Adverse symptoms attributed to e-cigarettes over 6 months among participants of a randomized controlled trial testing nicotine free-base e-cigarettes for smoking cessation: secondary analysis of the ESTxENDS trial
Abstract
Abstract Introduction People smoking tobacco cigarettes and switching to e-cigarettes report adverse symptoms attributed to e-cigarettes. We aimed at assessing the proportions and changes over 6 months in self-reported symptoms among participants of a large randomized controlled trial testing e-cigarettes for smoking cessation. Method We included participants from the intervention group of the Efficacy, Safety and Toxicology of ENDS (ESTxENDS) randomized controlled trial. They received e-cigarettes, freebase nicotine e-liquids and smoking cessation counseling, phone follow-up at 1-, 2-, 4-, 8-week, and a visit at 6 months after target quit date. A set of predefined adverse symptoms experienced while vaping or smoking were systematically assessed at each contact. We used descriptive statistics and mixed models to report proportion of symptoms over time in exclusive e-cigarette users. We assessed the effect of symptoms on smoking re-initiation and the effect of duration of exclusive e-cigarette use on the resolution of symptoms in marginal structural models. Results The intervention group included 622 participants, with a mean age of 40 (SD: 14) and 53% identified as men. After 1 week, the most commonly reported adverse symptoms among the 405 exclusive e-cigarette users were dry mouth (34%, 95 CI: 29%–39%), mouth/throat irritation (23%, 19%–27%), and cough (25%, 21%–29%). After 6 months, 256 exclusive e-cigarette users reported dry mouth (18%, 14%–23%), mouth/throat irritation…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 622 participants or records.
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