新型尼古丁和烟草产品,如电子烟(EC)加热的烟草产品或尼古丁袋已被讨论为可燃香烟和其他有毒形式的烟草产品的危害较小的替代品。它们减少危害的潜力在于从吸烟到新产品的有效过渡。已经发表了许多关于ECs停止功效的研究,结果相互矛盾。然而,一项全面的Cochrane综述对ECs的停止疗效具有高度确定性。这促使我们进行审查,以确定常见研究设计中的弱点,并总结研究设计中关于新尼古丁产品作为戒烟辅助手段的潜力的最佳实践。从Medline检索到的120篇文章被认为是合格的。该领域的大多数研究都是介入性试验,而观察性研究在戒烟评估中起着次要作用。在77%的报告中,主要对ECs的功效进行了评估,而加热烟草(17%)和不可燃产品(11%)的调查频率较低。确定疗效的措施是基于问卷的评估以及使用文件/患病率和禁欲率。研究的持续时间和样本量差异很大,中位数为3个月,参与者为156.5人,分别。在这次审查的帮助下,我们发现了常见研究设计中的几个弱点.纵向试验的一个主要限制是缺乏适用于在较长时间内验证使用状态的合规措施。完全依靠自我报告。此外,参与者戒烟的动机很少被定义,并且在大多数研究中没有考虑到深刻的熟悉期.这些弱点在多大程度上影响研究结果超出了本综述的范围。我们鼓励研究人员考虑从这次审查中得出的建议,以便以更可靠的方式确定产品的滥用责任和停止功效。最后,我们想提请注意低收入和中等收入国家缺少的数据,这些国家需要最紧急的戒烟策略来对抗吸烟流行。
New types of nicotine and tobacco products like electronic cigarettes (ECs), heated tobacco products or nicotine pouches have been discussed as less harmful alternatives to combustible cigarettes and other toxic forms of tobacco products. Their harm reduction potential lay in the efficient transition away from smoking to those new products. Numerous studies addressing the cessation efficacy of ECs have been published with contradictory outcomes. Yet, a comprehensive Cochrane review concluded with high certainty on the cessation efficacy of ECs. This prompted us to perform a review to identify weaknesses in common study designs and to summarize best practices for the study design on the potential of new nicotine products as cessation aids. 120 articles retrieved from Medline were found to be eligible. Most of the studies in the field were interventional trials while observational studies played a minor role in the evaluation of smoking cessation. Efficacy was predominantly assessed for ECs in 77% of the reports while heated tobacco (17%) and non-combustible products (11%) were less frequently investigated up to now. Measures to determine the efficacy were questionnaire-based assessments as well as use documentation/prevalence and abstinence rates. Studies varied largely in their duration and sample size with medians of 3 months and 156.5 participants, respectively.With the help of this review, we identified several weaknesses in the common study designs. One major limitation in longitudinal trials was the lack of compliance measures suited to verify the use status over longer time periods, relying solely on self-reports. Moreover, the motivation of the participants to quit was rarely defined and a profound familiarization period was not taken into account for the majority of the studies. To what extent such weaknesses influence the outcome of the studies was beyond the scope of this review. We encourage researchers to consider the recommendations which resulted from this review in order to determine the abuse liability and cessation efficacy of the products in a more robust manner. Finally, we like to call attention to the missing data for low- and middle-income countries which would require quitting strategies most urgently to combat the tobacco smoking epidemic.