Nicotine replacement therapy: evidence from observational studies versus clinical trials

Johnson George
Med J Aust 2012; 197 (1): 28. || doi: 10.5694/mja12.10653
Published online: 2 July 2012

In reply: The response of Chapman to my article is not surprising, given his involvement in the Alpert article.1 The recommendations of Alpert and colleagues have already been criticised internationally, and debate on the effectiveness of pharmacological smoking cessation therapies is not new. Meta-analyses have shown 50% to 70% greater quit rates for nicotine replacement therapy (NRT) compared with placebo or in controls.2,3 Advocates of cold turkey cessation question the effectiveness of NRT in the “real world”, using data from population studies.1,4,5

Multiple attempts are often necessary before a smoker can successfully quit. Smokers with a history of failure to quit without support may find behavioural counselling and pharmacological aids to be useful in their quit attempts and in achieving long-term success.

The National Health and Medical Research Council recommendations for developers of guidelines place randomised controlled trials well above observational studies in the study validity hierarchy. The submission to list nicotine patches on the Pharmaceutical Benefits Scheme was made by a consortium of independent public health organisations. Advocates of unassisted smoking cessation should provide stronger evidence to convince policymakers and practitioners.

  • Johnson George

  • Centre for Medicine Use and Safety, Monash University, Parkville, VIC.


Competing interests:

I am an investigator in the Give Up For Good clinical trial, evaluating a multidisciplinary smoking intervention initiated during hospital stay, funded by the Australian Research Council and an investigator-initiated research grant from Pfizer.

  • 1. Alpert HR, Connolly GN, Biener L. A prospective cohort study challenging the effectiveness of population-based medical intervention for smoking cessation. Tob Control 2012. doi: 10.1136/tobaccocontrol-2011-050129.
  • 2. Stead LF, Perera R, Bullen C, et al. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2008; (1): CD000146.
  • 3. Moore D, Aveyard P, Connock M, et al. Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis. BMJ 2009; 338: b1024.
  • 4. Pierce JP, Gilpin EA. Impact of over-the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. JAMA 2002; 288: 1260-1264.
  • 5. Alberg AJ, Patnaik JL, May JW, et al. Nicotine replacement therapy use among a cohort of smokers. J Addict Dis 2005; 24: 101-113.


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