February 15, 2019
Throat or mouth irritation was reported more often in the e-cigarette group compared with the nicotine replacement group.
Refillable e-cigarettes demonstrate greater efficacy for smoking cessation than nicotine replacement therapy when both products are accompanied by behavioral support. A 2-group, multicenter, pragmatic, individually randomized controlled trial was conducted at 3 stop-smoking service sites in the United Kingdom as part of the National Health Service (NHS) between May 2015 and February 2018. Results of the analysis were published in the New England Journal of Medicine.
Adults attending the UK NHS stop-smoking services were randomly assigned to receive either nicotine replacement products of their selection, including combinations of products, provided for ≥3 months, or an e-cigarette starter pack, with a recommendation to purchase additional e-liquids of the strength and flavor of their choice. All treatments included weekly face-to-face behavioral support for ≥4 weeks. The primary study outcome was sustained abstinence from smoking for 1 year, which was validated biochemically at the final visit. Secondary study outcomes included respiratory symptoms and participant-reported treatment usage.
A total of 886 participants were included, with 439 assigned to the e-cigarette group and 447 assigned to the nicotine replacement group. The 1-year abstinence rates were 18.0% in the e-cigarette group and 9.9% in the nicotine replacement group (relative risk [RR], 1.83; 95% CI, 1.30-2.58; P <.001), which was statistically significant. Of those participants who reported 1-year abstinence, individuals in the e-cigarette group were more likely than those in the nicotine replacement therapy group to use their assigned product at 1 year (80.0% [63 of 79 participants] vs 9.0% [4 of 44 participants], respectively).
Regarding adverse events, throat or mouth irritation was reported more often in the e-cigarette group compared with the nicotine replacement group (65.3% vs 51.2%, respectively). Moreover, nausea was reported more frequently in individuals in the nicotine replacement group than in those in the e-cigarette group (37.9% vs 31.3%, respectively). Individuals in the e-cigarette group reported greater decreases in the incidence of cough and phlegm production from baseline to 52 weeks compared with those in the nicotine replacement group (RR for cough, 0.8; 95% CI, 0.6-0.9 and RR for phlegm, 0.7; 95% CI, 0.6-0.9). No significant between-group differences were observed in the incidence of shortness of breath or wheezing.
The investigators concluded that refillable e-cigarettes exhibited greater effectiveness than nicotine replacement therapy, despite that nicotine replacement was provided in combinations and under expert guidance. Additional studies are warranted to establish whether the results of this study are generalizable outside the UK NHS services. E-cigarette studies that compare different levels of support are also merited.
Hajek P, Phillips-Waller A, Przulj D, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy [published online January 30, 2019]. N Engl J Med. doi:10.1056/NEJMoa1808779