The recent study on the effectiveness of a 16-hour transdermal nicotine patch in a medical practice setting, without intensive group counseling,1 serves to illustrate some issues about nicotine patch research that have been bothering me since I recently reviewed the smoking cessation literature.2 Although this study is well designed and appears well executed, there are some subtle problems that cast doubt on the conclusion that the patch was superior to placebo at all follow-up assessment points.
After 12 weeks of treatment, 26% of the placebo group was abstinent compared with 45% of the active patch group. However, cigarette abstinence during the nicotine patch administration is not equivalent to cigarette abstinence during placebo treatment. To consider them equivalent would be analogous to considering alcoholics abstinent if they were receiving intravenous alcohol, as long as they were not drinking. One could argue that the placebo patch group was much better
Antonuccio D. Will the Nicotine Patch Really Stick?. Arch Intern Med. 1994;154(8):923–927. doi:10.1001/archinte.1994.00420080133016