| Methods |
Country: UK
Recruitment: smoking cessation clinic |
| Participants |
116 clinic attenders, motivated to quit
55% female, average age 41/38, average cpd 31/27 (P < 0.05) |
| Interventions |
1. Nicotine gum (2 mg) unrestricted amount for at least 3 months
2. Placebo gum (1 mg unbuffered nicotine)
Level of support: high (group therapy 6 x 1 h weekly) |
| Outcomes |
Sustained abstinence at 12 months (6‐month and 12‐month PP)
Validation: CO (small number by confirmation from friend/relative only) |
| Notes |
The placebo gum was intended to match the active gum in taste but deliver minimal amounts of nicotine
Study was funded by Medical Research Council and Dept of Health and Social Security, and supported by AB Leo |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Quote: "treated in groups of about ten, taken in order from the waiting list" |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Quote: "Therapists and subjects were blind to the allocation" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
One sparticipant lost to follow‐up counted as a failure |
| Other bias |
High risk |
"Placebo" patch contained nicotine |
