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In their report of a randomized trial of nicotine lozenges, Shiffman et al¹ comment that the study demonstrated the efficacy and safety of the lozenges for smoking cessation. However, Penman and I have previously cautioned against generalizing the results of nicotine replacement therapy (NRT) efficacy trials conducted under relatively ideal conditions to more "real-world" conditions.²

The Shiffman et al study¹ was conducted under conditions that would rarely pertain to more usual clinical or over-the-counter settings. For example, subjects underwent a 1-week period of baseline monitoring prior to randomization (during which 9% dropped out), received lozenges free for up to 24 weeks, attended for assessment, advice, and/or lozenge distribution up to 7 times after baseline, received substantial cessation advice, and knew that 1 self-reported relapse or failed biochemical validation would mean ejection from the study. The study intensity and the volunteer nature of the subject population make it difficult to compare . . . [Full Text of this Article]