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。

电子烟戒烟目前仍存有争议。为了评估电子烟对个人戒烟的效果，2016年11月至2019年9月，研究组进行了一项随机临床试验，在加拿大17个研究点招募了376名有戒烟动机的成年人。将其随机分组，其中128例接受尼古丁电子烟戒烟，127例接受非尼古丁电子烟戒烟，121例接受无电子烟的戒断措施，均为期12周。每组均接受个体咨询辅导。主要终点为12周时的7天点戒断率。

376名参与者的平均年龄为52岁，其中女性占47%，分别有299名（80%）和278名（74%）参与者在12周和24周时自我报告吸烟状况。12周时，尼古丁电子烟加咨询组的点戒断率为21.9%，显著高于仅咨询组（9.1%）；但24周时为17.2%，与仅咨询组（9.9%）的差异不显著。12周时，非尼古丁电子烟加咨询组的点戒断率为17.3%，与仅咨询组（9.1%）差异不大；但24周时为20.5%，显著高于仅咨询组（9.9%）。尼古丁电子烟加咨询组的不良事件发生率为94%，非尼古丁电子烟加咨询组为93%，仅咨询组为73%，最常见的不良事件是咳嗽（64%）和口干（53%）。

总之，对于有戒烟动机的成年人，尼古丁电子烟加咨询与仅咨询相比显著增加了12周时的点戒断率，但在24周后，这种差异不再显著。

附：英文原文

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

Issue&Volume: 2020/11/10

Abstract:

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.

DOI: 10.1001/jama.2020.18889

Source: https://jamanetwork.com/journals/jama/article-abstract/2772759