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A randomized trial of E-cigarettes vs nicotine-replacement therapy

New England Journal of Medicine Feb 04, 2019

Hajek P, et al. - Researchers assessed the efficacy of e-cigarettes as a smoking-cessation aids. They found it beneficial in smoking cessation vs nicotine-replacement therapy.

Methods

  • Adults attending UK National Health Service stop-smoking services were randomly allocated to either the nicotine-replacement products of their choice, 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.
  • For at least 4 weeks, they included weekly behavioral support under the treatment.
  • Sustained abstinence for 1 year, validated biochemically at the final visit, was the primary outcome.
  • Candidates lost to follow-up or who did not provide biochemical validation were deemed not abstinent.
  • Participant-reported treatment usage and respiratory symptoms were considered under secondary outcomes.

Results

  • Ultimately 886 subjects underwent randomization.
  • They observed a 1-year abstinence rate of 18.0% in the e-cigarette group vs 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P < 0.001).
  • They noted that participants in the e-cigarette group were more likely to be using their assigned product at 52 weeks vs those in the nicotine-replacement group (80% [63 of 79 participants] vs 9% [4 of 44 participants]), among candidates who had 1 year of abstinence.
  • A higher incidence of throat or mouth irritation was seen in the e-cigarette group (65.3%, vs 51.2% in the nicotine-replacement group) while a higher incidence of nausea was seen in the nicotine-replacement group (37.9%, vs 31.3% in the e-cigarette group).
  • They reported a larger reduction in the incidence of cough and phlegm production from baseline to 52 weeks in the e-cigarette group vs 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).
  • They found no significant variation in the incidence of wheezing or shortness of breath between the groups.
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