Blondal 1999.
Study characteristics | ||
Methods | Study design: parallel RCT Country: Iceland Recruitment: community volunteers |
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Participants | 237 smokers (≥ 1 cigarettes per day) 33% men, average age 41 to 43, average tobacco use 25 g/day | |
Interventions | 1) Nicotine nasal spray (NNS) (0.5 mg/dose) plus 15 mg nicotine patches for 3 months, weaning over further 2 months. NNS could be continued for 1 year 2. Placebo nasal spray plus 15 mg nicotine patches on same schedule | |
Outcomes | Sustained abstinence at 12 months (6‐year data also reported)
Validation: CO < 10 ppm Adverse events: measured within 3 months of follow‐up (still using NRT) |
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Notes | 6‐year abstinence 19/118 versus 10/119, OR 2.1 Pharmacia and Upjohn provided the drugs and placebo for this study and measured the cotinine concentrations. Conflicts of interest: TB was a consultant for Pharmacia and Upjohn, and GG and AW are employed by Pharmacia and Upjohn |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer generated randomisation code at a local pharmacy" |
Allocation concealment (selection bias) | Low risk | Quote: "Pharmacy staff were blinded to the content of the bottles" |
Blinding (performance bias and detection bias) All outcomes | Low risk | Clinic staff, pharmacy staff and participants were all blinded to assignment. Codes not broken until after data entry and analyses completed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants followed up for at least 12 months |