1. In this randomized controlled trial, participants who received free e-cigarettes in addition to counseling had greater continuous abstinence from smoking at six months compared to those who received standard-of-care counseling alone.
2. Rates of nicotine use and adverse events were greater in the intervention group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: E-cigarettes allow users to inhale nicotine while avoiding many of the toxic combustion products of tobacco cigarettes. However, e-cigarette aerosols are also hypothesized to contribute to adverse biological effects, and literature discussing the safety and efficacy of e-cigarette use for tobacco cessation is scarce. In this randomized controlled trial, it was found that those who received e-cigarettes in addition to standard counseling were significantly more likely to have biochemically validated, continuous abstinence from tobacco smoking at six months versus those who received standard counseling alone. However, those in the intervention group had a lower rate of nicotine abstinence compared to the control group, largely due to the continued use of e-cigarettes. Those in the intervention group also had more adverse events overall compared to those in the control group, but the frequency of serious adverse events was similar between groups. Those who received e-cigarettes also had slightly fewer respiratory symptoms than those who received standard counseling alone. This study had several limitations, including transparency of group assignment, a short follow-up period, and a single-country design. Overall, these findings reinforce that e-cigarettes may be a valuable addition to standard care in reducing tobacco use in the short term.
Click here to read the study in NEJM
Relevant Reading: A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy
In-Depth [randomized controlled trial]:Â This multicenter, open-label, randomized controlled trial was conducted in Switzerland and involved 1,246 adults with a smoking history of at least five cigarettes per day for at least 12 months as well as a desire to quit smoking within three months of enrollment. Participants were randomized in a 1:1 ratio to receive either standard-of-care counseling or standard counseling plus two e-cigarette starter kits with up to 10 e-liquid bottles. Those who were assigned standard counseling alone also received a voucher valued at $50, which they could use for any purpose. Abstinence from smoking was biochemically validated by an anabasine level of less than 3ng per milliliter in a urine sample or an exhaled carbon monoxide level of 9 ppm or lower. Continuous abstinence from smoking at six months occurred in 28.9% (180 of 622) of the participants in the intervention group and 16.3% (102 of 624) in the control group (crude relative risk, 1.77; 95% Confidence Interval [CI], 1.43 to 2.20). A total of 59.6% of the participants in the intervention group and 38.5% in the control group reported abstinence from tobacco in the seven days before the six-month visit. However, only 20.1% of the intervention group and 33.7% of the control group reported abstinence from nicotine completely in that same period. During the follow-up period, 25 participants in the intervention group and 31 participants in the control group had a serious adverse event (p=0.49). However, of the participants in the intervention group, 272 (43.7%) reported 425 adverse events; of the participants in the control group, 229 (36.7%) reported 366 adverse events (relative risk, 1.19; 95% CI, 1.04 to 1.37; unadjusted p = 0.01). These results suggest that e-cigarettes may be a useful tool for smoking cessation, but the long-term consequences of increased e-cigarette use remain unclear.
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