e-Cigs Beat Nicotine Patch, Gum for Smoking Cessation in RCT

Troy Brown, RN

January 30, 2019

Smokers who use e-cigarettes to quit are almost twice as likely to stop smoking combustible tobacco at 1 year, compared with those who use nicotine replacement products such as patches or gum, a randomized trial has found. But not everyone is convinced e-cigarettes are the best approach.

The study by Peter Hajek, PhD, from Queen Mary University of London, United Kingdom, and colleagues was published online today in the New England Journal of Medicine.

"This is the first trial to test the efficacy of modern e-cigarettes in helping smokers quit. e-Cigarettes were almost twice as effective as the 'gold standard' combination of nicotine replacement products," Hajek said in a news release.

"Although a large number of smokers report that they have quit smoking successfully with the help of e-cigarettes, health professionals have been reluctant to recommend their use because of the lack of clear evidence from randomized controlled trials. This is now likely to change," he continued.

Although quitting smoking lowers the risk for lung cancer, which is critically important, the benefits seen in this trial need to be put in context, write Belinda Borrelli, PhD, and George T. O'Connor, MD, in an accompanying editorial.

"This evidence of effectiveness must be balanced against the short-term and long-term safety of e-cigarettes," they write. The short-term data presented in the study by Hajek and colleagues look good regarding safety endpoints. The long-term risks of e-cigarettes are largely unknown as yet, according to the editorialists, though some studies have shown that users of e-cigarattes experience tissue changes similar to those seen with traditional smoking.

By contrast, nicotine replacement products are known to have acceptable safety profiles, Borrelli and O'Connor note.

"An additional societal consideration is the effect of adult e-cigarette use on children and young adults. Adult use may not only expose children to e-cigarette vapor but also models addictive behavior," continue Borrelli, from the Center for Behavioral Science Research, Department of Health Policy and Health Services Research, Henry M. Goldman School of Dental Medicine, Boston University, and O'Connor, from the Pulmonary Center, Boston University School of Medicine, and Division of Pulmonary, Allergy, Sleep, and Critical Care Medicine, Boston Medical Center, in Massachuesetts.

In a separate editorial, Jeffrey M. Drazen, MD, editor-in-chief of the journal, and colleagues reiterate the potential harm to children and youth, given the flavorings used in e-cigarettes. They urge the US Food and Drug Administration (FDA) to remove flavored e-cigarette liquids from the market to keep them out of the hands of teenagers and children.

Vaping or a Patch and Gum

The researchers randomly assigned 886 participants in a smoking cessation program to receive either a 3-month supply of the nicotine replacement products of their choice, including combinations of products, or an e-cigarette starter pack with one bottle of nicotine e-liquid containing 18 mg of nicotine per milliliter. Participants in the e-cigarette group were told to purchase e-liquids of the flavors and strength they preferred after they finished using the first bottle.

All participants received treatment, including behavioral support, for 4 weeks or longer.

At the end of 1 year, 18.0% of those in the e-cigarette group met the study's primary endpoint of sustained abstinence, as validated with expired air carbon monoxide testing, compared with 9.9% of the participants who used nicotine replacement products (relative risk, 1.83; 95% confidence interval [CI], 1.30 – 2.58; P < .001).

Of those who were abstinent for 1 year, participants in the e-cigarette group were more likely to still be using their assigned product at 52 weeks than those in the nicotine replacement group (80% vs 9%).

Participants in the e-cigarette group were more likely to report throat or mouth irritation compared with those in the nicotine replacement group (65.3% vs 51.2%). Those in the nicotine replacement group were more likely to report nausea than those in the e-cigarette group (37.9% vs 31.3%).

The incidence of cough and phlegm production decreased more from baseline to week 52 in participants in the e-cigarette group compared with those in the nicotine replacement therapy group (relative risk for cough, 0.8; 95% CI, 0.6 – 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 – 0.9).

Caution Warranted

Nicotine is "amazingly addictive," and e-cigarettes "are nicotine delivery devices for humans," Drazen and colleagues write in their editorial.

The makers of e-cigarettes add flavorings to the e-liquid, which make them more appealing to first-time users, especially teenagers, they add.

"We think the FDA should simply ban the sale of flavored nicotine products for use in e-cigarettes. 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," the editorialists explain.

Although the study suggests that some active smokers may be able to quit or reduce smoking by inhaling nicotine via e-cigarettes, the study has "many limitations," Jay Peters, MD, professor and chief of pulmonary and critical care medicine, UT Health, San Antonio, Texas, told Medscape Medical News.

"First, subjects in the e-cigarette group were encouraged to try different flavors and strengths vs the initial product they were provided. Since e-cigarettes are not currently regulated, the amount of nicotine ingested and the long-term side effects of these products are unknown," Peters said.

"Second, the patients in the standard therapy group were given a 'standard therapy for up to 3 months.' Different sites used different replacement therapy, and subjects may not have been given a second therapy to support withdrawal symptoms (eg, nicotine gum, which requires patient education to adequately use it effectively)," he continued.

Peters added, "After 3 months, it is clear that the e-cigarette group probably continue to use what many consider an 'addictive flavored' therapy. The study depended on self-reported information and an exhaled carbon monoxide level, which only measured recent use of commercial cigarettes. While this study is interesting, it does little to answer the long-term benefit vs risk of e-cigarettes."

For now, Peters does not recommend e-cigarettes to his patients. "At this point, I tell patients that we do not know the benefits vs the risks of long-term use of e-cigarettes. Until e-cigarettes are regulated and studied over a longer period of time, I would always suggest using standard means to quit smoking and reassure that the average person has attempted to quit several times (up to or more than five times) before being successful," he explained.

Several authors report a variety of financial relationships with companies, including Johnson & Johnson and Pfizer. Complete information is available on the journal's website. Drazen, Morrissey, Campion, and Peters have disclosed no relevant financial relationships.

New Engl J Med. Published online January 30, 2019. Abstract; Borrelli and O'Connor, Editorial; Drazen et al, Editorial

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