
list |
|---|---|---|---|---|---|
cochrane-simplification-train-1500
|
cochrane-simplification-train-1500
|
We included three RCTs conducted in Australia, the United Kingdom, and the United States that enrolled a total of 225 eyes and analysed 219 eyes. The total number of people enrolled was not clear in two of the studies. Only adults were enrolled into these studies. Out of the eyes analysed, 119 had CXL (all using the epithelium-off technique) and 100 served as controls. One of these studies only reported comparative data on review outcomes. All three studies were at high risk for performance bias (lack of masking), detection bias (only one trial attempted to mask outcome assessment), and attrition bias (incomplete follow-up). It was not possible to pool data due to differences in measuring and reporting outcomes. We identified a further three unpublished trials that potentially had enrolled a total of 195 participants. There was limited evidence on the risk of progression. Analysis of the first few participants followed up to one year in one study suggested that eyes given CXL were less likely to have an increase in maximum keratometry of 1.5 D or more at 12 months compared to eyes given no treatment, but the confidence intervals (CI) were wide and compatible with no effect or more progression in the CXL group (risk ratio (RR) 0.12, 95% CI 0.01 to 2.00, 19 eyes). The same study reported the number of eyes with an increase of 2 D or more at 36 months in the whole cohort with a RR of 0.03 favouring CXL (95% CI 0.00 to 0.43, 94 eyes). Another study reported "progression" at 18 months using a different definition; people receiving CXL were less likely to progress, but again the effect was uncertain (RR 0.14, 95% CI 0.01 to 2.61, 44 eyes). We judged this to be very low-quality evidence due to the risk of bias of included studies, imprecision, indirectness and publication bias but noted that the size of the potential effect was large. On average, treated eyes had a less steep cornea (approximately 2 D less steep) (mean difference (MD) -1.92, 95% CI -2.54 to -1.30, 94 eyes, 1 RCT, very low-quality evidence) and better uncorrected visual acuity (approximately 2 lines or 10 letters better) (MD -0.20, 95% CI -0.31 to -0.09, 94 eyes, 1 RCT, very low-quality evidence) at 12 months. None of the studies reported loss of 0.2 logMAR acuity. The data on corneal thickness were inconsistent. There were no data available on quality of life or costs. Adverse effects were not uncommon but mostly transient and of low clinical significance. In one trial, 3 out of 12 participants treated with CXL had an adverse effect including corneal oedema, anterior chamber inflammation, and recurrent corneal erosions. In one trial at 3 years 3 out of 50 participants experienced adverse events including mild diffuse corneal oedema and paracentral infiltrate, peripheral corneal vascularisation, and subepithelial infiltrates and anterior chamber inflammation. No adverse effects were reported in the control groups. The evidence for the use of CXL in the management of keratoconus is limited due the lack of properly conducted RCTs.
|
The searches are current to August 2014. We found three randomised controlled trials, which were done in the United States, the United Kingdom, and Australia. A total of 219 eyes were randomly allocated to treatment with CXL or no treatment. In all three studies the surgery was done in the same way. None of the studies included children. Eyes treated with CXL were less likely to have problems with progression of bulging compared to eyes that were not treated. However, the studies were small and there were some concerns about the way they were done. It is therefore difficult to say exactly how much the treatment helped. None of the studies reported the risk of eyesight getting worse but, on average, treated eyes had better vision (about 10 letters better) compared to untreated eyes. None of the studies reported on a change in quality of life for the participant. The main adverse effects were inflammation and swelling; this occurred in approximately one in 10 participants. We judged the quality of the evidence to be very low because of problems in the way the studies were done and reported and the small number of eyes included.
|
10.1002/14651858.CD010621.pub2
|
[
"The searches are current to August 2014. We found three randomised controlled trials, which were done in the United States, the United Kingdom, and Australia. A total of 219 eyes were randomly allocated to treatment with CXL or no treatment. In all three studies the surgery was done in the same way. None of the studies included children. Eyes treated with CXL were less likely to have problems with progression of bulging compared to eyes that were not treated. However, the studies were small and there were some concerns about the way they were done. It is therefore difficult to say exactly how much the treatment helped. None of the studies reported the risk of eyesight getting worse but, on average, treated eyes had better vision (about 10 letters better) compared to untreated eyes. None of the studies reported on a change in quality of life for the participant. The main adverse effects were inflammation and swelling; this occurred in approximately one in 10 participants. We judged the quality of the evidence to be very low because of problems in the way the studies were done and reported and the small number of eyes included."
] |
cochrane-simplification-train-1501
|
cochrane-simplification-train-1501
|
We identified 18 studies (two RCTs and 16 non-randomized studies (NRSs)) comprising 11,043 women undergoing early medical abortion (≤ 9 weeks gestation) in 10 countries. Sixteen studies took place in low-to-middle income resource settings and two studies were in high-resource settings. One NRS study received analgesics from a pharmaceutical company. Five NRSs and one RCT did not report on funding; nine NRSs received all or partial funding from an anonymous donor. Five NRSs and one RCT received funding from government agencies, private foundations, or non-profit bodies. The intervention in the evidence is predominantly from women taking mifepristone in the presence of a healthcare provider, and subsequently taking misoprostol without healthcare provider supervision (e.g. at home). There is no evidence of a difference in rates of successful abortions between self-administered and provider-administered groups: for two RCTs, risk ratio (RR) 0.99, 95% confidence interval (CI) 0.97 to 1.01; 919 participants; moderate certainty of evidence. There is very low certainty of evidence from 16 NRSs: RR 0.99, 95% CI 0.97 to 1.01; 10,124 participants. For the outcome of ongoing pregnancy there may be little or no difference between the two groups: for one RCT: RR 1.69, 95% CI 0.41 to 7.02; 735 participants; low certainty of evidence; and very low certainty evidence for 11 NRSs: RR 1.28, 95% CI 0.65 to 2.49; 6691 participants. We are uncertain whether there are any differences in complications requiring surgical intervention, since we found no RCTs and evidence from three NRSs was of very low certainty: for three NRSs: RR 2.14, 95% CI 0.80 to 5.71; 2452 participants. This review shows that self-administering the second stage of early medical abortion procedures is as effective as provider-administered procedures for the outcome of abortion success. There may be no difference for the outcome of ongoing pregnancy, although the evidence for this is uncertain for this outcome. There is very low-certainty evidence for the risk of complications requiring surgical intervention. Data are limited by the scarcity of high-quality research study designs and the presence of risks of bias. This review provides insufficient evidence to determine the safety of self-administration when compared with administering medication in the presence of healthcare provider supervision. Future research should investigate the effectiveness and safety of self-administered medical abortion in the absence of healthcare provider supervision through the entirety of the medical abortion protocol (e.g. during administration of mifepristone or as part of a misoprostol-only regimen) and at later gestational ages (i.e. more than nine weeks). In the absence of any supervision from medical personnel, research is needed to understand how best to inform and support women who choose to self-administer, including when to seek clinical care.
|
We included 18 studies (two randomized controlled trials and 16 prospective cohort studies) covering 11,043 women undergoing early medical abortion (up to nine weeks gestation) in 10 countries that compared self-administered medical abortion to provider-administered medical abortion, after an initial clinic visit. Most studies (16) were conducted in low-to-middle resource settings and two studies in high-resource settings. The evidence described in this review is from studies published before 10 July 2019. Women who self-administer medical abortion drugs in early pregnancy (up to nine weeks gestational age) experience similar rates of completed abortion as women who undergo provider-administered procedures in low-to-middle and high-resource settings. Evidence about safety is uncertain. The evidence for the success of self-administered medical abortion compared to provider-administered medical abortion was of moderate certainty, due to low-certainty studies. The evidence for the safety of these interventions was very low, due to low-certainty studies.
|
10.1002/14651858.CD013181.pub2
|
[
"We included 18 studies (two randomized controlled trials and 16 prospective cohort studies) covering 11,043 women undergoing early medical abortion (up to nine weeks gestation) in 10 countries that compared self-administered medical abortion to provider-administered medical abortion, after an initial clinic visit. Most studies (16) were conducted in low-to-middle resource settings and two studies in high-resource settings. The evidence described in this review is from studies published before 10 July 2019. Women who self-administer medical abortion drugs in early pregnancy (up to nine weeks gestational age) experience similar rates of completed abortion as women who undergo provider-administered procedures in low-to-middle and high-resource settings. Evidence about safety is uncertain. The evidence for the success of self-administered medical abortion compared to provider-administered medical abortion was of moderate certainty, due to low-certainty studies. The evidence for the safety of these interventions was very low, due to low-certainty studies."
] |
cochrane-simplification-train-1502
|
cochrane-simplification-train-1502
|
This update of the 2010 review includes 96 studies, 57 from the previous update and 39 new studies, totalling 4512 participants. Most of the studies, covering a wide range of interventions, had fewer than 50 participants. All of the studies assessed repigmentation, however only five reported on all of our three primary outcomes which were quality of life, > 75% repigmentation and adverse effects. Of our secondary outcomes, six studies measured cessation of spread but none assessed long-term permanence of repigmentation resulting from treatment at two years follow-up. Most of the studies assessed combination therapies which generally reported better results. New interventions include seven new surgical interventions. We analysed the data from 25 studies which assessed our primary outcomes. We used the effect measures risk ratio (RR), and odds ratio (OR) with their 95% confidence intervals (CI) and where N is the number of participants in the study. We were only able to analyse one of nine studies assessing quality of life and this showed no statistically significant improvement between the comparators. Nine analyses from eight studies reported >75% repigmentation. In the following studies the repigmentation was better in the combination therapy group: calcipotriol plus PUVA (psoralen with UVA light) versus PUVA (paired OR 4.25, 95% CI 1.43 to 12.64, one study, N = 27); hydrocortisone-17-butyrate plus excimer laser versus excimer laser alone (RR 2.57, 95% CI 1.20 to 5.50, one study, N = 84); oral minipulse of prednisolone (OMP) plus NB-UVB (narrowband UVB) versus OMP alone (RR 7.41, 95% CI 1.03 to 53.26, one study, N = 47); azathioprine with PUVA versus PUVA alone (RR 17.77, 95% CI 1.08 to 291.82, one study, N = 58) and 8-Methoxypsoralen (8-MOP ) plus sunlight versus psoralen (RR 2.50, 95% CI 1.06 to 5.91, one study, N = 168). In these three studies ginkgo biloba was better than placebo (RR 4.40, 95% CI 1.08 to 17.95, one study, N = 47); clobetasol propionate was better than PUVAsol (PUVA with sunlight) (RR 4.70, 95% CI 1.14 to 19.39, one study, N = 45); split skin grafts with PUVAsol was better than minipunch grafts with PUVAsol (RR 1.89, 95% CI 1.25 to 2.85, one study, N = 64). We performed one meta-analysis of three studies, in which we found a non-significant 60% increase in the proportion of participants achieving >75% repigmentation in favour of NB-UVB compared to PUVA (RR 1.60, 95% CI 0.74 to 3.45; I² = 0%). Studies assessing topical preparations, in particular topical corticosteroids, reported most adverse effects. However, in combination studies it was difficult to ascertain which treatment caused these effects. We performed two analyses from a pooled analysis of three studies on adverse effects. Where NB-UVB was compared to PUVA, the NB-UVB group reported less observations of nausea in three studies (RR 0.13, 95% CI 0.02 to 0.69; I² = 0% three studies, N = 156) and erythema in two studies (RR 0.73, 95% CI 0.55 to 0.98; I² = 0%, two studies, N = 106), but not itching in two studies (RR 0.57, 95% CI 0.20 to 1.60; I² = 0%, two studies, N = 106). Very few studies only assessed children or included segmental vitiligo. We found one study of psychological interventions but we could not include the outcomes in our statistical analyses. We found no studies evaluating micropigmentation, depigmentation, or cosmetic camouflage. This review has found some evidence from individual studies to support existing therapies for vitiligo, but the usefulness of the findings is limited by the different designs and outcome measurements and lack of quality of life measures. There is a need for follow-up studies to assess permanence of repigmentation as well as high-quality randomised trials using standardised measures and which also address quality of life.
|
In this update search we found 39 new randomised controlled trials which, added to the 57 studies included previously, makes a total of 96 studies with 4512 participants. Twenty-one (21/39, 54%) of the new studies assessed new treatments, most of which involved the use of light. Narrowband UVB (NB-UVB) light was used in 35/96 (36% of all included studies), either alone or in combination with other therapies and achieved the best results. There were 18 surgical studies and 31 studies compared active treatment versus placebo. Half of the studies lasted longer than six months. Most of them 69/96 (72%) had fewer than 50 participants. Only seven studies assessed children and one study only recruited men. The majority of studies (53/96, 55%), most of which were of combination treatments with light, assessed more than 75% repigmentation. Eight studies reported a statistically significant result for this outcome, including the following four results: topical corticosteroids were better than PUVAsol (psoralen with sunlight), hydrocortisone plus laser light was better than laser light alone, ginkgo biloba was better than placebo and oral minipulse of prednisolone (OMP) plus NB-UVB was better than OMP alone. None of the studies reported the long-term benefit of the treatment i.e. two years' sustained repigmentation. The maximum follow-up time, reported in only one study, was one year post-treatment. Only 9/96 (9%) reported the quality of life of participants, but the majority of all studies (65/96, 68%) reported adverse effects, mainly for topical treatments, some of which caused itching, redness, skin thinning, telangiectasia and atrophy. Neither mometasone furoate nor hydrocortisone produced adverse effects. Some NB-UVB studies reported phototoxic reaction and Koebnerisation whereas some PUVA (psoralen with artificial light UVA as a light source) studies caused dizziness and nausea. Six studies reported cessation of spread of vitiligo, one of which showed that ginkgo biloba was more than twice as likely to stop vitiligo spreading than placebo. This review has highlighted the recent surge in vitiligo research providing insights into its causes. The majority of the studies reporting successful repigmentation were combinations of various interventions with light, indicating this is an effective, though not necessarily permanent, treatment for generalised vitiligo. In view of the fact that vitiligo has no cure, providing ways of coping with it could be of benefit to patients and should be part of standard care. Better designed studies, consensus on how to measure treatment success, more studies involving children and studies assessing psychological interventions, are needed. Since the last update (2010), the design and reporting of vitiligo trials have not greatly improved. Only five studies met the criteria for a well-designed trial. Poor design, the number and complexity of the treatments and the fact that many of the studies assessed individual vitiligo patches in the same participant, made comparison of the studies difficult. Consequently, we could only perform one meta-analysis of three studies comparing NB-UVB with PUVA which showed that NB-UVB has fewer side effects and is marginally better than PUVA.
|
10.1002/14651858.CD003263.pub5
|
[
"In this update search we found 39 new randomised controlled trials which, added to the 57 studies included previously, makes a total of 96 studies with 4512 participants. Twenty-one (21/39, 54%) of the new studies assessed new treatments, most of which involved the use of light. Narrowband UVB (NB-UVB) light was used in 35/96 (36% of all included studies), either alone or in combination with other therapies and achieved the best results. There were 18 surgical studies and 31 studies compared active treatment versus placebo. Half of the studies lasted longer than six months. Most of them 69/96 (72%) had fewer than 50 participants. Only seven studies assessed children and one study only recruited men. The majority of studies (53/96, 55%), most of which were of combination treatments with light, assessed more than 75% repigmentation. Eight studies reported a statistically significant result for this outcome, including the following four results: topical corticosteroids were better than PUVAsol (psoralen with sunlight), hydrocortisone plus laser light was better than laser light alone, ginkgo biloba was better than placebo and oral minipulse of prednisolone (OMP) plus NB-UVB was better than OMP alone. None of the studies reported the long-term benefit of the treatment i.e. two years' sustained repigmentation. The maximum follow-up time, reported in only one study, was one year post-treatment. Only 9/96 (9%) reported the quality of life of participants, but the majority of all studies (65/96, 68%) reported adverse effects, mainly for topical treatments, some of which caused itching, redness, skin thinning, telangiectasia and atrophy. Neither mometasone furoate nor hydrocortisone produced adverse effects. Some NB-UVB studies reported phototoxic reaction and Koebnerisation whereas some PUVA (psoralen with artificial light UVA as a light source) studies caused dizziness and nausea. Six studies reported cessation of spread of vitiligo, one of which showed that ginkgo biloba was more than twice as likely to stop vitiligo spreading than placebo. This review has highlighted the recent surge in vitiligo research providing insights into its causes. The majority of the studies reporting successful repigmentation were combinations of various interventions with light, indicating this is an effective, though not necessarily permanent, treatment for generalised vitiligo. In view of the fact that vitiligo has no cure, providing ways of coping with it could be of benefit to patients and should be part of standard care. Better designed studies, consensus on how to measure treatment success, more studies involving children and studies assessing psychological interventions, are needed. Since the last update (2010), the design and reporting of vitiligo trials have not greatly improved. Only five studies met the criteria for a well-designed trial. Poor design, the number and complexity of the treatments and the fact that many of the studies assessed individual vitiligo patches in the same participant, made comparison of the studies difficult. Consequently, we could only perform one meta-analysis of three studies comparing NB-UVB with PUVA which showed that NB-UVB has fewer side effects and is marginally better than PUVA."
] |
cochrane-simplification-train-1503
|
cochrane-simplification-train-1503
|
We found 23 potentially relevant trials, of which nine were eligible for inclusion in this review. The nine trials included in our meta-analysis had a total of 808 women. The overall risk of bias of included studies was low, as most studies properly reported their methods. Postoperative pain: Postoperative pain was measured on a visual analogue scale (VAS), with zero meaning 'no pain at all' and 10 signifying 'pain as bad as it could be.' Postoperative pain was significantly less, as determined by subjectively assessed pain score at six hours (MD -2.40, 95% CI -2.88 to -1.92, one study, 148 women, moderate-quality evidence) and 48 hours postoperatively (MD -1.90, 95% CI -2.80 to -1.00, two studies, 80 women, I² = 0%, moderate-quality evidence) in the laparoscopic myomectomy group compared with the open myomectomy group. This means that among women undergoing laparoscopic myomectomy, mean pain score at six hours and 48 hours would be likely to range from about three points lower to one point lower on a VAS zero-to-10 scale. No significant difference in postoperative pain score was noted between the laparoscopic and open myomectomy groups at 24 hours (MD -0.29, 95% CI -0.7 to 0.12, four studies, 232 women, I² = 43%, moderate-quality evidence). The overall quality of these findings is moderate; therefore further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. In-hospital adverse events: No evidence suggested a difference in unscheduled return to theatre (OR 3.04, 95% CI 0.12 to 75.86, two studies, 188 women, I² = 0%, low-quality evidence) and laparoconversion (OR 1.11, 95% CI 0.44 to 2.83, eight studies, 756 women, I² = 53%, moderate-quality evidence) when open myomectomy was compared with laparoscopic myomectomy. Only one study including 148 women reported injury to pelvic organs (no events were described in other studies), and no significant difference was noted between laparoscopic myomectomy and laparoscopically assisted mini-laparotomy myomectomy (OR 3.04, 95% CI 0.12 to 75.86). Significantly lower risk of postoperative fever was observed in the laparoscopic myomectomy group compared with groups treated with all types of open myomectomy (OR 0.44, 95% CI 0.26 to 0.77, I² = 0%, six studies, 635 women). This indicates that among women undergoing laparoscopic myomectomy, the risk of postoperative fever is 50% lower than among those treated with open surgery. No studies reported immediate hysterectomy, uterine rupture, thromboembolism or mortality. Six studies including 549 women reported haemoglobin drop, but these studies were not pooled because of extreme heterogeneity (I² = 97%) and therefore could not be included in the analysis. Laparoscopic myomectomy is a procedure associated with less subjectively reported postoperative pain, lower postoperative fever and shorter hospital stay compared with all types of open myomectomy. No evidence suggested a difference in recurrence risk between laparoscopic and open myomectomy. More studies are needed to assess rates of uterine rupture, occurrence of thromboembolism, need for repeat myomectomy and hysterectomy at a later stage.
|
Nine studies including 808 premenopausal women with uterine fibroids compared various methods of myomectomy. These studies were conducted in Italy (seven studies), Austria and China. The evidence is current to July 2014. Myomectomy by laparoscopy is a less painful procedure compared with open surgery. Postoperative pain was measured on a visual analogue scale (VAS), with zero meaning 'no pain at all' and 10 signifying 'pain as bad as it could be.' Results show that among women undergoing laparoscopic myomectomy, the mean pain score at six hours (mean difference (MD) -2.40, 95% confidence interval (CI) -2.88 to -1.92) and at 48 hours (MD -1.90, 95% CI -2.80 to -1.00) would be likely to range from about three points lower to one point lower on a VAS zero-to-10 scale. Results of our analysis regarding pain score at 24 hours were uncertain (MD -0.29, 95% CI -0.70 to 0.12). Risk of fever after the operation was reduced by 50% in women undergoing laparoscopic myomectomy (OR 0.44, 95% CI 0.26 to 0.77). Drop in haemoglobin level (indicating reduced blood loss) could not be compared because results of the analysis were not conclusive because of differences in results with even the same surgical techniques. Risk of injury to intestines and other organs could not be determined in this meta-analysis. No evidence was found of increased risk of recurrence of fibroids after laparoscopic surgery compared with open surgery (OR 1.12, 95% CI 0.63 to 1.99). The quality of the evidence ranged from very low to moderate. Some outcomes involved small numbers of participants, poor information about blinding in included studies and very wide confidence intervals.
|
10.1002/14651858.CD004638.pub3
|
[
"Nine studies including 808 premenopausal women with uterine fibroids compared various methods of myomectomy. These studies were conducted in Italy (seven studies), Austria and China. The evidence is current to July 2014. Myomectomy by laparoscopy is a less painful procedure compared with open surgery. Postoperative pain was measured on a visual analogue scale (VAS), with zero meaning 'no pain at all' and 10 signifying 'pain as bad as it could be.' Results show that among women undergoing laparoscopic myomectomy, the mean pain score at six hours (mean difference (MD) -2.40, 95% confidence interval (CI) -2.88 to -1.92) and at 48 hours (MD -1.90, 95% CI -2.80 to -1.00) would be likely to range from about three points lower to one point lower on a VAS zero-to-10 scale. Results of our analysis regarding pain score at 24 hours were uncertain (MD -0.29, 95% CI -0.70 to 0.12). Risk of fever after the operation was reduced by 50% in women undergoing laparoscopic myomectomy (OR 0.44, 95% CI 0.26 to 0.77). Drop in haemoglobin level (indicating reduced blood loss) could not be compared because results of the analysis were not conclusive because of differences in results with even the same surgical techniques. Risk of injury to intestines and other organs could not be determined in this meta-analysis. No evidence was found of increased risk of recurrence of fibroids after laparoscopic surgery compared with open surgery (OR 1.12, 95% CI 0.63 to 1.99). The quality of the evidence ranged from very low to moderate. Some outcomes involved small numbers of participants, poor information about blinding in included studies and very wide confidence intervals."
] |
cochrane-simplification-train-1504
|
cochrane-simplification-train-1504
|
We included five studies enrolling adults with frequent episodic TTH; 1812 participants took medication, of which 767 were included in comparisons of aspirin 1000 mg with placebo, and 405 in comparisons of aspirin 500 mg or 650 mg with placebo. Not all of these participants provided data for outcomes of interest in this review. Four studies specified using IHS diagnostic criteria; one predated commonly recognised criteria, but described comparable characteristics and excluded migraine. All participants treated headaches of at least moderate pain intensity. None of the included studies were at low risk of bias across all domains considered, although for most studies and domains this was likely to be due to inadequate reporting rather than poor methods. We judged one study to be at high risk of bias due to small size. There were no data for aspirin at any dose for the IHS preferred outcome of being pain free at two hours, or for being pain free at any other time, and only one study provided data equivalent to having no or mild pain at two hours (very low quality evidence). Use of rescue medication was lower with aspirin 1000 mg than with placebo (2 studies, 397 participants); 14% of participants used rescue medication with aspirin 1000 mg compared with 31% with placebo (NNTp 6.0, 95% confidence interval (CI) 4.1 to 12) (low quality evidence). Two studies (397 participants) reported a Patient Global Evaluation at the end of the study; we combined the top two categories for both studies to determine the number of participants who were 'satisfied' with treatment. Aspirin 1000 mg produced more satisfied participants (55%) than did placebo (37%) (NNT 5.7, 95% CI 3.7 to 12) (very low quality evidence). Adverse events were not different between aspirin 1000 mg and placebo (RR 1.1, 95% CI 0.8 to 1.5), or aspirin 500 mg or 650 mg and placebo (RR 1.3, 95% CI 0.8 to 2.0) (low quality evidence). Studies reported no serious adverse events. The quality of the evidence using GRADE comparing aspirin doses between 500 mg and 1000 mg with placebo was low or very low. Evidence was downgraded because of the small number of studies and events, and because the most important measures of efficacy were not reported. There were insufficient data to compare aspirin with any active comparator (paracetamol alone, paracetamol plus codeine, peppermint oil, or metamizole) at any of the doses tested. A single dose of aspirin between 500 mg and 1000 mg provided some benefit in terms of less frequent use of rescue medication and more participants satisfied with treatment compared with placebo in adults with frequent episodic TTH who have an acute headache of moderate or severe intensity. There was no difference between a single dose of aspirin and placebo for the number of people experiencing adverse events. The amount and quality of the evidence was very limited and should be interpreted with caution.
|
In September 2016, we searched the medical literature and found five studies involving 1812 participants looking at aspirin for frequent episodic tension-type headache. About 1668 participants were involved in comparisons between aspirin at doses between 500 mg and 1000 mg and placebo (a dummy tablet). The International Headache Society recommends the outcome of being pain free two hours after taking a medicine, but other outcomes are also suggested. No studies reported pain free at two hours, or other recognised outcomes, so there was limited information to analyse for outcomes about how well aspirin works. None of the studies reported on participants being pain free at two hours, and only one study reported an outcome we judged equivalent to being pain free or having only mild pain at two hours. For aspirin 1000 mg, about 10 participants in 100 used additional painkillers, compared with 30 in 100 with placebo (very low quality evidence). At the end of the study 55 in 100 participants were 'satisfied' with treatment compared with 37 in 100 with placebo (very low quality evidence). About 15 in 100 people taking aspirin 1000 mg reported having a side effect after one dose, which was the same as with placebo (low quality evidence). The quality of the evidence was low or very low for the comparisons between aspirin and placebo. Low and very low quality evidence means that we are very uncertain about the results.
|
10.1002/14651858.CD011888.pub2
|
[
"In September 2016, we searched the medical literature and found five studies involving 1812 participants looking at aspirin for frequent episodic tension-type headache. About 1668 participants were involved in comparisons between aspirin at doses between 500 mg and 1000 mg and placebo (a dummy tablet). The International Headache Society recommends the outcome of being pain free two hours after taking a medicine, but other outcomes are also suggested. No studies reported pain free at two hours, or other recognised outcomes, so there was limited information to analyse for outcomes about how well aspirin works. None of the studies reported on participants being pain free at two hours, and only one study reported an outcome we judged equivalent to being pain free or having only mild pain at two hours. For aspirin 1000 mg, about 10 participants in 100 used additional painkillers, compared with 30 in 100 with placebo (very low quality evidence). At the end of the study 55 in 100 participants were 'satisfied' with treatment compared with 37 in 100 with placebo (very low quality evidence). About 15 in 100 people taking aspirin 1000 mg reported having a side effect after one dose, which was the same as with placebo (low quality evidence). The quality of the evidence was low or very low for the comparisons between aspirin and placebo. Low and very low quality evidence means that we are very uncertain about the results."
] |
cochrane-simplification-train-1505
|
cochrane-simplification-train-1505
|
We included a total of five randomised studies (involving 805 women) evaluating different methods of analgesia for amniocentesis; there were no studies in women undergoing CVS. One RCT (N = 203) and one quasi-randomised study (N = 220) compared infiltrative local anaesthesia with no anaesthesia and found no statistical difference in experienced pain on the visual analogue scale (VAS) (mean differences (MD) -2.50 and 1.20; 95% confidence interval (CI) -6.98 to 1.98 and -2.67 to 5.07). One study (N = 200) compared light leg rubbing versus no intervention during amniocentesis and found no change in experienced anxiety (MD 0.2; 95% CI -0.63 to 1.03) or VAS pain score (MD 0.3; 95% CI -0.35 to 0.95) during amniocentesis. Another study with 62 patients did not find any benefit of using subfreezing temperature needle during amniocentesis in terms of decreased VAS pain score (MD -0.8; 95% CI -1.8 to 0.2). In addition, there was no difference between anticipated and actual pain (MD 0.4; 95% CI -0.82 to 1.62) (before/after comparison). There was also no difference in VAS pain scores in the study with 120 participants comparing lidocaine-prilocaine analgesic cream to placebo cream before amniocentesis (MD -0.6; 95% CI -1.44 to 0.24). In general, women who undergo amniocentesis could be informed that pain during procedure is minor and that there is currently insufficient evidence to support the use of local anaesthetics, leg rubbing or subfreezing the needle for pain reduction during procedure.
|
We identified five studies (involving a total of 805 women) that evaluated effectiveness of analgesia for pain during amniocentesis. Types of analgesia included local anaesthetics (either injected (two studies, 423 women) or applied topically (one study, 120 women)); use of a subfreezing (-14°C) needle (one study, 62 women); and leg rubbing (one study, 200 women). We found no studies evaluating analgesia during chorionic villus sampling. Each comparison failed to demonstrate positive affect on pain during amniocentesis. In general, women who undergo amniocentesis could be informed that pain during procedure is minor and that there is currently insufficient evidence to support the use of local anaesthetics, leg rubbing or subfreezing the needle for pain reduction during this procedure.
|
10.1002/14651858.CD008580.pub2
|
[
"We identified five studies (involving a total of 805 women) that evaluated effectiveness of analgesia for pain during amniocentesis. Types of analgesia included local anaesthetics (either injected (two studies, 423 women) or applied topically (one study, 120 women)); use of a subfreezing (-14°C) needle (one study, 62 women); and leg rubbing (one study, 200 women). We found no studies evaluating analgesia during chorionic villus sampling. Each comparison failed to demonstrate positive affect on pain during amniocentesis. In general, women who undergo amniocentesis could be informed that pain during procedure is minor and that there is currently insufficient evidence to support the use of local anaesthetics, leg rubbing or subfreezing the needle for pain reduction during this procedure."
] |
cochrane-simplification-train-1506
|
cochrane-simplification-train-1506
|
A total of 115 randomised controlled trials (26,134 participants) were included. In 54 studies paroxetine was compared with older ADs, in 21 studies with another SSRI, and in 40 studies with a newer or non-conventional antidepressant other than SSRIs. For the primary outcome (patients who responded to treatment), paroxetine was more effective than reboxetine at increasing patients who responded early to treatment (Odds Ratio (OR): 0.66, 95% Confidence Interval (CI) 0.50 to 0.87, number needed to treat to provide benefit (NNTb) = 16, 95% CI 10 to 50, at one to four weeks, 3 RCTs, 1375 participants, moderate quality of evidence), and less effective than mirtazapine (OR: 2.39, 95% CI 1.42 to 4.02, NNTb = 8, 95% CI 5 to 14, at one to four weeks, 3 RCTs, 726 participants, moderate quality of evidence). Paroxetine was less effective than citalopram in improving response to treatment (OR: 1.54, 95% CI 1.04 to 2.28, NNTb = 9, 95% CI 5 to 102, at six to 12 weeks, 1 RCT, 406 participants, moderate quality of evidence). We found no clear evidence that paroxetine was more or less effective compared with other antidepressants at increasing response to treatment at acute (six to 12 weeks), early (one to four weeks), or longer term follow-up (four to six months). Paroxetine was associated with a lower rate of adverse events than amitriptyline, imipramine and older ADs as a class, but was less well tolerated than agomelatine and hypericum. Included studies were generally at unclear or high risk of bias due to poor reporting of allocation concealment and blinding of outcome assessment, and incomplete reporting of outcomes. Some possibly clinically meaningful differences between paroxetine and other ADs exist, but no definitive conclusions can be drawn from these findings. In terms of response, there was a moderate quality of evidence that citalopram was better than paroxetine in the acute phase (six to 12 weeks), although only one study contributed data. In terms of early response to treatment (one to four weeks) there was moderate quality of evidence that mirtazapine was better than paroxetine and that paroxetine was better than reboxetine. However there was no clear evidence that paroxetine was better or worse compared with other antidepressants at increasing response to treatment at any time point. Even if some differences were identified, the findings from this review are better thought as hypothesis forming rather than hypothesis testing and it would be reassuring to see the conclusions replicated in future trials. Finally, most of included studies were at unclear or high risk of bias, and were sponsored by the drug industry. The potential for overestimation of treatment effect due to sponsorship bias should be borne in mind.
|
This review of the research on the effect of an antidepressant drug called paroxetine was conducted to shed light on the field of drug treatment for depression. In September 2012 we searched, in a wide ranging way, for all the useful studies (randomised controlled trials) which had been completed which compared paroxetine with any other antidepressant in treating people with depression. One hundred and fifteen studies were included in this review, with a total of 26,134 people. We grouped the studies according to the types of drug they compared paroxetine against; we then analysed the combined findings of these groups of studies. For the primary outcome (number of people who responded to treatment) paroxetine was more effective than reboxetine, but less effective than mirtazapine (in the early phase: one to four weeks follow-up) and probably citalopram (at endpoint: six weeks follow-up). There was some evidence that paroxetine is less well tolerated than agomelatine and St John's Wort, as more patients allocated to paroxetine experienced at least some side effects (though this finding for St John's Wort was only based on one study). In conclusion, some possibly meaningful differences between paroxetine and other antidepressants exist, but no definitive concluions can be drawn due to the limited number of studies per comparison. In addition, most of included studies were sponsored by the drug industry, which means they might potentially have overestimated the effect of paroxetine. Therefore, the results of this review should be interpreted with caution.
|
10.1002/14651858.CD006531.pub2
|
[
"This review of the research on the effect of an antidepressant drug called paroxetine was conducted to shed light on the field of drug treatment for depression. In September 2012 we searched, in a wide ranging way, for all the useful studies (randomised controlled trials) which had been completed which compared paroxetine with any other antidepressant in treating people with depression. One hundred and fifteen studies were included in this review, with a total of 26,134 people. We grouped the studies according to the types of drug they compared paroxetine against; we then analysed the combined findings of these groups of studies. For the primary outcome (number of people who responded to treatment) paroxetine was more effective than reboxetine, but less effective than mirtazapine (in the early phase: one to four weeks follow-up) and probably citalopram (at endpoint: six weeks follow-up). There was some evidence that paroxetine is less well tolerated than agomelatine and St John's Wort, as more patients allocated to paroxetine experienced at least some side effects (though this finding for St John's Wort was only based on one study). In conclusion, some possibly meaningful differences between paroxetine and other antidepressants exist, but no definitive concluions can be drawn due to the limited number of studies per comparison. In addition, most of included studies were sponsored by the drug industry, which means they might potentially have overestimated the effect of paroxetine. Therefore, the results of this review should be interpreted with caution."
] |
cochrane-simplification-train-1507
|
cochrane-simplification-train-1507
|
We included six RCTs that fulfilled the above criteria, with a total of 119 participants. The beta blockers studied were atenolol, propranolol, pindolol and metoprolol. All trials were of poor quality with the drugs administered over a short time (10 days to two months). None of the primary outcomes were reported by more than one study. Similarly, secondary outcome measures, with the exception of vascular resistance (as reported by three studies), were reported, each by only one study. Pooling of such results was deemed inappropriate. None of the trials showed a statistically significant worsening effect of beta blockers on time to claudication, claudication distance and maximal walking distance as measured on a treadmill, nor on calf blood flow, calf vascular resistance and skin temperature, when compared with placebo. No reports described adverse events associated with the beta blockers studied. Currently, no evidence suggests that beta blockers adversely affect walking distance, calf blood flow, calf vascular resistance and skin temperature in people with intermittent claudication. However, because of the lack of large published trials, beta blockers should be used with caution, if clinically indicated.
|
Currently, no evidence from randomised controlled trials suggests that beta blockers adversely affect walking distance in people with intermittent claudication, and beta blockers should be used with caution, if clinically indicated. The review authors identified six randomised controlled trials that involved a total of only 119 people with mild to moderate peripheral arterial disease. The beta blockers studied were propranolol, pindolol, atenolol and metoprolol. None of the trials showed clear worsening effects of beta blockers on time to claudication, claudication distance and maximal walking distance as measured on a treadmill, nor on calf blood flow, calf vascular resistance and skin temperature, when compared with placebo. Trial investigators reported no adverse events or issues regarding taking the beta blockers studied. Most of the trials were over 20 years old and reported findings between 1980 and 1991. All were small and of poor quality. The drugs were administered over a short time (10 days to two months), and most of the outcome measures were reported in single studies. Additional drugs－calcium channel blockers and combined alpha and beta blockers－were given during some of the trials.
|
10.1002/14651858.CD005508.pub3
|
[
"Currently, no evidence from randomised controlled trials suggests that beta blockers adversely affect walking distance in people with intermittent claudication, and beta blockers should be used with caution, if clinically indicated. The review authors identified six randomised controlled trials that involved a total of only 119 people with mild to moderate peripheral arterial disease. The beta blockers studied were propranolol, pindolol, atenolol and metoprolol. None of the trials showed clear worsening effects of beta blockers on time to claudication, claudication distance and maximal walking distance as measured on a treadmill, nor on calf blood flow, calf vascular resistance and skin temperature, when compared with placebo. Trial investigators reported no adverse events or issues regarding taking the beta blockers studied. Most of the trials were over 20 years old and reported findings between 1980 and 1991. All were small and of poor quality. The drugs were administered over a short time (10 days to two months), and most of the outcome measures were reported in single studies. Additional drugs－calcium channel blockers and combined alpha and beta blockers－were given during some of the trials."
] |
cochrane-simplification-train-1508
|
cochrane-simplification-train-1508
|
Altogether 223 patients with DTC participated in four trials. Overall, studies had a high risk of bias. We found no statistically significant differences between rhTSH and THW treatment in terms of successful ablation rate but significant benefits in radiation exposure to blood and bone marrow. One trial reported on benefits in some domains of health-related quality of life. There were no deaths and no serious adverse effects in DTC patients treated with either rhTSH or THW. Maximum follow up was 12 months. None of the included trials investigated complete or partial remission of metastatic tumour, secondary malignancies or economic outcomes. We did not find sufficient data comparing rhTSH with THW-aided radioiodine treatment for metastatic DTC. Results from four randomised controlled clinical trials suggest that rhTSH is as effective as THW on iodine-131 thyroid remnant ablation, with limited data on significant benefits in decreased whole body radiation exposure and health-related quality of life. It is still uncertain whether lower iodine-131 doses (1110 MBq or 1850 MBq versus 3700 MBq) are equally effective for remnant ablation under rhTSH stimulation. Randomised controlled clinical trials are needed to guide treatment selection for metastatic differentiated thyroid cancer.
|
Overall 223 patients with differentiated thyroid cancer participated in four studies. The duration of the intervention (injections of recombinant human thyrotropin) was two days in all trials. Studies were of rather low quality. We found no statistically significant differences between recombinant human thyrotropin and thyroid hormone withdrawal treatment in terms of successful reduction of thyroid remnants or cancer cells but significant benefits in radiation exposure to blood and bone marrow. One trial reported on benefits in some domains of health-related quality of life. There were no deaths and no serious adverse effects observed, however maximum follow up was only 12 months. None of the included trials investigated complete or partial remission of metastatic tumour, secondary malignancies or economic outcomes. We did not find sufficient data comparing recombinant human thyrotropin with thyroid hormone withdrawal-aided radioiodine treatment for metastatic differentiated cancer.
|
10.1002/14651858.CD008302.pub2
|
[
"Overall 223 patients with differentiated thyroid cancer participated in four studies. The duration of the intervention (injections of recombinant human thyrotropin) was two days in all trials. Studies were of rather low quality. We found no statistically significant differences between recombinant human thyrotropin and thyroid hormone withdrawal treatment in terms of successful reduction of thyroid remnants or cancer cells but significant benefits in radiation exposure to blood and bone marrow. One trial reported on benefits in some domains of health-related quality of life. There were no deaths and no serious adverse effects observed, however maximum follow up was only 12 months. None of the included trials investigated complete or partial remission of metastatic tumour, secondary malignancies or economic outcomes. We did not find sufficient data comparing recombinant human thyrotropin with thyroid hormone withdrawal-aided radioiodine treatment for metastatic differentiated cancer."
] |
cochrane-simplification-train-1509
|
cochrane-simplification-train-1509
|
Fifteen studies on 425 participants were included in the review, one of which was in abstract form only. Twelve studies were included in the meta-analysis across one or more of the three comparisons. The sample size of the included studies was small (12 to 43 participants) and overall study quality was moderate to low given the imprecision and risk of bias issues (i.e. missing information on sequence generation and allocation concealment as well as no blinding of outcome assessment and incomplete data). When upper limb training was compared to either no training or sham training, there was a small significant improvement in symptoms of dyspnoea with a mean difference (MD) of 0.37 points (95% confidence interval (CI) 0.02 to 0.72 points; data from four studies on 129 people). However, there was no significant improvement in dyspnoea when the studies of endurance training only (MD 0.41 points, 95% CI −0.13 to 0.95 points; data from two studies on 55 people) or resistance training only (MD 0.34 points, 95% CI −0.11 to 0.80 points; data from two studies on 74 people) were analysed. When upper limb training combined with lower limb training was compared to lower limb training alone, no significant difference in dyspnoea was shown (MD 0.36 points, 95% CI −0.04 to 0.76 points; data from three studies on 86 people). There were no studies which examined the effects on dyspnoea of upper limb training compared to another upper limb training intervention. There was no significant improvement in HRQoL when upper limb training was compared to either no training or sham training with a standardised mean difference (SMD) of 0.05 (95% CI −0.31 to 0.40; four studies on 126 people) or when upper limb training combined with lower limb training was compared to lower limb training alone (SMD 0.01, 95% CI −0.40 to 0.43; three studies on 95 people). Only one study, in which endurance upper limb training was compared to resistance upper limb training, reported on HRQoL and showed no between-group differences (St George's Respiratory Questionnaire MD 2.0 points, 95% CI −9 to 12; one study on 20 people). Positive findings were shown for the effects of upper limb training on the secondary outcome of unsupported endurance upper limb exercise capacity. When upper limb training was compared to either no training or sham training, there was a large significant improvement in unsupported endurance upper limb capacity (SMD 0.66, 95% CI 0.19 to 1.13; six studies on 142 people) which remained significant when the studies in this analysis of endurance training only were examined (SMD 0.99, 95% CI 0.32 to 1.66; four studies on 85 people) but not when the studies of resistance training only were examined (SMD 0.23, 95% CI −0.31 to 0.76; three studies on 57 people, P = 0.08 for test of subgroup differences). When upper limb training combined with lower limb training was compared to lower limb training alone, there was also a large significant improvement in unsupported endurance upper limb capacity (SMD 0.90, 95% CI 0.12 to 1.68; three studies on 87 people). A single study compared endurance upper limb training to resistance upper limb training with a significant improvement in the number of lifts performed in one minute favouring endurance upper limb training (MD 6.0 lifts, 95% CI 0.29 to 11.71 lifts; one study on 17 people). Available data were insufficient to examine the impact of disease severity on any outcome. Evidence from this review indicates that some form of upper limb exercise training when compared to no upper limb training or a sham intervention improves dyspnoea but not HRQoL in people with COPD. The limited number of studies comparing different upper limb training interventions precludes conclusions being made about the optimal upper limb training programme for people with COPD, although endurance upper limb training using unsupported upper limb exercises does have a large effect on unsupported endurance upper limb capacity. Future RCTs require larger participant numbers to compare the differences between endurance upper limb training, resistance upper limb training, and combining endurance and resistance upper limb training on patient-relevant outcomes such as dyspnoea, HRQoL and arm activity levels.
|
fifteen studies were included on 425 participants with COPD. However, only 12 studies provided sufficient information for analysis across one or more of the three comparisons described above. when arm training was compared to no arm training or a sham intervention in people with COPD, there was a small improvement in breathlessness. However, this improvement was not evident when the studies of combined arm and leg training were compared to leg training alone. No studies have examined whether breathlessness improves more with different types of arm training. Arm training had no effect on quality of life in any of the three comparisons. When endurance arm training was specifically examined, there was an improvement seen in the capacity of the arms to move and lift light weights compared to no training. These effects were not seen with arm strength training. the quality of the included studies was low to moderate due to the small number of participants (ranging from 12 to 43 participants per study), missing information on the methods of the study, and incomplete data on the outcomes. some form of arm training can provide a small improvement to breathlessness but does not improve the quality of life of people with COPD. More specifically, endurance arm training can increase the capacity of the arms to move light weights in people with COPD.
|
10.1002/14651858.CD011434.pub2
|
[
"fifteen studies were included on 425 participants with COPD. However, only 12 studies provided sufficient information for analysis across one or more of the three comparisons described above. when arm training was compared to no arm training or a sham intervention in people with COPD, there was a small improvement in breathlessness. However, this improvement was not evident when the studies of combined arm and leg training were compared to leg training alone. No studies have examined whether breathlessness improves more with different types of arm training. Arm training had no effect on quality of life in any of the three comparisons. When endurance arm training was specifically examined, there was an improvement seen in the capacity of the arms to move and lift light weights compared to no training. These effects were not seen with arm strength training. the quality of the included studies was low to moderate due to the small number of participants (ranging from 12 to 43 participants per study), missing information on the methods of the study, and incomplete data on the outcomes. some form of arm training can provide a small improvement to breathlessness but does not improve the quality of life of people with COPD. More specifically, endurance arm training can increase the capacity of the arms to move light weights in people with COPD."
] |
cochrane-simplification-train-1510
|
cochrane-simplification-train-1510
|
In total, we included 31 studies (with 3231 participants) in our review. Of those 31 studies, 28 (2976 participants) provided data for the meta-analyses. For the 28 studies, 24 were used for the comparison of neuraxial block versus general anaesthesia. Based on 11 studies that included 2152 participants, we did not find a difference between the two anaesthetic techniques for mortality at one month: risk ratio (RR) 0.78, 95% confidence interval (CI) 0.57 to 1.06; I2 = 24% (fixed-effect model). Based on six studies that included 761 participants, we did not find a difference in the risk of pneumonia: RR 0.77, 95% CI 0.45 to 1.31; I2 = 0%. Based on four studies that included 559 participants, we did not find a difference in the risk of myocardial infarction: RR 0.89, 95% CI 0.22 to 3.65; I2 = 0%. Based on six studies that included 729 participants, we did not find a difference in the risk of cerebrovascular accident: RR 1.48, 95% CI 0.46 to 4.83; I2 = 0%. Based on six studies that included 624 participants, we did not find a difference in the risk of acute confusional state: RR 0.85, 95% CI 0.51 to 1.40; I2 = 49%. Based on laboratory tests, the risk of deep vein thrombosis was decreased when no specific precautions or just early mobilization was used: RR 0.57, 95% CI 0.41 to 0.78; I2 = 0%; (number needed to treat for an additional beneficial outcome (NNTB) = 3, 95% CI 2 to 7, based on a basal risk of 76%) but not when low molecular weight heparin was administered: RR 0.98, 95% CI 0.52 to 1.84; I2 for heterogeneity between the two subgroups = 58%. For neuraxial blocks compared to general anaesthesia, we rated the quality of evidence as very low for mortality (at 0 to 30 days), pneumonia, myocardial infarction, cerebrovascular accident, acute confusional state, decreased rate of deep venous thrombosis in the absence of potent thromboprophylaxis, and return of patient to their own home. The number of studies comparing other anaesthetic techniques was limited. We did not find a difference between the two techniques, except for deep venous thrombosis in the absence of potent thromboprophylaxis. The studies included a wide variety of clinical practices. The number of participants included in the review is insufficient to eliminate a difference between the two techniques in the majority of outcomes studied. Therefore, large randomized trials reflecting actual clinical practice are required before drawing final conclusions.
|
The evidence is current to March 2014. In total, we included 31 studies (with 3231 participants) in our review. Of those 31 studies, 28 (2976 participants) provided data for the meta-analyses. The mean age of the participants varied from 75 to 86 years. Those studies were published between 1977 and 2013 and so covering a wide range of clinical practices and improvements in techniques over time. Two studies were funded by the anaesthetic drug manufacturer or by an agency with a commercial interest, one received charitable funding, and one was funded by a government agency. We reran the search in February 2017. Potential new studies of interest were added to a list of "Studies awaiting Classification" and will be incorporated into the formal review findings during the review update. The trial reports of many of the studies indicated a sub-suboptimal level of methodological rigour and the number of participants included was often insufficient to allow us to draw a definitive conclusion on many of the outcomes studied. We did not find any difference in mortality at one month (11 trials with 2152 participants) between neuraxial blocks and general anaesthesia. We also did not find a difference for pneumonia, myocardial infarction, cerebrovascular accident, acute confusional state, congestive heart failure, acute kidney injury, pulmonary embolism, number of patients transfused with red blood cells, length of surgery and length of hospital stay between these two anaesthetic techniques in two to twelve studies. Likewise, when potent prophylactic drugs (such as low molecular weight heparin) were used against postoperative clot formation, we did not find a difference in the risk of deep venous thrombosis. Without prophylaxis with potent anticoagulant drugs the risk of deep venous thrombosis was less with neuraxial block. The level of evidence was very low for mortality, pneumonia, myocardial infarction, cerebrovascular accident, acute confusional state, decrease in the incidence of deep venous thrombosis in the absence of potent prophylaxis, and return of patient to their own home. This means that any estimate of effect is very uncertain.
|
10.1002/14651858.CD000521.pub3
|
[
"The evidence is current to March 2014. In total, we included 31 studies (with 3231 participants) in our review. Of those 31 studies, 28 (2976 participants) provided data for the meta-analyses. The mean age of the participants varied from 75 to 86 years. Those studies were published between 1977 and 2013 and so covering a wide range of clinical practices and improvements in techniques over time. Two studies were funded by the anaesthetic drug manufacturer or by an agency with a commercial interest, one received charitable funding, and one was funded by a government agency. We reran the search in February 2017. Potential new studies of interest were added to a list of \"Studies awaiting Classification\" and will be incorporated into the formal review findings during the review update. The trial reports of many of the studies indicated a sub-suboptimal level of methodological rigour and the number of participants included was often insufficient to allow us to draw a definitive conclusion on many of the outcomes studied. We did not find any difference in mortality at one month (11 trials with 2152 participants) between neuraxial blocks and general anaesthesia. We also did not find a difference for pneumonia, myocardial infarction, cerebrovascular accident, acute confusional state, congestive heart failure, acute kidney injury, pulmonary embolism, number of patients transfused with red blood cells, length of surgery and length of hospital stay between these two anaesthetic techniques in two to twelve studies. Likewise, when potent prophylactic drugs (such as low molecular weight heparin) were used against postoperative clot formation, we did not find a difference in the risk of deep venous thrombosis. Without prophylaxis with potent anticoagulant drugs the risk of deep venous thrombosis was less with neuraxial block. The level of evidence was very low for mortality, pneumonia, myocardial infarction, cerebrovascular accident, acute confusional state, decrease in the incidence of deep venous thrombosis in the absence of potent prophylaxis, and return of patient to their own home. This means that any estimate of effect is very uncertain."
] |
cochrane-simplification-train-1511
|
cochrane-simplification-train-1511
|
We included six randomised controlled trials with moderate or high risk of bias, involving 2123 participants. There is moderate quality evidence that involving consumers in the development of patient information material results in material that is more relevant, readable and understandable to patients, without affecting their anxiety. This 'consumer-informed' material can also improve patients' knowledge. There is low quality evidence that using consumer interviewers instead of staff interviewers in satisfaction surveys can have a small influence on the survey results. There is low quality evidence that an informed consent document developed with consumer input (potential trial participants) may have little if any impact on understanding compared to a consent document developed by trial investigators only. There is very low quality evidence that telephone discussions and face-to-face group meetings engage consumers better than mailed surveys in order to set priorities for community health goals. They also result in different priorities being set for these goals. There is little evidence from randomised controlled trials of the effects of consumer involvement in healthcare decisions at the population level. The trials included in this review demonstrate that randomised controlled trials are feasible for providing evidence about the effects of involving consumers in these decisions.
|
This review shows that little research has been done to find the best ways of involving consumers in healthcare decisions at the population level. Most of the included trials compared consultations with consumers with no consultations with consumers. There is moderate quality evidence from two trials that involving consumers in the development of patient information material results in material that is more relevant, readable and understandable, without affecting anxiety. This 'consumer-informed' material can also improve knowledge. Two trials, which compared using consumer interviewers with staff interviewers as data collectors for patient satisfaction surveys, found small differences in satisfaction survey results, with less favourable results obtained when consumers were the interviewers. One trial comparing two informed consent documents, one developed with consumer input and the other developed by the trial investigators, showed that consumer input may have little if any impact on understanding of the trial described in the consent document. One trial, comparing two different methods for involving the public (telephone discussion and a face-to-face group meeting), showed that a face-to-face meeting is most likely to engage consumers and may result in different community health priorities.
|
10.1002/14651858.CD004563.pub2
|
[
"This review shows that little research has been done to find the best ways of involving consumers in healthcare decisions at the population level. Most of the included trials compared consultations with consumers with no consultations with consumers. There is moderate quality evidence from two trials that involving consumers in the development of patient information material results in material that is more relevant, readable and understandable, without affecting anxiety. This 'consumer-informed' material can also improve knowledge. Two trials, which compared using consumer interviewers with staff interviewers as data collectors for patient satisfaction surveys, found small differences in satisfaction survey results, with less favourable results obtained when consumers were the interviewers. One trial comparing two informed consent documents, one developed with consumer input and the other developed by the trial investigators, showed that consumer input may have little if any impact on understanding of the trial described in the consent document. One trial, comparing two different methods for involving the public (telephone discussion and a face-to-face group meeting), showed that a face-to-face meeting is most likely to engage consumers and may result in different community health priorities."
] |
cochrane-simplification-train-1512
|
cochrane-simplification-train-1512
|
We included 20 RCTs, including one unpublished study with 1343 participants. Two studies were awaiting classification as the full text for these studies was not available. One study evaluated pre-emptive opioids, and 19 studies evaluated preventive opioids. We considered only one study to be at low risk of bias for most domains. The surgeries and opioids used varied, although roughly half of the included studies were conducted in abdominal hysterectomy, and around a quarter used morphine as the intervention. All studies were conducted in secondary care. Pre-emptive opioids compared to postincision opioids For pre-emptive opioids in dental surgery, there may be a reduction in early acute postoperative pain (mean difference (MD) -1.20, 95% confidence interval (CI) -1.75 to -0.65; 40 participants; 1 study; low-quality evidence). This study did not report on adverse events (respiratory depression, bradycardia, or hypotension). There may be a reduction in late acute postoperative pain (MD -2.10, 95% CI -2.57 to -1.63; 40 participants; 1 study; low-quality evidence). This study did not report 24-hour morphine consumption. Preventive opioids compared to postincision opioids For preventive opioids, there was probably no reduction in early acute postoperative pain (MD 0.11, 95% CI -0.32 to 0.53; 706 participants; 10 studies; I2 = 61%; moderate-quality evidence). There were no events of respiratory depression in four studies (433 participants). There was no important reduction in late acute postoperative pain (MD -0.06, 95% CI -0.13 to 0.01; 668 participants; 9 studies; I2 = 0%; moderate-quality evidence). There may be a small reduction in 24-hour morphine consumption (MD -4.91 mg, 95% CI -9.39 mg to -0.44 mg; 526 participants; 11 studies; I2 = 82%; very low-quality evidence). There may be similar rates of bradycardia (risk ratio (RR) 0.33, 95% CI 0.01 to 7.88; 112 participants; 2 studies; I2 = 0%; low-quality evidence) and hypotension (RR 1.08, 95% CI 0.25 to 4.73; 88 participants; 2 studies; I2 = 0%; low-quality evidence). Due to the low quality of the evidence, we are uncertain whether pre-emptive opioids reduce postoperative pain. Based on the trials conducted thus far, there was no clear evidence that preventive opioids result in reductions in pain scores. It was unclear if there was a reduction in morphine consumption due to very low-quality of evidence. Too few studies reported adverse events to be able to draw any definitive conclusions. Once assessed, the two studies awaiting classification may alter the conclusions of the review.
|
We searched the medical literature for randomized controlled trials (a type of study in which participants are assigned to a treatment group using a random method) in March 2018. Participants were randomly allocated to one of two groups. One group was treated with opioids before the surgeon cut the skin, whilst the other group was given the same medication after the surgeon cut the skin. We identified 20 trials involving a total of 1343 participants aged over 15 years who were undergoing a variety of surgeries. In all but one trial, participants received general anaesthetic. Nearly all participants were low-risk patients. Only one of the trials used a pre-emptive dose of opioid. Key results In one small trial (40 participants) involving people undergoing dental surgery, use of pre-emptive opioids resulted in a small reduction in pain experienced in the first six hours after surgery and at 24 to 48 hours based on low-quality evidence. This study did not report on adverse events or 24-hour morphine consumption. For preventive opioids started before the first cut was made and continued over the first day after surgery, pain in the first six hours after surgery was similar to when the first opioid dose was given after the first cut to the skin (10 studies; 706 participants). Postoperative pain 24 to 48 hours after surgery was similar between groups (9 studies; 668 participants). The evidence for both these findings was of moderate quality. The following findings were supported by low- or very low-quality evidence. A reduction in 24-hour morphine consumption was too small to be clinically relevant (11 studies; 526 participants). Not all studies reported on adverse events, but the numbers of participants with respiratory depression (4 studies; 433 participants), low heart rate (2 studies; 112 participants), or low blood pressure (2 studies; 88 participants) were similar between groups. Quality of the evidence The quality of the evidence ranged from very low to moderate. The main issues concerning the included trials were high risk of bias due to limitations in how the findings were presented, the design and conduct of the studies, and wide variations in the findings, which led to uncertainty in the results. Consequently, we found no convincing evidence that starting opioids before the beginning of surgery reduces levels of pain after surgery or the need for continuing opioids.
|
10.1002/14651858.CD012624.pub2
|
[
"We searched the medical literature for randomized controlled trials (a type of study in which participants are assigned to a treatment group using a random method) in March 2018. Participants were randomly allocated to one of two groups. One group was treated with opioids before the surgeon cut the skin, whilst the other group was given the same medication after the surgeon cut the skin. We identified 20 trials involving a total of 1343 participants aged over 15 years who were undergoing a variety of surgeries. In all but one trial, participants received general anaesthetic. Nearly all participants were low-risk patients. Only one of the trials used a pre-emptive dose of opioid. Key results In one small trial (40 participants) involving people undergoing dental surgery, use of pre-emptive opioids resulted in a small reduction in pain experienced in the first six hours after surgery and at 24 to 48 hours based on low-quality evidence. This study did not report on adverse events or 24-hour morphine consumption. For preventive opioids started before the first cut was made and continued over the first day after surgery, pain in the first six hours after surgery was similar to when the first opioid dose was given after the first cut to the skin (10 studies; 706 participants). Postoperative pain 24 to 48 hours after surgery was similar between groups (9 studies; 668 participants). The evidence for both these findings was of moderate quality. The following findings were supported by low- or very low-quality evidence. A reduction in 24-hour morphine consumption was too small to be clinically relevant (11 studies; 526 participants). Not all studies reported on adverse events, but the numbers of participants with respiratory depression (4 studies; 433 participants), low heart rate (2 studies; 112 participants), or low blood pressure (2 studies; 88 participants) were similar between groups. Quality of the evidence The quality of the evidence ranged from very low to moderate. The main issues concerning the included trials were high risk of bias due to limitations in how the findings were presented, the design and conduct of the studies, and wide variations in the findings, which led to uncertainty in the results. Consequently, we found no convincing evidence that starting opioids before the beginning of surgery reduces levels of pain after surgery or the need for continuing opioids."
] |
cochrane-simplification-train-1513
|
cochrane-simplification-train-1513
|
We did not identify any completed RCTs that met our inclusion criteria. However, three eligible studies are in progress: ADEPT is a phase III trial comparing postoperative radiotherapy with or without cisplatin in HPV-positive T1-4a OPSCC patients. Included patients must have received minimally invasive surgery and demonstrated extra-capsular spread from disease in the neck. ECOG-E3311 is a phase II trial of treatment for HPV-positive locally advanced OPSCC (stages III-IVa + IVb without distant metastasis). Patients are stratified after minimally invasive surgery. Medium-risk patients are randomised to either standard or reduced-dose radiotherapy. PATHOS is a phase III trial of treatment for HPV-positive OPSCC (T1-3, N0-2b). Patients are stratified after minimally invasive surgery. Medium-risk patients are randomised to either standard or reduced-dose radiotherapy. High-risk patients are randomised to radiotherapy with or without concurrent cisplatin. This review highlights the current lack of high-quality randomised controlled trials studying treatment de-escalation after minimally invasive surgery in patients with HPV-positive OPSCC. However, trials that will meet the inclusion criteria for this review are in progress with results expected between 2021 and 2023.
|
In April 2018, we searched for randomised controlled trials (RCTs) that had compared reduced-dose radiotherapy/chemotherapy treatment with standard-dose treatment. We were interested in the outcomes of overall survival and disease-free survival, as well as the effects on swallowing ability and voice. Our searches did not identify any completed RCTs, however three relevant studies are ongoing and the first results are expected between 2021 and 2023. Currently there is no high-quality evidence comparing these two treatments, however such trials are in progress.
|
10.1002/14651858.CD012939.pub2
|
[
"In April 2018, we searched for randomised controlled trials (RCTs) that had compared reduced-dose radiotherapy/chemotherapy treatment with standard-dose treatment. We were interested in the outcomes of overall survival and disease-free survival, as well as the effects on swallowing ability and voice. Our searches did not identify any completed RCTs, however three relevant studies are ongoing and the first results are expected between 2021 and 2023. Currently there is no high-quality evidence comparing these two treatments, however such trials are in progress."
] |
cochrane-simplification-train-1514
|
cochrane-simplification-train-1514
|
We included 19 trials with 19 different randomised dose comparisons. No studies reported data on relapse rates or quality of life and only one compared low dose (> 1.5 to 3 mg/day) haloperidol to higher dose ranges. Using standard lower dose (> 3 to 7.5 mg/day) did not result in loss of efficacy (no clinically important improvement in global state, versus standard higher dose (> 7.5 to 15 mg/day, n = 48, 1 RCT, RR 1.09, 95% CI 0.7 to 1.8, very-low-quality evidence); versus high dose (> 15 to 35 mg/day, n = 81, 2 RCTs, RR 0.95, 95% CI 0.8 to 1.2, very-low-quality evidence). Doses of haloperidol in the range of > 3 to 7.5 mg/day had a lower rate of development of clinically significant extrapyramidal adverse effects than higher doses (clinically significant extrapyramidal adverse effects, versus standard higher dose, n = 64, 2 RCTs, RR 0.12, 95% CI 0.01 to 2.1, very-low-quality evidence); versus high dose, n = 144, 3 RCTs, RR 0.59, 95% CI 0.5 to 0.8, very-low-quality evidence; versus very high dose (> 35 mg/day, n = 86, 2 RCTs, RR 0.70, 95% CI 0.5 to 1.1, very-low-quality evidence). None of the other comparisons between dose ranges yielded statistically significant differences, but several, particularly with lower dose ranges, were underpowered to detect clinically meaningful differences. Noresults were conclusive and all were based on small, short studies of limited quality. However, it would be understandable if clinicians were cautious in prescribing doses in excess of 7.5 mg/day of haloperidol to a person with uncomplicated acute schizophrenia, and if people with schizophrenia were equally reticent to take greater doses. Further research is needed regarding the efficacy and tolerability of the lower dose ranges, especially > 1.5 to 3 mg/day.
|
The main aim of this review was to determine the best range of doses of haloperidol for the treatment of schizophrenia. Nineteen trials were included that compared varying doses of haloperidol. Despite over 30 years of trials, data on the effects of differing doses of haloperidol are sparse and poorly reported. This is especially so for the lower dose ranges generally used for the treatment of schizophrenia today. However, lower doses of haloperidol may be just as effective as higher doses but result in fewer side effects. This review also suggests that an important bias against haloperidol may exist in modern trials comparing new drugs with haloperidol. Results are not conclusive and are based on small, short studies of limited quality. The authors of the review note that it would be understandable if psychiatrists were cautious about prescribing doses above 7.5 mg a day and if people with schizophrenia did not want to take higher dosages. Further research is needed to assess the tolerability and effectiveness of lower doses. Low doses of haloperidol may be just as good as higher doses, but with fewer side effects. This plain language summary was written by a consumer, Benjamin Gray, Service User and Service User Expert. Rethink Mental Illness. Email: [email protected].
|
10.1002/14651858.CD001951.pub2
|
[
"The main aim of this review was to determine the best range of doses of haloperidol for the treatment of schizophrenia. Nineteen trials were included that compared varying doses of haloperidol. Despite over 30 years of trials, data on the effects of differing doses of haloperidol are sparse and poorly reported. This is especially so for the lower dose ranges generally used for the treatment of schizophrenia today. However, lower doses of haloperidol may be just as effective as higher doses but result in fewer side effects. This review also suggests that an important bias against haloperidol may exist in modern trials comparing new drugs with haloperidol. Results are not conclusive and are based on small, short studies of limited quality. The authors of the review note that it would be understandable if psychiatrists were cautious about prescribing doses above 7.5 mg a day and if people with schizophrenia did not want to take higher dosages. Further research is needed to assess the tolerability and effectiveness of lower doses. Low doses of haloperidol may be just as good as higher doses, but with fewer side effects. This plain language summary was written by a consumer, Benjamin Gray, Service User and Service User Expert. Rethink Mental Illness. Email: [email protected]."
] |
cochrane-simplification-train-1515
|
cochrane-simplification-train-1515
|
Eight trials met the inclusion criteria involving 504 patients in four cross-over and four parallel-group randomised controlled trials. Only two of the pre-stated six comparisons were addressed in these trials. Four trials compared antibiotic prophylaxis with antibiotics when clinically indicated. For patients using intermittent catheterisation, there were inconsistent findings about the effect of antibiotic prophylaxis on symptomatic urinary tract infection (UTI). Only one study found a significant difference in the frequency of UTI favouring prophylaxis. For patients using indwelling urethral catheterisation, one small trial reported fewer episodes of symptomatic UTI in the prophylaxis group. Four trials compared antibiotic prophylaxis with giving antibiotics when microbiologically indicated. For patients using intermittent catheterisation, there was limited evidence that receiving antibiotics reduced the rate of bacteriuria (asymptomatic and symptomatic). There was weak evidence that prophylactic antibiotics were better in terms of fewer symptomatic bacteriuria. No eligible trials were identified that compared alternative routes of catheter insertion. The data from eight trials comparing different antibiotic policies were sparse, particularly when intermittent catheterisation was considered separately from indwelling catheterisation. Possible benefits of antibiotic prophylaxis must be balanced against possible adverse effects, such as development of antibiotic resistant bacteria. These cannot be reliably estimated from currently available trials.
|
No trials were found comparing these different methods with each other. Sometimes people using the catheters develop urinary tract infections. There was some weak evidence that using antibiotics all the time reduced the chance of having a urinary tract infection while using intermittent catheters, but there was not enough information about side effects.
|
10.1002/14651858.CD004201.pub3
|
[
"No trials were found comparing these different methods with each other. Sometimes people using the catheters develop urinary tract infections. There was some weak evidence that using antibiotics all the time reduced the chance of having a urinary tract infection while using intermittent catheters, but there was not enough information about side effects."
] |
cochrane-simplification-train-1516
|
cochrane-simplification-train-1516
|
We did not identify any studies for inclusion in the previous version of this review. For this update, the literature search identified one low-quality controlled clinical trial involving 106 participants. The findings from this study suggest 'low-level' evidence to support high-intensity ambulatory (outpatient) multidisciplinary rehabilitation in reducing short- and long-term motor disability (continence, mobility and locomotion, cognition), when compared with standard outpatient care. We found improvement in some domains of disability (continence, communication) and psychosocial gains were maintained at six months follow-up. We found no evidence for improvement in overall participation (quality of life and societal relationship). No adverse events were reported as a result of multidisciplinary rehabilitation. We found no evidence for improvement in quality of life or cost-effectiveness of rehabilitation. It was also not possible to suggest best 'dose' of therapy. Since the last version of this review, one new study has been identified for inclusion. The best evidence to date comes from this CCT, which provides low quality evidence that higher intensity ambulatory (outpatient) multidisciplinary rehabilitation reduces short- and long-term disability in people with brain tumour compared with standard outpatient care. Our conclusions are tentative at best, given gaps in current research in this area. Although the strength of evidence has increased with the identification of a new controlled clinical trial in this updated review, further research is needed into appropriate and robust study designs; outcome measurement; caregiver needs; evaluation of optimal settings; type, intensity, duration of therapy; and cost-effectiveness of multidisciplinary rehabilitation in the brain tumour population.
|
We found one controlled clinical trial (poor quality) that compared multidisciplinary rehabilitation to standard outpatient care. The 106 people in this trial received treatment in the hospital outpatient clinic. Participants were in the multidisciplinary rehabilitation programme for up to eight weeks, and the results were measured at three and six months after completion of the programme. There was some evidence to support the benefit of multidisciplinary rehabilitation in reducing disability in people with primary brain tumour. People in the multidisciplinary rehabilitation group showed improvement in their functional abilities (e.g. continence, mobility) and cognitive function compared to the group with standard care only. Multidisciplinary rehabilitation was not harmful. Current research gaps highlight the need for high-quality research to explore the effectiveness of various aspects of multidisciplinary rehabilitation and caregiver needs in this patient population. The evidence in this review is up to date to January 2015.
|
10.1002/14651858.CD009509.pub3
|
[
"We found one controlled clinical trial (poor quality) that compared multidisciplinary rehabilitation to standard outpatient care. The 106 people in this trial received treatment in the hospital outpatient clinic. Participants were in the multidisciplinary rehabilitation programme for up to eight weeks, and the results were measured at three and six months after completion of the programme. There was some evidence to support the benefit of multidisciplinary rehabilitation in reducing disability in people with primary brain tumour. People in the multidisciplinary rehabilitation group showed improvement in their functional abilities (e.g. continence, mobility) and cognitive function compared to the group with standard care only. Multidisciplinary rehabilitation was not harmful. Current research gaps highlight the need for high-quality research to explore the effectiveness of various aspects of multidisciplinary rehabilitation and caregiver needs in this patient population. The evidence in this review is up to date to January 2015."
] |
cochrane-simplification-train-1517
|
cochrane-simplification-train-1517
|
We included 17 RCTs involving 1297 participants. Participants were stroke survivors living in the community or receiving inpatient rehabilitation. Most could walk 10 metres without assistance. Ten studies (835 participants) measured walking capacity (measuring how far the participant could walk in six minutes) demonstrating that CCT was superior to the comparison intervention (Six-Minute Walk Test: mean difference (MD), fixed-effect, 60.86 m, 95% confidence interval (CI) 44.55 to 77.17, GRADE: moderate). Eight studies (744 participants) measured gait speed, again finding in favour of CCT compared with other interventions (MD 0.15 m/s, 95% CI 0.10 to 0.19, GRADE: moderate). Both of these effects are considered clinically meaningful. We were able to pool other measures to demonstrate the superior effects of CCT for aspects of walking and balance (Timed Up and Go: five studies, 488 participants, MD -3.62 seconds, 95% CI -6.09 to -1.16; Activities of Balance Confidence scale: two studies, 103 participants, MD 7.76, 95% CI 0.66 to 14.87). Two other pooled balance measures failed to demonstrate superior effects (Berg Blance Scale and Step Test). Independent mobility, as measured by the Stroke Impact Scale, Functional Ambulation Classification and the Rivermead Mobility Index, also improved more in CCT interventions compared with others. Length of stay showed a non-significant effect in favour of CCT (two trials, 217 participants, MD -16.35, 95% CI -37.69 to 4.99). Eight trials (815 participants) measured adverse events (falls during therapy): there was a non-significant effect of greater risk of falls in the CCT groups (RD 0.03, 95% CI -0.02 to 0.08, GRADE: very low). Time after stroke did not make a difference to the positive outcomes, nor did the quality or size of the trials. Heterogeneity was generally low; risk of bias was variable across the studies with poor reporting of study conduct in several of the trials. There is moderate evidence that CCT is effective in improving mobility for people after stroke - they may be able to walk further, faster, with more independence and confidence in their balance. The effects may be greater later after the stroke, and are of clinical significance. Further high-quality research is required, investigating quality of life, participation and cost-benefits, that compares CCT with standard care and that also investigates the influence of factors such as stroke severity and age. The potential risk of increased falls during CCT needs to be monitored.
|
This is an update of the original review in 2010. We considered studies comparing circuit class therapy with conventional therapy for people with stroke, and included only high-quality studies with a low risk of being biased. We were interested in studies that compared these two approaches and their effects on the way people walk, how far, how fast, and how independently. We also looked for studies that investigated if the circuit classes were more or less likely to be harmful than conventional approaches. The evidence is current to January 2017. We found seventeen studies, involving 1297 participants, that compared circuit class rehabilitation with usual care or sham rehabilitation. Most trials reported the benefits of circuit classes for improving walking ability. More specifically, we combined the results from the studies and found moderate evidence that circuit classes were more effective in improving the person's ability to walk further, more independently, and faster and, in some cases, to balance more easily and confidently when compared with other types of therapy. There was a suggestion that people might fall more often in the circuit classes, and that they may be able to get home from rehabilitation hospital more quickly, but these two aspects were not confirmed using statistics. We also found that the positive effects of the circuit classes were experienced equally by people who had had their stroke more than a year ago compared with people who had had their stroke within the year. This means people can continue to improve longer after their stroke than was previously reported. More research is needed to see if it works for all people with any severity of stroke and if some tasks are better to practise than others. The quality of the studies overall was acceptable, given it is difficult to keep some aspects tightly controlled in rehabilitation studies. However, we have downgraded the quality rating to 'moderate' to acknowledge that some trials have the potential for bias.
|
10.1002/14651858.CD007513.pub3
|
[
"This is an update of the original review in 2010. We considered studies comparing circuit class therapy with conventional therapy for people with stroke, and included only high-quality studies with a low risk of being biased. We were interested in studies that compared these two approaches and their effects on the way people walk, how far, how fast, and how independently. We also looked for studies that investigated if the circuit classes were more or less likely to be harmful than conventional approaches. The evidence is current to January 2017. We found seventeen studies, involving 1297 participants, that compared circuit class rehabilitation with usual care or sham rehabilitation. Most trials reported the benefits of circuit classes for improving walking ability. More specifically, we combined the results from the studies and found moderate evidence that circuit classes were more effective in improving the person's ability to walk further, more independently, and faster and, in some cases, to balance more easily and confidently when compared with other types of therapy. There was a suggestion that people might fall more often in the circuit classes, and that they may be able to get home from rehabilitation hospital more quickly, but these two aspects were not confirmed using statistics. We also found that the positive effects of the circuit classes were experienced equally by people who had had their stroke more than a year ago compared with people who had had their stroke within the year. This means people can continue to improve longer after their stroke than was previously reported. More research is needed to see if it works for all people with any severity of stroke and if some tasks are better to practise than others. The quality of the studies overall was acceptable, given it is difficult to keep some aspects tightly controlled in rehabilitation studies. However, we have downgraded the quality rating to 'moderate' to acknowledge that some trials have the potential for bias."
] |
cochrane-simplification-train-1518
|
cochrane-simplification-train-1518
|
We identified two eligible cohort studies including 60 children with newly diagnosed HR NBL. All studies had methodological limitations, with regard to both internal (risk of bias) and external validity. As the studies were not comparable with regard to prognostic factors and treatment (and often used different outcome definitions), pooling of results was not possible. In one study, the objective response rate (ORR) was 73% after surgery; the median overall survival was 15 months (95% confidence interval (CI) 7 to 23); five-year overall survival was 14.6%; median event-free survival was 10 months (95% CI 7 to 13); and five-year event-free survival was 12.2%. In the other study, the ORR was 56% after myeloablative therapy and autologous stem cell transplantation; 10-year overall survival was 6.25%; and event-free survival was not reported. With regard to short-term adverse effects, one study showed a prevalence of 2% (95% CI 0% to 13%; best-case scenario) for death due to myelosuppression. After the first cycle of 131I-MIBG therapy in one study, platelet toxicity occurred in 38% (95% CI 18% to 61%), neutrophil toxicity in 50% (95% CI 28% to 72%) and haemoglobin toxicity in 69% (95% CI 44% to 86%); after the second cycle this was 60% (95% CI 36% to 80%) for platelets and neutrophils and 53% (95% CI 30% to 75%) for haemoglobin. In one study, the prevalence of hepatic toxicity during or within four weeks after last the MIBG treatment was 0% (95% CI 0% to 9%; best-case scenario). Neither study reported cardiovascular toxicity and sialoadenitis. One study assessed long-term adverse events in some of the children: there was elevated plasma thyroid-stimulating hormone in 45% (95% CI 27% to 65%) of children; in all children, free T4 was within the age-related normal range (0%, 95% CI 0% to 15%). There were no secondary malignancies observed (0%, 95% CI 0% to 9%), but only five children survived more than four years. We identified no RCTs or CCTs comparing the effectiveness of treatment including 131I-MIBG therapy versus treatment not including 131I-MIBG therapy in patients with newly diagnosed HR NBL. We found two small observational studies including chilren. They had high risk of bias, and not all relevant outcome results were available. Based on the currently available evidence, we cannot make recommendations for the use of 131I-MIBG therapy in patients with newly diagnosed HR NBL in clinical practice. More high-quality research is needed.
|
The evidence is current to April 2016. We found two cohort studies (where a group of people (the cohort) is followed over time, to examine different treatments received and subsequent outcomes) looking at 131I-MIBG treatment in 60 children with newly diagnosed HR NBL. The studies were not comparable with regard to the children, the ways they were treated and the ways the different outcomes were defined and so it was impossible to combine the results in an analysis. Not all relevant outcome results were available. The percentages of children whose cancer reduced or disappeared after treatment (response rate) were 56% and 73% in the two studies, but survival was still poor: overall survival (length of time that the child remained alive) was about 15 months, event-free survival (time during which there were no objective signs of tumor recurrence) was about 10 months. Overall survival five years after treatment was 14.6%, and after 10 years was 12.2%. With regard to short-term side effects, there were some low blood cell counts. There was no liver toxicity. The studies did not report on heart problems and infections of the salivary glands. One study assessed long-term side effects in some of the children: there was some evidence of thyroid (a gland in the neck) problems, which was brief in three children, but remained high in seven children, of whom five were prescribed medicine. There were no secondary cancers (where a different type of cancer has returned following the original cancer). Based on the currently available evidence, we cannot make recommendations for the use of 131I-MIBG therapy in patients with newly diagnosed HR NBL in clinical practice. More high-quality research is needed before definite conclusions can be made. All studies had problems relating to quality of the evidence.
|
10.1002/14651858.CD010349.pub2
|
[
"The evidence is current to April 2016. We found two cohort studies (where a group of people (the cohort) is followed over time, to examine different treatments received and subsequent outcomes) looking at 131I-MIBG treatment in 60 children with newly diagnosed HR NBL. The studies were not comparable with regard to the children, the ways they were treated and the ways the different outcomes were defined and so it was impossible to combine the results in an analysis. Not all relevant outcome results were available. The percentages of children whose cancer reduced or disappeared after treatment (response rate) were 56% and 73% in the two studies, but survival was still poor: overall survival (length of time that the child remained alive) was about 15 months, event-free survival (time during which there were no objective signs of tumor recurrence) was about 10 months. Overall survival five years after treatment was 14.6%, and after 10 years was 12.2%. With regard to short-term side effects, there were some low blood cell counts. There was no liver toxicity. The studies did not report on heart problems and infections of the salivary glands. One study assessed long-term side effects in some of the children: there was some evidence of thyroid (a gland in the neck) problems, which was brief in three children, but remained high in seven children, of whom five were prescribed medicine. There were no secondary cancers (where a different type of cancer has returned following the original cancer). Based on the currently available evidence, we cannot make recommendations for the use of 131I-MIBG therapy in patients with newly diagnosed HR NBL in clinical practice. More high-quality research is needed before definite conclusions can be made. All studies had problems relating to quality of the evidence."
] |
cochrane-simplification-train-1519
|
cochrane-simplification-train-1519
|
In total, 65 trials (total number of patients = 11,237) were included in this review. Twenty-eight trials (42%) were considered high quality. Statistically significant effects were found in favour of NSAIDs compared to placebo, but at the cost of statistically significant more side effects. There is moderate evidence that NSAIDs are not more effective than paracetamol for acute low-back pain, but paracetamol had fewer side effects. There is moderate evidence that NSAIDs are not more effective than other drugs for acute low-back pain. There is strong evidence that various types of NSAIDs, including COX-2 NSAIDs, are equally effective for acute low-back pain. COX-2 NSAIDs had statistically significantly fewer side-effects than traditional NSAIDs. The evidence from the 65 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute and chronic low-back pain without sciatica. However, effect sizes are small. Furthermore, there does not seem to be a specific type of NSAID which is clearly more effective than others. The selective COX-2 inhibitors showed fewer side effects compared to traditional NSAIDs in the RCTs included in this review. However, recent studies have shown that COX-2 inhibitors are associated with increased cardiovascular risks in specific patient populations.
|
Non-steroidal anti-inflammatory drugs (NSAIDs) are the most frequently prescribed medications worldwide and are commonly used for treating low-back pain. This review found 65 studies (including over 11,000 patients) of mixed methodological quality that compared various NSAIDs with placebo (an inactive substance that has no treatment value), other drugs, other therapies and with other NSAIDs. The review authors conclude that NSAIDs are slightly effective for short-term symptomatic relief in patients with acute and chronic low-back pain without sciatica (pain and tingling radiating down the leg). In patients with acute sciatica, no difference in effect between NSAIDs and placebo was found. The review authors also found that NSAIDs are not more effective than other drugs (paracetamol/acetaminophen, narcotic analgesics, and muscle relaxants). Placebo and paracetamol/acetaminophen had fewer side effects than NSAIDs, though the latter has fewer side effects than muscle relaxants and narcotic analgesics. The new COX-2 NSAIDs do not seem to be more effective than traditional NSAIDs, but are associated with fewer side effects, particularly stomach ulcers. However, other literature has shown that some COX-2 NSAIDs are associated with increased cardiovascular risk. The review noted a number of limitations in the studies. Only 42% of the studies were considered to be of high quality. Many of the studies had small numbers of patients, which limits the ability to detect differences between the NSAID and the control group. There are few data on long term results and long-term side effects.
|
10.1002/14651858.CD000396.pub3
|
[
"Non-steroidal anti-inflammatory drugs (NSAIDs) are the most frequently prescribed medications worldwide and are commonly used for treating low-back pain. This review found 65 studies (including over 11,000 patients) of mixed methodological quality that compared various NSAIDs with placebo (an inactive substance that has no treatment value), other drugs, other therapies and with other NSAIDs. The review authors conclude that NSAIDs are slightly effective for short-term symptomatic relief in patients with acute and chronic low-back pain without sciatica (pain and tingling radiating down the leg). In patients with acute sciatica, no difference in effect between NSAIDs and placebo was found. The review authors also found that NSAIDs are not more effective than other drugs (paracetamol/acetaminophen, narcotic analgesics, and muscle relaxants). Placebo and paracetamol/acetaminophen had fewer side effects than NSAIDs, though the latter has fewer side effects than muscle relaxants and narcotic analgesics. The new COX-2 NSAIDs do not seem to be more effective than traditional NSAIDs, but are associated with fewer side effects, particularly stomach ulcers. However, other literature has shown that some COX-2 NSAIDs are associated with increased cardiovascular risk. The review noted a number of limitations in the studies. Only 42% of the studies were considered to be of high quality. Many of the studies had small numbers of patients, which limits the ability to detect differences between the NSAID and the control group. There are few data on long term results and long-term side effects."
] |
cochrane-simplification-train-1520
|
cochrane-simplification-train-1520
|
Twenty-nine RCTs were included: 28 were placebo-controlled, double-blind RCTs and one compared different doses of rFVIIa. In the 'Risk of bias' assessment, most studies were found to have some threats to validity although therapeutic RCTs were found to be less prone to bias than prophylactic RCTs. Sixteen trials involving 1361 participants examined the prophylactic use of rFVIIa; 729 received rFVIIa. There was no evidence of mortality benefit (risk ratio (RR) 1.04; 95% confidence interval (CI) 0.55 to 1.97). There was decreased blood loss (mean difference (MD) -297 mL; 95% CI -416 to -178) and decreased red cell transfusion requirements (MD -261 mL; 95% CI -367 to -154) with rFVIIa treatment; however, these values were likely overestimated due to the inability to incorporate data from trials (four RCTs in the outcome of blood loss and three RCTs in the outcome of transfusion requirements) showing no difference of rFVIIa treatment compared to placebo. There was a trend in favour of rFVIIa in the number of participants transfused (RR 0.85; 95% CI 0.72 to 1.01). However, there was a trend against rFVIIa with respect to thromboembolic adverse events (RR 1.35; 95% CI 0.82 to 2.25). Thirteen trials involving 2929 participants examined the therapeutic use of rFVIIa; 1878 received rFVIIa. There were no outcomes where any observed advantage or disadvantage of rFVIIa over placebo could not have been observed by chance alone. There was a trend in favour of rFVIIa for reducing mortality (RR 0.91; 95% CI 0.78 to 1.06). However, there was a trend against rFVIIa for increased thromboembolic adverse events (RR 1.14; 95% CI 0.89 to 1.47). When all trials were pooled together to examine the risk of thromboembolic events, a significant increase in total arterial events was observed (RR 1.45; 95% CI 1.02 to 2.05). The effectiveness of rFVIIa as a more general haemostatic drug, either prophylactically or therapeutically, remains unproven. The results indicate increased risk of arterial events in patients receiving rFVIIa. The use of rFVIIa outside its current licensed indications should be restricted to clinical trials.
|
This review included 29 randomised controlled trials with 4290 patients. The trials showed modest reductions in total blood loss or red cells transfused (equivalent to less than one unit of red cell transfusion) with the use of rFVIIa. However, the reductions were likely to be overestimated due to the limitations of the data. We also observed an increase in the risk of having a blood clot in the arteries (such as a heart attack or stroke) in those patients receiving rFVIIa. When taken together, the data supporting the off-license use of recombinant FVIIa are weak. The use of rFVIIa outside its current licensed indications should be restricted to clinical trials.
|
10.1002/14651858.CD005011.pub4
|
[
"This review included 29 randomised controlled trials with 4290 patients. The trials showed modest reductions in total blood loss or red cells transfused (equivalent to less than one unit of red cell transfusion) with the use of rFVIIa. However, the reductions were likely to be overestimated due to the limitations of the data. We also observed an increase in the risk of having a blood clot in the arteries (such as a heart attack or stroke) in those patients receiving rFVIIa. When taken together, the data supporting the off-license use of recombinant FVIIa are weak. The use of rFVIIa outside its current licensed indications should be restricted to clinical trials."
] |
cochrane-simplification-train-1521
|
cochrane-simplification-train-1521
|
We identified five RCTs with 5039 participants; two studies had a low risk of bias for all domains. Four studies evaluated the drug pioglitazone, and one study evaluated rosiglitazone. The participants in different studies were heterogeneous. Recurrent stroke Three studies evaluated the number of participants with recurrent stroke (4979 participants, a single study contributing 3876 of these). Peroxisome proliferator-activated receptor gamma agonists probably reduce the recurrence of stroke compared with placebo (risk ratio (RR) 0.66, 95% confidence interval (CI) 0.44 to 0.99; moderate-quality evidence). Adverse events Evidence that adverse events occurred more frequently in participants treated with PPAR-γ agonists when compared with placebo was uncertain due to wide confidence interval and high levels of statistical heterogeneity: risk difference 10%, 95% CI -8% to 28%; low-quality evidence). Data were available on additional composite outcomes reflecting serious vascular events (all-cause death and other major vascular events; all-cause mortality, non-fatal myocardial infarction or non-fatal stroke) from one study in 984 people. This study provided low-quality evidence that PPAR-γ agonists led to fewer events (data not meta-analysed). Vascular events Peroxisome proliferator-activated receptor gamma agonists given over a mean duration of 34.5 months in a single trial of 984 participants may reduce serious vascular events expressed as a composite outcome of total events of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (RR 0.73, 95% CI 0.54 to 0.99; low-quality evidence). Other outcomes One study in 20 people measured insulin sensitivity, and one study in 40 people measured the ubiquitin-proteasome activity in carotid plaques. Our confidence in the improvements observed with PPAR-γ agonists were limited by small sample sizes and risk of bias. None of the studies reported the number of participants with disability due to vascular events or improvement in quality of life. Peroxisome proliferator-activated receptor gamma agonists probably reduce recurrent stroke and total events of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke, and may improve insulin sensitivity and the stabilisation of carotid plaques. Their effects on adverse events are uncertain. Our conclusions should be interpreted with caution considering the small number and the quality of the included studies. Further well-designed, double-blind RCTs with large samples are required to assess the efficacy and safety of PPAR-γ agonists in the secondary prevention of stroke and related vascular events in people with stroke or TIA.
|
We identified five studies to 30 July 2019 including a total of 5039 participants. Four studies evaluated the drug pioglitazone, and one study evaluated rosiglitazone. Four studies included participants who had no history of diabetes, and one study included only participants with diabetes. Compared with placebo tablets, PPAR-γ agonists reduced recurrent strokes and other blood vessel disease, improved the body's response to insulin, and stabilised fatty deposits in artery walls. The drugs also appeared to be well tolerated, but the evidence for this was inconclusive. Our conclusions should be interpreted with caution considering the small number of included studies and the limited quality of some of the studies. Further well-designed randomised controlled trials with large sample sizes are required.
|
10.1002/14651858.CD010693.pub5
|
[
"We identified five studies to 30 July 2019 including a total of 5039 participants. Four studies evaluated the drug pioglitazone, and one study evaluated rosiglitazone. Four studies included participants who had no history of diabetes, and one study included only participants with diabetes. Compared with placebo tablets, PPAR-γ agonists reduced recurrent strokes and other blood vessel disease, improved the body's response to insulin, and stabilised fatty deposits in artery walls. The drugs also appeared to be well tolerated, but the evidence for this was inconclusive. Our conclusions should be interpreted with caution considering the small number of included studies and the limited quality of some of the studies. Further well-designed randomised controlled trials with large sample sizes are required."
] |
cochrane-simplification-train-1522
|
cochrane-simplification-train-1522
|
We included five trials involving 639 clomiphene-resistant women with PCOS. Three studies compared UTND with LOD, and two compared UTND combined with gonadotropins with gonadotropins alone. The evidence was of low to very low quality. The main limitations were serious risk of bias due to poor reporting of methods, inconsistency resulting from heterogeneity, imprecision induced by limited sample size, and lack of reporting of clinically relevant outcomes such as live birth and surgical complications. UTND versus LOD No studies reported on the main outcome live birth. One study reported on surgical complications; however, the evidence for this outcome was of very low quality because it was based on one study with small sample size and there were no events in either arm. Thus, we are uncertain whether there is any difference in surgical complications between UTND and LOD. We are also uncertain whether there is any difference in pregnancy rate when comparing UTND with LOD (OR 0.54, 95% CI 0.28 to 1.03; I2 = 56%; 3 RCTs, n = 473; very-low quality evidence). UTND may lead to a slight decrease in ovulation rate when compared to LOD (OR 0.66, 95% CI 0.45 to 0.97; I2 = 0%; 3 RCTs, n = 473; low-quality evidence). This suggests that among clomiphene-resistant women with PCOS using LOD with an expected ovulation rate of 69.5%, the ovulation rate among women using UTND may be between 50.6% and 68.8% No studies reported on the outcomes OHSS and multiple pregnancy. There was also insufficient evidence to reach a conclusion regarding miscarriage as there was only one study of very low quality. UTND combined with gonadotropins versus gonadotropins alone No studies reported on the main outcomes live birth and incidence of surgical complications. The evidence for the outcomes OHSS, pregnancy, ovulation, miscarriage, and multiple pregnancy in this comparison was of very low quality. Thus, we are uncertain whether there is any difference in these outcomes for women with clomiphene-resistant PCOS using UTND combined with gonadotropins as compared with gonadotropins. Based on very low-quality evidence, It is uncertain whether there is any difference in pregnancy rate, incidence of surgical complications, and miscarriage rate between UTND and LOD in women with clomiphene-resistant PCOS. UTND may lead to a slight decrease in ovulation rate when compared to LOD. No studies reported on the outcomes live birth rate, incidence of OHSS, and multiple pregnancy rate. No studies reported on the main outcomes live birth and surgical complications for the comparison UTND combined with gonadotrophins versus gonadotrophins alone. The evidence for the outcomes OHSS, pregnancy, ovulation, miscarriage, and multiple pregnancy in this comparison was of very low quality. Thus, it is unclear if there is a difference in any of the outcomes between UTND combined with gonadotrophins versus gonadotrophins alone.
|
Five randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with 639 women were included in the review. Three compared UTND to LOD, and two compared UTND combined with gonadotropins to gonadotropins. UTND versus LOD The quality of the three studies was low to very low. None of the studies reported on the main outcome of live birth. Based on currently available evidence, we are uncertain whether pregnancy rate of women using UTND is different from that of LOD. UTND may lead to a small decrease in ovulation rate when compared to LOD. Thus, low-quality evidence suggests that among clomiphene-resistant women with PCOS using LOD with an expected ovulation rate of 69.5%, the rate among women using UTND may be between 50.6% and 68.8%. There is insufficient evidence to reach conclusions regarding surgical complications and miscarriage, as we found only one very low-quality study. None of the studies reported OHSS or multiple pregnancy rate. UTND combined with gonadotropins versus gonadotropins alone We were unable to assess the benefit or harm of applying UTND combined with gonadotropins for women with clomiphene-resistant PCOS, as we identified only two very low-quality trials that used different doses of gonadotropins. We assessed the quality of the evidence as low to very low due to poor explanations of study methodology and the limited number of included trials. Also, reporting on clinically relevant issues that are important for subfertile couples, such as live birth, was lacking.
|
10.1002/14651858.CD008583.pub2
|
[
"Five randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with 639 women were included in the review. Three compared UTND to LOD, and two compared UTND combined with gonadotropins to gonadotropins. UTND versus LOD The quality of the three studies was low to very low. None of the studies reported on the main outcome of live birth. Based on currently available evidence, we are uncertain whether pregnancy rate of women using UTND is different from that of LOD. UTND may lead to a small decrease in ovulation rate when compared to LOD. Thus, low-quality evidence suggests that among clomiphene-resistant women with PCOS using LOD with an expected ovulation rate of 69.5%, the rate among women using UTND may be between 50.6% and 68.8%. There is insufficient evidence to reach conclusions regarding surgical complications and miscarriage, as we found only one very low-quality study. None of the studies reported OHSS or multiple pregnancy rate. UTND combined with gonadotropins versus gonadotropins alone We were unable to assess the benefit or harm of applying UTND combined with gonadotropins for women with clomiphene-resistant PCOS, as we identified only two very low-quality trials that used different doses of gonadotropins. We assessed the quality of the evidence as low to very low due to poor explanations of study methodology and the limited number of included trials. Also, reporting on clinically relevant issues that are important for subfertile couples, such as live birth, was lacking."
] |
cochrane-simplification-train-1523
|
cochrane-simplification-train-1523
|
We included 70 studies that compared an opioid with placebo or no treatment, another opioid administered intramuscularly or intravenously or compared with TENS applied to the back. Sixty-one studies involving more than 8000 women contributed data to the review and these studies reported on 34 different comparisons; for many comparisons and outcomes only one study contributed data. All of the studies were conducted in hospital settings, on healthy women with uncomplicated pregnancies at 37 to 42 weeks' gestation. We excluded studies focusing on women with pre-eclampsia or pre-existing conditions or with a compromised fetus. Overall, the evidence was graded as low- or very low-quality regarding the analgesic effect of opioids and satisfaction with analgesia; evidence was downgraded because of study design limitations, and many of the studies were underpowered to detect differences between groups and so effect estimates were imprecise. Due to the large number of different comparisons, it was not possible to present GRADE findings for every comparison. For the comparison of intramuscular pethidine (50 mg/100 mg) versus placebo, no clear differences were found in maternal satisfaction with analgesia measured during labour (number of women satisfied or very satisfied after 30 minutes: 50 women; 1 trial; risk ratio (RR) 7.00, 95% confidence interval (CI) 0.38 to 128.87, very low-quality evidence), or number of women requesting an epidural (50 women; 1 trial; RR 0.50, 95% CI 0.14 to 1.78; very low-quality evidence). Pain scores (reduction in visual analogue scale (VAS) score of at least 40 mm: 50 women; 1 trial; RR 25, 95% CI 1.56 to 400, low-quality evidence) and pain measured in labour (women reporting pain relief to be "good" or "fair" within one hour of administration: 116 women; 1 trial; RR 1.75, 95% CI 1.24 to 2.47, low-quality evidence) were both reduced in the pethidine group, and fewer women requested any additional analgesia (50 women; 1 trial; RR 0.71, 95% CI 0.54 to 0.94, low-quality evidence). There was limited information on adverse effects and harm to women and babies. There were few results that clearly showed that one opioid was more effective than another. Overall, findings indicated that parenteral opioids provided some pain relief and moderate satisfaction with analgesia in labour. Opioid drugs were associated with maternal nausea, vomiting and drowsiness, although different opioid drugs were associated with different adverse effects. There was no clear evidence of adverse effects of opioids on the newborn. We did not have sufficient evidence to assess which opioid drug provided the best pain relief with the least adverse effects. Though most evidence is of low- or very-low quality, for healthy women with an uncomplicated pregnancy who are giving birth at 37 to 42 weeks, parenteral opioids appear to provide some relief from pain in labour but are associated with drowsiness, nausea, and vomiting in the woman. Effects on the newborn are unclear. Maternal satisfaction with opioid analgesia was largely unreported. The review needs to be examined alongside related Cochrane reviews. More research is needed to determine which analgesic intervention is most effective, and provides greatest satisfaction to women with acceptable adverse effects for mothers and their newborn.
|
We searched for trials on 11 May 2017. We included 70 studies though only 61 studies involving more than 8000 women contributed data to the review. All of the trials were conducted in hospital settings, on healthy women with uncomplicated pregnancies at 37 to 42 weeks' gestation. The trials compared an opioid (intramuscular or intravenous) with placebo (dummy treatment), no treatment, another opioid (or in three trials another medication or inhaled nitrous oxide) or transcutaneous electrical nerve stimulation (TENS) in 34 different comparisons. There were few opportunities to pool the findings, and for many outcomes only one trial contributed findings. The quality of the evidence was mainly assessed as low or very low for the outcomes of pain in labour and satisfaction with analgesia. Many of the studies included insufficient numbers of women to detect differences between groups. Overall, our findings indicate that opioids provided some pain relief during labour, although substantial proportions of women still reported moderate or severe pain. Opioid drugs were associated with nausea, vomiting and drowsiness, with different types of opioids causing different side effects. We did not have sufficient evidence to assess which opioid drug provided the best pain relief with the least adverse effects. Nor did we find clear evidence of adverse effects of opioids on the newborn. Maternal satisfaction with opioid analgesia appeared moderate although it was often unreported or reported in different ways. We did not have sufficient evidence to assess which opioid drugs women were most satisfied with. In this review we did not examine the effectiveness and safety of intramuscular or intravenous opioids compared with other methods of pain relief in labour such as epidural analgesia. The review needs to be examined alongside related Cochrane reviews. As injected opioid drugs are so widely used it is important that more research is carried out so that women can make informed choices about pain relief.
|
10.1002/14651858.CD007396.pub3
|
[
"We searched for trials on 11 May 2017. We included 70 studies though only 61 studies involving more than 8000 women contributed data to the review. All of the trials were conducted in hospital settings, on healthy women with uncomplicated pregnancies at 37 to 42 weeks' gestation. The trials compared an opioid (intramuscular or intravenous) with placebo (dummy treatment), no treatment, another opioid (or in three trials another medication or inhaled nitrous oxide) or transcutaneous electrical nerve stimulation (TENS) in 34 different comparisons. There were few opportunities to pool the findings, and for many outcomes only one trial contributed findings. The quality of the evidence was mainly assessed as low or very low for the outcomes of pain in labour and satisfaction with analgesia. Many of the studies included insufficient numbers of women to detect differences between groups. Overall, our findings indicate that opioids provided some pain relief during labour, although substantial proportions of women still reported moderate or severe pain. Opioid drugs were associated with nausea, vomiting and drowsiness, with different types of opioids causing different side effects. We did not have sufficient evidence to assess which opioid drug provided the best pain relief with the least adverse effects. Nor did we find clear evidence of adverse effects of opioids on the newborn. Maternal satisfaction with opioid analgesia appeared moderate although it was often unreported or reported in different ways. We did not have sufficient evidence to assess which opioid drugs women were most satisfied with. In this review we did not examine the effectiveness and safety of intramuscular or intravenous opioids compared with other methods of pain relief in labour such as epidural analgesia. The review needs to be examined alongside related Cochrane reviews. As injected opioid drugs are so widely used it is important that more research is carried out so that women can make informed choices about pain relief."
] |
cochrane-simplification-train-1524
|
cochrane-simplification-train-1524
|
Sixteen studies involving 1233 participants with mean forced expiratory volume in one second (FEV1) 30% to 51% predicted were included. There was a significant improvement in six-minute walk distance after three months of yoga involving pranayama timed breathing techniques (mean difference to control 45 metres, 95% confidence interval 29 to 61 metres; two studies; 74 participants), with similar improvements in single studies of pursed lip breathing (mean 50 metres; 60 participants) and diaphragmatic breathing (mean 35 metres; 30 participants). Effects on dyspnoea and health-related quality of life were inconsistent across trials. Addition of computerised ventilation feedback to exercise training did not provide additional improvement in dyspnoea-related quality of life (standardised mean difference -0.03; 95% CI -0.43 to 0.49; two studies; 73 participants) and ventilation feedback alone was less effective than exercise training alone for improving exercise endurance (mean difference -15.4 minutes; 95% CI -28.1 to -2.7 minutes; one study; 32 participants). No significant adverse effects were reported. Few studies reported details of allocation concealment, assessor blinding or intention-to-treat analysis. Breathing exercises over four to 15 weeks improve functional exercise capacity in people with COPD compared to no intervention; however, there are no consistent effects on dyspnoea or health-related quality of life. Outcomes were similar across all the breathing exercises examined. Treatment effects for patient-reported outcomes may have been overestimated owing to lack of blinding. Breathing exercises may be useful to improve exercise tolerance in selected individuals with COPD who are unable to undertake exercise training; however, these data do not suggest a widespread role for breathing exercises in the comprehensive management of people with COPD.
|
Sixteen trials with 1233 participants were included, most of whom had severe COPD. The breathing techniques studied included pursed lip breathing (breathing out slowly with the lips in a whistling position), diaphragmatic breathing (deep breathing focusing on the abdomen), pranayam yoga breathing (timed breathing with a focus on exhalation), changing the breathing pattern using computerised feedback to slow the respiratory rate and increase exhalation time, or combinations of these techniques. The study quality was generally low. Breathing exercises appeared to be safe for people with COPD. Yoga breathing, pursed lip breathing and diaphragmatic breathing improved the distance walked in six minutes by an average of 35 to 50 metres in four studies. Effects of breathing exercises on shortness of breath and well being were variable. When added to whole body exercise training, breathing exercises did not appear to have any additional benefit.
|
10.1002/14651858.CD008250.pub2
|
[
"Sixteen trials with 1233 participants were included, most of whom had severe COPD. The breathing techniques studied included pursed lip breathing (breathing out slowly with the lips in a whistling position), diaphragmatic breathing (deep breathing focusing on the abdomen), pranayam yoga breathing (timed breathing with a focus on exhalation), changing the breathing pattern using computerised feedback to slow the respiratory rate and increase exhalation time, or combinations of these techniques. The study quality was generally low. Breathing exercises appeared to be safe for people with COPD. Yoga breathing, pursed lip breathing and diaphragmatic breathing improved the distance walked in six minutes by an average of 35 to 50 metres in four studies. Effects of breathing exercises on shortness of breath and well being were variable. When added to whole body exercise training, breathing exercises did not appear to have any additional benefit."
] |
cochrane-simplification-train-1525
|
cochrane-simplification-train-1525
|
Eight trials with 316 participants met the inclusion criteria. Most of the included studies were single-centre studies that were carried out in clinics or hospitals with a sample size ranging from 14 to 84. We generally considered the included studies to be at unclear or high risk of bias, as they had one domain at high risk of bias, or three or more domains at unclear risk of bias. We did not identify any studies that reported valid data for time to complete wound healing. Meta-analysis of four studies including 116 participants indicated that participants receiving phototherapy may experience a greater proportion of wounds completely healed during follow-up compared with those receiving no phototherapy/placebo (64.5% for the phototherapy group versus 37.0% for the no phototherapy/placebo group; risk ratio 1.57, 95% confidence interval 1.08 to 2.28; low-quality evidence, downgraded for study limitations and imprecision). Two studies mentioned adverse events in the results; one study with 16 participants suggested that there were no device-related adverse events, and the other study with 14 participants suggested that there was no clear difference between phototherapy and placebo group. Four studies reported change in ulcer size, but primarily due to high heterogeneity, they were not combined. Results from individual trials (including 16 participants to 84 participants) generally suggested that after two to four weeks of treatment phototherapy may result in a greater reduction in ulcer size but the quality of the evidence was low due to unclear risk of bias in the original trial and small sample size. We based the analyses for quality of life and amputations on only one study each (28 participants and 23 participants respectively); both outcomes showed no clear difference between the phototherapy group and the no phototherapy/placebo group. This systematic review of randomised trials suggested that phototherapy, when compared to no phototherapy/placebo, may increase the proportion of wounds completely healed during follow-up and may reduce wound size in people with diabetes, but there was no evidence that phototherapy improves quality of life. Due to the small sample size and methodological flaws in the original trials, the quality of the evidence was low, which reduces our confidence in these results. Large, well-designed randomised controlled trials are needed to confirm whether phototherapy could be an effective option for the treatment of foot ulcers in people with diabetes.
|
We searched for randomised controlled trials comparing different phototherapies, or comparing phototherapy with other treatments or a placebo (sham treatment), for foot ulcers in adults with diabetes in October 2016. We included eight trials (316 participants). Most studies were undertaken in clinics or hospitals and had small numbers of participants (14 to 84). The average age in the included studies was from 53 to 68 years, and the ratio of females to males was 0.46 to 1.88. The included studies compared phototherapy with placebo or no phototherapy, on top of usual care (usual care could include treatments such as dressings, antibiotics, or wound cleaning). Treatment times ranged from 15 days to 20 weeks. The results suggested that phototherapy, when compared to no phototherapy or a placebo, may increase the proportion of wounds completely healed during follow-up and reduce wound size. However, as the included studies involved small numbers of participants and had drawbacks in study methods, our confidence in these results is limited. We did not find sufficient evidence that the potential harms or incidence of amputations differed between the phototherapy group and the no phototherapy/placebo group. We judged the quality of the evidence to be low due to a lack of data and risk of the study results being biased. Further high-quality studies are needed to confirm the benefits and harms of phototherapy. This plain language summary is up to date as of 26 October 2016.
|
10.1002/14651858.CD011979.pub2
|
[
"We searched for randomised controlled trials comparing different phototherapies, or comparing phototherapy with other treatments or a placebo (sham treatment), for foot ulcers in adults with diabetes in October 2016. We included eight trials (316 participants). Most studies were undertaken in clinics or hospitals and had small numbers of participants (14 to 84). The average age in the included studies was from 53 to 68 years, and the ratio of females to males was 0.46 to 1.88. The included studies compared phototherapy with placebo or no phototherapy, on top of usual care (usual care could include treatments such as dressings, antibiotics, or wound cleaning). Treatment times ranged from 15 days to 20 weeks. The results suggested that phototherapy, when compared to no phototherapy or a placebo, may increase the proportion of wounds completely healed during follow-up and reduce wound size. However, as the included studies involved small numbers of participants and had drawbacks in study methods, our confidence in these results is limited. We did not find sufficient evidence that the potential harms or incidence of amputations differed between the phototherapy group and the no phototherapy/placebo group. We judged the quality of the evidence to be low due to a lack of data and risk of the study results being biased. Further high-quality studies are needed to confirm the benefits and harms of phototherapy. This plain language summary is up to date as of 26 October 2016."
] |
cochrane-simplification-train-1526
|
cochrane-simplification-train-1526
|
We included 15 eligible studies (n = 7976; effective sample size = 6630), four of which were cluster trials. Eight studies were conducted in Malawi, four in India, and one apiece in Kenya, Zambia, and Cambodia. Six studies received funding or donations from industry whereas eight did not, and one study did not report the funding source. The overall risk of bias was high for six studies, unclear for three studies, and low for six studies. Among the 14 studies that contributed to meta-analyses, none (n = 5), some (n = 5) or all (n = 4) children were stabilised in hospital prior to commencement of the study. One small study included only children known to be HIV-infected, another study stratified the analysis for 'recovery' according to HIV status, while the remaining studies included HIV-uninfected or untested children. Across all studies, the intervention lasted between 8 and 16 weeks. Only five studies followed up children postintervention (maximum of six months), and generally reported on a limited number of outcomes. We found seven studies with 2261 children comparing home-based RUTF meeting the World Health Organization (WHO) recommendations for nutritional composition (referred to in this review as standard RUTF) with an alternative dietary approach (effective sample size = 1964). RUTF probably improves recovery (risk ratio (RR) 1.33; 95% confidence interval (CI) 1.16 to 1.54; 6 studies, 1852 children; moderate-quality evidence), and may increase the rate of weight gain slightly (mean difference (MD) 1.12 g/kg/day, 95% CI 0.27 to 1.96; 4 studies, 1450 children; low-quality evidence), but we do not know the effects on relapse (RR 0.55, 95% CI 0.30 to 1.01; 4 studies, 1505 children; very low-quality evidence) and mortality (RR 1.05, 95% CI 0.51 to 2.16; 4 studies, 1505 children; very low-quality evidence). Two quasi-randomised cluster trials compared standard, home-based RUTF meeting total daily nutritional requirements with a similar RUTF but given as a supplement to the usual diet (213 children; effective sample size = 210). Meta-analysis showed that standard RUTF meeting total daily nutritional requirements may improve recovery (RR 1.41, 95% CI 1.19 to 1.68; low-quality evidence) and reduce relapse (RR 0.11, 95% CI 0.01 to 0.85; low-quality evidence), but the effects are unknown for mortality (RR 1.36, 95% CI 0.46 to 4.04; very low-quality evidence) and rate of weight gain (MD 1.21 g/kg/day, 95% CI - 0.74 to 3.16; very low-quality evidence). Eight studies randomised 5502 children (effective sample size = 4456) and compared standard home-based RUTF with RUTFs of alternative formulations (e.g. using locally available ingredients, containing less or no milk powder, containing specific fatty acids, or with added pre- and probiotics). For recovery, it made little or no difference whether standard or alternative formulation RUTF was used (RR 1.03, 95% CI 0.99 to 1.08; 6 studies, 4188 children; high-quality evidence). Standard RUTF decreases relapse (RR 0.84, 95% CI 0.72 to 0.98; 6 studies, 4188 children; high-quality evidence). However, it probably makes little or no difference to mortality (RR 1.00, 95% CI 0.80 to 1.24; 7 studies, 4309 children; moderate-quality evidence) and may make little or no difference to the rate of weight gain (MD 0.11 g/kg/day, 95% CI −0.32 to 0.54; 6 studies, 3807 children; low-quality evidence) whether standard or alternative formulation RUTF is used. Compared to alternative dietary approaches, standard RUTF probably improves recovery and may increase rate of weight gain slightly, but the effects on relapse and mortality are unknown. Standard RUTF meeting total daily nutritional requirements may improve recovery and relapse compared to a similar RUTF given as a supplement to the usual diet, but the effects on mortality and rate of weight gain are not clear. When comparing RUTFs with different formulations, the current evidence does not favour a particular formulation, except for relapse, which is reduced with standard RUTF. Well-designed, adequately powered, pragmatic RCTs with standardised outcome measures, stratified by HIV status, and that include diarrhoea as an outcome, are needed.
|
We searched databases for studies up to the October 2018, and found 15 studies with 7976 children. Eight studies were conducted in Malawi, four in India, and one apiece in Kenya, Zambia, and Cambodia. One small study included only children infected with HIV, another study analysed children with and without HIV separately for the main outcome (recovery), while the other studies included children who were not infected with HIV or who were untested. Overall, we judged six studies to be at high risk of bias, three studies to be at unclear risk of bias, and six studies to be at low risk of bias. (With 'risk of bias', we mean the extent to which the methods used in a study enable it to determine the truth.) All the studies lasted between 8 and 16 weeks. Only five studies followed up children after the study (for a maximum of six months), and generally reported on a limited number of outcomes. Of our 15 included studies, six were linked to funding or donations from industry, one did not report the source of funding, and eight studies reported funding where sponsors did not include industry. Compared to alternative dietary approaches, standard RUTF probably improves recovery (moderate-quality evidence) and may increase the rate of weight gain slightly (low-quality evidence), but the effects on relapse and death are unknown (very low-quality evidence). With 'quality of evidence' we mean how confident we are that the particular finding represents the true effect. For example, 'very low-quality' means we are very uncertain about the finding, 'low-quality evidence' means the future research is very likely to change the finding, 'moderate-quality evidence' means that future studies may change this finding, and 'high-quality evidence' means that it is unlikely that future studies will change the finding. Standard RUTF meeting total daily nutritional requirements may improve recovery and relapse compared to a similar RUTF given supplementary to the usual diet (low-quality evidence), but for death and the rate of weight gain, the effects are not known (very low-quality evidence). When comparing RUTFs of different formulations, it makes little or no difference for recovery whether a standard or alternative formulation RUTF is used (high-quality evidence). For relapse, using standard RUTF decreases relapse (high-quality evidence). It probably makes little or no difference to death (moderate-quality evidence) and to the rate of weight gain (low-quality evidence) whether standard or alternative formulation RUTF is used. Well-designed, randomised controlled trials (experimental studies where participants meeting the inclusion criteria have an equal chance of being allocated to any of the intervention or control groups) in which analyses have been performed separately for children with and without HIV, and that also measure and report on diarrhoea occurrence, are needed.
|
10.1002/14651858.CD009000.pub3
|
[
"We searched databases for studies up to the October 2018, and found 15 studies with 7976 children. Eight studies were conducted in Malawi, four in India, and one apiece in Kenya, Zambia, and Cambodia. One small study included only children infected with HIV, another study analysed children with and without HIV separately for the main outcome (recovery), while the other studies included children who were not infected with HIV or who were untested. Overall, we judged six studies to be at high risk of bias, three studies to be at unclear risk of bias, and six studies to be at low risk of bias. (With 'risk of bias', we mean the extent to which the methods used in a study enable it to determine the truth.) All the studies lasted between 8 and 16 weeks. Only five studies followed up children after the study (for a maximum of six months), and generally reported on a limited number of outcomes. Of our 15 included studies, six were linked to funding or donations from industry, one did not report the source of funding, and eight studies reported funding where sponsors did not include industry. Compared to alternative dietary approaches, standard RUTF probably improves recovery (moderate-quality evidence) and may increase the rate of weight gain slightly (low-quality evidence), but the effects on relapse and death are unknown (very low-quality evidence). With 'quality of evidence' we mean how confident we are that the particular finding represents the true effect. For example, 'very low-quality' means we are very uncertain about the finding, 'low-quality evidence' means the future research is very likely to change the finding, 'moderate-quality evidence' means that future studies may change this finding, and 'high-quality evidence' means that it is unlikely that future studies will change the finding. Standard RUTF meeting total daily nutritional requirements may improve recovery and relapse compared to a similar RUTF given supplementary to the usual diet (low-quality evidence), but for death and the rate of weight gain, the effects are not known (very low-quality evidence). When comparing RUTFs of different formulations, it makes little or no difference for recovery whether a standard or alternative formulation RUTF is used (high-quality evidence). For relapse, using standard RUTF decreases relapse (high-quality evidence). It probably makes little or no difference to death (moderate-quality evidence) and to the rate of weight gain (low-quality evidence) whether standard or alternative formulation RUTF is used. Well-designed, randomised controlled trials (experimental studies where participants meeting the inclusion criteria have an equal chance of being allocated to any of the intervention or control groups) in which analyses have been performed separately for children with and without HIV, and that also measure and report on diarrhoea occurrence, are needed."
] |
cochrane-simplification-train-1527
|
cochrane-simplification-train-1527
|
Our search strategy identified six reports for potential inclusion. Of those, we included one trial (four reports) involving 158 women, which was at low risk of bias. The one included trial examined the effect of prenatal repair versus postnatal repair. For the primary infant outcome of neonatal mortality, there was no clear evidence of a difference identified for prenatal versus postnatal repair (one study, 158 infants, risk ratio (RR) 0.51, 95% confidence interval (CI) 0.05 to 5.54), however event rates were uncommon and so the analysis is likely to be underpowered to detect differences. Prenatal repair was associated with an earlier gestational age at birth (one study, 158 infants, mean difference (MD) -3.20 weeks, 95% CI -3.93 to -2.47) and a corresponding increase in both the risk of preterm birth before 37 weeks (one study, 158 infants, RR 5.30, 95% CI 3.11 to 9.04) and preterm birth before 34 weeks (one study, 158 infants, RR 9.23, 95% CI 3.45 to 24.71). Prenatal repair was associated with a reduction in shunt dependent hydrocephalus and moderate to severe hindbrain herniation. For women, prenatal repair was associated with increased preterm ruptured membranes (one study, 158 women, RR 6.15, 95% CI 2.75 to 13.78), although there was no clear evidence of difference in the risk of chorioamnionitis or blood transfusion, although again, event rates were uncommon. A number of this review's secondary infant and maternal outcomes were not reported. For the infant: days of hospital admission; survival to discharge; stillbirth; need for further surgery (e.g. skin grafting); neurogenic bladder dysfunction; childhood/infant quality of life. For the mother: admission to intensive care; women's emotional wellbeing and satisfaction with care. This review is based one small well-conducted study. There is insufficient evidence to recommend drawing firm conclusions on the benefits or harms of prenatal repair as an intervention for fetuses with spina bifida. Current evidence is limited by the small number of pregnancies that have been included in the single conducted randomised trial to date.
|
This review aimed to compare the effects of in utero repair versus repair as a newborn. We included one randomised controlled trial involving 158 women who were from 19 to 27 weeks pregnant with a baby with severe spina bifida and evidence of hindbrain herniation. For neonatal mortality, there was no clear difference identified for prenatal versus postnatal repair. However, the numbers of neonates who died were low and so the review was likely underpowered to detect any difference. Prenatal repair was associated with reduced need for shunt placement and a reduction in the risk of moderate to severe hindbrain herniation after birth. No direct complications of the repair procedure were evident, including orthopaedic deformities. Prenatal repair was associated with an increased risk of the women experiencing preterm ruptured membranes and subsequent preterm birth (both before 34 and 37 weeks). Severe maternal illness (infection and need for blood transfusion) were not clearly different; although the review was underpowered to detect any difference in these important, less common outcomes. The included trial was of high quality (low risk of bias) but included a small number of pregnancies. There is currently insufficient evidence to recommend in utero repair for unborn babies with spina bifida.
|
10.1002/14651858.CD008825.pub2
|
[
"This review aimed to compare the effects of in utero repair versus repair as a newborn. We included one randomised controlled trial involving 158 women who were from 19 to 27 weeks pregnant with a baby with severe spina bifida and evidence of hindbrain herniation. For neonatal mortality, there was no clear difference identified for prenatal versus postnatal repair. However, the numbers of neonates who died were low and so the review was likely underpowered to detect any difference. Prenatal repair was associated with reduced need for shunt placement and a reduction in the risk of moderate to severe hindbrain herniation after birth. No direct complications of the repair procedure were evident, including orthopaedic deformities. Prenatal repair was associated with an increased risk of the women experiencing preterm ruptured membranes and subsequent preterm birth (both before 34 and 37 weeks). Severe maternal illness (infection and need for blood transfusion) were not clearly different; although the review was underpowered to detect any difference in these important, less common outcomes. The included trial was of high quality (low risk of bias) but included a small number of pregnancies. There is currently insufficient evidence to recommend in utero repair for unborn babies with spina bifida."
] |
cochrane-simplification-train-1528
|
cochrane-simplification-train-1528
|
We identified six studies eligible for inclusion in this review; five RCTs and one NRS. Three completed RCTs (156 participants), one completed NRS (84 participants), and two ongoing RCTs. We identified one additional RCT awaiting classification. The completed studies were conducted between 1997 and 2015 and had a mean follow-up from 31 days to 2 years. One study included children receiving a HSCT (six participants), the other three studies only included adults: 218 participants with acute leukaemia receiving chemotherapy, and 16 with a haematological malignancy receiving a HSCT. The restrictive strategies varied from 70 g/L to 90 g/L. The liberal strategies also varied from 80 g/L to 120 g/L. Based on the GRADE rating methodology the overall quality of the included studies was very low to low across different outcomes. None of the included studies were free from bias for all 'Risk of bias' domains. One of the three RCTs was discontinued early for safety concerns after recruiting only six children, all three participants in the liberal group developed veno-occlusive disease (VOD). Evidence from RCTs A restrictive RBC transfusion policy may make little or no difference to: the number of participants who died within 100 days (two trials, 95 participants (RR: 0.25, 95% CI 0.02 to 2.69, low-quality evidence); the number of participants who experienced any bleeding (two studies, 149 participants; RR:0.93, 95% CI 0.73 to 1.18, low-quality evidence), or clinically significant bleeding (two studies, 149 participants, RR: 1.03, 95% CI 0.75 to 1.43, low-quality evidence); the number of participants who required RBC transfusions (three trials; 155 participants: RR: 0.97, 95% CI 0.90 to 1.05, low-quality evidence); or the length of hospital stay (restrictive median 35.5 days (interquartile range (IQR): 31.2 to 43.8); liberal 36 days (IQR: 29.2 to 44), low-quality evidence). We are uncertain whether the restrictive RBC transfusion strategy: decreases quality of life (one trial, 89 participants, fatigue score: restrictive median 4.8 (IQR 4 to 5.2); liberal median 4.5 (IQR 3.6 to 5) (very low-quality evidence); or reduces the risk of developing any serious infection (one study, 89 participants, RR: 1.23, 95% CI 0.74 to 2.04, very low-quality evidence). A restrictive RBC transfusion policy may reduce the number of RBC transfusions per participant (two trials; 95 participants; mean difference (MD) -3.58, 95% CI -5.66 to -1.49, low-quality evidence). Evidence from NRS We are uncertain whether the restrictive RBC transfusion strategy: reduces the risk of death within 100 days (one study, 84 participants, restrictive 1 death; liberal 1 death; very low-quality evidence); decreases the risk of clinically significant bleeding (one study, 84 participants, restrictive 3; liberal 8; very low-quality evidence); or decreases the number of RBC transfusions (adjusted for age, sex and acute myeloid leukaemia type geometric mean 1.25; 95% CI 1.07 to 1.47 - data analysis performed by the study authors) No NRS were found that looked at: quality of life; number of participants with any bleeding; serious infection; or length of hospital stay. No studies were found that looked at: adverse transfusion reactions; arterial or venous thromboembolic events; length of intensive care admission; or readmission to hospital. Findings from this review were based on four studies and 240 participants. There is low-quality evidence that a restrictive RBC transfusion policy reduces the number of RBC transfusions per participant. There is low-quality evidence that a restrictive RBC transfusion policy has little or no effect on: mortality at 30 to 100 days, bleeding, or hospital stay. This evidence is mainly based on adults with acute leukaemia who are having chemotherapy. Although, the two ongoing studies (530 participants) are due to be completed by January 2018 and will provide additional information for adults with haematological malignancies, we will not be able to answer this review's primary outcome. If we assume a mortality rate of 3% within 100 days we would need 1492 participants to have a 80% chance of detecting, as significant at the 5% level, an increase in all-cause mortality from 3% to 6%. Further RCTs are required in children.
|
We searched for randomised and prospective non-randomised trials. Six studies met our inclusion criteria, four are completed and two are still ongoing. An additional study is awaiting classification. The completed studies were conducted between 1997 and 2015 and included 240 participants. One study included children receiving a stem cell transplant and it was stopped early due to safety concerns (six children), the other three studies only included adults, 218 adults with acute leukaemia receiving chemotherapy, and 16 with a blood cancer receiving a stem cell transplant. Three studies were randomised controlled trials and the fourth was a non-randomised study. The haemoglobin threshold of the restrictive strategies varied across the studies. The sources of funding were reported in all four studies. One study was industry sponsored. The evidence is current to June 2016 and is mainly based on adults with acute leukaemia who are having chemotherapy. A restrictive red blood cell transfusion policy may reduce the number of red blood cell transfusions received by an individual. A restrictive red blood cell transfusion policy may have little or no effect on: whether an individual receives a red blood cell transfusion; death due to any cause; bleeding; or hospital stay. We are uncertain whether a restrictive red blood cell transfusion policy affects quality of life, or the risk of developing a serious infection. No studies were found that looked at: adverse reactions to transfusion; development of blood clots; length of stay in intensive care; or need to be readmitted to hospital. There are two ongoing trials (planning to recruit 530 adults) that are due to be completed by January 2018 and will provide additional information for adults with blood cancers. There are no ongoing trials in children. The overall quality of the evidence was very low to low as the included studies were at considerable risk of bias, the estimates were imprecise, and most of the evidence was only for adults with acute leukaemia.
|
10.1002/14651858.CD011305.pub2
|
[
"We searched for randomised and prospective non-randomised trials. Six studies met our inclusion criteria, four are completed and two are still ongoing. An additional study is awaiting classification. The completed studies were conducted between 1997 and 2015 and included 240 participants. One study included children receiving a stem cell transplant and it was stopped early due to safety concerns (six children), the other three studies only included adults, 218 adults with acute leukaemia receiving chemotherapy, and 16 with a blood cancer receiving a stem cell transplant. Three studies were randomised controlled trials and the fourth was a non-randomised study. The haemoglobin threshold of the restrictive strategies varied across the studies. The sources of funding were reported in all four studies. One study was industry sponsored. The evidence is current to June 2016 and is mainly based on adults with acute leukaemia who are having chemotherapy. A restrictive red blood cell transfusion policy may reduce the number of red blood cell transfusions received by an individual. A restrictive red blood cell transfusion policy may have little or no effect on: whether an individual receives a red blood cell transfusion; death due to any cause; bleeding; or hospital stay. We are uncertain whether a restrictive red blood cell transfusion policy affects quality of life, or the risk of developing a serious infection. No studies were found that looked at: adverse reactions to transfusion; development of blood clots; length of stay in intensive care; or need to be readmitted to hospital. There are two ongoing trials (planning to recruit 530 adults) that are due to be completed by January 2018 and will provide additional information for adults with blood cancers. There are no ongoing trials in children. The overall quality of the evidence was very low to low as the included studies were at considerable risk of bias, the estimates were imprecise, and most of the evidence was only for adults with acute leukaemia."
] |
cochrane-simplification-train-1529
|
cochrane-simplification-train-1529
|
37 studies fulfilled eligibility criteria, encompassing 5711 patients, 2866 randomised to routine tube use, and 2845 randomised to selective or No Tube use. Patients not having routine tube use had an earlier return of bowel function (p<0.00001), a decrease in pulmonary complications (p=0.09) and an insignificant trend toward increase in risk of wound infection (p=0.39) and ventral hernia (0.09). Anastomotic leak was no different between groups (p=0.70). Vomiting seemed to favour routine tube use, but with increased patient discomfort. Length of stay was shorter when no tube was used but the heterogeneity encountered in these analyses make rigorous conclusion difficult to draw for this outcome. No adverse events specifically related to tube insertion (direct tube trauma) were reported. Other outcomes were reported with insufficient frequency to be informative. Routine nasogastric decompression does not accomplish any of its intended goals and so should be abandoned in favour of selective use of the nasogastric tube.
|
This systematic review of 37 trials showed that routine use of nasogastric tube decompression after abdominal operations, rather than speeding recovery, may slow recovery down and increase the risk of some postoperative complications. On the other hand routine use may decrease the risk of wound infection and subsequent ventral hernia.
|
10.1002/14651858.CD004929.pub3
|
[
"This systematic review of 37 trials showed that routine use of nasogastric tube decompression after abdominal operations, rather than speeding recovery, may slow recovery down and increase the risk of some postoperative complications. On the other hand routine use may decrease the risk of wound infection and subsequent ventral hernia."
] |
cochrane-simplification-train-1530
|
cochrane-simplification-train-1530
|
Five trials involving 7391 women (2033 with a history of a pregnancy affected by a NTD and 5358 with no history of NTDs) were included. Four comparisons were made: 1) supplementation with any folate versus no intervention, placebo or other micronutrients without folate (five trials); 2) supplementation with folic acid alone versus no treatment or placebo (one trial); 3) supplementation with folate plus other micronutrients versus other micronutrients without folate (four trials); and 4) supplementation with folate plus other micronutrients versus the same other micronutrients without folate (two trials). The risk of bias of the trials was variable. Only one trial was considered to be at low risk of bias. The remaining studies lacked clarity regarding the randomisation method or whether the allocation to the intervention was concealed. All the participants were blinded to the intervention, though blinding was unclear for outcome assessors in the five trials. The results of the first comparison involving 6708 births with information on NTDs and other infant outcomes, show a protective effect of daily folic acid supplementation (alone or in combination with other vitamins and minerals) in preventing NTDs compared with no interventions/placebo or vitamins and minerals without folic acid (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.17 to 0.58); five studies; 6708 births; high quality evidence). Only one study assessed the incidence of NTDs and showed no evidence of an effect (RR 0.07, 95% CI 0.00 to 1.32; 4862 births) although no events were found in the group that received folic acid. Folic acid had a significant protective effect for reoccurrence (RR 0.34, 95% CI 0.18 to 0.64); four studies; 1846 births). Subgroup analyses suggest that the positive effect of folic acid on NTD incidence and recurrence is not affected by the explored daily folic acid dosage (400 µg (0.4 mg) or higher) or whether folic acid is given alone or with other vitamins and minerals. These results are consistent across all four review comparisons. There is no evidence of any preventive or negative effects on cleft palate (RR 0.73, 95% CI 0.05 to 10.89; three studies; 5612 births; low quality evidence), cleft lip ((RR 0.79, 95% CI 0.14 to 4.36; three studies; 5612 births; low quality evidence), congenital cardiovascular defects (RR 0.57, 95% CI 0.24 to 1.33; three studies; 5612 births; low quality evidence), miscarriages (RR 1.10, 95% CI 0.94 to 1.28; five studies; 7391 pregnancies; moderate quality evidence) or any other birth defects (RR 0.94, 95% CI 0.53 to 1.66; three studies; 5612 births; low quality evidence). There were no included trials assessing the effects of this intervention on neonatal death, maternal blood folate or anaemia at term. Folic acid, alone or in combination with vitamins and minerals, prevents NTDs, but does not have a clear effect on other birth defects.
|
This review confirms that folic acid supplementation prevents the first and second time occurrence of NTDs and shows there is not enough evidence to determine if folic acid prevents other birth defects. Information about the safety of other current and alternative supplementation schemes and any possible effects on other outcomes for mothers and babies is also lacking. This review of five trials, involving 7391 pregnancies (2033 with a history of a pregnancy affected by a NTD and 5358 with no history of NTDs), shows the protective effect of daily folic acid supplementation in doses ranging from 0.36 mg (360 µg) to 4 mg (4000 µg) a day, with and without other vitamins and minerals, before conception and up to 12 weeks of pregnancy, for preventing the recurrence of these defects. There were insufficient data to evaluate the effects on other outcomes such as cleft lip and palate, miscarriages or any other birth defects. More research is needed on different types of supplementation programmes and the use of different types of supplements (such as 5-methyl-tetrahydrofolate -5-MTHF), particularly in countries where folic acid fortification of staple foods like wheat or maize flour is not mandatory and where the prevalence of NTDs is still high. The overall quality of the evidence for neonatal outcomes was high for NTDs, whereas, it was of low quality for other neonatal outcomes. The overall quality of the evidence for maternal outcomes was rated as moderate.
|
10.1002/14651858.CD007950.pub3
|
[
"This review confirms that folic acid supplementation prevents the first and second time occurrence of NTDs and shows there is not enough evidence to determine if folic acid prevents other birth defects. Information about the safety of other current and alternative supplementation schemes and any possible effects on other outcomes for mothers and babies is also lacking. This review of five trials, involving 7391 pregnancies (2033 with a history of a pregnancy affected by a NTD and 5358 with no history of NTDs), shows the protective effect of daily folic acid supplementation in doses ranging from 0.36 mg (360 µg) to 4 mg (4000 µg) a day, with and without other vitamins and minerals, before conception and up to 12 weeks of pregnancy, for preventing the recurrence of these defects. There were insufficient data to evaluate the effects on other outcomes such as cleft lip and palate, miscarriages or any other birth defects. More research is needed on different types of supplementation programmes and the use of different types of supplements (such as 5-methyl-tetrahydrofolate -5-MTHF), particularly in countries where folic acid fortification of staple foods like wheat or maize flour is not mandatory and where the prevalence of NTDs is still high. The overall quality of the evidence for neonatal outcomes was high for NTDs, whereas, it was of low quality for other neonatal outcomes. The overall quality of the evidence for maternal outcomes was rated as moderate."
] |
cochrane-simplification-train-1531
|
cochrane-simplification-train-1531
|
One study (recruiting 48 women with idiopathic hyperprolactinemia) met our inclusion criteria; 46 women (42 pregnancies - 4/46 women did not conceive during the study period) were included in the analysis. The study compared the use of a dopamine agonist (bromocriptine, 2.5 mg to 5.0 mg/day until the end of the ninth week of gestation) versus a no-treatment control. The study was judged as being at a high risk of bias. It was not possible to carry out meta-analysis due to insufficient data. The study reported both of this review's primary outcomes of miscarriage and live birth. Results from this single study suggest that, compared to no treatment, oral bromocriptine was effective in preventing future miscarriage (risk ratio (RR) 0.28, 95% confidence interval (CI) 0.09 to 0.87, 46 participants (low-quality evidence)) in women with idiopathic hyperprolactinemia. There was no clear difference with regard to the other primary outcome of live births (RR 1.50, 95% CI 0.93 to 2.42, 46 participants (very low-quality evidence)). There was no difference with regard to this review's secondary outcome of conception (RR 0.92, 95% CI 0.77 to 1.09, 46 participants (very low-quality evidence)) between the group of women who received dopamine (21 out of 24 women conceived) and women in the no-treatment group (21 out of 22 women conceived). The included study only reported the serum prolactin levels in pregnant women and therefore the data could not be analyzed in this review. No other secondary outcomes relevant to this review were reported; adverse effects for women (nausea, vomiting, headache, vertigo, fatigue, hypotension, arrhythmia, and psychotic symptoms) and infants (birth defects, low birthweight, and developmental disabilities) were not reported. We downgraded the quality of the evidence for risk of bias in the one trial contributing outcome data (no description of allocation concealment, lack of blinding and possible reporting bias) and for imprecision (all effect estimates were based on small sample size, miscarriage was based on few events, and the 95% CIs of live birth and conception cross the line of no effect). Currently, there is insufficient evidence (from a single randomized trial with a small sample size, and judged to be at high risk of bias) to evaluate the effectiveness of dopamine agonists for preventing future miscarriage in women with idiopathic hyperprolactinemia and a history of recurrent miscarriage. We assessed outcomes using GRADE methodology. Miscarriage was assessed as low quality due to risk of bias concerns in the one trial contributing data (no description of allocation concealment, lack of blinding and possible reporting bias) and to imprecision (effect estimates were based on small sample size and few events). Live births and conception were assessed as of very low quality due to the same risk of bias concerns in study design and to imprecision (with a wide 95% CI consistent with either benefit or harm), and a small sample size. There were no data relating to adverse effects of the intervention for either the mother or her baby. Futher high-quality research in this area is warranted. There is a need for well-designed, larger RCTs to confirm and extend the findings of the trial reviewed here. Many questions remain unanswered. Some important considerations for future research include, the need for well-designed RCTs with large sample sizes, and for those studies to consider important outcomes (including adverse effects for both the mother and her baby). Future studies should examine the effectiveness and safety of various dopamine agonists including bromocriptine, cabergoline and quinagolide.
|
We searched for evidence on 30 June 2016 and identified one trial with a small number of women - 48 women were recruited but 46 women (42 pregnancies - 4/46 women did not conceive during the study period) are included in the analysis). The trial took place in Japan and was judged to have a high risk of bias. The trial included women (aged 24 to 40 years) with idiopathic hyperprolactinemia and a history of two to four spontaneous miscarriages; 24 had occult hyperprolactinemia with equal numbers in each group. Women were followed during the study (until the end of the ninth week of pregnancy) and then observed for one year afterwards. In the study, one group of women received a dopamine agonist, bromocriptine (2.5 to 5.0 mg/day until the end of the ninth week of gestation), and the other group of women did not receive any treatment (control group). Evidence from this study showed that the dopamine agonist bromocriptine was effective in preventing future miscarriage (low-quality evidence). However, live birth and conception rates remained similar between women who received bromocriptine and the women who did not receive treatment (very low-quality evidence). The study only reported on serum prolactin levels in the women who were pregnant. The study did not report on any adverse effects that dopamine agonists might possibly have for the women (e.g. nausea, vomiting, headache, vertigo, fatigue, hypotension, arrhythmia, and psychotic symptoms) or her baby (e.g. birth defects, low birthweight, and developmental disabilities). We rated the evidence for the review outcomes of miscarriage as low quality and live birth and conception as very low quality due to questions we had about the study design, the small number of women in the study, and because only one randomized controlled study was identified. Currently, there is not enough evidence (from one small trial) to evaluate the effectiveness and safety of dopamine agonists for preventing future miscarriage in women with idiopathic hyperprolactinemia and recurrent miscarriage history. There is a need for further, high-quality research in this area. Future studies (involving large numbers of women) are needed to expand on the findings of this review. Further studies should examine various dopamine agonists (including bromocriptine, cabergoline and quinagolide) and consider important outcomes (including adverse effects for both the mother and her baby).
|
10.1002/14651858.CD008883.pub2
|
[
"We searched for evidence on 30 June 2016 and identified one trial with a small number of women - 48 women were recruited but 46 women (42 pregnancies - 4/46 women did not conceive during the study period) are included in the analysis). The trial took place in Japan and was judged to have a high risk of bias. The trial included women (aged 24 to 40 years) with idiopathic hyperprolactinemia and a history of two to four spontaneous miscarriages; 24 had occult hyperprolactinemia with equal numbers in each group. Women were followed during the study (until the end of the ninth week of pregnancy) and then observed for one year afterwards. In the study, one group of women received a dopamine agonist, bromocriptine (2.5 to 5.0 mg/day until the end of the ninth week of gestation), and the other group of women did not receive any treatment (control group). Evidence from this study showed that the dopamine agonist bromocriptine was effective in preventing future miscarriage (low-quality evidence). However, live birth and conception rates remained similar between women who received bromocriptine and the women who did not receive treatment (very low-quality evidence). The study only reported on serum prolactin levels in the women who were pregnant. The study did not report on any adverse effects that dopamine agonists might possibly have for the women (e.g. nausea, vomiting, headache, vertigo, fatigue, hypotension, arrhythmia, and psychotic symptoms) or her baby (e.g. birth defects, low birthweight, and developmental disabilities). We rated the evidence for the review outcomes of miscarriage as low quality and live birth and conception as very low quality due to questions we had about the study design, the small number of women in the study, and because only one randomized controlled study was identified. Currently, there is not enough evidence (from one small trial) to evaluate the effectiveness and safety of dopamine agonists for preventing future miscarriage in women with idiopathic hyperprolactinemia and recurrent miscarriage history. There is a need for further, high-quality research in this area. Future studies (involving large numbers of women) are needed to expand on the findings of this review. Further studies should examine various dopamine agonists (including bromocriptine, cabergoline and quinagolide) and consider important outcomes (including adverse effects for both the mother and her baby)."
] |
cochrane-simplification-train-1532
|
cochrane-simplification-train-1532
|
We identified six randomised controlled trials with a total of 597 participants that were eligible for inclusion in the 2013 review. No new studies were eligible for inclusion in this update. Participants in the included studies, where dementia severity was reported, had mild to moderate severity of vascular dementia (four trials). The included studies tested varying doses and duration of Cerebrolysin treatment. Follow-up ranged from 15 days to three years. Five of included studies were conducted in China (three studies), Russia (one study), and Romania (one study), while relevant information of other study was unclear. Where details of funding were available, all studies were supported by the pharmaceutical industry (three studies). Cognitive function was measured using the Mini-Mental State Examination (MMSE) or Alzheimer's Disease Assessment Scale Cognitive Subpart, extended version (ADAS-cog+). Combining the MMSE and ADAS-cog+ data (three studies, 420 people), there was a beneficial effect of Cerebrolysin (SMD 0.36, 95% CI 0.13 to 0.58; very low-quality evidence). Global function was measured by Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC+) or Investigator's Clinical Global Impression (CGI). We assessed response rates on these measures (the proportion of participants with a CIBIC+ score of < 3; or at least moderate improvement of the CGI rating at the last visit). There was a beneficial effect of Cerebrolysin (two studies, 379 participants, RR 2.69, 95% CI 1.82 to 3.98; very low-quality evidence). Only one trial described mortality and reported no deaths. Four studies reported adverse events; data from two studies (379 people) were in a format that permitted meta-analysis, and there was no difference in rates of adverse effects (RR 0.91, 95% CI 0.29 to 2.85; very low-quality evidence). No studies reported on quality of life or caregiver burden. Courses of intravenous Cerebrolysin improved cognition and general function in people living with vascular dementia, with no suggestion of adverse effects. However, these data are not definitive. Our analyses were limited by heterogeneity, and the included papers had high risk of bias. If there are benefits of Cerebrolysin, the effects may be too small to be clinically meaningful. There have been no new studies of Cerebrolysin in vascular dementia since the last Cochrane Review. Cerebrolysin continues to be used and promoted as a treatment for vascular dementia, but the supporting evidence base is weak. Adequately powered, methodologically robust trials are needed to properly assess the effects of Cerebrolysin in vascular dementia.
|
We found six studies including a total of 597 people living with vascular dementia. The method of Cerebrolysin treatment differed across studies, with varying strengths of Cerebrolysin and treatment durations. The studies reported that Cerebrolysin had beneficial effects on memory and thinking and on daily functioning. There was no reported risk of side effects with treatment. None of the studies described quality of life of people living with vascular dementia or their caregivers. Although the studies suggested a benefit of Cerebrolysin treatment, the results are not definitive. The included studies had several issues that may have led to misleading results. Even if the benefit reported in the studies is real, the effect was modest and may not be important to people living with dementia. There is a need for a large, well-conducted study to better understand if Cerebrolysin is a useful treatment for people living with vascular dementia.
|
10.1002/14651858.CD008900.pub3
|
[
"We found six studies including a total of 597 people living with vascular dementia. The method of Cerebrolysin treatment differed across studies, with varying strengths of Cerebrolysin and treatment durations. The studies reported that Cerebrolysin had beneficial effects on memory and thinking and on daily functioning. There was no reported risk of side effects with treatment. None of the studies described quality of life of people living with vascular dementia or their caregivers. Although the studies suggested a benefit of Cerebrolysin treatment, the results are not definitive. The included studies had several issues that may have led to misleading results. Even if the benefit reported in the studies is real, the effect was modest and may not be important to people living with dementia. There is a need for a large, well-conducted study to better understand if Cerebrolysin is a useful treatment for people living with vascular dementia."
] |
cochrane-simplification-train-1533
|
cochrane-simplification-train-1533
|
Two trials were included in this review. There was no significant difference between the two treatment groups for the frequency of discontinuation for either contraceptive, although the women on NET-EN were 4% more likely to discontinue for personal reasons than those on DPMA. Discontinuation because of accidental pregnancy did not differ between the groups. Although the duration of bleeding and spotting events was the same in each group, women on DPMA were 21% more likely to develop amenorrhoea. Mean changes in body weight at 12 and 24 months, and in systolic and diastolic blood pressure at 12 months did not differ significantly between the studies. While the choice between DPMA and NET-EN as injectable progestogen contraceptives may vary between both health providers and patients, data from randomized controlled trials indicate little difference between the effects of these methods, except that women on DMPA are more likely to develop amenorrhoea. There is inadequate data to detect differences in some non-menstrual major and minor clinical effects.
|
In summary, therefore, data from the trials included in this review indicate little difference between the effects of these methods, except that women on DMPA are more likely to experience cessation of vaginal bleeding during its use. There was inadequate data to detect differences in some non-menstrual clinical effects, and considering that this contraceptive method remains in use in some countries, further research is indicated.
|
10.1002/14651858.CD005214.pub2
|
[
"In summary, therefore, data from the trials included in this review indicate little difference between the effects of these methods, except that women on DMPA are more likely to experience cessation of vaginal bleeding during its use. There was inadequate data to detect differences in some non-menstrual clinical effects, and considering that this contraceptive method remains in use in some countries, further research is indicated."
] |
cochrane-simplification-train-1534
|
cochrane-simplification-train-1534
|
A total of 15 trials (n = 888 randomised participants) were included, 13 were placebo controlled and three were head to head (two trials had more than two treatment arms). Eleven of the trials were conducted in Turkey, two in Japan, one in Iran and one in the UK. Most trials used the International Study Group criteria for Behçet's disease. Eleven different interventions were assessed. The interventions were grouped into two categories, topical and systemic. Only one study was assessed as being at low risk of bias. It was not possible to carry out a meta-analysis. The quality of the evidence ranged from moderate to very low and there was insufficient evidence to support or refute the use of any included intervention with regard to pain, episode duration, or episode frequency associated with oral ulcers, or safety of the interventions. Due to the heterogeneity of trials including trial design, choice of intervention, choice and timing of outcome measures, it was not possible to carry out a meta-analysis. Several interventions show promise and future trials should be planned and reported according to the CONSORT guidelines. Whilst the primary aim of many trials for Behç̧et's disease is not necessarily reduction of oral ulceration, reporting of oral ulcers in these studies should be standardised and pre-specified in the methodology. The use of a core outcome set for oral ulcer trials would be beneficial.
|
Authors from Cochrane Oral Health carried out this review of existing studies and the evidence is current up to 4 October 2013. The review includes 15 studies published from 1980 to 2012 in which 888 participants were randomised. Eleven of the trials were conducted in Turkey, two in Japan, one in Iran, and one in the UK. Thirteen different interventions were assessed, administered either topically or systemically. Topical interventions: sucralfate, interferon–alpha (different doses), cyclosporin A, triamcinolone acetonide ointment, phenytoin syrup mouthwash. Systemic interventions: aciclovir, thalidomide (different doses), corticosteroids, rebamipide, etanercept, colchicine, interferon–alpha, cyclosporin. There was insufficient evidence to support or refute the use of any included intervention with regard to pain, episode duration or episode frequency associated with oral ulcers, or the safety of the interventions. The quality of the evidence ranged from moderate to very low.
|
10.1002/14651858.CD011018.pub2
|
[
"Authors from Cochrane Oral Health carried out this review of existing studies and the evidence is current up to 4 October 2013. The review includes 15 studies published from 1980 to 2012 in which 888 participants were randomised. Eleven of the trials were conducted in Turkey, two in Japan, one in Iran, and one in the UK. Thirteen different interventions were assessed, administered either topically or systemically. Topical interventions: sucralfate, interferon–alpha (different doses), cyclosporin A, triamcinolone acetonide ointment, phenytoin syrup mouthwash. Systemic interventions: aciclovir, thalidomide (different doses), corticosteroids, rebamipide, etanercept, colchicine, interferon–alpha, cyclosporin. There was insufficient evidence to support or refute the use of any included intervention with regard to pain, episode duration or episode frequency associated with oral ulcers, or the safety of the interventions. The quality of the evidence ranged from moderate to very low."
] |
cochrane-simplification-train-1535
|
cochrane-simplification-train-1535
|
Four studies, involving a total of 183 participants and 257 teeth were identified. Each of the interventions aimed to reduce infection or alter the inflammatory response or both at the time of or shortly after the tooth or teeth were replanted. Each study assessed a different intervention and therefore it was not appropriate or possible to numerically synthesise the data. All evidence was rated as being of very low quality due to problems with risk of bias and imprecision of results. This means that we are very uncertain about all of the results presented in this review. One study at high risk of bias with 69 participants (138 teeth) compared a 20-minute soak with gentamycin sulphate for both groups prior to replantation with the experimental group receiving daily hyperbaric oxygen for 80 minutes for the first 10 days. There was some evidence of a benefit for the hyperbaric oxygen group in respect of periodontal healing, tooth survival, and pulpal healing. One study at unclear risk of bias with 22 participants (27 teeth) compared the use of two root canal medicaments, Ledermix and Ultracal. There was insufficient evidence of a difference for periodontal healing or tooth survival. This was the only study to formally report adverse events with none identified. Study authors reported that Ledermix caused a greater level of patient dissatisfaction with the colour of avulsed and replanted teeth. A third study at high risk of bias with 19 participants compared extra- or intra-oral endodontics for avulsed teeth which were stored dry for longer than 60 minutes before replantation. There was insufficient evidence of a difference in periodontal healing. The fourth study at high risk of bias with 73 participants compared a 10-minute soak in either thymosin alpha 1 or saline before replantation followed by daily gingival injections with these same medicaments for the first 7 days. There was some evidence of a benefit for thymosin alpha 1 with respect to periodontal healing and tooth survival. Based on the results of the included studies, there is insufficient evidence to support or refute the effectiveness of different interventions for avulsed and replanted permanent front teeth. The overall quality of existing evidence was very low, and therefore great caution should be exercised when generalising the results of the included trials. There is urgent need for further well-designed randomised controlled trials.
|
Authors from Cochrane Oral Health carried out this review and the evidence is up to date to 8 March 2018. The review investigated what treatments encourage the tooth to repair by periodontal healing. A total of four studies were included with a total of 183 participants with 257 teeth. One study involved children and young adults, with the other three involving children only. Each study evaluated a different treatment: hyperbaric oxygen, root canal pastes (Ledermix versus Ultracal), removal of the nerve of the tooth (pulp extirpation), and soaking the knocked out tooth in thymosin alpha 1. Each of the interventions aimed to reduce infection or change the inflammatory response or both, at the time of or shortly after the tooth or teeth were replanted. The evidence currently available is insufficient to draw reliable conclusions regarding the superiority of different interventions for knocked out and replanted permanent front teeth. There is urgent need for further well-designed randomised controlled trials. We judged the quality of the evidence to be very low due to problems with the design of the studies.
|
10.1002/14651858.CD006542.pub3
|
[
"Authors from Cochrane Oral Health carried out this review and the evidence is up to date to 8 March 2018. The review investigated what treatments encourage the tooth to repair by periodontal healing. A total of four studies were included with a total of 183 participants with 257 teeth. One study involved children and young adults, with the other three involving children only. Each study evaluated a different treatment: hyperbaric oxygen, root canal pastes (Ledermix versus Ultracal), removal of the nerve of the tooth (pulp extirpation), and soaking the knocked out tooth in thymosin alpha 1. Each of the interventions aimed to reduce infection or change the inflammatory response or both, at the time of or shortly after the tooth or teeth were replanted. The evidence currently available is insufficient to draw reliable conclusions regarding the superiority of different interventions for knocked out and replanted permanent front teeth. There is urgent need for further well-designed randomised controlled trials. We judged the quality of the evidence to be very low due to problems with the design of the studies."
] |
cochrane-simplification-train-1536
|
cochrane-simplification-train-1536
|
We included eight trials involving 743 participants (369 children and 374 adults). All trials gave antibiotics to both placebo and corticosteroid groups; no trials assessed corticosteroids as standalone treatment for sore throat. In addition to any effect of antibiotics and analgesia, corticosteroids increased the likelihood of complete resolution of pain at 24 hours by more than three times (risk ratio (RR) 3.2, 95% confidence interval (CI) 2.0 to 5.1, P < 0.001, I2 statistic 44%) and at 48 hours by 1.7 times. Fewer than four people need to be treated to prevent one person continuing to experience pain at 24 hours. Corticosteroids also reduced the mean time to onset of pain relief and the mean time to complete resolution of pain by 6 and 14 hours, respectively, although significant heterogeneity was present. At 24 hours, pain (assessed by visual analogue scores) was reduced by an additional 14% by corticosteroids. No difference in rates of recurrence, relapse or adverse events were reported for participants taking corticosteroids compared to placebo, although reporting of adverse events was poor. Oral or intramuscular corticosteroids, in addition to antibiotics, increase the likelihood of both resolution and improvement of pain in participants with sore throat. Further trials assessing corticosteroids in the absence of antibiotics and in children are warranted.
|
This systematic review combined the results of eight trials which looked at this question, including a total of 743 participants. Patients taking corticosteroids were three times more likely to experience complete resolution of their sore throat symptoms by 24 hours compared to those taking placebo. In addition, corticosteroids improved the time to onset of symptom relief and the time to complete resolution of symptoms, although the trials were not consistent for these outcomes. Adverse events, relapse rates and recurrence rates were not different for corticosteroid compared to placebo groups. Limitations of the review include the absence of any trials set in Europe and the fact that only two trials addressed the question in children. As all the included trials also gave antibiotics to all participants, we recommend that future research should examine the benefit of corticosteroids in patients who are not also taking antibiotics.
|
10.1002/14651858.CD008268.pub2
|
[
"This systematic review combined the results of eight trials which looked at this question, including a total of 743 participants. Patients taking corticosteroids were three times more likely to experience complete resolution of their sore throat symptoms by 24 hours compared to those taking placebo. In addition, corticosteroids improved the time to onset of symptom relief and the time to complete resolution of symptoms, although the trials were not consistent for these outcomes. Adverse events, relapse rates and recurrence rates were not different for corticosteroid compared to placebo groups. Limitations of the review include the absence of any trials set in Europe and the fact that only two trials addressed the question in children. As all the included trials also gave antibiotics to all participants, we recommend that future research should examine the benefit of corticosteroids in patients who are not also taking antibiotics."
] |
cochrane-simplification-train-1537
|
cochrane-simplification-train-1537
|
Of 10 eligible studies eight were included in the analyses; two were of insufficient quality. Three trials (746 patients, low quality of evidence) of efficacy in acute bronchitis in adults showed effectiveness for most outcomes in the liquid preparation but not for tablets. Three other trials (819 children, low quality of evidence) showed similar results for acute bronchitis in children. For both meta-analyses, we did not pool subtotals due to relevant heterogeneity induced by type of preparation. One study in patients with sinusitis (n = 103 adults, very low quality of evidence) showed significant treatment effects (complete resolution at day 21; RR 0.43, 95% confidence interval (CI) 0.30 to 0.62). One study in the common cold demonstrated efficacy after 10 days, but not five days (very low quality of evidence). We rated the study quality as moderate for all studies (unvalidated outcome assessment, minor attrition problems, investigator-initiated trials only). Based on the funnel plot there was suspicion of publication bias. There were no valid data for the treatment of other acute respiratory tract infections. Adverse events were more common with P. sidoides, but none were serious. P. sidoides may be effective in alleviating symptoms of acute rhinosinusitis and the common cold in adults, but doubt exists. It may be effective in relieving symptoms in acute bronchitis in adults and children, and sinusitis in adults. The overall quality of the evidence was considered low for main outcomes in acute bronchitis in children and adults, and very low for acute sinusitis and the common cold. Reliable data on treatment for other ARIs were not identified.
|
We reviewed 10 randomized clinical trials of which eight were of sufficient quality for inclusion into the analyses. Three trials dealt with acute bronchitis in adults and showed inconsistent but overall positive results for resolution of symptoms (all symptoms, cough and sputum production). For acute bronchitis in children, there were also three studies showing an inconsistent but overall positive combined effect. The available data indicate that the tablet form may be less effective compared to the alcoholic extract. However, the number of trials is not sufficient to prove this. One study each was available for the treatment of acute sinusitis and the common cold in adults. Both showed that the drug was effective in resolving all symptoms including headaches and nasal discharge when taken for an extended time period. Adverse events were more common with P. sidoides, but none were severe. Overall we considered the quality of the evidence low or very low for all major outcomes as there were few studies per disease entity, and all were from the same investigator (the manufacturer) and performed in the same region (Ukraine and Russia). Thus, in summary, there is limited evidence for the effectiveness of P. sidoides in the treatment of ARIs. The evidence is up to date as of April 2013.
|
10.1002/14651858.CD006323.pub3
|
[
"We reviewed 10 randomized clinical trials of which eight were of sufficient quality for inclusion into the analyses. Three trials dealt with acute bronchitis in adults and showed inconsistent but overall positive results for resolution of symptoms (all symptoms, cough and sputum production). For acute bronchitis in children, there were also three studies showing an inconsistent but overall positive combined effect. The available data indicate that the tablet form may be less effective compared to the alcoholic extract. However, the number of trials is not sufficient to prove this. One study each was available for the treatment of acute sinusitis and the common cold in adults. Both showed that the drug was effective in resolving all symptoms including headaches and nasal discharge when taken for an extended time period. Adverse events were more common with P. sidoides, but none were severe. Overall we considered the quality of the evidence low or very low for all major outcomes as there were few studies per disease entity, and all were from the same investigator (the manufacturer) and performed in the same region (Ukraine and Russia). Thus, in summary, there is limited evidence for the effectiveness of P. sidoides in the treatment of ARIs. The evidence is up to date as of April 2013."
] |
cochrane-simplification-train-1538
|
cochrane-simplification-train-1538
|
We included 27 trials with 12,835 cases of sore throat. We did not identify any new trials in this 2013 update. 1. Symptoms Throat soreness and fever were reduced by about half by using antibiotics. The greatest difference was seen at day three. The number needed to treat to benefit (NNTB) to prevent one sore throat at day three was less than six; at week one it was 21. 2. Non-suppurative complications The trend was antibiotics protecting against acute glomerulonephritis but there were too few cases to be sure. Several studies found antibiotics reduced acute rheumatic fever by more than two-thirds within one month (risk ratio (RR) 0.27; 95% confidence interval (CI) 0.12 to 0.60). 3. Suppurative complications Antibiotics reduced the incidence of acute otitis media within 14 days (RR 0.30; 95% CI 0.15 to 0.58); acute sinusitis within 14 days (RR 0.48; 95% CI 0.08 to 2.76); and quinsy within two months (RR 0.15; 95% CI 0.05 to 0.47) compared to those taking placebo. 4. Subgroup analyses of symptom reduction Antibiotics were more effective against symptoms at day three (RR 0.58; 95% CI 0.48 to 0.71) if throat swabs were positive for Streptococcus, compared to RR 0.78; 95% CI 0.63 to 0.97 if negative. Similarly at week one the RR was 0.29 (95% CI 0.12 to 0.70) for positive and 0.73 (95% CI 0.50 to 1.07) for negative Streptococcus swabs. Antibiotics confer relative benefits in the treatment of sore throat. However, the absolute benefits are modest. Protecting sore throat sufferers against suppurative and non-suppurative complications in high-income countries requires treating many with antibiotics for one to benefit. This NNTB may be lower in low-income countries. Antibiotics shorten the duration of symptoms by about 16 hours overall.
|
The review is current to July 2013 and included 27 trials with 12,835 cases of sore throat. All of the included studies were randomised, placebo-controlled trials which sought to determine if antibiotics helped reduce symptoms of either sore throat, fever and headache or the occurrence of more serious complications. Studies were conducted among both children and adults. The review found that antibiotics shorten the duration of pain symptoms by an average of about one day and can reduce the chance of rheumatic fever by more than two-thirds in communities where this complication is common. Other complications associated with sore throat are also reduced through antibiotic use. The quality of the included studies was moderate to high. However, there were very few recent trials included in the review (only three since 2000), hence it is unclear if changes in bacterial resistance in the community may have affected the effectiveness of antibiotics.
|
10.1002/14651858.CD000023.pub4
|
[
"The review is current to July 2013 and included 27 trials with 12,835 cases of sore throat. All of the included studies were randomised, placebo-controlled trials which sought to determine if antibiotics helped reduce symptoms of either sore throat, fever and headache or the occurrence of more serious complications. Studies were conducted among both children and adults. The review found that antibiotics shorten the duration of pain symptoms by an average of about one day and can reduce the chance of rheumatic fever by more than two-thirds in communities where this complication is common. Other complications associated with sore throat are also reduced through antibiotic use. The quality of the included studies was moderate to high. However, there were very few recent trials included in the review (only three since 2000), hence it is unclear if changes in bacterial resistance in the community may have affected the effectiveness of antibiotics."
] |
cochrane-simplification-train-1539
|
cochrane-simplification-train-1539
|
We screened 574 records for eligibility and included 21 trials in the review. The 21 trials randomised 1490 women and addressed 11 comparisons. These were: differences in training supervision (amount, individual versus group), in approach (one versus another, the effect of an additional component) and the exercise training (type of contraction, frequency of training). In women with stress urinary incontinence, 10% of those who received weekly or twice-weekly group supervision in addition to individual appointments with the therapist did not report improvement post-treatment compared to 43% of the group who had individual appointments only (risk ratio (RR) for no improvement 0.29, 95% confidence interval (CI) 0.15 to 0.55, four trials). Looking at this another way, 90% of those who had combined group and individual supervision reported improvement versus 57% of women receiving individual supervision only. While women receiving the combination of frequent group supervision and individual supervision of pelvic floor muscle training were more likely to report improvement, the confidence interval was wide, and more than half of the 'control' group (the women who did not get the additional weekly or twice-weekly group supervision) reported improvement. This finding, of subjective improvement in both active treatment groups, with more improvement reported by those receiving more health professional contact, was consistent throughout the review. We feel there are several reasons why caution is needed when interpreting the results of the review: there were few data in any comparison; a number of trials were confounded by comparing two arms with multiple differences in the approaches to pelvic floor muscle training; there was a likelihood of a relationship between attention and reporting of more improvement in women who were not blind to treatment allocation; some trials chose interventions that were unlikely to have a muscle training effect; and some trials did not adequately describe their intervention. This review found that the existing evidence was insufficient to make any strong recommendations about the best approach to pelvic floor muscle training. We suggest that women are offered reasonably frequent appointments during the training period, because the few data consistently showed that women receiving regular (e.g. weekly) supervision were more likely to report improvement than women doing pelvic floor muscle training with little or no supervision.
|
This review included 21 studies in 1490 women and looked at whether one way of teaching, supervising or performing these exercises was better than another. Women who had regular and repeated contact with the person who taught them to do the exercises and monitored their progress were more likely to report they were improved after treatment. Further research is needed because there were problems interpreting the studies, which meant we could not draw any firm conclusions about many of the other possible ways of teaching, supervising or performing these exercises.
|
10.1002/14651858.CD009508
|
[
"This review included 21 studies in 1490 women and looked at whether one way of teaching, supervising or performing these exercises was better than another. Women who had regular and repeated contact with the person who taught them to do the exercises and monitored their progress were more likely to report they were improved after treatment. Further research is needed because there were problems interpreting the studies, which meant we could not draw any firm conclusions about many of the other possible ways of teaching, supervising or performing these exercises."
] |
cochrane-simplification-train-1540
|
cochrane-simplification-train-1540
|
In this review, we included data from 30 trials involving 7289 women. We excluded 11 trials, identified 16 ongoing/unpublished trials and two trials are awaiting classification. Overall risk of bias for the trials was mixed. Comparison 1. 601 IU/d or more versus 600 IU/d or less of vitamin D alone or with any other nutrient (19 trials; 5214 participants) Supplementation with 601 IU/d or more of vitamin D during pregnancy may make little or no difference to the risk of pre-eclampsia (risk ratio (RR) 0.96, 95% confidence interval (CI) 0.65 to 1.42); 5 trials; 1553 participants,low-certainty evidence), may reduce the risk of gestational diabetes (RR 0.54, 95% CI 0.34 to 0.86; 5 trials; 1846 participants; moderate-certainty evidence), may make little or no difference to the risk of preterm birth (RR 1.25, 95% CI 0.92 to 1.69; 4 trials; 2294 participants; low-certainty evidence); and may make little or no difference to the risk of low birthweight (RR 0.90, 95% CI 0.66 to 1.24; 4 trials; 1550 participants; very low-certainty evidence) compared to women receiving 600 IU/d or less. Comparison 2. 4000 IU or more versus 3999 IU or less of vitamin D alone (15 trials; 4763 participants) Supplementation with 4000 IU/d or more of vitamin D during pregnancy may make little or no difference to the risk of: pre-eclampsia (RR 0.87, 95% CI 0.62 to 1.22; 4 trials, 1903 participants, low-certainty evidence); gestational diabetes (RR 0.89, 95% CI 0.56 to 1.42; 5 trials, 2276 participants; low-certainty evidence); preterm birth (RR 0.85, 95% CI 0.64 to 1.12; 6 trials, 2948 participants, low-certainty evidence); and low birthweight (RR 0.92, 95% CI 0.49 to 1.70; 2 trials; 1099 participants; low-certainty evidence) compared to women receiving 3999 IU/d or less. Adverse events (such as hypercalcaemia, hypocalcaemia, hypercalciuria, and hypovitaminosis D) were reported differently in most trials; however, in general, there was little to no side effects reported or similar cases between groups. Supplementing pregnant women with more than the current vitamin D recommendation may reduce the risk of gestational diabetes; however, it may make little or no difference to the risk of pre-eclampsia, preterm birth and low birthweight. Supplementing pregnant women with more than the current upper limit for vitamin D seems not to increase the risk of the outcomes evaluated. In general, the GRADE was considered low certainty for most of the primary outcomes due to serious risk of bias and imprecision of results. With respect to safety, it appears that vitamin D supplementation is a safe intervention during pregnancy, although the parameters used to determine this were either not reported or not consistent between trials. Future trials should be consistent in their reports of adverse events. There are 16 ongoing trials that when published, will increase the body of knowledge.
|
Evidence from 19 trials involving 5214 women suggest that supplementation with 601 IU/d or more of vitamin D during pregnancy may reduce the risk of gestational diabetes but may make little or no difference to the risk of pre-eclampsia, preterm birth or low birthweight compared to women receiving 600 IU/d or less. Evidence from 15 trials involving 4763 women suggests that supplementation with 4000 IU/d or more of vitamin D during pregnancy may make little or no difference to the risk of pre-eclampsia, gestational diabetes, preterm birth or low birthweight compared to women receiving 3999 IU/d or less. Adverse events were reported differently in most trials; in general, there was little to no side effects reported or similar cases between groups. Supplementing pregnant women with more than the current vitamin D recommendation may reduce the risk of gestational diabetes; however, it may make little or no difference in the risk of the other outcomes. Supplementing pregnant women with more than the current upper limit for vitamin D seems not to increase the risk of the outcomes evaluated. Vitamin D supplementation appears to be safe.
|
10.1002/14651858.CD013446
|
[
"Evidence from 19 trials involving 5214 women suggest that supplementation with 601 IU/d or more of vitamin D during pregnancy may reduce the risk of gestational diabetes but may make little or no difference to the risk of pre-eclampsia, preterm birth or low birthweight compared to women receiving 600 IU/d or less. Evidence from 15 trials involving 4763 women suggests that supplementation with 4000 IU/d or more of vitamin D during pregnancy may make little or no difference to the risk of pre-eclampsia, gestational diabetes, preterm birth or low birthweight compared to women receiving 3999 IU/d or less. Adverse events were reported differently in most trials; in general, there was little to no side effects reported or similar cases between groups. Supplementing pregnant women with more than the current vitamin D recommendation may reduce the risk of gestational diabetes; however, it may make little or no difference in the risk of the other outcomes. Supplementing pregnant women with more than the current upper limit for vitamin D seems not to increase the risk of the outcomes evaluated. Vitamin D supplementation appears to be safe."
] |
cochrane-simplification-train-1541
|
cochrane-simplification-train-1541
|
Forty-one trials involving 5449 women, met the inclusion criteria. These trials covered many interventions, including acupressure, acustimulation, acupuncture, ginger, chamomile, lemon oil, mint oil, vitamin B6 and several antiemetic drugs. There were no included studies of dietary and other lifestyle interventions. Evidence regarding the effectiveness of P6 acupressure, auricular (ear) acupressure and acustimulation of the P6 point was limited. Acupuncture (P6 or traditional) showed no significant benefit to women in pregnancy. The use of ginger products may be helpful to women, but the evidence of effectiveness was limited and not consistent, though three recent studies support ginger over placebo. There was only limited evidence from trials to support the use of pharmacological agents including vitamin B6, Doxylamine-pyridoxoine and other anti-emetic drugs to relieve mild or moderate nausea and vomiting. There was little information on maternal and fetal adverse outcomes and on psychological, social or economic outcomes. We were unable to pool findings from studies for most outcomes due to heterogeneity in study participants, interventions, comparison groups, and outcomes measured or reported. The methodological quality of the included studies was mixed. Risk of bias was low related to performance bias, detection bias and attrition bias for most studies. Selection bias risk was unclear for many studies and almost half of the studies did not fully or clearly report all pre-specified outcomes. Given the high prevalence of nausea and vomiting in early pregnancy, women and health professionals need clear guidance about effective and safe interventions, based on systematically reviewed evidence. There is a lack of high-quality evidence to support any particular intervention. This is not the same as saying that the interventions studied are ineffective, but that there is insufficient strong evidence for any one intervention. The difficulties in interpreting and pooling the results of the studies included in this review highlight the need for specific, consistent and clearly justified outcomes and approaches to measurement in research studies.
|
This review found a lack of high-quality evidence to back up any advice on which interventions to use. We examined 41 randomised controlled trials that included 5449 women in early pregnancy. These studies examined the effectiveness of many treatments including acupressure to the P6 point on the wrist, acustimulation, acupuncture, ginger, chamomile, vitamin B6, lemon oil, mint oil, and several drugs that are used to reduce nausea or vomiting. Some studies showed a benefit in improving nausea and vomiting symptoms for women, but generally effects were inconsistent and limited. Overall, studies had low risk of bias related to blinding and reporting on all participants in the studies. However some aspects of the studies were reported incompletely in a way that meant how participants were allocated to groups was unclear and not all results were fully and clearly reported. Most studies had different ways of measuring the symptoms of nausea and vomiting and therefore, we could not look at these findings together. Few studies reported maternal and fetal adverse outcomes and there was very little information on the effectiveness of treatments for improving women's quality of life.
|
10.1002/14651858.CD007575.pub4
|
[
"This review found a lack of high-quality evidence to back up any advice on which interventions to use. We examined 41 randomised controlled trials that included 5449 women in early pregnancy. These studies examined the effectiveness of many treatments including acupressure to the P6 point on the wrist, acustimulation, acupuncture, ginger, chamomile, vitamin B6, lemon oil, mint oil, and several drugs that are used to reduce nausea or vomiting. Some studies showed a benefit in improving nausea and vomiting symptoms for women, but generally effects were inconsistent and limited. Overall, studies had low risk of bias related to blinding and reporting on all participants in the studies. However some aspects of the studies were reported incompletely in a way that meant how participants were allocated to groups was unclear and not all results were fully and clearly reported. Most studies had different ways of measuring the symptoms of nausea and vomiting and therefore, we could not look at these findings together. Few studies reported maternal and fetal adverse outcomes and there was very little information on the effectiveness of treatments for improving women's quality of life."
] |
cochrane-simplification-train-1542
|
cochrane-simplification-train-1542
|
Of eleven studies identified, three (354 participants) were included: two with four-year follow up and one with 12-weeks follow up. Data were lacking on predefined outcomes; common outcomes were examined at different time-points and presented differently. Meta-analyses were not possible. In one study, oral corticosteroids at prednisolone-equivalent dose of 1 mg/kg alternate days slowed progression of lung disease; at two and four years, % predicted FEV1 in the 1 mg/kg group changed significantly more than in the placebo group (P < 0.02). During the first two years, the 2 mg/kg group was not significantly different from the placebo group. Linear growth retardation was observed from six months in the 2 mg/kg alternate days prednisolone group and from 24 months in the 1 mg/kg alternate days prednisolone group. Adverse events terminated one four-year study early. Year 10 follow up showed catch-up growth started two years after treatment ceased. Alternate-day treatment with oral corticosteroids may have impaired growth until adulthood in boys. Oral corticosteroids at prednisolone-equivalent dose of 1 to 2 mg/kg alternate days appear to slow progression of lung disease in CF; benefit should be weighed against occurrence of adverse events. Risk-benefit analysis of low-dose alternate days corticosteroids is important. No further trials of this intervention are anticipated, and hence the review will no longer be regularly updated. However, if any new data are published, these will be incorporate when available.
|
The review includes three trials; one for 12 weeks and two with four-year follow up. We could not combine any data. Trials showed that oral steroids of 1mg/kg to 2 mg/kg (prednisolone equivalent) given every other day seemed to slow the advance of lung disease. However, there are serious adverse effects such as cataracts and the slowing of growth at the higher dose. These led to one trial stopping early. Follow-up data show that catch-up growth started two years after treatment ceased. Treatment must use the lowest effective dose and the shortest duration of therapy to reduce the risk of a permanent effect on growth. A dose of 1 mg/kg on alternate days might be considered for up to 24 months, but close attention should be paid to adverse effects. We do not expect any further trials of this treatment to be undertaken, so we do not plan to continue to regularly update the review. However, if any new information is published, we will include this when it is available. This is an update of a previously published review.
|
10.1002/14651858.CD000407.pub4
|
[
"The review includes three trials; one for 12 weeks and two with four-year follow up. We could not combine any data. Trials showed that oral steroids of 1mg/kg to 2 mg/kg (prednisolone equivalent) given every other day seemed to slow the advance of lung disease. However, there are serious adverse effects such as cataracts and the slowing of growth at the higher dose. These led to one trial stopping early. Follow-up data show that catch-up growth started two years after treatment ceased. Treatment must use the lowest effective dose and the shortest duration of therapy to reduce the risk of a permanent effect on growth. A dose of 1 mg/kg on alternate days might be considered for up to 24 months, but close attention should be paid to adverse effects. We do not expect any further trials of this treatment to be undertaken, so we do not plan to continue to regularly update the review. However, if any new information is published, we will include this when it is available. This is an update of a previously published review."
] |
cochrane-simplification-train-1543
|
cochrane-simplification-train-1543
|
We included 10 trials reported in 9 publications (N = 1651). Only one trial out of 10 was assessed at low risk of bias. Five trials used the currently recommended daily dose for the drug, and two trials used lower daily doses available over the counter. Three trials investigated NSAIDs no longer approved for human use. The follow-up duration was short in all studies but one. Three trials (n = 918) compared the effects of NSAIDs to those of placebo on pain reduction. The pooled mean difference showed comparable pain reduction (visual analogue scale, 0 to 100) in the NSAIDs and placebo groups (MD -4.56, 95% CI -11.11 to 1.99). Heterogeneity was high (I2 = 82%), and the quality of the evidence was very low. When we excluded one trial with a short follow-up of eight hours, the mean difference further decreased (MD -0.09, 95% CI -9.89 to 9.71). Three trials (n = 753) compared NSAIDs to placebo regarding global improvement. We found low-quality evidence that NSAIDs are more effective than placebo with a risk ratio of 1.14 (95% CI 1.03 to 1.27). One trial (n = 214) studied the effect of NSAIDs on disability, finding very low-quality evidence that NSAIDs are no more effective than placebo on disability. Four trials (n = 967) comparing NSAIDs to placebo reported adverse effects, with low-quality evidence that the risk for adverse effects is higher in the NSAID group than in the placebo group (RR 1.40, 95% CI 1.02 to 1.93). The adverse effects reported in this review are consistent with those previously reported in the literature. This updated systematic review including 10 trials evaluating the efficacy of NSAIDs versus placebo or other drugs in people with sciatica reports low- to very low-level evidence using the GRADE criteria. The efficacy of NSAIDs for pain reduction was not significant. NSAIDs showed a better global improvement compared to placebo. These findings must be interpreted with caution, as the level of evidence according to the GRADE classification was very low for the outcome pain reduction and low for global improvement due to small study samples, inconsistent results, imprecision, and a high risk of bias in the included trials. While the trials included in the analysis were not powered to detect potential rare side effects, we found an increased risk for side effects in the short-term NSAIDs use. As NSAIDs are frequently prescribed, the risk-benefit ratio of prescribing the drug needs to be considered.
|
We searched for both published and unpublished trials up to 24 June 2015. We included 10 trials (reported in 9 publications) with 1651 participants that compared NSAIDs with placebo or other drugs. Participants in the trials were 16 to 75 years of age and reported sciatica. The trials followed the participants for a short time, up to three weeks. NSAIDs are no more effective in reducing pain in sciatica than placebo or other drugs. NSAIDs are more effective in overall improvement compared to placebo or other drugs, but this finding should be interpreted with caution as the methodological quality of included trials is low. There is an increased risk of side effects when using NSAIDs compared to placebo. In light of the potentially serious adverse effects associated with NSAIDs, and as this drug is frequently prescribed, high-quality trials in different patient populations are warranted to address the short- and long-term benefits and long-term risks of NSAIDs. The quality of the evidence in this review ranged from very low to low that NSAIDs are more effective than placebo, therefore the results of this review should be interpreted with caution.
|
10.1002/14651858.CD012382
|
[
"We searched for both published and unpublished trials up to 24 June 2015. We included 10 trials (reported in 9 publications) with 1651 participants that compared NSAIDs with placebo or other drugs. Participants in the trials were 16 to 75 years of age and reported sciatica. The trials followed the participants for a short time, up to three weeks. NSAIDs are no more effective in reducing pain in sciatica than placebo or other drugs. NSAIDs are more effective in overall improvement compared to placebo or other drugs, but this finding should be interpreted with caution as the methodological quality of included trials is low. There is an increased risk of side effects when using NSAIDs compared to placebo. In light of the potentially serious adverse effects associated with NSAIDs, and as this drug is frequently prescribed, high-quality trials in different patient populations are warranted to address the short- and long-term benefits and long-term risks of NSAIDs. The quality of the evidence in this review ranged from very low to low that NSAIDs are more effective than placebo, therefore the results of this review should be interpreted with caution."
] |
cochrane-simplification-train-1544
|
cochrane-simplification-train-1544
|
We included 12 studies with altogether 671 participants. Two high quality randomized controlled trials with altogether 141 participants demonstrated clinical improvement of carpal tunnel syndrome at one month or less following local corticosteroid compared to placebo injection (relative risk 2.58 (95% confidence intervals 1.72 to 3.87)). One trial compared local corticosteroid injection to oral corticosteroid and at 12 weeks after treatment there was significantly more improvement in the injection group (mean difference -7.10 (95% confidence intervals -11.68 to -2.52)). In one trial, the rate of improvement after one month was greater after local than systemic corticosteroid injection (relative risk 3.17 (95% confidence intervals 1.02 to 9.87)). In one trial, symptoms did not improve significantly more in the injection group at eight weeks after injection compared to treatment with anti-inflammatory medication and splinting (mean difference 0.10 (95% confidence intervals -0.33 to 0.53)). Two injections versus one injection of local corticosteroid did not provide further clinical improvement, mean difference -3.80 (95% CI -9.27 to 1.67). Local corticosteroid injection for carpal tunnel syndrome provides greater clinical improvement in symptoms one month after injection compared to placebo. Significant symptom relief beyond one month has not been demonstrated. Local corticosteroid injection provides significantly greater clinical improvement than oral corticosteroid for up to three months. Local corticosteroid injection does not significantly improve clinical outcome compared to either anti-inflammatory treatment and splinting after eight weeks or Helium-Neon laser treatment after six months. Two local corticosteroid injections do not provide significant added clinical benefit compared to one injection.
|
This systematic review confirmed the effectiveness of local corticosteroid injection for relief of symptoms for severe carpal tunnel syndrome up to one month after injection. Local corticosteroid injection provides significantly greater clinical improvement compared to oral corticosteroid up to three months after treatment. Two injections of local corticosteroid do not provide significant further clinical improvement of symptoms. Further research is required to determine length of benefit of local corticosteroid injection and benefit for mild and moderate carpal tunnel syndrome.
|
10.1002/14651858.CD001554.pub2
|
[
"This systematic review confirmed the effectiveness of local corticosteroid injection for relief of symptoms for severe carpal tunnel syndrome up to one month after injection. Local corticosteroid injection provides significantly greater clinical improvement compared to oral corticosteroid up to three months after treatment. Two injections of local corticosteroid do not provide significant further clinical improvement of symptoms. Further research is required to determine length of benefit of local corticosteroid injection and benefit for mild and moderate carpal tunnel syndrome."
] |
cochrane-simplification-train-1545
|
cochrane-simplification-train-1545
|
Three studies with 1306 women are included in the review and compared intramuscular versus intravenous oxytocin administered just after the birth of the anterior shoulder or soon after the birth of the baby. Studies were carried out in hospital settings in Turkey and Thailand and recruited women with singleton, term pregnancies. Overall, the included studies were at moderate risk of bias: none of the studies provided clear information on allocation concealment or attempted to blind staff or women. For GRADE outcomes the quality of the evidence was very low, with downgrading due to study design limitations and imprecision of effect estimates. Only one study reported severe postpartum haemorrhage (blood loss 1000 mL or more) and showed no clear difference between the intramuscular and intravenous oxytocin groups (risk ratio (RR) 0.11, 95% confidence interval (CI) 0.01 to 2.04; 256 women; very low-quality evidence). No woman required hysterectomy in either group in one study (no estimable data, very low-quality evidence), and in another study one woman in each group received a blood transfusion (RR 1.00, 95% CI 0.06 to 15.82; 256 women; very low-quality evidence). Other important outcomes (maternal death, hypotension, maternal dissatisfaction with the intervention and neonatal jaundice) were not reported by any of the included studies. There were no clear differences between groups for other prespecified secondary outcomes reported (postpartum haemorrhage 500 mL or more, use of additional uterotonics, retained placenta or manual removal of the placenta). Very low-quality evidence indicates no clear difference between the comparative benefits and risks of intramuscular and intravenous oxytocin when given to prevent excessive blood loss after vaginal birth. Appropriately designed randomised trials with adequate sample sizes are needed to assess whether the route of prophylactic oxytocin after vaginal birth affects maternal or infant outcomes. Such studies could be large enough to detect clinically important differences in major side effects that have been reported in observational studies and should also consider the acceptability of the intervention to mothers and providers as important outcomes.
|
We searched for evidence on 7 September 2017 and identified three studies (together including 1306 women) comparing intramuscular versus intravenous administration of oxytocin to women during or immediately after the birth of the baby. Studies were carried out in hospitals in Turkey (two) and Thailand (one) and recruited women having only one baby, at term (not early or late). The methods that the studies used to divide women into treatment groups were not clear, and in all three included studies women and staff would have been aware of which treatment they received. This may have had an impact on results and means we cannot be confident in the evidence. The included studies did not report several important outcomes. Only one study reported severe blood loss (a litre or more) after birth and showed that there may be little or no difference between giving intramuscular and intravenous oxytocin. None of the women in one study needed surgery to remove their uterus (womb) after either intramuscular or intravenous oxytocin, and in another study two women needed a blood transfusion, one after intramuscular oxytocin and one after intravenous oxytocin. The quality of the evidence was low or very low, so we had very little confidence in the results. The studies did not report other important outcomes, such as death of the mother, low blood pressure, mothers' dissatisfaction with intramuscular or intravenous oxytocin, and number of babies with jaundice (yellowing of the skin). We found little or no clear difference between intramuscular and intravenous oxytocin for blood loss of 500 mL or more, use of additional drugs to reduce bleeding, and the placenta either not being delivered naturally or having to be removed by doctors. The findings from the three included studies did not clearly show which method of giving oxytocin was better for the mother or baby and more research is needed to answer this question. There was only a small number of included studies and our important outcomes did not occur very often, so there was insufficient evidence to decide whether intramuscular or intravenous oxytocin is more effective and safer for women in the third stage of labour.
|
10.1002/14651858.CD009332.pub3
|
[
"We searched for evidence on 7 September 2017 and identified three studies (together including 1306 women) comparing intramuscular versus intravenous administration of oxytocin to women during or immediately after the birth of the baby. Studies were carried out in hospitals in Turkey (two) and Thailand (one) and recruited women having only one baby, at term (not early or late). The methods that the studies used to divide women into treatment groups were not clear, and in all three included studies women and staff would have been aware of which treatment they received. This may have had an impact on results and means we cannot be confident in the evidence. The included studies did not report several important outcomes. Only one study reported severe blood loss (a litre or more) after birth and showed that there may be little or no difference between giving intramuscular and intravenous oxytocin. None of the women in one study needed surgery to remove their uterus (womb) after either intramuscular or intravenous oxytocin, and in another study two women needed a blood transfusion, one after intramuscular oxytocin and one after intravenous oxytocin. The quality of the evidence was low or very low, so we had very little confidence in the results. The studies did not report other important outcomes, such as death of the mother, low blood pressure, mothers' dissatisfaction with intramuscular or intravenous oxytocin, and number of babies with jaundice (yellowing of the skin). We found little or no clear difference between intramuscular and intravenous oxytocin for blood loss of 500 mL or more, use of additional drugs to reduce bleeding, and the placenta either not being delivered naturally or having to be removed by doctors. The findings from the three included studies did not clearly show which method of giving oxytocin was better for the mother or baby and more research is needed to answer this question. There was only a small number of included studies and our important outcomes did not occur very often, so there was insufficient evidence to decide whether intramuscular or intravenous oxytocin is more effective and safer for women in the third stage of labour."
] |
cochrane-simplification-train-1546
|
cochrane-simplification-train-1546
|
Ten RCTs (361 participants) met our inclusion criteria. Five RCTs (152 participants, 134 analysed) with low to moderate quality of evidence compared standard recombinant interferon with placebo or control. There was no significant difference for mortality (5 studies (134 participants): RR 0.89, 95% CI 0.06 to 13.23), relapses (1 study (36 participants): RR 0.72, 95% CI 0.28 to 1.88), sustained virological response (4 studies (98 participants): RR 3.25, 95% CI 0.81 to 13.07), treatment discontinuation (4 studies (116 participants): RR 4.59, 95% CI 0.49 to 42.69) and number with adverse events (5 studies (143 participants): RR 3.56, 95% CI 0.98 to 13.01). End of treatment response was significantly more for standard interferon (5 studies (132 participants): RR 8.62, 95% CI 3.03 to 24.55). There was overall low to unclear risk of bias and no significant heterogeneity. One RCT (50 participants) with moderate quality of evidence compared PEG interferon and standard interferon. There was no significant difference in mortality (RR 0.33, 95% CI 0.01 to 7.81), relapses (RR 0.72, 95% CI 0.41 to 1.25), sustained virological response (RR 2.40, 95% CI 0.99 to 5.81), treatment discontinuation (RR 0.11, 95% CI 0.01 to 1.96) and number with major adverse events (RR 0.11, 95% CI 0.01 to 1.96). End of treatment response was significantly more for PEG interferon (RR 1.53, 95% CI 1.09 to 2.15). There was overall low risk of bias. Two RCTs (97 participants) with moderate quality of evidence compared two doses of two different preparations of PEG interferon. Subgroup analysis comparing high and low doses of PEG interferon alpha-2a (135 µg/week versus 90 µg/week) and PEG interferon alpha-2b (1 µg/kg versus 0.5 µg/kg body weight/week) found no significant difference in mortality (2 studies (97 participants): RR 4.30, 95% CI 0.76 to 24.33), relapses (1 study (81 participants): RR 1.11, 95% CI 0.45 to 2.77), end of treatment response (2 studies (97 participants): RR 1.42, 95% CI 0.51 to 3.90), sustained virological response (2 studies (97 participants): RR 1.19, 95% CI 0.68 to 2.07), treatment discontinuation (2 studies (97 participants): RR 1.20, 95% CI 0.63 to 2.28), patients with adverse events (2 studies (97 participants): RR 1.05, 95% CI 0.61 to 1.83) or serious adverse events (2 studies (97 participants): RR 1.24, 95% CI 0.72 to 2.14). Both had overall low risk of bias and no significant subgroup differences. Two RCTs (62 participants) with moderate quality of evidence compared standard or PEG interferon alone or in combination with ribavirin. The only reported outcome in both was treatment discontinuation which was significantly more with ribavirin in the one study (RR 0.34, 95% CI 0.14 to 0.84) and pooled 7/10 in the second. No RCTs had data on time to recovery, cost-effectiveness, quality of life, and other outcomes and in peritoneal dialysis. Our review demonstrated that in CKD patients on haemodialysis with HCV infection treatment with standard interferon brings about an end of treatment but not a sustained virological response and is relatively well tolerated. PEG interferon is more effective than standard interferon for end of treatment response but not for sustained response; both were equally tolerated. Increasing doses of PEG interferon did not improve responses but high and low doses are equally tolerated. Addition of ribavirin results in more treatment discontinuation.
|
This review collates the available evidence from standardised studies for treatment of HCV in dialysis patients and did not include uncontrolled studies. Ten studies all in haemodialysis with about 300 patients showed that standard interferon was effective in producing a short term response which was not sustained and was well tolerated. Pegylated interferon was more effective than standard interferon in producing a short-term response but not a sustained one and both were equally tolerated. Increasing the dose of pegylated interferon did not improve response but was tolerated. Addition of ribavirin to interferon resulted in more treatment discontinuation. Adverse effects of interferons include flu like symptoms, sleep disturbances, decreased appetite, vomiting, diarrhoea or constipation, hair loss and low blood counts. Limitations of this review are that only a few studies were available with few participants, and patients with serious disease were excluded from studies in anticipation of side effects. Hence evidence available was not of high quality.
|
10.1002/14651858.CD007003.pub2
|
[
"This review collates the available evidence from standardised studies for treatment of HCV in dialysis patients and did not include uncontrolled studies. Ten studies all in haemodialysis with about 300 patients showed that standard interferon was effective in producing a short term response which was not sustained and was well tolerated. Pegylated interferon was more effective than standard interferon in producing a short-term response but not a sustained one and both were equally tolerated. Increasing the dose of pegylated interferon did not improve response but was tolerated. Addition of ribavirin to interferon resulted in more treatment discontinuation. Adverse effects of interferons include flu like symptoms, sleep disturbances, decreased appetite, vomiting, diarrhoea or constipation, hair loss and low blood counts. Limitations of this review are that only a few studies were available with few participants, and patients with serious disease were excluded from studies in anticipation of side effects. Hence evidence available was not of high quality."
] |
cochrane-simplification-train-1547
|
cochrane-simplification-train-1547
|
The acetylcholinesterase inhibitor plus antipsychotic showed benefit over antipsychotic and placebo in the following outcomes. 1. Mental state - PANSS negative symptoms average end point score (2 RCTs, n = 31, MD -1.69 95% CI -2.80 to -0.57), PANSS General Psychopathology average end point score (2 RCTs, n = 31, MD -3.86 95% CI -5.40 to -2.32), and improvement in depressive symptoms showed at least by one short-term study as measured by CDSS scale (data skewed). 2. Cognitive domains - attention, (1 RCT, n = 73, MD 1.20 95% CI 0.14 to 2.26), visual memory (2 RCTs, n = 48 , MD 1.90 95% CI 0.52 to 3.28), verbal memory and language (3 RCTs, n = 42, MD 3.46 95% CI 0.67 to 6.26) and executive functioning (1 RCT, n = 24, MD 17.10 95% CI 0.70 to 33.50). 3. Tolerability - EPSE: AIMS, (1 RCT, n = 35, MD 1.50 95% CI 1.04 to 1.96). No difference was noted between the two arms in other outcomes. The overall rate of participants leaving studies early was low (13.6 %) and showed no clear difference between the two groups. The results seem to favour the use of acetylcholinesterase inhibitors in combination with antipsychotics on a few domains of mental state and cognition, but because of the various limitations in the studies as mentioned in the main text, the evidence is weak. This review highlights the need for large, independent, well designed, conducted and reported pragmatic randomised studies.
|
This review compares the effects of acetylcholinesterase inhibitors alone, or in combination with antipsychotics, compared with antipsychotics alone, or placebo plus antipsychotics. Adding acetylcholinesterase inhibitors with antipsychotics may improve the general psychopathology/negative symptomatology/depressive symptoms in people with schizophrenia. Also, the combination may be useful in improving the attention/reaction time and memory areas of cognition. The major limitation of the results was that most of the studies found were short-term studies. Considering the chronic, severe and enduring nature of schizophrenia, one cannot get a true picture unless well designed long-term studies are done. We hope that this review will highlight the need for more studies in this area.
|
10.1002/14651858.CD007967.pub2
|
[
"This review compares the effects of acetylcholinesterase inhibitors alone, or in combination with antipsychotics, compared with antipsychotics alone, or placebo plus antipsychotics. Adding acetylcholinesterase inhibitors with antipsychotics may improve the general psychopathology/negative symptomatology/depressive symptoms in people with schizophrenia. Also, the combination may be useful in improving the attention/reaction time and memory areas of cognition. The major limitation of the results was that most of the studies found were short-term studies. Considering the chronic, severe and enduring nature of schizophrenia, one cannot get a true picture unless well designed long-term studies are done. We hope that this review will highlight the need for more studies in this area."
] |
cochrane-simplification-train-1548
|
cochrane-simplification-train-1548
|
37 studies were included in the review (3551 participants). Antidepressants versus placebo: results for dropouts did not show evidence of difference, 31 studies, 2819 participants, RR 1.03 (Cl 95% 0.93 to 1.14). Looking at Abstinence from cocaine use, even though not statistically significant, the difference shown by the analysis in the three-weeks abstinence rate was in favour of antidepressants (eight studies, 942 participants, RR 1.22 (Cl 95% 0.99 to 1.51)). Considering only studies involving tricyclics, five studies, 367 participants, or only desipramine, four studies, 254 participants, the evidence was in favour of antidepressants. However, selecting only studies with operationally defined diagnostic criteria, statistical significance favouring antidepressants, as well as the trend for significance shown by the full sample, disappeared. Looking at safety issues, the results did not show evidence of differences (number of patients withdrawn for medical reasons, thirteen studies, 1396 participants, RR 1.39 (Cl 95% 0.91 to 2.12)). Subgroup analysis considering length of the trial, associated opioid dependence or associated psychosocial interventions as confounding factors, failed in showing consistent and statistically significant differences in favour of antidepressants. Antidepressants versus other drugs: Comparing antidepressants with dopamine agonists or with anticonvulsants, no evidence of differences was shown on dropouts and on other outcomes (abstinence from cocaine use, adverse events). At the current stage of evidence data do not support the efficacy of antidepressants in the treatment of cocaine abuse/dependence. Partially positive results obtained on secondary outcome measures, such as depression severity, do not seem to be associated with an effect on direct indicators of cocaine abuse/dependence. Antidepressants cannot be considered a mainstay of treatment for unselected cocaine abusers/dependents.
|
Current evidence from randomised controlled trials does not support the use of antidepressants. Positive results obtained by antidepressants on mood-related outcomes are consistent with the primary effect of antidepressants. They do not seem to be associated with any effect on dropouts from treatment, cocaine use or side effects, which are direct indicators of cocaine abuse and dependence. A total of 37 randomised controlled clinical studies involving 3551 participants were included in the review. All the studies except one took place in the USA; 33 trials were conducted with outpatients in the community or in mental health centres. In 10 trials patients were also treated for opioid dependence with methadone or buprenorphine. The antidepressants included desipramine, fluoxetine and bupropion and the mean duration of the trials was 10.7 weeks. The included studies utilised 43 different rating instruments and differed in design, quality, characteristics of patients, tested medication, services and the treatments delivered.
|
10.1002/14651858.CD002950.pub3
|
[
"Current evidence from randomised controlled trials does not support the use of antidepressants. Positive results obtained by antidepressants on mood-related outcomes are consistent with the primary effect of antidepressants. They do not seem to be associated with any effect on dropouts from treatment, cocaine use or side effects, which are direct indicators of cocaine abuse and dependence. A total of 37 randomised controlled clinical studies involving 3551 participants were included in the review. All the studies except one took place in the USA; 33 trials were conducted with outpatients in the community or in mental health centres. In 10 trials patients were also treated for opioid dependence with methadone or buprenorphine. The antidepressants included desipramine, fluoxetine and bupropion and the mean duration of the trials was 10.7 weeks. The included studies utilised 43 different rating instruments and differed in design, quality, characteristics of patients, tested medication, services and the treatments delivered."
] |
cochrane-simplification-train-1549
|
cochrane-simplification-train-1549
|
Two trials (one RCT and one CCT) (total 80 participants) met the review criteria. Both trials scored poorly on the methodological quality assessment. There was 'insufficient evidence' for VR programs for (a)‘competitive employment’, in altering rates of job retention, changes in employment, improvement in rates of re-entry into the labour force; (b) for altering ‘work ability' by improving participants’ confidence in the accommodation request process, or employability maturity or job seeking activity. No evidence could be assimilated for changes in proportions of persons in supported employment or on disability pensions, nor for cost-effectiveness. There was inconclusive evidence to support VR for pwMS. However, the review highlights some of the challenges in providing VR for pwMS. Clinicians need to be aware of vocational issues, and to understand and manage barriers for maintaining employment. Proactive and timely VR programs should incorporate practical solutions to deal with work disability, workplace accommodation and educate employers, and the wider community. Liaison with policy makers is imperative for government initiatives that encourage work focused VR programs. Future research in VR should focus on improving methodological and scientific rigour of clinical trials; on the development of appropriate and valid outcome measures; and on cost effectiveness of VR programs.
|
Among the pertinent medical literature, only two studies, comprising a total of 80 participants, met the criteria of the methodological quality necessary for their inclusion in this review, although the subsequent quality assessment revealed they scored poorly. Furthermore, the two studies were carried out in USA, with limited generalisability in other geographical/cultural settings. The whole data neither supports nor refutes the effectiveness or cost-effectiveness of VR programs for persons with MS. The data also identified critical points worth of future attention: more awareness of vocational issues by professionals; putting in place practical solutions such as a proper workplace accommodations and employers' education; asking for political/governmental initiatives to really support disabled employees; taking into account that supported withdrawal from work at the proper time is as important as supported re-entering to work. Further research are necessary also to improve the methodology of the researches and to identify those individuals most likely to benefit.
|
10.1002/14651858.CD007256.pub2
|
[
"Among the pertinent medical literature, only two studies, comprising a total of 80 participants, met the criteria of the methodological quality necessary for their inclusion in this review, although the subsequent quality assessment revealed they scored poorly. Furthermore, the two studies were carried out in USA, with limited generalisability in other geographical/cultural settings. The whole data neither supports nor refutes the effectiveness or cost-effectiveness of VR programs for persons with MS. The data also identified critical points worth of future attention: more awareness of vocational issues by professionals; putting in place practical solutions such as a proper workplace accommodations and employers' education; asking for political/governmental initiatives to really support disabled employees; taking into account that supported withdrawal from work at the proper time is as important as supported re-entering to work. Further research are necessary also to improve the methodology of the researches and to identify those individuals most likely to benefit."
] |
cochrane-simplification-train-1550
|
cochrane-simplification-train-1550
|
We included 18 trials (1463 participants) in the review. Thirteen trials involved people undergoing hip replacement, three involved people undergoing knee replacement and two included both people with hip and knee replacements. Only six trials reported using an adequate method of allocation concealment, and only two trials blinded participants. Few trials reported sufficient data to analyse the major outcomes of the review (pain, function, health-related quality of life, global assessment, postoperative anxiety, total adverse events and re-operation rate). There did not appear to be an effect of time on any outcome, so we chose to include only the latest time point available per outcome in the review. In people undergoing hip replacement, preoperative education may not offer additional benefits over usual care. The mean postoperative anxiety score at six weeks with usual care was 32.16 on a 60-point scale (lower score represents less anxiety) and was 2.28 points lower with preoperative education (95% confidence interval (CI) -5.68 to 1.12; 3 RCTs, 264 participants, low-quality evidence), an absolute risk difference of -4% (95% CI -10% to 2%). The mean pain score up to three months postoperatively with usual care was 3.1 on a 10-point scale (lower score represents less pain) and was 0.34 points lower with preoperative education (95% CI -0.94 to 0.26; 3 RCTs, 227 participants; low-quality evidence), an absolute risk difference of -3% (95% CI -9% to 3%). The mean function score at 3 to 24 months postoperatively with usual care was 18.4 on a 68-point scale (lower score represents better function) and was 4.84 points lower with preoperative education (95% CI -10.23 to 0.66; 4 RCTs, 177 participants; low-quality evidence), an absolute risk difference of -7% (95% CI -15% to 1%). The number of people reporting adverse events, such as infection and deep vein thrombosis, did not differ between groups, but the effect estimates are uncertain due to very low quality evidence (23% (17/75) reported events with usual care versus 18% (14/75) with preoperative education; risk ratio (RR) 0.79; 95% CI 0.19 to 3.21; 2 RCTs, 150 participants). Health-related quality of life, global assessment of treatment success and re-operation rates were not reported. In people undergoing knee replacement, preoperative education may not offer additional benefits over usual care. The mean pain score at 12 months postoperatively with usual care was 80 on a 100-point scale (lower score represents less pain) and was 2 points lower with preoperative education (95% CI -3.45 to 7.45; 1 RCT, 109 participants), an absolute risk difference of -2% (95% CI -4% to 8%). The mean function score at 12 months postoperatively with usual care was 77 on a 100-point scale (lower score represents better function) and was no different with preoperative education (0; 95% CI -5.63 to 5.63; 1 RCT, 109 participants), an absolute risk difference of 0% (95% CI -6% to 6%). The mean health-related quality of life score at 12 months postoperatively with usual care was 41 on a 100-point scale (lower score represents worse quality of life) and was 3 points lower with preoperative education (95% CI -6.38 to 0.38; 1 RCT, 109 participants), an absolute risk difference of -3% (95% CI -6% to 1%). The number of people reporting adverse events, such as infection and deep vein thrombosis, did not differ between groups (18% (11/60) reported events with usual care versus 13% (7/55) with preoperative education; RR 0.69; 95% CI 0.29 to 1.66; 1 RCT, 115 participants), an absolute risk difference of -6% (-19% to 8%). Global assessment of treatment success, postoperative anxiety and re-operation rates were not reported. Although preoperative education is embedded in the consent process, we are unsure if it offers benefits over usual care in terms of reducing anxiety, or in surgical outcomes, such as pain, function and adverse events. Preoperative education may represent a useful adjunct, with low risk of undesirable effects, particularly in certain patients, for example people with depression, anxiety or unrealistic expectations, who may respond well to preoperative education that is stratified according to their physical, psychological and social need.
|
This summary of a Cochrane review presents what we know from research on whether preoperative education improves outcomes (e.g. pain, function) compared with usual care in people receiving hip or knee replacement. After searching for all relevant studies to May 2013, we included nine new studies since the last review, giving a total of 18 studies (1463 participants); 13 trials included 1074 people (73% of the total) undergoing hip replacement, three involved people undergoing knee replacement and two included both people with hip and knee replacements. Most participants were women (59%) and the mean age of participants was within the range of 58 to 73 years Postoperative anxiety (lower scores mean less anxiety): People with hip replacement who had preoperative education had postoperative anxiety at six weeks that was 2.28 points lower (ranging from 5.68 points lower to 1.12 points higher) (4% absolute improvement, ranging from 10% improvement to 2% worsening). - People who had usual care for hip replacement rated their postoperative anxiety score as 32.16 points on a scale of 20 to 80 points. Pain (lower scores mean less pain): People with hip replacement who had preoperative education had pain at up to three months that was 0.34 points lower (ranging from 0.94 points lower to 0.26 points higher) (3% absolute improvement, ranging from 9% improvement to 3% worsening). - People who had usual care for hip replacement rated their pain score as 3.1 points on a scale of 0 to 10 points. Function (lower scores mean better function or less disability): People with hip replacement who had preoperative education had function at 3 to 24 months that was 4.84 points lower (ranging from 10.23 points lower to 0.66 points higher) (7% absolute improvement, ranging from 15% improvement to 1% worsening). - People who had usual care for hip replacement rated their function score as 18.4 points on a scale of 0 to 68 points. Side effects: About 5 fewer people out of 100 had adverse events (such as infection or deep vein thrombosis) with preoperative education compared with usual care but this estimate is uncertain. - 18 out of 100 people reported adverse events with preoperative education for hip replacement. - 23 out of 100 people reported adverse events with usual care for hip replacement. This review shows that in people receiving hip or knee replacement who are provided with preoperative education: There is low-quality evidence suggesting that preoperative education may not improve pain, function, health-related quality of life and postoperative anxiety any more than usual care. Further research is very likely to have an important impact on our confidence in these estimates and is likely to change the estimates. Health-related quality of life, global assessment of treatment success and re-operation rates were not reported. We are uncertain whether preoperative education results in any fewer adverse events, such as infection or deep vein thrombosis, compared with usual care, due to the very low quality evidence.
|
10.1002/14651858.CD003526.pub3
|
[
"This summary of a Cochrane review presents what we know from research on whether preoperative education improves outcomes (e.g. pain, function) compared with usual care in people receiving hip or knee replacement. After searching for all relevant studies to May 2013, we included nine new studies since the last review, giving a total of 18 studies (1463 participants); 13 trials included 1074 people (73% of the total) undergoing hip replacement, three involved people undergoing knee replacement and two included both people with hip and knee replacements. Most participants were women (59%) and the mean age of participants was within the range of 58 to 73 years Postoperative anxiety (lower scores mean less anxiety): People with hip replacement who had preoperative education had postoperative anxiety at six weeks that was 2.28 points lower (ranging from 5.68 points lower to 1.12 points higher) (4% absolute improvement, ranging from 10% improvement to 2% worsening). - People who had usual care for hip replacement rated their postoperative anxiety score as 32.16 points on a scale of 20 to 80 points. Pain (lower scores mean less pain): People with hip replacement who had preoperative education had pain at up to three months that was 0.34 points lower (ranging from 0.94 points lower to 0.26 points higher) (3% absolute improvement, ranging from 9% improvement to 3% worsening). - People who had usual care for hip replacement rated their pain score as 3.1 points on a scale of 0 to 10 points. Function (lower scores mean better function or less disability): People with hip replacement who had preoperative education had function at 3 to 24 months that was 4.84 points lower (ranging from 10.23 points lower to 0.66 points higher) (7% absolute improvement, ranging from 15% improvement to 1% worsening). - People who had usual care for hip replacement rated their function score as 18.4 points on a scale of 0 to 68 points. Side effects: About 5 fewer people out of 100 had adverse events (such as infection or deep vein thrombosis) with preoperative education compared with usual care but this estimate is uncertain. - 18 out of 100 people reported adverse events with preoperative education for hip replacement. - 23 out of 100 people reported adverse events with usual care for hip replacement. This review shows that in people receiving hip or knee replacement who are provided with preoperative education: There is low-quality evidence suggesting that preoperative education may not improve pain, function, health-related quality of life and postoperative anxiety any more than usual care. Further research is very likely to have an important impact on our confidence in these estimates and is likely to change the estimates. Health-related quality of life, global assessment of treatment success and re-operation rates were not reported. We are uncertain whether preoperative education results in any fewer adverse events, such as infection or deep vein thrombosis, compared with usual care, due to the very low quality evidence."
] |
cochrane-simplification-train-1551
|
cochrane-simplification-train-1551
|
60 studies recruiting 6542 participants met the inclusion criteria. CFC-BDP (57 studies): In non-oral steroid treated patients, at doses of 400mcg/day or less CFC-BDP produced significant improvements from baseline in a number of efficacy measures compared with placebo, including forced expiratory volume in one second (FEV1) 360 ml (95% CI 260 to 460); FEV1 (% predicted) WMD 12.41% (95% CI 8.18 to 16.64) and morning peak expiratory flow rate (am PEF) WMD 35.95 L/min (95% CI 27.85 to 44.04). BDP also led to reductions in rescue beta-2 agonist use compared with placebo of -2.32 puffs/d (95% CI -2.55 to -2.09) and reduced the relative risk (RR) of trial withdrawal due to an asthma exacerbation 0.25 (95% CI 0.12 to 0.51). Subgroup analyses based on treatment duration provide support to the proposal that a treatment period of greater than four weeks is required to realise a fuller treatment effect. In oral steroid treated patients BDP led to significantly greater reductions in oral prednisolone use WMD -4.91 mg/d (95% CI -5.88 to -3.94 mg/d) and greater likelihood of withdrawing oral steroid treatment RR 8.02 (95% CI 3.23 to 19.92). HFA-BDP (3 studies): In non-oral steroid-treated patients, HFA-BDP was significantly more effective than placebo in improving FEV1, morning and evening PEF, FEF25 to 75%, reduced asthma symptoms and beta2-agonists daily consumption. Significant effects for such outcomes were apparent after six weeks of treatment. In oral steroid treated patients, HFA-BDP improved significantly FEV1 and am PEF. The summary estimates for these outcomes suggested a high level of heterogeneity, and divergent aims of the studies may contribute to the variation we observed. Limited data on adverse events were reported. This review has quantified the efficacy of CFC-BDP and HFA-BDP in the treatment of chronic asthma and strongly supports its use. Current asthma guidelines recommend titration of dose to individual patient response, but the published data provide little support for dose titration above 400 mcg/d in patients with mild to moderate asthma. There are insufficient data to draw any conclusions concerning dose-response in people with severe asthma.
|
This review of trials found that BDP delivered with the old and new propellant is effective in helping people with chronic asthma. BDP at all doses improves airflow, reduces symptoms and the need for rescue bronchodilators. The review only included studies conducted for more than 4 weeks. The drug was well tolerated and the safety profile was comparable with placebo. The findings apply to both children and adults. The effects of the new propellant suggest that it could be more effective than the older version, although a different review will address that particular question.
|
10.1002/14651858.CD002738.pub2
|
[
"This review of trials found that BDP delivered with the old and new propellant is effective in helping people with chronic asthma. BDP at all doses improves airflow, reduces symptoms and the need for rescue bronchodilators. The review only included studies conducted for more than 4 weeks. The drug was well tolerated and the safety profile was comparable with placebo. The findings apply to both children and adults. The effects of the new propellant suggest that it could be more effective than the older version, although a different review will address that particular question."
] |
cochrane-simplification-train-1552
|
cochrane-simplification-train-1552
|
Fifteen studies (two with long term follow-up studies) were identified examining a range of interventions. In terms of main findings, twelve studies evaluated brief trauma focused cognitive behavioural interventions (TF-CBT). TF-CBT was more effective than a waiting list intervention (6 studies, 471 participants; SMD -0.64, 95% CI -1.06, -0.23) and supportive counselling (4 studies, 198 participants; SMD -0.67, 95% CI -1.12, -0.23). Effects against supportive counselling were still present at 6 month follow-up (4 studies, 170 participants; SMD -0.64, 95% CI -1.02, -0.25). There was no evidence of the effectiveness of a structured writing intervention when compared against minimal intervention (2 studies, 149 participants; SMD -0.15, 95% CI -0.48, 0.17). There was evidence that individual TF-CBT was effective for individuals with acute traumatic stress symptoms compared to both waiting list and supportive counselling interventions. The quality of trials included was variable and sample sizes were often small. There was considerable clinical heterogeneity in the included studies and unexplained statistical heterogeneity observed in some comparisons. This suggests the need for caution in interpreting the results of this review. Additional high quality trials with longer follow up periods are required to further test TF-CBT and other forms of psychological intervention.
|
However, previous reviews have found that single session individual interventions and interventions provided to all have not been effective at preventing PTSD. A range of other forms of intervention have been developed to try to reduce psychological distress for individuals exposed to trauma. This review evaluated the results of 15 studies that tested a diverse range of psychological interventions aimed at treating acute traumatic stress problems. There was evidence to support the use of trauma focused cognitive behavioural therapy with such individuals, although there were a number of potential biases in identified studies which means the results should be treated with some caution. Further research is required to evaluate longer terms effects of TF-CBT, to explore potential benefits of other forms of intervention and to identify the most effective ways of providing psychological help in the early stages after a traumatic event.
|
10.1002/14651858.CD007944.pub2
|
[
"However, previous reviews have found that single session individual interventions and interventions provided to all have not been effective at preventing PTSD. A range of other forms of intervention have been developed to try to reduce psychological distress for individuals exposed to trauma. This review evaluated the results of 15 studies that tested a diverse range of psychological interventions aimed at treating acute traumatic stress problems. There was evidence to support the use of trauma focused cognitive behavioural therapy with such individuals, although there were a number of potential biases in identified studies which means the results should be treated with some caution. Further research is required to evaluate longer terms effects of TF-CBT, to explore potential benefits of other forms of intervention and to identify the most effective ways of providing psychological help in the early stages after a traumatic event."
] |
cochrane-simplification-train-1553
|
cochrane-simplification-train-1553
|
None of the 1328 studies that were identified satisfied the inclusion criteria. Based on this review, we cannot make any new recommendations on the effectiveness of adrenaline auto-injectors for the treatment of anaphylaxis. Although randomized, double-blind, placebo-controlled clinical trials of high methodological quality are necessary to define the true extent of benefits from the administration of adrenaline in anaphylaxis via an auto-injector, such trials are unlikely to be performed in individuals experiencing anaphylaxis because of ethical concerns associated with randomization to placebo. There is, however, a need to consider trials in which, for example, auto-injectors of different doses of adrenaline and differing devices are compared in order to provide greater clarity on the dose and device of choice. Such trials would be practically challenging to conduct. In the absence of appropriate trials, we recommend that adrenaline administration by auto-injector should still be regarded as the most effective first-line treatment for the management of anaphylaxis in the community. In countries where auto-injectors are not commonly used, it may be possible to conduct trials to compare administration of adrenaline via auto-injector with adrenaline administered by syringe and ampoule, or comparing the effectiveness of two different types of auto-injector.
|
We therefore conducted a systematic review of the literature, searching key databases for high quality published and unpublished material on the use of adrenaline auto-injectors during episodes of anaphylaxis in the community. We also contacted the relevant pharmaceutical companies to see if they had any such information on the topic. Our searches found many studies relating to anaphylaxis and adrenaline auto-injector use but no randomized controlled trials on this subject. We concluded that the use of adrenaline auto-injectors in anaphylaxis is based on the best available information at present. There is no evidence from randomized controlled trials for the effectiveness of adrenaline auto-injectors in the emergency treatment of anaphylaxis in the community. Such trials would ideally involve comparison of adrenaline with placebo; however, use of a placebo in anaphylaxis treatment would be unethical. We therefore recommend that auto-injectors remain the medication of first choice in the treatment of anaphylaxis in the community.
|
10.1002/14651858.CD008935.pub2
|
[
"We therefore conducted a systematic review of the literature, searching key databases for high quality published and unpublished material on the use of adrenaline auto-injectors during episodes of anaphylaxis in the community. We also contacted the relevant pharmaceutical companies to see if they had any such information on the topic. Our searches found many studies relating to anaphylaxis and adrenaline auto-injector use but no randomized controlled trials on this subject. We concluded that the use of adrenaline auto-injectors in anaphylaxis is based on the best available information at present. There is no evidence from randomized controlled trials for the effectiveness of adrenaline auto-injectors in the emergency treatment of anaphylaxis in the community. Such trials would ideally involve comparison of adrenaline with placebo; however, use of a placebo in anaphylaxis treatment would be unethical. We therefore recommend that auto-injectors remain the medication of first choice in the treatment of anaphylaxis in the community."
] |
cochrane-simplification-train-1554
|
cochrane-simplification-train-1554
|
We identified 45 references out of 953 search results, of which 14 studies met the inclusion criteria involving 3528 rectal cancer patients. We did not consider the risk of bias of the included studies to have impacted on the quality of the evidence. Data were analysed according to an intention-to-treat principle with a mean conversion rate of 14.5% (range 0% to 35%) in the laparoscopic group. There was moderate quality evidence that laparoscopic and open TME had similar effects on five-year disease-free survival (OR 1.02; 95% CI 0.76 to1.38, 4 studies, N = 943). The estimated effects of laparoscopic and open TME on local recurrence and overall survival were similar, although confidence intervals were wide, both with moderate quality evidence (local recurrence: OR 0.89; 95% CI 0.57 to1.39 and overall survival rate: OR 1.15; 95% CI 0.87 to1.52). There was moderate to high quality evidence that the number of resected lymph nodes and surgical margins were similar between the two groups. For the short-term results, length of hospital stay was reduced by two days (95% CI -3.22 to -1.10), moderate quality evidence), and the time to first defecation was shorter in the LTME group (-0.86 days; 95% CI -1.17 to -0.54). There was moderate quality evidence that 30 days morbidity were similar in both groups (OR 0.94; 95% CI 0.8 to 1.1). There were fewer wound infections (OR 0.68; 95% CI 0.50 to 0.93) and fewer bleeding complications (OR 0.30; 95% CI 0.10 to 0.93) in the LTME group. There was no clear evidence of any differences in quality of life after LTME or OTME regarding functional recovery, bladder and sexual function. The costs were higher for LTME with differences up to GBP 2000 for direct costs only. We have found moderate quality evidence that laparoscopic total mesorectal excision (TME) has similar effects to open TME on long term survival outcomes for the treatment of rectal cancer. The quality of the evidence was downgraded due to imprecision and further research could impact on our confidence in this result. There is moderate quality evidence that it leads to better short-term post-surgical outcomes in terms of recovery for non-locally advanced rectal cancer. Currently results are consistent in showing a similar disease-free survival and overall survival, and for recurrences after at least three years and up to 10 years, although due to imprecision we cannot rule out superiority of either approach. We await long-term data from a number of ongoing and recently completed studies to contribute to a more robust analysis of long-term disease free, overall survival and local recurrence.
|
In this updated review, we have assessed all randomised studies of laparoscopic and open TME for rectal cancer, to compare and combine their results. We included 14 trials reporting on a total of 3528 patients undergoing rectal cancer surgery. In 14.5% of those having laparoscopic surgery needed conversion to open surgery by a large incision in the abdomen due to difficulties or problems during the procedure. There is currently moderate quality evidence that laparoscopic total mesorectal excision (LTME) has similar effects to open TME (OTME) on long term survival outcomes for the treatment of rectal cancer. The estimated effect was imprecise and further research could impact on our confidence int this result. There is moderate quality evidence that it leads to better short-term post-surgical outcomes in terms of length of hospital stay. We found that pain was lower in the LTME group and that resumption of diet was better. We did not find clear evidence of a difference in quality of life between the two groups, but costs were higher for LTME. We await long-term data from a number of ongoing and recently completed studies to contribute to our understanding of the effects of these surgical approaches on long-term disease free, overall survival and local recurrence.
|
10.1002/14651858.CD005200.pub3
|
[
"In this updated review, we have assessed all randomised studies of laparoscopic and open TME for rectal cancer, to compare and combine their results. We included 14 trials reporting on a total of 3528 patients undergoing rectal cancer surgery. In 14.5% of those having laparoscopic surgery needed conversion to open surgery by a large incision in the abdomen due to difficulties or problems during the procedure. There is currently moderate quality evidence that laparoscopic total mesorectal excision (LTME) has similar effects to open TME (OTME) on long term survival outcomes for the treatment of rectal cancer. The estimated effect was imprecise and further research could impact on our confidence int this result. There is moderate quality evidence that it leads to better short-term post-surgical outcomes in terms of length of hospital stay. We found that pain was lower in the LTME group and that resumption of diet was better. We did not find clear evidence of a difference in quality of life between the two groups, but costs were higher for LTME. We await long-term data from a number of ongoing and recently completed studies to contribute to our understanding of the effects of these surgical approaches on long-term disease free, overall survival and local recurrence."
] |
cochrane-simplification-train-1555
|
cochrane-simplification-train-1555
|
Very few studies directly assessed the effectiveness of corticosteroids for RA treatment and many were of poor methodologic quality. Only seven of 34 studies identified by our search met criteria for inclusion. Our results indicated that corticosteroids were significantly more effective than placebo controls for four of six outcomes assessed [standardized mean difference for tender joints = -0.37 (95%CI: -0.59, -0.14), swollen joints = -0.41 (-0.67, -0.16), pain = -0.43 (-0.74, -0.12), and functional status = -0.57 (-0.92, -0.22)]. The results for grip strength and ESR were not significant [GS = +0.30 (-0.19, +0.80), weighted mean difference (WMD) for ESR = -7.03 (-18.06, +4.01)]. The single trial that compared prednisone to aspirin indicated no statistically significant difference between these groups for joint tenderness (0.10 (-0.35, +0.55) and for ESR [0.00 (-11.09, +11.09]. Overall, the four outcomes assessed in the single trial that compared prednisone to chloroquine suggested that there was no statistically significant differenece in the effectiveness of these two agents [SMD for joint tenderness = +0.23 (-0.30, +0.75), swollen joints = +0.43 (-0.11, +0.96), functional status = -0.27 (-0.80, +0.26), and WMD for ESR = -16.00 (-30.58, -1.42)]. Based on the limited data available, moderate-term prednisone treatment of RA appears to be superior to placebo and comparable to treatment with aspirin or chloroquine in improving several common rheumatoid arthritis disease activity measures.
|
We included studies that used prednisone (or a comparable corticosteroid preparation) at a mean dose of less than or equal to 15 mg per day. We included studies that utilized either placebo controls or active controls (i.e. comparative studies). Very few studies directly assessed the effectiveness of corticosteroids for RA treatment and many were of poor methodologic quality. Only seven of 34 studies identified by our search met criteria for inclusion. Our results indicated that corticosteroids were significantly more effective than placebo controls for four of six outcomes assessed [standardized mean difference for tender joints = -0.37 (95%CI: -0.59, -0.14), swollen joints = -0.41 (-0.67, -0.16), pain = -0.43 (-0.74, -0.12), and functional status = -0.57 (-0.92, -0.22)]. The results for grip strength and ESR were not significant [GS = +0.30 (-0.19, +0.80), weighted mean difference (WMD) for ESR = -7.03 (-18.06, +4.01)]. The single trial that compared prednisone to aspirin indicated no statistically significant difference between these groups for joint tenderness (0.10 (-0.35, +0.55) and for ESR [0.00 (-11.09, +11.09]. Overall, the four outcomes assessed in the single trial that compared prednisone to chloroquine suggested that there was no statistically significant differenece in the effectiveness of these two agents [SMD for joint tenderness = +0.23 (-0.30, +0.75), swollen joints = +0.43 (-0.11, +0.96), functional status = -0.27 (-0.80, +0.26), and WMD for ESR = -16.00 (-30.58, -1.42)].
|
10.1002/14651858.CD001158
|
[
"We included studies that used prednisone (or a comparable corticosteroid preparation) at a mean dose of less than or equal to 15 mg per day. We included studies that utilized either placebo controls or active controls (i.e. comparative studies). Very few studies directly assessed the effectiveness of corticosteroids for RA treatment and many were of poor methodologic quality. Only seven of 34 studies identified by our search met criteria for inclusion. Our results indicated that corticosteroids were significantly more effective than placebo controls for four of six outcomes assessed [standardized mean difference for tender joints = -0.37 (95%CI: -0.59, -0.14), swollen joints = -0.41 (-0.67, -0.16), pain = -0.43 (-0.74, -0.12), and functional status = -0.57 (-0.92, -0.22)]. The results for grip strength and ESR were not significant [GS = +0.30 (-0.19, +0.80), weighted mean difference (WMD) for ESR = -7.03 (-18.06, +4.01)]. The single trial that compared prednisone to aspirin indicated no statistically significant difference between these groups for joint tenderness (0.10 (-0.35, +0.55) and for ESR [0.00 (-11.09, +11.09]. Overall, the four outcomes assessed in the single trial that compared prednisone to chloroquine suggested that there was no statistically significant differenece in the effectiveness of these two agents [SMD for joint tenderness = +0.23 (-0.30, +0.75), swollen joints = +0.43 (-0.11, +0.96), functional status = -0.27 (-0.80, +0.26), and WMD for ESR = -16.00 (-30.58, -1.42)]."
] |
cochrane-simplification-train-1556
|
cochrane-simplification-train-1556
|
We identified nine studies meeting the inclusion criteria, including a Turkish study that is awaiting formal translation. There were 1244 participants randomised in classically designed RCTs, of whom 1197 had evaluable data, and 138 patients enrolled in an enriched enrolment, randomised withdrawal (EERW) trial. Overall, 600 participants were treated with transdermal fentanyl patches, 382 with various formulations of morphine, 36 with methadone, and 221 with paracetamol plus codeine. There were major sources of potential bias, including lack of blinding, small size, high levels of attrition, and inconsistent reporting. We could not compare data in a meaningful analysis regarding adverse events such as nausea, abdominal pain, gastrointestinal bleeding, and confusion. These events may have been attributable to the underlying disease process. There were insufficient comparable data for meta-analysis to be undertaken or to produce numbers needed to treat (NNT) for the analgesic effect. In seven studies with 461 participants reporting pain intensity results after about two weeks, the mean or median pain scores were on the borderline of mild and moderate pain. Most participants would have had no worse than mild pain on treatment. Another reported that 77% of participants using transdermal fentanyl had an undefined successful outcome. Fewer participants experienced constipation with transdermal fentanyl (28%) than with oral morphine (46%), giving a risk ratio of 0.61 (95% CI 0.47 to 0.78); the NNT to prevent constipation was 5.5 (95% CI 3.8 to 10). The randomised trial literature for effectiveness of transdermal fentanyl is limited, but it is an important medicine. Most studies recruited fewer than 100 participants and did not provide data appropriate for meta-analysis. Only a few reported how many patients had good pain relief but, where data were reported, a majority had no worse than mild pain within a reasonably short time period. The evidence pointed to a useful and significant reduction in complaints about constipation for transdermal fentanyl compared with oral morphine.
|
We found nine studies involving 1244 patients. The studies were often small, used different study designs, and compared fentanyl with many different drugs. Most patients had pain that went from moderate or severe before transdermal fentanyl to no worse than mild pain when using transdermal fentanyl. Only 3 in 10 patients were constipated using transdermal fentanyl compared with 5 in 10 using oral morphine. We could not analyse the data in a meaningful way regarding harmful (adverse) events such as nausea, abdominal pain, gastrointestinal bleeding, and confusion. These events may have been attributable to the underlying disease processes. The effect of the patch can continue after it has been taken off due to medicine that has been taken up by the skin. Used patches need to be disposed of carefully. We could wish for more consistency in study design, and especially in study reporting, which should include the outcome of pain reduced to tolerable levels – no worse than mild pain – so that patients with cancer are not bothered by pain.
|
10.1002/14651858.CD010270.pub2
|
[
"We found nine studies involving 1244 patients. The studies were often small, used different study designs, and compared fentanyl with many different drugs. Most patients had pain that went from moderate or severe before transdermal fentanyl to no worse than mild pain when using transdermal fentanyl. Only 3 in 10 patients were constipated using transdermal fentanyl compared with 5 in 10 using oral morphine. We could not analyse the data in a meaningful way regarding harmful (adverse) events such as nausea, abdominal pain, gastrointestinal bleeding, and confusion. These events may have been attributable to the underlying disease processes. The effect of the patch can continue after it has been taken off due to medicine that has been taken up by the skin. Used patches need to be disposed of carefully. We could wish for more consistency in study design, and especially in study reporting, which should include the outcome of pain reduced to tolerable levels – no worse than mild pain – so that patients with cancer are not bothered by pain."
] |
cochrane-simplification-train-1557
|
cochrane-simplification-train-1557
|
We included 11 RCTs (962 participants). Eight RCTs (762 participants) were carried out on adults (18 to 80 years of age), two (128 participants) involved children (two to 16 years) and one RCT (72 participants) included patients aged 60 to 75 years. Of the 11 included studies, we judged three to be at low risk of bias, and the remaining eight RCTs at unclear or high risk of bias. Six RCTs (383 participants) estimated the primary outcome, time to awakening after stopping general anaesthesia, which was reduced in the entropy as compared to the standard practice group (mean difference (MD) -5.42 minutes, 95% confidence interval (CI) -8.77 to -2.08; moderate quality of evidence). We noted heterogeneity for this outcome; on performing subgroup analysis this was found to be due to studies that included participants undergoing major, long duration surgeries (off-pump coronary artery bypass grafting, major urological surgery). The MD for time to awakening with four studies on ambulatory procedures was -3.20 minutes (95% CI -3.94 to -2.45). No trial reported the second primary outcome, mortality at 24 hours, 30 days, and one year with the use of entropy monitoring. Eight trials (797 participants) compared the secondary outcome, postoperative recall of intraoperative events (awareness) in the entropy and standard practice groups. Awareness was reported by only one patient in the standard practice group, making meaningful estimation of benefit of entropy monitoring difficult; moderate quality of evidence. All 11 RCTs compared the amount of anaesthetic agent used between the entropy and standard practice groups. Six RCTs compared the amount of propofol, four compared the amount of sevoflurane and one the amount of isoflurane used between the groups. Analysis of three studies (166 participants) revealed that the MD of propofol consumption between the entropy group and control group was -11.56 mcg/kg/min (95% CI -24.05 to 0.92); low quality of evidence. Analysis of another two studies (156 participants) showed that the MD in sevoflurane consumption in the entropy group compared to the control group was -3.42 mL (95% CI -6.49 to -0.35); moderate quality of evidence. No trial reported on the secondary outcome of the cost of general anaesthesia. Three trials (170 participants) estimated MD in time to readiness to leave the PACU of the entropy group as compared to the control group (MD -5.94 minutes, 95% CI -16.08 to 4.20; low quality of evidence). Heterogeneity was noted, which was due to the difference in anaesthetic technique (propofol-based general anaesthesia) in one study. The remaining two studies had used volatile-based general anaesthesia. The MD in time to readiness to leave the PACU was -4.17 minutes (95% CI -6.84 to -1.51) with these two studies. The evidence as regards time to awakening, recall of intraoperative awareness and reduction in inhalational anaesthetic agent use was of moderate quality. The quality of evidence of as regards reduction in intravenous anaesthetic agent (propofol) use, as well as time to readiness to leave the PACU was found to be of low quality. As the data are limited, further studies consisting of more participants will be required for ascertaining benefits of entropy monitoring. Further studies are needed to assess the effect of entropy monitoring on focal issues such as short-term and long-term mortality, as well as cost of general anaesthesia.
|
We included studies that compared entropy monitoring to the standard practice of administering anaesthetic drugs according to changes in heart rate, blood pressure, tearing, sweating or movement in response to surgery. The evidence is current to September 2014. We included adults and children aged two to 16 years. The participants underwent all types of surgery, except brain surgery, under general anaesthesia. We reran the search in January 2016. We identified one potential new study of interest; we will incorporate it into the formal review findings during the review update. We found 11 studies, with a total of 962 participants. Six studies (383 participants) found minimally shorter time to awakening in the entropy group. No study reported on death occurring in the first 24 hours after surgery or within 30 days to a year after surgery. Eight studies (797 participants) evaluated recollection of intraoperative events (awareness). Adverse events were rare and no benefit was evident. All 11 studies compared anaesthetic medicine use: six compared propofol (given in the vein) and five evaluated anaesthetic gas (sevoflurane or isoflurane). Limited studies were analysed because of differences in methodology and units of measurement. Analysis of three studies (166 participants) found reduced propofol use, and two studies (156 participants) found lower sevoflurane use in the entropy group. No study reported on cost of general anaesthesia. Three studies found shorter length of stay in the postanaesthesia care unit (PACU) in the entropy group. The evidence for assessing reduction in time to awakening, recall of intraoperative events and amount of inhalation of anaesthetic agents used is of moderate quality. The quality of evidence as regards intravenous anaesthetic agent used and length of stay in the PACU is of low quality.
|
10.1002/14651858.CD010135.pub2
|
[
"We included studies that compared entropy monitoring to the standard practice of administering anaesthetic drugs according to changes in heart rate, blood pressure, tearing, sweating or movement in response to surgery. The evidence is current to September 2014. We included adults and children aged two to 16 years. The participants underwent all types of surgery, except brain surgery, under general anaesthesia. We reran the search in January 2016. We identified one potential new study of interest; we will incorporate it into the formal review findings during the review update. We found 11 studies, with a total of 962 participants. Six studies (383 participants) found minimally shorter time to awakening in the entropy group. No study reported on death occurring in the first 24 hours after surgery or within 30 days to a year after surgery. Eight studies (797 participants) evaluated recollection of intraoperative events (awareness). Adverse events were rare and no benefit was evident. All 11 studies compared anaesthetic medicine use: six compared propofol (given in the vein) and five evaluated anaesthetic gas (sevoflurane or isoflurane). Limited studies were analysed because of differences in methodology and units of measurement. Analysis of three studies (166 participants) found reduced propofol use, and two studies (156 participants) found lower sevoflurane use in the entropy group. No study reported on cost of general anaesthesia. Three studies found shorter length of stay in the postanaesthesia care unit (PACU) in the entropy group. The evidence for assessing reduction in time to awakening, recall of intraoperative events and amount of inhalation of anaesthetic agents used is of moderate quality. The quality of evidence as regards intravenous anaesthetic agent used and length of stay in the PACU is of low quality."
] |
cochrane-simplification-train-1558
|
cochrane-simplification-train-1558
|
Eight studies (11 study comparisons) were identified, all of which compared cognitive and/or behavioural treatments versus treatment as usual control groups. Seven studies (ten comparisons) had usable data for meta-analyses. These studies demonstrated that patients receiving any variant of cognitive behavioural treatment exhibited significantly fewer symptoms post-treatment than those receiving treatment as usual (SMD -1.24, 95% CI -1.61 to -0.87, I² test for heterogeneity 33.4%). Different types of cognitive and/or behavioural treatments showed similar differences in effect when compared with treatment as usual. The overall treatment effect appeared to be influenced by differences in baseline severity. The findings of this review suggest that psychological treatments derived from cognitive behavioural models are an effective treatment for adult patients with obsessive compulsive disorder. Larger high quality randomised controlled trials involving longer follow up periods are needed, to further test cognitive behavioural treatments, and other psychological approaches, in comparison to each other and control conditions. Future trials should examine the predictors of response to each treatment, and also conduct cost-effectiveness evaluations.
|
We reviewed studies that compared psychological interventions to treatment as usual groups who either received no treatment, or were on a waiting list for treatment or received usual care. We found eight studies, which together suggested that cognitive and/or behavioural treatments were better than treatment as usual conditions at reducing clinical symptoms. Baseline OCD severity and depressive symptom level predicted the degree of response. However, the conclusions were based on a small number of randomised controlled trials with small sample sizes. There were no trials of other forms of psychological treatment such as psychodynamic therapy and client-centred therapy, and a lack of available evidence for the long-term effectiveness of psychological treatments.
|
10.1002/14651858.CD005333.pub2
|
[
"We reviewed studies that compared psychological interventions to treatment as usual groups who either received no treatment, or were on a waiting list for treatment or received usual care. We found eight studies, which together suggested that cognitive and/or behavioural treatments were better than treatment as usual conditions at reducing clinical symptoms. Baseline OCD severity and depressive symptom level predicted the degree of response. However, the conclusions were based on a small number of randomised controlled trials with small sample sizes. There were no trials of other forms of psychological treatment such as psychodynamic therapy and client-centred therapy, and a lack of available evidence for the long-term effectiveness of psychological treatments."
] |
cochrane-simplification-train-1559
|
cochrane-simplification-train-1559
|
The primary outcome measures were complete clearance of lesions after the first treatment cycle and recurrence rate at 12 months. Our secondary outcomes included the number of lesions that cleared after each treatment cycle, the number of treatment cycles needed to achieve clearance, the recurrence rates at > 12 months, cosmetic outcome, quality of life assessment, and adverse outcomes as reported by both participant and clinician. We included 9 studies, with a total of 363 participants. One study demonstrated statistically significantly greater clearance of lesions of Bowen's disease with MAL-PDT (methyl aminolevulinate with photodynamic therapy) when compared with placebo-PDT (RR (risk ratio) 1.68, 95% CI (confidence interval) 1.12 to 2.52; n = 148) or cryotherapy (RR 1.17, 95% CI 1.01 to 1.37; n = 215), but there was no significant difference when MAL-PDT was compared to 5-FU (5-fluorouracil). One study demonstrated statistically significantly greater clearance of lesions with ALA-PDT (5-aminolevulinic acid with photodynamic therapy) versus 5-FU (RR 1.83, 95% CI 1.10 to 3.06; n = 66), but no statistically significant difference in recurrence rates at 12 months (RR 0.33, 95% CI 0.07 to 1.53). Cryotherapy showed no statistically significant difference in clearance rates (RR 0.99, 95% CI 0.78 to 1.26) or recurrences at 1 year (RR 1.48, 95% CI 0.53 to 4.17) when compared to 5-FU in 1 study of 127 participants. One study compared imiquimod to placebo and demonstrated statistically significantly greater clearance rates in the imiquimod group (9/15 lesions) compared to placebo (0/16) (Fisher's Exact P value < 0.001). The imiquimod group did not report any recurrences at 12 months, but at 18 months, 2/16 participants in the placebo group had developed early invasive squamous cell carcinoma. Overall, there has been very little good-quality research on treatments for Bowen's disease. There is limited evidence from single studies to suggest MAL-PDT is an effective treatment. Although cosmetic outcomes appear favourable with PDT, five-year follow-up data are needed. Significantly more lesions cleared with MAL-PDT compared to cryotherapy. No significant difference in clearance was seen when MAL-PDT was compared with 5-FU, but one study found a significant difference in clearance in favour of ALA-PDT when compared to 5-FU. There was no significant difference in clearance when cryotherapy was compared to 5-FU. The lack of quality data for surgery and topical cream therapies has limited the scope of this review to one largely about PDT studies. The age group, number, and size of lesions and site(s) affected may all influence therapeutic choice; however, there was not enough evidence available to provide guidance on this. More studies are required in the immunosuppressed populations as different therapeutic options may be preferable. Specific recommendations cannot be made from the data in this review, so we cannot give firm conclusions about the comparative effectiveness of treatments.
|
We included 9 randomised controlled trials, with a total of 363 participants. No studies examined surgical methods. Photodynamic therapy appears to be an effective treatment and has the benefit of minimal scarring compared with cryotherapy or 5-fluorouracil. Cryotherapy is convenient and less expensive, but does not appear to be as effective as photodynamic therapy and results in more scarring; 5-aminolevulinic acid with photodynamic therapy (ALA-PDT) appears to be more effective than 5-fluorouracil, whereas methyl aminolevulinate with photodynamic therapy (MAL-PDT) does not appear to be as good as 5-fluorouracil. One study demonstrated benefit with imiquimod cream. Specific recommendations cannot be made from these data, so this review cannot give firm conclusions about the comparative effectiveness of treatments. There is a clear need for future research to focus on a range of different studies comparing various therapies with each other, and in particular to surgical treatments to provide high-quality evidence to guide clinical practice. The age group, number and size of lesions, sites affected, and immunological status may all influence therapeutic choices. Longer-term follow up (up to 10 years) is needed to determine the effect of treatments on risk of progression of lesions of Bowen's disease to squamous cell carcinoma.
|
10.1002/14651858.CD007281.pub2
|
[
"We included 9 randomised controlled trials, with a total of 363 participants. No studies examined surgical methods. Photodynamic therapy appears to be an effective treatment and has the benefit of minimal scarring compared with cryotherapy or 5-fluorouracil. Cryotherapy is convenient and less expensive, but does not appear to be as effective as photodynamic therapy and results in more scarring; 5-aminolevulinic acid with photodynamic therapy (ALA-PDT) appears to be more effective than 5-fluorouracil, whereas methyl aminolevulinate with photodynamic therapy (MAL-PDT) does not appear to be as good as 5-fluorouracil. One study demonstrated benefit with imiquimod cream. Specific recommendations cannot be made from these data, so this review cannot give firm conclusions about the comparative effectiveness of treatments. There is a clear need for future research to focus on a range of different studies comparing various therapies with each other, and in particular to surgical treatments to provide high-quality evidence to guide clinical practice. The age group, number and size of lesions, sites affected, and immunological status may all influence therapeutic choices. Longer-term follow up (up to 10 years) is needed to determine the effect of treatments on risk of progression of lesions of Bowen's disease to squamous cell carcinoma."
] |
cochrane-simplification-train-1560
|
cochrane-simplification-train-1560
|
We included 45 trials (involving 1619 participants) in this update of our review. Electromechanical and robot-assisted arm training improved activities of daily living scores (SMD 0.31, 95% confidence interval (CI) 0.09 to 0.52, P = 0.0005; I² = 59%; 24 studies, 957 participants, high-quality evidence), arm function (SMD 0.32, 95% CI 0.18 to 0.46, P < 0.0001, I² = 36%, 41 studies, 1452 participants, high-quality evidence), and arm muscle strength (SMD 0.46, 95% CI 0.16 to 0.77, P = 0.003, I² = 76%, 23 studies, 826 participants, high-quality evidence). Electromechanical and robot-assisted arm training did not increase the risk of participant dropout (RD 0.00, 95% CI -0.02 to 0.02, P = 0.93, I² = 0%, 45 studies, 1619 participants, high-quality evidence), and adverse events were rare. People who receive electromechanical and robot-assisted arm training after stroke might improve their activities of daily living, arm function, and arm muscle strength. However, the results must be interpreted with caution although the quality of the evidence was high, because there were variations between the trials in: the intensity, duration, and amount of training; type of treatment; participant characteristics; and measurements used.
|
We identified 45 trials (involving 1619 participants) up to January 2018 and included them in our review. Twenty-four different electromechanical devices were described in the trials, which compared electromechanical and robot-assisted arm training with a variety of other interventions. Participants were between 21 to 80 years of age, the duration of the trials ranged from two to 12 weeks, the size of the trials was between eight and 127 participants, and the primary outcome (activities of daily living: the most important target variable measured) differed between the included trials. Electromechanical and robot-assisted arm training improved activities of daily living in people after stroke, and function and muscle strength of the affected arm. As adverse events, such as injuries and pain, were seldom described, these devices can be applied as a rehabilitation tool, but we still do not know when or how often they should be used. The quality of the evidence was high.
|
10.1002/14651858.CD006876.pub5
|
[
"We identified 45 trials (involving 1619 participants) up to January 2018 and included them in our review. Twenty-four different electromechanical devices were described in the trials, which compared electromechanical and robot-assisted arm training with a variety of other interventions. Participants were between 21 to 80 years of age, the duration of the trials ranged from two to 12 weeks, the size of the trials was between eight and 127 participants, and the primary outcome (activities of daily living: the most important target variable measured) differed between the included trials. Electromechanical and robot-assisted arm training improved activities of daily living in people after stroke, and function and muscle strength of the affected arm. As adverse events, such as injuries and pain, were seldom described, these devices can be applied as a rehabilitation tool, but we still do not know when or how often they should be used. The quality of the evidence was high."
] |
cochrane-simplification-train-1561
|
cochrane-simplification-train-1561
|
We included 10 RCTs that involved a total of 300 participants whose mean age was 54.4 years. Women accounted for fewer than 25% of all study participants. Nine trials which randomised 284 participants to receive exercise-based rehabilitation (151 participants) or no exercise (133 participants) were included in the main analysis. One cross-over RCT compared high-intensity interval training with continued moderate-intensity training in 16 participants. We reported findings for all trials at their longest follow-up (median 12 weeks). Exercise-based cardiac rehabilitation increased exercise capacity (VO2peak) compared with no exercise control (MD 2.49 mL/kg/min, 95% CI 1.63 to 3.36; N = 284; studies = 9; moderate quality evidence). There was evidence from one trial that high-intensity interval exercise training was more effective in improving exercise capacity than continuous moderate-intensity exercise (MD 2.30 mL/kg/min, 95% CI 0.59 to 4.01; N = 16; 1 study). Four studies reported health-related quality of life (HRQoL) measured using SF-36, Profile of Quality of Life in the Chronically Ill (PLC) and the World Health Organization Quality Of Life (WHOQoL) - BREF. Due to the variation in HRQoL outcomes and methods of reporting we were unable to meta-analyse results across studies, but there was no evidence of a difference between exercise-based cardiac rehabilitation and control in 18 of 21 HRQoL domains reported, or between high and moderate intensity exercise in any of the 10 HRQoL domains reported. One adverse event was reported by one study. Exercise-based cardiac rehabilitation improves exercise capacity, but exercise was found to have no impact on health-related quality of life in the short-term (median 12 weeks follow-up), in heart transplant recipients whose health is stable. There was no evidence of statistical heterogeneity across trials for exercise capacity and no evidence of small study bias. The overall risk of bias in included studies was judged as low or unclear; more than 50% of included studies were assessed at unclear risk of bias with respect to allocation concealment, blinding of outcome assessors and declaration of conflicts of interest. Evidence quality was assessed as moderate according to GRADE criteria. We found moderate quality evidence suggesting that exercise-based cardiac rehabilitation improves exercise capacity, and that exercise has no impact on health-related quality of life in the short-term (median 12 weeks follow-up), in heart transplant recipients. Cardiac rehabilitation appears to be safe in this population, but long-term follow-up data are incomplete and further good quality and adequately-powered trials are needed to demonstrate the longer-term benefits of exercise on safety and impact on both clinical and patient-related outcomes, such as health-related quality of life, and healthcare costs.
|
We searched for randomised controlled trials (experiments that randomly allocate participants to one of two or more treatment groups) looking at the effectiveness of exercise-based rehabilitation programmes compared with no exercise, or a different type or intensity of exercise, in people aged 18 years or over, who were heart transplant recipients. We included 10 trials that studied 300 people who were heart transplant recipients. Nine studies compared exercise with no exercise; one study compared high-intensity interval training with continuous moderate-intensity exercise. We found that exercise-based cardiac rehabilitation led to an increase in the exercise capacity of heart transplant recipients compared to not undertaking exercise. There was evidence of better exercise capacity following high-intensity interval training compared to continuous moderate-intensity exercise. Four studies reported health-related quality of life, but there was no evidence of differences between exercise training and no exercise training in most (18/21) aspects reported, or between high- and moderate-intensity exercise. One adverse event was reported in one study. Risk of bias in the included studies was assessed as low or unclear; lack of reporting made assessment for more than half of included studies challenging. Six (of 10) trials reported sources of funding. None reported funding from agencies with commercial interests in the results. Poor reporting or few participants in the analyses led to evidence quality being judged as moderate for both exercise capacity and health-related quality of life. Evidence suggested that exercise-based cardiac rehabilitation improves exercise capacity, and that exercise has no impact on health-related quality of life in the short-term (median 12 weeks follow-up), in heart transplant recipients whose health is stable. Further research is needed to establish long-term impacts of exercise-based rehabilitation on important aspects such as risk of death and hospital admission.
|
10.1002/14651858.CD012264.pub2
|
[
"We searched for randomised controlled trials (experiments that randomly allocate participants to one of two or more treatment groups) looking at the effectiveness of exercise-based rehabilitation programmes compared with no exercise, or a different type or intensity of exercise, in people aged 18 years or over, who were heart transplant recipients. We included 10 trials that studied 300 people who were heart transplant recipients. Nine studies compared exercise with no exercise; one study compared high-intensity interval training with continuous moderate-intensity exercise. We found that exercise-based cardiac rehabilitation led to an increase in the exercise capacity of heart transplant recipients compared to not undertaking exercise. There was evidence of better exercise capacity following high-intensity interval training compared to continuous moderate-intensity exercise. Four studies reported health-related quality of life, but there was no evidence of differences between exercise training and no exercise training in most (18/21) aspects reported, or between high- and moderate-intensity exercise. One adverse event was reported in one study. Risk of bias in the included studies was assessed as low or unclear; lack of reporting made assessment for more than half of included studies challenging. Six (of 10) trials reported sources of funding. None reported funding from agencies with commercial interests in the results. Poor reporting or few participants in the analyses led to evidence quality being judged as moderate for both exercise capacity and health-related quality of life. Evidence suggested that exercise-based cardiac rehabilitation improves exercise capacity, and that exercise has no impact on health-related quality of life in the short-term (median 12 weeks follow-up), in heart transplant recipients whose health is stable. Further research is needed to establish long-term impacts of exercise-based rehabilitation on important aspects such as risk of death and hospital admission."
] |
cochrane-simplification-train-1562
|
cochrane-simplification-train-1562
|
We identified 13 eligible studies with 2001 participants (mean or median age range 58 to 73 years) and two ongoing studies. We categorised studies into eight comparisons, all against cardiac care and additional other active drugs or placebo. These comparisons investigated the efficacy of levosimendan versus dobutamine, enoximone or placebo, epinephrine versus norepinephrine-dobutamine, amrinone versus dobutamine, dopexamine versus dopamine, enoximone versus dopamine and nitric oxide versus placebo. All trials were published in peer-reviewed journals, and analysis was done by the intention-to-treat (ITT) principle. Twelve of 13 trials were small with few included participants. Acknowledgement of funding by the pharmaceutical industry or missing conflict of interest statements emerged in five of 13 trials. In general, confidence in the results of analysed studies was reduced due to serious study limitations, very serious imprecision or indirectness. Domains of concern, which show a high risk of more than 50%, include performance bias (blinding of participants and personnel) and bias affecting the quality of evidence on adverse events. Levosimendan may reduce short-term mortality compared to a therapy with dobutamine (RR 0.60, 95% CI 0.37 to 0.95; 6 studies; 1776 participants; low-quality evidence; NNT: 16 (patients with moderate risk), NNT: 5 (patients with CS)). This initial short-term survival benefit with levosimendan vs. dobutamine is not confirmed on long-term follow up. There is uncertainty (due to lack of statistical power) as to the effect of levosimendan compared to therapy with placebo (RR 0.48, 95% CI 0.12 to 1.94; 2 studies; 55 participants, very low-quality evidence) or enoximone (RR 0.50, 95% CI 0.22 to 1.14; 1 study; 32 participants, very low-quality evidence). All comparisons comparing other positive inotropic, inodilative or vasodilative drugs presented uncertainty on their effect on short-term mortality with very low-quality evidence and based on only one RCT. These single studies compared epinephrine with norepinephrine-dobutamine (RR 1.25, 95% CI 0.41 to 3.77; 30 participants), amrinone with dobutamine (RR 0.33, 95% CI 0.04 to 2.85; 30 participants), dopexamine with dopamine (no in-hospital deaths from 70 participants), enoximone with dobutamine (two deaths from 40 participants) and nitric oxide with placebo (one death from three participants). Apart from low quality of evidence data suggesting a short-term mortality benefit of levosimendan compared with dobutamine, at present there are no robust and convincing data to support a distinct inotropic or vasodilator drug-based therapy as a superior solution to reduce mortality in haemodynamically unstable people with cardiogenic shock or LCOS. Considering the limited evidence derived from the present data due to a generally high risk of bias and imprecision, it should be emphasised that there remains a great need for large, well-designed randomised trials on this topic to close the gap between daily practice in critical care medicine and the available evidence. It seems to be useful to apply the concept of 'early goal-directed therapy' in cardiogenic shock and LCOS with early haemodynamic stabilisation within predefined timelines. Future clinical trials should therefore investigate whether such a therapeutic concept would influence survival rates much more than looking for the 'best' drug for haemodynamic support.
|
This evidence is current to June 2017. We included 13 studies with 2001 participants with CS or LCOS as complications of myocardial infarction, heart failure or cardiac surgery, with follow-up periods between the length of the recovery period up to 12 months. Four studies were funded by a drug manufacturer. We compared different approaches to standard therapies with possible addition of inotropic or vasoconstrictive drugs as levosimendan, dobutamine, enoximone, epinephrine. This review presents low-quality evidence that levosimendan compared to dobutamine reduces short-term mortality. The survival benefit with levosimendan vs. dobutamine is not confirmed on long-term follow up. Very low-quality evidence shows uncertainty around the effect of levosimendan compared to placebo or enoximone. Very low-quality evidence shows uncertainty on the comparison of epinephrine with norepinephrine-dobutamine, amrinone or enoximone with dobutamine, dopexamine with dopamine, and nitric oxide with placebo. We have reduced confidence in the results of the studies that we analysed (low- or very low-quality evidence) due to serious study limitations, very serious imprecision or indirectness.
|
10.1002/14651858.CD009669.pub3
|
[
"This evidence is current to June 2017. We included 13 studies with 2001 participants with CS or LCOS as complications of myocardial infarction, heart failure or cardiac surgery, with follow-up periods between the length of the recovery period up to 12 months. Four studies were funded by a drug manufacturer. We compared different approaches to standard therapies with possible addition of inotropic or vasoconstrictive drugs as levosimendan, dobutamine, enoximone, epinephrine. This review presents low-quality evidence that levosimendan compared to dobutamine reduces short-term mortality. The survival benefit with levosimendan vs. dobutamine is not confirmed on long-term follow up. Very low-quality evidence shows uncertainty around the effect of levosimendan compared to placebo or enoximone. Very low-quality evidence shows uncertainty on the comparison of epinephrine with norepinephrine-dobutamine, amrinone or enoximone with dobutamine, dopexamine with dopamine, and nitric oxide with placebo. We have reduced confidence in the results of the studies that we analysed (low- or very low-quality evidence) due to serious study limitations, very serious imprecision or indirectness."
] |
cochrane-simplification-train-1563
|
cochrane-simplification-train-1563
|
Ten trials involving 2412 participants were included. The vaccines investigated were calf-lymph derived first-generation vaccines (Dryvax, APVS, Lancy-vaxina, Lister), and cell-cultured second-generation vaccines (ACAM, CCSV). Vaccines were investigated in different dilutions. All undiluted vaccines induced a reaction in 95% of people vaccinated in terms of pustule and immunogenicity. Also 1:10 dilutions were fully efficient when the starting concentration was defined. Serious adverse events were reported in 1% to 2% of the volunteers. Fever was observed in 11% to 22% of participants, and headache in roughly half of the participants. Fever was less frequent when new vaccines were administered, but rates of headache were similar in new and old vaccines. The evidence shows that stockpiled vaccines have maintained their immunogenicity and new cell-cultured vaccines are similar to stockpiled vaccines in terms of vaccination success rate and immunogenicity. First- and second-generation vaccines diluted to at least 1:10 are as effective as undiluted vaccine in terms of clinical success rate and immunogenicity. Dilution did not reduce the frequency of adverse events. Success rate and immunogenicity were similar in naive and previously vaccinated persons, but there were fewer adverse events in previously vaccinated persons. The rate of adverse events found in this review reveals the need for further development and improvement of smallpox vaccines.
|
The review identified 10 trials that involved 2412 participants. Overall, the quality of the trials was not high but the review showed that stockpiles of the vaccines maintained their effectiveness even when diluted. New second-generation vaccines seemed to be effective but still have adverse events. There were too few participants overall to be able to assess rare outcomes. Further research is needed, particularly on the third-generation vaccines.
|
10.1002/14651858.CD004913.pub2
|
[
"The review identified 10 trials that involved 2412 participants. Overall, the quality of the trials was not high but the review showed that stockpiles of the vaccines maintained their effectiveness even when diluted. New second-generation vaccines seemed to be effective but still have adverse events. There were too few participants overall to be able to assess rare outcomes. Further research is needed, particularly on the third-generation vaccines."
] |
cochrane-simplification-train-1564
|
cochrane-simplification-train-1564
|
Three studies involving 170 participants compared the azapirone buspirone with placebo. No study provided enough usable information on our primary efficacy outcome (response). For our primary acceptability outcome, moderate-quality evidence indicated that azapirones had lower acceptability than placebo: risk ratio (RR) for dropouts for any reason 2.13 (95% confidence interval (CI) 1.11 to 4.07; 3 studies, 170 participants. Evidence for secondary efficacy outcomes were of low quality. Results on efficacy between azapirone and placebo in terms of agoraphobia (standardised mean difference (SMD) -0.01, 95% CI -0.56 to 0.53; 1 study, 52 participants), general anxiety (mean difference (MD) -2.20, 95% CI -5.45 to 1.06; 2 studies, 115 participants) and depression (MD -1.80, 95% CI -5.60 to 2.00; 1 study, 52 participants) were uncertain. None of the studies provided information for the assessment of allocation concealment or sequence generation. Conflicts of interest were not explicitly expressed. The risk of attrition bias was rated high for all three studies. Information on adverse effects other than dropouts for any reason was insufficient to include in the analyses. The efficacy of azapirones is uncertain due to the lack of meta-analysable data for the primary outcome and low-quality evidence for secondary efficacy outcomes. A small amount of moderate-quality evidence suggested that the acceptability of azapirones for panic disorder was lower than for placebo. However, only trials of one azapirone (namely buspirone) were included in this review; this, combined with the small sample size, limits our conclusions. If further research is to be conducted, studies with larger sample sizes, with different azapirones and with less risk of bias are necessary to draw firm conclusions regarding azapirones for panic disorder.
|
There was not enough information to work out whether azapirones are any more or less effective than placebo in causing substantial improvements in panic disorder overall. A small amount of moderate-quality evidence suggests that the acceptability of azapirones for panic disorder is lower than for placebo. There was not enough information to compare any differences in adverse effects caused by azapirones and placebo. Studies with larger sample sizes and fewer risks of bias should be carried out. Studies should report how participants were allocated to each treatment, and whether the trials were financially sponsored by the manufacturer of the drug. Study protocols should be registered to avoid selective reporting of outcomes by authors. Trials need to test azapirones other than buspirone to determine their effectiveness. Remission or response should be reported as the efficacy outcome and longer-term outcomes need to be addressed to establish whether the effect is transient or durable. Trials should better report any harms experienced by participants during the trial.
|
10.1002/14651858.CD010828.pub2
|
[
"There was not enough information to work out whether azapirones are any more or less effective than placebo in causing substantial improvements in panic disorder overall. A small amount of moderate-quality evidence suggests that the acceptability of azapirones for panic disorder is lower than for placebo. There was not enough information to compare any differences in adverse effects caused by azapirones and placebo. Studies with larger sample sizes and fewer risks of bias should be carried out. Studies should report how participants were allocated to each treatment, and whether the trials were financially sponsored by the manufacturer of the drug. Study protocols should be registered to avoid selective reporting of outcomes by authors. Trials need to test azapirones other than buspirone to determine their effectiveness. Remission or response should be reported as the efficacy outcome and longer-term outcomes need to be addressed to establish whether the effect is transient or durable. Trials should better report any harms experienced by participants during the trial."
] |
cochrane-simplification-train-1565
|
cochrane-simplification-train-1565
|
We included 27 trials involving 1976 participants Trials were conducted in Europe, China, Brazil, Canada and New Zealand and involved patients undergoing elective abdominal surgery (18), orthopaedic surgery (4), cardiac surgery (4) and thyroidectomy (1). Twelve studies were limited to participants with an American Society of Anaesthesiologists grade of I-II or I-III. A total of 17 trials contained at least one domain judged to be at high risk of bias, and only two studies were judged to be at low risk of bias across all domains. Of greatest concern was the risk of bias associated with inadequate blinding, as most of the outcomes assessed by this review were subjective. Only six trials were judged to be at low risk of bias because of blinding. In 19 trials including 1351 participants, preoperative carbohydrate treatment was associated with shortened length of hospital stay compared with placebo or fasting (by 0.30 days; 95% confidence interval (CI) 0.56 to 0.04; very low-quality evidence). No significant effect on length of stay was noted when preoperative carbohydrate treatment was compared with placebo (14 trials including 867 participants; mean difference -0.13 days; 95% CI -0.38 to 0.12). Based on two trials including 86 participants, preoperative carbohydrate treatment was also associated with shortened time to passage of flatus when compared with placebo or fasting (by 0.39 days; 95% CI 0.70 to 0.07), as well as increased postoperative peripheral insulin sensitivity (three trials including 41 participants; mean increase in glucose infusion rate measured by hyperinsulinaemic euglycaemic clamp of 0.76 mg/kg/min; 95% CI 0.24 to 1.29; high-quality evidence). As reported by 14 trials involving 913 participants, preoperative carbohydrate treatment was not associated with an increase or a decrease in the risk of postoperative complications compared with placebo or fasting (risk ratio of complications 0.98, 95% CI 0.86 to 1.11; low-quality evidence). Aspiration pneumonitis was not reported in any patients, regardless of treatment group allocation. Preoperative carbohydrate treatment was associated with a small reduction in length of hospital stay when compared with placebo or fasting in adult patients undergoing elective surgery. It was found that preoperative carbohydrate treatment did not increase or decrease postoperative complication rates when compared with placebo or fasting. Lack of adequate blinding in many studies may have contributed to observed treatment effects for these subjective outcomes, which are subject to possible biases.
|
The evidence is current up to March 2014. We identified 27 studies and included the outcomes of 1976 participants. Studies investigated the outcomes of patients undergoing planned surgical procedures on the abdomen (18), the bones or joints (4), the heart (4) or the thyroid gland (1). Eighteen studies compared carbohydrate supplements versus an identical appearing placebo drink that did not contain carbohydrates; in six of these studies, an additional group of patients had nothing to eat or drink for at least six hours before surgery. In nine studies, taking carbohydrate supplements was compared with having nothing to eat or drink for six hours before surgery. The primary outcomes of length of hospital stay and complication rate were reported by 19 and 14 studies, respectively. Patients given carbohydrates before planned surgical procedures went home between 0.04 and 0.56 days sooner than those receiving a placebo drink or having nothing to eat or drink before surgery. Carbohydrate supplements had little or no effect on complication rate or on how people feel in-hospital during recovery from surgery. The overall quality of the evidence varied from very low to high. The quality of evidence in support of carbohydrate supplements resulting in a shorter hospital stay was very low because the included studies had important flaws in their design, a very wide range of results was described and evidence revealed that studies showing no differences in length of hospital stay may not have been published. When we looked only at well-conducted studies, we found that carbohydrate supplements had little or no effect on length of hospital stay. The quality of evidence to support the effects of carbohydrate supplements on complication rate was low because issues with study design were identified and results were not similar across studies.
|
10.1002/14651858.CD009161.pub2
|
[
"The evidence is current up to March 2014. We identified 27 studies and included the outcomes of 1976 participants. Studies investigated the outcomes of patients undergoing planned surgical procedures on the abdomen (18), the bones or joints (4), the heart (4) or the thyroid gland (1). Eighteen studies compared carbohydrate supplements versus an identical appearing placebo drink that did not contain carbohydrates; in six of these studies, an additional group of patients had nothing to eat or drink for at least six hours before surgery. In nine studies, taking carbohydrate supplements was compared with having nothing to eat or drink for six hours before surgery. The primary outcomes of length of hospital stay and complication rate were reported by 19 and 14 studies, respectively. Patients given carbohydrates before planned surgical procedures went home between 0.04 and 0.56 days sooner than those receiving a placebo drink or having nothing to eat or drink before surgery. Carbohydrate supplements had little or no effect on complication rate or on how people feel in-hospital during recovery from surgery. The overall quality of the evidence varied from very low to high. The quality of evidence in support of carbohydrate supplements resulting in a shorter hospital stay was very low because the included studies had important flaws in their design, a very wide range of results was described and evidence revealed that studies showing no differences in length of hospital stay may not have been published. When we looked only at well-conducted studies, we found that carbohydrate supplements had little or no effect on length of hospital stay. The quality of evidence to support the effects of carbohydrate supplements on complication rate was low because issues with study design were identified and results were not similar across studies."
] |
cochrane-simplification-train-1566
|
cochrane-simplification-train-1566
|
The present updated review included 25 RCTs involving 3278 participants. The small number of trials in each comparison group and the heterogeneity of outcome measures precluded quantitative analysis of data for all but one outcome: pain intensity. In two pooled studies, the mean self-reported visual analogue scale (VAS; 0 to 100 mm) score for topical prilocaine-phenylephrine (PP) was higher than the mean self-reported VAS (0 to 100 mm) score for topical tetracaine-epinephrine-cocaine (TAC) by 5.59 points (95% confidence interval (CI) 2.16 to 13.35). Most trials that compared infiltrated and topical anaesthetics were at high risk of bias, which is likely to have affected their results. Researchers found that several cocaine-free topical anaesthetics provided effective analgesic efficacy. However, data regarding the efficacy of each topical agent are based mostly on single comparisons in trials with unclear or high risk of bias. Mild, self-limited erythematous skin induration occurred in one of 1042 participants who had undergone application of TAC. Investigators reported no serious complications among any of the participants treated with cocaine-based or cocaine-free topical anaesthetics. The overall quality of the evidence according to the GRADE system is low owing to limitations in design and implementation, imprecision of results and high probability of publication bias (selective reporting of data). Additional well-designed RCTs with low risk of bias are necessary before definitive conclusions can be reached. We have found two new studies published since the last version of this review was prepared. We have added these studies to those previously included and have conducted an updated analysis, which resulted in the same review conclusions as were presented previously. Mostly descriptive analysis indicates that topical anaesthetics may offer an efficacious, non-invasive means of providing analgesia before suturing of dermal lacerations. Use of cocaine-based topical anaesthetics might be hard to justify, given the availability of other effective topical anaesthetics without cocaine. However, the overall quality of the evidence according to the GRADE system is low owing to limitations in design and implementation, imprecision of results and high probability of publication bias (selective reporting of data). Additional well-designed RCTs with low risk of bias are necessary before definitive conclusions can be reached.
|
Study characteristics: The evidence is current to December 2016. We included in this review 25 randomized controlled trials involving 3278 participants. Studies included both adults and children. Fifteen of the included trials used self-reporting of pain intensity by trial participants to determine the effectiveness of local anaesthetics. Key results: Study results suggest that directly applying local anaesthetics to the skin is an effective, non-invasive way of providing pain control during suturing or stapling of skin lacerations. Study findings on the efficacy of individual topical anaesthetics were limited by study design, and data on the efficacy of each topical agent were obtained mostly from single trials. Researchers reported no serious side effects following the use of cocaine-containing or cocaine-free topical anaesthetics. The overall broadly comparable effectiveness of cocaine-free topical anaesthetics for skin laceration repair brings into question the necessity to include cocaine as a component of local anaesthetic solutions. The small number of trials in each comparison group and the range of outcome measures assessed prevented pooling and quantitative analysis of data for all but the single outcome of pain intensity. Additional studies are necessary to directly compare the effectiveness of different formulations of topical anaesthetics. Our review was limited to pain control for repair of superficial lacerations, and our results might not be generalizable to deeper lacerations or more complex procedures performed on intact skin. Further research is needed to strengthen the evidence and to overcome the weakness of the included studies. Quality of the evidence: The overall quality of the evidence was low owing to limitations in study design, ways that studies were carried out (implementation), imprecision of results and high probability of selective data reporting. Most of the trials that compared infiltrated and topical anaesthetics were at high risk of bias, and this was likely to influence measured effects.
|
10.1002/14651858.CD005364.pub3
|
[
"Study characteristics: The evidence is current to December 2016. We included in this review 25 randomized controlled trials involving 3278 participants. Studies included both adults and children. Fifteen of the included trials used self-reporting of pain intensity by trial participants to determine the effectiveness of local anaesthetics. Key results: Study results suggest that directly applying local anaesthetics to the skin is an effective, non-invasive way of providing pain control during suturing or stapling of skin lacerations. Study findings on the efficacy of individual topical anaesthetics were limited by study design, and data on the efficacy of each topical agent were obtained mostly from single trials. Researchers reported no serious side effects following the use of cocaine-containing or cocaine-free topical anaesthetics. The overall broadly comparable effectiveness of cocaine-free topical anaesthetics for skin laceration repair brings into question the necessity to include cocaine as a component of local anaesthetic solutions. The small number of trials in each comparison group and the range of outcome measures assessed prevented pooling and quantitative analysis of data for all but the single outcome of pain intensity. Additional studies are necessary to directly compare the effectiveness of different formulations of topical anaesthetics. Our review was limited to pain control for repair of superficial lacerations, and our results might not be generalizable to deeper lacerations or more complex procedures performed on intact skin. Further research is needed to strengthen the evidence and to overcome the weakness of the included studies. Quality of the evidence: The overall quality of the evidence was low owing to limitations in study design, ways that studies were carried out (implementation), imprecision of results and high probability of selective data reporting. Most of the trials that compared infiltrated and topical anaesthetics were at high risk of bias, and this was likely to influence measured effects."
] |
cochrane-simplification-train-1567
|
cochrane-simplification-train-1567
|
We included seven RCTs that involved a total of 542 women; of these, five recruited post-menopausal women (aged from 56 to 70 years) (422 women). We assessed all studies to be at high risk of bias. Meta-analyses comparing the overall effectiveness of treatments during acute phases of infection and rates of recurrence were conducted. Analysis of three studies involving 282 women that looked at CHM versus antibiotics suggested that CHM had a higher rate of effectiveness for acute UTI (RR 1.21, 95% CI 1.11 to 33) and reduced recurrent UTI rates (RR 0.28, 95% CI 0.09 to 0.82). Analysis of two studies involving 120 women that compared CHM plus antibiotics versus antibiotics alone found the combined intervention had a higher rate of effectiveness for acute UTI (RR 1.24, 95% CI 1.04 to 1.47) and resulted in lower rates of recurrent infection six months after the study (RR 0.53, 95% CI 0.35 to 0.80). One study comparing different CHM treatments found Er Xian Tang was more effective in treating acute infection in post-menopausal women than San Jin Pian (80 women: RR 1.28, 95% CI 1.03 to 1.57). Analysis showed that active CHM treatments specifically formulated for recurrent UTI were more effective in reducing infection incidence than generic CHM treatments that were more commonly used for acute UTI (RR 0.40, 95% CI 0.21 to 0.77). Only two studies undertook to report adverse events; neither reported the occurrence of any adverse events. Evidence from seven small studies suggested that CHM as an independent intervention or in conjunction with antibiotics may be beneficial for treating recurrent UTIs during the acute phase of infection and may reduce the recurrent UTI incidence for at least six months post-treatment. CHM treatments specifically formulated for recurrent UTI may be more effective than herbal treatments designed to treat acute UTI. However, the small number and poor quality of the included studies meant that it was not possible to formulate robust conclusions on the use of CHM for recurrent UTI in women either alone or as an adjunct to antibiotics.
|
The studies suggested that CHM used either on its own or with antibiotic treatment may be more effective than antibiotics alone for relieving acute UTIs and preventing recurrent episodes. There were only two studies that explicitly stated that adverse events were to be reported; neither reported any adverse events. However, studies were small and assessed as having poor methodological quality; and most study participants were post-menopausal. Therefore, results should be interpreted cautiously and can only be considered as preliminary findings that may not be relevant to pre-menopausal women. Further research is required to provide more rigorous evidence before CHM can be routinely recommended as a treatment option for recurrent UTIs.
|
10.1002/14651858.CD010446.pub2
|
[
"The studies suggested that CHM used either on its own or with antibiotic treatment may be more effective than antibiotics alone for relieving acute UTIs and preventing recurrent episodes. There were only two studies that explicitly stated that adverse events were to be reported; neither reported any adverse events. However, studies were small and assessed as having poor methodological quality; and most study participants were post-menopausal. Therefore, results should be interpreted cautiously and can only be considered as preliminary findings that may not be relevant to pre-menopausal women. Further research is required to provide more rigorous evidence before CHM can be routinely recommended as a treatment option for recurrent UTIs."
] |
cochrane-simplification-train-1568
|
cochrane-simplification-train-1568
|
There was a significant reduction in the weekly hot flush frequency for HT compared to placebo (WMD -17.92, 95% CI -22.86 to -12.99). This was equivalent to a 75% reduction in frequency (95% CI 64.3 to 82.3) for HT relative to placebo. Symptom severity was also significantly reduced compared to placebo (OR 0.13, 95% CI 0.07 to 0.23). Withdrawal for lack of efficacy occurred significantly more often on placebo therapy (OR 10.51, 95% CI 5.00 to 22.09). Withdrawal for adverse events, commonly breast tenderness, oedema, joint pain and psychological symptoms, was not significantly increased (OR 1.25, 95% CI 0.83 to 1.90), although the occurrence of any adverse events was significantly increased for HT (OR 1.41, 95% CI 1.00 to 1.99). In women who were randomised to placebo treatment, a 57.7% (95% CI 45.1 to 67.7) reduction in hot flushes was observed between baseline and end of study. Oral HT is highly effective in alleviating hot flushes and night sweats. Therapies purported to reduce such symptoms must be assessed in blinded trials against a placebo or a validated therapy because of the large placebo effect seen in well conducted randomised controlled trials, and also because during menopause symptoms may fluctuate and after menopause symptoms often decline. Withdrawals due to side-effects were only marginally increased in the HT groups despite the inability to tailor HT in these fixed dose trials. Comparisons of hormonal doses, product types or regimens require analysis of trials with these specific "within study" comparisons.
|
The review of scientifically well conducted trials found that taking oral oestrogen or combined oestrogen and progestogen hormone replacement therapy greatly reduces the frequency and severity of these symptoms. This effect was significantly greater than the reduction of symptoms seen with placebo (dummy tablets) over time. No adverse effects were found but as the trials were only short term, more research is needed.
|
10.1002/14651858.CD002978.pub2
|
[
"The review of scientifically well conducted trials found that taking oral oestrogen or combined oestrogen and progestogen hormone replacement therapy greatly reduces the frequency and severity of these symptoms. This effect was significantly greater than the reduction of symptoms seen with placebo (dummy tablets) over time. No adverse effects were found but as the trials were only short term, more research is needed."
] |
cochrane-simplification-train-1569
|
cochrane-simplification-train-1569
|
Five trials comprising of 233 participants met our inclusion criteria. Each study described the use of a different rTMS device that delivered different waveforms at different frequencies. All five trials were relatively small studies but generally they demonstrated a low risk of bias. When considering the impact of tinnitus on patients' quality of life, the results of only one study demonstrated a statistically significant improvement in Tinnitus Handicap Inventory (THI) scores at four months follow-up (defined as a 'partial improvement' by the study authors (THI reduction of 21% to 80%)) when low-frequency rTMS was compared with a sham control treatment. However, no statistically significant improvement was demonstrated by another two studies that considered rTMS at the same frequency. Furthermore, this single positive finding should be taken in the context of the many different variables which were recorded at many different points in time by the study authors. In accordance with our pre-specified subgroup analysis we extracted the data from one study to consider the differential effectiveness between 'lower' low-frequency rTMS (1 Hz) and 'higher' low-frequency rTMS (10 Hz, 25 Hz). In doing this we were able to demonstrate a statistically significant difference between rTMS employing a frequency of 1 Hz and the sham group when considering tinnitus severity and disability after four months follow-up ('partial' improvement). However, no statistically significant difference was demonstrated between 10 Hz and 25 Hz rTMS, and the sham control group, when considering the severity and disability of tinnitus at four months follow-up. When considering tinnitus loudness in patients undergoing rTMS we were able to demonstrate a statistically significant reduction in tinnitus loudness when the results of two studies were pooled (risk ratio 4.17, 95% confidence interval 1.30 to 13.40). However, this finding was based on two small trials and consequently the confidence interval was particularly wide. No serious adverse effects were reported in any of the trials. There is very limited support for the use of low-frequency rTMS for the treatment of patients with tinnitus. When considering the impact of tinnitus on patients' quality of life, support is from a single study with a low risk of bias based on a single outcome measure at a single point in time. When considering the impact on tinnitus loudness, this is based on the analysis of pooled data with a large confidence interval. Studies suggest that rTMS is a safe treatment for tinnitus in the short-term, however there were insufficient data to provide any support for the safety of this treatment in the long-term. More prospective, randomised, placebo-controlled, double-blind studies with large sample sizes are needed to confirm the effectiveness of rTMS for tinnitus patients. Uniform, validated, tinnitus-specific questionnaires and measurement scales should be used in future studies.
|
Our search for studies retrieved 283 articles. Of these, five trials comprising 233 tinnitus patients met our inclusion criteria and were included in the review. The first study considered the use of 'complex waveform rTMS', the second looked at the use of high-frequency rTMS, and the other three studies considered the use of low-frequency rTMS. We found that the use of low-frequency rTMS resulted in 'partial improvement' in tinnitus severity and disability in one study, however these results were not replicated in two other studies that considered rTMS at the same frequency. Furthermore, this single positive finding should be taken in the context of the many different variables which were recorded at many different points in time by the study authors. We were able to demonstrate an improvement in tinnitus loudness in patients undergoing rTMS when we combined the results of two other studies. rTMS is a safe treatment for patients with tinnitus in the short-term, however no data were available to verify safety in the long-term.
|
10.1002/14651858.CD007946.pub2
|
[
"Our search for studies retrieved 283 articles. Of these, five trials comprising 233 tinnitus patients met our inclusion criteria and were included in the review. The first study considered the use of 'complex waveform rTMS', the second looked at the use of high-frequency rTMS, and the other three studies considered the use of low-frequency rTMS. We found that the use of low-frequency rTMS resulted in 'partial improvement' in tinnitus severity and disability in one study, however these results were not replicated in two other studies that considered rTMS at the same frequency. Furthermore, this single positive finding should be taken in the context of the many different variables which were recorded at many different points in time by the study authors. We were able to demonstrate an improvement in tinnitus loudness in patients undergoing rTMS when we combined the results of two other studies. rTMS is a safe treatment for patients with tinnitus in the short-term, however no data were available to verify safety in the long-term."
] |
cochrane-simplification-train-1570
|
cochrane-simplification-train-1570
|
Four trials (979 participants) were eligible for inclusion in this review. One trial in patients with recently healed venous ulcers (n = 153) compared recurrence rates with and without compression and found that compression significantly reduced ulcer recurrence at six months (Risk ratio (RR) 0.46, 95% CI 0.27 to 0.76). Two trials compared high-compression hosiery (equivalent to UK class 3) with moderate-compression hosiery (equivalent to UK class 2). The first study (n=300) found no significant reduction in recurrence at five years follow up with high-compression hosiery compared with moderate-compression (RR 0.82, 95% CI 0.61 to 1.12). The second study (n = 338) assessed ulcer recurrence at three years follow up and found that high-compression hosiery reduced recurrence compared with moderate-compression (RR 0.57, 95% CI 0.39 to 0.81). Statistically significant heterogeneity precluded meta-analysis of the results from these studies. Patient-reported compliance rates were reported in both trials;,there was significantly higher compliance with medium-compression than with high-compression hosiery in one and no significant difference in the second. A fourth trial (166 patients) found no statistically significant difference in recurrence between two types of medium (UK class 2) compression hosiery (Medi versus Scholl: RR 0.74, 95% CI 0.45 to 1.2). No trials of compression bandages for preventing ulcer recurrence were identified. There is evidence from one trial that compression hosiery reduces rates of reulceration of venous ulcers compared with no compression. Results from one trial suggest that recurrence is lower in high-compression hosiery than in medium-compression hosiery at three years whilst another trial found no difference at 5 years. Rates of patient intolerance of compression hosiery were high. There is insufficient evidence to aid selection of different types, brands, or lengths of compression hosiery.
|
One small trial confirms that compression reduces ulcer recurrence compared with no compression. There is some evidence that people wearing high rather than moderate-compression hosiery are less likely to get a new ulcer. It is not clear whether moderate strength hosiery is better tolerated than high compression. There is, therefore, some evidence that compression hosiery might prevent ulcers, but the evidence is not strong.
|
10.1002/14651858.CD002303.pub3
|
[
"One small trial confirms that compression reduces ulcer recurrence compared with no compression. There is some evidence that people wearing high rather than moderate-compression hosiery are less likely to get a new ulcer. It is not clear whether moderate strength hosiery is better tolerated than high compression. There is, therefore, some evidence that compression hosiery might prevent ulcers, but the evidence is not strong."
] |
cochrane-simplification-train-1571
|
cochrane-simplification-train-1571
|
We identified no new studies for inclusion in this update. In total we included one trial, excluded 18 trials, classed one trial as ongoing, and classed another as awaiting classification. The total number of participants in the included trial was 10, and the methodological quality of this trial was moderate because of high risk of bias in relation to two domains (random sequence generation and allocation concealment) but low risk of bias for the four remaining domains (blinding, incomplete outcome data, selective reporting, and any other bias). The included trial was a short-term cross-over randomised trial undertaken in Canada, which tested the effects of adding three seemingly identical prosthetic weights (150 g vs 770 g vs 1625 g) to the prostheses of a total of 10 participants with unilateral dysvascular transfemoral amputation. Eight participants were over 60 years of age. Trial authors found that four participants preferred the addition of the lightest weight (150 g), five preferred the middle weight (770 g), and one preferred the heaviest weight (1625 g). Researchers interpreted this as equating to user satisfaction (success) and reported no adverse effects. The limited evidence presented in this review is of very low quality and is insufficient to inform the choice of prosthetic rehabilitation, including the optimum weight of the prosthesis, after unilateral transfemoral amputation in older dysvascular people. A programme of research that includes randomised controlled trials to examine key interventions is urgently required in this area.
|
Reviewers found only one controlled trial of moderate methodological quality (most recent search, 14 June 2018). This trial had a cross-over design, and each of the 10 participants had three seemingly identical prosthetic weights added to the prosthesis below the knee in random order. All artificial limbs were modular-style prostheses. The participants - nine men and one woman - were over 50 years of age, and eight were over 60 years old. Over the few hours of the trial, four participants preferred the lightest weight (150 g), five preferred the medium weight (770 g), and one preferred the heaviest weight (1625 g). Seven of the 10 people successfully ranked the weights from lightest to heaviest. The weights did not alter participants' walking speed in a two-minute walk test. Study authors reported no adverse effects. The inclusion of only one trial with a small number of participants, short exposure to different weights in a laboratory setting, and the fact that there were differences in weight between people and their prostheses limit the usefulness of these findings. The limited evidence included in this review is of very low quality and is insufficient to inform the choice of prosthetic rehabilitation, including optimum weight of the prosthesis, after unilateral transfemoral amputation in older dysvascular people.
|
10.1002/14651858.CD005260.pub4
|
[
"Reviewers found only one controlled trial of moderate methodological quality (most recent search, 14 June 2018). This trial had a cross-over design, and each of the 10 participants had three seemingly identical prosthetic weights added to the prosthesis below the knee in random order. All artificial limbs were modular-style prostheses. The participants - nine men and one woman - were over 50 years of age, and eight were over 60 years old. Over the few hours of the trial, four participants preferred the lightest weight (150 g), five preferred the medium weight (770 g), and one preferred the heaviest weight (1625 g). Seven of the 10 people successfully ranked the weights from lightest to heaviest. The weights did not alter participants' walking speed in a two-minute walk test. Study authors reported no adverse effects. The inclusion of only one trial with a small number of participants, short exposure to different weights in a laboratory setting, and the fact that there were differences in weight between people and their prostheses limit the usefulness of these findings. The limited evidence included in this review is of very low quality and is insufficient to inform the choice of prosthetic rehabilitation, including optimum weight of the prosthesis, after unilateral transfemoral amputation in older dysvascular people."
] |
cochrane-simplification-train-1572
|
cochrane-simplification-train-1572
|
The updated search did not reveal any further studies that met our inclusion criteria. The number of included studies therefore remains at 10 with the number of participants randomised still 283. One study comparing carbamazepine with placebo as the sole treatment for schizophrenia was abandoned early due to high relapse rate with 26 out of 31 participants relapsing by three months. No effect of carbamazepine was evident with no difference in relapse between the two groups (1 RCT n = 31, RR 1.07 CI 0.78 to 1.45). Another study compared carbamazepine with antipsychotics as the sole treatment for schizophrenia. No differences in terms of mental state were found when comparing 50% reduction in Brief Psychiatric Rating Scale (BPRS) scores (1 RCT n = 38, RR 1.23 CI 0.78 to 1.92). A favourable effect for carbamazepine was found when more people who received the antipsychotic (perphenazine) had parkinsonism (1 RCT n = 38, RR 0.03 CI 0.00 to 0.043). Eight studies compared adjunctive carbamazepine versus adjunctive placebo, we were able use GRADE for quality of evidence for these results. Adding carbamazepine to antipsychotic treatment was as acceptable as adding placebo with no difference between the numbers leaving the study early from each group (8 RCTs n = 182, RR 0.47 CI 0.16 to 1.35, very low quality evidence). Carbamazepine augmentation was superior compared with antipsychotics alone in terms of overall global improvement, but participant numbers were low (2 RCTs n = 38, RR 0.57 CI 0.37 to 0.88). There were no differences for the mental state outcome of 50% reduction in BPRS scores (6 RCTs n = 147, RR 0.86 CI 0.67 to 1.12, low quality evidence). Less people in the carbamazepine augmentation group had movement disorders than those taking haloperidol alone (1 RCT n = 20, RR 0.38 CI 0.14 to 1.02). No data were available for the effects of carbamazepine on subgroups of people with schizophrenia and aggressive behaviour, negative symptoms or EEG abnormalities or with schizoaffective disorder. Based on currently available randomised trial-derived evidence, carbamazepine cannot be recommended for routine clinical use for treatment or augmentation of antipsychotic treatment of schizophrenia. At present large, simple well-designed and reported trials are justified - especially if focusing on people with violent episodes and people with schizoaffective disorders or those with both schizophrenia and EEG abnormalities.
|
This review focuses on the effectiveness of carbamazepine for people with schizophrenia. A search of the Cochrane Schizophrenia Group's trials register was carried out July 2012. Ten studies were found with 283 people. Carbamazepine was compared with no active medication (‘dummy’ or placebo treatment), versus an antipsychotic or when taken in addition to an antipsychotic. However, all of the 10 studies were small and information in them was of a poor standard. There is therefore a lack of evidence whether carbamazepine reduces symptoms and side effects in people with schizophrenia or similar mental health problems. Larger well-designed trials are necessary to provide stronger evidence before carbamazepine can be recommended as a treatment for people with schizophrenia. This plain language summary has been written by a consumer Ben Gray: Service User and Service User Expert. Rethink Mental Illness.
|
10.1002/14651858.CD001258.pub3
|
[
"This review focuses on the effectiveness of carbamazepine for people with schizophrenia. A search of the Cochrane Schizophrenia Group's trials register was carried out July 2012. Ten studies were found with 283 people. Carbamazepine was compared with no active medication (‘dummy’ or placebo treatment), versus an antipsychotic or when taken in addition to an antipsychotic. However, all of the 10 studies were small and information in them was of a poor standard. There is therefore a lack of evidence whether carbamazepine reduces symptoms and side effects in people with schizophrenia or similar mental health problems. Larger well-designed trials are necessary to provide stronger evidence before carbamazepine can be recommended as a treatment for people with schizophrenia. This plain language summary has been written by a consumer Ben Gray: Service User and Service User Expert. Rethink Mental Illness."
] |
cochrane-simplification-train-1573
|
cochrane-simplification-train-1573
|
The 12 included studies involved 10,953 residents in 355 (range 1 to 85) care homes in ten countries. Nine studies were cluster-randomised controlled trials and three studies were patient-randomised controlled trials. The interventions evaluated were diverse and often multifaceted. Medication review was a component of ten studies. Four studies involved multidisciplinary case-conferencing, five studies involved an educational element for health and care professionals and one study evaluated the use of clinical decision support technology. We did not combine the results in a meta-analysis due to heterogeneity across studies. Interventions to optimise prescribing may lead to fewer days in hospital (one study out of eight; low certainty evidence), a slower decline in health-related quality of life (one study out of two; low certainty evidence), the identification and resolution of medication-related problems (seven studies; low certainty evidence), and may lead to improved medication appropriateness (five studies out of five studies; low certainty evidence). We are uncertain whether the intervention improves/reduces medicine costs (five studies; very low certainty evidence) and it may make little or no difference on adverse drug events (two studies; low certainty evidence) or mortality (six studies; low certainty evidence). The risk of bias across studies was heterogeneous. We could not draw robust conclusions from the evidence due to variability in design, interventions, outcomes and results. The interventions implemented in the studies in this review led to the identification and resolution of medication-related problems and improvements in medication appropriateness, however evidence of a consistent effect on resident-related outcomes was not found. There is a need for high-quality cluster-randomised controlled trials testing clinical decision support systems and multidisciplinary interventions that measure well-defined, important resident-related outcomes.
|
We found 12 studies involving 10,953 residents in 355 care homes in ten countries that evaluated interventions to optimise prescribing for care home residents. Most of the interventions had several components, often involving a review of medicines with a pharmacist and doctor. Some interventions included a teaching component and one study used Information Technology (IT). We found no evidence of benefit of the interventions with respect to reducing adverse drug events (harmful effects caused by medicines) or death. One study led to residents having fewer days in hospital; however, the majority of studies did not show a benefit in relation to reducing hospital admissions. One study led to a slower decline in health-related quality of life. Problems relating to medicines were found and addressed through the interventions used in the studies. Prescribing was improved based on criteria used to assess the appropriateness of prescribing in five studies. We judged the overall quality of the evidence for the reported outcomes to be low for adverse drug events (harmful effects caused by medicines), hospital admissions, death, quality-of-life, medication-related problems, medication appropriateness, and very low for the cost of medicines. More high-quality studies need to be done to gather more evidence for these and other types of interventions. Further studies are needed to evaluate new technologies, including computer systems that support prescribing decisions. More work needs to be done to make sure that researchers are consistently measuring outcomes that are important to care home residents.
|
10.1002/14651858.CD009095.pub3
|
[
"We found 12 studies involving 10,953 residents in 355 care homes in ten countries that evaluated interventions to optimise prescribing for care home residents. Most of the interventions had several components, often involving a review of medicines with a pharmacist and doctor. Some interventions included a teaching component and one study used Information Technology (IT). We found no evidence of benefit of the interventions with respect to reducing adverse drug events (harmful effects caused by medicines) or death. One study led to residents having fewer days in hospital; however, the majority of studies did not show a benefit in relation to reducing hospital admissions. One study led to a slower decline in health-related quality of life. Problems relating to medicines were found and addressed through the interventions used in the studies. Prescribing was improved based on criteria used to assess the appropriateness of prescribing in five studies. We judged the overall quality of the evidence for the reported outcomes to be low for adverse drug events (harmful effects caused by medicines), hospital admissions, death, quality-of-life, medication-related problems, medication appropriateness, and very low for the cost of medicines. More high-quality studies need to be done to gather more evidence for these and other types of interventions. Further studies are needed to evaluate new technologies, including computer systems that support prescribing decisions. More work needs to be done to make sure that researchers are consistently measuring outcomes that are important to care home residents."
] |
cochrane-simplification-train-1574
|
cochrane-simplification-train-1574
|
Eight randomised controlled trials, enrolling 10,037 children, met our inclusion criteria. Seven of the trials were conducted in Africa. In general, the included studies were at a low risk of bias. There may have been a risk of performance bias as trial participants were aware which intervention group they were in, but we did not consider this likely to have biased the outcome measurement. We were unable to assess the risk of reporting bias in half of the trials and two trials were at high risk of attrition bias. Any specially formulated food versus standard care - the provision of food increased the recovery rate by 29% (RR 1.29, 95% CI 1.20 to 1.38; 2152 children, two trials; moderate quality evidence), decreased the number dropping out by 70% (RR 0.30, 95% CI 0.22 to 0.39; 1974 children, one trial; moderate quality evidence), and improved weight-for-height (MD 0.20 z-score, 95% CI 0.03 to 0.37; 1546 children, two trials; moderate quality evidence). The reduction in mortality did not reach statistical significance (RR 0.44; 95% CI 0.14 to 1.36; 1974 children, one trial; low quality evidence). Lipid-based nutrient supplements versus any blended foods (dry food mixtures, without high lipid content), at full doses - there was no significant difference in mortality (RR 0.93, 95% CI 0.54 to 1.62; 6367 children, five trials; moderate quality evidence), progression to severe malnutrition (RR 0.88, 95% CI 0.72 to 1.07; 4537 children, three trials; high quality evidence), or the number of dropouts from the nutritional programme (RR 1.14, 95% CI 0.62 to 2.11; 5107 children, four trials; moderate quality evidence). However, lipid-based nutrient supplements significantly increased the number of children recovered (RR 1.10, 95% CI 1.04 to 1.16; 6367 children, five trials; moderate quality evidence), and decreased the number of non-recovering children (RR 0.53, 95% CI 0.40 to 0.69; 4537 children, three trials; high quality evidence). LNS also improved weight gain, weight-for-height, and mid-upper arm circumference, although for these outcomes, the improvement was modest (moderate quality evidence). One trial observed more children with vomiting in the lipid-based nutrient supplements group compared to those receiving blended food (RR 1.43, 95% CI 1.11 to 1.85; 2712 children, one trial; low quality evidence). Foods at complementary doses - no firm conclusion could be drawn on the comparisons between LNS at complementary dose and blended foods at complementary or full dose (low quality evidence). Lipid-based nutrient supplements versus specific types of blended foods - a recently developed enriched blended food (CSB++) resulted in similar outcomes to LNS (4758 children, three trials; moderate to high quality evidence). Different types of blended foods - in one trial, CSB++ did not show any significant benefit over locally made blended food, for example, Misola, in number who recovered, number who died, or weight gain (moderate to high quality evidence). Improved adequacy of home diet - no study evaluated the impact of improving adequacy of local diet, such as local foods prepared at home according to a given recipe or of home processing of local foods (soaking, germination, malting, fermentation) in order to increase their nutritional content. In conclusion, there is moderate to high quality evidence that both lipid-based nutrient supplements and blended foods are effective in treating children with MAM. Although lipid-based nutrient supplements (LNS) led to a clinically significant benefit in the number of children recovered in comparison with blended foods, LNS did not reduce mortality, the risk of default or progression to SAM. It also induced more vomiting. Blended foods such as CSB++ may be equally effective and cheaper than LNS. Most of the research so far has focused on industrialised foods, and on short-term outcomes of MAM. There are no studies evaluating interventions to improve the quality of the home diet, an approach that should be evaluated in settings where food is available, and nutritional education and habits are the main determinants of malnutrition. There are no studies from Asia, where moderate acute malnutrition is most prevalent.
|
We searched eight electronic databases and three trials registers (in October 2012 for all except Embase, which was searched in August 2012). We also searched the reference lists of relevant papers and contacted nutrition-related organisations and researchers in this field. We found eight relevant randomised controlled trials, enrolling 10,037 children under five years of age. All but one study was conducted in Africa. The risk of bias in the studies was generally low, though two studies had a high dropout rate. The participants were aware which intervention group they were in and this may have influenced their behaviour but we thought it unlikely it would have influenced the results since the outcomes measured were objective ones. For four of the studies, we were unable to assess if the study authors reported all the outcomes they intended to measure. When any type of specially formulated food was compared to standard care (medical care and counselling without foods), the children treated with foods had a higher chance of recovering from moderate malnutrition (two studies), greater improvement in nutritional status (two studies), and a lower number of dropouts (one study). A reduction in mortality was not shown. When lipid-based nutrient supplements (which are food with high energy density and high lipid content) at full dose were compared to blended foods at full dose (which are dry food mixtures without high lipid content), there was no difference between these two types of foods in terms of number of deaths (five studies), children progressing to severe acute malnutrition (three studies), and children dropping out (four studies). However, lipid-based nutrient supplements increased the number recovered by 10% (five studies), decreased the number of children non-recovering (three studies), and slightly improved the nutritional status among the recovered. One study observed more children vomiting when given lipid-based nutrient supplements compared to blended foods, but this was not reported by the other studies. No other side effects were reported. Few studies evaluated foods at complementary dosage (i.e. foods given in low quantity, just to complement the diet and not to fully substitute it), and no conclusion could be drawn from these studies. When specific foods were compared to each other, a type of corn-soy blended food called CSB++ compared to lipid-based nutrient supplements resulted in similar outcomes, while results of another blended food (CSB pre-mix) versus lipid-based nutrient supplements were unclear. In one study, CSB++ did not show any significant benefit over locally-made blended foods, for example, Misola. No study evaluated the impact of improving adequacy of local diet, such as local foods prepared at home according to a given recipe or of home processing of local foods (soaking, germination, malting, fermentation) in order to increase their nutritional content. In conclusion, there is moderate to high quality evidence that both lipid-based nutrient supplements and blended foods are effective in treating children with moderate acute malnutrition. Although lipid-based nutrient supplements (LNS) led to a clinically significant benefit in the number of children recovered in comparison with blended foods, LNS did not reduce mortality, the risk of default or progression to SAM. It also induced more vomiting. Blended foods such as CSB++ may be equally effective and cheaper than LNS. There are no studies evaluating special recipes to improve the adequacy of the usual home diet, an approach that should be evaluated in settings where food is available, and nutritional education and habits are the main determinants of malnutrition. There are no studies from Asia, where moderate acute malnutrition is most prevalent.
|
10.1002/14651858.CD009584.pub2
|
[
"We searched eight electronic databases and three trials registers (in October 2012 for all except Embase, which was searched in August 2012). We also searched the reference lists of relevant papers and contacted nutrition-related organisations and researchers in this field. We found eight relevant randomised controlled trials, enrolling 10,037 children under five years of age. All but one study was conducted in Africa. The risk of bias in the studies was generally low, though two studies had a high dropout rate. The participants were aware which intervention group they were in and this may have influenced their behaviour but we thought it unlikely it would have influenced the results since the outcomes measured were objective ones. For four of the studies, we were unable to assess if the study authors reported all the outcomes they intended to measure. When any type of specially formulated food was compared to standard care (medical care and counselling without foods), the children treated with foods had a higher chance of recovering from moderate malnutrition (two studies), greater improvement in nutritional status (two studies), and a lower number of dropouts (one study). A reduction in mortality was not shown. When lipid-based nutrient supplements (which are food with high energy density and high lipid content) at full dose were compared to blended foods at full dose (which are dry food mixtures without high lipid content), there was no difference between these two types of foods in terms of number of deaths (five studies), children progressing to severe acute malnutrition (three studies), and children dropping out (four studies). However, lipid-based nutrient supplements increased the number recovered by 10% (five studies), decreased the number of children non-recovering (three studies), and slightly improved the nutritional status among the recovered. One study observed more children vomiting when given lipid-based nutrient supplements compared to blended foods, but this was not reported by the other studies. No other side effects were reported. Few studies evaluated foods at complementary dosage (i.e. foods given in low quantity, just to complement the diet and not to fully substitute it), and no conclusion could be drawn from these studies. When specific foods were compared to each other, a type of corn-soy blended food called CSB++ compared to lipid-based nutrient supplements resulted in similar outcomes, while results of another blended food (CSB pre-mix) versus lipid-based nutrient supplements were unclear. In one study, CSB++ did not show any significant benefit over locally-made blended foods, for example, Misola. No study evaluated the impact of improving adequacy of local diet, such as local foods prepared at home according to a given recipe or of home processing of local foods (soaking, germination, malting, fermentation) in order to increase their nutritional content. In conclusion, there is moderate to high quality evidence that both lipid-based nutrient supplements and blended foods are effective in treating children with moderate acute malnutrition. Although lipid-based nutrient supplements (LNS) led to a clinically significant benefit in the number of children recovered in comparison with blended foods, LNS did not reduce mortality, the risk of default or progression to SAM. It also induced more vomiting. Blended foods such as CSB++ may be equally effective and cheaper than LNS. There are no studies evaluating special recipes to improve the adequacy of the usual home diet, an approach that should be evaluated in settings where food is available, and nutritional education and habits are the main determinants of malnutrition. There are no studies from Asia, where moderate acute malnutrition is most prevalent."
] |
cochrane-simplification-train-1575
|
cochrane-simplification-train-1575
|
This updated review includes a total of 25 studies, with outcome data for 11,246 mothers and babies enrolled in 21 studies. We assessed the overall risk of bias of included studies to be low or unclear, mainly because of limited reporting or uncertainty in how randomisation was generated or concealed (which led us to downgrade the quality of most outcomes to moderate), and the impracticability of blinding participants. When compared with routine care, programmes offering additional social support for at-risk pregnant women may slightly reduce the number of babies born with a birthweight less than 2500 g from 127 per 1000 to 120 per 1000 (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.86 to 1.04; 16 studies, n = 11,770; moderate-quality evidence), and the number of babies born with a gestational age less than 37 weeks at birth from 128 per 1000 to 117 per 1000 (RR 0.92, 95% CI 0.84 to 1.01, 14 studies, n = 12,282; moderate-quality evidence), though the confidence intervals for the pooled effect for both of these outcomes just crossed the line of no effect, suggesting any effect is not large. There may be little or no difference between interventions for stillbirth/neonatal death (RR 1.11, 95% CI 0.88 to 1.41; 15 studies, n = 12,091; low-quality evidence). Secondary outcomes of moderate quality suggested that there is probably a reduction in caesarean section (from 215 per 1000 to 194 per 1000; RR 0.90, 95% CI 0.83 to 0.97; 15 studies, n = 9550), a reduction in the number of antenatal hospital admissions per participant (RR 0.78, 95% CI 0.68 to 0.91; 4 studies; n = 787), and a reduction in the mean number of hospitalisation episodes (mean difference −0.05, 95% CI −0.06 to −0.04; 1 study, n = 1525) in the social support group, compared to the controls. Postnatal depression and women's satisfaction were reported in different ways in the studies that considered these outcomes and so we could not include data in a meta-analysis. In one study postnatal depression appeared to be slightly lower in the support group in women who screened positively on the Edinbugh Postnatal Depression Scale at eight to 12 weeks postnatally (RR 0.74, 95% CI 0.55 to 1.01; 1 study, n = 1008; moderate-quality evidence). In another study, again postnatal depression appeared to be slightly lower in the support group and this was a self-report measure assessed at six weeks postnatally (RR 0.85, 95% CI 0.69 to 1.05; 1 study, n = 458; low-quality evidence). A higher proportion of women in one study reported that their prenatal care was very helpful in the supported group (RR 1.17, 95% CI 1.05 to 1.30; 1 study, n = 223; moderate-quality evidence), although in another study results were similar. Another study assessed satisfaction with prenatal care as being "not good" in 51 of 945 in the additional support group, compared with 45 of 942 in the usual care group. No studies considered long-term morbidity for the infant. No single outcome was reported in all studies. Subgroup analysis demonstrated consistency of effect when the support was provided by a healthcare professional or a trained lay worker. The descriptions of the additional social support were generally consistent across all studies and included emotional support, tangible support such as home visits, and informational support. Pregnant women need the support of caring family members, friends, and health professionals. While programmes that offer additional social support during pregnancy are unlikely to have a large impact on the proportion of low birthweight babies or birth before 37 weeks' gestation and no impact on stillbirth or neonatal death, they may be helpful in reducing the likelihood of caesarean birth and antenatal hospital admission.
|
We searched for evidence on 5 February 2018. We identified 21 randomised controlled trials from which 11,246 mother-baby pairs contributed results for this review. Examples of the additional social support include information, home visits, telephone calls and stress management. The overall quality of evidence for most outcomes was moderate. It was not possible to blind women to which group they were in. We found that women who received additional social support during pregnancy may be slightly less likely to have a baby with low birthweight (16 studies, 11,770 babies), or give birth too early (14 studies, 12,282 babies). The number of babies that died around the time of birth was similar for both groups of women (15 studies, 12,091 babies). Women who received the additional social support were, however, probably less likely to be admitted to hospital during their pregnancy (4 studies, 787 women), or to have a caesarean birth (15 studies, 9550 women). Women with additional social support may be less likely to be depressed (1 study, 1008 women). Findings around satisfaction with care were mixed, with one study reporting the support group being more satisfied, whilst another study suggested women in the usual care group were more satisfied. The findings did not appear to be different if the social support was provided by trained lay people or health professionals. Although programmes that offer additional social support during pregnancy are unlikely to prevent the pregnancy from resulting in a low birthweight or early birth, before 37 weeks of pregnancy, they may be helpful in reducing the likelihood of antenatal hospital admissions and the need for caesarean births. Additional social support is not powerful enough to improve the outcomes of the pregnancy during which it is provided, as measured by the outcomes considered in this review. The factors contributing to deprivation require social change in order to bring about improvements in health for mothers and their newborn babies.
|
10.1002/14651858.CD000198.pub3
|
[
"We searched for evidence on 5 February 2018. We identified 21 randomised controlled trials from which 11,246 mother-baby pairs contributed results for this review. Examples of the additional social support include information, home visits, telephone calls and stress management. The overall quality of evidence for most outcomes was moderate. It was not possible to blind women to which group they were in. We found that women who received additional social support during pregnancy may be slightly less likely to have a baby with low birthweight (16 studies, 11,770 babies), or give birth too early (14 studies, 12,282 babies). The number of babies that died around the time of birth was similar for both groups of women (15 studies, 12,091 babies). Women who received the additional social support were, however, probably less likely to be admitted to hospital during their pregnancy (4 studies, 787 women), or to have a caesarean birth (15 studies, 9550 women). Women with additional social support may be less likely to be depressed (1 study, 1008 women). Findings around satisfaction with care were mixed, with one study reporting the support group being more satisfied, whilst another study suggested women in the usual care group were more satisfied. The findings did not appear to be different if the social support was provided by trained lay people or health professionals. Although programmes that offer additional social support during pregnancy are unlikely to prevent the pregnancy from resulting in a low birthweight or early birth, before 37 weeks of pregnancy, they may be helpful in reducing the likelihood of antenatal hospital admissions and the need for caesarean births. Additional social support is not powerful enough to improve the outcomes of the pregnancy during which it is provided, as measured by the outcomes considered in this review. The factors contributing to deprivation require social change in order to bring about improvements in health for mothers and their newborn babies."
] |
cochrane-simplification-train-1576
|
cochrane-simplification-train-1576
|
We included seven randomised controlled trials involving 493 participants. In all studies the participants were adults undergoing septoplasty. These studies were heterogeneous and the quality of the body of evidence ranged from low to very low. Few of the studies provided reliable data for the primary outcome in this review. Local anaesthetic injection versus no treatment/placebo Two studies (142 participants) compared local anaesthetic injection versus placebo but these studies did not report postoperative pain at 12, 24 or 48 hours. It is unclear whether local anaesthetic injection changed the risk of vomiting (odds ratio (OR) 3.10, 95% confidence interval (CI) 0.12 to 79.23; 60 participants; one study) (low-quality evidence). Neither study reported the requirement for additional analgesia, duration of hospitalisation or uncontrollable postoperative bleeding. Local anaesthetic application via nasal packing versus no packing/packing with placebo Four studies (301 participants) used nasal packing postoperatively and compared the addition of local anaesthetic to the pack versus packing with a placebo added. Compared with packing with placebo, the addition of local anaesthetic to nasal packing reduced the pain score on a VAS (ranging from 0 to 100) at 12 hours (mean difference (MD) -16.95, 95% CI -22.27 to -11.62; 151 participants; two studies; I2 = 49%) (low-quality evidence) and at 24 hours postoperatively (MD -7.53, 95% CI -9.76 to -5.29; 268 participants; four studies; I2 = 83%) (very low-quality evidence). These studies did not report postoperative pain at 48 hours. The addition of local anaesthetic to nasal packing decreased the requirement for additional analgesia (OR 0.15, 95% CI 0.07 to 0.34; 151 participants; two studies; I2 = 15%) (moderate-quality evidence). No studies reported duration of hospitalisation, postoperative vomiting or uncontrollable postoperative bleeding. No studies compared the addition of local anaesthetic to nasal packing versus no packing. Sphenopalatine ganglion block versus no treatment/placebo One study (50 participants) compared sphenopalatine ganglion block versus no treatment but this study did not report postoperative pain, requirement for additional analgesia, duration of hospitalisation, vomiting or uncontrollable postoperative bleeding. The addition of local anaesthesia to nasal packs (if these are being used) following septal surgery may reduce postoperative pain within the first 12 hours, compared to nasal packing with a placebo added. The effect is uncertain at 24 hours because the quality of the evidence is very low. Evidence was lacking for other outcomes, including adverse effects. There is a lack of evidence about the effects of local anaesthesia added to nasal packing compared to no nasal packing. There is also a lack of evidence about the effects of local anaesthesia given by injection and the effects of sphenopalatine ganglion block.
|
The evidence is current to January 2018. We included seven studies, recruiting 493 patients. The participants were adults having septoplasty in all of the included studies and the percentage of females ranged from 20.7% to 58.3%. Two studies, recruiting 142 participants, assessed local anaesthetic injection. Four studies, recruiting 301 participants, used nasal packing postoperatively and assessed the addition of a local anaesthetic to the nasal pack. One study, recruiting 50 participants, assessed a regional nerve block. No studies were funded by the anaesthetic drug manufacturer. Local anaesthetic injection compared to no treatment/placebo The main outcome we looked at was the effect on reducing pain at 12, 24 and 48 hours postoperatively. Two studies assessed local injection of anaesthesia, but neither reported on pain at these times. It is unclear whether local injection increased postoperative vomiting. Neither study reported uncontrollable postoperative bleeding. Local anaesthetic application via nasal packing compared to no packing/packing with placebo Four studies that used nasal packing after the operation assessed the addition of a local anaesthetic to the pack compared to packing with a placebo added. Four of these studies reported pain at 12 or 24 hours (or both) postoperatively. Local anaesthetic added to nasal packing reduced pain by 17.0 points on a 100-point scale at 12 hours postoperatively and by 7.5 points at 24 hours postoperatively. These studies did not report on pain at 48 hours postoperatively. Local anaesthetic application by nasal packing decreased the need for additional analgesia (painkillers) postoperatively. No studies reported postoperative vomiting or uncontrollable postoperative bleeding. No studies evaluated local anaesthetic application via nasal packing compared to no packing. Regional nerve block compared to no treatment/placebo One study compared a regional nerve block with no treatment, but this study did not report postoperative pain or any of our other outcomes. We graded the quality of evidence for the use of local anaesthetic injection as low, which means that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. We downgraded the quality of the evidence because of the small number of patients and events. We graded the quality of evidence for the use of local anaesthetic applied to nasal packing as low at 12 hours postoperatively and very low at 48 hours. We downgraded the quality of the evidence because of the poor conduct of the studies and because the results were not similar across studies. We did not grade the quality of evidence for the use of regional nerve block because none of our review outcomes were reported by the one study looking at this. The addition of local anaesthesia to nasal packs (if these are being used) following septal surgery may reduce postoperative pain within the first 12 hours postoperatively compared to nasal packing with a placebo added. However, our review revealed a lack of evidence on which to base comparisons of the various types of local anaesthesia. This review should prompt further research comparing local anaesthesia by injection, as an addition to nasal packing and as a regional nerve block following septal surgery.
|
10.1002/14651858.CD012047.pub2
|
[
"The evidence is current to January 2018. We included seven studies, recruiting 493 patients. The participants were adults having septoplasty in all of the included studies and the percentage of females ranged from 20.7% to 58.3%. Two studies, recruiting 142 participants, assessed local anaesthetic injection. Four studies, recruiting 301 participants, used nasal packing postoperatively and assessed the addition of a local anaesthetic to the nasal pack. One study, recruiting 50 participants, assessed a regional nerve block. No studies were funded by the anaesthetic drug manufacturer. Local anaesthetic injection compared to no treatment/placebo The main outcome we looked at was the effect on reducing pain at 12, 24 and 48 hours postoperatively. Two studies assessed local injection of anaesthesia, but neither reported on pain at these times. It is unclear whether local injection increased postoperative vomiting. Neither study reported uncontrollable postoperative bleeding. Local anaesthetic application via nasal packing compared to no packing/packing with placebo Four studies that used nasal packing after the operation assessed the addition of a local anaesthetic to the pack compared to packing with a placebo added. Four of these studies reported pain at 12 or 24 hours (or both) postoperatively. Local anaesthetic added to nasal packing reduced pain by 17.0 points on a 100-point scale at 12 hours postoperatively and by 7.5 points at 24 hours postoperatively. These studies did not report on pain at 48 hours postoperatively. Local anaesthetic application by nasal packing decreased the need for additional analgesia (painkillers) postoperatively. No studies reported postoperative vomiting or uncontrollable postoperative bleeding. No studies evaluated local anaesthetic application via nasal packing compared to no packing. Regional nerve block compared to no treatment/placebo One study compared a regional nerve block with no treatment, but this study did not report postoperative pain or any of our other outcomes. We graded the quality of evidence for the use of local anaesthetic injection as low, which means that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. We downgraded the quality of the evidence because of the small number of patients and events. We graded the quality of evidence for the use of local anaesthetic applied to nasal packing as low at 12 hours postoperatively and very low at 48 hours. We downgraded the quality of the evidence because of the poor conduct of the studies and because the results were not similar across studies. We did not grade the quality of evidence for the use of regional nerve block because none of our review outcomes were reported by the one study looking at this. The addition of local anaesthesia to nasal packs (if these are being used) following septal surgery may reduce postoperative pain within the first 12 hours postoperatively compared to nasal packing with a placebo added. However, our review revealed a lack of evidence on which to base comparisons of the various types of local anaesthesia. This review should prompt further research comparing local anaesthesia by injection, as an addition to nasal packing and as a regional nerve block following septal surgery."
] |
cochrane-simplification-train-1577
|
cochrane-simplification-train-1577
|
For this update, we screened 1645 publications of which 45 met the inclusion criteria (20 additional studies to the previous reviews). In total, we analysed data from 18 drugs and 4696 participants. There was a very high degree of statistical and clinical heterogeneity in the trials and we discuss the reasons for this in the review. There were some sources of potential bias in the included studies, including a lack of description of the methods of blinding and allocation concealment, and the small size of the study populations. We included studies investigating pemoline and modafinil in participants with multiple sclerosis (MS)-associated fatigue and methylphenidate in patients suffering from advanced cancer and fatigue in meta-analysis. Treatment results pointed to weak and inconclusive evidence for the efficacy of amantadine, pemoline and modafinil in multiple sclerosis and for carnitine and donepezil in cancer-related fatigue. Methylphenidate and pemoline seem to be effective in patients with HIV, but this is based only on one study per intervention, with only a moderate number of participants in each study. Meta-analysis shows an estimated superior effect for methylphenidate in cancer-related fatigue (standardised mean difference (SMD) 0.49, 95% confidence interval (CI) 0.15 to 0.83). Therapeutic effects could not be described for dexamphetamine, paroxetine or testosterone. There were a variety of results for the secondary outcomes in some studies. Most studies had low participant numbers and were heterogeneous. In general, adverse reactions were mild and had little or no impact. Based on limited evidence, we cannot recommend a specific drug for the treatment of fatigue in palliative care patients. Fatigue research in palliative care seems to focus on modafinil and methylphenidate, which may be beneficial for the treatment of fatigue associated with palliative care although further research about their efficacy is needed. Dexamethasone, methylprednisolone, acetylsalicylic acid, armodafinil, amantadine and L-carnitine should be further examined. Consensus is needed regarding fatigue outcome parameters for clinical trials.
|
We searched the literature in April 2014 and found 45 randomised controlled trials for this update of the review. We analysed data from 4696 participants who received treatment for their fatigue. The trials dealt with neurological diseases (such as multiple sclerosis (753 participants), post-polio syndrome (58) and Parkinson's disease (19)), different types of cancer (3223), HIV/AIDS (514), end-stage renal disease (56), multi-type advanced disease in hospice patients (30), amyotrophic lateral sclerosis (28) and end-stage chronic lung disease (15). There was weak evidence for the efficacy of amantadine, pemoline and modafinil in reducing fatigue in patients with multiple sclerosis. There was also weak evidence for the efficacy of carnitine and donepezil for cancer-related fatigue. One small trial showed that people with HIV/AIDS and fatigue seemed to benefit from treatment with methylphenidate or pemoline. There was some low-quality evidence from small trials that methylphenidate, a stimulant drug that improves concentration, is effective for the management of cancer-related fatigue. There was no information about dexamphetamine, paroxetine or testosterone. Previous studies have shown that erythropoietin and darbepoetin, drugs that improve anaemia (a shortage of red cells or haemoglobin in the blood), are also effective for cancer-related fatigue. However, due to safety concerns and side effects shown by more recent studies, erythropoietin and darbepoetin should no longer be used. Therefore, we excluded these drugs from this review update. Overall, most side effects of the investigated drugs seemed to be mild. Based on limited evidence from small studies, the evidence does not support the use of a specific drug for the treatment of fatigue in palliative care. Future trials should measure fatigue in advanced disease using comparable and standardised measures.
|
10.1002/14651858.CD006788.pub3
|
[
"We searched the literature in April 2014 and found 45 randomised controlled trials for this update of the review. We analysed data from 4696 participants who received treatment for their fatigue. The trials dealt with neurological diseases (such as multiple sclerosis (753 participants), post-polio syndrome (58) and Parkinson's disease (19)), different types of cancer (3223), HIV/AIDS (514), end-stage renal disease (56), multi-type advanced disease in hospice patients (30), amyotrophic lateral sclerosis (28) and end-stage chronic lung disease (15). There was weak evidence for the efficacy of amantadine, pemoline and modafinil in reducing fatigue in patients with multiple sclerosis. There was also weak evidence for the efficacy of carnitine and donepezil for cancer-related fatigue. One small trial showed that people with HIV/AIDS and fatigue seemed to benefit from treatment with methylphenidate or pemoline. There was some low-quality evidence from small trials that methylphenidate, a stimulant drug that improves concentration, is effective for the management of cancer-related fatigue. There was no information about dexamphetamine, paroxetine or testosterone. Previous studies have shown that erythropoietin and darbepoetin, drugs that improve anaemia (a shortage of red cells or haemoglobin in the blood), are also effective for cancer-related fatigue. However, due to safety concerns and side effects shown by more recent studies, erythropoietin and darbepoetin should no longer be used. Therefore, we excluded these drugs from this review update. Overall, most side effects of the investigated drugs seemed to be mild. Based on limited evidence from small studies, the evidence does not support the use of a specific drug for the treatment of fatigue in palliative care. Future trials should measure fatigue in advanced disease using comparable and standardised measures."
] |
cochrane-simplification-train-1578
|
cochrane-simplification-train-1578
|
Three studies that included 410 participants met the inclusion criteria of the review. We did not identify any ongoing trials. Two included studies were at low risk of selection, attrition, and reporting biases, but were at high risk of performance and detection biases due to the inability to blind participants to the intervention. One included study was at high risk of attrition bias. The overall quality of the evidence for each comparison ranged from very low to moderate; the main limitations were risk of bias and imprecision. Initiation rate of contraceptive implants at the first postpartum check-up visit was significantly higher in the immediate insertion group than in the delayed insertion group (RR 1.41, 95% CI 1.28 to 1.55; three studies, 410 participants; moderate quality evidence). There appeared to be little or no difference between the groups in the continuation rate of contraceptive implant used at six months after insertion (RR 1.02, 95% CI 0.93 to 1.11; two studies, 125 participants; low quality evidence) or at 12 months after insertion (RR 1.04; 95% CI 0.81 to 1.34; one study, 64 participants;very low quality evidence) Women who received an immediate postpartum contraceptive implant insertion had a higher mean number of days of abnormal vaginal bleeding within six weeks postpartum (MD 5.80 days, 95% CI 3.79 to 7.81; one study, 215 participants; low quality evidence) and a higher rate of other side effects in the first six weeks after birth (RR 2.06, 95% CI 1.38 to 3.06; one study, 215 participants; low quality evidence) than those who received a delayed postpartum insertion. There appeared to be little or no difference between the groups in heavy, irregular vaginal bleeding or associated severe cramping within 12 months (RR 1.01, 95% CI 0.72 to 1.44, one study, 64 participants;very low quality evidence). It was unclear whether there was any difference between the groups in scores for participant satisfaction on a 0-10 scale (MD -0.40, 95% CI -1.26 to 0.46, low quality evidence), or in rates of unintended pregnancy (RR 1.82, 95% CI 0.38 to 8.71, 1 RCT, 64 women, very low quality evidence) at 12 months, or in rate of breastfeeding rate at six months (RR 2.01, 95% CI 0.72 ro 5.63, 1 RCT, 64 women, very low quality evidence) rate did not differ significantly between the groups. Evidence from this review indicates that the rate of initiation of contraceptive implant at the first postpartum check-up visit was higher with immediate postpartum insertion than with delayed insertion. There appeared to be little or no difference between the groups in the continuation rate of contraceptive implant use at 6 months. It was unclear whether there was any difference between the groups in continuation of contraceptive use at 12 months or in the unintended pregnancy rate at 12 months.
|
We searched for randomised studies up to 28 October 2016. We looked at whether insertion of contraceptive implant soon after childbirth or when women come back for the first postpartum check-up affected use of this contraception method. We included three studies with a total of 410 women. Use of a contraceptive implant was higher when it was applied right after childbirth than when it was applied four to six weeks later. There appeared to be little or no difference between the groups in the continuation rate of contraceptive implant use at 6 months. It was unclear whether there was any difference between the groups in continuation of contraceptive use at 12 months or in the unintended pregnancy rate at 12 months. Although vaginal bleeding and other adverse effects in the first six weeks after birth including nausea, hair loss, hirsutism, headache, and acne seem to be higher in women that receive this method a few days after childbirth rather than four to six weeks later, this finding however cannot be definitely concluded as all participants knew the nature of the intervention they received (were not blinded) and the reports of these adverse effects were not objectively assessed. It was unclear whether there was any difference between the groups at 12 months in heavy, irregular vaginal bleeding or associated severe cramping, rates of unintended pregnancy, or in measures of participants' satisfaction. Nor was it clear whether there was any difference in breastfeeding rates at 6 months. The included studies were conducted in the USA, and generalisation of these findings to other population or settings should be applied with caution. Overall, the quality of the evidence was moderate to very low. The main limitations were imprecision and risk of bias (related to lack of blinding and to attrition). Further good quality, well-designed randomised controlled trials will provide additional information.
|
10.1002/14651858.CD011913.pub2
|
[
"We searched for randomised studies up to 28 October 2016. We looked at whether insertion of contraceptive implant soon after childbirth or when women come back for the first postpartum check-up affected use of this contraception method. We included three studies with a total of 410 women. Use of a contraceptive implant was higher when it was applied right after childbirth than when it was applied four to six weeks later. There appeared to be little or no difference between the groups in the continuation rate of contraceptive implant use at 6 months. It was unclear whether there was any difference between the groups in continuation of contraceptive use at 12 months or in the unintended pregnancy rate at 12 months. Although vaginal bleeding and other adverse effects in the first six weeks after birth including nausea, hair loss, hirsutism, headache, and acne seem to be higher in women that receive this method a few days after childbirth rather than four to six weeks later, this finding however cannot be definitely concluded as all participants knew the nature of the intervention they received (were not blinded) and the reports of these adverse effects were not objectively assessed. It was unclear whether there was any difference between the groups at 12 months in heavy, irregular vaginal bleeding or associated severe cramping, rates of unintended pregnancy, or in measures of participants' satisfaction. Nor was it clear whether there was any difference in breastfeeding rates at 6 months. The included studies were conducted in the USA, and generalisation of these findings to other population or settings should be applied with caution. Overall, the quality of the evidence was moderate to very low. The main limitations were imprecision and risk of bias (related to lack of blinding and to attrition). Further good quality, well-designed randomised controlled trials will provide additional information."
] |
cochrane-simplification-train-1579
|
cochrane-simplification-train-1579
|
We included seven published trials: six comparing fetal pulse oximetry and CTG with CTG alone (or when fetal pulse oximetry values were blinded) and one comparing fetal pulse oximetry plus CTG with fetal ECG plus CTG. The published trials, with some unpublished data, were at high risk of bias in terms of the impractical nature of blinding participants and clinicians, as well as high risk or unclear risk of bias for outcome assessor for all but one report. Selection bias, attrition bias, reporting bias and other sources of bias were of low or unclear risk. The trials reported on a total of 8013 pregnancies. Differing entry criteria necessitated separate analyses, rather than meta-analysis of all trials. Systematic review of four trials from 34 weeks not requiring fetal blood sampling (FBS) prior to study entry showed no evidence of differences in the overall caesarean section rate between those monitored with fetal oximetry and those not monitored with fetal pulse oximetry or for whom the fetal pulse oximetry results were masked (average risk ratio (RR) 0.99 using random-effects, 95% confidence intervals (CI) 0.86 to 1.13, n = 4008, I² = 45%). There was evidence of a higher risk of caesarean section in the group with fetal oximetry plus CTG than in the group with fetal ECG plus CTG (one study, n = 180, RR 1.56, 95% CI 1.06 to 2.29). Neonatal seizures and neonatal encephalopathy were rare in both groups. No studies reported details of long-term disability. There was evidence of a decrease in caesarean section for nonreassuring fetal status in the fetal pulse oximetry plus CTG group compared to the CTG group, gestation from 34 weeks (average RR (random-effects) 0.65, 95% CI 0.46 to 0.90, n = 4008, I² = 63%). There was no evidence of differences between groups in caesarean section for dystocia, although the overall incidence rates varied between the trials. The addition of fetal pulse oximetry does not reduce overall caesarean section rates. One study found a higher caesarean section rate in the group monitored with fetal pulse oximetry plus CTG, compared with fetal ECG plus CTG. The data provide limited support for the use of fetal pulse oximetry when used in the presence of a nonreassuring CTG, to reduce caesarean section for nonreassuring fetal status. A better method than pulse oximetry is required to enhance the overall evaluation of fetal well-being in labour.
|
The review identified seven trials involving 8013 women. Fetal pulse oximetry plus CTG showed no difference in caesarean section rates overall, nor any difference in the mother's or newborn's health, compared with CTG alone. If there was concern about the baby's well-being before the fetal pulse oximetry probe was placed, the use of fetal pulse oximetry reduced caesarean sections performed for the baby's well-being. The one trial of oximetry with CTG compared with CTG and fetal ECG showed an increase in the caesarean rate in the oximetry group. In two of the trials, the company making the fetal pulse oximetry machines provided some funding. A better method than fetal pulse oximetry is needed for checking on the well-being of the baby during labour.
|
10.1002/14651858.CD004075.pub4
|
[
"The review identified seven trials involving 8013 women. Fetal pulse oximetry plus CTG showed no difference in caesarean section rates overall, nor any difference in the mother's or newborn's health, compared with CTG alone. If there was concern about the baby's well-being before the fetal pulse oximetry probe was placed, the use of fetal pulse oximetry reduced caesarean sections performed for the baby's well-being. The one trial of oximetry with CTG compared with CTG and fetal ECG showed an increase in the caesarean rate in the oximetry group. In two of the trials, the company making the fetal pulse oximetry machines provided some funding. A better method than fetal pulse oximetry is needed for checking on the well-being of the baby during labour."
] |
cochrane-simplification-train-1580
|
cochrane-simplification-train-1580
|
In this review update, we included five new trials, bringing the total number of included studies to eight. The included trials (pertaining to 10 papers), provided data on 1973 participants and assessed the impact of cancer genetic risk assessment on outcomes including perceived risk of inherited cancer, and psychological distress. This review suggests that cancer genetic risk-assessment services help to reduce distress, improve the accuracy of the perceived risk of breast cancer, and increase knowledge about breast cancer and genetics. The health professional delivering the risk assessment does not appear to have a significant impact on these outcomes. This review found favourable outcomes for patients after risk assessment for familial breast cancer. However, there were too few papers to make any significant conclusions about how best to deliver cancer genetic risk-assessment services. Further research is needed assessing the best means of delivering cancer risk assessment, by different health professionals, in different ways and in alternative locations.
|
This review included eight trials (10 papers) which covered the process of risk assessment for familial breast cancer. These focused on the psychosocial impact on patients, as well as other outcomes and aspects of service delivery, and provided data on 1973 participants. Due to the limited number of trials, this review found insufficient evidence to make any firm conclusions about the best way to deliver risk-assessment services for individuals concerned about a family history of breast cancer. All eight included studies did, however, demonstrate improvements in psychological well-being and a decrease in the levels of cancer worry as a result of the risk-assessment service. Although limited, the findings of this review suggest that cancer genetic risk-assessment services can help to reduce distress, improve the accuracy of the individual's perceived risk of breast cancer, and increase knowledge about breast cancer and genetics. Existing evidence suggests that such services do not cause patients any harm and, in the short-term, can have a positive effect by helping to ease distress and decrease cancer worry. From this review, it does not appear that the health professional delivering the risk assessment has a significant impact on these outcomes.
|
10.1002/14651858.CD003721.pub3
|
[
"This review included eight trials (10 papers) which covered the process of risk assessment for familial breast cancer. These focused on the psychosocial impact on patients, as well as other outcomes and aspects of service delivery, and provided data on 1973 participants. Due to the limited number of trials, this review found insufficient evidence to make any firm conclusions about the best way to deliver risk-assessment services for individuals concerned about a family history of breast cancer. All eight included studies did, however, demonstrate improvements in psychological well-being and a decrease in the levels of cancer worry as a result of the risk-assessment service. Although limited, the findings of this review suggest that cancer genetic risk-assessment services can help to reduce distress, improve the accuracy of the individual's perceived risk of breast cancer, and increase knowledge about breast cancer and genetics. Existing evidence suggests that such services do not cause patients any harm and, in the short-term, can have a positive effect by helping to ease distress and decrease cancer worry. From this review, it does not appear that the health professional delivering the risk assessment has a significant impact on these outcomes."
] |
cochrane-simplification-train-1581
|
cochrane-simplification-train-1581
|
Three randomised controlled trials with a total of 63 participants were found comparing SLT with placebo for speech disorders in Parkinson's disease. Data were available from 41 participants in two trials. Vocal loudness for reading a passage increased by 6.3 dB (P = 0.0007) in one trial, and 11.0 dB (P = 0.0002) in another trial. An increase was also seen in both of these trials for monologue speaking of 5.4 dB (P = 0.002) and 11.0 dB (P = 0.0002), respectively. It is likely that these areclinically significant improvements. After six months, patients from the first trial were still showing a statistically significant increase of 4.5 dB (P = 0.0007) for reading and 3.5 dB for monologue speaking. Some measures of speech monotonicity and articulation were investigated; however, all these results were non-significant. Although improvements in speech impairments were noted in these studies, due to the small number of patients examined, methodological flaws, and the possibility of publication bias, there is insufficient evidence to conclusively support or refute the efficacy of SLT for speech problems in Parkinson's disease. A large well designed placebo-controlled RCT is needed to demonstrate SLT's effectiveness in Parkinson's disease. The trial should conform to CONSORT guidelines. Outcome measures with particular relevance to patients with Parkinson’s disease should be chosen and patients followed for at least six months to determine the duration of any improvement.
|
Only randomised controlled trials were included in this review. These were studies where two groups of patients were compared, one group had speech and language therapy, the other did not receive any therapy intended to improve speech. The patients were assigned to each of the groups in a random fashion so as to reduce the potential for bias. Three trials with a total of 63 patients were found comparing speech and language therapy with an untreated group. The quality of the methods used in these trials was variable, with all studies failing in at least one critical area. All three of the controlled trials reported a positive effect of speech and language therapy for speech disorders in Parkinson's disease. Many of the outcome measures examined appeared to improve by a clinically significant amount after therapy. However, it should be noted that there were flaws in the methods used in these studies and only a small number of patients with Parkinson’s disease were examined. This means that there is insufficient evidence to absolutely prove or disprove the benefit of speech and language therapy for the treatment of speech disorders in Parkinson's disease patients, but lack of evidence does not mean lack of effect. A large well designed placebo-controlled randomised trial is needed to assess the effectiveness of speech and language therapy for speech disorders in Parkinson's disease. Outcome measures with particular relevance to people with Parkinson’s disease should be chosen and the patients followed for at least six months to determine the duration of any improvement.
|
10.1002/14651858.CD002812.pub2
|
[
"Only randomised controlled trials were included in this review. These were studies where two groups of patients were compared, one group had speech and language therapy, the other did not receive any therapy intended to improve speech. The patients were assigned to each of the groups in a random fashion so as to reduce the potential for bias. Three trials with a total of 63 patients were found comparing speech and language therapy with an untreated group. The quality of the methods used in these trials was variable, with all studies failing in at least one critical area. All three of the controlled trials reported a positive effect of speech and language therapy for speech disorders in Parkinson's disease. Many of the outcome measures examined appeared to improve by a clinically significant amount after therapy. However, it should be noted that there were flaws in the methods used in these studies and only a small number of patients with Parkinson’s disease were examined. This means that there is insufficient evidence to absolutely prove or disprove the benefit of speech and language therapy for the treatment of speech disorders in Parkinson's disease patients, but lack of evidence does not mean lack of effect. A large well designed placebo-controlled randomised trial is needed to assess the effectiveness of speech and language therapy for speech disorders in Parkinson's disease. Outcome measures with particular relevance to people with Parkinson’s disease should be chosen and the patients followed for at least six months to determine the duration of any improvement."
] |
cochrane-simplification-train-1582
|
cochrane-simplification-train-1582
|
Eighty-three studies, 36 of which were new to this update, met the inclusion criteria, representing 29,536 participants. Overall, we judged 16 studies to be at low risk of bias and 21 studies to be at high risk of bias. All other studies were judged to be at unclear risk of bias. Results were not sensitive to the exclusion of studies at high risk of bias. We pooled all studies comparing more versus less support in the main analysis. Findings demonstrated a benefit of behavioural support in addition to pharmacotherapy. When all studies of additional behavioural therapy were pooled, there was evidence of a statistically significant benefit from additional support (RR 1.15, 95% CI 1.08 to 1.22, I² = 8%, 65 studies, n = 23,331) for abstinence at longest follow-up, and this effect was not different when we compared subgroups by type of pharmacotherapy or intensity of contact. This effect was similar in the subgroup of eight studies in which the control group received no behavioural support (RR 1.20, 95% CI 1.02 to 1.43, I² = 20%, n = 4,018). Seventeen studies compared interventions matched for contact time but that differed in terms of the behavioural components or approaches employed. Of the 15 comparisons, all had small numbers of participants and events. Only one detected a statistically significant effect, favouring a health education approach (which the authors described as standard counselling containing information and advice) over motivational interviewing approach (RR 0.56, 95% CI 0.33 to 0.94, n = 378). There is high-certainty evidence that providing behavioural support in person or via telephone for people using pharmacotherapy to stop smoking increases quit rates. Increasing the amount of behavioural support is likely to increase the chance of success by about 10% to 20%, based on a pooled estimate from 65 trials. Subgroup analysis suggests that the incremental benefit from more support is similar over a range of levels of baseline support. More research is needed to assess the effectiveness of specific components that comprise behavioural support.
|
We looked for studies that included smokers and provided or offered medication to everyone. People in the studies were then randomly split into groups which received different amounts or kinds of behavioural support. To assess whether the support given helped people to quit, the studies had to count the number of people not smoking after six months or more. We did not look at studies that only included pregnant women. We searched for studies in June 2018. We included 83 studies, with almost 30,000 people. Most studies included people who wanted to quit smoking, but a small number of studies offered support to people who were not trying to quit. Combining results from 65 trials suggested that increasing the amount of behavioural support for people using a stop-smoking medication increases the chances of quitting smoking. About 17% of people in the groups receiving less or no support quit smoking, compared to about 20% in the groups receiving more support. Providing some support via personal contact, face-to-face or telephone, is helpful. Few studies compared different types of support. More research is needed to find out if some types of behavioural support help more people using medication to quit smoking. We judged the overall quality of evidence to be high, meaning further research is very unlikely to change our results. This review has been updated twice and both times the findings remained very similar, even though many new studies were added.
|
10.1002/14651858.CD009670.pub4
|
[
"We looked for studies that included smokers and provided or offered medication to everyone. People in the studies were then randomly split into groups which received different amounts or kinds of behavioural support. To assess whether the support given helped people to quit, the studies had to count the number of people not smoking after six months or more. We did not look at studies that only included pregnant women. We searched for studies in June 2018. We included 83 studies, with almost 30,000 people. Most studies included people who wanted to quit smoking, but a small number of studies offered support to people who were not trying to quit. Combining results from 65 trials suggested that increasing the amount of behavioural support for people using a stop-smoking medication increases the chances of quitting smoking. About 17% of people in the groups receiving less or no support quit smoking, compared to about 20% in the groups receiving more support. Providing some support via personal contact, face-to-face or telephone, is helpful. Few studies compared different types of support. More research is needed to find out if some types of behavioural support help more people using medication to quit smoking. We judged the overall quality of evidence to be high, meaning further research is very unlikely to change our results. This review has been updated twice and both times the findings remained very similar, even though many new studies were added."
] |
cochrane-simplification-train-1583
|
cochrane-simplification-train-1583
|
Five studies (n = 333 patients) were included in the review. Three studies were judged to be at low risk of bias. Two studies were judged to be at high risk of bias due to blinding. Intramuscular methotrexate was superior to placebo for maintenance of remission at 40 weeks follow-up. Sixty-five per cent of patients in the intramuscular methotrexate group maintained remission compared to 39% of placebo patients (RR 1.67, 95% CI 1.05 to 2.67; 76 patients).The number needed to treat to prevent one relapse was four. A GRADE analysis indicated that the overall quality of evidence supporting this outcome was moderate due to sparse data (40 events). There was no statistically significant difference in maintenance of remission at 36 weeks follow-up between oral methotrexate (12.5 mg/week) and placebo. Ninety per cent of patients in the oral methotrexate group maintained remission compared to 67% of placebo patients (RR 1.67, 95% CI 1.05 to 2.67; 22 patients). A GRADE analysis indicated that the overall quality of evidence supporting this outcome was low due to very sparse data (17 events). A pooled analysis of two small studies (n = 50) showed no statistically significant difference in continued remission between oral methotrexate (12.5 mg to 15 mg/week) and 6-mercaptopurine (1 mg/kg/day) for maintenance of remission. Seventy-seven per cent of methotrexate patients maintained remission compared to 57% of 6-mercaptopurine patients (RR 1.36, 95% CI 0.92 to 2.00). A GRADE analysis indicated that the overall quality of evidence supporting this outcome was very low due to high risk of bias in one study (no blinding) and very sparse data (33 events). One small (13 patients) poor quality study found no difference in continued remission between methotrexate and 5-aminosalicylic acid (RR 2.62, 95% CI 0.23 to 29.79). A pooled analysis of two studies (n = 145) including one high quality trial (n = 126) found no statistically significant difference in maintenance of remission at 36 to 48 weeks between combination therapy (methotrexate and infliximab) and infliximab monotherapy. Fifty-four percent of patients in the combination therapy group maintained remission compared to 53% of monotherapy patients (RR 1.02, 95% CI 0.76 to 1.38, P = 0.95). A GRADE analysis indicated that the overall quality of evidence supporting this outcome was low due to high risk of bias in one study (no blinding) and sparse data (78 events). Adverse events were generally mild in nature and resolved upon discontinuation or with folic acid supplementation. Common adverse events included nausea and vomiting, symptoms of a cold, abdominal pain, headache, joint pain or arthralgia, and fatigue. Moderate quality evidence indicates that intramuscular methotrexate at a dose of 15 mg/week is superior to placebo for maintenance of remission in Crohn's disease. Intramuscular methotrexate appears to be safe. Low dose oral methotrexate (12.5 to 15 mg/week) does not appear to be effective for maintenance of remission in Crohn's disease. Combination therapy (methotrexate and infliximab) does not appear to be any more effective for maintenance of remission than infliximab monotherapy. The results for efficacy outcomes between methotrexate and 6-mercaptopurine and methotrexate and 5-aminosalicylic acid were uncertain. Large-scale studies of methotrexate given orally at higher doses for maintenance of remission in Crohn’s disease may provide stronger evidence for the use of methotrexate in this manner.
|
This review identified five studies that included a total of 333 participants. Two studies compared methotrexate (administered by pill or intramuscular injection) to a placebo (a sugar pill or a saline injection). One of these two studies also compared methotrexate to 6-mercaptopurine (an immunosuppressive drug). One small study compared methotrexate to both 6-mercaptopurine and 5-aminosalicylic acid (an anti-inflammatory drug). Two studies compared combination therapy with methotrexate and infliximab (a biological drug that is a tumour necrosis factor-alpha antagonist) to infliximab used by itself. One high quality study (76 patients) shows that methotrexate (15 mg/week) injected intramuscularly (i.e. into muscles located in the arm or thigh) for 40 weeks is superior to placebo for preventing relapse (return of disease symptoms) among patients whose disease became inactive while taking higher doses of intramuscular methotrexate (25 mg/week). Side effects occurred in a small number of patients. These side effects are usually mild in nature and include nausea and vomiting, cold symptoms, abdominal pain, headache, joint pain and fatigue. One small study (22 patients) found no difference in continued remission between low dose methotrexate (12.5 mg/week) taken orally and placebo and suggests that low dose oral methotrexate is not an effective treatment for inactive Crohn's disease. However this result is uncertain due to the small number of patients assessed in the study. Large-scale studies of methotrexate given orally at higher doses for maintenance of remission in Crohn’s disease may provide stronger evidence for the use of methotrexate in this manner. A pooled analysis of two studies (50 patients) found no difference in continued remission between oral methotrexate (12.5 to 15 mg/week) and 6-mercaptopurine (1 mg/kg/day). No firm conclusions can be drawn as these results are uncertain due to poor study quality and small numbers of patients. A small study (13 patients) found no difference in continued remission between methotrexate and 5-aminosalicylic acid. No conclusions can be drawn from this study as the results are very uncertain due to poor study quality and small numbers of patients. A pooled analysis of two studies (145 patients) found no difference in continued remission between combination therapy and infliximab. Combination therapy with methotrexate and infliximab does not appear to be any more effective for maintenance of remission than infliximab used by itself. This result is uncertain because one study was of poor quality (the other was high quality) and small numbers of patients.
|
10.1002/14651858.CD006884.pub3
|
[
"This review identified five studies that included a total of 333 participants. Two studies compared methotrexate (administered by pill or intramuscular injection) to a placebo (a sugar pill or a saline injection). One of these two studies also compared methotrexate to 6-mercaptopurine (an immunosuppressive drug). One small study compared methotrexate to both 6-mercaptopurine and 5-aminosalicylic acid (an anti-inflammatory drug). Two studies compared combination therapy with methotrexate and infliximab (a biological drug that is a tumour necrosis factor-alpha antagonist) to infliximab used by itself. One high quality study (76 patients) shows that methotrexate (15 mg/week) injected intramuscularly (i.e. into muscles located in the arm or thigh) for 40 weeks is superior to placebo for preventing relapse (return of disease symptoms) among patients whose disease became inactive while taking higher doses of intramuscular methotrexate (25 mg/week). Side effects occurred in a small number of patients. These side effects are usually mild in nature and include nausea and vomiting, cold symptoms, abdominal pain, headache, joint pain and fatigue. One small study (22 patients) found no difference in continued remission between low dose methotrexate (12.5 mg/week) taken orally and placebo and suggests that low dose oral methotrexate is not an effective treatment for inactive Crohn's disease. However this result is uncertain due to the small number of patients assessed in the study. Large-scale studies of methotrexate given orally at higher doses for maintenance of remission in Crohn’s disease may provide stronger evidence for the use of methotrexate in this manner. A pooled analysis of two studies (50 patients) found no difference in continued remission between oral methotrexate (12.5 to 15 mg/week) and 6-mercaptopurine (1 mg/kg/day). No firm conclusions can be drawn as these results are uncertain due to poor study quality and small numbers of patients. A small study (13 patients) found no difference in continued remission between methotrexate and 5-aminosalicylic acid. No conclusions can be drawn from this study as the results are very uncertain due to poor study quality and small numbers of patients. A pooled analysis of two studies (145 patients) found no difference in continued remission between combination therapy and infliximab. Combination therapy with methotrexate and infliximab does not appear to be any more effective for maintenance of remission than infliximab used by itself. This result is uncertain because one study was of poor quality (the other was high quality) and small numbers of patients."
] |
cochrane-simplification-train-1584
|
cochrane-simplification-train-1584
|
We identified four studies (13 reports), with 2818 participants, and one ongoing study. Overall certainty of evidence ranged from high to very low. There is probably little or no difference between TAVI and SAVR for the following short-term outcomes: all-cause mortality (RR 0.69, 95% CI 0.33 to 1.44; SAVR 11 deaths per 1000, TAVI 8 deaths per 1000 (95% CI 4 to 16); 2818 participants; 4 studies; moderate-certainty evidence); stroke (RR 0.73, 95% CI 0.42 to 1.25; SAVR 21 strokes per 1000, TAVI 16 strokes per 1000 (95% CI 9 to 27); 2818 participants; 4 studies; moderate-certainty evidence); MI (RR 0.82, 95% CI 0.42 to 1.58; SAVR 14 MI per 1000, TAVI 11 MI per 1000 (95% CI 6 to 21); 2748 participants; 3 studies; moderate-certainty evidence); and cardiac death (RR 0.71, 95% CI 0.32 to 1.56; SAVR 10 cardiac deaths per 1000, TAVI 7 cardiac deaths per 1000 (95% CI 3 to 16); 2818 participants; 4 studies; moderate-certainty evidence). TAVI may reduce the risk of short-term rehospitalisation, although the confidence interval also includes the possibility of no difference in risk between groups (RR 0.64, 95% CI 0.39 to 1.06; SAVR 30 cases per 1000, TAVI 19 cases per 1000 (95% CI 12 to 32); 2468 participants; 2 studies; low-certainty evidence). TAVI, compared with SAVR, probably increases the risk of PPM implantation (RR 3.65, 95% CI 1.50 to 8.87; SAVR 47 per 1000, TAVI 170 cases per 1000 (95% CI 70 to 413); number needed to treat for an additional harmful outcome (NNTH) = 7; 2683 participants; 3 studies; moderate-certainty evidence). We are uncertain whether TAVI, compared with SAVR, affects the LOS in days, although it appears to be associated with shorter LOS. TAVI, compared with SAVR, reduces the risk of atrial fibrillation (RR 0.21, 95% CI 0.15 to 0.30; 2683 participants; 3 studies), AKI (RR 0.30, 95% CI 0.16 to 0.58; 2753 participants; 4 studies), and bleeding (RR 0.31, 95% CI 0.16 to 0.62; 2753 participants; 4 studies) (all high-certainty evidence). Our meta-analysis indicates that, in the short term, TAVI probably has little or no mortality difference compared to SAVR for severe AS in individuals with low surgical risk. Similarly, there is probably little or no difference in risk of stroke, MI, and cardiac death between the two approaches. TAVI may reduce the risk of rehospitalisation, but we are uncertain about the effects on LOS. TAVI reduces the risk of atrial fibrillation, AKI, and bleeding. However, this benefit is offset by the increased risk of PPM implantation. Long-term follow-up data are needed to further assess and validate these outcomes, especially durability, in the low surgical risk population.
|
The four clinical trials included 2818 participants who were randomly allocated to undergo either TAVI or surgical aortic valve replacement (SAVR). The trials were multicentre and took place in Australia, Canada, France, Japan, the Netherlands, New Zealand, the USA, Denmark, and Sweden. Moderate-certainty evidence from clinical trials shows that, in the short term (i.e. during hospitalisation and up to 30 days of follow-up), there is probably little or no difference between TAVI compared with SAVR in risk of death due to any cause, stroke (insult to the brain), myocardial infarction (injury or death of heart muscle), or death due to cardiac causes (e.g. myocardial infarction or failure of the heart muscle pump). Low-certainty evidence shows that TAVI may reduce the risk of rehospitalisation compared with SAVR. We are uncertain whether TAVI, compared with SAVR, affects the length of hospital stay, although it appears to be associated with shorter duration of hospitalisation. High-certainty evidence shows that fewer people had atrial fibrillation (a type of irregular heart rhythm), acute kidney injury (insult to the kidney), and bleeding when they underwent TAVI, compared with SAVR. However, moderate-certainty evidence shows that TAVI probably increases the risk of permanent pacemaker implantation (a device that is placed to artificially set the heart rhythm), compared with SAVR. We consider the overall quality of evidence to be moderate for most relevant outcomes (death, stroke, myocardial infarction, cardiac death, and risk of permanent pacemaker implantation), with the exception of rehospitalisation (low-quality evidence) and length of hospital stay (very low quality evidence). The evidence for atrial fibrillation, acute kidney injury, and bleeding was of high quality.
|
10.1002/14651858.CD013319.pub2
|
[
"The four clinical trials included 2818 participants who were randomly allocated to undergo either TAVI or surgical aortic valve replacement (SAVR). The trials were multicentre and took place in Australia, Canada, France, Japan, the Netherlands, New Zealand, the USA, Denmark, and Sweden. Moderate-certainty evidence from clinical trials shows that, in the short term (i.e. during hospitalisation and up to 30 days of follow-up), there is probably little or no difference between TAVI compared with SAVR in risk of death due to any cause, stroke (insult to the brain), myocardial infarction (injury or death of heart muscle), or death due to cardiac causes (e.g. myocardial infarction or failure of the heart muscle pump). Low-certainty evidence shows that TAVI may reduce the risk of rehospitalisation compared with SAVR. We are uncertain whether TAVI, compared with SAVR, affects the length of hospital stay, although it appears to be associated with shorter duration of hospitalisation. High-certainty evidence shows that fewer people had atrial fibrillation (a type of irregular heart rhythm), acute kidney injury (insult to the kidney), and bleeding when they underwent TAVI, compared with SAVR. However, moderate-certainty evidence shows that TAVI probably increases the risk of permanent pacemaker implantation (a device that is placed to artificially set the heart rhythm), compared with SAVR. We consider the overall quality of evidence to be moderate for most relevant outcomes (death, stroke, myocardial infarction, cardiac death, and risk of permanent pacemaker implantation), with the exception of rehospitalisation (low-quality evidence) and length of hospital stay (very low quality evidence). The evidence for atrial fibrillation, acute kidney injury, and bleeding was of high quality."
] |
cochrane-simplification-train-1585
|
cochrane-simplification-train-1585
|
We found 13 trials (1960 patients). Lipid-based amphotericin B was not more effective than conventional amphotericin B on mortality (relative risk (RR) 0.5; 95% confidence interval (CI) 0.64 to 1.14) but decreased invasive fungal infection (RR 0.65; 95% CI 0.44 to 0.97), nephrotoxicity defined as a 100% increase in serum creatinine (RR 0.45; 95% CI 0.37 to 0.54), and number of dropouts (RR 0.78; 95% CI 0.62 to 0.97). For the drug used in most patients, AmBisome (4 trials, 1214 patients), there was no significant difference in mortality (RR 0.77; 95% CI 0.54 to 1.10) whereas it tended to be more effective than conventional amphotericin B on invasive fungal infection (RR 0.63; 95% CI 0.39 to 1.01, P value 0.053). AmBisome, amphotericin B in Intralipid (6 trials, 379 patients), amphotericin B colloidal dispersion (ABCD) (2 trials, 262 patients), and amphotericin B lipid complex (ABLC) (1 trial, 105 patients) all decreased the occurrence of nephrotoxicity, but conventional amphotericin B was rarely administered under optimal circumstances. It is not clear whether there are any advantages of lipid-based formulations if conventional amphotericin B is administered under optimal circumstances, and their high cost prohibits routine use in most settings. There is a need for large trials comparing lipid-based formulations of amphotericin B with conventional amphotericin B given in the same dose, with routine premedication for prevention of infusion-related toxicity, and with supplementation with fluid, potassium, and magnesium for prevention of nephrotoxicity.
|
The review found that lipid formulations of amphotericin B had fewer adverse effects (less nephrotoxicity and fewer dropouts) than conventional amphotericin B. However, it is not clear whether there are any advantages of these formulations if conventional amphotericin B is administered under optimal circumstances.
|
10.1002/14651858.CD000969.pub2
|
[
"The review found that lipid formulations of amphotericin B had fewer adverse effects (less nephrotoxicity and fewer dropouts) than conventional amphotericin B. However, it is not clear whether there are any advantages of these formulations if conventional amphotericin B is administered under optimal circumstances."
] |
cochrane-simplification-train-1586
|
cochrane-simplification-train-1586
|
Fifteen studies were included in the review. Studies included children with a range of severe neurological impairments in differing settings, for example, home and critical care. Several different treatment modalities were assessed, and a wide range of outcome measures were used. Most studies used a non-randomised design and included small sample groups. Only four randomised controlled trials were identified. Non-randomised design, lack of information about how participants were selected and who completed outcome measures and incomplete reporting led to high or unclear risk of bias in many studies. Results from low-quality studies suggest that use of non-invasive ventilation, mechanically assisted coughing, high-frequency chest wall oscillation (HFCWO), positive expiratory pressure and supportive seating may confer potential benefits. No serious adverse effects were reported for ventilatory support or airway clearance interventions other than one incident in a clinically unstable child following mechanically assisted coughing. Night-time positioning equipment and spinal bracing were shown to have a potentially negative effect for some participants. However, these findings must be considered as tentative and require testing in future randomised trials. This review found no high-quality evidence for any single intervention for the management of respiratory morbidity in children with severe global developmental delay. Our search yielded data on a wide range of interventions of interest. Significant differences in study design and in outcome measures precluded the possibility of meta-analysis. No conclusions on efficacy or safety of interventions for respiratory morbidity in children with severe global developmental delay can be made based upon the findings of this review. A co-ordinated approach to future research is vital to ensure that high-quality evidence becomes available to guide treatment for this vulnerable patient group.
|
We carried out a wide database search to look for studies of interventions for the management of breathing problems in children with severe neurological impairment. We found 15 studies of interest, which included a number of different types of treatment. The results showed that several different treatments provided potential benefits, and for most interventions no serious adverse effects were reported. However, the quality of the studies was not good enough to inspire confidence in the findings. Night-time positioning equipment and spinal bracing were shown to have a potentially negative effect in some participants. Although some studies looked at the same type of treatment, they used it in different ways or used different measures to assess effectiveness, so we could not put the results together. Of the 15 studies included here, only four used the 'gold standard' study design for health interventions. The remainder of the studies used less robust study designs, which limits the strength of the results. Further well-designed randomised studies including larger numbers of participants are required to guide healthcare professionals to select the most effective treatments.
|
10.1002/14651858.CD010382.pub2
|
[
"We carried out a wide database search to look for studies of interventions for the management of breathing problems in children with severe neurological impairment. We found 15 studies of interest, which included a number of different types of treatment. The results showed that several different treatments provided potential benefits, and for most interventions no serious adverse effects were reported. However, the quality of the studies was not good enough to inspire confidence in the findings. Night-time positioning equipment and spinal bracing were shown to have a potentially negative effect in some participants. Although some studies looked at the same type of treatment, they used it in different ways or used different measures to assess effectiveness, so we could not put the results together. Of the 15 studies included here, only four used the 'gold standard' study design for health interventions. The remainder of the studies used less robust study designs, which limits the strength of the results. Further well-designed randomised studies including larger numbers of participants are required to guide healthcare professionals to select the most effective treatments."
] |
cochrane-simplification-train-1587
|
cochrane-simplification-train-1587
|
We included in this update 28 studies (4287 women) with sample sizes ranging from 20 to 372. Most studies had low risk of bias for randomisation, attrition, and selective reporting. Less than half of these studies had adequate allocation concealment, and most were unblinded. Using GRADE, we determined that the quality of evidence ranged from moderate to very low. We downgraded evidence for risk of bias, imprecision, and inconsistency. Overall comparison of second-generation versus first-generation (i.e. gold standard hysteroscopic ablative) techniques revealed no evidence of differences in amenorrhoea at 1 year and 2 to 5 years' follow-up (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.78 to 1.27; 12 studies; 2145 women; I² = 77%; and RR 1.16, 95% CI 0.78 to 1.72; 672 women; 4 studies; I² = 80%; very low-quality evidence) and showed subjective improvement at 1 year follow-up based on a Pictorial Blood Assessment Chart (PBAC) (< 75 or acceptable improvement) (RR 1.03, 95% CI 0.98 to 1.09; 5 studies; 1282 women; I² = 0%; and RR 1.12, 95% CI 0.97 to 1.28; 236 women; 1 study; low-quality evidence). Study results showed no difference in patient satisfaction between second- and first-generation techniques at 1 year follow-up (RR 1.01, 95% CI 0.98 to 1.04; 11 studies; 1750 women; I² = 36%; low-quality evidence) nor at 2 to 5 years' follow-up (RR 1.02, 95% CI 0.93 to 1.13; 672 women; 4 studies; I² = 81%). Compared with first-generation techniques, second-generation endometrial ablation techniques were associated with shorter operating times (mean difference (MD) -13.52 minutes, 95% CI -16.90 to -10.13; 9 studies; 1822 women; low-quality evidence) and more often were performed under local rather than general anaesthesia (RR 2.8, 95% CI 1.8 to 4.4; 6 studies; 1434 women; low-quality evidence). We are uncertain whether perforation rates differed between second- and first-generation techniques (RR 0.32, 95% CI 0.10 to 1.01; 1885 women; 8 studies; I² = 0%). Trials reported little or no difference between second- and first-generation techniques in requirement for additional surgery (ablation or hysterectomy) at 1 year follow-up (RR 0.72, 95% CI 0.41 to 1.26; 6 studies: 935 women; low-quality evidence). At 5 years, results showed probably little or no difference between groups in the requirement for hysterectomy (RR 0.85, 95% CI 0.59 to 1.22; 4 studies; 758 women; moderate-quality evidence). Approaches to endometrial ablation have evolved from first-generation techniques to newer second- and third-generation approaches. Current evidence suggests that compared to first-generation techniques (endometrial laser ablation, transcervical resection of the endometrium, rollerball endometrial ablation), second-generation approaches (thermal balloon endometrial ablation, microwave endometrial ablation, hydrothermal ablation, bipolar radiofrequency endometrial ablation, endometrial cryotherapy) are of equivalent efficacy for heavy menstrual bleeding, with comparable rates of amenorrhoea and improvement on the PBAC. Second-generation techniques are associated with shorter operating times and are performed more often under local rather than general anaesthesia. It is uncertain whether perforation rates differed between second- and first-generation techniques. Evidence was insufficient to show which second-generation approaches were superior to others and to reveal the efficacy and safety of third-generation approaches versus first- and second-generation techniques.
|
This review identified 28 randomised controlled trials undertaken in 4287 women. Most of the women knew which treatment they were receiving, which may have influenced their judgements about menstrual blood loss and satisfaction. Other aspects of study quality varied among trials. Evidence is current to May 2018. Nineteen of the 28 trials acknowledged that they received funding, supplies of equipment, or technical assistance from the pharmaceutical industry and from equipment manufacturers. Moderate- to very low-quality evidence suggests that first- and second-generation approaches were equally effective in the treatment of HMB. Newer (second-generation) treatment approaches were safer in terms of rate of fluid overload, cervical lacerations, and haematometra, with similar rates of uterine perforation. The newer approaches (second-generation ablation) were quicker and were more likely to be done under local (rather than general) anaesthesia compared with first-generation approaches. Most women in both groups were satisfied with results of the procedure. Not enough evidence is available to show which second-generation approaches are superior to others, and information about third-generation approaches is not available for comparison. Evidence ranged from moderate to very low quality. Few studies were blinded, data were limited, and heterogeneity was substantial for some outcomes, leading to downgrading of the quality of evidence.
|
10.1002/14651858.CD001501.pub5
|
[
"This review identified 28 randomised controlled trials undertaken in 4287 women. Most of the women knew which treatment they were receiving, which may have influenced their judgements about menstrual blood loss and satisfaction. Other aspects of study quality varied among trials. Evidence is current to May 2018. Nineteen of the 28 trials acknowledged that they received funding, supplies of equipment, or technical assistance from the pharmaceutical industry and from equipment manufacturers. Moderate- to very low-quality evidence suggests that first- and second-generation approaches were equally effective in the treatment of HMB. Newer (second-generation) treatment approaches were safer in terms of rate of fluid overload, cervical lacerations, and haematometra, with similar rates of uterine perforation. The newer approaches (second-generation ablation) were quicker and were more likely to be done under local (rather than general) anaesthesia compared with first-generation approaches. Most women in both groups were satisfied with results of the procedure. Not enough evidence is available to show which second-generation approaches are superior to others, and information about third-generation approaches is not available for comparison. Evidence ranged from moderate to very low quality. Few studies were blinded, data were limited, and heterogeneity was substantial for some outcomes, leading to downgrading of the quality of evidence."
] |
cochrane-simplification-train-1588
|
cochrane-simplification-train-1588
|
We included 18 trials (633 participants) in this update of this review. Treadmill training improved gait speed (MD = 0.09 m/s; 95% confidence interval (CI) 0.03 to 0.14; P = 0.001; I2 = 24%; moderate quality of evidence), stride length (MD = 0.05 metres; 95% CI 0.01 to 0.09; P = 0.01; I2 = 0%; low quality of evidence), but walking distance (MD = 48.9 metres; 95% CI -1.32 to 99.14; P = 0.06; I2 = 91%; very low quality of evidence) and cadence did not improve (MD = 2.16 steps/minute; 95% CI -0.13 to 4.46; P = 0.07; I2 = 28%; low quality of evidence) at the end of study. Treadmill training did not increase the risk of patients dropping out from intervention (RD = -0.02; 95% CI -0.06 to 0.02; P = 0.32; I2 = 13%; moderate quality of evidence). Adverse events were not reported in included studies. This update of our systematic review provides evidence from eighteen trials with moderate to low risk of bias that the use of treadmill training in patients with PD may improve clinically relevant gait parameters such as gait speed and stride length (moderate and low quality of evidence, respectively). This apparent benefit for patients is, however, not supported by all secondary variables (e.g. cadence and walking distance). Comparing physiotherapy and treadmill training against other alternatives in the treatment of gait hypokinesia such as physiotherapy without treadmill training this type of therapy seems to be more beneficial in practice without increased risk. The gain seems small to moderate clinically relevant. However, the results must be interpreted with caution because it is not known how long these improvements may last and some studies used no intervention in the control group and underlie some risk of bias. Additionally the results were heterogenous and we found variations between the trials in patient characteristics, the duration and amount of training, and types of treadmill training applied.
|
We identified 18 relevant trials, involving 633 participants which evaluated this type of therapy, up to September 2014. Treadmill training did improve gait speed, and stride length; but walking distance and cadence did not improve. Acceptability of treadmill training for study participants was good and adverse events were rare. It seems that such devices could be beneficial and could be applied in routine rehabilitation. However, it is still not clear when and how often they should be used and how long a benefit lasts. The quality of this evidence for the primary outcomes was moderate to low. Adverse events were not reported in studies and drop outs did not occur more frequently in people receiving treadmill training. Also we investigated only gait parameters, improvements of activities and/or quality of life were not investigated.
|
10.1002/14651858.CD007830.pub4
|
[
"We identified 18 relevant trials, involving 633 participants which evaluated this type of therapy, up to September 2014. Treadmill training did improve gait speed, and stride length; but walking distance and cadence did not improve. Acceptability of treadmill training for study participants was good and adverse events were rare. It seems that such devices could be beneficial and could be applied in routine rehabilitation. However, it is still not clear when and how often they should be used and how long a benefit lasts. The quality of this evidence for the primary outcomes was moderate to low. Adverse events were not reported in studies and drop outs did not occur more frequently in people receiving treadmill training. Also we investigated only gait parameters, improvements of activities and/or quality of life were not investigated."
] |
cochrane-simplification-train-1589
|
cochrane-simplification-train-1589
|
We scanned more than 6800 citations and included six studies with a total of 333 participants in the analysis. There were insufficient data to assess the effect on survival. The use of CSF significantly reduced the number of episodes of febrile neutropenia episodes (Rate Ratio = 0.63; 95% confidence interval (CI) 0.46 to 0.85; P = 0.003, with substantial heterogeneity), the length of hospitalisation (weighted mean difference (WMD) = -1.58; 95% CI -3.00 to -0.15; P = 0.03), and number of infectious disease episodes (Rate Ratio = 0.56; 95% CI 0.39 to 0.80; P = 0.002). Despite these results, CSF did not influence the length of episodes of neutropenia (WMD = -1.11; 95% CI -3.55 to 1.32; P = 0.4) or delays in chemotherapy courses (Rate Ratio = 0.75; 95% CI 0.47 to 1.20; P = 0.23) . Children with ALL treated with CSF benefit from shorter hospitalisation and fewer infections. However, there was no evidence of shortened duration of neutropenia nor fewer treatment delays. There was also no useful information about survival. The role of CSF in the context of febrile neutropenia episodes is still uncertain. Although current data show statistical benefit with CSF use, substantial heterogeneity between included trials does not allow this conclusion.
|
There is a lack of studies to determine the best CSF dose for children and only a small number of RCTs evaluating the role of CSF in children's ALL. The prophylactic administration of CSF reduces hospital stay, and risk of infections. The authors did not find evidence that CSF reduces febrile neutropenia episodes, their duration, or treatment delays in children with ALL undergoing chemotherapy. Follow up was too short to provide useful information on any possible effect on relapse or survival.
|
10.1002/14651858.CD004139.pub2
|
[
"There is a lack of studies to determine the best CSF dose for children and only a small number of RCTs evaluating the role of CSF in children's ALL. The prophylactic administration of CSF reduces hospital stay, and risk of infections. The authors did not find evidence that CSF reduces febrile neutropenia episodes, their duration, or treatment delays in children with ALL undergoing chemotherapy. Follow up was too short to provide useful information on any possible effect on relapse or survival."
] |
cochrane-simplification-train-1590
|
cochrane-simplification-train-1590
|
Twenty-six studies, randomising 2959 women, were included in this review. Inhaled analgesia versus a different type of inhaled analgesia Pain relief was measured using a Visual Analogue Scale (VAS) from 0 to 100 mm where 100 corresponds to the most relief. Pain intensity was measured using a VAS from 0 to 100 mm, where 0 corresponds to no pain at all and 100 corresponds to the worst pain. The highest score for pain relief is the most positive in contrast to 'pain intensity' in which the higher score is more negative. Flurane derivatives were found to offer better pain relief than nitrous oxide in first stage of labour as measured by a lower pain intensity score (average mean difference (MD) 14.39, 95% confidence interval (CI) 4.41 to 24.37, three studies, 70 women), also a higher pain relief score for flurane derivatives compared with nitrous oxide (average MD -16.32, 95% CI -26.85 to -5.79, two studies, 70 women). Substantial heterogeneity was found in the analyses of pain intensity (P = 0.003) and in the analysis of pain relief (P = 0.002).These findings should be considered with caution because of the questionable design of the included cross-over trials. More nausea was found in the nitrous oxide group compared with the flurane derivatives group (risk ratio (RR) 6.60 95% CI 1.85 to 23.52, two studies, 98 women). Inhaled analgesia versus placebo or no treatment Placebo or no treatment was found to offer less pain relief compared to nitrous oxide (average RR 0.06, 95% CI 0.01 to 0.34, two studies, 310 women; MD -3.50, 95% CI -3.75 to -3.25, one study, 509 women). However, nitrous oxide resulted in more side effects for women such as nausea (RR 43.10, 95% CI 2.63 to 706.74, one study, 509 women), vomiting (RR 9.05, 95% CI 1.18 to 69.32, two studies, 619 women), dizziness (RR 113.98, 95% CI 7.09 to 1833.69, one study, 509 women) and drowsiness (RR 77.59, 95% CI 4.80 to 1254.96, one study, 509 women) when compared with placebo or no treatment. There were no significant differences found for any of the outcomes in the studies comparing one strength versus a different strength of inhaled analgesia, in studies comparing different delivery systems or in the study comparing inhaled analgesia with TENS. Due to lack of data, the following outcomes were not analysed within the review: sense of control; satisfaction with childbirth experience; effect on mother/baby interaction; breastfeeding; admission to special care baby unit; poor infant outcomes at long-term follow-up; or costs. Inhaled analgesia appears to be effective in reducing pain intensity and in giving pain relief in labour. However, substantial heterogeneity was detected for pain intensity. Furthermore, nitrous oxide appears to result in more side effects compared with flurane derivatives. Flurane derivatives result in more drowsiness when compared with nitrous oxide. When inhaled analgesia is compared with no treatment or placebo, nitrous oxide appears to result in even more side effects such as nausea, vomiting, dizziness and drowsiness. There is no evidence for differences for any of the outcomes comparing one strength verus a different strength of inhaled analgesia, comparing different delivery systems or comparing inhaled analgesia with TENS.
|
In this review of 26 randomised controlled trials of 2959 women, the effectiveness and safety of inhaled analgesia as pain relief for women in labour were studied. It was found that inhaled analgesia may help relieve pain during labour but women have to be informed about the side effects, such as nausea, vomiting, dizziness and drowsiness. Inhaled analgesia may help relieve labour pain without adversely increasing operative delivery rates (forceps or vacuum extraction, caesarian section), or affecting neonatal well being. Flurane derivatives were found to be slightly more effective than nitrous oxide for the reduction of pain and for pain relief although nitrous oxide also helped to relieve pain when compared with no treatment. Women who used nitrous oxide were more likely to experience nausea compared with flurane derivatives. When nitrous oxide was compared with no treatment or placebo, nitrous oxide resulted in side effects such as nausea, vomiting, dizziness and drowsiness. There was no information for satisfaction with childbirth experience or sense of control in labour in these studies and further research on these two important outcomes would be helpful.
|
10.1002/14651858.CD009351.pub2
|
[
"In this review of 26 randomised controlled trials of 2959 women, the effectiveness and safety of inhaled analgesia as pain relief for women in labour were studied. It was found that inhaled analgesia may help relieve pain during labour but women have to be informed about the side effects, such as nausea, vomiting, dizziness and drowsiness. Inhaled analgesia may help relieve labour pain without adversely increasing operative delivery rates (forceps or vacuum extraction, caesarian section), or affecting neonatal well being. Flurane derivatives were found to be slightly more effective than nitrous oxide for the reduction of pain and for pain relief although nitrous oxide also helped to relieve pain when compared with no treatment. Women who used nitrous oxide were more likely to experience nausea compared with flurane derivatives. When nitrous oxide was compared with no treatment or placebo, nitrous oxide resulted in side effects such as nausea, vomiting, dizziness and drowsiness. There was no information for satisfaction with childbirth experience or sense of control in labour in these studies and further research on these two important outcomes would be helpful."
] |
cochrane-simplification-train-1591
|
cochrane-simplification-train-1591
|
Eighteen studies (7446 participants) compared cinacalcet in addition to standard therapy with no treatment or placebo plus standard therapy. In adults with GFR category G5 (GFR below 15 mL/min/1.73 m²) treated with dialysis, routine cinacalcet treatment had little or no effect on all-cause mortality (RR 0.97, 95% CI 0.89 to 1.05), imprecise effects on cardiovascular mortality (RR 0.67, 95% CI 0.16 to 2.87), and prevented surgical parathyroidectomy (RR 0.49, 95% CI 0.40 to 0.59) and hypercalcaemia (RR 0.23, 95% CI 0.05 to 0.97), but increased hypocalcaemia (RR 6.98, 95% CI 5.10 to 9.53), nausea (RR 2.02, 95% CI 1.45 to 2.81) and vomiting (RR 1.97, 95% CI 95% CI 1.73 to 2.24). Cinacalcet decreased serum PTH (MD -281.39 pg/mL, 95% CI -325.84 to -234.94) and calcium (MD -0.87 mg/dL, 95% CI -0.96 to -0.77) levels, but had little or no effect on serum phosphorous levels (MD -0.23 mg/dL, 95% CI -0.58 to 0.12). Data were sparse for adults with GFR categories G3a to G4 (GFR 15 to 60 mL/min/1.73 m²) and kidney transplant recipients. Overall, based on GRADE criteria, evidence for cinacalcet in adults with GFR category G5 treated with dialysis (mortality, parathyroidectomy, hypocalcaemia, and nausea) is of high or moderate quality. High quality evidence suggests "further research is very unlikely to change our confidence in the estimate of treatment effect" and moderate quality evidence is "further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate". Information for adults with less severe CKD GFR category G3a to G4 is of low or very low quality. This means that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Routine cinacalcet therapy reduced the need for parathyroidectomy in adults treated with dialysis and elevated PTH levels but does not improve all-cause or cardiovascular mortality. Cinacalcet increases risks of nausea, vomiting and hypocalcaemia, suggesting harms may outweigh benefits in this population.
|
A newer treatment called cinacalcet showed promise for improving abnormal mineral levels but the effects of this drug on patient outcomes (the way patients feel function and survive) were unclear from early studies. We have updated an earlier review dated 2006 to include studies that assessed the effects of cinacalcet in about 7500 people with chronic kidney disease. While cinacalcet improves some blood abnormalities, it does not improve risk of death or heart disease in people treated with dialysis. In addition, people who take cinacalcet may experience increased nausea, vomiting and the need for blood tests to check blood calcium levels. The current research is high-quality and means that additional new studies are unlikely to change our confidence in these results. Information for the use of cinacalcet in people with milder forms of kidney disease and those with a kidney transplant is insufficient to guide decision making.
|
10.1002/14651858.CD006254.pub2
|
[
"A newer treatment called cinacalcet showed promise for improving abnormal mineral levels but the effects of this drug on patient outcomes (the way patients feel function and survive) were unclear from early studies. We have updated an earlier review dated 2006 to include studies that assessed the effects of cinacalcet in about 7500 people with chronic kidney disease. While cinacalcet improves some blood abnormalities, it does not improve risk of death or heart disease in people treated with dialysis. In addition, people who take cinacalcet may experience increased nausea, vomiting and the need for blood tests to check blood calcium levels. The current research is high-quality and means that additional new studies are unlikely to change our confidence in these results. Information for the use of cinacalcet in people with milder forms of kidney disease and those with a kidney transplant is insufficient to guide decision making."
] |
cochrane-simplification-train-1592
|
cochrane-simplification-train-1592
|
We included four studies with a total of 272 participants (6 to 18 years of age) who had either chronic neuropathic pain, complex regional pain syndrome type 1, irritable bowel syndrome, functional abdominal pain, or functional dyspepsia. All of the studies were small. One study investigated amitriptyline versus gabapentin (34 participants), two studies investigated amitriptyline versus placebo (123 participants), and one study investigated citalopram versus placebo (115 participants). Due to a lack of available data we were unable to complete any quantitative analysis. Risk of bias for the four included studies varied, due to issues with randomisation and allocation concealment (low to unclear risk); blinding of participants, personnel, and outcome assessors (low to unclear risk); reporting of results (low to unclear risk); and size of the study populations (high risk). We judged the remaining domains, attrition and other potential sources of bias, as low risk of bias. Primary outcomes No studies reported our primary outcomes of participant-reported pain relief of 30% or greater or 50% or greater, or Patient Global Impression of Change. Secondary outcomes All studies measured adverse events, with very few reported (11 out of 272 participants). All but one adverse event occurred in the active treatment groups (amitriptyline, citalopram, and gabapentin). Adverse events in all studies, across active treatment and comparator groups, were considered to be a mild reaction, such as nausea, dizziness, drowsiness, tiredness, and abdominal discomfort (very low-quality evidence). There were also very few withdrawals due to adverse events, again all but one from the active treatment groups (very low-quality evidence). No serious adverse events were reported across any of the studies (very low-quality evidence). There were few or no data for our remaining secondary outcomes. Quality of evidence For the outcomes with available data, we downgraded the quality of the evidence by three levels to very low-quality due to too few data and the fact that the number of events was too small to be meaningful. We identified only a small number of studies with small numbers of participants and insufficient data for analysis. As we could undertake no meta-analysis, we are unable to comment about efficacy or harm from the use of antidepressants to treat chronic non-cancer pain in children and adolescents. Similarly, we could not comment on our remaining secondary outcomes: Carer Global Impression of Change; requirement for rescue analgesia; sleep duration and quality; acceptability of treatment; physical functioning; and quality of life. We know from adult randomised controlled trials that some antidepressants, such as amitriptyline, can provide some pain relief in certain chronic non-cancer pain conditions.
|
In September 2016 we searched for clinical trials in which antidepressants were used to treat chronic nerve, menstrual, muscular, joint, or stomach pain. We found four trials with a total of 272 participants (aged 6 to 18 years old) who had nerve pain, general painful inflammation, stomach pain, or irritable bowel syndrome, for more than 3 months. No studies reported on pain relief of 30% or greater, or 50% or greater. Side effects were uncommon, and occurred only as mild reactions such as nausea, dizziness, drowsiness, tiredness, and abdominal discomfort (4 due to amitriptyline, 5 due to citalopram, 1 due to gabapentin, and 1 due to placebo). These 11 participants withdrew from the study due to these mild side effects. There were no serious side effects. We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low-quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. The available evidence in this review was of very low-quality due to a lack of data and small study sizes.
|
10.1002/14651858.CD012535.pub2
|
[
"In September 2016 we searched for clinical trials in which antidepressants were used to treat chronic nerve, menstrual, muscular, joint, or stomach pain. We found four trials with a total of 272 participants (aged 6 to 18 years old) who had nerve pain, general painful inflammation, stomach pain, or irritable bowel syndrome, for more than 3 months. No studies reported on pain relief of 30% or greater, or 50% or greater. Side effects were uncommon, and occurred only as mild reactions such as nausea, dizziness, drowsiness, tiredness, and abdominal discomfort (4 due to amitriptyline, 5 due to citalopram, 1 due to gabapentin, and 1 due to placebo). These 11 participants withdrew from the study due to these mild side effects. There were no serious side effects. We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low-quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. The available evidence in this review was of very low-quality due to a lack of data and small study sizes."
] |
cochrane-simplification-train-1593
|
cochrane-simplification-train-1593
|
Sixty-one studies (37,250 participants) compared oral sumatriptan with placebo or an active comparator. Most of the data were for the 50 mg and 100 mg doses. Sumatriptan surpassed placebo for all efficacy outcomes. For sumatriptan 50 mg versus placebo the NNTs were 6.1, 7.5, and 4.0 for pain-free at two hours and headache relief at one and two hours, respectively. NNTs for sustained pain-free and sustained headache relief during the 24 hours postdose were 9.5 and 6.0, respectively. For sumatriptan 100 mg versus placebo the NNTs were 4.7, 6.8, 3.5, 6.5, and 5.2, respectively, for the same outcomes. Results for the 25 mg dose were similar to the 50 mg dose, while sumatriptan 100 mg was significantly better than 50 mg for pain-free and headache relief at two hours, and for sustained pain-free during 24 hours. Treating early, during the mild pain phase, gave significantly better NNTs for pain-free at two hours and sustained pain-free during 24 hours than did treating established attacks with moderate or severe pain intensity. Relief of associated symptoms, including nausea, photophobia, and phonophobia, was greater with sumatriptan than with placebo, and use of rescue medication was lower with sumatriptan than with placebo. For the most part, adverse events were transient and mild and were more common with the sumatriptan than with placebo, with a clear dose response relationship (25 mg to 100 mg). Sumatriptan was compared directly with a number of active treatments, including other triptans, paracetamol (acetaminophen), acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), and ergotamine combinations. Oral sumatriptan is effective as an abortive treatment for migraine attacks, relieving pain, nausea, photophobia, phonophobia, and functional disability, but is associated with increased adverse events.
|
This review found that a single dose was effective in relieving migraine headache pain and associated symptoms of nausea, sensitivity to light, and sensitivity to sound. Pain was reduced from moderate or severe to no pain by two hours in about 3 in 10 people (32%) taking sumatriptan 100 mg, compared with about 1 in 10 (11%) taking placebo. Pain was reduced from moderate or severe to no worse than mild pain by two hours in 6 in 10 people (61%) taking sumatriptan 100 mg, compared with about 3 in 10 (32%) taking placebo. Almost a quarter (24%) of people taking sumatriptan 100 mg had freedom from pain at two hours which was sustained during 24 hours without the use of rescue medication, compared with fewer than 1 in 10 (8%) taking placebo. In addition to relieving headache pain, sumatriptan also relieved symptoms of nausea and sensitivity to light and sound by two hours in about half of those who took it, compared with about one-third of those taking placebo. Adverse events were mostly of short duration and mild or moderate in severity, and were experienced by about 4 in 10 (43%) of people taking sumatriptan 100 mg, and by 2 in 10 (23%) taking placebo. The 50 mg dose had slightly lower efficacy, but was associated with fewer adverse events. Treating attacks while pain was still mild was more effective than treating established attacks with moderate or severe pain intensity.
|
10.1002/14651858.CD008615.pub2
|
[
"This review found that a single dose was effective in relieving migraine headache pain and associated symptoms of nausea, sensitivity to light, and sensitivity to sound. Pain was reduced from moderate or severe to no pain by two hours in about 3 in 10 people (32%) taking sumatriptan 100 mg, compared with about 1 in 10 (11%) taking placebo. Pain was reduced from moderate or severe to no worse than mild pain by two hours in 6 in 10 people (61%) taking sumatriptan 100 mg, compared with about 3 in 10 (32%) taking placebo. Almost a quarter (24%) of people taking sumatriptan 100 mg had freedom from pain at two hours which was sustained during 24 hours without the use of rescue medication, compared with fewer than 1 in 10 (8%) taking placebo. In addition to relieving headache pain, sumatriptan also relieved symptoms of nausea and sensitivity to light and sound by two hours in about half of those who took it, compared with about one-third of those taking placebo. Adverse events were mostly of short duration and mild or moderate in severity, and were experienced by about 4 in 10 (43%) of people taking sumatriptan 100 mg, and by 2 in 10 (23%) taking placebo. The 50 mg dose had slightly lower efficacy, but was associated with fewer adverse events. Treating attacks while pain was still mild was more effective than treating established attacks with moderate or severe pain intensity."
] |
cochrane-simplification-train-1594
|
cochrane-simplification-train-1594
|
We identified two eligible studies: one of CPAP and one of CNEP (published as an abstract). Both were unblinded studies with mainly unclear risk of bias due to lack of adequate information to assess this. The CPAP study enrolled 37 children to oxygen mask and CPAP and reported improvement in respiratory rate and oxygen saturation in both arms after 30 minutes of application. The CNEP study was published as an abstract and included 33 infants with bronchiolitis. In the CNEP study there was a reduction in the fraction of inspired oxygen (FiO2) (less than 30% within one hour of initiation of therapy) in four participants in the CNEP group compared to none in the control group (RR 10.7, 95% CI 0.6 to 183.9). One infant required CPAP and mechanical ventilation in the control group while all infants in the CNEP group were managed without intubation (RR for both outcomes 0.40, 95% CI 0.02 to 9.06). None of the trials reported on mortality. No adverse events were reported in ether of the included trials. There is a lack of well-designed, controlled trials of non-invasive modes of respiratory support in children with AHRF. Studies assessing the outcomes mortality, avoidance of intubation and its associated complications, hospital stay and patient comfort are needed.
|
We included two studies in the review: one study of CNEP included 33 participants younger than one year old who had bronchiolitis and one study of CPAP included 37 participants who had dengue fever related illness. Both studies reported short-term improvements but no reports of clinically significant outcomes are available. With a small number of patients in both studies, the safety of either approach could not be evaluated. Both studies have methodological issues and were under-powered (had too few patients to detect a significant difference). No adverse events were reported in ether of the included trials. Well-designed, multicentre, controlled studies with adequate numbers of infants and which assess clinically important outcomes are needed, as we cannot comment on the safety of the intervention as it was not evaluated in the current studies. The major limitation of this review is that it has a very limited number of studies which include a very small sample of children.
|
10.1002/14651858.CD003699.pub4
|
[
"We included two studies in the review: one study of CNEP included 33 participants younger than one year old who had bronchiolitis and one study of CPAP included 37 participants who had dengue fever related illness. Both studies reported short-term improvements but no reports of clinically significant outcomes are available. With a small number of patients in both studies, the safety of either approach could not be evaluated. Both studies have methodological issues and were under-powered (had too few patients to detect a significant difference). No adverse events were reported in ether of the included trials. Well-designed, multicentre, controlled studies with adequate numbers of infants and which assess clinically important outcomes are needed, as we cannot comment on the safety of the intervention as it was not evaluated in the current studies. The major limitation of this review is that it has a very limited number of studies which include a very small sample of children."
] |
cochrane-simplification-train-1595
|
cochrane-simplification-train-1595
|
Thirteen relevant trials with 1770 participants were included. All of them were of low quality. Fifty-two studies still need to be assessed because the original authors could not be interviewed. None of these trials analysed mortality, health related quality of life, economic outcomes or compliance. Compared to antithyroid drugs alone the results showed that Chinese herbal medicines combined with antithyroid drugs may offer benefits in lowering relapse rates, reducing the incidence of adverse effects, relieving symptoms, improving thyroid antibody status and thyroid function. Two trials investigated Chinese herbal medicine versus radioiodine and reported improvements in anxiety, tachycardia and heat intolerance. However, thyroid function - with the exception of restored thyroid stimulating hormone (TSH) - was not significantly altered. The results suggest that traditional Chinese herbal medicines added to other routine treatment have a therapeutic potential for people with hyperthyroidism. However, due to methodological limitations, we could not identify a well-designed trial to provide strong evidence for Chinese traditional herbal medicine in the treatment of hyperthyroidism. Thus, we currently cannot recommend any single preparation or formulation for clinical use.
|
Thirteen relevant trials with 1770 participants were analysed. All of them were of low quality. None of these trials analysed mortality, health related quality of life, economic outcomes or compliance with treatments. Some of these herbs may show benefits in improving symptoms, thyroid function and adverse effects. Unfortunately, we were unable to find reliable evidence to recommend a specific herbal preparation from 103 investigated formulations.
|
10.1002/14651858.CD005450.pub2
|
[
"Thirteen relevant trials with 1770 participants were analysed. All of them were of low quality. None of these trials analysed mortality, health related quality of life, economic outcomes or compliance with treatments. Some of these herbs may show benefits in improving symptoms, thyroid function and adverse effects. Unfortunately, we were unable to find reliable evidence to recommend a specific herbal preparation from 103 investigated formulations."
] |
cochrane-simplification-train-1596
|
cochrane-simplification-train-1596
|
Thirty-eight studies, involving some 12,400 participants, were included. The majority were descriptive studies, or randomisation processes did not relate to the data extracted, and most studies were judged to be at high risk of bias. Studies consistently show that oral substitution treatment for opioid-dependent injecting drug users with methadone or buprenorphine is associated with statistically significant reductions in illicit opioid use, injecting use and sharing of injecting equipment. It is also associated with reductions in the proportion of injecting drug users reporting multiple sex partners or exchanges of sex for drugs or money, but has little effect on condom use. It appears that the reductions in risk behaviours related to drug use do translate into reductions in cases of HIV infection. However, because of the high risk of bias and variability in several aspects of the studies, combined totals were not calculated. Oral substitution treatment for injecting opioid users reduces drug-related behaviours with a high risk of HIV transmission, but has less effect on sex-related risk behaviours. The lack of data from randomised controlled studies limits the strength of the evidence presented in this review.
|
This review looks at original studies that reported the frequency or prevalence of risk behaviours, or information on HIV infection related to substitution treatment of opioid dependence to assess the extent to which oral substitution treatment prevents the transmission of HIV infection. It was not possible to accurately estimate the extent of reduction, but it is clear that oral substitution treatment reduces risk behaviours and also the probability of HIV infection amongst injecting drug users in substitution treatment.
|
10.1002/14651858.CD004145.pub4
|
[
"This review looks at original studies that reported the frequency or prevalence of risk behaviours, or information on HIV infection related to substitution treatment of opioid dependence to assess the extent to which oral substitution treatment prevents the transmission of HIV infection. It was not possible to accurately estimate the extent of reduction, but it is clear that oral substitution treatment reduces risk behaviours and also the probability of HIV infection amongst injecting drug users in substitution treatment."
] |
cochrane-simplification-train-1597
|
cochrane-simplification-train-1597
|
Of 1041 publications obtained from the search strategy, we examined nine studies. Four studies were excluded, and five studies with 211 participants were eligible for inclusion. There was no difference in the immediate success rate of IAL when compared with IVAS in the closed manual reduction of acute anterior shoulder dislocation (RR 0.95; 95% CI 0.83 to 1.10). There were significantly fewer adverse effects associated with IAL compared with IVAS (RR 0.16; 95% CI 0.06 to 0.43). The mean time spent in the emergency department was significantly less with IAL compared with IVAS (MD 109.46 minutes; 95% CI 84.60 to 134.32). One trial reported significantly less time for reduction with IVAS (105 seconds; 95% CI 84.0 to 126.1) compared with IAL (284.6 seconds; 95% CI 185.3 to 383.9). One trial reported no joint infection associated with intra-articular lignocaine injection and no mortality associated with either IAL or IVAS. We observed no significant difference between IAL and IVAS with regard to the immediate success rate of reduction, pain during reduction, post-reduction pain relief and reduction failure. Compared to IVAS, IAL may be less expensive and may be associated with fewer adverse effects and a shorter recovery time.
|
The review authors searched the medical literature and identified five studies comparing these two methods. The studies included 211 patients with acute anterior shoulder dislocation; 113 patients underwent intra-articular lignocaine injection and 98 underwent intravenous analgesia with sedation. The review found that there may be no difference in the immediate success of manual reduction of the dislocated shoulder between patients receiving intra-articular lignocaine injection and those who received intravenous analgesia and sedation. However, intra-articular lignocaine injection may be associated with fewer side effects and a shorter stay in the emergency department before discharge from hospital. Compared with intravenous analgesia and sedation, intra-articular lignocaine may also be cheaper. However, the relatively small number of studies included in the review and the relatively small number of patients in each study means that the results of the review preclude definitive conclusions regarding the superiority of either method..
|
10.1002/14651858.CD004919.pub2
|
[
"The review authors searched the medical literature and identified five studies comparing these two methods. The studies included 211 patients with acute anterior shoulder dislocation; 113 patients underwent intra-articular lignocaine injection and 98 underwent intravenous analgesia with sedation. The review found that there may be no difference in the immediate success of manual reduction of the dislocated shoulder between patients receiving intra-articular lignocaine injection and those who received intravenous analgesia and sedation. However, intra-articular lignocaine injection may be associated with fewer side effects and a shorter stay in the emergency department before discharge from hospital. Compared with intravenous analgesia and sedation, intra-articular lignocaine may also be cheaper. However, the relatively small number of studies included in the review and the relatively small number of patients in each study means that the results of the review preclude definitive conclusions regarding the superiority of either method.."
] |
cochrane-simplification-train-1598
|
cochrane-simplification-train-1598
|
Seven trials, totaling 542 participants, met the eligibility criteria. Studies varied widely on risk of bias, interventions used and outcome measures reported. From these studies, there was no evidence to suggest that psychosocial intervention promotes global quality of life for patients with head and neck cancer at end of intervention (MD 1.23, 95% CI -5.82 to 8.27) as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This quality of life tool includes five functional scales, namely cognitive, physical, emotional, social and role. There was no evidence to demonstrate that psychosocial intervention provides an immediate or medium-term improvement on any of these five functional scales. From the data available, there was no significant change in levels of anxiety (SMD -0.09, 95% CI -0.40 to 0.23) or depression following intervention (SMD -0.03, 95% CI -0.24 to 0.19). At present, there is insufficient evidence to refute or support the effectiveness of psychosocial intervention for patients with head and neck cancer. The evidence for psychosocial intervention is limited by the small number of studies, methodological shortcomings such as lack of power, difficulties with comparability between types of interventions and a wide divergence in outcome measures used. Future research should be targeted at patients who screen positive for distress and use validated outcome measures, such as the EORTC scale, as a measure of quality of life. These studies should implement interventions that are theoretically derived. Other shortcomings should be addressed in future studies, including using power calculations that may encourage multi-centred collaboration to ensure adequate sample sizes are recruited.
|
We identified seven studies, with a total of 542 adult patients who had head and neck cancer. However, many of the studies had shortcomings in their design or reporting. This has made it difficult to draw reliable conclusions. Overall, this review did not find any improvement in general quality of life or in levels of anxiety and depression following psychosocial intervention. In conclusion, there was limited good-quality evidence in this area, making it difficult to draw conclusions about the effectiveness of psychosocial interventions. Future good-quality research is required in this field and should target those in need of psychosocial intervention, in order to guide service development.
|
10.1002/14651858.CD009441.pub2
|
[
"We identified seven studies, with a total of 542 adult patients who had head and neck cancer. However, many of the studies had shortcomings in their design or reporting. This has made it difficult to draw reliable conclusions. Overall, this review did not find any improvement in general quality of life or in levels of anxiety and depression following psychosocial intervention. In conclusion, there was limited good-quality evidence in this area, making it difficult to draw conclusions about the effectiveness of psychosocial interventions. Future good-quality research is required in this field and should target those in need of psychosocial intervention, in order to guide service development."
] |
cochrane-simplification-train-1599
|
cochrane-simplification-train-1599
|
No studies were included in this review. Although it is generally recognised that CFA may be episodic and resolve spontaneously, treatment with analgesics and anti-inflammatory agents may be needed. While this approach may be sufficient to manage symptoms, it is disappointing that no randomised controlled trials to rigorously evaluate these agents were found, nor could the authors identify any quasi-randomised. This systematic review has identified the need for a well-designed adequately-powered randomised controlled trial to assess the efficacy and safety of pharmacological agents for the symptomatic management of cystic fibrosis-related arthritis (CFA and HPO) in adults and children with cystic fibrosis. Studies should also better define the two conditions. A study has recently been conducted in CFA and may help fill this gap when analysed and published. There are no trials included in the review up to January 2016. We will continue to run searches to identify any potentially relevant studies; however, we do not plan to update other sections of the review until new studies are published.
|
We planned to report evidence from clinical studies to evaluate the effectiveness and safety of different anti-inflammatory analgesic drugs compared with placebo, with each other or with no treatment. However, we were disappointed that we could not find any completed randomised controlled studies of these treatments or any evidence from non-randomised controlled studies. One study in cystic fibrosis-related arthropathy has finished and may provide some evidence when published. We suggest that there should be a randomised controlled study to look at the effects and the safety of using anti-inflammatory drugs or painkillers or both to manage the symptoms of cystic fibrosis-related arthritis. This is an update of a previously published review (date of last search 19 January 2016). Since no studies have been included in the review up until January 2016, we will still search for studies every two years, but will not publish an updated version of this review until we can include any new studies.
|
10.1002/14651858.CD006838.pub4
|
[
"We planned to report evidence from clinical studies to evaluate the effectiveness and safety of different anti-inflammatory analgesic drugs compared with placebo, with each other or with no treatment. However, we were disappointed that we could not find any completed randomised controlled studies of these treatments or any evidence from non-randomised controlled studies. One study in cystic fibrosis-related arthropathy has finished and may provide some evidence when published. We suggest that there should be a randomised controlled study to look at the effects and the safety of using anti-inflammatory drugs or painkillers or both to manage the symptoms of cystic fibrosis-related arthritis. This is an update of a previously published review (date of last search 19 January 2016). Since no studies have been included in the review up until January 2016, we will still search for studies every two years, but will not publish an updated version of this review until we can include any new studies."
] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.