Transdermal nicotine plus support in patients attending hospital with smoking-related diseases: A placebo-controlled study

Background. Cessation rates in smokers attending special clinics or their General Practitioners can be increased by transdermal nicotine (TNS). This study assesses the efficacy of TNS as an adjunct to advice and support in helping patients attending hospital with smoking-related diseases to stop smoking. Methods. In a double-blind, placebo-controlled, randomized manner, 234 inpatients and outpatients with smoking-related respiratory or cardiovascular disease, aged 18-75 years, who were willing to try to stop smoking, were advised by their hospital doctor to stop smoking. This was reinforced by repeated advice and encouragement from the Smoking Cessation Counsellor initially and at 2, 4, 8 and 12 weeks, supplemented by a 24 h patch in adjusted doses over that period. Those not smoking at 12 weeks were followed up at 26 and 52 weeks. Self-reported complete abstinence from 12 to 52 weeks was validated by expired air carbon monoxide measurement at 12, 26 and 52 weeks. Results. Twenty-four (21%) of 115 TNS patients were verified as non-smokers at 12, 26 and 52 weeks and claimed continued abstinence, compared with 17 (14%) of 119 in the placebo (P) group (P=0.15) - 5% confidence limits for odds ratio of abstinence on TNS compared to P: 0.83, 3.37. Cessation was related to increasing age (P=0.02) and lower Fagerstrom score (P=0.05). Minor skin reactions were more frequent in the TNS group (47% TNS; 34% P), as was nausea (12% TNS; 3% P). Severe skin reactions were rare (5% TNS; 4% P). Conclusion. The suggestion that TNS produces an increase of 50% in relative terms (7% absolute increase) in smoking cessation over placebo in this population of hospital patients is sufficiently strong to warrant a further study large enough to answer whether or not this result was due to chance.