OBJECTIVE -To review the effects of monotherapy with ␣-glucosidase inhibitors (AGIs) for patients with type 2 diabetes, with respect to mortality, morbidity, glycemic control, insulin levels, plasma lipids, body weight, and side effects. RESEARCH DESIGN AND METHODS -We systematically searched the CochraneCentral register of Controlled Trials, MEDLINE, EMBASE, Current Contents, LILACS, databases of ongoing trials, and reference lists, and we contacted experts and manufacturers. Inclusion criteria were randomized controlled trials of at least 12 weeks' duration, AGI monotherapy compared with any intervention, and one of the following outcome measures: mortality, morbidity, GHb, blood glucose, lipids, insulin levels, body weight, or side effects. Two independent reviewers assessed all abstracts, extracted all data, and assessed quality. We contacted all authors for data clarification. Continuous data were expressed as weighted mean differences and analyzed with a random-effects model. Possible influences of study characteristics and quality were assessed in sensitivity and meta-regression analyses.RESULTS -Forty-one studies were included in the review (30 acarbose, 7 miglitol, 1 voglibose, and 3 combined), and heterogeneity was limited. We found no evidence for an effect on mortality or morbidity. Compared with placebo, AGIs had a beneficial effect on GHb (acarbose Ϫ0.77%; miglitol Ϫ0.68%), fasting and postload blood glucose and postload insulin. With acarbose dosages higher than 50 mg t.i.d., the effect on GHb was the same, but the occurrence of side effects increased. Acarbose decreased the BMI by 0.17 kg/m 2 (95% CI 0.08 -0.26). None of the AGIs had an effect on plasma lipids. Compared with sulfonylurea, AGIs seemed inferior with respect to glycemic control, but they reduced fasting and postload insulin levels. For comparisons with other agents, little data were available.CONCLUSIONS -We found no evidence for an effect on mortality or morbidity. AGIs have clear beneficial effects on glycemic control and postload insulin levels but not on plasma lipids. There is no need for dosages higher than 50 mg acarbose t.i.d. Diabetes Care 28:166 -175, 2005A lpha-glucosidase inhibitors (AGIs; acarbose, miglitol, voglibose) are widely used in the treatment of patients with type 2 diabetes. AGIs delay the absorption of carbohydrates from the small intestine and thus have a lowering effect on postprandial blood glucose and insulin levels.In modern medicine, the efficacy of an intervention should be investigated in well-designed randomized trials. Results from the trials should be collected in a high-quality systematic review, if possible with a meta-analysis. And finally, the evidence should have its repercussions on practice guidelines.How does this apply for AGIs? Recommendations on when to use AGIs and the evidence used for these recommendations appear to be different in various guidelines. For example, the guideline by the European Diabetes Policy Group (1) and a consensus statement by the American Diabetes Association (2)...
Objective To assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients' management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice.Design 24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial.Setting 15 general practices in the eastern part of the Netherlands.Participants Patients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded.Interventions A comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients' own initiative). Outcome measuresThe primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients' management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale.Results 165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15.58). ConclusionsComprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group.Trial registration Clinical trials NCT00128765.
Analysis 2.13. Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 13 Change in body mass index (Kg/m2). Analysis 2.14. Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 14 Total deaths.. .. .. .. . Analysis 2.15. Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 15 Disease related deaths.. .. .. Analysis 2.16. Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 16 Occurence of adverse effects.. .. Analysis 2.17. Comparison 2 Acarbose versus sulphonylurea (SU), Outcome
Objective: To measure the effectiveness of strategies to implement clinical guidelines and the influence of organisational characteristics on hospital care.Methods: Systematic review and meta regression analysis including randomised controlled trials, controlled clinical trials and controlled before-and-after studies.Results: 53 studies were identified, including 81 comparisons. The total effect of all intervention strategies appeared to be Odds ratio 2.13 (SD 1.72-2.65). Intervention strategies (such as educational material, reminders, feedback) and other professional interventions that mostly comprised revisions of professional roles were found to be relatively strong components of multi faceted interventions. Outcomes of organisational effect modifiers were better in a learning environment in inpatient studies than in outpatient studies. Interventions developed outside hospitals yielded better outcomes; OR 4.62 (SD 2.82-7.57) versus OR 1.78 (SD 1.36-2.23). Conclusion:Both single and multifaceted interventions seemed to be effective in hospital settings. Evidence for the effects of organisational determinants remained limited.
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