Effectiveness of a nicotine patch in helping people stop smoking: results of a randomised trial in general practice. Imperial Cancer Research Fund General Practice Research Group.
OBJECTIVE
To assess the effectiveness of 12 weeks' treatment with a 24 hour transdermal nicotine patch in helping heavy smokers to stop smoking; also to assess the value of a specially written support booklet about smoking cessation and patch use compared with a simple advice pamphlet.


METHODS
Double blind placebo controlled randomised trial with a 2 x 2 factorial design.


METHODS
19 general practices in Oxfordshire.


METHODS
1686 heavy smokers aged 25-64 (mean cigarette consumption 24/day; mean duration of smoking 25 years).


METHODS
Sustained cessation for the last four weeks of the 12 week treatment period, confirmed by saliva cotinine estimation (226/262 cases; 86.3%) or expired carbon monoxide concentration (36/262; 13.7%). Patients lost to follow up (155/1686; 9%) were assumed to have continued to smoke.


RESULTS
Cessation was confirmed in 163 patients (19.4%) using the nicotine patch and 99 patients (11.7%) using the placebo patch (difference 7.6% (95% confidence interval 4.2% to 11.1%); p < 0.0001). There was no significant advantage in using the more detailed written support material. The most important adverse effect of the patch was local skin irritation, which occurred in 15.8% (133/842) and 5.1% (43/844) of patients using the nicotine and placebo patches respectively, was graded as severe in 4.8% (40) and 1.1% (nine), and was stated as a reason for withdrawal from the trial in 9.5% (80) and 2.8% (24).


CONCLUSIONS
Nicotine patches are effective in a general practice setting with nursing support, but the extent to which this effect is sustained cannot be assessed until the results of longer term follow up are known.
D000279:Administration, Cutaneous; D000328:Adult; D004311:Double-Blind Method; D005194:Family Practice; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage*; D010349:Patient Compliance; D012871:Skin Diseases / Q000209:etiology; D012893:Sleep Wake Disorders / Q000209:etiology; D016540:Smoking Cessation / Q000379:methods / Q000523:psychology; D012944:Social Support; D013375:Substance Withdrawal Syndrome / Q000534:rehabilitation; D016896:Treatment Outcome
D009538:Nicotine