EFFECTIVENESS OF A NICOTINE PATCH IN HELPING PEOPLE STOP SMOKING - RESULTS OF A RANDOMIZED TRIAL IN GENERAL-PRACTICE

Objective-To assess the effectiveness of 12 weeks' treatment with a 24 hour transdermal nicotine patch in helping heavy smokers to stop smok ing; also to assess the value of a specially written support booklet a bout smoking cessation and patch use compared with a simple advice pam phlet. Design-Double blind placebo controlled randomised trial with a 2 x 2 factorial design. Setting-19 general practices in Oxfordshire. S ubjects-1686 heavy smokers aged 25-64 (mean cigarette consumption 24/d ay; mean duration of smoking 25 years). Main outcome measure-Sustained cessation for the last four weeks of the 12 week treatment period, co nfirmed by saliva cotinine estimation (226/262 cases; 86.3%) or expire d carbon monoxide concentration (36/262; 13.7%). Patients lost to foll ow up (155/1686; 9%) were assumed to have continued to smoke. Results- Cessation was confirmed in 163 patients (19.4%) using the nicotine pat ch and '' patients (11.7%) using the placebo patch (difference 7.6% (9 5% confidence interval 4.2% to 11.1%); p < 0.0001). There was no signi ficant advantage in using the more detailed written support material. The most important adverse effect of the patch was local skin irritati on, which occurred in 15.8% (133/842) and 5.1% (43/844) of patients us ing the nicotine and placebo patches respectively, was graded as sever e in 4.8% (40) and 1.1% (nine), and was stated as a reason for withdra wal from the trial in 9.5% (80) and 2.8% (24). Conclusion-Nicotine pat ches are effective in a general practice setting with nursing support, but the extent to which this effect is sustained cannot be assessed u ntil the results of longer term follow up are known.