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PubMed2006

Accuracy of monoclonal stool antigen test for the diagnosis of H. pylori infection: a systematic review and meta-analysis.

OBJECTIVE: To perform a systematic review and a meta-analysis of accuracy of monoclonal stool antigen test (SAT) for the diagnosis of Helicobacter pylori infection. METHODS SELECTION OF STUDIES: assessing the accuracy of monoclonal SAT for the diagnosis of H. pylori infection. SEARCH STRATEGY: electronic and manual bibliographical searches. DATA EXTRACTION: independently done by two reviewers. DATA SYNTHESIS: meta-analyses combining the sensitivities, specificities, and likelihood ratios (LRs) of the individual studies. RESULTS: Twenty-two studies, including 2,499 patients, evaluated the monoclonal SAT before eradication therapy. Pooled sensitivity, specificity, LR+, and LR- were: 0.94 (95% CI 0.93-0.95), 0.97 (0.96-0.98), 24 (15-41), and 0.07 (0.04-0.12). The accuracy of both monoclonal and polyclonal SAT was evaluated together in 13 pretreatment studies, and higher pooled sensitivity was demonstrated with the monoclonal technique (0.95 vs 0.83). Twelve studies, including 957 patients, assessed the monoclonal SAT to confirm eradication after therapy. Pooled sensitivity, specificity, LR+, and LR- were 0.93 (0.89-0.96), 0.96 (0.94-0.97), 17 (12-23), and 0.1 (0.07-0.15). Both tests were evaluated together in eight post-treatment studies and, again, the monoclonal technique showed higher sensitivity (0.91 vs 0.76). Heterogeneity among studies disappeared when a single outlier study was excluded. Subanalysis depending on the reference method, the study population, or the study quality showed similar results. CONCLUSION: Monoclonal SAT is an accurate noninvasive method both for the initial diagnosis of H. pylori infection and for the confirmation of its eradication after treatment. The monoclonal technique has higher sensitivity than the polyclonal one, especially in the post-treatment setting.

Antigens, Bacterial↗

PubMed2007

Systematic review and meta-analysis of clinically relevant adverse events from HMG CoA reductase inhibitor trials worldwide from 1982 to present.

PURPOSE: Our objective was to determine the association of clinically relevant adverse events from a systematic review and meta-analysis of statin randomized controlled trials (RCT). METHODS: We performed the meta-analysis in the manner of a Cochrane Collaboration systematic review. Outcomes were discontinuances of therapy or muscle-related symptoms due to adverse events. We searched for articles from 1982 through June 2006 in MEDLINE and other databases. The main inclusion criteria were double blind, placebo controlled RCTs with a monotherapy intervention of any marketed statin and active surveillance of adverse events. We excluded studies of drug interactions, organ transplants, or exercise, or those not meeting all of the study quality criteria. The primary analysis was a statin formulation stratified fixed-effect model using Peto odds-ratios (POR). Secondary analyses explored the stability of the primary results. RESULTS: Over 86,000 study participants from 119 studies were included. Available statins were associated with a lower POR of discontinuance (overall: 0.88 [0.84, 0.93], largest effect with pravastatin: 0.79 [0.74, 0.84]), an elevated POR of rhabdomyolysis (1.59 [0.54, 4.70]) and myositis (2.56 [1.12, 5.85]), and null odds of myalgia (1.09 [0.97, 1.23]). Cerivastatin by comparison demonstrated larger PORs for discontinuances and muscle-related adverse events. Secondary analyses demonstrated the stability of the results. CONCLUSIONS: Overall, discontinuation of statin therapy due to adverse events was no worse than placebo. The risks of muscle-related adverse events were in general agreement with the known risks of statins.

Humans↗

PubMedDate not supplied

[Fish consumption and coronary mortality in the general population: a meta-analysis of cohort studies].

In order to estimate the effect of fish intake on ischemic heart disease mortality in the general population, we performed a meta-analysis of the epidemiologic studies involving participants free of disease at baseline published on the topic. All of the 7 studies published to date were cohort studies; however, only 5 of them reported the results with enough detail to be used in a formal meta-analysis. The total number of participants in these studies was 27,656, with an average follow-up in each study between 7.5 and 25 years and a total of 1,731 coronary deaths. The combined estimate of the relative risk for an intake of 30 g/day of fish compared to no intake was 0.96 (95% CI: 0.93-1.00; P = 0.058). Due to the presence of statistically significant heterogeneity among the studies, unexplained by a priori factors, we combined the studies assuming a random effects model, obtaining a relative risk estimate of 0.92 (95% CI: 0.84-1.01; P = 0.090). These results, together with the results of the only clinical trial of fish intake performed in post-myocardial infarction patients, in which an intake of 200-400 g/week of fatty fish reduced total mortality by 29% (relative risk of intake compared to no intake 0.71; 95% CI: 0.54-0.93), suggest a moderate beneficial effect of fish intake on coronary mortality.

Cohort Studies↗

PubMed1991

Surfactant replacement therapy in respiratory distress syndrome. Meta-analysis of clinical trials of single-dose surfactant extracts.

Replacement therapy with surfactant extracts in premature infants with respiratory distress syndrome has been evaluated in several clinical trials. The results of individual trials do not provide conclusive evidence that administration of a single dose of surfactant improves morbidity or mortality. Meta-analysis is a statistical method to combine the results of such clinical trials, and combined analysis provides a means to overcome the problem of not being able to detect significant small differences in individual trials due to these small sample sizes. Seven clinical trials (277 patients treated with nonhuman surfactant extract and 263 controls) met the criteria for analysis; five outcome measurements (mortality, patent ductus arteriosus, pneumothorax, intraventricular hemorrhage, and bronchopulmonary dysplasia) were selected to estimate the treatment effect. The meta-analysis showed that a single dose of surfactant administered before the first breath or within 15 hours of birth significantly decreased the mortality rate (95% confidence interval = -0.19 to -0.03) and the risk of developing pneumothorax (95% confidence interval = -0.28 to 0.14) in infants with respiratory distress syndrome. Further clinical trials are needed to evaluate other aspects of surfactant replacement therapy in premature infants because inconsistent results were observed among the seven analyzed studies.

Confidence Intervals↗

PubMed2006

Accuracy of Helicobacter pylori diagnostic tests in patients with bleeding peptic ulcer: a systematic review and meta-analysis.

OBJECTIVE: To perform a systematic review and a meta-analysis of diagnostic accuracy of the different tests aimed to detect Helicobacter pylori infection in patients with upper gastrointestinal bleeding (UGIB). METHODS SELECTION OF STUDIES: assessing the accuracy of H. pylori diagnostic methods in patients with UGIB. SEARCH STRATEGY: electronic bibliographical searches. DATA EXTRACTION: independently done by two reviewers. DATA SYNTHESIS: meta-analyses of the different tests were performed combining the sensitivities, specificities, and likelihood ratios (LRs) of the individual studies. RESULTS: Studies showed a high degree of heterogeneity. Pooled sensitivity, specificity, LR+ and LR- (95% confidence interval (CI)) for the different methods were: Rapid urease test (16 studies/1,417 patients): 0.67 (0.64-0.70), 0.93 (0.90-0.96), 9.6 (5.1-18.1), and 0.31 (0.22-0.44). Histology (10 studies/827 patients): 0.70 (0.66-0.74), 0.90 (0.85-0.94), 6.7 (2.5-18.4), and 0.23 (0.12-0.46). Culture (3 studies/314 patients): 0.45 (0.39-0.51), 0.98 (0.92-1.00), 19.6 (4-96), and 0.31 (0.05-1.9). Urea breath test (8 studies/520 patients): 0.93 (0.90-0.95), 0.92 (0.87-0.96), 9.5 (3.9-23.3), and 0.11 (0.07-0.16). Stool antigen test (6 studies/377 patients): 0.87 (0.82-0.91), 0.70 (0.62-0.78), 2.3 (1.4-4), and 0.2 (0.13-0.3). Serology (9 studies/803 patients): 0.88 (0.85-0.90), 0.69 (0.62-0.75), 2.5 (1.6-4.1), and 0.25 (0.19-0.33). CONCLUSION: Biopsy-based methods, such as rapid urease test, histology, and culture, have a low sensitivity, but a high specificity, in patients with UGIB. The accuracy of 13C-urea breath test remains very high in these patients. Stool antigen test is less accurate in UGIB. Although serology seems not to be influenced by UGIB, it cannot be recommended as the first diagnostic test for H. pylori infection in this setting.

Antigens, Bacterial↗

PubMed2001

Effectiveness of home based support for older people: systematic review and meta-analysis.

OBJECTIVE: To evaluate the effectiveness of home visiting programmes that offer health promotion and preventive care to older people. DESIGN: Systematic review and meta-analysis of 15 studies of home visiting. PARTICIPANTS: older people living at home, including frail older people at risk of adverse outcomes. OUTCOME MEASURES: Mortality, admission to hospital, admission to institutional care, functional status, health status. RESULTS: Home visiting was associated with a significant reduction in mortality. The pooled odds ratio for eight studies that assessed mortality in members of the general elderly population was 0.76 (95% confidence interval 0.64 to 0.89). Five studies of home visiting to frail older people who were at risk of adverse outcomes also showed a significant reduction in mortality (0.72; 0.54 to 0.97). Home visiting was associated with a significant reduction in admissions to long term institutional care in members of the general elderly population (0.65; 0.46 to 0.91). For three studies of home visiting to frail, "at risk" older people, the pooled odds ratio was 0.55 (0.35 to 0.88). Meta-analysis of six studies of home visiting to members of the general elderly population showed no significant reduction in admissions to hospital (odds ratio 0.95; 0.80 to 1.09). Three studies showed no significant effect on health (standardised effect size 0.06; -0.07 to 0.18). Four studies showed no effect on activities of daily living (0.05; -0.07 to 0.17). CONCLUSION: Home visits to older people can reduce mortality and admission to long term institutional care.

Aged↗

PubMed2005

The relationship between job satisfaction and health: a meta-analysis.

BACKGROUND: A vast number of published studies have suggested a link between job satisfaction levels and health. The sizes of the relationships reported vary widely. Narrative overviews of this relationship have been published, but no systematic meta-analysis review has been conducted. METHODS: A systematic review and meta-analysis of 485 studies with a combined sample size of 267 995 individuals was conducted, evaluating the research evidence linking self-report measures of job satisfaction to measures of physical and mental wellbeing. RESULTS: The overall correlation combined across all health measures was r = 0.312 (0.370 after Schmidt-Hunter adjustment). Job satisfaction was most strongly associated with mental/psychological problems; strongest relationships were found for burnout (corrected r = 0.478), self-esteem(r = 0.429), depression (r = 0.428), and anxiety(r = 0.420). The correlation with subjective physical illness was more modest (r = 0.287). CONCLUSIONS: Correlations in excess of 0.3 are rare in this context. The relationships found suggest that job satisfaction level is an important factor influencing the health of workers. Organisations should include the development of stress management policies to identify and eradicate work practices that cause most job dissatisfaction as part of any exercise aimed at improving employee health. Occupational health clinicians should consider counselling employees diagnosed as having psychological problems to critically evaluate their work-and help them to explore ways of gaining greater satisfaction from this important aspect of their life.

Burnout, Professional↗

PubMed1998

Handsewn vs. stapled anastomoses in colon and rectal surgery: a meta-analysis.

PURPOSE: Trials comparing handsewn with stapled anastomoses in colon and rectal surgery have not found statistical differences. Despite this, authors have differed in their conclusions as to which technique is superior. To help determine whether differences in patient outcomes are present, a meta-analysis of all trials was performed. METHOD: A meta-analysis of all randomized, controlled trials assessing handsewn and stapled colon and rectal anastomoses was done using a fixed-effects model. Outcome variables were mortality, technical problems, leak rates, wound infections, strictures, and cancer recurrence. Outcomes were assessed for all anastomoses involving the colon and for the subset of colorectal anastomoses. RESULTS: Thirteen distinct trials met the inclusion criteria. Intraoperative technical problems were more likely to occur with stapled than with handsewn anastomoses for all anastomoses (P < 0.0001) and for colorectal anastomoses (P < 0.001). Strictures were also more common following stapled anastomoses (P = 0.015 for all anastomoses; P = 0.028 for colorectal anastomoses). All other outcome measures, including mortality, clinical and radiologic leak rates, and local cancer recurrence rates showed no difference between groups. CONCLUSION: Although intraoperative technical problems and postoperative strictures were more common with stapled anastomoses, other outcome measures showed no difference between groups. Thus, both techniques are effective, and the choice may be based on personal preference.

Anastomosis, Surgical↗

PubMed1997

Understanding the variability in the effectiveness of community heart health programs: a meta-analysis.

Over the past 25 years, community interventions to reduce cardiovascular disease (CVD) have been conducted around the world with very mixed results. This study uses meta-analysis to assess whether the variation in the observed effectiveness of community heart health programs (CHHP) is related to characteristics of the intervention program, the population under study, or the evaluation methods. A CHHP is defined as any primary prevention program that attempted to reduce the population burden of CVD by shifting the distribution of risk factors in a general population. To be included in the meta-analysis, a study must have utilized a reference group in the evaluation, employed a repeated independent cross-sectional measurement design, and reported sufficient outcome information for at least one of four major risk factors: smoking, total cholesterol, blood pressure, and body weight. Results of these studies are summarized with the effect size measure (Yi1-Yi2)-(Yr1-Yr2)Sr1 where Y = outcome measure, S = standard deviation of the outcome measure, 1 = baseline, 2 = follow-up. i = intervention, and r = reference community. This measure, which reports the net change in the intervention group in terms of the variability in the reference population before the start of the intervention, permits comparison across different outcome measures and facilitates the aggregation of effects across studies. Generalized least squares regression, which permits the incorporation of multiple, dependent effect sizes from a single study, was used to assess the impact of characteristics of the intervention (prevention strategy, type of mass communication, community organization, and environmental change), the population (setting, gender, year of follow-up measurement), and the evaluation design and implementation (the number of communities, matching of communities, the follow-up time, the response rate, and covariate adjustment in the analysis) on the effect sizes. The results of this analysis suggest that the characteristics of the evaluation method account for much of the heterogeneity in the outcome of CHHPs, though some intervention characteristics also play a role.

Blood Pressure↗

PubMed2006

Do selective COX-2 inhibitors increase the risk of cerebrovascular events? A meta-analysis of randomized controlled trials.

OBJECTIVES: To evaluate the risk of cerebrovascular events (CVEs) associated with selective cyclooxygenase-2 inhibitors (coxibs). METHOD: Systematic review and meta-analysis of randomized controlled trials (RCTs). A fixed-effect model was used to estimate the odds ratios (ORs) for risk of CVE associated with coxibs compared against placebo, non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and other coxibs. RESULTS: Forty trials (88 116 patients) were included in the meta-analysis. The overall pooled OR for CVE for any coxib against placebo was 1.03 (95% CI: 0.71, 1.50). Comparing individual coxibs against placebo, we found that celecoxib, rofecoxib, etoricoxib and lumiracoxib were associated with higher CVE risks and valdecoxib was associated with a lower CVE risk, although there were no significant differences detected. There was also no significant difference in risk of CVE when comparing coxibs against any non-selective NSAIDs; the corresponding pooled OR was 0.86 (95% CI: 0.64, 1.16). CONCLUSION: On the basis of a detailed analysis of available RCTs, there does not appear to be any significant difference in risk of CVEs associated with coxibs when compared against placebo or non-selective NSAIDs. It is likely that the increased risk of thrombotic vascular events associated with coxibs is largely attributable to an increased risk of myocardial infarction, rather than CVEs.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed2001

Do steroids reduce morbidity of tonsillectomy? Meta-analysis of randomized trials.

OBJECTIVES/HYPOTHESIS: The study aims to reconcile conflicting published reports regarding the clinical efficacy of a single intraoperative dose of dexamethasone in reducing post-tonsillectomy morbidity. STUDY DESIGN: Systematic overview (meta-analysis). METHODS: To critically evaluate the existing evidence, we performed a formal meta-analysis of eight double-blinded, randomized, placebo-controlled studies of dexamethasone in pediatric patients undergoing tonsillectomy or adenotonsillectomy. Reduction in postoperative emesis and pain, as well as early return to soft or solid diet, were studied as distinct end points. RESULTS: Children being given a single intraoperative dose of dexamethasone (dosing, 0.15-1.0 mg/kg; maximum dose, 8-25 mg) were two times less likely to vomit in the first 24 hours than children being given placebo (relative risk [RR] = 0.55; 95% confidence interval [CI], 0.41-0.74; P < .0001). Routine use in four children would be expected to result in one less patient having post-tonsillectomy emesis (risk difference [RD] = -0.24; 95% CI, -0.38 to -0.10; P = .0006). In addition, children being given dexamethasone were more likely to advance to a soft or solid diet on post-tonsillectomy day 1 (RR = 1.69; 95% CI, 1.02-2.79; P = .04) than those being given placebo. Because of missing data and varied outcome measures, pain could not be meaningfully analyzed as a distinct end point. CONCLUSION: Given the frequency of tonsillectomy, relative safety and low cost of dexamethasone, and the reduction in postoperative morbidity, we recommend routine use of a single intravenous dose during pediatric tonsillectomy.

Adenoidectomy↗

PubMed2005

Influence of alcohol on the progression of hepatitis C virus infection: a meta-analysis.

BACKGROUND & AIMS: A convincing, yet inconsistent, pattern has emerged that demonstrates increased progression of HCV-related liver disease with heavy alcohol use. The aim was to perform a meta-analysis to quantify the effect of alcohol on cirrhosis risk among persons infected with HCV. METHODS: A meta-analysis of 20 articles, involving more than 15,000 HCV chronically infected persons, published between 1995 and 2004 was undertaken to explore the relationship between advanced liver disease and the consumption of alcohol. RESULTS: The pooled relative risk of cirrhosis associated with heavy alcohol intake (defined in the range of at least 210-560 g per week) was 2.33 (95% confidence interval, 1.67-3.26) by the random effects model. The risk of HCV-related liver disease associated with heavy alcohol intake increased with severity of the outcome; the lowest (1.63; 95% confidence interval, 1.22-2.17) and highest (3.54; 2.14-5.85) pooled relative risk estimates were obtained for advanced fibrosis and decompensated cirrhosis, respectively. The regression effect of alcohol might, however, be underestimated in studies investigating the risk of HCV-related cirrhosis because they necessarily include patients undergoing liver biopsy and could therefore under-represent heavy alcohol users. CONCLUSIONS: The evidence overwhelmingly shows a worsened outcome for those with chronic HCV and concurrent alcohol use. Studies varied widely in their definition of significant alcohol intake, and so the true threshold above which alcohol accelerates HCV disease progression remains uncertain. Alcohol consumption should be minimized as much as possible in those who have chronic HCV until a safe threshold is more definitively determined.

Alcohol Drinking↗

PubMed2000

A meta-analysis of antimycobacterial therapy for Crohn's disease.

OBJECTIVE: Various therapies have been studied for the treatment of Crohn's disease, including antimycobacterial therapy. Meta-analysis was used to evaluate the effect of antimycobacterial therapy in patients with Crohn's disease. METHODS: Randomized, controlled trials comparing antimycobacterial therapy with placebo were identified. Key outcome data were abstracted and the results were pooled to yield odds ratios for maintenance of remission in treated versus control groups. RESULTS: A total of eight randomized trials were identified. Six trials were fully published and were included in the primary analysis. Two trials used antimycobacterial therapy in combination with corticosteroids to induce remission in patients with active Crohn's disease, followed by maintenance therapy with antimycobacterial agents. In these trials, control patients received corticosteroids to induce remission but no antimycobacterial therapy. Pooling of these trials yielded an odds ratio of maintenance of remission in treatment versus control of 3.37 (95% confidence interval [CI], 1.38-8.24) in favor of antimycobacterial therapy. The remaining four trials used antimycobacterial therapy combined with standard therapy in patients with Crohn's disease. In these trials, control patients received standard therapy alone. Pooling of these trials yielded an odds ratio of maintenance of remission in treatment versus control of 0.69 (95% CI, 0.39-1.21) in favor of standard therapy. CONCLUSIONS: These results suggest that antimycobacterial therapy is effective in maintaining remission in patients with Crohn's disease after a course of corticosteroids combined with antimycobacterial therapy to induce remission. Treatment of Crohn's disease with antimycobacterial therapy does not seem to be effective without a course of corticosteroids to induce remission. Because of the small number of studies included in this meta-analysis, the results should be interpreted with caution.

Adrenal Cortex Hormones↗

PubMed1990

The predictability of suicidal behavior: the results of a meta-analysis of published studies.

Using a method of literature review known as meta-analysis, 81 articles were selected describing comparative research into possible differences between two or more of the following groups: nonsuicidals, suicide ideators, first-ever attempters, nonlethal repeaters, and suicides. Differential characteristics are described per comparison category. On the basis of their review, the authors conclude that, generally speaking, suicide prediction research has made little headway over the past 25 years. The many problems in this field of research are discussed and suggestions for improvements are offered; for example, a uniform definition and standardized measurement of variables are outlined, and standard requirements for designs of studies on suicide prediction are formulated.

Humans↗

PubMed1998

Quinine for nocturnal leg cramps: a meta-analysis including unpublished data.

OBJECTIVE: With respect to the use of quinine for the treatment of nocturnal leg cramps, to determine whether the findings of a previously performed meta-analysis of published data are altered with the addition of unpublished data, and whether publication bias is present in this area. DESIGN: A meta-analysis of eight (four published and four unpublished) randomized, double-blind, placebo-controlled trials, seven of which had a crossover design. SETTING: Randomized trials that were available as of July 1997. SUBJECTS: Ambulatory patients (659) who suffered from regular nocturnal leg cramps. MAIN RESULTS: When individual patient data from all crossover studies were pooled, persons had 3.60 (95% confidence interval [CI] 2.15, 5.05) fewer cramps in a 4-week period when taking quinine compared with placebo. This compared with an estimate of 8.83 fewer cramps (95% CI 4.16, 13.49) from pooling published studies alone. The corresponding relative risk reductions were 21% (95% CI 12%, 30%) and 43% (95% CI 21%, 65%), respectively. Compared with placebo, the use of quinine was associated with an increased incidence of side effects, particularly tinnitus. Publication bias is present in the reporting of the efficacy of quinine for this indication, as almost all published studies reported larger estimates of its efficacy than did unpublished studies. CONCLUSIONS: This study confirms that quinine is efficacious in the prevention of nocturnal leg cramps. However, its benefit may not be as large as reported from the pooling of published studies alone. Given the side effect profile of quinine, nonpharmacologic therapy (e.g., regular passive stretching of the affected muscle) is the best first-line treatment. For persons who find this ineffective and whose quality of life is significantly affected, a trial of quinine is warranted. Prescribing physicians must closely monitor the risks and benefits in individual patients. Publication bias is present in this area even though there is controversy about the role of quinine in the treatment of leg cramps. To minimize the possibility of this bias, persons performing medication-related meta-analyses should seek high-quality unpublished data from drug regulatory agencies and pharmaceutical companies.

Humans↗

PubMed1996

Continuous labor support from labor attendant for primiparous women: a meta-analysis.

OBJECTIVE: To evaluate the available literature on the effects of continuous labor support among primiparous women. DATA SOURCES: We did a Medline search using the keywords "labor support," "doula," and "monitrice." Papers published in English from 1965 to May 1995 were eligible for this review. We also cross-checked all the references in the selected reports. METHODS OF STUDY SELECTION: We identified seven randomized clinical trials published during that period; four of these were eligible for our meta-analysis. DATA EXTRACTION AND SYNTHESIS: Meta-analysis of four studies conducted among young, low-income, primiparous women who gave birth on a busy labor floor in the absence of a companion suggested that continuous labor support by a labor attendant shortens the duration of labor by 2.8 hours (95% confidence interval [CI] 2.2-3.4), doubles spontaneous vaginal birth (relative risk [RR] 2.01, 95% CI 1.5-2.7) and halves the frequency of oxytocin use (RR 0.44, 95% CI 0.4-0.7), forceps use (RR 0.46, 95% CI 0.3-0.7), and cesarean delivery rate (RR 0.54, 95% CI 0.4-0.7). Women with labor support also reported higher satisfaction and a better postpartum course. CONCLUSION: Labor support may have important positive effects on obstetric outcomes among young, disadvantaged women. Further studies on benefit relative to cost are needed before a broad-scale program is advocated.

Delivery, Obstetric↗

PubMed1996

Adjuvant chemotherapy plus tamoxifen compared with tamoxifen alone for postmenopausal breast cancer: meta-analysis of quality-adjusted survival.

BACKGROUND: Adjuvant tamoxifen for early breast cancer provides an improvement in relapse-free (RFS) and overall survival (OS), especially for older women. We carried out a meta-analysis to find out whether the benefit of adding chemotherapy to tamoxifen outweighs its costs in terms of toxic effects for postmenopausal patients. METHODS: The meta-analysis of quality-adjusted survival was based on data from 3920 patients aged 50 years or older with node-positive breast cancer randomly assigned in nine trials that compared combination chemotherapy plus tamoxifen with tamoxifen alone. The nine trials were included in the worldwide overview conducted by the early breast cancer trialists' collaborative group (EBCTCG). The quality-adjusted time without symptoms or toxicity (Q-TWiST) method was used to provide treatment comparisons incorporating differences in quality of life associated with subjective toxic effects of treatment and symptoms of disease relapse. FINDINGS: Within 7 years of follow-up the modest benefit of increased RFS and OS for patients who received chemotherapy just balanced the costs in terms of acute toxic side-effects. Chemotherapy-treated patients gained an average of 5.4 months of RFS and 2 months of OS (neither statistically significant), but had to receive cytotoxic treatment for between 2 and 24 months to achieve these gains. No values of preference weights for time spent undergoing chemotherapy and time after relapse gave significantly more Q-TWiST with chemotherapy plus tamoxifen than with tamoxifen alone. INTERPRETATION: Within 7 years of follow-up, adjuvant chemoendocrine therapy did not provide more quality-adjusted survival time than tamoxifen alone for women aged 50 years or older with node-positive breast cancer. Better selection and administration of chemotherapy regimen, different scheduling of chemotherapy and tamoxifen, and appropriate use of patient and tumour characteristics may increase the therapeutic advantage of the combination.

Antineoplastic Agents, Hormonal↗

PubMed2002

Increased risk of colorectal neoplasia in patients with primary sclerosing cholangitis and ulcerative colitis: a meta-analysis.

BACKGROUND: Published data on the risk of colorectal neoplasia in patients with ulcerative colitis with and without primary sclerosing cholangitis are conflicting. A meta-analysis was performed to synthesize available publications and to compare the risk of colorectal neoplasia in patients with ulcerative colitis with and without primary sclerosing cholangitis. METHODS: By using MEDLINE and manual search methods, studies were identified that compared the risk of colorectal neoplasia (dysplasia and carcinoma) in patients with ulcerative colitis with and without primary sclerosing cholangitis. In addition, citations were reviewed in relevant articles and proceedings from gastroenterology meetings, and investigators were contacted when data were incomplete. The summary odds ratio (OR) was then calculated for the risk for patients with ulcerative colitis and primary sclerosing cholangitis of having colorectal neoplasia develop compared with that of patients with ulcerative colitis without primary sclerosing cholangitis. RESULTS: Eleven studies met all eligibility criteria for the meta-analysis. Patients with ulcerative colitis and primary sclerosing cholangitis are at increased risk of colorectal dysplasia and carcinoma compared with patients with ulcerative colitis alone; OR 4.79: 95% CI [3.58, 6.41] with the Mantel-Haenszel method, and OR 5.11: 95% CI [3.15, 8.29] with the Der Simonian and Laird method. This increased risk is present even when the risk of colorectal carcinoma alone is considered; OR 4.09: 95% CI [2.89, 5.76] and OR 4.26: 95% CI [2.80, 6.48] by using, respectively, the Mantel-Haenszel and the Der Simonian and Laird methods. CONCLUSIONS: Patients with ulcerative colitis and primary sclerosing cholangitis have a significantly higher risk for the development of colorectal neoplasia than patients with ulcerative colitis but not primary sclerosing cholangitis. More intensive colonoscopic surveillance should be considered for patients with ulcerative colitis and primary sclerosing cholangitis.

Cholangitis, Sclerosing↗