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Clinical Guidelines for Effective Use

Michael C. Fiore, MD, MPH; Douglas E. Jorenby, PhD; Timothy B. Baker, PhD; Susan L. Kenford

JAMA. 1992;268(19):2687-2694.

Abstract
Objective.
—A comprehensive review of transdermal nicotine treatment for tobacco dependence, with recommendations derived from the research literature.

Data Sources.
—English-language clinical trials.

Study Selection.
—Clinical trials using placebo-controlled, double-blind methodology (11 studies) with at least 6 months of follow-up after treatment (eight studies) and biochemical verification of smoking status.

Data Synthesis.
—Nicotine patches produce end-of-treatment smoking cessation rates that range from 18% to 77%; these rates are about twice those of placebo-treated subjects. Nicotine patches produced 6-month abstinence rates of 22% to 42%, while placebo patches produced quit rates of 5% to 28%. Nicotine patches appear to reduce some, but not all, nicotine withdrawal symptoms. For instance, while the patch reduces craving for cigarettes and negative moods, it does not appear to reduce hunger or weight gain. The clinical trials literature suggests that proper adjuvant smoking cessation counseling is crucial in determining successful long-term outcome with the nicotine patch, and suggests that 6 to 8 weeks of patch therapy may be an adequate duration for most patients.

Conclusions.
—Nicotine patches are an effective aid to tobacco dependence treatment. However, success rates vary greatly across research studies and may be influenced highly by the nature and intensity of adjuvant smoking cessation counseling. More research is needed to identify optimal duration, dosage, and individualization of patch therapy. The impact of nicotine patches (more than 5 million users with $1 billion in sales for 1992) also raises important ethical and public health issues.

(JAMA. 1992;268:2687-2694)

Author Affiliations
From the Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison.

Footnotes
Drs Fiore, Jorenby, and Baker and Ms Kenford have worked on clinical research studies funded in part by Elan Pharmaceutical and Lederle Laboratories. Dr Fiore has also received honoraria for educational activities from CIBA-GEIGY Corp, Marion Merrell Dow, Inc, and Lederle Laboratories Division.

Reprint requests to Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Room 7275 MSC, 1300 University Ave, Madison, WI 53706 (Dr Fiore).

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