Peter Hajek, Ph.D., Anna Phillips-Waller, B.Sc., Dunja Przulj, Ph.D., Francesca Pesola, Ph.D., Katie Myers Smith, D.Psych., Natalie Bisal, M.Sc., Jinshuo Li, M.Phil., Steve Parrott, M.Sc., Peter Sasieni, Ph.D., Lynne Dawkins, Ph.D., Louise Ross, Maciej Goniewicz, Ph.D., Pharm.D., et al.- The New England Journal of Medicine
E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-cessation treatments.
We randomly assigned adults attending U.K. National Health Service stop-smoking services to either nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter]), with a recommendation to purchase further e-liquids of the flavor and strength of their choice. Treatment included weekly behavioral support for at least 4 weeks. The primary outcome was sustained abstinence for 1 year, which was validated biochemically at the final visit. Participants who were lost to follow-up or did not provide biochemical validation were considered to not be abstinent. Secondary outcomes included participant-reported treatment usage and respiratory symptoms.
A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P<0.001). Among participants with 1-year abstinence, those in the e-cigarette group were more likely than those in the nicotine-replacement group to use their assigned product at 52 weeks (80% [63 of 79 participants] vs. 9% [4 of 44 participants]). Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3%, vs. 51.2% in the nicotine-replacement group) and nausea more frequently in the nicotine-replacement group (37.9%, vs. 31.3% in the e-cigarette group). The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9). There were no significant between-group differences in the incidence of wheezing or shortness of breath.
E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support. (Funded by the National Institute for Health Research and Cancer Research UK; Current Controlled Trials number, ISRCTN60477608.)
Supported by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (project number, 12/167/135) and by a grant (A16893) from the Cancer Research UK Prevention Trials Unit.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
This article was published on January 30, 2019, at NEJM.org.
A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
We thank all trial participants and the managers and clinicians of participating National Health Service stop-smoking services; the members of the trial steering committee and data monitoring and ethics committee (listed in Table S15 in the Supplementary Appendix); NIHR research project managers (Simon Bevan, Alexa Cross, Avril Lloyd, and Jennifer Cook) and other NIHR staff; and the staff of the Barts Clinical Trials Unit (in particular, Irene Kaimi, Benoit Aigret, Richard Ostler, Samanah Haidary, and Alberto Stella).