Clavel 1992 +NG.
Methods | Randomized trial of acupuncture Country: France Recruitment: Community volunteers responding to circulated leaflet 2x2 factorial design (Smokers in this study who were randomized to placebo nicotine gum are represented by the study labelled 'Clavel 1992') |
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Participants | 481 adults aged over 18, smoking >10 cigs/day | |
Interventions | a) facial acupuncture to two points (GB8 and Bitong), with active nicotine gum (2mg dose, up to 30 pieces/day, during first 6 months) b) sham acupuncture (wrong points 2cm from the above), with active nicotine gum (administration as above) Acupuncture given on days 0, 7 and 28 | |
Outcomes | Sustained abstinence at 1 and 13 months. (Outcome at 4 years reported in another publication) 'Need for cigarette' estimated weekly for 1 month Validation: nil | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details: 'Tirés au sort' |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding (performance bias and detection bias) All outcomes | Low risk | Factorial, double‐dummy design; described as double blind; no details of blinding of the observer |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 80% dropout at one month |
Other bias | Unclear risk | No description of baseline differences |