A randomized trial of E-cigarettes versus nicotine-replacement therapy
Hajek, P, Phillips-Waller, A, Przulj, D, Pesola, F, Smith, KM, Bisal, N, Li, J, Parrott, S, Sasieni, P, Dawkins, L, Ross, L, Goniewicz, M, Wu, Q and McRobbie, HJ (2019). A randomized trial of E-cigarettes versus nicotine-replacement therapy. New England Journal of Medicine. 380 (7), pp. 629-637.
|Authors||Hajek, P, Phillips-Waller, A, Przulj, D, Pesola, F, Smith, KM, Bisal, N, Li, J, Parrott, S, Sasieni, P, Dawkins, L, Ross, L, Goniewicz, M, Wu, Q and McRobbie, HJ|
© 2019 Massachusetts Medical Society. BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSIONS E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support.
|Keywords||Humans; Tobacco Use Disorder; Nicotine; Treatment Outcome; Smoking Cessation; Adult; Middle Aged; Female; Male; Vaping; Electronic Nicotine Delivery Systems; Tobacco Use Cessation Devices|
|Journal||New England Journal of Medicine|
|Journal citation||380 (7), pp. 629-637|
|Publisher||Massachusetts Medical Society|
|Digital Object Identifier (DOI)||doi:10.1056/NEJMoa1808779|
|14 Feb 2019|
|Publication process dates|
|Deposited||05 Apr 2019|
|Accepted||30 Jan 2019|
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