ABSTRACT
BACKGROUND: Smokers hospitalized with acute coronary syndrome (ACS) are at high risk for subsequent ischemic events. Nevertheless, over two-thirds of patients continue to smoke after an acute myocardial infarction. Bupropion hydrochloride has proven efficacy as a smoking cessation aid, but data regarding its safety and efficacy in ACS patients are limited. METHODS: In a double-blind, randomized controlled trial, we compared the safety and efficacy of 8 weeks of treatment with bupropion slow-release (SR) or placebo for smokers hospitalized with ACS as an adjunct to nurse-led hospital- and telephone-based support. Primary efficacy outcome was smoking abstinence at 1 year. Primary safety outcome was clinical events at 1 year. RESULTS: A total of 151 patients were enrolled; all but 2 completed follow-up. Abstinence rates at 3 months were 45% and 44% in the bupropion SR and placebo groups, respectively (P = .99); 37% vs 42% (P = .61) at 6 months; and 31% vs 33% (P = .86) at 1 year. On multivariate analysis, an invasive procedure performed during index hospitalization was an independent predictor for smoking abstinence at 1 year (odds ratio [OR], 4.2; 95% confidence interval [CI], 1.22-14.19). Presence of adverse effects attributed to treatment was a negative predictor for smoking cessation (OR, 0.23; 95% CI, 0.07-0.78). Treatment with bupropion SR was not associated with an increase in clinical events or change in blood pressure or body mass index, but dizziness was more common compared with placebo (14% vs 1.4%; P = .005). CONCLUSION: In hospitalized patients with ACS who received continuous, intensive nurse counseling about smoking cessation, bupropion did not increase the rates of smoking abstinence.
Subject(s)
Acute Coronary Syndrome/complications , Bupropion/therapeutic use , Dopamine Uptake Inhibitors/therapeutic use , Smoking Cessation/methods , Smoking/drug therapy , Counseling , Double-Blind Method , Female , Humans , Male , Treatment OutcomeABSTRACT
STUDY DESIGN: A systematic review of randomized controlled trials. OBJECTIVE: To determine the effectiveness of shoe insoles in the prevention and treatment of nonspecific back pain compared with placebo, no intervention, or other interventions. SUMMARY OF BACKGROUND DATA: There is lack of theoretical and clinical knowledge of the use of insoles for prevention or treatment of back pain. METHODS: We searched electronic databases from inception to October 2008. We reviewed reference lists in review articles, guidelines, and in the included trials; conducted citation tracking; and contacted individuals with expertise in this domain. One review author conducted the searches and blinded the retrieved references for authors, institution, and journal. Two review authors independently selected the relevant articles. Two different review authors independently assessed the methodological quality and clinical relevance and extracted the data from each trial using the criteria recommended by the Cochrane Back Review Group. RESULTS: Six randomized controlled trials met inclusion criteria: 3 examined prevention of back pain (2061 participants) and 3 examined mixed populations (256 participants) without being clear whether they were aimed at primary or secondary prevention or treatment. No treatment trials were found. There is strong evidence that the use of insoles does not prevent back pain. There is limited evidence that insoles alleviate back pain or adversely shift the pain to the lower extremities. CONCLUSION: There is strong evidence that insoles are not effective for the prevention of back pain. The current evidence on insoles as treatment for low back pain does not allow any conclusions.
