Stapleton 2013.
Methods | BUPROPION Randomized controlled trial Setting: Smoking cessation clinics, UK Recruitment: People attending smoking cessation clinics |
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Participants | 1071 daily smokers; 47% M, av age 41, av CPD 20, >25% history of depression | |
Interventions | 1. Bupropion for 8 weeks, started prior to TQD (exact period NS), 150 mg/d for first 6d, then 300 mg for remainder 2. Bupropion (as above) + NRT (choice of single product, 12 weeks started on TQD, dosage determined on individual basis) 3. NRT only (as above) All groups: 7 weekly behavioural support sessions as per standard service protocol. Mainly group, 60‐90 mins each |
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Outcomes | Prolongued abstinence at 6m Validation: CO < 10 ppm |
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Notes | Funding: Department of Health for England. Study medication provided free of charge by Pfizer UK, GSK UK and Novartis UK. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerized. “Randomization and packaging was organized by an independent statistician at the host site.” |
Allocation concealment (selection bias) | Low risk | “On enrolment, participants selected their envelope from a large batch and signed it before breaking the seal to reveal their allocation.” |
Blinding (performance bias and detection bias) All outcomes | High risk | Open label, no blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 61.5% followed up at both 1 and 6m, no significant difference between groups. Prolonged abstinence only imputed for 16% of total. |