Showing papers in "Cochrane Database of Systematic Reviews in 2006"

Cholinesterase inhibitors for Alzheimer's disease

Abstract: Background ** This review is awaiting update with a new protocol. The methods used for the review were acceptable when the review was published but do not meet contemporary standards, and the review is also considerably out of date. Therefore, readers should note that the review may not represent a reliable basis for decision making. ** Since the introduction of the first cholinesterase inhibitor (ChEI) in 1997, most clinicians and probably most patients would consider the cholinergic drugs, donepezil, galantamine and rivastigmine, to be the first line pharmacotherapy for mild to moderate Alzheimer's disease. The drugs have slightly different pharmacological properties, but they all work by inhibiting the breakdown of acetylcholine, an important neurotransmitter associated with memory, by blocking the enzyme acetylcholinesterase. The most that these drugs could achieve is to modify the clinical manifestations of Alzheimer's disease. Cochrane reviews of each ChEI for Alzheimer's disease have been completed. Objectives To assess the effects of donepezil, galantamine and rivastigmine in people with mild, moderate or severe dementia due to Alzheimer's disease based on evidence summarised in three existing Cochrane Reviews Search methods The Cochrane Dementia and Cognitive Improvement Group's Specialized Register was searched using the terms 'donepezil', 'E2020' , 'Aricept' , galanthamin* galantamin* reminyl, rivastigmine, exelon, "ENA 713" and ENA-713 on 12 June 2005. This Register contains up-to-date records of all major health care databases and many ongoing trial databases. Selection criteria All unconfounded, blinded, randomized trials of at least six months in which treatment with a ChEI at the usual recommended dose was compared with placebo or another ChEI for patients with mild, moderate or severe dementia due to Alzheimer's disease. Data collection and analysis Data were extracted by one reviewer (JSB), pooled where appropriate and possible, and the pooled treatment effects, or the risks and benefits of treatment, estimated. Main results The results of 10 randomized, double blind, placebo controlled trials demonstrate that treatment for 6 months, with donepezil, galantamine or rivastigmine at the recommended dose for people with mild, moderate or severe dementia due to Alzheimer's disease produced improvements in cognitive function, on average -2.37 points (95%CI -2.73 to -2.02, p<0.00001), in the midrange of the 70 point ADAS-Cog Scale. Study clinicians rated global clinical state more positively in treated patients. Benefits of treatment were also seen on measures of activities of daily living and behaviour. None of these treatment effects are large. The effects are similar for patients with severe dementia, although there is very little evidence, from only two trials. More patients leave ChEI treatment groups, (29%), than leave the placebo groups (18%). There is evidence of more adverse events in total in the patients treated with a ChEI than with placebo. Although many types of adverse event were reported, nausea, vomiting, diarrhoea, were significantly more frequent in the ChEI groups than in placebo. There is only one randomized, double blind study in which two ChEIs are compared, donepezil compared with rivastigmine. There is no evidence of a difference between donepezil and rivastigmine for cognitive function, activities of daily living and behavioural disturbance at two years. Fewer patients suffer adverse events on donepezil than rivastigmine. Authors' conclusions The three cholinesterase inhibitors are efficacious for mild to moderate Alzheimer's disease. Despite the slight variations in the mode of action of the three cholinesterase inhibitors there is no evidence of any differences between them with respect to efficacy. The evidence from one large trial shows fewer adverse events associated with donepezil compared with rivastigmine.

Exercise for overweight or obesity.

Abstract: Overweight and obesity are important public health problems and are associated with many serious health conditions. The risk of developing overweight and obesity depends on lifestyle factors such as food intake and physical activity levels. Treatment for overweight and obesity therefore commonly involves diet and exercise. We found that exercise has a positive effect on body weight and cardiovascular disease risk factors in people with overweight or obesity, particularly when combined with diet, and that exercise improves health even if no weight is lost. No data were identified on adverse events, quality of life, morbidity, costs or mortality.

Memantine for dementia

Abstract: Background Memantine, a low affinity antagonist to glutamate NMDA receptors, may prevent excitatory neurotoxicity in dementia. Objectives To determine efficacy and safety of memantine for people with Alzheimer's disease (AD), vascular (VD) and mixed dementia. Search methods The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group was searched on 8 February 2006. This register contains references from all major healthcare databases and many ongoing trial databases and is updated regularly. In addition, the search engines Copernic and Google were used to identify unpublished trials through inspection of the websites of licensing bodies like the FDA , EMEA and NICE and of companies' websites (Lundbeck, Merz, Forest, Suntori etc) and clinical trials registries. Selection criteria Double-blind, parallel group, placebo-controlled, randomized trials of memantine in people with dementia. Data collection and analysis Data were pooled where possible. Intention-to-treat (ITT) and observed case (OC) analyses are reported. Main results 1. Moderate to severe AD. Two out of three six month studies show a small beneficial effect of memantine. Pooled data indicate a beneficial effect at six months on cognition (2.97 points on the 100 point SIB, 95% CI 1.68 to 4.26, P < 0.00001), activities of daily living (1.27 points on the 54 point ADCS-ADLsev, 95% CI 0.44 to 2.09, P = 0.003) and behaviour (2.76 points on the 144 point NPI, 95% CI 0.88 to 4.63, P=0.004), supported by clinical impression of change (0.28 points on the 7 point CIBIC+, 95% CI 0.15 to 0.41, P < 0.0001). 2. Mild to moderate AD. Pooled data from three unpublished studies indicate a marginal benefical effect at six months on ITT cognition (0.99 points on the 70 point ADAS-Cog, 95% CI 0.21 to 1.78, P = 0.01) which was barely detectable clinically (0.13 CIBIC+ points, 95% CI 0.01 to 0.25, P = 0.03) but no effect on behaviour, activities of daily living or OC analysis of cognition. 3. Mild to moderate vascular dementia. Pooled data from two six month studies indicated a small beneficial effect of memantine on cognition (1.85 ADAS-Cog points, 95% CI 0.88 to 2.83, P = 0.0002), and behaviour (0.84 95% CI 0.06 to 0.91, P = 0.03) but this was not supported by clinical global measures. 4. Patients taking memantine were slightly less likely to develop agitation (134/1739, 7.7% versus 175/1873, 9.3% OR 0.78, 95% CI 0.61 to 0.99, P = 0.04). This effect was slightly larger, but still small, in moderate to severe AD (58/506 [12%] vs 88/499 [18%]; OR = 0.6, 95% CI 0.42 to 0.86, P = 0.005). There is no evidence either way about whether it has an effect on agitation which is already present. 5. Memantine is well tolerated. Authors' conclusions Memantine has a small beneficial effect at six months in moderate to severe AD. In patients with mild to moderate dementia, the small beneficial effect on cognition was not clinically detectable in those with vascular dementia and was detectable in those with AD. Memantine is well tolerated.

Continuous positive airways pressure for obstructive sleep apnoea in adults

Abstract: BACKGROUND: Obstructive sleep apnoea is the periodic reduction (hypopnoea) or cessation (apnoea) of breathing due to narrowing or occlusion of the upper airway during sleep. The main symptom is daytime sleepiness and it has been suggested it is linked to premature death, hypertension, ischaemic heart disease, stroke and road traffic accidents. OBJECTIVES: The main treatment for sleep apnoea is with the use of continuous positive airways pressure (CPAP), which requires a flow generator and mask. These are used at night to prevent apnoea, hypoxia and sleep disturbance. The objective was to assess the effects of CPAP in the treatment of obstructive sleep apnoea in adults. SEARCH STRATEGY: We searched the Cochrane Airways Group Trials Register and reference lists of articles. We consulted experts in the field. Searches were current to July 2005. SELECTION CRITERIA: We included randomised trials comparing nocturnal CPAP with an inactive control or oral appliances in adults with obstructive sleep apnoea (an apnoea and hypopnoea index greater than five per hour). Trials had a minimum intervention period of two weeks. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and two review authors extracted data independently. Study authors were contacted for missing information. Parallel and crossover group trials were analysed separately. MAIN RESULTS: Thirty-six trials involving 1718 people met the inclusion criteria. Study quality was mixed. Compared with control, CPAP showed significant improvements in objective and subjective sleepiness and several quality of life, cognitive function and depression measures (parallel-group studies: Epworth sleepiness scale (ESS) -3.83 units, 95% CI -4.57 to -3.09; crossover studies: ESS -1.84 units, 95% CI -2.57 to -1.11). Twenty-four hour systolic and diastolic blood pressures were lower with CPAP compared with control (parallel-group trials). Compared with oral appliances, CPAP significantly reduced the apnoea and hypopnoea index (crossover studies: -7.97 events/hr, 95% CI -9.56 to -6.38) and improved sleep efficiency (crossover studies: 2.31%, 95% CI 0.02 to 4.6) and minimum oxygen saturation (4.14%, 95% CI 3.25 to 5.03). Responders to both treatments expressed a strong preference for the oral appliance. However, participants were more likely to withdraw on OA than on CPAP therapy. AUTHORS' CONCLUSIONS: CPAP is effective in reducing symptoms of sleepiness and improving quality of life measures in people with moderate and severe obstructive sleep apnoea (OSA). It is more effective than oral appliances in reducing respiratory disturbances in these people but subjective outcomes are more equivocal. Certain people tend to prefer oral appliances to CPAP where both are effective. This could be because they offer a more convenient way of controlling OSA. Short-term data indicate that CPAP leads to lower blood pressure than in controls. Long-term data are required for all outcomes in order to determine whether the initial benefits seen in short-term clinical trials persist. Language: en

Viscosupplementation for the treatment of osteoarthritis of the knee

Abstract: Background Osteoarthritis (OA) is the most prevalent chronic joint disorder worldwide and is associated with significant pain and disability. Objectives To assess the effects of viscosupplementation in the treatment of OA of the knee. The products were hyaluronan and hylan derivatives (Adant, Arthrum H, Artz (Artzal, Supartz), BioHy (Arthrease, Euflexxa, Nuflexxa), Durolane, Fermathron, Go-On, Hyalgan, Hylan G-F 20 (Synvisc Hylan G-F 20), Hyruan, NRD-101 (Suvenyl), Orthovisc, Ostenil, Replasyn, SLM-10, Suplasyn, Synject and Zeel compositum). Search strategy MEDLINE (up to January (week 1) 2006 for update), EMBASE, PREMEDLINE, Current Contents up to July 2003, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched. Specialised journals and reference lists of identified randomised controlled trials (RCTs) and pertinent review articles up to December 2005 were handsearched. Selection criteria RCTs of viscosupplementation for the treatment of people with a diagnosis of OA of the knee were eligible. Single and double-blinded studies, placebo-based and comparative studies were eligible. At least one of the four OMERACT III core set outcome measures had to be reported (Bellamy 1997). Data collection and analysis Each trial was assessed independently by two reviewers for its methodological quality using a validated tool. All data were extracted by one reviewer and verified by a second reviewer. Continuous outcome measures were analysed as weighted mean differences (WMD) with 95% confidence intervals (CI). However, where different scales were used to measure the same outcome, standardized mean differences (SMD) were used. Dichotomous outcomes were analyzed by relative risk (RR). Main results Seventy-six trials with a median quality score of 3 (range 1 to 5) were identified. Follow-up periods varied between day of last injection and eighteen months. Forty trials included comparisons of hyaluronan/hylan and placebo (saline or arthrocentesis), ten trials included comparisons of intra-articular (IA) corticosteroids, six trials included comparisons of nonsteroidal anti-inflammatory drugs (NSAIDs), three trials included comparisons of physical therapy, two trials included comparisons of exercise, two trials included comparisons of arthroscopy, two trials included comparisons of conventional treatment, and fifteen trials included comparisons of other hyaluronans/hylan. The pooled analyses of the effects of viscosupplements against 'placebo' controls generally supported the efficacy of this class of intervention. In these same analyses, differential efficacy effects were observed for different products on different variables and at different timepoints. Of note is the 5 to 13 week post injection period which showed a percent improvement from baseline of 28 to 54% for pain and 9 to 32% for function. In general, comparable efficacy was noted against NSAIDs and longer-term benefits were noted in comparisons against IA corticosteroids. In general, few adverse events were reported in the hyaluronan/hylan trials included in these analyses. Authors' conclusions Based on the aforementioned analyses, viscosupplementation is an effective treatment for OA of the knee with beneficial effects: on pain, function and patient global assessment; and at different post injection periods but especially at the 5 to 13 week post injection period. It is of note that the magnitude of the clinical effect, as expressed by the WMD and standardised mean difference (SMD) from the RevMan 4.2 output, is different for different products, comparisons, timepoints, variables and trial designs. However, there are few randomised head-to-head comparisons of different viscosupplements and readers should be cautious, therefore, in drawing conclusions regarding the relative value of different products. The clinical effect for some products, against placebo, on some variables at some timepoints is in the moderate to large effect-size range. Readers should refer to relevant tables to review specific detail given the heterogeneity in effects across the product class and some discrepancies observed between the RevMan 4.2 analyses and the original publications. Overall, the analyses performed are positive for the HA class and particularly positive for some products with respect to certain variables and timepoints, such as pain on weight bearing at 5 to 13 weeks postinjection. In general, sample-size restrictions preclude any definitive comment on the safety of the HA class of products; however, within the constraints of the trial designs employed no major safety issues were detected. In some analyses viscosupplements were comparable in efficacy to systemic forms of active intervention, with more local reactions but fewer systemic adverse events. In other analyses HA products had more prolonged effects than IA corticosteroids. Overall, the aforementioned analyses support the use of the HA class of products in the treatment of knee OA.

Exercise for type 2 diabetes mellitus

Abstract: Background Exercise is generally recommended for people with type 2 diabetes mellitus. However, some studies evaluate an exercise intervention including diet or behaviour modification or both, and the effects of diet and exercise are not differentiated. Some exercise studies involve low participant numbers, lacking power to show significant differences which may appear in larger trials. Objectives To assess the effects of exercise in type 2 diabetes mellitus. Search methods Trials were identified through the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and manual searches of bibliographies. Selection criteria All randomised controlled trials comparing any type of well-documented aerobic, fitness or progressive resistance training exercise with no exercise in people with type 2 diabetes mellitus. Data collection and analysis Two authors independently selected trials, assessed trial quality and extracted data. Study authors were contacted for additional information. Any information on adverse effects was collected from the trials. Main results Fourteen randomised controlled trials comparing exercise against no exercise in type 2 diabetes were identified involving 377 participants. Trials ranged from eight weeks to twelve months duration. Compared with the control, the exercise intervention significantly improved glycaemic control as indicated by a decrease in glycated haemoglobin levels of 0.6% (-0.6 % HbA1c, 95% confidence interval (CI) -0.9 to -0.3; P < 0.05). This result is both statistically and clinically significant. There was no significant difference between groups in whole body mass, probably due to an increase in fat free mass (muscle) with exercise, as reported in one trial (6.3 kg, 95% CI 0.0 to 12.6). There was a reduction in visceral adipose tissue with exercise (-45.5 cm2, 95% CI -63.8 to -27.3), and subcutaneous adipose tissue also decreased. No study reported adverse effects in the exercise group or diabetic complications. The exercise intervention significantly increased insulin response (131 AUC, 95% CI 20 to 242) (one trial), and decreased plasma triglycerides (-0.25 mmol/L, 95% CI -0.48 to -0.02). No significant difference was found between groups in quality of life (one trial), plasma cholesterol or blood pressure. Authors' conclusions The meta-analysis shows that exercise significantly improves glycaemic control and reduces visceral adipose tissue and plasma triglycerides, but not plasma cholesterol, in people with type 2 diabetes, even without weight loss.

Donepezil for dementia due to Alzheimer's disease

Abstract: Background Alzheimer's disease is the most common cause of dementia in older people. One of the aims of therapy is to inhibit the breakdown of a chemical neurotransmitter, acetylcholine, by blocking the relevant enzyme. This can be done by a group of chemicals known as cholinesterase inhibitors. Objectives The objective of this review is to assess whether donepezil improves the well-being of patients with dementia due to Alzheimer's disease. Search methods The Cochrane Dementia and Cognitive Improvement Group's Specialized Register was searched using the terms 'donepezil', 'E2020' and 'Aricept' on 5 April 2006. This Register contains up-to-date records of all major health care databases and many ongoing trial databases. Members of the Donepezil Study Group and Eisai Inc were contacted. Selection criteria All unconfounded, double-blind, randomized controlled trials in which treatment with donepezil was compared with placebo for patients with mild, moderate or severe dementia due to Alzheimer's disease. Data collection and analysis Data were extracted by one reviewer (JSB), pooled where appropriate and possible, and the pooled treatment effects, or the risks and benefits of treatment estimated. Main results 24 trials are included, involving 5796 participants, of which 15 reported results in sufficient detail for the meta-analyses. Most trials were of 6 months or less duration in selected patients. Patients in 20 trials had mild to moderate disease, in two trials moderate to severe, and in two severe disease. Available outcome data cover domains including cognitive function, activities of daily living, behaviour, global clinical state, adverse events and health care resource costs. For cognition there is a statistically significant improvement for both 5 and 10 mg/day of donepezil at 24 weeks compared with placebo on the ADAS-Cog scale (-2.01 points MD, 95%CI -2.69 to -1.34, P < 0.00001); -2.80 points, MD 95% CI -3.74 to -2.10, P < 0.00001) and for 10 mg/day donepezil compared with placebo at 24 weeks (5.55 SIB points, 95% CI 3.60 to 7.49, p<0.00001) and 52 weeks (1.84 MMSE points, 95% CI, 0.53 to 3.15, P =0.006). The results show some improvement in global clinical state (assessed by a clinician) in people treated with 5 and 10 mg/day of donepezil compared with placebo at 24 weeks for the number of patients showing improvement (OR 2.38, 95% CI 1.78 to 3.19, P = < 0.00001, OR 1.82, 95% CI 1.42 to 2.35, P < 0.00001). Benefits of treatment were also seen on measures of activities of daily living and behaviour, but not on the quality of life score. There were significantly more withdrawals before the end of treatment from the 10 mg/day (289/1125 24% 10 mg/day vs 219/1079 20% placebo, OR 1.35, 95% CI 1.11 to 1.65, P = 0.003) but not the 5 mg/day, (100/561 18% 5 mg/day vs 109/568 19% placebo, OR 0.91, 95% CI 0.68 to 1.24, P = 0.56) donepezil group compared with placebo which may have resulted in some overestimation of beneficial changes at 10 mg/day. Benefits on the 10 mg/day dose were marginally larger than on the 5 mg/day dose. The results were similar for all severities of disease. Two studies presented results for health resource use, and the associated costs. There were no significant differences between treatment and placebo for any item, the cost of any item, and for the total costs, and total costs including the informal carer costs. Many adverse events were recorded, with more incidents of nausea, vomiting, diarrhoea, muscle cramps, dizziness, fatigue and anorexia (significant risk associated with treatment) in the 10 mg/day group, compared with placebo. There were more incidents of anorexia, diarrhoea, and muscle cramps in the 5 mg/day group compared with placebo, but not of dizziness, fatigue, nausea or vomiting. Very few patients left a trial as a direct result of the intervention. Authors' conclusions People with mild, moderate or severe dementia due to Alzheimer's disease treated for periods of 12, 24 or 52 weeks with donepezil experienced benefits in cognitive function, activities of daily living and behaviour. Study clinicians rated global clinical state more positively in treated patients, and measured less decline in measures of global disease severity. There is some evidence that use of donepezil is neither more nor less expensive compared with placebo when assessing total health care resource costs. Benefits on the 10 mg/day dose were marginally larger than on the 5 mg/day dose. Taking into consideration the better tolerability of the 5 mg/day donepezil compared with the 10 mg/day dose, together with the lower cost, the lower dose may be the better option. The debate on whether donepezil is effective continues despite the evidence of efficacy from the clinical studies because the treatment effects are small and are not always apparent in practice.

Prophylactic corticosteroids for preterm birth

Abstract: Reason for withdrawal from publication May 2006 The 'Prophylactic corticosteroids for preterm birth' review has been withdrawn from Issue 3, 2006 of The Cochrane Library because it has been updated by a new review entitled 'Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth'.

Intraarticular corticosteroid for treatment of osteoarthritis of the knee

Abstract: BACKGROUND: Osteoarthritis (OA) is a common joint disorder. In the knee, injections of corticosteroids into the joint (intra-articular (IA)) may relieve inflammation, and reduce pain and disability. OBJECTIVES: To evaluate the efficacy and safety of IA corticosteroids in treatment of OA of the knee. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2003), MEDLINE, EMBASE, PREMEDLINE (all to July 2003), and Current Contents (Sept 2000). Specialised journals, trial reference lists and review articles were handsearched. SELECTION CRITERIA: Randomised controlled trials of IA corticosteroids for patients with OA of the knee: single/double blind, placebo-based/comparative studies, reporting at least one core OMERACT III outcome measure. DATA COLLECTION AND ANALYSIS: Methodological quality of trials was assessed, and data were extracted in duplicate. Fixed effect and random effects models, giving weighted mean differences (WMD), were used for continuous variables. Dichotomous outcomes were analysed by relative risk AUTHORS CONCLUSIONS : The short-term benefit of IA corticosteroids in treatment of knee OA is well established, and few side effects have been reported. Longer term benefits have not been confirmed based on the RevMan analysis. The response to HA products appears more durable. In this review, some discrepancies were observed between the RevMan 4.2 analysis and the original publication. These are likely the result of using secondary rather than primary data and the statistical methods available in RevMan 4.2. Future trials should have standardised outcome measures and assessment times, run longer, investigate different patient subgroups, and clinical predictors of response (those associated with inflammation and structural damage)

Methods of consumer involvement in developing healthcare policy and research, clinical practice guidelines and patient information material

Abstract: Background The importance of consumer involvement in health care is widely recognised Consumers can be involved in developing healthcare policy and research, clinical practice guidelines and patient information material, through consultations to elicit their views or through collaborative processes Consultations can be single events, or repeated events, large or small scale They can involve individuals or groups of consumers to allow debate; the groups may be convened especially for the consultation or be established consumer organisations They can be organised in different forums and through different media Objectives To assess the effects of consumer involvement and compare different methods of involvement in developing healthcare policy and research, clinical practice guidelines, and patient information material Search methods For the 2006 version of this review (Nilsen 2006) we searched: the Cochrane Consumers and Communication Review Group's Specialised Register (4 May 2006); the Cochrane Controlled Trials Register (CENTRAL) (The Cochrane Library, Issue 1 2006), MEDLINE (1966 to January Week 2 2006); EMBASE (1980 to Week 03 2006); CINAHL (1982 to December Week 2 2005), PsycINFO (1806 to January Week 3 2006); Sociological Abstracts (1952 to 24 January 2006); and SIGLE (System for Information on Grey Literature in Europe) (1980 to 2003/1) We scanned reference lists from relevant articles and contacted authors For the 2009 update we revised the previous search strategies and searched: the Cochrane Central Register of Controlled Trials (CENTRAL), including the Cochrane Consumers and Communication Review Group's Specialised Register (The Cochrane Library, Issue 2 2009), MEDLINE (1950 to May Week 1 2009); EMBASE (1980 to Week 19 2009); CINAHL (1981 to 8 July 2009), PsycINFO (1806 to May Week 1 2009); Sociological Abstracts (1952 to 11 May 2009) We did not search OpenSIGLE for the review update We scanned reference lists from relevant articles and searched the Science Citation Index Expanded and the Social Sciences Citation Index (1975 to 9 September 2009) for studies citing the included studies in this review Selection criteria Randomised controlled trials assessing methods for involving consumers in developing healthcare policy and research, clinical practice guidelines or patient information material The outcome measures were: participation or response rates of consumers; consumer views elicited; consumer influence on decisions, healthcare outcomes or resource utilisation; consumers' or professionals' satisfaction with the involvement process or resulting products; impact on the participating consumers; costs Data collection and analysis Two review authors independently selected trials for inclusion, assessed their quality and extracted data We contacted trial authors for clarification and to seek missing data We presented results in a narrative summary and pooled data as appropriate Main results 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 Authors' conclusions 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

Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis.

Abstract: Background Cholecystectomy is one of the most frequently performed operations. Open cholecystectomy has been the gold standard for over 100 years. Laparoscopic cholecystectomy was introduced in the 1980s. Objectives To compare the beneficial and harmful effects of laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Search strategy We searched The Cochrane Hepato-Biliary Group Controlled Trials Register (April 2004), The Cochrane Library (Issue 1, 2004), MEDLINE (1966 to January 2004), EMBASE (1980 to January 2004), Web of Science (1988 to January 2004), and CINAHL (1982 to January 2004) for randomised trials. Selection criteria All published and unpublished randomised trials in patients with symptomatic cholecystolithiasis comparing any kind of laparoscopic cholecystectomy versus any kind of open cholecystectomy. No language limitations were applied. Data collection and analysis Two authors independently performed selection of trials and data extraction. The methodological quality of the generation of the allocation sequence, allocation concealment, blinding, and follow-up was evaluated to assess bias risk. Analyses were based on the intention-to-treat principle. Authors were requested additional information in case of missing data. Sensitivity and subgroup analyses were performed when appropriate. Main results Thirty-eight trials randomised 2338 patients. Most of the trials had high bias risk. There was no significant difference regarding mortality ( risk difference 0,00, 95% confidence interval (CI) -0.01 to 0.01). Meta-analysis of all trials suggests less overall complications in the laparoscopic group, but the high-quality trials show no significant difference ('allocation concealment' high-quality trials risk difference, random effects -0.01, 95% CI -0.05 to 0.02). Laparoscopic cholecystectomy patients have a shorter hospital stay ( weighted mean difference (WMD), random effects -3 days, 95% CI -3.9 to -2.3) and convalescence ( WMD, random effects -22.5 days, 95% CI -36.9 to -8.1) compared to open cholecystectomy. Authors' conclusions No significant differences were observed in mortality, complications and operative time between laparoscopic and open cholecystectomy. Laparoscopic cholecystectomy is associated with a significantly shorter hospital stay and a quicker convalescence compared with the classical open cholecystectomy. These results confirm the existing preference for the laparoscopic cholecystectomy over open cholecystectomy.

Acetaminophen for osteoarthritis

Abstract: Background Osteoarthritis (OA) is the most common form of arthritis. Published guidelines and expert opinion are divided over the relative role of acetaminophen (also called paracetamol or Tylenol) and non-steroidal anti-inflammatory drugs (NSAIDs) as first-line pharmacologic therapy. The comparative safety of acetaminophen and NSAIDs is also important to consider. This update to the original 2003 review includes nine additional RCTs. Objectives To assess the efficacy and safety of acetaminophen versus placebo and versus NSAIDs (ibuprofen, diclofenac, arthrotec, celecoxib, naproxen, rofecoxib) for treating OA. Search methods We searched MEDLINE (up to July 2005), EMBASE (2002-July 2005), Cochrane Central Register of Controlled Trials (CENTRAL), ACP Journal Club, DARE, Cochrane Database of Systematic Reviews (all from 1994 to July 2005). Reference lists of identified RCTs and pertinent review articles were also hand searched. Selection criteria Published randomized controlled trials (RCTs) evaluating the efficacy and safety of acetaminophen alone in OA were considered for inclusion. Data collection and analysis Pain, physical function and global assessment outcomes were reported. Results for continuous outcome measures were expressed as standardized mean differences (SMD). Dichotomous outcome measures were pooled using relative risk (RR) and the number needed to treat (NNT) was calculated. Main results Fifteen RCTs involving 5986 participants were included in this review. Seven RCTs compared acetaminophen to placebo and ten RCTs compared acetaminophen to NSAIDs. In the placebo-controlled RCTs, acetaminophen was superior to placebo in five of the seven RCTs and had a similar safety profile. Compared to placebo, a pooled analysis of five trials of overall pain using multiple methods demonstrated a statistically significant reduction in pain (SMD -0.13, 95% CI -0.22 to -0.04), which is of questionable clinical significance. The relative percent improvement from baseline was 5% with an absolute change of 4 points on a 0 to 100 scale. The NNT to achieve an improvement in pain ranged from 4 to 16. In the comparator-controlled RCTs, acetaminophen was less effective overall than NSAIDs in terms of pain reduction, global assessments and in terms of improvements in functional status. No significant difference was found overall between the safety of acetaminophen and NSAIDs, although patients taking traditional NSAIDS were more likely to experience an adverse GI event (RR 1.47, (95% CI 1.08 to 2.00). 19% of patients in the traditional NSAID group versus 13% in the acetaminophen group experienced an adverse GI event. However, the median trial duration was only 6 weeks and it is difficult to assess adverse outcomes in a relatively short time period. Authors' conclusions The evidence to date suggests that NSAIDs are superior to acetaminophen for improving knee and hip pain in people with OA. The size of the treatment effect was modest, and the median trial duration was only six weeks, therefore, additional considerations need to be factored in when making the decision between using acetaminophen or NSAIDs. In OA subjects with moderate-to-severe levels of pain, NSAIDs appear to be more effective than acetaminophen.

The effectiveness of atypical antipsychotics for the treatment of aggression and psychosis in Alzheimer's disease.

Abstract: Background Aggression, agitation or psychosis occur in the majority of people with dementia at some point in the illness. There have been a number of trials of atypical antipsychotics to treat these symptoms over the last five years, and a systematic review is needed to evaluate the evidence in a balanced way. Objectives To determine whether evidence supports the use of atypical antipsychotics for the treatment of aggression, agitation and psychosis in people with Alzheimer's disease. Search methods The trials were identified from a last updated search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 7 December 2004 using the terms olanzapine, quetiapine, risperidone, clozapine, amisulpride, sertindole, zotepine, aripiprazole, ziprasidone. This Register contains articles from all major healthcare databases and many ongoing trials databases and is updated regularly. Selection criteria Randomised, placebo-controlled trials, with concealed allocation, where dementia and psychosis and/or aggression were assessed. Data collection and analysis 1. Three reviewers extracted data from included trials 2. Data were pooled where possible, and analysed using appropriate statistical methods 3. Analysis included patients treated with an atypical antipsychotic, compared with placebo Main results Sixteen placebo controlled trials have been completed with atypical antipsychotics although only nine had sufficient data to contribute to a meta-analysis and only five have been published in full in peer reviewed journals. No trials of amisulpiride, sertindole or zotepine were identified which met the criteria for inclusion. The included trials led to the following results: 1. There was a significant improvement in aggression with risperidone and olanzapine treatment compared to placebo. 2. There was a significant improvement in psychosis amongst risperidone treated patients. 3. Risperidone and olanzapine treated patients had a significantly higher incidence of serious adverse cerebrovascular events (including stroke), extrapyramidal side effects and other important adverse outcomes. 4. There was a significant increase in drop-outs in risperidone (2 mg) and olanzapine (5-10 mg) treated patients. 5. The data were insufficient to examine impact upon cognitive function. Authors' conclusions Evidence suggests that risperidone and olanzapine are useful in reducing aggression and risperidone reduces psychosis, but both are associated with serious adverse cerebrovascular events and extrapyramidal symptoms. Despite the modest efficacy, the significant increase in adverse events confirms that neither risperidone nor olanzapine should be used routinely to treat dementia patients with aggression or psychosis unless there is severe distress or risk of physical harm to those living and working with the patient. Although insufficient data were available from the considered trials, a meta-analysis of seventeen placebo controlled trials of atypical neuroleptics for the treatment of behavioural symptoms in people with dementia conducted by the Food and Drug Administration suggested a significant increase in mortality (OR 1.7). A peer-reviewed meta-analysis (Schneider 2005) of 15 placebo controlled studies (nine unpublished) found similarly increased risk in mortality (OR=1.54, 95% CI 0.004 to 0.02, p=0.01) for the atypical neuroleptics.

Developmental care for promoting development and preventing morbidity in preterm infants

Abstract: Background Preterm infants experience a range of morbidity related to the immaturity of their organ systems and to concurrent disease states. There is concern that an unfavourable environment in the neonatal intensive care unit (NICU) may compound this morbidity. Modification of the environment could minimize the iatrogenic effects. Developmental care is a broad category of interventions designed to minimize the stress of the NICU environment. These interventions may include elements such as control of external stimuli (vestibular, auditory, visual, tactile), clustering of nursery care activities, and positioning or swaddling of the preterm infant. Individual strategies have also been combined to form programs, such as the 'Newborn Individualized Developmental Care and Assessment Program' (NIDCAP) (Als 1986). Objectives In preterm infants, do developmental care interventions reduce neurodevelopmental delay, poor weight gain, length of hospital stay, length of mechanical ventilation, physiological stress and other clinically relevant adverse outcomes? Search methods The Neonatal Review Group search strategy was utilized. Searches were made of MEDLINE from 1966 to June, 2005 and of CINAHL, The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2005), and conference and symposia proceedings in the English language from 1990 to June, 2005. A search of EMBASE was also made from 2003 to June 2005. A list of all relevant articles was sent to two experts in the field to identify any omissions or additional unpublished studies. Selection criteria Randomized trials in which elements of developmental care are compared to routine nursery care for infants < 37 weeks gestation and that measured clinically relevant outcomes. Reports were in English or a language for which a translator was available. Computerized searches were conducted and all potentially relevant titles and abstracts were extracted. Retrieved articles were assessed for relevance independently by two reviewers, based on predetermined criteria. Articles that met all criteria for relevance were assessed for methodological quality based on predetermined criteria. Articles judged to have the appropriate quality by both reviewers were included in the analysis. Data collection and analysis Data were extracted independently by the two authors. Meta-analyses were conducted for each intervention where the same outcome measures and/or instruments were used within comparable time points. Main results This review detected 36 eligible randomized controlled trials involving four major groups of developmental care interventions, 19 sub-groups and multiple clinical outcomes. In addition, the long-term outcomes of a previously included trial were added to the review. The results of the review indicate that developmental care interventions demonstrate limited benefit to preterm infants with respect to: decreased moderate-severe chronic lung disease, decreased incidence of necrotizing enterocolitis and improved family outcome. Conversely, an increase in mild lung disease and an increase in the length of stay were demonstrated in infants receiving developmental care compared to controls. There is also very limited evidence of the long-term positive effect of NIDCAP on behavior and movement at 5 years corrected age but no effect on cognition. Other individualized developmental care interventions have also demonstrated some effect in enhancing neurodevelopmental outcome. Although a limited number of other benefits were demonstrated, those results were from single studies with small sample sizes. The lack of blinding of the assessors was a significant methodological flaw in half of the studies. The cost of the interventions and personnel was not considered in any of the studies. Authors' conclusions Because of the inclusion of multiple interventions in most studies, the determination of the effect of any single intervention is difficult. Although there is evidence of limited benefit of developmental care interventions overall, and no major harmful effects reported, there were a large number of outcomes for which no or conflicting effects were demonstrated. The single trials that did show a significant effect of an intervention on a major clinical outcome were based on small sample sizes, and the findings were often not supported in other small trials. Before a clear direction for practice can be supported, evidence demonstrating more consistent effects of developmental care interventions on important short- and long-term clinical outcomes is needed. The economic impact of the implementation and maintenance of developmental care practices should be considered by individual institutions.

Pharmacotherapy for post traumatic stress disorder (PTSD)

Abstract: Background Posttraumatic stress disorder (PTSD) is a prevalent and disabling disorder. By definition prior psychological trauma plays a causal role in the disorder, and psychotherapy is a widely accepted intervention. Nevertheless there is growing evidence that PTSD is characterized by specific psychobiological dysfunctions, and this has contributed to a growing interest in the use of medication in its treatment. Objectives The authors aimed to undertake a systematic review of randomized controlled trials (RCTs) of the pharmacotherapy of posttraumatic stress disorder (PTSD) following the guidelines and using the software of the Cochrane Collaboration, and to provide an estimate of the effects of medication in this disorder. Secondary objectives were to explore questions about whether particular classes of medication are more effective and/or acceptable than others in the treatment of PTSD, and about which factors (clinical and methodological) predict response to pharmacotherapy. Search strategy Studies of the pharmacotherapy of PTSD were identified using literature searches of MEDLINE (1966 to 1999, using the textwords posttraumatic, post-traumatic, medication, pharmacotherapy) and other electronic databases (PSYCLIT; National PTSD Center Pilots database; Dissertation Abstracts; Cochrane Collaboration Depression, Anxiety & Neurosis Controlled Trials Register). In addition, published and unpublished RCTs were requested from PTSD researchers and pharmaceutical companies. An initial broad strategy was undertaken to find not only RCTs, but also open-label trials and reviews of the pharmacotherapy of PTSD; additional studies were sought in reference lists of retrieved articles and included studies in any language. Selection criteria All RCTs of PTSD (including both placebo controlled and comparative trials), whether published or unpublished, but completed prior to the end of 1999 were considered for the review. Data collection and analysis Selected RCTs were independently assessed and collated by 2 raters, and Review Manager (RevMan) software was used to capture data on treatment response and PTSD symptom ratings. Ratings of subtypes of PTSD symptoms (intrusive/re-experiencing, avoidant/numbing, hyperarousal), of comorbid symptoms (depression, anxiety), and of quality of life were included where possible. A range of additional information, which may explain possible clinical and methodological heterogeneity amongst the trials, was also captured. Summary statistics for dichotomous and continous measures were calculated, heterogeneity was assessed, and subgroup/sensitivity analyses undertaken. Main results 15 short-term (12 weeks or less) RCTs were found, of which 9 had sufficient data for inclusion in the analysis. Methodological limitations were particularly apparent in early work; these included short (5 weeks or less) duration of trials and a reliance on self-report scales (rather than use of standardized clinician-rated scales). Despite these and other potentially important differences between the trials, many trials demonstrated efficacy for medication over placebo. Summary statistics were calculated for the Clinical Global Impressions scale change item (CGI-C) or close equivalent from 10 sets of data including various antidepressants and other agents - the proportion of non-responders was lower in the pharmacotherapy group than in the control group (relative risk (95% CI) = 0.72 (0.64, 0.83)). Similarly, summary statistics for the intrusion, avoidance and total scales of the Impact of Events Scale (IES) from 4sets of data again including various agents showed a statistically (and clinically) significant difference between medication and placebo (Weighted Mean Difference (95% CI) = -3.81 (-6.72,-0.91), -3.31(-5.24,-1.37), -7.18 (-11.86,-2.50) respectively). Authors' conclusions Medication treatments can be effective in PTSD, acting to reduce its core symptoms, and should be considered as part of the treatment of this disorder. The existing evidence base does not provide sufficient data to suggest particular predictors of response to treatment, or to demonstrate that any particular class of medication is more effective or better tolerated than any other. However, the largest trials showing efficacy to date have been with the SSRIs, and in contrast, there have been negative studies of some agents. Given the high prevalence and enormous personal and societal costs of PTSD, there is a need for additional controlled trials in this area. Additional questions for future research include the effects of medication on quality of life in PTSD, appropriate dose and duration of medication, the use of medication in different trauma groups, in pediatric and geriatric subjects, and the value of early (prophylactic), combined (with psychotherapy), and long-term (maintenance) medication treatment.

Exercise in prevention and treatment of anxiety and depression among children and young people

Abstract: Depression and anxiety are common psychological disorders for children and adolescents. Psychological (e.g. psychotherapy), psychosocial (e.g. cognitive behavioral therapy) and biological (e.g. SSRIs or tricyclic drugs) treatments are the most common treatments being offered. The large variety of therapeutic interventions give rise to questions of clinical effectiveness and side effects. Physical exercise is inexpensive with few, if any, side effects. The objective of this review is to assess the effects of exercise interventions in reducing or preventing anxiety or depression in children and young people up to 20 years of age.

Oral appliances for obstructive sleep apnoea

Abstract: Background Obstructive sleep apnoea-hypopnoea (OSAH) is a syndrome characterised by recurrent episodes of partial or complete upper airway obstruction during sleep that are usually terminated by an arousal. Nasal continuous positive airway pressure (CPAP) is the primary treatment for OSAH , but many patients are unable or unwilling to comply with this treatment. Oral appliances (OA) are an alternative treatment for OSAH. Objectives The objective was to review the effects of OA in the treatment of OSAH in adults. Search strategy We searched the Cochrane Airways Group Specialised Register. Searches were current as of June 2005. Reference lists of articles were also searched. Selection criteria Randomised trials comparing OA with control or other treatments in adults with OSAH . Data collection and analysis Two authors independently extracted data and assessed trial quality. Study authors were contacted for missing information. Main results Sixteen studies (745 participants) met the inclusion criteria. All the studies had some shortcomings, such as small sample size, under-reporting of methods and data, and lack of blinding. OA versus control appliances (six studies): OA reduced daytime sleepiness in two crossover trials (WMD -1.81;95%CI -2.72 to -0.90), and improved apnoea-hypopnoea index (AHI) (-10.78; 95% CI-15.53 to -6.03 parallel group data - five studies). OA versus CPAP (nine studies): OA were less effective than CPAP in reducing apnoea-hypopnoea index (parallel group studies: WMD 13 (95% CI 7.63 to 18.36), two trials; crossover studies: WMD 7.97; (95% CI 6.38 to 9.56, seven trials). However, no significant difference was observed on symptom scores. CPAP was more effective at improving minimum arterial oxygen saturation during sleep compared with OA. In two small crossover studies, participants preferred OA therapy to CPAP. OA versus corrective upper airway surgery (one study): Symptoms of daytime sleepiness were initially lower with surgery, but this difference disappeared at 12 months. AHI did not differ significantly initially, but did so after 12 months in favour of OA. Authors' conclusions There is increasing evidence suggesting that OA improves subjective sleepiness and sleep disordered breathing compared with a control. CPAP appears to be more effective in improving sleep disordered breathing than OA. The difference in symptomatic response between these two treatments is not significant, although it is not possible to exclude an effect in favour of either therapy. Until there is more definitive evidence on the effectiveness of OA in relation to CPAP, with regard to symptoms and long-term complications, it would appear to be appropriate to recommend OA therapy to patients with mild symptomatic OSAH, and those patients who are unwilling or unable to tolerate CPAP therapy. Future research should recruit patients with more severe symptoms of sleepiness, to establish whether the response to therapy differs between subgroups in terms of quality of life, symptoms and persistence with usage. Long-term data on cardiovascular health are required.

Decompressive craniectomy for the treatment of refractory high intracranial pressure in traumatic brain injury

Abstract: Background High intracranial pressure (ICP) is the most frequent cause of death and disability after a severe traumatic brain injury (TBI) High ICP is usually treated with general maneuvers (normothermia, sedation, etc) and a set of first-line therapeutic measures (moderate hypocapnia, mannitol, etc) When these measures fail to control high ICP, second-line therapies are initiated Of these, barbiturates, hyperventilation, moderate hypothermia, or removal of a variable amount of skull bone (decompressive craniectomy) are used Objectives To assess the effects of secondary decompressive craniectomy on outcomes and quality of life for patients with severe TBI in whom conventional medical therapeutic measures have failed to control a raised ICP Search methods We searched the following electronic databases: Cochrane Injuries Group Specialised Register, CENTRAL (The Cochrane Library), MEDLINE, PubMed, EMBASE, ZETOC, CINAHL, and Controlled Trials metaRegister (wwwcontrolled-trialscom/mrct/search) We searched the Internet using Google Scholar (http://scholargooglecom) and handsearched relevant conference proceedings We also contacted experts in the field and authors of included studies The searches were last conducted in May 2008 Selection criteria Randomized or quasi-randomized studies assessing patients over the age of 12 months with severe TBI who underwent decompressive craniectomy to control ICP refractory to conventional medical treatments Data collection and analysis The electronic search and handsearching results were examined for reports of potentially relevant trials, which were then retrieved in full The selection criteria were applied, data extraction performed, and studies assessed for methodological quality Main results We found only one trial with 27 participants, conducted in a pediatric population Decompressive craniectomy was associated with a risk ratio (RR) for death of 054 (95% CI 017 to 172) and a RR of 054 (95% CI 029 to 101) for an unfavorable outcome (death, vegetative status, or severe disability 6 to 12 months after injury) To date, no results are available to confirm or refute the effectiveness of decompressive craniectomy in adults Authors' conclusions There is no evidence from randomized controlled trials that supports the routine use of secondary decompressive craniectomy to reduce unfavorable outcomes in adults with severe TBI and refractory high ICP In the study with a pediatric population, decompressive craniectomy reduced the risk of death and unfavorable outcomes Despite the wide CI for death and the small sample size of this one identified study, the treatment may be justified in patients below the age of 18 years when maximal medical treatment has failed to control ICP There are two ongoing randomized controlled trials of decompressive craniectomy (RescueICP and DECRA) that will allow further conclusions on the efficacy of this procedure in adults

Interventions to improve water quality for preventing diarrhoea (review).

Abstract: Diarrhoeal diseases are a leading cause of mortality and morbidity especially among young children in developing countries. While many of the infectious agents associated with diarrhoeal disease are potentially waterborne the evidence for reducing diarrhoea in settings where it is endemic by improving the microbiological quality of drinking water has been equivocal. The objectives were to assess the effectiveness of interventions to improve water quality for preventing diarrhoea. We searched the Cochrane Infectious Diseases Group Specialized Register CENTRAL MEDLINE EMBASE and LILACS. We also hand-searched relevant conference proceedings contacted researchers and organizations working in the field and checked references from identified studies. Randomized and quasi-randomized controlled trials comparing interventions aimed at improving the microbiological quality of drinking water with no intervention in children and adults living in settings where diarrhoeal disease is endemic. Two authors independently assessed trial quality and extracted data. We used meta-analyses to estimate pooled measures of effect where appropriate and investigated potential sources of heterogeneity using subgroup analyses. Thirty trials (including 38 independent comparisons) covering over 53000 participants met the inclusion criteria. Differences between the trials limited the comparability of results and pooling by meta-analysis. In general the evidence suggests that interventions to improve the microbiological quality of drinking water are effective in preventing diarrhoea both for populations of all ages and children less than five years old. Subgroup analyses suggest that household interventions are more effective in preventing diarrhoea than interventions at the water source. Effectiveness was positively associated with compliance. Effectiveness was not conditioned on the presence of improved water supplies or sanitation in the study setting and was not enhanced by combining the intervention to improve water quality with other common environmental interventions intended to prevent diarrhoea. Interventions to improve water quality are generally effective in preventing diarrhoea and interventions to improve water quality at the household level are more effective than those at the source. Significant heterogeneity among the trials suggests that the actual level of effectiveness may depend on a variety of conditions that research to date cannot fully explain. Rigorous blinded multi-arm randomized controlled trials conducted over a longer duration in a variety if settings may help clarify the potential effectiveness. (authors)

Influenza vaccine for patients with chronic obstructive pulmonary disease

Abstract: Background: Influenza vaccinations are currently recommended in the care of people with COPD, but these recommendations are based largely on evidence from observational studies with very few randomised controlled trials (RCTs) reported. Influenza infection causes excess morbidity and mortality in COPD patients but there is also the potential for influenza vaccination to cause adverse effects or not to be cost effective. Objectives: To evaluate the evidence from RCTs for a treatment effect of influenza vaccination in COPD subjects. Outcomes of interest were exacerbation rates, hospitalisations, mortality, lung function and adverse effects. Search strategy: We searched the Cochrane Airways Group Specialised Register of trials, and reference lists of articles. References were also provided by a number of drug companies we contacted. The latest search was carried out in May 2009. Selection criteria: RCTs that compared live or inactivated virus vaccines with placebo, either alone or with another vaccine in persons with COPD. Studies of people with asthma were excluded. Data collection and analysis: Two reviewers extracted data. All entries were double checked. Study authors and drug companies were contacted for missing information. Main results: Eleven trials were included but only six of these were specifically performed in COPD patients. The others were conducted on elderly and high-risk individuals, some of whom had chronic lung disease. Inactivated vaccine in COPD patients resulted in a significant reduction in the total number of exacerbations per vaccinated subject compared with those who received placebo (weighted mean difference (WMD) -0.37, 95% confidence interval -0.64 to -0.11, P = 0.006). This was due to the reduction in "late" exacerbations occurring after three or four weeks (WMD -0.39, 95% CI -0.61 to -0.18, P = 0.0004). In Howells 1961, the number of patients experiencing late exacerbations was also significantly less (odds ratio 0.13, 95% CI 0.04 to 0.45, P = 0.002). Both Howells 1961 and Wongsurakiat 2004 found that inactivated influenza vaccination reduced influenza -related respiratory infections (WMD 0.19, 95% CI 0.07 to 0.48, P = 0.0005). In both COPD patient and in elderly patients (only a minority of whom had COPD), there was a significant increase in the occurrence of local adverse reactions in vaccinees, but the effects were generally mild and transient. There was no evidence of an effect of intranasal live attenuated virus when this was added to inactivated intramuscular vaccination. The studies are too small to have detected any effect on mortality. An updated search conducted in September 2001 did not yield any further studies. A search in 2003 yielded two further reports of the same eligible study Gorse 2003. A search in 2004 yielded two reports of the another eligible study Wongsurakiat 2004. The author informed us of another report of the same study Wongsurakiat 2004/2. An update search inMay 2006 did not identify any new studies for consideration. Authors' conclusions: It appears, from the limited number of studies performed, that inactivated vaccine reduces exacerbations in COPD patients. The size of effect was similar to that seen in large observational studies, and was due to a reduction in exacerbations occurring three or more weeks after vaccination, and due to influenza. There is a mild increase in transient local adverse effects with vaccination, but no evidence of an increase in early exacerbations. Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Early enteral nutrition within 24h of colorectal surgery versus later commencement of feeding for postoperative complications

Abstract: Background The role of early postoperative enteral nutrition after gastrointestinal surgery is controversial. Traditional management consist of 'nil by mouth', where patients receive fluids followed by solids when tolerated. Although several trials have implicated lower incidence of septic complications and faster wound healing upon early enteral feeding, other trials have shown opposite results. The immediate advantage of caloric intake could be a faster recovery with fewer complications, to be evaluated systematically. Objectives To evaluate whether early commencement of postoperative enteral nutrition compared to traditional management (no nutritional supply) is associated with fewer complications in patients undergoing gastrointestinal surgery Search strategy We searched the Cochrane Central Register of Controlled Trials, PUBMED, EMBASE, and LILACS from 1979 (first RCT published) to March 2006. We manually scanned the references from the relevant articles, and consulted primary authors for additional information. Selection criteria We looked for randomised controlled trials (RCT's) comparing early commencement of feeding (within 24 hours) with no feeding in patients undergoing gastrointestinal surgery. Early enteral nutrition is defined as all oral intakes (i.e. registered oral intake, supplemented oral feeding) and any kind of tube feeding (gastric, duodenal or jejunal) containing caloric content. No feeding is traditional management, defined as none caloric oral intake or any kind of tube feeding before bowel function. The definition 'no nutrition' includes non caloric placebo and water. Data collection and analysis The three authors independently assessed the identified trials, and extracted the relevant data using a specifically developed data extraction sheet. Primary end points of interest were: Wound infections and intraabdominal abscesses, postoperative complications such as acute myocardial infarction, postoperative thrombosis or pneumonia, anastomotic leakages, mortality, length of hospital stay, and significant adverse effects. We combined data to estimate the common relative risk of postoperative complications, and calculated the associated 95% confidence intervals. For analysis, we used fixed effects model (risk ratios to summarise the treatment effect) whenever feasible. The treatment effect on length of stay was estimated using effect size (presented as mean +/- SD). Some outcomes were not analysed but presented in a descriptive way. We used a random effects model to estimate overall risk ratio and effect size. Main results We identified thirteen randomised controlled trials, with a total of 1173 patients, all undergoing gastrointestinal surgery. Individual clinical complications failed to reach statistical significance, but the direction of effect indicates that earlier feeding may reduce the risk of post surgical complications. Mortality was the only outcome showing a significant benefit, but not necessarily associated with early commencement of feeding, as the reported cause of death was anastomotic leakage, reoperation, and acute myocardial infarction. Authors' conclusions Although non-significant results, there is no obvious advantage in keeping patients 'nil by mouth' following gastrointestinal surgery, and this review support the notion on early commencement of enteral feeding.

Aerobic exercise for women during pregnancy

Abstract: Background Physiological responses of the fetus (especially increase in heart rate) to single, brief bouts of maternal exercise have been documented frequently. Many pregnant women wish to engage in aerobic exercise during pregnancy, but are concerned about possible adverse effects on the outcome of pregnancy. Objectives To assess the effects of advising healthy pregnant women to engage in regular aerobic exercise (at least two to three times per week), or to increase or reduce the intensity, duration, or frequency of such exercise, on physical fitness, the course of labour and delivery, and the outcome of pregnancy. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2009), MEDLINE (1966 to August 2009), EMBASE (1980 to August 2009), Conference Papers Index (earliest to August 2009), contacted researchers in the field and searched reference lists of retrieved articles. Selection criteria Acceptably controlled trials of prescribed exercise programs in healthy pregnant women. Data collection and analysis Both review authors independently assessed trial quality and extracted data. We contacted study authors for additional information. Main results We included 14 trials involving 1014 women. The trials were small and not of high methodologic quality. Of the nine trials reporting on physical fitness, six reported significant improvement in physical fitness in the exercise group, although inconsistencies in summary statistics and measures used to assess fitness prevented quantitative pooling of results. Eleven trials reported on pregnancy outcomes. A pooled increased risk of preterm birth (risk ratio 1.82, 95% confidence interval (CI) 0.35 to 9.57) with exercise, albeit statistically non-significant, does not cohere with the absence of effect on mean gestational age (mean difference +0.10, 95% CI -0.11 to +0.30 weeks), while the results bearing on growth of the fetus are inconsistent. One small trial reported that physically fit women who increased the duration of exercise bouts in early pregnancy and then reduced that duration in later pregnancy gave birth to larger infants with larger placentas. Authors' conclusions Regular aerobic exercise during pregnancy appears to improve (or maintain) physical fitness. Available data are insufficient to infer important risks or benefits for the mother or infant. Larger and better trials are needed before confident recommendations can be made about the benefits and risk of aerobic exercise in pregnancy.

Alcoholics Anonymous and other 12‐step programmes for alcohol dependence

Abstract: Alcoholics Anonymous (AA) is an international organization of recovering alcoholics that offers emotional support through self-help groups and a model of abstinence for people recovering from alcohol dependence, using a 12-step approach. Although it is the most common, AA is not the only 12-step intervention available there are other 12-step approaches (labelled Twelve Step Facilitation (TSF)). Objectives To assess the effectiveness of AA or TSF programmes compared to other psychosocial interventions in reducing alcohol intake, achieving abstinence, maintaining abstinence, improving the quality of life of affected people and their families, and reducing alcohol associated accidents and health problems. Selection criteria Studies involving adults (>18) of both genders with alcohol dependence attending on a voluntary or coerced basis AA or TSF programmes comparing no treatment, other psychological interventions, 12-step variants were used. Eight trials involving 3417 people were included. AA may help patients to accept treatment and keep patients in treatment more than alternative treatments, though the evidence for this is from one small study that combined AA with other interventions and should not be regarded as conclusive. Other studies reported similar retention rates regardless of treatment group. Three studies compared AA combined with other interventions against other treatments and found few differences in the amount of drinks and percentage of drinking days. Severity of addiction and drinking consequence did not seem to be differentially influenced by TSF versus comparison treatment interventions, and no conclusive differences in treatment drop out rates were reported. Included studies did not allow a conclusive assessment of the effect of TSF in promoting complete abstinence.

Patient controlled opioid analgesia versus conventional opioid analgesia for postoperative pain.

Abstract: Background Patients may control postoperative pain by self-administration of intravenous opioids using devices designed for this purpose (patient controlled analgesia or PCA). A 1992 meta-analysis by Ballantyne found a strong patient preference for PCA over conventional analgesia but disclosed no differences in analgesic consumption or length of postoperative hospital stay. Although Ballantyne's meta-analysis found that PCA did have a small but statistically significant benefit upon pain intensity, Walder's review in 2001 did not find a significant differences in pain intensity and pain relief between PCA and conventionally treated groups. Objectives To evaluate the efficacy of PCA versus conventional analgesia (such as a nurse administering an analgesic upon a patient's request) for postoperative pain control. Search methods Randomized controlled trials (RCTs) were identified from the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2004, Issue 3), MEDLINE (1966 to 2004), and EMBASE (1994 to 2004). Additional reports were identified from the reference lists of retrieved papers. Selection criteria RCTs of PCA versus conventional analgesia that employed pain intensity as a primary or secondary outcome were selected. These trials included RCTs that compared PCA without a continuous background infusion versus conventional parenteral analgesic regimens. Studies that explicitly stated they involved patients with chronic pain were excluded. Data collection and analysis Trials were scored using the Oxford Quality Scale. Meta-analyses were performed of outcomes that included analgesic efficacy assessed by a Visual Analog Scale (VAS), analgesic consumption, patient satisfaction, length of stay and adverse effects. A sufficient number of the retrieved trials reported these parameters to permit meta-analyses. Main results Fifty-five studies with 2023 patients receiving PCA and 1838 patients assigned to a control group met inclusion criteria. PCA provided better pain control and greater patient satisfaction than conventional parenteral 'as-needed' analgesia. Patients using PCA consumed higher amounts of opioids than the controls and had a higher incidence of pruritus (itching) but had a similar incidence of other adverse effects. There was no difference in the length of hospital stay. Authors' conclusions This review provides evidence that PCA is an efficacious alternative to conventional systemic analgesia for postoperative pain control.

Anticholinergic drugs versus placebo for overactive bladder syndrome in adults

Abstract: Background Around 16% of adults have symptoms of overactive bladder (urgency with frequency and/or urge incontinence). The prevalence increases with age. Anticholinergic drugs are commonly used to treat this condition. Objectives To determine the effects of anticholinergic drugs for the treatment of overactive bladder syndrome. Search methods We searched the Cochrane Incontinence Group Specialised Trials Register (searched 14 June 2005) and the reference lists of relevant articles. Selection criteria Randomised or quasi-randomised trials in adults with overactive bladder syndrome that compared an anticholinergic drug with placebo treatment or no treatment. Data collection and analysis Two reviewer authors independently assessed eligibility, trial quality and extracted data. Data were processed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2005). Main results Sixty -one trials, 42 with parallel-group designs and 19 crossover trials were included (11,956 adults). Most trials were described as double-blind but were variable in other aspects of quality. The crossover trials did not present data in a way that allowed inclusion in the meta-analysis. Nine medications were tested: darifenacin; emepronium bromide or carrageenate; oxybutynin; propiverine; propantheline; tolterodine; trospium chloride; and solifenacin. One trial included the newer, slow release formulation of tolterodine. At the end of the treatment period, cure or improvement (relative risk (RR) 1.39, 95%CI 1.28 to 1.51), difference in leakage episodes in 24 hours (weighted mean difference (WMD) -0.54; 95% CI -0.67 to -0.41) and difference in number of voids in 24 hours (WMD -0.69; 95%CI -0.84 to -0.54) were statistically significant favouring medication. Statistically significant but modest sized improvements in quality of life scores were reported in recently completed trials. There was three times the rate of dry mouth in the medication group (RR 3.00 95% CI 2.70 to 3.34) but no statistically significant difference in withdrawal (RR 1.11, 95% CI 0.91 to 1.36). Sensitivity analysis, while limited by small numbers of trials, showed little likelihood that the effects were modified by age, sex, diagnosis, or choice of drug. Authors' conclusions The use of anticholinergic drugs by people with overactive bladder syndrome results in statistically significant improvements in symptoms. Recent trials suggest that this is associated with modest improvement in quality of life. Dry mouth is a common side effect of therapy but did not seem to have an effect on the numbers of withdrawals. It is not clear whether any benefits are sustained during long-term treatment or after treatment stops.

Interventions for promoting the initiation of breastfeeding

Abstract: Background Despite the widely documented health advantages of breastfeeding over formula feeding, initiation rates remain relatively low in many high-income countries, particularly among women in lower income groups. Objectives To evaluate the effectiveness of interventions which aim to encourage women to breastfeed in terms of changes in the number of women who start to breastfeed. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (July 2007), handsearched the Journal of Human Lactation, Health Promotion International and Health Education Quarterly from inception to 15 August 2007, and scanned reference lists of all articles obtained. Selection criteria Randomised controlled trials, with or without blinding, of any breastfeeding promotion intervention in any population group except women and infants with a specific health problem. Data collection and analysis One review author independently extracted data and assessed trial quality, checked by a second author. We contacted investigators to obtain missing information. Main results Eleven trials were included. Statistical analyses were conducted on data from eight trials (1553 women). Five studies (582 women) on low incomes in the USA with typically low breastfeeding rates showed breastfeeding education had a significant effect on increasing initiation rates compared to standard care (risk ratio (RR) 1.57, 95% confidence interval (CI) 1.15 to 2.15, P = 0.005). Subgroup analyses showed that one-to-one, needs-based, informal repeat education sessions and generic, formal antenatal education sessions are effective in terms of an increase in breastfeeding rates among women on low incomes regardless of ethnicity and feeding intention. Needs-based, informal peer support in the antenatal and postnatal periods was also shown to be effective in one study conducted among Latina women who were considering breastfeeding in the USA (RR 4.02, 95% CI 2.63 to 6.14, P < 0.00001). Authors' conclusions This review showed that health education and peer support interventions can result in some improvements in the number of women beginning to breastfeed. Findings from these studies suggest that larger increases are likely to result from needs-based, informal repeat education sessions than more generic, formal antenatal sessions. These findings are based only on studies conducted in the USA, among women on low incomes with varied ethnicity and feeding intention, and this raises some questions regarding generalisability to other settings.

Patient support and education for promoting adherence to highly active antiretroviral therapy for HIV/AIDS

Abstract: Background Adherence to prescribed regimens is required to derive maximal benefit from many highly active antiretroviral therapy (HAART) regimens in people living with HIV/AIDS. Objectives To conduct a systematic review of the research literature on the effectiveness of patient support and education to improve adherence to HAART. Search methods A systematic search of electronic databases was performed from January 1996 to May 2005. Selection criteria Randomized controlled trials examining the effectiveness of patient support and education to improve adherence to HAART were considered for inclusion. Only those studies that measured adherence at a minimum of six weeks were included. Data collection and analysis Study selection, quality assessments and data abstraction were performed independently by two reviewers. Main results Nineteen studies involving a total of 2,159 participants met criteria for inclusion. It was not possible to conduct a meta-analysis due to study heterogeneity with respect to populations, interventions, comparison groups, outcomes, and length of follow-up. Sample sizes ranged from 22 to 367. The populations studied ranged from general HIV-positive populations to studies focusing exclusively on children, women, Latinos, or adults with a history of alcohol dependence, to studies focusing almost exclusively on men. Study interventions included cognitive behavioral therapy, motivational interviewing, medication management strategies, and interventions indirectly targeting adherence, such as programs directed to reduce risky sexual behaviours. Ten studies demonstrated a beneficial effect of the intervention on adherence. We found that interventions targeting practical medication management skills, those administered to individuals vs groups, and those interventions delivered over 12 weeks or more were associated with improved adherence outcomes. We also found that interventions targeting marginalized populations such as women, Latinos, or patients with a past history of alcoholism were not successful at improving adherence. We were unable to determine whether effective adherence interventions were associated with improved virological or immunological outcomes. Most studies had several methodological shortcomings leaving them vulnerable to potential biases. Authors' conclusions We found evidence to support the effectiveness of patient support and education interventions intended to improve adherence to antiretroviral therapy. Interventions targeting practical medication management skills, those interventions administered to individuals vs groups, and those interventions delivered over 12 weeks or more were associated with improved adherence outcomes. There is a need for standardization and increased methodological rigour in the conduct of adherence trials.

Complementary and alternative therapies for pain management in labour

Abstract: Background Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined currently available evidence supporting the use of alternative and complementary therapies for pain management in labour. Objectives To examine the effects of complementary and alternative therapies for pain management in labour on maternal and perinatal morbidity. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (February 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2006, Issue 1), MEDLINE (1966 to February 2006), EMBASE (1980 to February 2006) and CINAHL (1980 to February 2006). Selection criteria The inclusion criteria included published and unpublished randomised controlled trials comparing complementary and alternative therapies (but not biofeedback) with placebo, no treatment or pharmacological forms of pain management in labour. All women whether primiparous or multiparous, and in spontaneous or induced labour, in the first and second stage of labour were included. Data collection and analysis Meta-analysis was performed using relative risks for dichotomous outcomes and mean differences for continuous outcomes. The outcome measures were maternal satisfaction, use of pharmacological pain relief and maternal and neonatal adverse outcomes. Main results Fourteen trials were included in the review with data reporting on 1537 women using different modalities of pain management; 1448 women were included in the meta-analysis. Three trials involved acupuncture (n = 496), one audio-analgesia (n = 24), two trials acupressure (n = 172), one aromatherapy (n = 22), five trials hypnosis (n = 729), one trial of massage (n = 60), and relaxation (n = 34). The trials of acupuncture showed a decreased need for pain relief (relative risk (RR) 0.70, 95% confidence interval (CI) 0.49 to 1.00, two trials 288 women). Women taught self-hypnosis had decreased requirements for pharmacological analgesia (RR 0.53, 95% CI 0.36 to 0.79, five trials 749 women) including epidural analgesia (RR 0.30, 95% CI 0.22 to 0.40) and were more satisfied with their pain management in labour compared with controls (RR 2.33, 95% CI 1.15 to 4.71, one trial). No differences were seen for women receiving aromatherapy, or audio analgesia. Authors' conclusions Acupuncture and hypnosis may be beneficial for the management of pain during labour; however, the number of women studied has been small. Few other complementary therapies have been subjected to proper scientific study.

Guided tissue regeneration for periodontal infra‐bony defects

Abstract: BACKGROUND: Conventional treatment of destructive periodontal (gum) disease arrests the disease but does not usually regain the bone support or connective tissue lost in the disease process. Guided tissue regeneration (GTR) is a surgical procedure that specifically aims to regenerate the periodontal tissues when the disease is advanced and could overcome some of the limitations of conventional therapy. OBJECTIVES: To assess the efficacy of GTR in the treatment of periodontal infra-bony defects measured against conventional surgery (open flap debridement (OFD)) and factors affecting outcomes. SEARCH STRATEGY: We conducted an electronic search of the Cochrane Oral Health Group Trials Register, MEDLINE and EMBASE up to April 2004. Handsearching included Journal of Periodontology, Journal of Clinical Periodontology, Journal of Periodontal Research and bibliographies of all relevant papers and review articles up to April 2004. In addition, we contacted experts/groups/companies involved in surgical research to find other trials or unpublished material or to clarify ambiguous or missing data and posted requests for data on two periodontal electronic discussion groups. SELECTION CRITERIA: Randomised, controlled trials (RCTs) of at least 12 months duration comparing guided tissue regeneration (with or without graft materials) with open flap debridement for the treatment of periodontal infra-bony defects. Furcation involvements and studies specifically treating aggressive periodontitis were excluded. DATA COLLECTION AND ANALYSIS: Screening of possible studies and data extraction was conducted independently. The methodological quality of studies was assessed in duplicate using individual components and agreement determined by Kappa scores. Methodological quality was used in sensitivity analyses to test the robustness of the conclusions. The Cochrane Oral Health Group statistical guidelines were followed and the results expressed as mean differences (MD and 95% CI) for continuous outcomes and risk ratios (RR and 95% CI) for dichotomous outcomes calculated using random-effects models. Any heterogeneity was investigated. The primary outcome measure was change in clinical attachment. MAIN RESULTS: The search produced 626 titles, of these 596 were clearly not relevant to the review. The full text of 32 studies of possible relevance was obtained and 15 studies were excluded. Therefore 17 RCTs were included in this review, 16 studies testing GTR alone and two testing GTR+bone substitutes (one study had both test treatment arms).No tooth loss was reported in any study although these data are incomplete where patient follow up was not complete. For attachment level change, the mean difference between GTR and OFD was 1.22 mm (95% CI Random Effects: 0.80 to 1.64, chi squared for heterogeneity 69.1 (df = 15), P < 0.001, I(2) = 78%) and for GTR + bone substitutes was 1.25 mm (95% CI 0.89 to 1.61, chi squared for heterogeneity 0.01 (df = 1), P = 0.91). GTR showed a significant benefit when comparing the numbers of sites failing to gain 2 mm attachment with risk ratio 0.54 (95% CI Random Effects: 0.31 to 0.96, chi squared for heterogeneity 8.9 (df = 5), P = 0.11). The number needed to treat (NNT) for GTR to achieve one extra site gaining 2 mm or more attachment over open flap debridement was therefore 8 (95% CI 5 to 33), based on an incidence of 28% of sites in the control group failing to gain 2 mm or more of attachment. For baseline incidences in the range of the control groups of 3% and 55% the NNTs are 71 and 4. Probing depth reduction was greater for GTR than OFD: 1.21 mm (95% CI 0.53 to 1.88, chi squared for heterogeneity 62.9 (df = 10), P < 0.001, I(2) = 84%) or GTR + bone substitutes, weighted mean difference 1.24 mm (95% CI 0.89 to 1.59, chi squared for heterogeneity 0.03 (df = 1), P = 0.85). For gingival recession, a statistically significant difference between GTR and open flap debridement controls was evident (mean difference 0.26 mm (95% CI Random Effects: 0.08, 0.43, chi squared for heterogeneity 2.7 (df = 8), P = 0.95), with a greater change in recession from baseline for the control group. Regarding hard tissue probing at surgical re-entry, a statistically significant greater gain was found for GTR compared with open flap debridement. This amounted to a weighted mean difference of 1.39 mm (95% CI 1.08 to 1.71, chi squared for heterogeneity 0.85 (df = 2), P = 0.65). For GTR + bone substitutes the difference was greater, with mean difference 3.37 mm (95% CI 3.14 to 3.61). Adverse effects were generally minor although with an increased treatment time for GTR. Exposure of the barrier membrane was frequently reported with a lack of evidence of an effect on healing. AUTHORS' CONCLUSIONS: GTR has a greater effect on probing measures of periodontal treatment than open flap debridement, including improved attachment gain, reduced pocket depth, less increase in gingival recession and more gain in hard tissue probing at re-entry surgery. However there is marked variability between studies and the clinical relevance of these changes is unknown. As a result, it is difficult to draw general conclusions about the clinical benefit of GTR. Whilst there is evidence that GTR can demonstrate a significant improvement over conventional open flap surgery, the factors affecting outcomes are unclear from the literature and these might include study conduct issues such as bias. Therefore, patients and health professionals need to consider the predictability of the technique compared with other methods of treatment before making final decisions on use. Since trial reports were often incomplete, we recommend that future trials should follow the CONSORT statement both in their conduct and reporting. There is therefore little value in future research repeating simple, small efficacy studies. The priority should be to identify factors associated with improved outcomes as well as investigating outcomes relevant to patients. Types of research might include large observational studies to generate hypotheses for testing in clinical trials, qualitative studies on patient-centred outcomes and trials exploring innovative analytic methods such as multilevel modelling. Open flap surgery should remain the control comparison in these studies.

Marine oil, and other prostaglandin precursor, supplementation for pregnancy uncomplicated by pre‐eclampsia or intrauterine growth restriction

Abstract: Background Population studies have shown that higher intakes of marine foods during pregnancy are associated with longer gestations, higher infant birthweights and a low incidence of pre-eclampsia. It is suggested that the fatty acids of marine foods may be the underlying cause of these associations. Objectives To estimate the effects of marine oil, and other prostaglandin precursor, supplementation during pregnancy on the risk of pre-eclampsia, preterm birth, low birthweight and small-for-gestational age. Search methods We searched the Cochrane Pregnancy and Childbirth Group Trials Register (December 2005), The Cochrane Central Register of Controlled Trials (The Cochrane Library 2005, Issue 2) and MEDLINE (1966 to April 2005). Selection criteria All randomised trials comparing oral marine oil, or other prostaglandin precursor, supplementation during pregnancy with either placebo or no treatment. Trials were excluded if their aim was to treat women with established pre-eclampsia or suspected intrauterine growth restriction. Data collection and analysis Two review authors independently assessed trials for inclusion, data extraction and trial quality. Main results Six trials, involving 2783 women, are included in this review. Three of these were rated as high quality, including the largest trial with 1477 women. Women allocated a marine oil supplement had a mean gestation that was 2.6 days longer than women allocated to placebo or no treatment (weighted mean difference (WMD), 2.55 days, 95% confidence interval (CI) 1.03 to 4.07 days; 3 trials, 1621 women). This was not reflected in a clear difference between the two groups in the relative risk (RR) of birth before 37 completed weeks, although women allocated marine oil did have a lower risk of giving birth before 34 completed weeks' gestation (RR 0.69, 95% CI 0.49 to 0.99; 2 trials, 860 women). Birthweight was slightly greater in infants born to women in the marine oil group compared with control (WMD 47 g, 95% CI 1 g to 93 g; 3 trials, 2440 women). However, there were no overall differences between the groups in the proportion of low birthweight or small-for-gestational age babies. There was no clear difference in the relative risk of pre-eclampsia between the two groups. Authors' conclusions There is not enough evidence to support the routine use of marine oil, or other prostaglandin precursor, supplements during pregnancy to reduce the risk of pre-eclampsia, preterm birth, low birthweight or small-for-gestational age.