Biberman 2003.
Methods | SELEGILINE Randomized controlled trial Setting: 3 community‐based clinic, Israel Recruitment: mailing to members of public health service provider |
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Participants | 109 smokers (15+ CPD); 38% F, av. age 42, av. CPD 27‐30 | |
Interventions | 1. Selegiline 10 mg/day for 26 weeks, nicotine patch 21 mg for 8 weeks incl tapering 2. Placebo & nicotine patch Both arms: Behavioural support from trained family physician; weekly then fortnightly visits for 12w | |
Outcomes | Abstinence at 52 w, continuous with validation at each visit Validation: negative for urine nicotine, cotinine, 3‐hydroxycotinine (Niccheck) | |
Notes | No serious AEs, no significant differences in AEs, 2 selegiline discontinuations. Funding not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Four hundred dice‐throwing generated a randomized sequence code; 199 containers prepacked with selegiline and 201 containers prepacked with placebo were numbered accordingly." Judged adequate. |
Allocation concealment (selection bias) | Low risk | "The code was sealed, kept secretly and was revealed for the first time when the last participant finished the 12 months of follow‐up. The first participant who joined the trial after the initial visit run‐in phase received the first bottle from the container set number 001, the second participant from set number 002 and so on. The trial coordinator arranged participant’s allocation." Judged adequate. |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Double‐blind" (see above) "No discontinuation difference for selegiline or placebo was observed among the groups, which implies masking success." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 19 lost to follow‐up, included as smokers in MA. |