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Background Nicotine replacement therapy is an effective treatment for nicotine-d

ID: 3021190 • Letter: B

Question

Background Nicotine replacement therapy is an effective treatment for nicotine-dependent smokers. However, cessation rates are modest, and preliminary studies suggest that combination therapy may be superior. We compared the efficacy of the nicotine inhaler plus nicotine patch vs nicotine inhaler plus placebo patch for smoking cessation.

Methods A double-blind, randomized, placebo-controlled trial was conducted in 400 subjects who had smoked 10 or more cigarettes per day for 3 years or longer. Group 1 (n = 200) received the nicotine inhaler plus nicotine patch (delivering 15 mg of nicotine per 16 hours) for 6 weeks, then inhaler plus placebo patch for 6 weeks, then inhaler alone for 14 weeks. Group 2 (n = 200) received the nicotine inhaler plus placebo patch for 12 weeks, then inhaler for 14 weeks. Inhaler was used at a rate of 6 to 12 cartridges per day ad libitum for 3 months and then tapered off. The main outcome measure was complete abstinence (self-reported).

Results Group 1 vs group 2 complete abstinence rates were 60.5% and 47.5% at 6 weeks (P = .009), 42.0% and 31.0% at 12 weeks (P = .02), 25.0% and 22.5% at 6 months (P = .56), and 19.5% and 14.0% at 12 months (P = .14).

What would a type II error be for this study?

Explanation / Answer

Type 2 error will be that for group 2 nicotine inhlaer dont have much effect on the treatment. it is not that effective when used first.