E-Cigs Show Some Benefit as Smoking Cessation Aid in Clinical Trial

Electronic cigarettes (e-cigarettes) helped people better stick to smoking cessation in the randomized controlled ESTxENDS trial.

Participants smoking at least five tobacco cigarettes a day at baseline showed validated continuous abstinence from tobacco smoking at 6 months in 28.9% of cases after getting free e-cigarettes and counseling, which was significantly better than the 16.3% abstinence demonstrated by peers who received standard counseling and a voucher for any therapy (RR 1.77, 95% CI 1.43-2.20), reported Reto Auer, MD, of the University of Bern, Switzerland, and co-authors.

Additionally, abstinence from smoking 7 days prior to the 6-month check-in occurred in 59.6% of the intervention group and 38.5% of the control group, study authors reported in the New England Journal of Medicine.

These findings of e-cigarettes’ effectiveness may be related to their method of nicotine delivery, commented Richard Stumacher, MD, of Northwell Health in Mount Kisco, New York.

“We all know that nicotine patches or nicotine gum don’t deliver nicotine in the same way as a cigarette or an e-cigarette does and therefore, [they have] a different effect and a different use pattern,” Stumacher told MedPage Today.

“Switching over to an e-cigarette, where you can have more frequent and multiple, smaller hits of nicotine rather than a flat, kind of plateaued-like amount of nicotine over a longer period of time, is going to be more useful for patients who are already addicted to cigarettes because it mimics their cigarette pattern.”

However, the ESTxENDS investigators reported that 20.1% of intervention patients and 33.7% of the control group still used nicotine in the 7 days prior to the follow-up visit, leading them to caution that “the attributes that make e-cigarettes potentially attractive for smoking cessation may also encourage prolonged use, so rigorous evaluation of their safety and toxicologic profile is an urgent requirement.”

Nancy Rigotti, MD, of Massachusetts General Hospital and Harvard Medical School in Boston, urged clinicians to engage with the use of e-cigarettes as a method for some patients to try and quit smoking.

“E-cigarettes are neither completely harmless nor ‘magic bullets’ that help every tobacco smoker quit, but they can and do help some. It is now time for the medical community to acknowledge this progress and add e-cigarettes to the smoking-cessation toolkit,” Rigotti wrote in an accompanying editorial. “Clinicians should be prepared to have a risk-benefit discussion about e-cigarettes with their patients who smoke and recommend a trial of the products in appropriate situations.”

Stumacher also stressed a nuanced and individualized approach to deciding whether or not to utilize e-cigarettes as a smoking cessation tool.

“If you really want to know if it’s good for you or not, you really need to sit down with your doctor, and it may be that you need to sit down with a pulmonologist and not just your doctor, to really help make that decision of a harm reduction/risk-benefit profile customized to you and what your issues are. I think that would be the safest way to go,” he said.

The ESTxENDS trial randomized 1,246 participants 1:1 to the e-cigarette intervention or control therapy. Adult candidates had been recruited by various advertisement campaigns. Data were collected from five sites across Switzerland from July 2018 through June 2021. The study cohort had a mean age of 38 and 47% were women.

Eligible participants were adults who had smoked at least five cigarettes per day for at least 12 months and wanted to quit smoking within 3 months after enrollment. Auer’s group excluded those who were pregnant or breastfeeding, people who had used nicotine replacement therapy or another smoking-cessation drug in the previous 3 months, and those who already regularly used e-cigarettes or tobacco-heating systems in the previous 3 months.

The intervention protocol incorporated traditional smoking cessation with the addition of e-cigarette use. Participants received two starter e-cigarette kits, along with five 0.8-ohm replacement coils at the start of the study. They were allowed to select flavors and nicotine concentrations for the e-cigarettes, were allowed to use the devices as needed, and were able to order replacement e-liquids through the study for 6 months.

Control treatment consisted of standard smoking cessation therapy, including cognitive behavioral therapy, motivational interviewing, and, when agreed upon by the patient and provider, use of supportive drugs for smoking cessation. Treatments were personalized to an individual’s nicotine dependence.

Adverse events were seen in more people in the intervention group (43.7% vs 36.7%, P=0.01), as those who received e-cigarettes had more COVID-19 diagnosed, Auer and colleagues noted. Serious adverse events emerged in 4% and 5% of e-cigarette and control groups, respectively, the most common being musculoskeletal complaints and psychiatric disorders.

Study limitations included the inability to blind patients to their group assignment. Intervention measures were provided to participants free of charge, but nicotine replacement therapy for the control group was not.

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