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

BMJ. 1993 May 15;306(6888):1304-8. doi: 10.1136/bmj.306.6888.1304.

Abstract

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.

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

Setting: 19 general practices in Oxfordshire.

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

Main outcome measure: 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).

Conclusion: 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Double-Blind Method
  • Family Practice
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Nicotine / administration & dosage*
  • Patient Compliance
  • Skin Diseases / etiology
  • Sleep Wake Disorders / etiology
  • Smoking Cessation* / methods
  • Smoking Cessation* / psychology
  • Social Support
  • Substance Withdrawal Syndrome / rehabilitation
  • Treatment Outcome

Substances

  • Nicotine