Objective: To estimate the overall efficacy and optimal use of the nicotine patch for treating tobacco dependence.
Data sources: Nicotine patch efficacy studies published through September 1993, identified through MEDLINE, Psychological Abstracts, and Food and Drug Administration new drug applications.
Study selection: Double-blind, placebo-controlled nicotine patch studies of 4 weeks or longer with random assignment of subjects, biochemical confirmation of abstinence, and subjects not selected on the basis of specific diseases (eg, coronary artery disease).
Data extraction: Pooled abstinence rates and combined odds ratios (ORs) at end of treatment and 6-month follow-up were examined overall and in terms of patch type (16-hour vs 24-hour), patch treatment duration, dosage reduction (weaning), counseling format (individual vs group), and intensity of adjuvant behavioral counseling.
Data synthesis: Across 17 studies (n = 5098 patients) meeting inclusion criteria, overall abstinence rates for the active patch were 27% (vs 13% for placebo) at the end of treatment and 22% (vs 9% for placebo) at 6 months. The combined ORs for efficacy of active patch vs placebo patch were 2.6 at the end of treatment and 3.0 at 6 months. The active patch was superior to the placebo patch regardless of patch type (16-hour vs 24-hour), patch treatment duration, weaning, counseling format, or counseling intensity. The 16-hour and 24-hour patches appeared equally efficacious, and extending treatment beyond 8 weeks did not appear to increase efficacy. The pooled abstinence data showed that intensive behavioral counseling had a reliable but modest positive impact on quit rates.
Conclusions: The nicotine patch is an effective aid to quitting smoking across different patch-use strategies. Active patch subjects were more than twice as likely to quit smoking as individuals wearing a placebo patch, and this effect was present at both high and low intensities of counseling. The nicotine patch is an effective smoking cessation aid and has the potential to improve public health significantly.