Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, Milan, Italy.
Nicotine Tob Res. 2019 Jan 1;21(1):119-126. doi: 10.1093/ntr/nty047.
E-cigarettes may be positively used in tobacco cessation treatments. However, neither the World Health Organization nor the American Food and Drug Administration has recognized them as effective cessation aids. Data about the efficacy and safety of e-cigarettes are still limited and controversial.
This was a double-blind randomized controlled study. The main focus of this article is on a secondary outcome of the study, that is, the assessment of effectiveness and safety of e-cigarettes in achieving smoking cessation in a group of chronic smokers voluntarily involved in long-term lung cancer screening. Participants were randomized into three arms with a 1:1:1 ratio: e-cigarettes (Arm 1), placebo (Arm 2), and control (Arm 3). All subjects also received a low-intensity counseling.
Two hundred ten smokers were randomized (70 to nicotine e-cigarettes, 70 nicotine-free placebo e-cigarettes, and 70 to control groups). About 25% of participants who followed a cessation program based on the use of e-cigarettes (Arm 1 and Arm 2) were abstinent after 3 months. Conversely, only about 10% of smokers in Arm 3 stopped. A Kruskal-Wallis test showed significant differences in daily cigarettes smoking across the three arms (K-W = 6.277, p = .043). In particular, participants in Arm 1 reported a higher reduction rate (M = -11.6441, SD = 7.574) than participants in Arm 2 (M = -10.7636, SD = 8.156) and Arm 3 (M = -9.1379, SD = 8.8127).
Our findings support the efficacy and safety of e-cigarettes in a short-term period. E-cigarettes use led to a higher cessation rate. Furthermore, although all participants reported a significant reduction of daily cigarette consumption compared to the baseline, the use of e-cigarettes (including those without nicotine) allowed smokers to achieve better results.
E-cigarettes increased the stopping rate as well as the reduction of daily cigarettes in participants who continued smoking. In fact, although all participants reported a significant reduction of tobacco consumption compared to the baseline, the use of e-cigarettes allowed smokers to achieve a better result. It could be worthwhile to associate this device with new ICT-driven models of self-management support in order to enable people to better handle behavioral changes and side effects. This is true for ready-to-quit smokers (such as our participants) but can also be advantageous for less motivated smokers engaged in clinical settings.
电子烟可能被积极用于烟草戒断治疗。然而,世界卫生组织和美国食品药品监督管理局都没有认可它们为有效的戒烟辅助工具。关于电子烟的疗效和安全性的数据仍然有限且存在争议。
这是一项双盲随机对照研究。本文的主要重点是研究的次要结果,即在一组自愿参与长期肺癌筛查的慢性吸烟者中,评估电子烟在戒烟方面的有效性和安全性。参与者按照 1:1:1 的比例随机分为三组:电子烟(第 1 组)、安慰剂(第 2 组)和对照组(第 3 组)。所有受试者还接受了低强度的咨询。
共有 210 名吸烟者被随机分组(70 名使用尼古丁电子烟,70 名使用不含尼古丁的安慰剂电子烟,70 名对照组)。约 25%的参与者遵循基于电子烟使用的戒烟计划(第 1 组和第 2 组)在 3 个月后成功戒烟。相比之下,只有约 10%的第 3 组吸烟者戒烟。Kruskal-Wallis 检验显示三组之间的每日吸烟量存在显著差异(K-W = 6.277,p =.043)。特别是,第 1 组的参与者报告的减少率更高(M = -11.6441,SD = 7.574),而第 2 组(M = -10.7636,SD = 8.156)和第 3 组(M = -9.1379,SD = 8.8127)的参与者报告的减少率较低。
我们的研究结果支持电子烟在短期内在疗效和安全性方面的优势。电子烟的使用导致更高的戒烟率。此外,尽管所有参与者报告与基线相比,每日吸烟量有显著减少,但电子烟的使用(包括不含尼古丁的电子烟)使吸烟者获得了更好的结果。将电子烟与新的基于信息通信技术的自我管理支持模式相结合,以帮助人们更好地应对行为改变和副作用,这可能是值得的。对于准备戒烟的吸烟者(如我们的参与者)来说,这是如此,对于在临床环境中参与的动机较低的吸烟者来说,也可能是有利的。