Nicotine electronic cigarettes: No difference in abstinence from placebo or nicotine patches
1. Nicotine-containing electronic cigarettes offer no statistical improvement in 6-month abstinence rates in comparison to placebo non-nicotine-containing electronic cigarettes or transdermal nicotine replacement patches.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Smoking tobacco is a strong risk factor for numerous illnesses, including cancer and cardiovascular disease. Electronic cigarettes (e-cigarettes), which deliver nicotine in the form of a vapor, first emerged in 2004 as an alternative to smoking. While they have been proposed as a potential method for smoking cessation, no studies have adequately investigated the rate of success.
This study was a partially-blinded randomized control trial comparing nicotine e-cigarettes, transdermal nicotine replacement therapy (patches), and placebo e-cigarettes without nicotine, in addition to cognitive-behavioral modification. No significant risk difference in cessation rates was found between nicotine e-cigarettes and patches, and nicotine-containing e-cigarettes and placebo e-cigarettes. This study was a first attempt to quantify the benefits of e-cigarettes as a smoking cessation device in addition to cognitive-behavioral intervention. The study is limited by the variability in the available e-cigarettes. Further, no conclusions can be made regarding the efficacy of nicotine e-cigarettes compared to patches in smoking cessation. However, the study did find reduced total consumption of regular tobacco cigarettes among those who also received e-cigarettes (i.e. dual use). The long term health impacts of this will require further study.
Lead author Christopher Bullen MHChB talks to 2 Minute Medicine:
“While our results don’t show any clear-cut differences between e-cigarettes and patches in terms of quit success after six months, it certainly seems that e-cigarettes were more effective in helping smokers who didn’t quit to cut down. It’s also interesting that the people who took part in our study seemed to be much more enthusiastic about e-cigarettes than patches, as evidenced by the far greater proportion of people in both of the e-cigarette groups who said they’d recommend them to family or friends, compared to patches.”
In-Depth [randomized controlled trial]: This study was a partially-single blinded randomized controlled trial conducted at one clinical site. A total of 657 patients were randomized to nicotine-containing electronic cigarettes (e-cigarettes), transdermal nicotine replacement therapy (patches), or placebo non-nicotine-containing e-cigarettes, and followed for 1 week before and 12 weeks following their chosen quit day. All randomized patients were referred to smoking cessation cognitive-behavioral services. The primary outcome measured was smoking cessation (measured by self-reported abstinence (< 5 cigarettes in total) over the entire study period with secondary verification by measured carbon monoxide exhalation). At 6 months, 7.3% of the nicotine e-cigarette group had verified abstinence, 5.8% with patches, and 4.1% with placebo e-cigarettes (RR for nicotine e-cigarettes vs. patches: 1.51, 95% CI -2.49 to 5.51; RR for nicotine e-cigarettes vs. placebo e-cigarettes: 1.51, 95% CI -2.29 to 8.61). No significant differences between the interventions in any of the secondary outcomes were found. No adverse effects were associated with nicotine e-cigarettes. Cessation rates for e-cigarette users with cognitive-behavioral intervention were similar to findings from prior studies on e-cigarette user cessation rates.
The study was limited by the authors’ perceived difference in efficacy of nicotine e-cigarettes as compared to placebo or to patches when the powering of the study. Multiple biases exist as this was a single site study. In addition, the investigators were unable to blind whether a patient received an e-cigarette or patch. This may explain the greater loss to follow-up among the group randomized to patches and those who completed follow-up may not be representative. Finally, confounding may have resulted from differences in nicotine (lower than advertised) among e-cigarette cartridges may have limited their efficacy.
By Philip Hewes and Mimmie Kwong
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