Showing papers in "Cochrane Database of Systematic Reviews in 2008"

Interventions for enhancing medication adherence.

Abstract: Background People who are prescribed self-administered medications typically take less than half the prescribed doses. Efforts to assist patients with adherence to medications might improve the benefits of prescribed medications, but also might increase their adverse effects. Objectives To update a review summarizing the results of randomized controlled trials (RCTs) of interventions to help patients follow prescriptions for medications for medical problems, including mental disorders but not addictions. Search methods We updated searches of The Cochrane Library, MEDLINE, CINAHL, EMBASE, International Pharmaceutical Abstracts (IPA), PsycINFO (all via OVID) and Sociological Abstracts (via CSA) in January 2007 with no language restriction. We also reviewed bibliographies in articles on patient adherence and articles in our personal collections, and contacted authors of relevant original and review articles. Selection criteria Articles were selected if they reported an unconfounded RCT of an intervention to improve adherence with prescribed medications, measuring both medication adherence and treatment outcome, with at least 80% follow-up of each group studied and, for long-term treatments, at least six months follow-up for studies with positive initial findings. Data collection and analysis Study design features, interventions and controls, and results were extracted by one review author and confirmed by at least one other review author. We extracted adherence rates and their measures of variance for all methods of measuring adherence in each study, and all outcome rates and their measures of variance for each study group, as well as levels of statistical significance for differences between study groups, consulting authors and verifying or correcting analyses as needed. The studies differed widely according to medical condition, patient population, intervention, measures of adherence, and clinical outcomes. Therefore, we did not feel that quantitative analysis was scientifically justified; rather, we conducted a qualitative analysis. Main results For short-term treatments, four of ten interventions reported in nine RCTs showed an effect on both adherence and at least one clinical outcome, while one intervention reported in one RCT significantly improved patient adherence, but did not enhance the clinical outcome. For long-term treatments, 36 of 83 interventions reported in 70 RCTs were associated with improvements in adherence, but only 25 interventions led to improvement in at least one treatment outcome. Almost all of the interventions that were effective for long-term care were complex, including combinations of more convenient care, information, reminders, self-monitoring, reinforcement, counseling, family therapy, psychological therapy, crisis intervention, manual telephone follow-up, and supportive care. Even the most effective interventions did not lead to large improvements in adherence and treatment outcomes. Authors' conclusions For short-term treatments several quite simple interventions increased adherence and improved patient outcomes, but the effects were inconsistent from study to study with less than half of studies showing benefits. Current methods of improving adherence for chronic health problems are mostly complex and not very effective, so that the full benefits of treatment cannot be realized. High priority should be given to fundamental and applied research concerning innovations to assist patients to follow medication prescriptions for long-term medical disorders.

Physical activity and enhanced fitness to improve cognitive function in older people without known cognitive impairment

Abstract: Physical activity is beneficial for healthy ageing. It may also help maintain good cognitive function in older age. Aerobic activity improves cardiovascular fitness, but it is not known whether this sort of fitness is necessary for improved cognitive function. Eleven studies of aerobic physical activity programmes for healthy people over the age of 55 years have been included in this review. Eight of these 11 studies reported that aerobic exercise interventions resulted in increased fitness of the trained group and an improvement in at least one aspect of cognitive function. The largest effects were on cognitive speed, auditory and visual attention. However, the cognitive functions which improved were not the same in each study and the majority of comparisons yielded no significant results. The data are insufficient to show that the improvements in cognitive function which can be attributed to physical exercise are due to improvements in cardiovascular fitness.

Helmets for preventing injury in motorcycle riders.

Abstract: Background: Motorcycle crash victims form a high proportion of those killed or injured in road traffic accidents. Injuries to the head, following motorcycle crashes, are a common cause of severe morbidity and mortality. It seems intuitive that helmets should protect against head injuries but it has been argued that motorcycle helmet use decreases rider vision and increases neck injuries. This review will collate the 'current available evidence on helmets and their impact on mortality, and head, face and neck injuries following motorcycle crashes. Objectives: To quantify the effectiveness of wearing a motorcycle helmet in reducing mortality and head and neck injury following motorcycle crashes. Search strategy: Databases including the Cochrane Injuries Group Specialised Register, Cochrane Central Register of Controlled Trials (The Cochrane Library issue 1,2003), MEDLINE (January 1966 to February 2003), EMBASE (January 1985 to February 2003), CINAHL (January 1982 to February 2003), IRRD (International Road Research Documentation), TRANSDOC, TRIS (Transport Research Information Service), ATRI (Australian Transport Index) (1976 to Feb 2003), Science Citation Index were searched for relevant articles. Web sites of traffic and road accident research bodies including government agencies were also searched. Reference lists from topic reviews, identified studies and bibliographies were examined for relevant articles. Selection criteria: We considered for inclusion studies that investigated a population of motorcycle riders who had crashed, examining helmet use as an intervention and with outcomes that included one or more of the following: death, head, neck or facial injury. Studies included any that compared an intervention and control group and, therefore, included any randomised controlled trials, non-randomised controlled trials, cohort, case-control and cross-sectional studies. Ecological and case series studies were excluded. Data collection and analysis: Two reviewers independently screened reference lists for eligible articles. Two reviewers independently assessed articles for inclusion criteria. Data were abstracted by two independent reviewers using a standard abstraction form. Main results: Fifty-three observational studies were identified of varying quality. Despite methodological differences there was a remarkable consistency in results, particularly for mortality and head injury outcomes. Motorcycle helmets appear to reduce the risk of mortality although, due to heterogeneity in study design, an overall estimate of effect was not calculated. There was some evidence that the effect of helmets on mortality is modified by speed. Motorcycle helmets were found to reduce the risk of head injury and from five well-conducted studies the risk reduction is estimated to be 72% (OR 0.28, 95%CI 0.23,0.35). Insufficient evidence was found to estimate the effect of motorcycle helmets compared with no helmet on facial or neck injuries. However, studies of poorer quality suggest that helmets have no effect on the risk of neck injuries and are protective for facial injury. There was insufficient evidence to demonstrate whether differences in helmet type confer more or less advantage in injury reduction. Conclusions: Motorcycle helmets reduce the risk of mortality and head injury in motorcycle riders who crash, although the former effect may be modified by other crash factors such as speed. Further well-conducted research is required to determine the effects of helmets and different helmet types on mortalIty, head, neck and facial injuries. However, the findings suggest that global efforts to reduce road traffic injuries may be facilitated by increasing helmet use by motorcyclists.

Midwife-led versus other models of care for childbearing women

Abstract: Background: Midwives are primary providers of care for childbearing women around the world. However, there is a lack of synthesised information to establish whether there are differences in morbidity and mortality, effectiveness and psychosocial outcomes between midwife-led and other models of care. Objectives: To compare midwife-led models of care with other models of care for childbearing women and their infants. Search strategy: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2008), Cochrane Effective Practice and Organisation of Care Group's Trials Register (January 2008), Current Contents (1994 to January 2008), CINAHL (1982 to August 2006), Web of Science, BIOSIS Previews, ISI Proceedings, (1990 to 2008), and the WHO Reproductive Health Library, No. 9. Selection criteria: All published and unpublished trials in which pregnant women are randomly allocated to midwife-led or other models of care during pregnancy, and where care is provided during the ante-and intrapartum period in the midwife-led model. Data collection and analysis: All authors evaluated methodological quality. Two authors independently checked the data extraction. Main results: We included 11trials (12,276 women). Women who had midwife-led models of care were less likely to experience antenatal hospitalisation, risk ratio (RR) 0.90, 95% confidence interval (CI) 0.81 to 0.99), the use of regional analgesia (RR 0.81, 95% CI 0.73 to 0.91), episiotomy (RR 0.82, 95% CI 0.77 to 0.88), and instrumental delivery (RR 0.86, 95% CI 0.78 to 0.96) and were more likely to experience no intrapartum analgesia/ anaesthesia (RR 1.16, 95% CI 1.05 to 1.29), spontaneous vaginal birth (RR 1.04, 95% CI 1.02 to 1.06), to feel in control during labour and childbirth (RR 1.74, 95% CI .32 to 2.30), attendance at birth by a known midwife (RR 7.84, 95% CI 4.15 to 14.81) and initiate breastfeeding (RR 1.35, 95% CI 1.03 to 1.76). In addition, women who were randomised to receive midwife-led care were less likely to experience fetal loss before 24 weeks' gestation (RR 0.79, 95% CI 0.65 to 0.97), and their babies were more likely to have a shorter length of hospital stay (mean difference -2.00, 95% CI -2.15 to -1.85). There were no statistically significant differences between groups for overall fetal loss/neonatal death (RR 0.83, 95% CI 0.70 to 1.00), or fetal loss/neonatal death of at least 24 weeks (RR 1.01, 95% CI 0.67 to 1.53). Authors' conclusions: All women should be offered midwife-led models of care and women should be encouraged to ask for this option.

Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women

Abstract: Background Osteoporosis is an abnormal reduction in bone mass and bone deterioration leading to increased fracture risk. Alendronate belongs to the bisphosphonate class of drugs, which act to inhibit bone resorption by interfering with the activity of osteoclasts. Objectives To assess the efficacy of alendronate in the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Search methods We searched CENTRAL, MEDLINE and EMBASE for relevant randomized controlled trials published between 1966 to 2007. Selection criteria Women receiving at least one year of alendronate, for postmenopausal osteoporosis, were compared to those receiving placebo and/or concurrent calcium/vitamin D. The outcome was fracture incidence. Data collection and analysis We undertook study selection and data abstraction in duplicate. We performed meta-analysis of fracture outcomes using relative risks and a > 15% relative change was considered clinically important. We assessed study quality through reporting of allocation concealment, blinding and withdrawals. Main results Eleven trials representing 12,068 women were included in the review. Relative (RRR) and absolute (ARR) risk reductions for the 10 mg dose were as follows. For vertebral fractures, a significant 45% RRR was found (RR 0.55, 95% CI 0.45 to 0.67). This was significant for both primary prevention, with 45% RRR (RR 0.55, 95% CI 0.38 to 0.80) and 2% ARR, and secondary prevention with 45% RRR (RR 0.55, 95% CI 0.43 to 0.69) and 6% ARR. For non-vertebral fractures, a significant 16% RRR was found (RR 0.84, 95% CI 0.74 to 0.94). This was significant for secondary prevention, with 23% RRR (RR 0.77, 95% CI 0.64 to 0.92) and 2% ARR, but not for primary prevention (RR 0.89, 95% CI 0.76 to 1.04). There was a significant 40% RRR in hip fractures (RR 0.60, 95% CI 0.40 to 0.92), but only secondary prevention was significant with 53% RRR (RR 0.47, 95% CI 0.26 to 0.85) and 1% ARR. The only significance found for wrist was in secondary prevention, with a 50% RRR (RR 0.50 95% CI 0.34 to 0.73) and 2% ARR. For adverse events, we found no statistically significant differences in any included study. However, observational data raise concerns regarding potential risk for upper gastrointestinal injury and, less commonly, osteonecrosis of the jaw. Authors' conclusions At 10 mg per day, both clinically important and statistically significant reductions in vertebral, non-vertebral, hip and wrist fractures were observed for secondary prevention ('gold' level evidence, www.cochranemsk.org). We found no statistically significant results for primary prevention, with the exception of vertebral fractures, for which the reduction was clinically important ('gold' level evidence).

Long-term results of laparoscopic colorectal cancer resection.

Abstract: Background Although minimally invasive surgery has been accepted for a variety of disorders, laparoscopic resection of colorectal cancer is performed by few. Concern about oncological radicality and long term outcome has limited the adoption of laparoscopic surgery for colorectal cancer. Objectives To determine long-term outcome after laparoscopically-assisted versus open surgery for non-metastasised colorectal cancer. Search methods The Cochrane library, EMBASE, Pub med and Cancer Lit were searched for published and unpublished randomised controlled trials. Selection criteria Randomised clinical trials comparing laparoscopically-assisted and open surgery for non-metastasised colorectal cancer were included. Studies that did not report any long-term outcomes were excluded. Data collection and analysis Two reviewers independently assessed the studies and extracted data. RevMan 4.2 was used for statistical analysis. Main results Thirty-three randomised clinical trials (RCT) comparing laparoscopically-assisted versus open surgery for colorectal cancer were identified. Twelve of these trials, involving 3346 patients, reported long-term outcome and were included in the current analysis. No significant differences in the occurrence of incisional hernia, reoperations for incisional hernia or reoperations for adhesions were found between laparoscopically assisted and open surgery (2 RCT, 474 pts, 7.9% vs 10.9%;P = 0.32 and 2 RCT, 474 pts, 4.0% vs 2.8%; P = 0.42 and 1 RCT, 391 pts, 1.1% vs 2.5%;P = 0.30, respectively). Rates of recurrence at the site of the primary tumor were similar (colon cancer: 4 RCT, 938 pts, 5.2% vs 5.6%; OR (fixed) 0.84 (95% CI 0.47 to 1.52)(P = 0.57); rectal cancer: 4 RCT, 714 pts, 7.2% vs 7.7%; OR (fixed) 0.81 (95% CI 0.45 to 1.43) (P = 0.46). No differences in the occurrence of port-site/wound recurrences were observed (P=0.16). Similar cancer-related mortality was found after laparoscopic surgery compared to open surgery ( colon cancer: 5 RCT, 1575 pts, 14.6% vs 16.4%; OR (fixed) 0.80 (95% CI 0.61 to 1.06) (P=0.15); rectal cancer: 3 RCT, 578 pts, 9.2% vs 10.0%; OR (fixed) 0.66 (95% CI 0.37 to 1.19) (P=0.16). Four studies were included in the meta-analyses on hazard ratios for tumour recurrence in laparoscopic colorectal cancer surgery. No significant difference in recurrence rate was observed between laparoscopic and open surgery (hazard ratio for tumour recurrence in the laparoscopic group 0.92; 95% CI 0.76-1.13). No significant difference in tumour recurrence between laparoscopic and open surgery for colon cancer was observed (hazard ratio for tumour recurrence in the laparoscopic group 0.86; 95% CI 0.70-1.08). Authors' conclusions Laparoscopic resection of carcinoma of the colon is associated with a long term outcome no different from that of open colectomy. Further studies are required to determine whether the incidence of incisional hernias and adhesions is affected by method of approach. Laparoscopic surgery for cancer of the upper rectum is feasible, but more randomised trials need to be conducted to assess long term outcome.

Music therapy for depression

Abstract: Background Depression is a highly prevalent disorder associated with reduced social functioning, impaired quality of life, and increased mortality. Music therapy has been used in the treatment of a variety of mental disorders, but its impact on those with depression is unclear. Objectives To examine the efficacy of music therapy with standard care compared to standard care alone among people with depression and to compare the effects of music therapy for people with depression against other psychological or pharmacological therapies. Search methods CCDANCTR-Studies and CCDANCTR-References were searched on 7/11/2007, MEDLINE, PsycINFO, EMBASE, PsycLit, PSYindex, and other relevant sites were searched in November 2006. Reference lists of retrieved articles were hand searched, as well as specialist music and arts therapies journals. Selection criteria All randomised controlled trials comparing music therapy with standard care or other interventions for depression. Data collection and analysis Data on participants, interventions and outcomes were extracted and entered onto a database independently by two review authors. The methodological quality of each study was also assessed independently by two review authors. The primary outcome was reduction in symptoms of depression, based on a continuous scale. Main results Five studies met the inclusion criteria of the review. Marked variations in the interventions offered and the populations studied meant that meta-analysis was not appropriate. Four of the five studies individually reported greater reduction in symptoms of depression among those randomised to music therapy than to those in standard care conditions. The fifth study, in which music therapy was used as an active control treatment, reported no significant change in mental state for music therapy compared with standard care. Dropout rates from music therapy conditions appeared to be low in all studies. Authors' conclusions Findings from individual randomised trials suggest that music therapy is accepted by people with depression and is associated with improvements in mood. However, the small number and low methodological quality of studies mean that it is not possible to be confident about its effectiveness. High quality trials evaluating the effects of music therapy on depression are required.

St John's wort for major depression

Abstract: Background In some countries extracts of the plant Hypericum perforatum L. (popularly called St. John's wort) are widely used for treating patients with depressive symptoms. Objectives To investigate whether extracts of hypericum are more effective than placebo and as effective as standard antidepressants in the treatment of major depression; and whether they have fewer adverse effects than standard antidepressant drugs. Search methods Trials were searched in computerised databases, by checking bibliographies of relevant articles, and by contacting manufacturers and researchers. Selection criteria Trials were included if they: (1) were randomised and double-blind; (2) included patients with major depression; (3) compared extracts of St. John's wort with placebo or standard antidepressants; (4) included clinical outcomes assessing depressive symptoms. Data collection and analysis At least two independent reviewers extracted information from study reports. The main outcome measure for assessing effectiveness was the responder rate ratio (the relative risk of having a response to treatment). The main outcome measure for adverse effects was the number of patients dropping out due to adverse effects. Main results A total of 29 trials (5489 patients) including 18 comparisons with placebo and 17 comparisons with synthetic standard antidepressants met the inclusion criteria. Results of placebo-controlled trials showed marked heterogeneity. In nine larger trials the combined response rate ratio (RR) for hypericum extracts compared with placebo was 1.28 (95% confidence interval (CI), 1.10 to 1.49) and from nine smaller trials was 1.87 (95% CI, 1.22 to 2.87). Results of trials comparing hypericum extracts and standard antidepressants were statistically homogeneous. Compared with tri- or tetracyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs), respectively, RRs were 1.02 (95% CI, 0.90 to 1.15; 5 trials) and 1.00 (95% CI, 0.90 to 1.11; 12 trials). Both in placebo-controlled trials and in comparisons with standard antidepressants, trials from German-speaking countries reported findings more favourable to hypericum. Patients given hypericum extracts dropped out of trials due to adverse effects less frequently than those given older antidepressants (odds ratio (OR) 0.24; 95% CI, 0.13 to 0.46) or SSRIs (OR 0.53, 95% CI, 0.34-0.83). Authors' conclusions The available evidence suggests that the hypericum extracts tested in the included trials a) are superior to placebo in patients with major depression; b) are similarly effective as standard antidepressants; c) and have fewer side effects than standard antidepressants. The association of country of origin and precision with effects sizes complicates the interpretation.

Pit and fissure sealants for preventing dental decay in the permanent teeth of children and adolescents.

Abstract: BACKGROUND: Fissure sealants used on occlusal tooth surfaces were introduced in the 1960s for protecting pits and fissures from dental caries. Although sealants have demonstrated to be effective in preventing caries, their efficacy may be related to the background caries prevalence in the population. OBJECTIVES: The primary objective of this review was to evaluate the caries prevention of resin based pit and fissure sealants and glass ionomer cements or sealants in children and adolescents. SEARCH STRATEGY: We searched the Cochrane Oral Health Group's Trials Register (last update December 2002), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 4, 2002), MEDLINE via OVID (1966 to December 2002), EMBASE (1974 to February 2002), SCISEARCH, SIGLE, CAplus, INSPEC, JICST-EPLUS, NTIS, PASCAL (February 2002) and DARE, NHS EED, HTA (March 2002). Reference lists from included articles and review articles were searched for additional relevant articles. All relevant studies in most languages were considered and translated. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials of at least 12 months in duration in which sealants were used for preventing caries in children and adolescents under 20 years of age were included. The primary outcome was the increment in the numbers of carious occlusal surfaces of premolars and molars. DATA COLLECTION AND ANALYSIS: In the first phase, two reviewers independently examined whether a given study was likely to be relevant on the basis of the title, key words and abstract. In the second phase, four of the reviewers independently classified studies to be included in final analyses. Study authors were contacted for additional information. In the split-mouth studies relative risk ratios were calculated for the paired differences of tooth surfaces being carious or not. In studies comparing resin based sealant with no treatment, fixed effect meta-analyses were used to combine the estimates of relative risk ratios. In one parallel group study, the mean DFS data as continuous data, the effect estimate being the difference in mean DFS, was calculated from data of occlusal surfaces of teeth included in the test and control groups. MAIN RESULTS: Eight trials were included in this review of which seven trials were split-mouth studies and one a parallel group study. Six studies provided data for comparing sealant with no treatment and three studies for comparing glass ionomers with resin based sealants. The overall effectiveness of resin based sealants in preventing dental decay on first molars was high. Based on five split-mouth studies with 5 to 10 year old children there were significant differences in favour of the second-generation resin sealant compared with no treatment with pooled relative risk values of 0.14, 0.24, 0.30, 0.43 at 12, 24, 36 and 48 to 54 months respectively. The reductions in caries therefore ranged from 86% at 12 months to 57% at 48 to 54 months. The 24 month parallel group study comparing second-generation resin sealant with control in 12 to 13 year old children found also significantly more caries in the control group children with DFS = 0.65 (95% CI 0.47 to 0.83). Allocation concealment was classified adequate in three of these six studies. However the information on background levels of caries in the population was insufficient to conduct further analyses to estimate the effectiveness of resin based sealants related to baseline caries prevalence.Only one study provided data for the comparison between glass ionomer sealant and control. Based on this, there is not enough information to say whether ionomer sealants are effective, or not. The results of three studies comparing resin sealants with glass ionomer sealants were conflicting and the meta-analyses were not carried out. REVIEWERS' CONCLUSIONS: Sealing with resin based sealants is a recommended procedure to prevent caries of the occlusal surfaces of permanent molars. However,

Cognitive behaviour therapy for chronic fatigue syndrome in adults

Abstract: Background Chronic fatigue syndrome (CFS) is a common, debilitating and serious health problem. Cognitive behaviour therapy (CBT) may help to alleviate the symptoms of CFS. Objectives To examine the effectiveness and acceptability of CBT for CFS, alone and in combination with other interventions, compared with usual care and other interventions. Search methods CCDANCTR-Studies and CCDANCTR-References were searched on 28/3/2008. We conducted supplementary searches of other bibliographic databases. We searched reference lists of retrieved articles and contacted trial authors and experts in the field for information on ongoing/completed trials. Selection criteria Randomised controlled trials involving adults with a primary diagnosis of CFS, assigned to a CBT condition compared with usual care or another intervention, alone or in combination. Data collection and analysis Data on patients, interventions and outcomes were extracted by two review authors independently, and risk of bias was assessed for each study. The primary outcome was reduction in fatigue severity, based on a continuous measure of symptom reduction, using the standardised mean difference (SMD), or a dichotomous measure of clinical response, using odds ratios (OR), with 95% confidence intervals (CI). Main results Fifteen studies (1043 CFS participants) were included in the review. When comparing CBT with usual care (six studies, 373 participants), the difference in fatigue mean scores at post-treatment was highly significant in favour of CBT (SMD -0.39, 95% CI -0.60 to -0.19), with 40% of CBT participants (four studies, 371 participants) showing clinical response in contrast with 26% in usual care (OR 0.47, 95% CI 0.29 to 0.76). Findings at follow-up were inconsistent. For CBT versus other psychological therapies, comprising relaxation, counselling and education/support (four studies, 313 participants), the difference in fatigue mean scores at post-treatment favoured CBT (SMD -0.43, 95% CI -0.65 to -0.20). Findings at follow-up were heterogeneous and inconsistent. Only two studies compared CBT against other interventions and one study compared CBT in combination with other interventions against usual care. Authors' conclusions CBT is effective in reducing the symptoms of fatigue at post-treatment compared with usual care, and may be more effective in reducing fatigue symptoms compared with other psychological therapies. The evidence base at follow-up is limited to a small group of studies with inconsistent findings. There is a lack of evidence on the comparative effectiveness of CBT alone or in combination with other treatments, and further studies are required to inform the development of effective treatment programmes for people with CFS.

Exercise or exercise and diet for preventing type 2 diabetes mellitus

Abstract: The incidence of type 2 diabetes is associated with the 'Westernised lifestyle', mainly in terms of dietary habits and physical activity. Thus an intensive diet and exercise intervention might prevent or delay the appearance of diabetes in persons at high risk. The objective of this review is to assess the effects of exercise or exercise and diet for preventing type 2 diabetes mellitus.

Interventions to improve outpatient referrals from primary care to secondary care.

Abstract: Background The primary care specialist interface is a key organisational feature of many health care systems. Patients are referred to specialist care when investigation or therapeutic options are exhausted in primary care and more specialised care is needed. Referral has considerable implications for patients, the health care system and health care costs. There is considerable evidence that the referral processes can be improved.

Excisional surgery versus ablative surgery for ovarian endometriomata.

Abstract: Background Endometriomata are endometriotic deposits within the ovary The surgical management of these blood filled cysts is controversial The laparoscopic approach to the management of endometriomata is favoured over a laparotomy approach as it offers the advantage of a shorter hospital stay, faster patient recovery and decreased hospital costs Currently the commonest procedures for the treatment of ovarian endometriomata are either excision of the cyst capsule or drainage and electrocoagulation of the cyst wall Objectives The objective of this review was to determine the most effective technique for treating an ovarian endometrioma, either excision of the cyst capsule or drainage and electrocoagulation of the cyst wall, measuring the outcomes improvement in pain symptoms and fertility The primary endpoints assessed were the relief of pain and, in women desiring to conceive, the subsequent pregnancy rate (either spontaneous or as part of fertility treatment) Secondary outcomes assessed were the recurrence of the endometrioma and the recurrence of symptoms Search methods The review authors searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of trials (to 31st August 2009), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, Issue 3), MEDLINE (1966 to August 2009), EMBASE (1980 to August 2009) and reference lists of articles; and handsearched relevant journals and conference proceedings and contacted leaders in the field of endoscopic surgery throughout the worldThe Cochrane Menstrual Disorders and Subfertility Group Specialised Register is based on regular searches of MEDLINE, EMBASE, CINHAL and CENTRAL Selection criteria Randomised controlled trials of excision of the cyst capsule versus drainage and electrocoagulation of the cyst in the management of ovarian endometriomata Data collection and analysis Review authors assessed eligibility and trial quality Main results Two randomised studies of the laparoscopic management of ovarian endometriomata, size greater than 3 cm, for the primary symptom of pain were included For the primary outcome measures laparoscopic excision of the cyst wall of the endometrioma was associated with a reduced recurrence rate of the symptoms of dysmenorrhoea (painful periods) (odds ratio (OR) 015, 95% CI 006 to 038), dyspareunia (OR 008, 95% CI 001 to 051) and non-menstrual pelvic pain (OR 010, 95% CI 002 to 056) In those women subsequently attempting to conceive excision of the cyst wall was also associated with a subsequent increased spontaneous pregnancy rate in women who had documented prior subfertility (OR 521, 95% CI 204 to1329) compared to women who underwent laparoscopic ablation of the endometrioma For the secondary outcome measures laparoscopic excision of the cyst wall was associated with a reduced rate of recurrence of the endometrioma (OR 041, 95% CI 018 to 093) and with a reduced requirement for further surgery (OR 021, 95% CI 005 to 079) compared with surgery to ablate the endometrioma A further randomised study was identified that demonstrated an increased ovarian follicular response to gonadotrophin stimulation for women who had undergone excisional surgery when compared to ablative surgery (mean difference (MD) 06, 95% CI 004 to116) There is insufficient evidence to support excisional surgery over ablative surgery with respect to the chances of pregnancy after controlled ovarian stimulation and intra-uterine insemination (OR 140, 95% CI 047 to 415) Authors' conclusions There is good evidence that excisional surgery for endometriomata provides a more favourable outcome than drainage and ablation with regard to the recurrence of the endometrioma, recurrence of pain symptoms, and subsequent spontaneous pregnancy in women who were previously subfertile Consequently this approach should be the favoured surgical approach However in women who may subsequently undergo fertility treatment, insufficient evidence exists to determine the favoured surgical approach

Luteal phase support in assisted reproduction cycles

Abstract: Background The aspiration of the granulosa cells that surround the oocyte and the use of gonadotropin releasing hormone agonists (GnRHa) during assisted reproduction technology (ART) treatment can interfere with the production, during the luteal phase, of progesterone, which is necessary for successful implantation of the embryo. Providing hormonal supplementation during the luteal phase with either progesterone itself, or human chorionic gonadotropin (hCG), which stimulates progesterone production, may improve implantation and, thus, pregnancy rates. Objectives To determine (1) if luteal phase support after assisted reproduction increases the pregnancy rate, (2) the optimal hormone for luteal phase support, i.e. hCG, progesterone, or a combination of both, and (3) the optimal route of progesterone administration. Search strategy We searched the Cochrane Menstrual Disorders & Subfertility Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1971 to Dec 2003), EMBASE (1985 to Dec 2003). We handsearched reference lists of relevant articles were scanned, and abstract books from scientific meetings up to December 2003. Selection criteria Randomized controlled trials of luteal phase support after ART treatment, comparing hCG or progesterone with placebo or no treatment, comparing progesterone with hCG, progesterone plus hCG, or progesterone plus estrogen, or comparing different routes of progesterone administration. Quasi-randomized trials were excluded from the main analyses, but included in a secondary analysis for each comparison. Data collection and analysis For each comparison, data on live birth, ongoing and clinical pregnancy per embryo or gamete transfer procedure, miscarriage per clinical pregnancy, ovarian hyperstimulation syndrome (OHSS) per transfer, and multiple pregnancy per clinical pregnancy were extracted into 2 x 2 tables and subgrouped by use of GnRHa in the ovarian stimulation regimen. The odds ratio (OR) and risk difference (RD) were calculated. Main results Fifty-nine studies were included in the review. Luteal phase support with hCG provided significant benefit, compared to placebo or no treatment, in terms of increased ongoing pregnancy rates (odds ratio (OR) 2.38, 95% confidence interval (CI) 1.32 to 4.29) and decreased miscarriage rates (OR 0.12, 95% CI 0.03 to 0.50), but only when GnRHa was used. The odds of OHSS increased 20-fold when hCG was used in cycles with GnRHa. Progesterone use resulted in a small but significant increase in pregnancy rates (OR 1.34, 95% CI 1.01 to 1.79) when trials with and without GnRHa were grouped together, but no effect on the miscarriage rate was observed. No significant difference was found between progesterone and hCG or between progesterone and progesterone plus hCG or estrogen in terms of pregnancy or miscarriage rates, but the odds of OHSS were more than 2-fold higher with treatments involving hCG than with progesterone alone(OR 3.06, 95% CI 1.59 to 5.86). Comparing routes of progesterone administration, reductions in clinical pregnancy rate with the oral route, compared to the intramuscular or vaginal routes, did not reach statistical significance, but there was evidence of benefit of the intramuscular over the vaginal route for the outcomes of ongoing pregnancy and live birth. No significant difference in pregnancy rate was observed between vaginal progesterone gel and other types of vaginal progesterone. Reviewers' conclusions Luteal phase support with hCG or progesterone after assisted reproduction results in an increased pregnancy rate. hCG does not provide better results than progesterone, and is associated with a greater risk of OHSS when used with GnRHa. The optimal route of progesterone administration has not yet been established.

Non‐steroidal anti‐inflammatory drugs for low‐back pain

Abstract: Background Non-steroidal anti-inflammatory drugs (NSAIDs) are the most frequently prescribed medications worldwide and are widely used for patients with low-back pain. Selective COX-2 inhibitors are currently available and used for patients with low-back pain. Objectives The objective was to assess the effects of NSAIDs and COX-2 inhibitors in the treatment of non-specific low-back pain and to assess which type of NSAID is most effective. Search methods We searched the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Trials up to and including June 2007 if reported in English, Dutch or German. We also screened references given in relevant reviews and identified trials. Selection criteria Randomised trials and double-blind controlled trials of NSAIDs in non-specific low-back pain with or without sciatica were included. Data collection and analysis Two review authors independently extracted data and assessed methodological quality. All studies were also assessed on clinical relevance, from which no further interpretations or conclusions were drawn. If data were considered clinically homogeneous, a meta-analysis was performed. If data were lacking for clinically homogeneous trials, a qualitative analysis was performed using a rating system with four levels of evidence (strong, moderate, limited, no evidence). Main results 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. Authors' conclusions 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.

Behavioral interventions to reduce risk for sexual transmission of HIV among men who have sex with men.

Abstract: Background Men who have sex with men (MSM) remain at great risk for HIV infection. Program planners and policy makers need descriptions of interventions and quantitative estimates of intervention effects to make informed decisions concerning prevention funding and research. The number of intervention strategies for MSM that have been examined with strong research designs has increased substantially in the past few years. Objectives 1. To locate and describe outcome studies evaluating the effects of behavioral HIV prevention interventions for MSM. 2. To summarize the effectiveness of these interventions in reducing unprotected anal sex. 3. To identify study characteristics associated with effectiveness. 4. To identify gaps and indicate future research, policy, and practice needs. Search methods We searched electronic databases, current journals, manuscripts submitted by researchers, bibliographies of relevant articles, conference proceedings, and other reviews for published and unpublished reports from 1988 through December 2007. We also asked researchers working in HIV prevention about new and ongoing studies. Selection criteria Studies were considered in scope if they examined the effects of behavioral interventions aimed at reducing risk for HIV or STD transmission among MSM. We reviewed studies in scope for criteria of outcome relevance (measurement of at least one of a list of behavioral or biologic outcomes, e.g., unprotected sex or incidence of HIV infections) and methodologic rigor (randomized controlled trials or certain strong quasi-experimental designs with comparison groups). Data collection and analysis We used fixed and random effects models to summarize rate ratios (RR) comparing intervention and control groups with respect to count outcomes (number of occasions of or partners for unprotected anal sex), and corresponding prevalence ratios (PR) for dichotomous outcomes (any unprotected anal sex vs. none). We used published formulas to convert effect sizes and their variances for count and dichotomous outcomes where necessary. We accounted for intraclass correlation (ICC) in community-level studies and adjusted for baseline conditions in all studies. We present separate results by intervention format (small group, individual, or community-level) and by type of intervention delivered to the comparison group (minimal or no HIV prevention in the comparison condition versus standard or other HIV prevention in the comparison condition). We examine rate ratios stratified according to characteristics of participants, design, implementation, and intervention content. For small group and individual-level interventions we used a stepwise selection process to identify a multivariable model of predictors of reduction in occasions of or partners for unprotected anal sex. We used funnel plots to examine publication bias, and Q (a chi-squared statistic with degrees of freedom = number of interventions minus 1) to test for heterogeneity. Main results We found 44 studies evaluating 58 interventions with 18,585 participants. Formats included 26 small group interventions, 21 individual-level interventions, and 11 community-level interventions. Sixteen of the 58 interventions focused on HIV-positives. The 40 interventions that were measured against minimal to no HIV prevention intervention reduced occasions of or partners for unprotected anal sex by 27% (95% confidence interval [CI] = 15% to 37%). The other 18 interventions reduced unprotected anal sex by 17% beyond changes observed in standard or other interventions (CI = 5% to 27%). Intervention effects were statistically homogeneous, and no independent variable was statistically significantly associated with intervention effects at alpha=.05. However, a multivariable model selected by backward stepwise elimination identified four study characteristics associated with reduction in occasions of or partners for unprotected anal sex among small group and individual-level interventions at alpha=.10. The most favorable reductions in episodes of or partners for unprotected anal sex (33% to 35% decreases) were observed among studies with count outcomes, those with shorter intervention spans (<=1 month), those with better retention in the intervention condition than in the comparison condition, and those with minimal to no HIV prevention intervention delivered to the comparison condition. Because there were only 11 community-level studies we did not search for a multivariable model for community-level interventions. In stratified analyses including only one variable at a time, the greatest reductions (40% to 54% decreases) in number of episodes of or partners for unprotected anal sex among community-level interventions were observed among studies where groups were assigned randomly rather than by convenience, studies with shorter recall periods and longer follow-up, studies with more than 25% non-gay identifying MSM, studies in which at least 90% of participants were white, and studies in which the intervention addressed development of personal skills. Authors' conclusions Behavioral interventions reduce self-reported unprotected anal sex among MSM. These results indicate that HIV prevention for this population can work and should be supported. Results of previous studies provide a benchmark for expectations in new studies. Meta-analysis can inform future design and implementation in terms of sample size, target populations, settings, goals for process measures, and intervention content. When effects differ by design variables, which are deliberately selected and planned, awareness of these characteristics may be beneficial to future designs. Researchers designing future small group and individual-level studies should keep in mind that to date, effects of the greatest magnitude have been observed in studies that used count outcomes and a shorter intervention span (up to 1 month). Among small group and individual-level studies, effects were also greatest when the comparison condition included minimal to no HIV prevention content. Nevertheless, statistically significant favorable effects were also seen when the comparison condition included standard or other HIV prevention content. Researchers choosing the latter option for new studies should plan for larger sample sizes based on the smaller expected net intervention effect noted above. When effects differ by implementation variables, which become evident as the study is conducted but are not usually selected or planned, caution may be advised so that future studies can reduce bias. Because intervention effects were somewhat stronger (though not statistically significantly so) in studies with a greater attrition in the comparison condition, differential retention may be a threat to validity. Extra effort should be given to retaining participants in comparison conditions. Among community-level interventions, intervention effects were strongest among studies with random assignment of groups or communities. Therefore the inclusion of studies where assignment of groups or communities was by convenience did not exaggerate the summary effect. The greater effectiveness of interventions including more than 25% non-gay identifying MSM suggests that when they can be reached, these men may be more responsive than gay-identified men to risk reduction efforts. Non-gay identified MSM may have had less exposure to previous prevention messages, so their initial exposure may have a greater impact. The greater effectiveness of interventions that include efforts to promote personal skills such as keeping condoms available and behavioral self-management indicates that such content merits strong consideration in development and delivery of new interventions for MSM. And the finding that interventions were most effective for majority white populations underscores the critical need for effective interventions for MSM of African and Latino descent. Further research measuring the incidence of HIV and other STDs is needed. Because most studies were conducted among mostly white men in the US and Europe, more evaluations of interventions are needed for African American and Hispanic MSM as well as MSM in the developing world. More research is also needed to further clarify which behavioral strategies (e.g., reducing unprotected anal sex, having oral sex instead of anal sex, reducing number of partners, avoiding serodiscordant partners, strategic positioning, or reducing anal sex even with condom use) are most effective in reducing transmission among MSM, the messages most effective in promoting these behaviors, and the methods and settings in which these messages can be most effectively delivered.

Dipeptidyl peptidase‐4 (DPP‐4) inhibitors for type 2 diabetes mellitus

Abstract: Background In type 2 diabetes mellitus there is a progressive loss of beta-cell function. One new approach yielding promising results is the use of the orally active dipeptidyl peptidase-4 (DPP-4) inhibitors like sitagliptin and vildagliptin. Objectives To assess the effects of dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus. Search methods Studies were obtained from computerised searches of MEDLINE, EMBASE and The Cochrane Library. Selection criteria Studies were included if they were randomised controlled trials in adult people with type 2 diabetes mellitus and had a trial duration of at least 12 weeks. Data collection and analysis Two authors independently assessed risk of bias and extracted data. Pooling of studies was performed by means of fixed-effect meta-analysis. Main results Twenty-five studies of good quality were identified, 11 trials evaluated sitagliptin and 14 trials vildagliptin treatment. Altogether, 6743 patients were randomised in sitagliptin and 6121 patients in vildagliptin studies, respectively. Sitagliptin and vildagliptin studies ranged from 12 to 52 weeks duration. No data were published on mortality, diabetic complications, costs of treatment and health-related quality of life. Sitagliptin and vildagliptin therapy in comparison with placebo resulted in an HbA1c reduction of approximately 0.7% and 0.6%, respectively. Data on comparisons with active comparators were limited but indicated no improved metabolic control following DPP-4 intervention in contrast to other hypoglycaemic agents. Sitagliptin and vildagliptin therapy did not result in weight gain but weight loss was more pronounced following placebo interventions. No definite conclusions could be drawn from published data on sitagliptin and vildagliptin effects on measurements of beta-cell function. Overall, sitagliptin and vildagliptin were well tolerated, no severe hypoglycaemia was reported in patients taking sitagliptin or vildagliptin. All-cause infections increased significantly after sitagliptin treatment but did not reach statistical significance following vildagliptin therapy. All published randomised controlled trials of at least 12 weeks treatment with sitagliptin and vildagliptin only reported routine laboratory safety measurements Authors' conclusions DPP-4 inhibitors have some theoretical advantages over existing therapies with oral antidiabetic compounds but should currently be restricted to individual patients. Long-term data especially on cardiovascular outcomes and safety are urgently needed before widespread use of these new agents. More information on the benefit-risk ratio of DPP-4 inhibitor treatment is necessary especially analysing adverse effects on parameters of immune function. Also, long-term data are needed investigating patient-oriented parameters like health-related quality of life, diabetic complications and all-cause mortality.

Interventions for emergency contraception (Review).

Abstract: Emergency contraception is using a drug or copper intrauterine device (Cu-IUD) to prevent pregnancy shortly after unprotected intercourse. Several interventions are available for emergency contraception. Information on the comparative efficacy safety and convenience of these methods is crucial for reproductive health care providers and the women they serve. The objectives were to determine which emergency contraceptive method following unprotected intercourse is the most effective safe and convenient to prevent pregnancy. The search included the Cochrane Controlled Trials Register Popline MEDLINE PubMed Biosis/Embase Chinese biomedical databases and UNDP/UNFPA/WHO/World Bank Special Programme on Human Reproduction (HRP) emergency contraception database (December 2006). Content experts and pharmaceutical companies were contacted. Randomised controlled trials and controlled clinical trials including women attending services for emergency contraception following a single act of unprotected intercourse were eligible. Data on outcomes and trial characteristics were extracted in duplicate and independently by two reviewers. Quality assessment was also done by two reviewers independently. Meta-analysis results are expressed as relative risk (RR) using a fixed-effects model with 95% confidence interval (CI). In the presence of statistically significant heterogeneity a random-effect model was applied. Eighty-one trials with 45842 women were included. Most trials were conducted in China (70/81). There were more pregnancies with levonorgestrel compared to mid-dose (25-50 mg) (15 trials RR: 2.01; 95% CI: 1.27 to 3.17) or low-dose mifepristone (less than 25 mg) (9 trials RR: 1.43; 95% CI: 1.02 to 2.01). Low-dose mifepristone was less effective than mid-dose (20 trials RR:0.67; 95% CI: 0.49 to 0.92) but this effect was no longer statistically significant when only high quality trials were considered (6 trials RR: 0.75; 95% CI: 0.50 to 1.10). Single dose levonorgestrel (1.5 mg) administration seemed to have similar effectiveness as the standard 12 hours apart split-dose (0.75 mg twice) (2 trials 3830 women; RR: 0.77 95% CI: 0.45 to 1.30). Levonorgestrel was more effective than the Yuzpe regimen in preventing pregnancy (2 trials RR: 0.51; 95% CI: 0.31 to 0.83). CDB-2914 (a second-generation progesterone receptor modulator) may be as effective as levonorgestrel (1 trial 1549 women; RR:1.89; 95% CI: 0.75 to 4.64) but the conficence interval is wide and the result compatible with higher or lower effectiveness. Delay in the onset of subsequent menses was the main unwanted effect of mifepristone and seemed to be dose-related. Mifepristone middle dose (25-50 mg) was superior to other hormonal regimens. Mifepristone low dose (less than 25 mg) could be more effective than levonorgestrel 0.75 mg (two doses) but this was not conclusive. Levonorgestrel proved more effective than the Yuzpe regimen. The copper IUD was another effective emergency contraceptive that can provide ongoing contraception. (authors)

Physiotherapy interventions for ankylosing spondylitis.

Abstract: Background Ankylosing spondylitis (AS) is a chronic, inflammatory rheumatic disease. Physiotherapy is considered an important part of the overall management of AS. Objectives To summarise the available scientific evidence on the effectiveness of physiotherapy interventions in the management of AS. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, CINAHL and PEDro up to January 2007 for all relevant publications, without any language restrictions. We checked the reference lists of relevant articles and contacted the authors of included articles. Selection criteria We included randomised and quasi-randomised studies with AS patients and where at least one of the comparison groups received physiotherapy. The main outcomes of interest were pain, stiffness, spinal mobility, physical function and patient global assessment. Data collection and analysis Two reviewers independently selected trials for inclusion, extracted data and assessed trial quality. Investigators were contacted to obtain missing information. Main results Eleven trials with a total of 763 participants were included in this updated review. Four trials compared individualised home exercise programs or a supervised exercise program with no intervention and reported low quality evidence for effects in spinal mobility (Relative percentage differences (RPDs) from 5-50%) and physical function (four points on a 33-point scale). Three trials compared supervised group physiotherapy with an individualised home-exercise program and reported moderate quality evidence for small differences in spinal mobility (RPDs 7.5-18%) and patient global assessment (1.46 cm) in favour of supervised group exercises. In one study, a three-week inpatient spa-exercise therapy followed by 37 weeks of weekly outpatient group physiotherapy (without spa) was compared with weekly outpatient group physiotherapy alone; there was moderate quality evidence for effects in pain (18%), physical function (24%) and patient global assessment (27%) in favour of the combined spa-exercise therapy. One study compared daily outpatient balneotherapy and an exercise program with only exercise program, and another study compared balneotherapy with fresh water therapy. None of these studies showed significant between-group differences. One study compared an experimental exercise program with a conventional program; statistically significant change scores were reported on nearly all spinal mobility measures and physical function in favour of the experimental program. Authors' conclusions The results of this review suggest that an individual home-based or supervised exercise program is better than no intervention; that supervised group physiotherapy is better than home exercises; and that combined inpatient spa-exercise therapy followed by group physiotherapy is better than group physiotherapy alone.

Hand washing for preventing diarrhoea

Abstract: Background Diarrhoea is a common cause of morbidity and a leading cause of death among children aged less than five years, particularly in low- and middle-income countries. It is transmitted by ingesting contaminated food or drink, by direct person-to-person contact, or from contaminated hands. Hand washing is one of a range of hygiene promotion interventions that can interrupt the transmission of diarrhoea-causing pathogens. Objectives To evaluate the effects of interventions to promote hand washing on diarrhoeal episodes in children and adults. Search methods In May 2007, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2007, Issue 2), MEDLINE, EMBASE, LILACS, PsycINFO, Science Citation Index and Social Science Citation Index, ERIC, SPECTR, Bibliomap, RoRe, The Grey Literature, and reference lists of articles. We also contacted researchers and organizations in the field. Selection criteria Randomized controlled trials, where the unit of randomization is an institution (eg day-care centre), household, or community, that compared interventions to promote hand washing or a hygiene promotion that included hand washing with no intervention to promote hand washing. Data collection and analysis Two authors independently assessed trial eligibility and risk of bias. We stratified the analyses for cluster adjusted and non-adjusted trials. Where appropriate, incidence rate ratios (IRR) were pooled using the generic inverse variance method and random-effects model with 95% confidence intervals (CI). Main results Fourteen randomized controlled trials met the inclusion criteria. Eight trials were institution-based in high-income countries, five were community-based in low or middle-income countries, and one was in a high-risk group (people with acquired immune deficiency syndrome (AIDS)). Considering only trial results that adjusted for cluster randomization, interventions promoting hand washing resulted in a 39% reduction in diarrhoea episodes in children in institutions in high-income countries (IRR 0.61, 95% CI 0.40 to 0.92; 2 trials) and a 32% reduction in such episodes in children living in communities in low- or middle-income countries (IRR 0.68, 95% CI 0.52 to 0.90; 4 trials). Authors' conclusions Interventions that promote hand washing can reduce diarrhoea episodes by about one-third. This significant reduction is comparable to the effect of providing clean water in low-income areas. However, trials with longer follow up and that test different methods of promoting hand washing are needed.

Electromechanical and robot‐assisted arm training for improving arm function and activities of daily living after stroke

Abstract: Background Electromechanical and robot-assisted arm training devices are used in rehabilitation and might help to improve arm function after stroke. Objectives To assess the effectiveness of electromechanical and robot-assisted arm training for improving activities of daily living and arm function and motor strength of patients after stroke, and the acceptability and safety of the therapy. Search methods We searched the Cochrane Stroke Group Trials Register (last searched October 2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2007), MEDLINE (1950 to October 2007), EMBASE (1980 to October 2007), CINAHL (1982 to October 2007), AMED (1985 to October 2007), SPORTDiscus (1949 to October 2007), PEDro (searched October 2007), COMPENDEX (1972 to October 2007) and INSPEC (1969 to October 2007). We also handsearched relevant conference proceedings, searched trials and research registers, checked reference lists, and contacted trialists, experts and researchers in our field, and manufacturers of commercial devices. Selection criteria Randomised controlled trials comparing electromechanical and robot-assisted arm training for recovery of arm function with other rehabilitation interventions or no treatment for patients after stroke. Data collection and analysis Two review authors independently selected trials for inclusion, assessed trial quality and extracted data. We contacted trialists for additional information. We analysed the results as standardised mean differences (SMDs) for continuous variables and relative risk differences (RD) for dichotomous variables. Main results We included 11 trials (328 participants) in this review. Electromechanical and robot-assisted arm training did not improve activities of daily living (SMD = 0.29; 95% confidence interval (CI) -0.47 to 1.06; P = 0.45; I2 = 85%). Arm motor function and arm motor strength improved (SMD = 0.68, 95% CI 0.24 to 1.11; P = 0.002; I2 = 56% and SMD = 01.03, 95% CI 0.29 to 1.78; P = 0.007; I2 = 79% respectively). Electromechanical and robot-assisted arm training did not increase the risk of patients to drop out (RD) (fixed-effect model) = 0.01; 95% CI -0.05 to 0.06; P = 0.77; I2 = 0.0%) and adverse events were rare. Authors' conclusions Patients who receive electromechanical and robot-assisted arm training after stroke are not more likely to improve their activities of daily living, but arm motor function and strength of the paretic arm may improve. However, the results must be interpreted with caution because there were variations between the trials in the duration, amount of training and type of treatment, and in the patient characteristics.

Individual patient education for low back pain

Abstract: While many different types of patient education are widely used, the effect of individual patient education for low-back pain (LBP) has not yet been systematically reviewed. Objectives To determine whether individual patient education is effective in the treatment of non-specific low-back pain and which type is most effective. Studies were selected if the design was a randomised controlled trial; if patients experienced LBP; if the type of intervention concerned individual patient education, and if the publication was written in English, German, or Dutch. The methodological quality was independently assessed by two review authors. Articles that met at least 50% of the quality criteria were considered high quality. Main outcome measures were pain intensity, global measure of improvement, back pain-specific functional status, return-to-work, and generic functional status. Analysis comprised a qualitative analysis. Evidence was classified as strong, moderate, limited, conflicting or no evidence. Of the 24 studies included in this review, 14 (58%) were of high quality. Individual patient education was compared with no intervention in 12 studies; with non-educational interventions in 11 studies; and with other individual educational interventions in eight studies. Results showed that for patients with subacute LBP, there is strong evidence that an individual 2.5 hour oral educational session is more effective on short-term and long-term return-to-work than no intervention. Educational interventions that were less intensive were not more effective than no intervention. Furthermore, there is strong evidence that individual education for patients with (sub)acute LBP is as effective as non-educational interventions on long-term pain and global improvement and that for chronic patients, individual education is less effective for back pain-specific function when compared to more intensive interventions. Comparison of different types of individual education did not show significant differences.

Probiotics for treatment of Clostridium difficile‐associated colitis in adults

Abstract: Background Probiotics are live microorganisms consisting of non-pathogenic yeast and bacteria that are believed to restore the microbial balance of the gastrointestinal tract altered by infection with Clostridium difficile (C. difficile). Objectives To assess the efficacy of probiotics in the treatment of antibiotic associated C. difficile colitis. Search methods The databases MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and Cochrane IBD/FBD Specialized Trials register were searched to locate all published reports from 1966 to 2007. Selection criteria Randomized, prospective studies using probiotics alone or in conjunction with conventional antibiotics for the treatment of documented C. difficile colitis were eligible for inclusion. Data collection and analysis Data extraction and analysis was done independently by two authors. Main results Four studies met the inclusion criteria and were included in the review. The four studies examined the use of probiotics in conjunction with conventional antibiotics (vancomycin or metronidazole) for the treatment of recurrence or an initial episode of C. difficile colitis in adults. The studies were small in size and had methodological problems. A statistically significant benefit for probiotics combined with antibiotics was found in one study. McFarland 1994 found that patients receiving S. boulardii were significantly less likely than patients receiving placebo to experience recurrence of C. difficile diarrhea (RR 0.59; 95% CI 0.35 to 0.98). No benefit of probiotics treatment was found in the other studies. Authors' conclusions There is insufficient evidence to recommend probiotic therapy as an adjunct to antibiotic therapy for C. difficile colitis. There is no evidence to support the use of probiotics alone in the treatment of C. difficile colitis.

Omega-3 polyunsaturated fatty acids (PUFA) for type 2 diabetes mellitus.

Abstract: Background: People with type 2 diabetes mellitus are at increased risk from cardiovascular disease. Dietary omega-3 polyunsaturated fatty acids (PUFAs) are known to reduce triglyceride levels, but their impact on cholesterol levels, glycemic control and vascular outcomes are not well known. Objectives: To determine the effects of omega-3 PUFA supplementation on cardiovascular outcomes, cholesterol levels and glycemic control in people with type 2 diabetes mellitus. Search strategy: We carried out a comprehensive search of The Cochrane Library, MEDLINE, EMBASE, bibliographies of relevant papers and contacted experts for identifying additional trials. Selection criteria: All randomised controlled trials were included where omega-3 PUFA supplementation or dietary intake was randomly allocated and unconfounded in people with type 2 diabetes. Authors of large trials were contacted for missing information. Data collection and analysis: Trials were assessed for inclusion. Authors were contacted formissing information. Data was extracted and quality assessed independently in duplicate. Fixed-effect meta-analysis was carried out. Main results: Twenty three randomised controlled trials (1075 participants) were included with a mean treatment duration of 8.9 weeks. The mean dose of omega-3 PUFA used in the trials was 3.5 g/d. No trials with vascular events or mortality endpoints were identified. Among those taking omega-3 PUFA triglyceride levels were significantly lowered by 0.45 mmol/L (95% confidence interval (CI) -0.58 to - 0.32, P < 0.00001) and VLDL cholesterol lowered by -0.07 mmol/L (95% CI -0.13 to 0.00, P = 0.04). LDL cholesterol levels were raised by 0.11 mmol/L (95% CI 0.00 to 0.22, P = 0.05). No significant change in or total or HDL cholesterol, HbA1c, fasting glucose, fasting insulin or body weight was observed. The increase in VLDL remained significant only in trials of longer duration and in hypertriglyceridemic patients. The elevation in LDL cholesterol was non-significant in subgroup analyses. No adverse effects of the intervention were reported. Authors' conclusions: Omega-3 PUFA supplementation in type 2 diabetes lowers triglycerides and VLDL cholesterol, but may raise LDL cholesterol (although results were non-significant in subgroups) and has no statistically significant effect on glycemic control or fasting insulin. Trials with vascular events or mortality defined endpoints are needed. Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Mupirocin ointment for preventing Staphylococcus aureus infections in nasal carriers.

Abstract: Background Staphylococcus aureus (S. aureus) is the leading nosocomial (hospital acquired) pathogen in hospitals throughout the world. Traditionally, control of S. aureus has been focused on preventing cross-infection between patients, however, it has been shown repeatedly that a large proportion of nosocomial S. aureus infections originate from the patient's own flora. Nasal carriage of S. aureus is now considered a well defined risk factor for subsequent infection in various groups of patients. Local antibiotic treatment with mupirocin ointment is often used to eradicate nasal S. aureus. Objectives To determine whether the use of mupirocin nasal ointment in patients with identified S. aureus nasal carriage reduced S. aureus infection rates. Search methods For this first update we searched the Cochrane Wounds Group Specialised Register (searched 9 September 2010); The Cochrane Central Register of Controlled Trials (CENTRAL) - The Cochrane Library 2010 Issue 3; Ovid MEDLINE (2007 to September Week 1 2010); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, September 10, 2010);Ovid EMBASE (2007 to 2010 Week 36); and EBSCO CINAHL (2007 to 10 September 2010). No language or publication restrictions were applied. Selection criteria Randomised controlled trials (RCTs) comparing nasal mupirocin with no treatment or placebo or alternative nasal treatment in the prevention of S. aureus infections in nasal S. aureus carriers were included. Data collection and analysis Titles, abstracts and full-text articles of studies retrieved from the search process were independently assessed by two authors for inclusion. From included studies a data extraction form was made and the quality of the trial was assessed. The primary outcome was the S. aureus infection rate (any site). Secondary outcomes were time to infection, mortality, adverse events and infection rate caused by micro-organisms other than S. aureus. Main results Nine RCTs involving 3396 participants met the inclusion criteria. Patient populations varied and several types of nosocomial S. aureus infection were described including bacteraemia, exit-site infections, peritonitis, respiratory tract infections, skin infections, surgical site infections (SSI) and urinary tract infections. After pooling the eight studies that compared mupirocin with placebo or with no treatment, there was a statistically significant reduction in the rate of S. aureus infection associated with intranasal mupirocin (RR 0.55, 95% CI 0.43 to 0.70). A planned subgroup analysis of surgical trials demonstrated a significant reduction in the rate of nosocomial S. aureus infection rate associated with mupirocin use (RR 0.55, 95% CI 0.34 to 0.89) however this effect disappeared if the analysis only included surgical site infections caused by S. aureus (RR 0.63, 95% CI 0.38 to 1.04), possibly due to a lack of power. The infection rate caused by micro-organisms other than S. aureus was significantly higher in patients treated with mupirocin compared with control patients (RR 1.38 95% CI 1.118 to 1.72). Authors' conclusions In people who are nasal carriers of S. aureus, the use of mupirocin ointment results in a statistically significant reduction in S. aureus infections.

Folic acid with or without vitamin B12 for the prevention and treatment of healthy elderly and demented people

Abstract: Background Folate deficiency can result in congenital neural tube defects and megaloblastic anaemia. Low folate levels may be due to insufficient dietary intake or inefficient absorption, but impaired metabolic utilization also occurs. Because B12 deficiency can produce a similar anaemia to folate deficiency, there is a risk that folate supplementation can delay the diagnosis of B12 deficiency, which can cause irreversible neurological damage. Folic acid supplements may sometimes therefore include vitamin B12 supplements with simultaneous administration of vitamin B12. Lesser degrees of folate inadequacy are associated with high blood levels of the amino acid homocysteine which has been linked with the risk of arterial disease, dementia and Alzheimer's disease. There is therefore interest in whether dietary supplementation can improve cognitive function in the elderly. However, any apparent benefit from folic acid which was given in combination with B12 needs to be "corrected" for any effect of vitamin B12 alone. A separate Cochrane review of vitamin B12 and cognitive function has therefore been published. Objectives To examine the effects of folic acid supplementation, with or without vitamin B12, on elderly healthy or demented people, in preventing cognitive impairment or retarding its progress. Search methods Trials were identified from a search of the Cochrane Dementia and Cognitive Improvement Group's Specialized Register on 10 October 2007 using the terms: folic acid, folate, vitamin B9, leucovorin, methyltetrahydrofolate, vitamin B12, cobalamin and cyanocobalamin. This Register contains references from all major health care databases and many ongoing trials databases. In addition MEDLINE, EMBASE, CINAHL, PsychINFO and LILACS were searched (years 2003-2007) for additional trials of folate with or without vitamin B12 on healthy elderly people. Selection criteria All double-blind, placebo-controlled, randomized trials, in which supplements of folic acid with or without vitamin B12 were compared with placebo for elderly healthy people or people with any type of dementia or cognitive impairment. Data collection and analysis The reviewers independently applied the selection criteria and assessed study quality. One reviewer extracted and analysed the data. In comparing intervention with placebo, weighted mean differences and standardized mean difference or odds ratios were estimated. Main results Eight randomized controlled trials fulfilled the inclusion criteria for this review. Four trials enrolled healthy older people, and four recruited participants with mild to moderate cognitive impairment or dementia with or without diagnosed folate deficiency. Pooling the data was not possible owing to heterogeneity in sample selections, outcomes, trial duration, and dosage. Two studies involved a combination of folic acid and vitamin B12. There is no adequate evidence of benefit from folic acid supplemententation with or without vitamin B12 on cognitive function and mood of unselected healthy elderly people. However, in one trial enrolling a selected group of healthy elderly people with high homocysteine levels, 800 mcg/day folic acid supplementation over three years was associated with significant benefit in terms of global functioning (WMD 0.05, 95% CI 0.004 to 0.096, P = 0.033); memory storage (WMD 0.14, 95% CI 0.04 to 0.24, P = 0.006) and information-processing speed (WMD 0.09, 95% CI 0.02 to 0.16, P = 0.016). Four trials involved people with cognitive impairment. In one pilot trial enrolling people with Alzheimer's disease, the overall response to cholinesterase inhibitors significantly improved with folic acid at a dose of 1mg/day (odds ratio: 4.06, 95% CI 1.22 to 13.53; P = 0.02) and there was a significant improvement in scores on the Instrumental Activities of Daily Living and the Social Behaviour subscale of the Nurse's Observation Scale for Geriatric Patients (WMD 4.01, 95% CI 0.50 to 7.52, P = 0.02). Other trials involving people with cognitive impairment did not show any benefit in measures of cognitive function from folic acid, with or without vitamin B12. Folic acid plus vitamin B12 was effective in reducing serum homocysteine concentrations (WMD -5.90, 95% CI -8.43 to -3.37, P < 0.00001). Folic acid was well tolerated and no adverse effects were reported. Authors' conclusions The small number of studies which have been done provide no consistent evidence either way that folic acid, with or without vitamin B12, has a beneficial effect on cognitive function of unselected healthy or cognitively impaired older people. In a preliminary study, folic acid was associated with improvement in the response of people with Alzheimer's disease to cholinesterase inhibitors. In another, long-term use appeared to improve the cognitive function of healthy older people with high homocysteine levels. More studies are needed on this important issue.

Open surgical procedures for incisional hernias

Abstract: Background Incisional hernias occur frequently after abdominal surgery and can cause serious complications. The choice of a type of open operative repair is controversial. Determining the type of open operative repair is controversial, as the recurrence rate may be as high as 54%. This a update of an earlier version. Objectives To identify the best available open operative techniques for incisional hernias. Search methods Electronic databases MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched from 1990 to 14 September 2010 and trials were identified from the known trial reference lists. Selection criteria Studies were eligible for inclusion if they were randomized trials comparing different techniques for open operative techniques for incisional hernias. Data collection and analysis Statistical analyses were performed using the fixed effects model. Results were expressed as relative risk for dichotomous outcomes and weighted mean difference for continuous outcomes with 95% confidence intervals. Main results Eight trials comparing different open repairs for incisional hernias were identified; one trial was excluded. The included studies enrolled 1,141 patients. The results of three trials comparing suture repair versus mesh repair were pooled. Hernia recurrence was more frequent, wound infection less frequent in the direct suture group compared to the onlay or sublay mesh groups. The recurrence rates of two trials comparing onlay and sublay positions were pooled. This comparison yielded no difference in recurrences (two studies pooled), although operation time was shorter in the onlay group (one study). No difference was found in recurrence, satisfaction with cosmetics, or infection between the onlay standard mesh and skin autograft groups, following analysis pooling the two treatment arms. However, the analysis demonstrated less pain in the skin autograft group. Other trials comparing different mesh materials or different positions of the mesh, or comparing mesh with the components separation technique are described individually. The comparison between lightweight and standard mesh showed a trend for more recurrences in the lightweight group. The comparison between onlay and intraperitoneal mesh positions resulted in non significant fewer hernia recurrences, less seroma formation and more postoperative pain in the intraperitoneal group. No differences in the recurrence rates between the components separation and the intraperitoneal mesh technique. An update in October 2010 did not yield any further studies. Authors' conclusions There is good evidence from three trials that open mesh repair is superior to suture repair in terms of recurrences, but inferior when considering wound infection. Six trials yielded insufficient evidence as to which type of mesh or which mesh position (on- or sublay) should be used. There was also insufficient evidence to advocate the use of the components separation technique.

Interventions for treating depression after stroke.

Abstract: Background Depressive and anxiety disorders following stroke are often undiagnosed or inadequately treated. This may reflect difficulties with the diagnosis of abnormal mood among older people with stroke-related disability, but may also reflect uncertainty about the effectiveness of such therapies in this setting. Objectives To determine whether pharmacological, psychological, or electroconvulsive treatment (ECT) of depression in patients with stroke can improve outcome. Search strategy The Cochrane Stroke Group Trials Register (last searched June 2003). The Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2002), MEDLINE (1966 to September 2002), EMBASE (1980 to September 2002), CINAHL (1982 to September 2002), PsychINFO (1967 to September 2002), Applied Science and Technology Plus (1986 to September 2002), Arts and Humanities Index (1991 to September 2002), Biological Abstracts (1969 to September 2002), General Science Plus (1994 to September 2002), Science Citation Index (1992 to September 2002), Social Sciences Citation Index (1991 to September 2002), and Sociofile (1974 to September 2002). Reference lists from relevant articles and textbooks were searched, and authors of known studies and pharmaceutical companies who manufacture psychotropic medications were contacted. Selection criteria Randomised and quasi-randomised controlled trials comparing different types of pharmaceutical agents with placebo, or various forms of psychotherapy with standard care (or attention control), in patients with recent, clinically diagnosed, acute stroke, where treatment was explicitly intended of treat depression. Data collection and analysis Primary analyses focussed on the prevalence of diagnosable depressive disorder at the end of treatment. Secondary outcomes included depression or mood scores on standard scales, disability or physical function, death, recurrent stroke, and adverse effects. We did not pool the data for summary scores. We performed meta-analysis for only some binary endpoints and data on adverse events. Main results Nine trials, with 780 participants, were included in the review. Data were available for seven trials of pharmaceutical agents, and two trials of psychotherapy. There were no trials of ECT. The analyses were complicated by the lack of standardised diagnostic and outcome criteria, and differing analytic methods. There was no strong evidence of benefit of either pharmacotherapy or psychotherapy in terms of a complete remission of depression following stroke. There was evidence of a reduction (improvement) in scores on depression rating scales, and an increase in the proportion of participants with anxiety at the end of follow up. Authors' conclusions This review found no evidence to support the routine use of pharmacotherapeutic or psychotherapeutic treatment for depression after stroke. More research is required before recommendations can be made about the most appropriate management of depression following stroke.

Selective serotonin re-uptake inhibitors (SSRIs) versus placebo for obsessive compulsive disorder (OCD).

Abstract: Background Obsessive compulsive disorder is a common and disabling disorder. A significant proportion of patients manifest a chronic course. Individual randomised controlled trials (RCTs) have shown that selective serotonin re-uptake inhibitors (SSRIs) are effective in this condition. Previous systematic reviews or meta-analyses summarising the evidence are methodologically problematic or limited in the scope of their analysis. Objectives To examine the efficacy and adverse effects of serotonin re-uptake inhibitors (SSRIs) versus placebo for obsessive compulsive disorder (OCD) in adults. Search methods CCDANCTR-Studies and CCDANCTR-References were searched on 12/11/2007. Reference lists were checked. Experts in the field were contacted. Selection criteria All RCTs and quasi-RCTs examining the efficacy of SSRIs compared with placebo for OCD in adults were eligible for inclusion. Data collection and analysis Selection of studies and data extraction were carried out by two review authors independently, and quality assessment of studies was undertaken. Data analysis was conducted using Review Manager software. Summary measures were produced using the weighted mean difference (WMD) for continuous data and relative risk (RR) for dichotomous data, with 95% confidence intervals (CI). SSRIs were examined as an overall group of drugs, and as individual drugs. Main results Seventeen studies were included in the review, involving 3097 participants. Based on all 17 studies, SSRIs as a group were more effective than placebo in reducing the symptoms of OCD between 6 and 13 weeks post-treatment, measured using the Yale-Brown Obsessive Compulsive Scale (YBOCS) (WMD -3.21, 95% CI -3.84 to -2.57). The WMD for individual SSRI drugs were similar and not statistically different. Based on 13 studies (2697 participants), SSRIs were more effective than placebo in achieving clinical response at post-treatment (RR 1.84, 95% CI 1.56 to 2.17). The pooled RR was shown to be similar between individual SSRI drugs. Although reported adverse effects data were more limited, with few exceptions, the overall and individual adverse effects for the different SSRIs were always worse than for placebo and, in the majority of cases, the difference was statistically significant. Nausea, headache and insomnia were always reported amongst the most common adverse effects in trials of each of the drugs. Authors' conclusions SSRIs are more effective than placebo for OCD, at least in the short-term, although there are differences between the adverse effects of individual SSRI drugs. The longer term efficacy and tolerability of different SSRI drugs for OCD has yet to be established.