Transdermal nicotine patches plus counselling increased smoking cessation
ACP J Club. 1991 Nov-Dec;115:85. doi:10.7326/ACPJC-1991-115-3-085
Tønnesen P, Nørregaard J, Simonsen K, Säwe U. A double-blind trial of a 16-hour transdermal nicotine patch in smoking cessation. N Engl J Med. 1991 Aug 1;325:311-5.
To test the efficacy and safety of a transdermal nicotine patch in smoking cessation.
Randomized, double-blind, placebo-controlled trial lasting 52 weeks.
Ambulatory care clinic in Denmark.
The first 310 eligible participants were selected from a volunteer sample of approximately 500. Eligible participants were ≥ 20 years old, had smoked ≥ 10 cigarettes per day for at least 3 years, and were motivated to stop smoking. Exclusion criteria included cardiovascular disease, pregnancy or breast feeding, regular use of psychotropic drugs, drug or alcohol abuse, use of smokeless tobacco, or chronic dermatologic disorders. 289 smokers (72% women) attended the first clinic visit and were enrolled in the study. 3 participants were lost to follow-up and counted as smokers in the analysis.
Participants were randomly allocated to daily use of a nicotine (n = 145) or placebo (n = 144) skin patch, to be worn 16 hours per day for 12 to 16 weeks. Participants also attended the clinic 6 times during the follow-up period where they were assessed for weight, carbon monoxide and cotinine levels, and side effects. Participants received brief advice on smoking cessation at each visit.
Main outcome measures
Self-reported abstinence from smoking, verified by carbon monoxide concentration of ≤ 10 ppm in expired air.
The nicotine-patch group had a higher rate of abstinence (with brief lapses allowed) than the placebo patch group (P< 0.001). After 6, 12, and 52 weeks, respectively, 53%, 41%, and 17% of the nicotine-patch group had not resumed smoking compared with 17%, 10%, and 4% of the placebo group (95% CIs for the differences 26% to 47%, 22% to 40%, and 6% to 19%, P < 0.001). At 52 weeks, 11 % (17% with brief lapses) of the nicotine-patch group were abstinent compared with 2% (4% with brief lapses) of the placebo group (P < 0.001). 78% of those receiving nicotine and 58% of those receiving placebo correctly guessed which group they were in, but there was no difference in abstinence between those who correctly identified their treatment and those who did not.
Transdermal nicotine patches for 16 hours a day for 12 to 16 weeks plus brief counseling increased the abstinence rate after 52 weeks for smokers who volunteered for smoking cessation, compared with placebo and counseling.
Source of funding: Kabi Pharmacia Therapeutics, Helsingborg, Sweden.
Address for article reprint: Dr. P. Tonnesen, Rudolph Berghs Gade 20, DK-2100, Copenhagen, Denmark.
This is one of several recent trials testing the efficacy of transdermal nicotine patch in smoking cessation. The results of these studies are similar in that use of the nicotine patch results in better control of withdrawal symptoms and higher rates of cessation than does placebo. The large sample size and 52-week follow-up are important strengths of this study. Although most participants were able to tell whether they were receiving placebo or active drug, the use of an objective measure of smoking status, expired carbon monoxide, makes the imperfect blinding a minor problem. The brief advice (< 5 minutes) on cessation given by the investigators along with a description of the nicotine patch is comparable to the amount of time a busy physician might spend with his or her patients who smoke, increasing the relevance to daily medical practice. The result of this intervention, a 52-week cessation rate with nicotine patch of 17% compared with 4% in the placebo group, is both clinically and statistically significant. The nicotine patch is a simpler way of delivering nicotine replacement than is nicotine gum. The transdermal nicotine patch may be an effective adjunct to smoking cessation efforts when it is released in the United States. We must remember that Tønnesen and colleagues found that the nicotine patch was effective when given to "motivated" smokers and combined with brief cessation advice. However, a strong behavior modification program administered in association with the nicotine patch is likely to be much more helpful than the patch alone.
Allan Prochazka, MD, MSc
Denver Veterans Affairs Medical CenterDenver, Colorado, USA