Tønnesen 1988.
Study characteristics | ||
Methods | Study design: parallel RCT Country: Denmark Recruitment: primary care |
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Participants | 113 low‐ to medium‐dependence smokers, motivated to quit (19 or less on Horn‐Russell scale) 44% men, average age 45, average cigarettes per day 20 60 highly‐dependent smokers 42% men, average age 45, average cigarettes per day 26 to 28 | |
Interventions | Group A: low/medium dependence 1) Nicotine Gum (2 mg) for 16 weeks 2) Placebo Group B: high‐dependence 1) Nicotine gum 4 mg for 6 weeks then 2 mg 2) Nicotine gum 2 mg | |
Outcomes | Sustained abstinence at 12 months (24 months also reported)
Validation: CO Adverse events: measured during counselling sessions to end of treatment (either 16 or 20 weeks) |
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Notes | "This study was supported in part by a grant from the Danish National Tuberculosis Foundation. A.B. Leo, Halsingborg, Sweden and H. Lundbeck A.S., Denmark supplied the nicotine and placebo chewing gum". Conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants stratified by dependence, then [quote]: "subjects on each list were then randomly assigned to treatment in blocks of two" |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Gum was packaged and produced to be indistinguishable between 2 mg, 4 mg and placebo |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants who attended 1st counselling session were included in analyses, regardless of attendance or level of gum use Only 2/173 were lost to follow‐up |