Clinical trial examines the efficacy of e-cigarettes for smoking cessation

Nicotine-containing electronic cigarettes (e-cigs) are often used by smokers as an aid to stopping smoking. However, evidence is limited regarding their efficacy compared with traditional nicotine replacement therapy, and no evidence is available on comparative efficacy with varenicline.A new study conducted at seven hospital sites in China has evaluated whether e-cigs are superior to nicotine replacement therapy and noninferior to varenicline in helping smokers quit.The randomized clinical trial included participants who had been smoking at least 10 cigarettes per day for the past five years and who were motivated to quit. Participants were not currently using any stop-smoking medications or e-cigs.Participants were randomized to receive a cartridge-based e-cig (nicotine salt 30 mg/mL for 2 weeks, followed by 50 mg/mL thereafter), varenicline (0.5 mg once daily for 3 days; 0.5 mg twice daily for 4 days; followed by 1 mg twice daily thereafter) or nicotine chewing gum 2 mg (for smokers of ≤ 20 cigarettes/day) or 4 mg (> 20 cigarettes/day). All products were provided for 12 weeks and accompanied by minimal behavioural support (an invitation to join a self-help internet forum).The primary outcome was sustained abstinence from smoking at six months, as validated by an expired-air carbon monoxide reading (< 8 parts per million). Participants lost to follow-up were included as nonabstainers.Results showed the following:The study included 1,068 participants, 33.5% female, mean age 33.9 years. A total of 409 (38.3%), 409 (38.3%) and 250 (23.4%) participants were randomized to receive e-cigs, varenicline and nicotine replacement therapy, respectively. At six months, biochemically validated abstinence rates were 15.7% (n=64) for e-cigs, 14.2% (n=58) for varenicline, and 8.8% (n=22) for nicotine replacement therapy. The quit rate in the e-cigs group was noninferior to the varenicline group (absolute risk reduction, 1.47%; 95%CI, −1.41% to 4.34%) and higher than the nicotine replacement therapy group (odds ratio, 1.92; 95%CI, 1.15–3.21). Treatment adherence was similar in all three groups during the initial three months. However, 257 participants (62.8%) in the e-cigs group were still using e-cigs at six months, while no further use of study medications was seen in the other two groups. The most common adverse reactions were throat irritation (7.8%) and mouth irritation (6.9%) in the e-cigs group, nausea (8.8%) in the varenicline group, and throat irritation (8.0%) and mouth irritation (8.8%) in the nicotine replacement therapy group. No serious adverse events were recorded.The authors conclude that in this randomized clinical trial involving 1,068 smokers,e-cigs were as effective as varenicline and more effective than nicotine chewing gum, when all treatments were provided with minimal behavioural support. The authors point out that almost 63% of individuals the e-cig group were still using e-cigs at the six-month study endpoint. Although switching to e-cigs is expected to pose fewer health risks than continued smoking, some adverse health outcomes of long-term e-cig use are likely. Further studies are needed to assess the relative benefits and harms of ongoing e-cig use.Reference1. Lin HX, Liu Z, Hajek P, et al. Efficacy of electronic cigarettes vs varenicline and nicotine chewing gum as an aid to stop smoking. A randomized clinical trial. JAMA Intern Med 2024. Published online January 29, 2024. (accessed February 1, 2024).

Clinical trial examines the efficacy of e-cigarettes for smoking cessation

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