Amid the FDA’s crackdown on the e-cigarette industry due to rising rates of teen vaping, a new randomized trial revealed e-cigs are effective for their original purpose: The devices were almost twice as successful as other nicotine replacement therapies, like patches and gums, in helping people stop smoking.
The study, published online Jan. 30 in The New England Journal of Medicine, randomized 886 participants who attended a smoking cessation program in the United Kingdom. All participants received in-person behavioral support weekly for at least four weeks, but about half were randomized to a second-generation, e-cigarette starter pack while the other half received three months’ worth of nicotine replacement products of their choice (including product combinations).
One year later, 18 percent of patients in the e-cigarette group had stopped smoking compared to 9.9 percent in the nicotine replacement group. These findings were validated by measuring exhaled carbon monoxide levels.
“Both e-cigarettes and nicotine-replacement products were perceived to be less satisfying than cigarettes,” lead author Peter Hajek, PhD, from Queen Mary University of London, and colleagues wrote. “However, e-cigarettes provided greater satisfaction and were rated as more helpful to refrain from smoking than nicotine-replacement products.”
Participants in the e-cigarette group reported less severe urges to smoke than those taking other nicotine replacement products, along with smaller increases in irritability, restlessness and inability to concentrate during the first week of abstinence from smoking.
Hajek et al. noted their e-cig participants had greater success in quitting smoking than those from previous trials, which might be explained by several factors.
“This could be due to the inclusion of smokers seeking help in quitting, the provision of face-to-face support, and the use of refillable e-cigarettes with free choice of e-liquids,” they wrote. “Previous trials provided limited or no face-to-face support and used first-generation cartridge products. Refillable devices are generally more efficient at nicotine delivery.”
The e-cigarette group reported lower incidence of cough and phlegm throughout the one-year period than those in the nicotine replacement group, but one potentially concerning finding was the high rate of continued e-cig use among abstainers. Eighty percent of e-cig participants who stopped using traditional cigarettes still vaped one year later, while only 9 percent of those who quit with other nicotine replacement therapies continued to use their assigned products for that long.
“This differential pattern of long-term use raises concerns about the health consequences of long-term e-cigarette use,” Belinda Borrelli, PhD, and George T. O’Connor, MD, wrote in a related editorial. “E-cigarette vapor contains many toxins and exerts potentially adverse biologic effects on human cells in vitro or in animal models, although toxin levels and biologic effects are generally lower than those of tobacco smoke.”
For this reason, the editorialists said, indefinite e-cigarette use shouldn’t be seen as a “completely successful smoking-cessation outcome.”
“We recommend that e-cigarettes be used only when FDA-approved treatments (combined with behavioral counseling) fail, that patients be advised to use the lowest dose needed to manage their cravings, and that there be a clear timeline and ‘off ramp’ for use,” Borrelli and O’Connor wrote. “Use of e-cigarettes should be monitored by health care providers, like other pharmacologic smoking-cessation treatments.”
Hajek and co-authors noted their findings might not be generalizable outside the U.K., to smokers who aren’t actively looking to quit or for those who try e-cigarettes for reasons other than quitting smoking. They said several participants in the nicotine replacement group also used e-cigarettes during the trial, but that would only weaken the conclusions about the effectiveness of e-cigs for quitting smoking.
The study adds another layer of complexity to regulatory decisions regarding e-cigarettes, as vaping was recently deemed an “epidemic” among teenagers by U.S. Surgeon General Jerome Adams, MD. FDA Commissioner Scott Gottlieb, MD, has also been aggressive against the industry, announcing plans to ban flavored products that might appeal to adolescents at most convenience stores and gas stations and halting online sales until websites meet certain age-verification standards. Those limitations would apply to all flavors other than mint, menthol and tobacco.
“The public health problem that e-cigarettes can help solve—by helping people who are users of combustible tobacco products stop smoking by switching to vaping—is adequately addressed by liquids that are not flavored to appeal to adolescents,” Drazen and co-authors wrote. “We urge the FDA to use its statutory powers in regulating nicotine delivery devices to take the bold step of removing these flavored products from the market.”