Cottraux 1983.
Methods | Study design: Randomized controlled trial Country: France Recruitment: Community volunteers Group size: 15 |
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Participants | 558 (418 in arms of interest) community volunteers; 24% women, av. cpd 31 Therapists; 2 per group, qualifications not described | |
Interventions | 1. Behaviour therapy. Includes discussion, training in relaxation. 3 x 3‐hr sessions over 2 wks. Relaxation and stress‐desensitization audiotape for daily use 2. Acupuncture (not included in MA) 3. Placebo ‐ lactose capsules for 2 wks. Met 2 x 10‐min with a doctor 4. 1‐yr waiting‐list control. | |
Outcomes | Abstinence at 12 m Validation: none. Assessor blind to treatment condition | |
Notes | Although 3 described by authors as placebo the 2 meetings with a doctor make it more comparable with an advice intervention, so 1 vs 3 used in comparison 1.3.1 and 1 vs 4 in comparison 1.5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized, stratified by presence of another smoker in household, method not described |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No validation and some participants were on a waiting‐list control |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5% lost to follow‐up, included in ITT analysis |