加拿大犹太总医院Kristian B. Filion团队比较了电子烟联合咨询与仅咨询相比的戒烟效果。2020年11月10日，该研究发表在《美国医学会杂志》上。
Title: Effect of e-Cigarettes Plus Counseling vs Counseling Alone on Smoking Cessation: A Randomized Clinical Trial
Author: Mark J. Eisenberg, Andréa Hébert-Losier, Sarah B. Windle, Todd Greenspoon, Tim Brandys, Tamàs Fülp, Thang Nguyen, Stéphane Elkouri, Martine Montigny, Igor Wilderman, Olivier F. Bertrand, Joanna Alexis Bostwick, John Abrahamson, Yves Lacasse, Smita Pakhale, Josselin Cabaussel, Kristian B. Filion, E Investigators
Importance Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial.
Objective To evaluate e-cigarettes with individual counseling for smoking cessation.
Design, Setting, and Participants A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported.
Interventions Randomization to nicotine e-cigarettes (n=128), nonnicotine e-cigarettes (n=127), or no e-cigarettes (n=121) for 12 weeks. All groups received individual counseling.
Main Outcomes and Measures The primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence.
Results Among 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI, –1.2 to 15.7]). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, –0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%).
Conclusions and Relevance Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed.