[Intended and unintended effects of e-cigarettes in clinical studies: a plea for (more) transparency].

IF 1.2 Q4 RESPIRATORY SYSTEM
Pneumologie Pub Date : 2024-08-01 Epub Date: 2024-01-24 DOI:10.1055/a-2243-9399
Reiner Hanewinkel, Sabina Ulbricht
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引用次数: 0

Abstract

E-cigarettes are used in clinical trials to facilitate smoking cessation. Due to the health risks associated with the use of e-cigarettes, the results of clinical trials should be fully reported, including continued exclusive use and dual use of tobacco and e-cigarettes. Nicotine cessation outcomes should be reported as the primary endpoint as well as the analysis of tobacco cessation alone. As there is currently no robust evidence that reducing cigarette consumption provides substantial health benefits, cigarette consumption reduction should not be used as a health outcome in clinical trials. Continued nicotine dependence should be included as an "adverse event" in the reporting of trial results.

[电子烟在临床研究中的预期效果和意外效果:要求(更多)透明度]。
临床试验中使用电子烟来促进戒烟。由于使用电子烟存在健康风险,临床试验结果应全面报告,包括继续完全使用以及烟草和电子烟的双重使用。尼古丁戒断结果应作为主要终点以及单独戒烟分析进行报告。由于目前还没有有力的证据表明减少香烟消费会带来实质性的健康益处,因此在临床试验中不应将减少香烟消费作为一项健康结果。在报告试验结果时,持续尼古丁依赖应被列为 "不良事件"。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Pneumologie
Pneumologie RESPIRATORY SYSTEM-
CiteScore
1.80
自引率
16.70%
发文量
416
期刊介绍: Organ der Deutschen Gesellschaft für Pneumologie DGP Organ des Deutschen Zentralkomitees zur Bekämpfung der Tuberkulose DZK Organ des Bundesverbandes der Pneumologen BdP Fachärzte für Lungen- und Bronchialheilkunde, Pneumologen und Allergologen
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