BACKGROUND: Electronic cigarettes (ECs) are handheld electronic vaping devices that produce an aerosol by heating an e-liquid. People who smoke, healthcare providers, and regulators want to know if ECs can help people quit smoking, and if they are safe to use for this purpose. This is a review update conducted as part of a living systematic review. OBJECTIVES: To examine the safety, tolerability, and effectiveness of using EC to help people who smoke tobacco achieve long-term smoking abstinence, in comparison to non-nicotine EC, other smoking cessation treatments, and no treatment. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 February 2024 and the Cochrane Tobacco Addiction Group's Specialized Register to 1 February 2023, reference-checked, and contacted study authors. SELECTION CRITERIA: We included trials randomizing people who smoke to an EC or control condition. We included uncontrolled intervention studies in which all participants received an EC intervention. Studies had to report an eligible outcome. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods for screening and data extraction. We used the risk of bias tool (RoB 1) and GRADE to assess the certainty of evidence. Critical outcomes were abstinence from smoking after at least six months, adverse events (AEs), and serious adverse events (SAEs). Important outcomes were biomarkers, toxicants/carcinogens, and longer-term EC use. We used a fixed-effect Mantel-Haenszel model to calculate risk ratios (RRs) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data in pairwise and network meta-analyses (NMA). MAIN RESULTS: We included 90 completed studies (two new to this update), representing 29,044 participants, of which 49 were randomized controlled trials (RCTs). Of the included studies, we rated 10 (all but one contributing to our main comparisons) at low risk of bias overall, 61 at high risk overall (including all non-randomized studies), and the remainder at unclear risk. Nicotine EC results in increased quit rates compared to nicotine replacement therapy (NRT) (high-certainty evidence) (RR 1.59, 95% CI 1.30 to 1.93
I AUTHORS' CONCLUSIONS: There is high-certainty evidence that ECs with nicotine increase quit rates compared to NRT and moderate-certainty evidence that they increase quit rates compared to ECs without nicotine. Evidence comparing nicotine EC with usual care or no treatment also suggests benefit, but is less certain due to risk of bias inherent in the study design. Confidence intervals were, for the most part, wide for data on AEs, SAEs, and other safety markers, with no evidence for a difference in AEs between nicotine and non-nicotine ECs nor between nicotine ECs and NRT, but low-certainty evidence for increased AEs compared with behavioural support/no support. Overall incidence of SAEs was low across all study arms. We did not detect evidence of serious harm from nicotine EC, but longer, larger studies are needed to fully evaluate EC safety. Our included studies tested regulated nicotine-containing EC
illicit products and/or products containing other active substances (e.g. tetrahydrocannabinol (THC)) may have different harm profiles. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-to-date information to decision-makers, this is a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.