Planer 2011.
Methods | BUPROPION Randomized controlled trial Setting: hospitals, Jersulem, Israel Recruitment: patients hospitalised for acute coronary syndrome in 2 separate campuses in Jerusalem |
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Participants | 151 smokers of > 10 cpd with diagnosis of acute coronary syndrome, motivated to quit. av. age: 51.9 yrs, 79.9% M, av. cpd 31 |
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Interventions | 1. Bupropion 150 mg 1xday for 3 days, then 2x day for 2m 2. Placebo, same schedule Both arms: counselling (at least 15 min of motivational support) during hospitalisation and continued after discharge (at least 2 visits with physician and nurse at 1 and 2m and weekly telephone call by nurse during first and second month, then monthly telephone calls during rest of the year) |
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Outcomes | Self‐reported continuous abstinence at 12m Validation: none |
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Notes | New for 2013 update. Study stopped early after interim analysis indicated no benefit OR adjusted for age, sex, invasive procedure, risk factors, Fagerstrom score, cpd: 0.90 (95% CI 0.39‐2.09) Funding: GlaxoSmithKline |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomized," method not specified |
Allocation concealment (selection bias) | Unclear risk | Method not specified |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and staff blind to treatment assignment, "Numbered study bottles were supplied by the study coordinator and remained concealed from the patients and medical staff." No biochemical validation but participants blind to condition so differential misreport unlikely. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 lost to follow‐up in each group |