First Clinical Trial of Electronic Cigarettes Suggests They May Be More Effective Than Traditional NRT Products

The results of the first clinical trial of electronic cigarettes, reported yesterday in the journal BMC Public Health, suggest that these devices may be more effective than traditional NRT products for smoking cessation and may be particularly effective in smokers who are unmotivated to quit.

(see: Polosa R, et al. Effect of an Electronic Nicotine Delivery Device [e-Cigarette] on Smoking Reduction and Cessation: A Prospective 6-Month Pilot Study. BMC Public Health 2011; 11:786 doi:10.1186/1471-2458-11-786)

The subjects were 40 healthy, adult, regular smokers with no interest in quitting. They were provided with electronic cigarettes and minimal intervention (a baseline and four follow-up clinic visits). They were not instructed to try to quit smoking, but were simply allowed to use the electronic cigarettes however they wished.

The sustained smoking abstinence rate at six-month follow-up was 22.5%.

The proportion of subjects who experienced a sustained reduction in the amount smoked by at least 50% was 32.5%.

Thus, 55% of subjects either cut down their consumption by 50% or more or quit smoking altogether at six months follow-up.

No serious adverse events were reported in the study.

The authors conclude: "Although not formally regulated as a pharmaceutical product, the e-Cigarette can help smokers to remain abstinent or reduce their cigarette consumption. By replacing tobacco cigarettes, the e-cigarette can only save lives. Here we show for the first time that e-Cigarettes can substantially decrease cigarette consumption without causing significant side effects in smokers not intending to quit."

The Rest of the Story

Based on a Cochrane review of seven studies that measured smoking cessation using nicotine replacement therapy (NRT), the average 6-month point prevalence of smoking abstinence is only 17.8%, and the 6-month point prevalence of smoking abstinence in the pooled data from these studies is only 11.9%. However, these were generally studies of smokers who were motivated to quit. The fact that this trial found a 6-month abstinence rate of 22.5% among a sample of smokers who were not motivated to quit is quite encouraging.

Moreover, the NRT clinical trials generally involved substantial intervention and encouragement to quit smoking. This trial simulated a real-life experience, where no motivation or support was offered to subjects to quit smoking. In fact, smokers who expressed interest in cessation services were withdrawn from the study. The fact that 22.5% of smokers quit and an additional 32.5% reduced their cigarette consumption by at least half suggests that electronic cigarettes are a promising strategy for both harm reduction (reduction in cigarette consumption) and smoking cessation.

Further trials are necessary to confirm these results and especially, to try electronic cigarettes as a strategy for smoking cessation among smokers who are motivated to quit. Nevertheless, the results of this initial clinical trial are encouraging. Electronic cigarettes appear to be a promising strategy for smoking cessation. Use of these devices among smokers who are unable to quit with other available methods (such as NRT) should be encouraged by health professionals, anti-smoking groups, and the FDA.