Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.
Departments of Medicine and Epidemiology, Biostatistics, and Occupational Health, McGill University, Montréal, Québec, Canada.
JAMA. 2020 Nov 10;324(18):1844-1854. doi: 10.1001/jama.2020.18889.
Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial.
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.
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.
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.
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%).
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.
ClinicalTrials.gov Identifier: NCT02417467.
电子烟（电子烟）戒烟仍然存在争议。
评估针对戒烟的电子烟和个人咨询。
设计、地点和参与者：一项随机临床试验于 2016 年 11 月至 2019 年 9 月在加拿大的 17 个地点招募了有戒烟意愿的成年人（筛查 801 人；274 人不合格，151 人拒绝）。由于制造延误，试验提前终止（376/486 名参与者，目标的 77%）。报告截至 24 周（2020 年 3 月）的结果。
随机分配至尼古丁电子烟（n=128）、非尼古丁电子烟（n=127）或无电子烟（n=121）治疗 12 周。所有组均接受个人咨询。
主要终点是 12 周时的点患病率（7 天回顾，使用呼出的一氧化碳进行生物化学验证），从提前终止后的第 52 周改变。缺失数据的参与者被假定为吸烟。7 个次要终点在多个随访中进行了检查，包括其他随访时的点患病率、持续戒烟、每日吸烟量变化、严重不良事件、不良事件、因不良反应而辍学以及治疗依从性。
在 376 名随机参与者（平均年龄 52 岁；178 名女性[47%]）中，299 名（80%）和 278 名（74%）分别在 12 周和 24 周时自我报告了吸烟状态。尼古丁电子烟加咨询组与单独咨询组在 12 周时的点患病率（21.9%比 9.1%；风险差异[RD]，12.8[95%CI，4.0 至 21.6]）显著更高，但在 24 周时无显著差异（17.2%比 9.9%；RD，7.3[95%CI，-1.2 至 15.7]）。尼古丁电子烟加咨询组的非尼古丁电子烟组在 12 周时的点患病率与单独咨询组无显著差异（17.3%比 9.1%；RD，8.2[95%CI，-0.1 至 16.6]），但在 24 周时显著更高（20.5%比 9.9%；RD，10.6[95%CI，1.8 至 19.4]）。不良事件很常见（尼古丁电子烟加咨询组：120[94%]；非尼古丁电子烟加咨询组：118[93%]；仅咨询组：88[73%]），最常见的是咳嗽（64%）和口干（53%）。
在有戒烟意愿的成年人中，尼古丁电子烟加咨询与单独咨询相比，12 周时的点患病率显著增加。然而，24 周时的差异不再显著，并且由于提前终止和尼古丁与非尼古丁电子烟不一致的结果，试验解释受到限制，这表明需要进一步研究。
ClinicalTrials.gov 标识符：NCT02417467。
