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Showing papers in "Cochrane Database of Systematic Reviews in 2009"


Journal ArticleDOI
TL;DR: It is shown that combined behavioural lifestyle interventions compared to standard care or self-help can produce a significant and clinically meaningful reduction in overweight in children and adolescents.
Abstract: Childhood obesity affects both the physical and psychosocial health of children and may put them at risk of ill health as adults. More information is needed about the best way to treat obesity in children and adolescents. In this review, 64 studies were examined including 54 studies on lifestyle treatments (with a focus on diet, physical activity or behaviour change) and 10 studies on drug treatment to help overweight and obese children and their families with weight control. No surgical treatment studies were suitable to include in this review. This review showed that lifestyle programs can reduce the level of overweight in child and adolescent obesity 6 and 12 months after the beginning of the program. In moderate to severely obese adolescents, a reduction in overweight was found when either the drug orlistat, or the drug sibutramine were given in addition to a lifestyle program, although a range of adverse effects was also noted. Information on the long-term outcome of obesity treatment in children and adolescents was limited and needs to be examined in some high quality studies.

1,758 citations


Journal ArticleDOI
TL;DR: Educational meetings alone or combined with other interventions, can improve professional practice and healthcare outcomes for the patients and is most likely to be small and similar to other types of continuing medical education, such as audit and feedback, and educational outreach visits.
Abstract: Background Educational meetings are widely used for continuing medical education. Previous reviews found that interactive workshops resulted in moderately large improvements in professional practice, whereas didactic sessions did not. Objectives To assess the effects of educational meetings on professional practice and healthcare outcomes. Search methods We updated previous searches by searching the Cochrane Effective Practice and Organisation of Care Group Trials Register and pending file, from 1999 to March 2006. Selection criteria Randomised controlled trials of educational meetings that reported an objective measure of professional practice or healthcare outcomes. Data collection and analysis Two authors independently extracted data and assessed study quality. Studies with a low or moderate risk of bias and that reported baseline data were included in the primary analysis. They were weighted according to the number of health professionals participating. For each comparison, we calculated the risk difference (RD) for dichotomous outcomes, adjusted for baseline compliance; and for continuous outcomes the percentage change relative to the control group average after the intervention, adjusted for baseline performance. Professional and patient outcomes were analysed separately. We considered 10 factors to explain heterogeneity of effect estimates using weighted meta-regression supplemented by visual analysis of bubble and box plots. Main results In updating the review, 49 new studies were identified for inclusion. A total of 81 trials involving more than 11,000 health professionals are now included in the review. Based on 30 trials (36 comparisons), the median adjusted RD in compliance with desired practice was 6% (interquartile range 1.8 to 15.9) when any intervention in which educational meetings were a component was compared to no intervention. Educational meetings alone had similar effects (median adjusted RD 6%, interquartile range 2.9 to 15.3; based on 21 comparisons in 19 trials). For continuous outcomes the median adjusted percentage change relative to control was 10% (interquartile range 8 to 32%; 5 trials). For patient outcomes the median adjusted RD in achievement of treatment goals was 3.0 (interquartile range 0.1 to 4.0; 5 trials). Based on univariate meta-regression analyses of the 36 comparisons with dichotomous outcomes for professional practice, higher attendance at the educational meetings was associated with larger adjusted RDs (P < 0.01); mixed interactive and didactic education meetings (median adjusted RD 13.6) were more effective than either didactic meetings (RD 6.9) or interactive meetings (RD 3.0). Educational meetings did not appear to be effective for complex behaviours (adjusted RD -0.3) compared to less complex behaviours; they appeared to be less effective for less serious outcomes (RD 2.9) than for more serious outcomes. Authors' conclusions Educational meetings alone or combined with other interventions, can improve professional practice and healthcare outcomes for the patients. The effect is most likely to be small and similar to other types of continuing medical education, such as audit and feedback, and educational outreach visits. Strategies to increase attendance at educational meetings, using mixed interactive and didactic formats, and focusing on outcomes that are likely to be perceived as serious may increase the effectiveness of educational meetings. Educational meetings alone are not likely to be effective for changing complex behaviours.

1,579 citations


Journal ArticleDOI
TL;DR: In this paper, the effects of interventions designed to reduce the incidence of falls in elderly people (living in the community, or in institutional or hospital care) were assessed using the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register.
Abstract: BACKGROUND: Approximately 30 per cent of people over 65 years of age and living in the community fall each year; the number is higher in institutions Although less than one fall in 10 results in a fracture, a fifth of fall incidents require medical attention OBJECTIVES: To assess the effects of interventions designed to reduce the incidence of falls in elderly people (living in the community, or in institutional or hospital care) SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2003), Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2003), MEDLINE (1966 to February 2003), EMBASE (1988 to 2003 Week 19), CINAHL (1982 to April 2003), The National Research Register, Issue 2, 2003, Current Controlled Trials (wwwcontrolled-trialscom accessed 11 July 2003) and reference lists of articles No language restrictions were applied Further trials were identified by contact with researchers in the field SELECTION CRITERIA: Randomised trials of interventions designed to minimise the effect of, or exposure to, risk factors for falling in elderly people Main outcomes of interest were the number of fallers, or falls Trials reporting only intermediate outcomes were excluded DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data Data were pooled using the fixed effect model where appropriate MAIN RESULTS: Sixty two trials involving 21,668 people were includedInterventions likely to be beneficial:Multidisciplinary, multifactorial, health/environmental risk factor screening/intervention programmes in the community both for an unselected population of older people (4 trials, 1651 participants, pooled RR 073, 95%CI 063 to 085), and for older people with a history of falling or selected because of known risk factors (5 trials, 1176 participants, pooled RR 086, 95%CI 076 to 098), and in residential care facilities (1 trial, 439 participants, cluster-adjusted incidence rate ratio 060, 95%CI 050 to 073) A programme of muscle strengthening and balance retraining, individually prescribed at home by a trained health professional (3 trials, 566 participants, pooled relative risk (RR) 080, 95% confidence interval (95%CI) 066 to 098) Home hazard assessment and modification that is professionally prescribed for older people with a history of falling (3 trials, 374 participants, RR 066, 95% CI 054 to 081) Withdrawal of psychotropic medication (1 trial, 93 participants, relative hazard 034, 95%CI 016 to 074) Cardiac pacing for fallers with cardioinhibitory carotid sinus hypersensitivity (1 trial, 175 participants, WMD -520, 95%CI -940 to -100) A 15 week Tai Chi group exercise intervention (1 trial, 200 participants, risk ratio 051, 95%CI 036 to 073) Interventions of unknown effectiveness:Group-delivered exercise interventions (9 trials, 1387 participants) Individual lower limb strength training (1 trial, 222 participants) Nutritional supplementation (1 trial, 46 participants) Vitamin D supplementation, with or without calcium (3 trials, 461 participants) Home hazard modification in association with advice on optimising medication (1 trial, 658 participants), or in association with an education package on exercise and reducing fall risk (1 trial, 3182 participants) Pharmacological therapy (raubasine-dihydroergocristine, 1 trial, 95 participants) Interventions using a cognitive/behavioural approach alone (2 trials, 145 participants) Home hazard modification for older people without a history of falling (1 trial, 530 participants) Hormone replacement therapy (1 trial, 116 participants) Correction of visual deficiency (1 trial, 276 participants)Interventions unlikely to be beneficial:Brisk walking in women with an upper limb fracture in the previous two years (1 trial, 165 participants) AUTHORS' CONCLUSIONS: Interventions to prevent falls that are likely to be effective are now available; less is known about their effectiveness in preventing fall-related injuries Costs per fall prevented have been established for four of the interventions and careful economic modelling in the context of the local healthcare system is important Some potential interventions are of unknown effectiveness and further research is indicated Language: en

1,496 citations


Journal ArticleDOI
TL;DR: Methadone is an effective maintenance therapy intervention for the treatment of heroin dependence as it retains patients in treatment and decreases heroin use better than treatments that do not utilise opioid replacement therapy, and does not show a statistically significant superior effect on criminal activity.
Abstract: BACKGROUND: Methadone maintenance was the first widely used opioid replacement therapy to treat heroin dependence, and it remains the best-researched treatment for this problem. Despite the widespread use of methadone in maintenance treatment for opioid dependence in many countries, it is a controversial treatment whose effectiveness has been disputed. OBJECTIVES: To evaluate the effects of methadone maintenance treatment (MMT) compared with treatments that did not involve opioid replacement therapy (i.e., detoxification, offer of drug-free rehabilitation, placebo medication, wait-list controls) for opioid dependence. SEARCH STRATEGY: We searched the following databases up to Dec 2008: the Cochrane Controlled Trials Register, EMBASE, PubMED, CINAHL, Current Contents, Psychlit, CORK [www. state.vt.su/adap/cork], Alcohol and Drug Council of Australia (ADCA) [www.adca.org.au], Australian Drug Foundation (ADF-VIC) [www.adf.org.au], Centre for Education and Information on Drugs and Alcohol (CEIDA) [www.ceida.net.au], Australian Bibliographic Network (ABN), and Library of Congress databases, available NIDA monographs and the College on Problems of Drug Dependence Inc. proceedings, the reference lists of all identified studies and published reviews; authors of identified RCTs were asked about other published or unpublished relevant RCTs. SELECTION CRITERIA: All randomised controlled clinical trials of methadone maintenance therapy compared with either placebo maintenance or other non-pharmacological therapy for the treatment of opioid dependence. DATA COLLECTION AND ANALYSIS: Reviewers evaluated the papers separately and independently, rating methodological quality of sequence generation, concealment of allocation and bias. Data were extracted independently for meta-analysis and double-entered. MAIN RESULTS: Eleven studies met the criteria for inclusion in this review, all were randomised clinical trials, two were double-blind. There were a total number of 1969 participants. The sequence generation was inadequate in one study, adequate in five studies and unclear in the remaining studies. The allocation of concealment was adequate in three studies and unclear in the remaining studies. Methadone appeared statistically significantly more effective than non-pharmacological approaches in retaining patients in treatment and in the suppression of heroin use as measured by self report and urine/hair analysis (6 RCTs, RR = 0.66 95% CI 0.56-0.78), but not statistically different in criminal activity (3 RCTs, RR=0.39; 95%CI: 0.12-1.25) or mortality (4 RCTs, RR=0.48; 95%CI: 0.10-2.39). AUTHORS' CONCLUSIONS: Methadone is an effective maintenance therapy intervention for the treatment of heroin dependence as it retains patients in treatment and decreases heroin use better than treatments that do not utilise opioid replacement therapy. It does not show a statistically significant superior effect on criminal activity or mortality.

1,415 citations


Journal ArticleDOI
TL;DR: A randomised controlled trials of methods to increase response to postal or electronic questionnaires found substantial heterogeneity among trial results in half of the strategies, which could improve the quality of health research.
Abstract: BACKGROUND: Postal and electronic questionnaires are widely used for data collection in epidemiological studies but non-response reduces the effective sample size and can introduce bias. Finding ways to increase response to postal and electronic questionnaires would improve the quality of health research. OBJECTIVES: To identify effective strategies to increase response to postal and electronic questionnaires. SEARCH STRATEGY: We searched 14 electronic databases to February 2008 and manually searched the reference lists of relevant trials and reviews, and all issues of two journals. We contacted the authors of all trials or reviews to ask about unpublished trials. Where necessary, we also contacted authors to confirm methods of allocation used and to clarify results presented. We assessed the eligibility of each trial using pre-defined criteria. SELECTION CRITERIA: Randomised controlled trials of methods to increase response to postal or electronic questionnaires. DATA COLLECTION AND ANALYSIS: We extracted data on the trial participants, the intervention, the number randomised to intervention and comparison groups and allocation concealment. For each strategy, we estimated pooled odds ratios (OR) and 95% confidence intervals (CI) in a random-effects model. We assessed evidence for selection bias using Egger's weighted regression method and Begg's rank correlation test and funnel plot. We assessed heterogeneity among trial odds ratios using a Chi(2) test and the degree of inconsistency between trial results was quantified using the I(2) statistic. MAIN RESULTS: PostalWe found 481 eligible trials. The trials evaluated 110 different ways of increasing response to postal questionnaires. We found substantial heterogeneity among trial results in half of the strategies. The odds of response were at least doubled using monetary incentives (odds ratio 1.87; 95% CI 1.73 to 2.04; heterogeneity P < 0.00001, I(2) = 84%), recorded delivery (1.76; 95% CI 1.43 to 2.18; P = 0.0001, I(2) = 71%), a teaser on the envelope - e.g. a comment suggesting to participants that they may benefit if they open it (3.08; 95% CI 1.27 to 7.44) and a more interesting questionnaire topic (2.00; 95% CI 1.32 to 3.04; P = 0.06, I(2) = 80%). The odds of response were substantially higher with pre-notification (1.45; 95% CI 1.29 to 1.63; P < 0.00001, I(2) = 89%), follow-up contact (1.35; 95% CI 1.18 to 1.55; P < 0.00001, I(2) = 76%), unconditional incentives (1.61; 1.36 to 1.89; P < 0.00001, I(2) = 88%), shorter questionnaires (1.64; 95% CI 1.43 to 1.87; P < 0.00001, I(2) = 91%), providing a second copy of the questionnaire at follow up (1.46; 95% CI 1.13 to 1.90; P < 0.00001, I(2) = 82%), mentioning an obligation to respond (1.61; 95% CI 1.16 to 2.22; P = 0.98, I(2) = 0%) and university sponsorship (1.32; 95% CI 1.13 to 1.54; P < 0.00001, I(2) = 83%). The odds of response were also increased with non-monetary incentives (1.15; 95% CI 1.08 to 1.22; P < 0.00001, I(2) = 79%), personalised questionnaires (1.14; 95% CI 1.07 to 1.22; P < 0.00001, I(2) = 63%), use of hand-written addresses (1.25; 95% CI 1.08 to 1.45; P = 0.32, I(2) = 14%), use of stamped return envelopes as opposed to franked return envelopes (1.24; 95% CI 1.14 to 1.35; P < 0.00001, I(2) = 69%), an assurance of confidentiality (1.33; 95% CI 1.24 to 1.42) and first class outward mailing (1.11; 95% CI 1.02 to 1.21; P = 0.78, I(2) = 0%). The odds of response were reduced when the questionnaire included questions of a sensitive nature (0.94; 95% CI 0.88 to 1.00; P = 0.51, I(2) = 0%).ElectronicWe found 32 eligible trials. The trials evaluated 27 different ways of increasing response to electronic questionnaires. We found substantial heterogeneity among trial results in half of the strategies. The odds of response were increased by more than a half using non-monetary incentives (1.72; 95% CI 1.09 to 2.72; heterogeneity P < 0.00001, I(2) = 95%), shorter e-questionnaires (1.73; 1.40 to 2.13; P = 0.08, I(2) = 68%), including a statement that others had responded (1.52; 95% CI 1.36 to 1.70), and a more interesting topic (1.85; 95% CI 1.52 to 2.26). The odds of response increased by a third using a lottery with immediate notification of results (1.37; 95% CI 1.13 to 1.65), an offer of survey results (1.36; 95% CI 1.15 to 1.61), and using a white background (1.31; 95% CI 1.10 to 1.56). The odds of response were also increased with personalised e-questionnaires (1.24; 95% CI 1.17 to 1.32; P = 0.07, I(2) = 41%), using a simple header (1.23; 95% CI 1.03 to 1.48), using textual representation of response categories (1.19; 95% CI 1.05 to 1.36), and giving a deadline (1.18; 95% CI 1.03 to 1.34). The odds of response tripled when a picture was included in an e-mail (3.05; 95% CI 1.84 to 5.06; P = 0.27, I(2) = 19%). The odds of response were reduced when "Survey" was mentioned in the e-mail subject line (0.81; 95% CI 0.67 to 0.97; P = 0.33, I(2) = 0%), and when the e-mail included a male signature (0.55; 95% CI 0.38 to 0.80; P = 0.96, I(2) = 0%). AUTHORS' CONCLUSIONS: Health researchers using postal and electronic questionnaires can increase response using the strategies shown to be effective in this systematic review.

1,312 citations


Reference EntryDOI
TL;DR: The review suggests that practice-based IPC interventions can improve healthcare processes and outcomes, but due to the small number of studies, sample sizes, problems with conceptualising and measuring collaboration, and heterogeneity of interventions and settings, it is difficult to draw generalisable inferences about the key elements of IPC.
Abstract: BACKGROUND: Poor interprofessional collaboration (IPC) can negatively affect the delivery of health services and patient care. Interventions that address IPC problems have the potential to improve professional practice and healthcare outcomes. OBJECTIVES: To assess the impact of practice-based interventions designed to change IPC, compared to no intervention or to an alternate intervention, on one or more of the following primary outcomes: patient satisfaction and/or the effectiveness and efficiency of the health care provided. Secondary outcomes include the degree of IPC achieved. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group Specialised Register (2000-2007), MEDLINE (1950-2007) and CINAHL (1982-2007). We also handsearched the Journal of Interprofessional Care (1999 to 2007) and reference lists of the five included studies. SELECTION CRITERIA: Randomised controlled trials of practice-based IPC interventions that reported changes in objectively-measured or self-reported (by use of a validated instrument) patient/client outcomes and/or health status outcomes and/or healthcare process outcomes and/or measures of IPC. DATA COLLECTION AND ANALYSIS: At least two of the three reviewers independently assessed the eligibility of each potentially relevant study. One author extracted data from and assessed risk of bias of included studies, consulting with the other authors when necessary. A meta-analysis of study outcomes was not possible given the small number of included studies and their heterogeneity in relation to clinical settings, interventions and outcome measures. Consequently, we summarised the study data and presented the results in a narrative format. MAIN RESULTS: Five studies met the inclusion criteria; two studies examined interprofessional rounds, two studies examined interprofessional meetings, and one study examined externally facilitated interprofessional audit. One study on daily interdisciplinary rounds in inpatient medical wards at an acute care hospital showed a positive impact on length of stay and total charges, but another study on daily interdisciplinary rounds in a community hospital telemetry ward found no impact on length of stay. Monthly multidisciplinary team meetings improved prescribing of psychotropic drugs in nursing homes. Videoconferencing compared to audioconferencing multidisciplinary case conferences showed mixed results; there was a decreased number of case conferences per patient and shorter length of treatment, but no differences in occasions of service or the length of the conference. There was also no difference between the groups in the number of communications between health professionals recorded in the notes. Multidisciplinary meetings with an external facilitator, who used strategies to encourage collaborative working, was associated with increased audit activity and reported improvements to care. AUTHORS' CONCLUSIONS: In this updated review, we found five studies (four new studies) that met the inclusion criteria. The review suggests that practice-based IPC interventions can improve healthcare processes and outcomes, but due to the limitations in terms of the small number of studies, sample sizes, problems with conceptualising and measuring collaboration, and heterogeneity of interventions and settings, it is difficult to draw generalisable inferences about the key elements of IPC and its effectiveness. More rigorous, cluster randomised studies with an explicit focus on IPC and its measurement, are needed to provide better evidence of the impact of practice-based IPC interventions on professional practice and healthcare outcomes. These studies should include qualitative methods to provide insight into how the interventions affect collaboration and how improved collaboration contributes to changes in outcomes.

1,104 citations


Journal ArticleDOI
TL;DR: Evidence is provided that PRT is an effective intervention for improving physical functioning in older people, including improving strength and the performance of some simple and complex activities, and some caution is needed with transferring these exercises for use with clinical populations.
Abstract: Background Muscle weakness in old age is associated with physical function decline. Progressive resistance strength training (PRT) exercises are designed to increase strength. Objectives To assess the effects of PRT on older people and identify adverse events. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialized Register (to March 2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2007, Issue 2), MEDLINE (1966 to May 01, 2008), EMBASE (1980 to February 06 2007), CINAHL (1982 to July 01 2007) and two other electronic databases. We also searched reference lists of articles, reviewed conference abstracts and contacted authors. Selection criteria Randomised controlled trials reporting physical outcomes of PRT for older people were included. Data collection and analysis Two review authors independently selected trials, assessed trial quality and extracted data. Data were pooled where appropriate. Main results One hundred and twenty one trials with 6700 participants were included. In most trials, PRT was performed two to three times per week and at a high intensity. PRT resulted in a small but significant improvement in physical ability (33 trials, 2172 participants; SMD 0.14, 95% CI 0.05 to 0.22). Functional limitation measures also showed improvements: e.g. there was a modest improvement in gait speed (24 trials, 1179 participants, MD 0.08 m/s, 95% CI 0.04 to 0.12); and a moderate to large effect for getting out of a chair (11 trials, 384 participants, SMD -0.94, 95% CI -1.49 to -0.38). PRT had a large positive effect on muscle strength (73 trials, 3059 participants, SMD 0.84, 95% CI 0.67 to 1.00). Participants with osteoarthritis reported a reduction in pain following PRT(6 trials, 503 participants, SMD -0.30, 95% CI -0.48 to -0.13). There was no evidence from 10 other trials (587 participants) that PRT had an effect on bodily pain. Adverse events were poorly recorded but adverse events related to musculoskeletal complaints, such as joint pain and muscle soreness, were reported in many of the studies that prospectively defined and monitored these events. Serious adverse events were rare, and no serious events were reported to be directly related to the exercise programme. Authors' conclusions This review provides evidence that PRT is an effective intervention for improving physical functioning in older people, including improving strength and the performance of some simple and complex activities. However, some caution is needed with transferring these exercises for use with clinical populations because adverse events are not adequately reported.

939 citations


Reference EntryDOI
TL;DR: Smoking cessation interventions in pregnancy reduce the proportion of women who continue to smoke in late pregnancy, and reduce low birthweight and preterm birth.
Abstract: BACKGROUND: Tobacco smoking in pregnancy remains one of the few preventable factors associated with complications in pregnancy, low birthweight, preterm birth and has serious long-term health implications for women and babies. Smoking in pregnancy is decreasing in high-income countries and increasing in low- to middle-income countries and is strongly associated with poverty, low educational attainment, poor social support and psychological illness. OBJECTIVES: To assess the effects of smoking cessation interventions during pregnancy on smoking behaviour and perinatal health outcomes. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (June 2008), the Cochrane Tobacco Addiction Group's Trials Register (June 2008), EMBASE, PsycLIT, and CINAHL (all from January 2003 to June 2008). We contacted trial authors to locate additional unpublished data. SELECTION CRITERIA: Randomised controlled trials where smoking cessation during pregnancy was a primary aim of the intervention. DATA COLLECTION AND ANALYSIS: Trials were identified and data extracted by one person and checked by a second. Subgroup analysis was conducted to assess the effect of risk of trial bias, intensity of the intervention and main intervention strategy used. MAIN RESULTS: Seventy-two trials are included. Fifty-six randomised controlled trials (over 20,000 pregnant women) and nine cluster-randomised trials (over 5000 pregnant women) provided data on smoking cessation outcomes.There was a significant reduction in smoking in late pregnancy following interventions (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.93 to 0.96), an absolute difference of six in 100 women who stopped smoking during pregnancy. However, there is significant heterogeneity in the combined data (I(2) > 60%). In the trials with the lowest risk of bias, the interventions had less effect (RR 0.97, 95% CI 0.94 to 0.99), and lower heterogeneity (I(2) = 36%). Eight trials of smoking relapse prevention (over 1000 women) showed no statistically significant reduction in relapse.Smoking cessation interventions reduced low birthweight (RR 0.83, 95% CI 0.73 to 0.95) and preterm birth (RR 0.86, 95% CI 0.74 to 0.98), and there was a 53.91g (95% CI 10.44 g to 95.38 g) increase in mean birthweight. There were no statistically significant differences in neonatal intensive care unit admissions, very low birthweight, stillbirths, perinatal or neonatal mortality but these analyses had very limited power. AUTHORS' CONCLUSIONS: Smoking cessation interventions in pregnancy reduce the proportion of women who continue to smoke in late pregnancy, and reduce low birthweight and preterm birth. Smoking cessation interventions in pregnancy need to be implemented in all maternity care settings. Given the difficulty many pregnant women addicted to tobacco have quitting during pregnancy, population-based measures to reduce smoking and social inequalities should be supported.

896 citations


Journal ArticleDOI
TL;DR: To assess the extent to which publication of a cohort of clinical trials is influenced by the statistical significance, perceived importance, or direction of their results, five studies were included and found no significant association between either funding mechanism, investigator rank, or sex and publication.
Abstract: Background The tendency for authors to submit, and of journals to accept, manuscripts for publication based on the direction or strength of the study findings has been termed publication bias. Objectives To assess the extent to which publication of a cohort of clinical trials is influenced by the statistical significance, perceived importance, or direction of their results. Search methods We searched the Cochrane Methodology Register (The Cochrane Library [Online] Issue 2, 2007), MEDLINE (1950 to March Week 2 2007), EMBASE (1980 to Week 11 2007) and Ovid MEDLINE In-Process & Other Non-Indexed Citations (March 21 2007). We also searched the Science Citation Index (April 2007), checked reference lists of relevant articles and contacted researchers to identify additional studies. Selection criteria Studies containing analyses of the association between publication and the statistical significance or direction of the results (trial findings), for a cohort of registered clinical trials. Data collection and analysis Two authors independently extracted data. We classified findings as either positive (defined as results classified by the investigators as statistically significant (P < 0.05), or perceived as striking or important, or showing a positive direction of effect) or negative (findings that were not statistically significant (P ≥ 0.05), or perceived as unimportant, or showing a negative or null direction in effect). We extracted information on other potential risk factors for failure to publish, when these data were available. Main results Five studies were included. Trials with positive findings were more likely to be published than trials with negative or null findings (odds ratio 3.90; 95% confidence interval 2.68 to 5.68). This corresponds to a risk ratio of 1.78 (95% CI 1.58 to 1.95), assuming that 41% of negative trials are published (the median among the included studies, range = 11% to 85%). In absolute terms, this means that if 41% of negative trials are published, we would expect that 73% of positive trials would be published. Two studies assessed time to publication and showed that trials with positive findings tended to be published after four to five years compared to those with negative findings, which were published after six to eight years. Three studies found no statistically significant association between sample size and publication. One study found no significant association between either funding mechanism, investigator rank, or sex and publication. Authors' conclusions Trials with positive findings are published more often, and more quickly, than trials with negative findings.

759 citations


Journal ArticleDOI
TL;DR: No evidence of improvement in functional benefit or reduction in length of hospital stay with supplements is found, although Mortality may be reduced in older people who are undernourished.
Abstract: Evidence for the effectiveness of nutritional supplements containing protein and energy, often prescribed for older people, is limited. Malnutrition is more common in this age group and deterioration of nutritional status can occur during illness. It is important to establish whether supplementing the diet is an effective way of improving outcomes for older people at risk from malnutrition. This review examined trials for improvement in nutritional status and clinical outcomes when extra protein and energy were provided, usually as commercial 'sip-feeds'.

748 citations


Reference EntryDOI
TL;DR: Restrictive episiotomy policies appear to have a number of benefits compared to routine episiotome policies, and there was an increased risk of anterior perineal trauma with restrictive episiotomies.
Abstract: Background Episiotomy is done to prevent severe perineal tears, but its routine use has been questioned. The relative effects of midline compared with midlateral episiotomy are unclear. Objectives The objective of this review was to assess the effects of restrictive use of episiotomy compared with routine episiotomy during vaginal birth. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2008). Selection criteria Randomized trials comparing restrictive use of episiotomy with routine use of episiotomy; restrictive use of mediolateral episiotomy versus routine mediolateral episiotomy; restrictive use of midline episiotomy versus routine midline episiotomy; and use of midline episiotomy versus mediolateral episiotomy. Data collection and analysis The two review authors independently assessed trial quality and extracted the data. Main results We included eight studies (5541 women). In the routine episiotomy group, 75.15% (2035/2708) of women had episiotomies, while the rate in the restrictive episiotomy group was 28.40% (776/2733). Compared with routine use, restrictive episiotomy resulted in less severe perineal trauma (relative risk (RR) 0.67, 95% confidence interval (CI) 0.49 to 0.91), less suturing (RR 0.71, 95% CI 0.61 to 0.81) and fewer healing complications (RR 0.69, 95% CI 0.56 to 0.85). Restrictive episiotomy was associated with more anterior perineal trauma (RR 1.84, 95% CI 1.61 to 2.10). There was no difference in severe vaginal/perineal trauma (RR 0.92, 95% CI 0.72 to 1.18); dyspareunia (RR 1.02, 95% CI 0.90 to 1.16); urinary incontinence (RR 0.98, 95% CI 0.79 to 1.20) or several pain measures. Results for restrictive versus routine mediolateral versus midline episiotomy were similar to the overall comparison. Authors' conclusions Restrictive episiotomy policies appear to have a number of benefits compared to policies based on routine episiotomy. There is less posterior perineal trauma, less suturing and fewer complications, no difference for most pain measures and severe vaginal or perineal trauma, but there was an increased risk of anterior perineal trauma with restrictive episiotomy.

Reference EntryDOI
TL;DR: Frail older people confined to institutions may sustain fewer hip and other non-vertebral fractures if given vitamin D with calcium supplements, and there is no evidence of advantage of analogues of vitamin D compared with vitamin D.
Abstract: Background Due to their known effects on bone metabolism, vitamin D and related compounds have been proposed for the prevention of osteoporosis and fractures. Objectives To determine the effects of supplementation with Vitamin D or a Vitamin D analogue in the prevention of fractures of the axial and appendicular skeleton in elderly men or women with involutional or post-menopausal osteoporosis. Search strategy We searched MEDLINE, EMBASE, CINAHL, LILACS, CABNAR, BIOSIS, HEALTHSTAR, Current Contents, The Cochrane Database of Systematic Reviews, the Cochrane Musculoskeletal Injuries Group trials register, and bibliographies of identified trials and reviews. Date of the most recent search: September 2000. Selection criteria Any randomised or quasi-randomised trial which compared vitamin D or a vitamin D analogue, either alone or in combination with calcium supplementation, with a placebo, no intervention, or the administration of calcium supplements, with eligible fracture outcomes, in elderly men or women with involutional or post-menopausal osteoporosis. Data collection and analysis Two reviewers independently assessed trial quality, by use of a nine item scale, and extracted data. Additional information was sought from trialists. Where possible the data were pooled. Pooling of data, where it was admissible, used pooled relative risk and fixed effects model. Main results Almost all estimates of treatment effects are based on single studies. Administration of vitamin D3 alone without calcium co-supplementation was not associated with any reduction in incidence of hip fracture (relative risk (RR) 1.20, 95% confidence interval (CI) 0.83, 1.75) or other non-vertebral fracture. Administration of vitamin D3 with calcium co-supplementation to frail elderly people in sheltered accommodation was associated with a reduction in incidence of hip fracture (RR 0.74, 95% CI 0.60, 0.91). In healthy younger, ambulant participants the effect on hip fracture is unknown (RR 0.36, 95% CI 0.01, 8.78), although there appears to be a significant overall effect on non-vertebral fracture incidence in this group ( RR 0.46, 95% CI 0.23,0.90). Calcitriol (1,25 dihdyroxy vitamin D) was effective in reducing the incidence of vertebral deformity (RR 0.49, 95% CI 0.25, 0.95). Calcitriol was more effective than calcium in reducing the frequency of new vertebral deformities during the third year of treatment (RR 0.28, 95% CI 0.15, 0.52). 1-alpha-hydroxy vitamin D was effective in reducing the incidence of non-vertebral fractures in a single small study of elderly people whose mobility was impaired by neurological disease (RR 0.12, 95% CI 0.02, 0.95). No statistically significant effects were found for other comparisons of vitamin D or its analogues against each other, with and without calcium supplementation. Reviewer's conclusions Uncertainty remains about the efficacy of regimens which include vitamin D or its analogues in fracture prevention. Particularly if co-supplementation of calcium is required, significant cost differences are likely to exist between regimens. Further large randomised trials are currently being conducted to clarify the effectiveness of community fracture prevention programmes employing vitamin D supplementation.

Reference EntryDOI
TL;DR: The limited evidence suggests that weight loss following gastric bypass is greater than vertical banded gastroplasty or adjustable gastric banding, but similar to isolated sleeve gastrectomy and banded Gastric bypass, which is more effective than conventional management.
Abstract: Obesity is associated with many health problems and a higher risk of death. Bariatric (weight loss) surgery for obesity is usually only considered when all other treatments have failed. People who are eligible for surgery have a body mass index (BMI) greater than 40 or greater than 35 with related conditions such as type 2 diabetes. Recently, it has been suggested that people with a lower BMI may benefit from surgery. A number of different bariatric procedures are available, and these can be carried out through open (traditional) surgery or laparoscopic (keyhole) surgery. It is not clear which procedures are the most effective in reducing weight or have the least complications. The review aimed to compare these bariatric procedures with each other and with conventional treatment (such as drugs, diet and exercise). The review found that surgery results in greater weight loss than conventional treatment in people with BMI greater than 30 as well as those with more severe obesity. Surgery also leads to some improvements in quality of life and obesity related diseases such as hypertension and diabetes. However, complications (for example pulmonary embolism), side-effects (for example heartburn) and some deaths may occur. Although several different surgical procedures are available, not all have been compared with each other. Gastric bypass had greater weight loss than vertical banded gastroplasty or adjustable gastric banding, but similar to isolated sleeve gastrectomy and banded gastric bypass. Isolated sleeve gastrectomy appears to result in greater weight loss than adjustable gastric banding. The evidence comparing vertical banded gastroplasty with adjustable gastric banding was not clear. Complications may occur with any bariatric procedure, but information from the included trials did not allow us to reach any conclusions about the safety of these procedures compared with each other.

Journal ArticleDOI
TL;DR: The role for antenatal magnesium sulphate therapy as a neuroprotective agent for the preterm fetus is not yet established and outcomes later in childhood should be evaluated to determine the presence or absence of later potentially important neurologic effects, particularly on motor or cognitive function.
Abstract: Background Epidemiological and basic science evidence suggests that magnesium sulphate before birth may be neuroprotective for the fetus. Objectives To assess the effects of magnesium sulphate as a neuroprotective agent when given to women considered at risk of preterm birth. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2008). Selection criteria Randomised controlled trials of antenatal magnesium sulphate therapy in women threatening or likely to give birth at less than 37 weeks' gestational age. For one subgroup analysis, studies were broadly categorised by the primary intent of the study into "neuroprotective intent", or "other intent (maternal neuroprotective - pre-eclampsia)", or "other intent (tocolytic)". Data collection and analysis At least two authors assessed trial eligibility and quality, and extracted data. Main results Five trials (6145 babies) were eligible for this review. Antenatal magnesium sulphate therapy given to women at risk of preterm birth substantially reduced the risk of cerebral palsy in their child (relative risk (RR) 0.68; 95% Confidence interval (CI) 0.54 to 0.87; five trials; 6145 infants). There was also a significant reduction in the rate of substantial gross motor dysfunction (RR 0.61; 95% CI 0.44 to 0.85; four trials; 5980 infants). No statistically significant effect of antenatal magnesium sulphate therapy was detected on paediatric mortality (RR 1.04; 95% CI 0.92 to 1.17; five trials; 6145 infants), or on other neurological impairments or disabilities in the first few years of life. Overall there were no significant effects of antenatal magnesium therapy on combined rates of mortality with cerebral palsy, although there were significant reductions for the neuroprotective groups RR 0.85; 95% CI 0.74 to 0.98; four trials; 4446 infants, but not for the other intent subgroups. There were higher rates of minor maternal side effects in the magnesium groups, but no significant effects on major maternal complications. Authors' conclusions The neuroprotective role for antenatal magnesium sulphate therapy given to women at risk of preterm birth for the preterm fetus is now established. The number of women needed to be treated to benefit one baby by avoiding cerebral palsy is 63 (95% confidence interval 43 to 155). Given the beneficial effects of magnesium sulphate on substantial gross motor function in early childhood, outcomes later in childhood should be evaluated to determine the presence or absence of later potentially important neurological effects, particularly on motor or cognitive function.

Journal ArticleDOI
TL;DR: Efficacy was demonstrated for dichotomous outcomes equating to moderate or substantial pain relief, alongside lower rates for lack of efficacy discontinuations with increasing dose, in patients with postherpetic neuralgia and painful diabetic neuropathy.
Abstract: Background Antiepileptic drugs have been used in pain management since the 1960s. Pregabalin is a recently developed antiepileptic drug also used in management of chronic neuropathic pain conditions. Objectives To assess analgesic efficacy and associated adverse events of pregabalin in acute and chronic pain. Search methods We searched MEDLINE, EMBASE, and CENTRAL to May 2009 for randomised controlled trials (RCTs). Additional studies were identified from the reference lists of retrieved papers and on-line clinical trial databases. Selection criteria Randomised, double blind trials reporting on the analgesic effect of pregabalin, with subjective pain assessment by the patient as either the primary or a secondary outcome. Data collection and analysis Two independent review authors extracted data and assessed trial quality. Numbers-needed-to-treat-to-benefit (NNTs) were calculated, where possible, from dichotomous data for effectiveness, adverse events and study withdrawals. Main results There was no clear evidence of beneficial effects of pregabalin in established acute postoperative pain. No studies evaluated pregabalin in chronic nociceptive pain, like arthritis. Pregabalin at doses of 300 mg, 450 mg, and 600 mg daily was effective in patients with postherpetic neuralgia, painful diabetic neuropathy, central neuropathic pain, and fibromyalgia (19 studies, 7003 participants). Pregabalin at 150 mg daily was generally ineffective. Efficacy was demonstrated for dichotomous outcomes equating to moderate or substantial pain relief, alongside lower rates for lack of efficacy discontinuations with increasing dose. The best (lowest) NNT for each condition for at least 50% pain relief over baseline (substantial benefit) for 600 mg pregabalin daily compared with placebo were 3.9 (95% confidence interval 3.1 to 5.1) for postherpetic neuralgia, 5.0 (4.0 to 6.6) for painful diabetic neuropathy, 5.6 (3.5 to 14) for central neuropathic pain, and 11 (7.1 to 21) for fibromyalgia. With 600 mg pregabalin daily somnolence typically occurred in 15% to 25% and dizziness occurred in 27% to 46%. Treatment was discontinued due to adverse events in 18 to 28%. The proportion of participants reporting at least one adverse event was not affected by dose, nor was the number with a serious adverse event, which was not more than with placebo. Higher rates of substantial benefit were found in postherpetic neuralgia and painful diabetic neuropathy than in central neuropathic pain and fibromyalgia. For moderate and substantial benefit on any outcome NNTs for the former were generally six and below for 300 mg and 600 mg daily; for fibromyalgia NNTs were much higher, and generally seven and above. Authors' conclusions Pregabalin has proven efficacy in neuropathic pain conditions and fibromyalgia. A minority of patients will have substantial benefit with pregabalin, and more will have moderate benefit. Many will have no or trivial benefit, or will discontinue because of adverse events. Individualisation of treatment is needed to maximise pain relief and minimise adverse events. There is no evidence to support the use of pregabalin in acute pain scenarios.

Journal ArticleDOI
TL;DR: This review evaluates the results of three randomised controlled trials, which analysed the effectiveness and safety of male circumcision for preventing acquisition of HIV in heterosexual men, and formulated a comprehensive and exhaustive search strategy to identify all relevant studies.
Abstract: Background The findings from observational studies reviews and meta- analyses supported by biological theories that circumcised men appear less likely to acquire human immunodeficiency virus (HIV) has contributed to the recent ground swell of support for considering male circumcision as a strategy for preventing sexually acquired infection. We sought to elucidate and appraise the global evidence from published and unpublished studies that circumcision can be used as an intervention to prevent HIV infection. Objectives 1) To assess the evidence of an interventional effect of male circumcision for preventing acquisition of HIV-1 and HIV-2 by men through heterosexual intercourse; 2) To examine the feasibility and value of performing individual person data (IPD) meta-analysis. Search strategy We searched online for published and unpublished studies in The Cochrane Library (issue 2 2002) MEDLINE (April 2002) EMBASE (February 2002) and AIDSLINE (August 2001). We also searched databases listing conference abstracts scanned reference lists of articles and contacted authors of included studies. Selection criteria We searched for randomized and quasi- randomized controlled trials of male circumcisions or in their absence observational studies that compare acquisition rates of HIV-1 and HIV-2 infection in circumcised and uncircumcised heterosexual men. Data collection and analysis Independent reviewers selected studies assessed study quality and extracted data. We stratified studies based on study design and on whether they included participants from the general population or high-risk groups (such as patients treated for sexually transmitted infections). We expressed findings as crude and adjusted odds ratios (OR) together with their 95% confidence intervals (CI) and conducted a sensitivity analysis to explore the effect of adjustment on study results. We investigated whether the method of circumcision ascertainment influenced study outcomes. Main results We identified no completed randomized controlled trials. Three randomized controlled trials are currently underway or commencing shortly. We found 35 observational studies: 16 conducted in the general population and 19 in high-risk populations. It seems unlikely that potential confounding factors were completely accounted for in any of the included studies. In particular important risk factors such as religion and sexual practices were not adequately accounted for in many of the included studies. General population study results: The single cohort study (N = 5516) showed a significant difference in HIV transmission rates between circumcised and uncircumcised men [OR = 0.58; 95% CI: 0.36 to 0.96]. Results for the 14 cross-sectional studies were inconsistent with point estimates for unadjusted odds ratios varying between 0.28 and 1.73. Six studies had statistically significant results four in the direction of benefit and two in the direction of harm. The test for heterogeneity between the cross-sectional studies was highly significant (chi-square = 77.59; df = 13; P-value < 0.00001). Nine studies reported adjusted odds ratios with eight in the direction of benefit ranging from 0.26 to 0.80. Use of adjusted results tended to show stronger evidence of an association although they remained heterogeneous (chi-square = 75.2; df = 13; P-value < 0.00001). Only one case-control study was found (N = 51) which had a non-significant result [OR = 1.90; 95% CI: 0.50 to 7.20]. High- risk group study results: The four cohort studies identified found a protective effect from circumcision with point estimates for unadjusted odds ratios varying from 0.10 to 0.39. Two of these studies had statistically significant results. Two studies reported adjusted odds ratios both protective with one being significant. The chi-square test for between-study heterogeneity was not significant (chi-square = 5.21; df = 3; P-value = 0.16). All eleven cross- sectional studies reporting unadjusted results found benefit from circumcision eight of which had statistically significant results. Estimates of effect varied from an unadjusted odds ratio of 0.10 to 0.66. Between-study heterogeneity was significant with the chi-square = 29.77; df = 10; P-value = 0.0009. Four of these studies reported adjusted odds ratios ranging from 0.20 to 0.59 and all were significant. One additional cross-sectional study only reported an adjusted odds ratio ranging from 0.20 to 0.59 and all were significant. All three case- control studies found a protective effect of circumcision on HIV status two being statistically significant. Point estimates varied from unadjusted odds ratios of 0.37 to 0.88. One reported an adjusted odds ratio showing a significant protective effect. Adverse effects: No studies reported on the adverse effects of circumcision. In most studies circumcision had taken place during childhood or adolescence before the studies commenced. Authors conclusions We found insufficient evidence to support an interventional effect of male circumcision on HIV acquisition in heterosexual men. The results from existing observational studies show a strong epidemiological association between male circumcision and prevention of HIV especially among high-risk groups. However observational studies are inherently limited by confounding which is unlikely to be fully adjusted for. In the light of forthcoming results from RCTs the value of IPD analysis of the included studies is doubtful. The results of these trials will need to be carefully considered before circumcision is implemented as a public health intervention for prevention of sexually transmitted HIV. (authors)

Journal ArticleDOI
TL;DR: Gink go biloba appears to be safe in use with no excess side effects compared with placebo, and the evidence that Ginkgo biloba has predictable and clinically significant benefit for people with dementia or cognitive impairment is inconsistent and unreliable.
Abstract: Background Extracts of the leaves of the maidenhair tree, Ginkgo biloba, have long been used in China as a traditional medicine for various disorders of health. A standardized extract is widely prescribed for the treatment of a range of conditions including memory and concentration problems, confusion, depression, anxiety, dizziness, tinnitus and headache. The mechanisms of action are thought to reflect the action of several components of the extract and include increasing blood supply by dilating blood vessels, reducing blood viscosity, modification of neurotransmitter systems, and reducing the density of oxygen free radicals. Objectives To assess the efficacy and safety of Ginkgo biloba for dementia or cognitive decline. Search methods Trials were identified on 10 October 2006 through a search of the Cochrane Dementia and Cognitive Improvement Group's Specialized Register which contains records from all main medical databases (MEDLINE, EMBASE, CINAHL, PsycINFO, SIGLE, LILACS), from ongoing trials databases such as Clinicaltrials.gov and Current Controlled Trials and many other sources. The search terms used were ginkgo*, tanakan, EGB-761, EGB761, "EGB 761" and gingko*. Selection criteria Randomized, double-blind studies, in which extracts of Ginkgo biloba at any strength and over any period were compared with placebo for their effects on people with acquired cognitive impairment, including dementia, of any degree of severity. Data collection and analysis Data were extracted from the published reports of the included studies, pooled where appropriate and the treatment effects or the risks and benefits estimated. Main results Clinical global improvement as assessed by the physician, was dichotomized between participants who showed improvement or were unchanged and those who were worse. There are benefits associated with Ginkgo (dose greater than 200 mg/day) at 24 weeks (207/276 compared with 178/273, OR 1.66, 95% CI 1.12 to 2.46, P=.001) (2 studies), but not for the lower dose. Cognition shows benefit for Ginkgo (any dose) at 12 weeks (SMD -0.65, 95% CI -1.22 to -0.09 P=0.02, 5 studies) but not at 24 weeks. Five studies assessed activities of daily living (ADLs), using different scales. Some scales are more comprehensive than just ADLs. The results show benefit for Ginkgo (dose less than 200 mg/day) compared with placebo at 12 weeks (MD -5.0, 95% CI -7.88, -2.12, p=0.0007, one study), and at 24 weeks (SMD -0.16, 95% CI -0.31 to -0.01, p=0.03, 3 studies) but there are no differences at the higher dose. No study assessed mood and function separately, but one study used the ADAS-Noncog, which assesses function over several domains, but not cognitive function. There was no difference between Ginkgo and placebo. There are no significant differences between Ginkgo and placebo in the proportion of participants experiencing adverse events. There are no data available on Quality of Life, measures of depression or dependency. Authors' conclusions Ginkgo biloba appears to be safe in use with no excess side effects compared with placebo. Many of the early trials used unsatisfactory methods, were small, and we cannot exclude publication bias. The evidence that Ginkgo has predictable and clinically significant benefit for people with dementia or cognitive impairment is inconsistent and unconvincing.

Journal Article
TL;DR: Significantly improved outcomes suggest VH should be performed in preference to AH where possible, however, for some important outcomes, the analyses were underpowered to detect important differences, or they were simply not reported in trials.
Abstract: BACKGROUND: The three approaches to hysterectomy for benign disease are abdominal hysterectomy (AH), vaginal hysterectomy (VH), and laparoscopic hysterectomy (LH). Laparoscopic hysterectomy has three further subdivisions depending on the part of the procedure performed laparoscopically. OBJECTIVES: To assess the most beneficial and least harmful surgical approach to hysterectomy for women with benign gynaecological conditions. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of controlled trials (15 August 2008), CENTRAL (The Cochrane Library 2008, Issue 3), MEDLINE (1950 to August 2008), EMBASE (1980 to August 2008), Biological Abstracts (1969 to August 2008), the National Research Register, and relevant citation lists. SELECTION CRITERIA: Only randomised controlled trials comparing one surgical approach to hysterectomy with another were included. DATA COLLECTION AND ANALYSIS: Independent selection of trials and data extraction were employed following Cochrane guidelines. MAIN RESULTS: There were 34 included studies with 4495 women. The benefits of VH versus AH were speedier return to normal activities (mean difference (MD) 9.5 days), fewer febrile episodes or unspecified infections (odds ratio (OR) 0.42), and shorter duration of hospital stay (MD 1.1 days). The benefits of LH versus AH were speedier return to normal activities (MD 13.6 days), lower intraoperative blood loss (MD 45 cc), a smaller drop in haemoglobin (MD 0.55 g/dl), shorter hospital stay (MD 2.0 days), and fewer wound or abdominal wall infections (OR 0.31) at the cost of more urinary tract (bladder or ureter) injuries (OR 2.41) and longer operation time (MD 20.3 minutes). The benefits of LAVH versus TLH were fewer febrile episodes or unspecified infection (OR 3.77) and shorter operation time (MD 25.3 minutes). There was no evidence of benefits of LH versus VH and the operation time (MD 39.3 minutes) as well as substantial bleeding (OR 2.76) were increased in LH. For some important outcomes, the analyses were underpowered to detect important differences or they were simply not reported in trials. Data were absent for many important long-term outcome measures. AUTHORS' CONCLUSIONS: Because of equal or significantly better outcomes on all parameters, VH should be performed in preference to AH where possible. Where VH is not possible, LH may avoid the need for AH however the length of the surgery increases as the extent of the surgery performed laparoscopically increases. The surgical approach to hysterectomy should be decided by the woman in discussion with her surgeon in light of the relative benefits and hazards.

Journal ArticleDOI
TL;DR: A minority of interventions showed larger effects, but no specific reminder or contextual features were significantly associated with effect magnitude, and further research must identify design features and contextual factors consistently associated with larger improvements in provider behaviour.
Abstract: Background The opportunity to improve care by delivering decision support to clinicians at the point of care represents one of the main incentives for implementing sophisticated clinical information systems. Previous reviews of computer reminder and decision support systems have reported mixed effects, possibly because they did not distinguish point of care computer reminders from e-mail alerts, computer-generated paper reminders, and other modes of delivering ‘computer reminders’. Objectives To evaluate the effects on processes and outcomes of care attributable to on-screen computer reminders delivered to clinicians at the point of care. Search methods We searched the Cochrane EPOC Group Trials register, MEDLINE, EMBASE and CINAHL and CENTRAL to July 2008, and scanned bibliographies from key articles. Selection criteria Studies of a reminder delivered via a computer system routinely used by clinicians, with a randomised or quasi-randomised design and reporting at least one outcome involving a clinical endpoint or adherence to a recommended process of care. Data collection and analysis Two authors independently screened studies for eligibility and abstracted data. For each study, we calculated the median improvement in adherence to target processes of care and also identified the outcome with the largest such improvement. We then calculated the median absolute improvement in process adherence across all studies using both the median outcome from each study and the best outcome. Main results Twenty-eight studies (reporting a total of thirty-two comparisons) were included. Computer reminders achieved a median improvement in process adherence of 4.2% (interquartile range (IQR): 0.8% to 18.8%) across all reported process outcomes, 3.3% (IQR: 0.5% to 10.6%) for medication ordering, 3.8% (IQR: 0.5% to 6.6%) for vaccinations, and 3.8% (IQR: 0.4% to 16.3%) for test ordering. In a sensitivity analysis using the best outcome from each study, the median improvement was 5.6% (IQR: 2.0% to 19.2%) across all process measures and 6.2% (IQR: 3.0% to 28.0%) across measures of medication ordering. In the eight comparisons that reported dichotomous clinical endpoints, intervention patients experienced a median absolute improvement of 2.5% (IQR: 1.3% to 4.2%). Blood pressure was the most commonly reported clinical endpoint, with intervention patients experiencing a median reduction in their systolic blood pressure of 1.0 mmHg (IQR: 2.3 mmHg reduction to 2.0 mmHg increase). Authors' conclusions Point of care computer reminders generally achieve small to modest improvements in provider behaviour. A minority of interventions showed larger effects, but no specific reminder or contextual features were significantly associated with effect magnitude. Further research must identify design features and contextual factors consistently associated with larger improvements in provider behaviour if computer reminders are to succeed on more than a trial and error basis.

Journal ArticleDOI
TL;DR: There is low- to moderate-quality evidence that RTT improves upper and lower limb function; improvements were sustained up to six months post treatment; and the evidence has been rated 'moderate' or 'low' when using the GRADE system.
Abstract: Graeme J. Hankey MD, FRCP Section Editor The inclusion of active practice of task-specific motor activities is popular in therapy approaches to stroke rehabilitation. The objective of this review was to determine if repetitive task training after stroke improves global, upper, or lower limb function and if treatment effects are influenced by the amount, type, or timing of practice. We searched the Cochrane Stroke Trials Register (to October 2006); The Cochrane Library, MEDLINE, EMBASE, CINAHL, AMED, SportDiscus, Science Citation Index, Index to Theses, ZETOC, PEDro, and OT Seeker (all to September 2006); and OT search (to March 2006). We also searched for unpublished/non-English language trials; combed conference proceedings and reference lists; requested information on bulletin boards; and contacted trial authors. Selection …

Reference EntryDOI
TL;DR: There is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care, and available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects.
Abstract: BACKGROUND: Acupuncture is often used for migraine prophylaxis but its effectiveness is still controversial. This review (along with a companion review on'Acupuncture for tension-type headache') represents an updated version of a Cochrane review originally published in Issue 1, 2001, of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in patients with migraine. SEARCH STRATEGY: The Cochrane Pain, Palliative& Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008. SELECTION CRITERIA: We included randomized trials with a post-randomization observation period of at least 8 weeks that compared the clinical effects of an acupuncture intervention with a control (no prophylactic treatment or routine care only), a sham acupuncture intervention or another intervention in patients with migraine. DATA COLLECTION AND ANALYSIS: Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (outcome of primary interest), migraine attacks, migraine days, headache days and analgesic use. Pooled effect size estimates were calculated using a random-effects model. MAIN RESULTS: Twenty-two trials with 4419 participants (mean 201, median 42, range 27 to 1715) met the inclusion criteria. Sixtrials (including two large trials with 401 and 1715 patients) compared acupuncture to no prophylactic treatment or routine care only. After 3 to 4 months patients receiving acupuncture had higher response rates and fewer headaches. The only study with long-term follow up saw no evidence that effects dissipated up to 9 months after cessation of treatment. Fourteen trials compared a'true' acupuncture intervention with a variety of sham interventions. Pooled analyses did not show a statistically significant superiority for true acupuncture for any outcome in any of the time windows, but the results of single trials varied considerably. Four trials compared acupuncture to proven prophylactic drug treatment. Overall in these trials acupuncture was associated with slightly better outcomes and fewer adverse effects than prophylactic drug treatment. Two small low-quality trials comparing acupuncture with relaxation (alone or in combination with massage) could not be interpreted reliably. AUTHORS' CONCLUSIONS: In the previous version of this review, evidence in support of acupuncture for migraine prophylaxis was considered promising but insufficient. Now, with 12 additional trials, there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of'true' acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment.

Reference EntryDOI
TL;DR: Routine 'active management' is superior to 'expectant management' in terms of blood loss, post partum haemorrhage and other serious complications of the third stage of labour.
Abstract: Background Expectant management of the third stage of labour involves allowing the placenta to deliver spontaneously or aiding by gravity or nipple stimulation. Active management involves administration of a prophylactic oxytocic after delivery, early cord clamping and cutting, and controlled cord traction of the umbilical cord. Objectives The objective of this review was to assess the effects of active versus expectant management on blood loss, post partum haemorrhage and other maternal and perinatal complications of the third stage of labour. Search strategy We searched the Cochrane Pregnancy and Childbirth Group trials register. Selection criteria Randomised trials comparing active and expectant management of the third stage of labour in women with singleton pregnancies whose babies were presenting head first and who were expecting a vaginal delivery. Data collection and analysis Trial quality was assessed and data were extracted independently by the reviewers. Main results Four studies were included. Three of the trials were of good quality. Compared to expectant management, active management (in the setting of a maternity hospital) was associated with the following reduced risks: maternal blood loss (weighted mean difference -79.33 millilitres, 95% confidence interval -94.29 to -64. 37); post partum haemorrhage of more than 500 millilitres (odds ratio 0.34, 95% confidence interval 0.28 to 0.41); prolonged third stage of labour (weighted mean difference -3.40 minutes, 95% confidence interval -4.66 to -2.13). Active management was associated with an increased risk of maternal nausea (odds ratio 1. 95, 95% confidence interval 1.58 to 2.42), vomiting and raised blood pressure (probably due to the use of ergometrine). No advantages or disadvantages were apparent for the baby. Reviewer's conclusions Routine 'active management' is superior to 'expectant management' in terms of blood loss, post partum haemorrhage and other serious complications of the third stage of labour. Active managment is, however, associated with an increased risk of unpleasant side effects (eg nausea and vomiting), and hypertension, where ergometrine is used. Active management should be the routine management of choice for women expecting a single baby by vaginal delivery in a maternity hospital. The implications are less clear for other settings including domiciliary practice (in developing and industrialised countries).

Reference EntryDOI
TL;DR: A combination of topical and systemic prophylactic antibiotics reduces RTIs and overall mortality in adult patients receiving intensive care and the risk of resistance occurring as a negative consequence of antibiotic use was appropriately explored.
Abstract: Background Pneumonia is an important cause of mortality in intensive care units (ICUs). The incidence of pneumonia in ICU patients ranges between 7% and 40%, and the crude mortality from ventilator-associated pneumonia may exceed 50%. Although not all deaths in patients with this form of pneumonia are directly attributable to pneumonia, it has been shown to contribute to mortality in ICUs independently of other factors that are also strongly associated with such deaths. Objectives To assess the effects of prophylactic antibiotic regimens, such as selective decontamination of the digestive tract (SDD) for the prevention of respiratory tract infections (RTIs) and overall mortality in adults receiving intensive care. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, issue 1), which contains the Cochrane Acute Respiratory Infections (ARI) Group's Specialised Register; MEDLINE (January 1966 to March 2009); and EMBASE (January 1990 to March 2009). Selection criteria Randomised controlled trials (RCTs) of antibiotic prophylaxis for RTIs and deaths among adult ICU patients. Data collection and analysis At least two review authors independently extracted data and assessed trial quality. Main results We included 36 trials involving 6914 people. There was variation in the antibiotics used, patient characteristics and risk of RTIs and mortality in the control groups. In trials comparing a combination of topical and systemic antibiotics, there was a significant reduction in both RTIs (number of studies = 16, odds ratio (OR) 0.28, 95% confidence interval (CI) 0.20 to 0.38) and total mortality (number of studies = 17, OR 0.75, 95% CI 0.65 to 0.87) in the treated group. In trials comparing topical antimicrobials alone (or comparing topical plus systemic versus systemic alone) there was a significant reduction in RTIs (number of studies = 17, OR 0.44, 95% CI 0.31 to 0.63) but not in total mortality (number of studies = 19, OR 0.97, 95% CI 0.82 to 1.16) in the treated group. Authors' conclusions A combination of topical and systemic prophylactic antibiotics reduces RTIs and overall mortality in adult patients receiving intensive care. Treatment based on the use of topical prophylaxis alone reduces respiratory infections but not mortality. The risk of resistance occurring as a negative consequence of antibiotic use was appropriately explored only in one trial which did not show any such effect.

Journal ArticleDOI
TL;DR: Low to very low quality evidence from two intensive advocacy trials (12 hours plus duration) showed reduced severe physical abuse in women leaving a shelter at 24 months, and the quality of evidence was moderate to low for brief advocacy and very low for intensive advocacy.
Abstract: Intimate partner abuse is common in all societies and damages the health of survivors and their children in the short and long term. Advocacy may decrease the impact of this abuse on women's health.The objective of this review is to assess the effects of advocacy interventions conducted within or outside of health care settings on women who have experienced intimate partner abuse.

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TL;DR: A systematic review suggests a benefit of individual education on glycaemic control when compared with usual care in a subgroup of those with a baseline HbA1c greater than 8%, but overall there did not appear to be a significant difference between individual education and usual care.
Abstract: Type 2 diabetes is a common and costly chronic disease which is associated with significant premature mortality and morbidity. Although patient education is an integral component of diabetes care, there remain uncertainties regarding the effectiveness of different methods and modes of education. Objectives To evaluate the effectiveness of individual patient education on metabolic control, diabetes knowledge and psychosocial outcomes. Randomized controlled and controlled clinical trials which evaluated individual education for adults with type 2 diabetes were used. The intervention was individual face-to-face patient education while control individuals received usual care, routine treatment or group education. Only studies that assessed outcome measures at least six months from baseline were included. Nine studies involving 1359 participants met the inclusion criteria. Six studies compared individual education to usual care and three compared individual education to group education (361 participants). There were no long-term studies and overall the quality of the studies was not high. In the six studies comparing individual face-to-face education to usual care, individual education did not significantly improve glycaemic control (weighted mean difference (WMD) in HbA1c -0.1% (95% confidence interval (CI) -0.3 to 0.1, P = 0.33) over a 12 to 18 month period. However, there did appear to be a significant benefit of individual education on glycaemic control in a subgroup analysis of three studies involving participants with a higher mean baseline HbA1c greater than 8% (WMD -0.3% (95% CI -0.5 to -0.1, P = 0.007). In the two studies comparing individual to group education, there was no significant difference in glycaemic control between individual or group education at 12 to 18 months with a WMD in HbA1c of 0.03% (95% CI -0.02 to 0.1, P = 0.22). There was no significant difference in the impact of individual versus usual care or group education on body mass index systolic or diastolic blood pressure. There were too few studies to perform a meta-analysis on the effect of individual education on dietary self management, diabetes knowledge, psychosocial outcomes and smoking habits. No data were available on the other main outcome measures of diabetes complications or health service utilization and cost analysis in these studies.

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TL;DR: A low-GI diet can improve glycaemic control in diabetes without compromising hypoglycaemic events, as assessed in 11 relevant randomised controlled trials involving 402 participants.
Abstract: Background The aim of diabetes management is to normalise blood glucose levels, since improved blood glucose control is associated with reduction in development, and progression, of complications. Nutritional factors affect blood glucose levels, however there is currently no universal approach to the optimal dietary treatment for diabetes. There is controversy about how useful the glycaemic index (GI) is in diabetic meal planning. Improved glycaemic control through diet could minimise medications, lessen risk of diabetic complications, improve quality of life and increase life expectancy. Objectives To assess the effects of low glycaemic index, or low glycaemic load, diets on glycaemic control in people with diabetes. Search methods We performed electronic searches of The Cochrane Library, MEDLINE, EMBASE and CINAHL with no language restriction. Selection criteria We assessed randomised controlled trials of four weeks or longer that compared a low glycaemic index, or low glycaemic load, diet with a higher glycaemic index, or load, or other diet for people with either type 1 or 2 diabetes mellitus, whose diabetes was not already optimally controlled. Data collection and analysis Two reviewers independently extracted data on study population, intervention and outcomes for each included study, using standardised data extraction forms. Main results Eleven relevant randomised controlled trials involving 402 participants were identified. There was a significant decrease in the glycated haemoglobin A1c (HbA1c) parallel group of trials, the weighted mean difference (WMD) was -0.5% with a 95% confidence interval (CI) of - 0.9 to -0.1, P = 0.02; and in the cross-over group of trials the WMD was -0.5% with a 95% CI of -1.0 to -0.1, P = 0.03. Episodes of hypoglycaemia were significantly fewer with low compared to high GI diet in one trial (difference of -0.8 episodes per patient per month, P < 0.01), and proportion of participants reporting more than 15 hyperglycaemic episodes per month was lower for low-GI diet compared to measured carbohydrate exchange diet in another study (35% versus 66%, P = 0.006). No study reported on mortality, morbidity or costs. Authors' conclusions A low-GI diet can improve glycaemic control in diabetes without compromising hypoglycaemic events.

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TL;DR: To assess the effectiveness of CCT in improving access to care and health outcomes, in particular for poorer populations in low and middle income countries, a wide range of international databases were searched, including the Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE.
Abstract: Background Conditional cash transfers (CCT) provide monetary transfers to households on the condition that they comply with some pre-defined requirements. CCT programmes have been justified on the grounds that demand-side subsidies are necessary to address inequities in access to health and social services for poor people. In the past decade they have become increasingly popular, particularly in middle income countries in Latin America. Objectives To assess the effectiveness of CCT in improving access to care and health outcomes, in particular for poorer populations in low and middle income countries. Search methods We searched a wide range of international databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE, in addition to development studies and economic databases. We also searched the websites and online resources of numerous international agencies, organisations and universities to find relevant grey literature. The original searches were conducted between November 2005 and April 2006. An updated search in MEDLINE was carried out in May 2009. Selection criteria CCT were defined as monetary transfers made to households on the condition that they comply with some pre-determined requirements in relation to health care. Studies had to include an objective measure of at least one of the following outcomes: health care utilisation, health expenditure, health outcomes or equity outcomes. Eligible study designs were: randomised controlled trial, interrupted time series analysis, or controlled before-after study of the impact of health financing policies following criteria used by the Cochrane Effective Practice and Organisation of Care Group. Data collection and analysis We performed qualitative analysis of the evidence. Main results We included ten papers reporting results from six intervention studies. Overall, design quality and analysis limited the risks of bias. Several CCT programmes provided strong evidence of a positive impact on the use of health services, nutritional status and health outcomes, respectively assessed by anthropometric measurements and self-reported episodes of illness. It is hard to attribute these positive effects to the cash incentives specifically because other components may also contribute. Several studies provide evidence of positive impacts on the uptake of preventive services by children and pregnant women. We found no evidence about effects on health care expenditure. Authors' conclusions Conditional cash transfer programmes have been the subject of some well-designed evaluations, which strongly suggest that they could be an effective approach to improving access to preventive services. Their replicability under different conditions - particularly in more deprived settings - is still unclear because they depend on effective primary health care and mechanisms to disburse payments. Further rigorous evaluative research is needed, particularly where CCTs are being introduced in low income countries, for example in Sub-Saharan Africa or South Asia.

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TL;DR: First-line low-dose thiazides reduce all morbidity and mortality outcomes and first-line ACE inhibitors and calcium channel blockers are inferior to first-liners beta-blockers.
Abstract: Background Sustained elevated blood pressure, unresponsive to lifestyle measures, leads to a critically important clinical question: What class of drug to use first-line? This review answers that question. Objectives Primary objective: To quantify the benefits and harms of the major first-line anti-hypertensive drug classes: thiazides, beta-blockers, calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors, alpha-blockers, and angiotensin II receptor blockers (ARB). Search methods Electronic search of MEDLINE (Jan. 1966-June 2008), EMBASE, CINAHL, the Cochrane clinical trial register, using standard search strategy of the hypertension review group with additional terms. Selection criteria Randomized trials of at least one year duration comparing one of 6 major drug classes with a placebo or no treatment. More than 70% of people must have BP >140/90 mmHg at baseline. Data collection and analysis The outcomes assessed were mortality, stroke, coronary heart disease (CHD), cardiovascular events (CVS), decrease in systolic and diastolic blood pressure, and withdrawals due to adverse drug effects. Risk ratio (RR) and a fixed effects model were used to combine outcomes across trials. Main results Of 57 trials identified, 24 trials with 28 arms, including 58,040 patients met the inclusion criteria. Thiazides (19 RCTs) reduced mortality (RR 0.89, 95% CI 0.83, 0.96), stroke (RR 0.63, 95% CI 0.57, 0.71), CHD (RR 0.84, 95% CI 0.75, 0.95) and CVS (RR 0.70, 95% CI 0.66, 0.76). Low-dose thiazides (8 RCTs) reduced CHD (RR 0.72, 95% CI 0.61, 0.84), but high-dose thiazides (11 RCTs) did not (RR 1.01, 95% CI 0.85, 1.20). Beta-blockers (5 RCTs) reduced stroke (RR 0.83, 95% CI 0.72, 0.97) and CVS (RR 0.89, 95% CI 0.81, 0.98) but not CHD (RR 0.90, 95% CI 0.78, 1.03) or mortality (RR 0.96, 95% CI 0.86, 1.07). ACE inhibitors (3 RCTs) reduced mortality (RR 0.83, 95% CI 0.72-0.95), stroke (RR 0.65, 95% CI 0.52-0.82), CHD (RR 0.81, 95% CI 0.70-0.94) and CVS (RR 0.76, 95% CI 0.67-0.85). Calcium-channel blocker (1 RCT) reduced stroke (RR 0.58, 95% CI 0.41, 0.84) and CVS (RR 0.71, 95% CI 0.57, 0.87) but not CHD (RR 0.77 95% CI 0.55, 1.09) or mortality (RR 0.86 95% CI 0.68, 1.09). No RCTs were found for ARBs or alpha-blockers. Authors' conclusions First-line low-dose thiazides reduce all morbidity and mortality outcomes. First-line ACE inhibitors and calcium channel blockers may be similarly effective but the evidence is less robust. First-line high-dose thiazides and first-line beta-blockers are inferior to first-line low-dose thiazides.

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TL;DR: The primary outcome was depression reduction, based on a dichotomous measure of clinical response, using relative risk (RR), and on a continuous measure of depression symptoms, using the mean difference (MD), with 95% confidence intervals (CI).
Abstract: Background Concern has been expressed about the relevance of secondary care studies to primary care patients specifically about the effectiveness of antidepressant medication. There is a need to review the evidence of only those studies that have been conducted comparing antidepressant efficacy with placebo in primary care-based samples. Objectives To determine the efficacy and tolerability of antidepressants in patients (under the age of 65 years) with depression in primary care. Search methods All searches were conducted in September 2007. The Cochrane Depression, Anxiety and Neurosis Group (CCDAN) Controlled Trials Register was searched, together with a supplementary search of MEDLINE, PsycINFO, EMBASE, LILACS, CINAHL and PSYNDEX. Abstracts of all possible studies for inclusion were assessed independently by two reviewers. Further trials were sought through searching the reference lists of studies initially identified and by scrutinising other relevant review papers. Selected authors and experts were also contacted. Selection criteria Studies were selected if they were randomised controlled trials of tricyclic antidepressants (TCAs) or selective serotonin reuptake inhibitors (SSRIs) versus placebo in adults. Older patients (over 65 years) were excluded. Patients had to be recruited from a primary care setting. For continuous outcomes the Hamilton Depression scale of the Montgomery Asberg Scale was required. Data collection and analysis Data were extracted using data extraction forms by two reviewers independently, with disagreements resolved by discussion. A similar process was used for the validity assessment. Pooling of results was done using Review Manager 5. The primary outcome was depression reduction, based on a dichotomous measure of clinical response, using relative risk (RR), and on a continuous measure of depression symptoms, using the mean difference (MD), with 95% confidence intervals (CI). Main results There were fourteen studies (16 comparisons) with extractable data included in the review, of which ten studies examined TCAs, two examined SSRIs and two included both classes, all compared with placebo. The number of participants in the intervention groups was 1364 and in the placebo groups 919. Nearly all studies were of short duration, typically 6-8 weeks. Pooled estimates of efficacy data showed an RR of 1.24, 95% CI 1.11-1.38 in favour of TCAs against placebo. For SSRIs this was 1.28, 95% CI 1.15 to 1.43.. The numbers needed to treat (NNT) for TCAs ranged from 7 to 16 {median NNT 9} patient expected event rate ranged from 63% to 26% respectively) and for SSRIs from 7 to 8 {median NNT 7} (patient expected event rate ranged from 48% to 42% respectively) . The numbers needed to harm (NNH for withdrawal due to side effects) ranged from 4 to 30 for TCAs (excluding three studies with no harmful events leading to withdrawal) and 20 to 90 for SSRIs. Authors' conclusions Both TCAs and SSRIs are effective for depression treated in primary care.

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TL;DR: No convincing evidence from the trials identified that blood pressure lowering in late-life prevents the development of dementia or cognitive impairment in hypertensive patients with no apparent prior cerebrovascular disease is identified.
Abstract: Background This is an update of a previous review (McGuinness 2006). Hypertension and cognitive impairment are prevalent in older people. Hypertension is a direct risk factor for vascular dementia (VaD) and recent studies have suggested hypertension impacts upon prevalence of Alzheimer's disease (AD). Therefore does treatment of hypertension prevent cognitive decline? Objectives To assess the effects of blood pressure lowering treatments for the prevention of dementia and cognitive decline in patients with hypertension but no history of cerebrovascular disease. Search methods The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group, The Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, LILACS as well as many trials databases and grey literature sources were searched on 13 February 2008 using the terms: hypertens$ OR anti-hypertens$. Selection criteria Randomized, double-blind, placebo controlled trials in which pharmacological or non-pharmacological interventions to lower blood pressure were given for at least six months. Data collection and analysis Two independent reviewers assessed trial quality and extracted data. The following outcomes were assessed: incidence of dementia, cognitive change from baseline, blood pressure level, incidence and severity of side effects and quality of life. Main results Four trials including 15,936 hypertensive subjects were identified. Average age was 75.4 years. Mean blood pressure at entry across the studies was 171/86 mmHg. The combined result of the four trials reporting incidence of dementia indicated no significant difference between treatment and placebo (236/7767 versus 259/7660, Odds Ratio (OR) = 0.89, 95% CI 0.74, 1.07) and there was considerable heterogeneity between the trials. The combined results from the three trials reporting change in Mini Mental State Examination (MMSE) did not indicate a benefit from treatment (Weighted Mean Difference (WMD) = 0.42, 95% CI 0.30, 0.53). Both systolic and diastolic blood pressure levels were reduced significantly in the three trials assessing this outcome (WMD = -10.22, 95% CI -10.78, -9.66 for systolic blood pressure, WMD = -4.28, 95% CI -4.58, -3.98 for diastolic blood pressure). Three trials reported adverse effects requiring discontinuation of treatment and the combined results indicated no significant difference (OR = 1.01, 95% CI 0.92, 1.11). When analysed separately, however, more patients on placebo in Syst Eur 1997 were likely to discontinue treatment due to side effects; the converse was true in SHEP 1991. Quality of life data could not be analysed in the four studies. Analysis of the included studies in this review was problematic as many of the control subjects received antihypertensive treatment because their blood pressures exceeded pre-set values. In most cases the study became a comparison between the study drug against a usual antihypertensive regimen. Authors' conclusions There is no convincing evidence from the trials identified that blood pressure lowering in late-life prevents the development of dementia or cognitive impairment in hypertensive patients with no apparent prior cerebrovascular disease. There were significant problems identified with analysing the data, however, due to the number of patients lost to follow-up and the number of placebo patients who received active treatment. This introduced bias. More robust results may be obtained by conducting a meta-analysis using individual patient data.