Assessment and Implications of Article Comparing E-cigarettes to Nicotine Replacement Therapies

by Mary P. Martinasek Ph.D., RRT and Caroline Bakyta, student researcher
Affiliation: University of Tampa

Where things started

Chinese pharmacist Hon Lik patented the first commercially electronic cigarette (e-cigarette).[1] Lik was not only an inventor but also a heavy smoker. He created this device after his father, who was also a heavy smoker, died of lung cancer. These devices, upon inhalation, produce an aerosol from the liquid nicotine and propellants that are housed in the chamber.

Progressing in development and use since the e-cigarette release year to the public, e-cigarettes are advertised to aid individuals in tobacco cessation.

The JUUL^TM is a novel product that has gained national attention due to alarming use among teens. Younger populations may find the JUUL and other electronic nicotine delivery systems attractive due to experience seeking and risk-taking behaviors in the social development of this age group.[2] The recent JUUL advertisements have been in response to the FDA request to provide evidence that the company is not targeting youth/young adults.

Despite the widespread use of the JUUL[3], the only U.S. FDA approved method of over-the-counter cessation are the nicotine replacement therapies (NRT)— the nicotine gum, patch, and lozenge.[4] There remains much debate and discourse over the effectiveness of e-cigarettes for cessation, as advertised. Some anti-tobacco organizations raise concerns of dual-use and negative effects on youth and young adults who are cigarette naïve (never smoked a regular cigarette).

Researchers are continuing to evaluate e-cigarettes, however, with a lack of standardization and quality control the market is saturated with a dearth of products and devices making it difficult to make generalizations.

Making headlines

Recently an article was published in the New England Journal of Medicine and publicized by media. The article was entitled “A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy”.[5]

As a respiratory therapist, it is important that we understand the study, the results, and the implications to practice.

This 2015-2018 UK, multi-center based study aimed to compare the cessation success of e-cigarettes to UK-approved nicotine replacement therapies (NRTs).

The outcome of the study was one-year abstinence. In this study, one-year abstinence was defined as self-report of smoking no more than five cigarettes from two weeks after the quit date and an exhaled CO of less than 8 ppm at week 52.

Study design

The study design was an individually randomized control design, meaning individuals did not choose which group they wanted to participate in, but were randomly placed based on a computer random number generator into either:

(1) NRT of choice or as encouraged, a combination of NRT or
(2) an e-cigarette starter pack containing refillable liquid nicotine in the amount of 18 mg/ml.

Both groups received approximately four weekly one-on-one sessions of face-to-face behavioral counseling and exhaled CO measurements for assessment of tobacco cessation. Additionally, the participants were asked not to switch assigned products for at least four weeks.

Excluded from the study were pregnant/breastfeeding participants.

Cessation assessment was performed by contacting participants by phone for self-report of amount/quit of traditional cigarette use. Those who reduced or quit smoking traditional cigarettes were asked to return for a follow-up CO measurement.

Study results

The results indicate that of the 886 participants initially enrolled in the study, the final number of participants in their study was 123.

Those who dropped out of the study or were lost to follow-up were considered not to be abstinent and remained in the final data analysis.

Data analysis was conducted to assess one-year abstinence rates that adjusted for age of initiation of smoking, center from which they participated in and Fagerström test of dependence.[6] This means these attributes were basically removed from the data analysis in order to just assess just e-cigarettes and NRT.

The final data analysis—one-year abstinence rate—was 18% in the e-cigarette group (79 participants), compared to the 9.9% (44 participants) in the NRT group.

Although four weeks of counseling was encouraged, the data results included only those who attended at least one counseling visit. There was no data to indicate the number of behavioral counseling visits for each group (E-cigarette vs. NRT).

What RTs need to know

When being the consumer of research, always ask questions about the research and get involved in journal clubs or research when interested.

Implications for respiratory therapists include the following:

1. Continued research and validated research (repeated and proven by other researchers) is important to help us understand how best to help our patients quit smoking. Traditional cigarettes contain over 7000 chemicals, so quitting is very important. Social environment plays a factor in smoking, therefore behavioral counseling is a vital part to quit attempts.[7]
2. NRTs are proven to reduce craving intensity and frequency with the plan to eventually wean a person off of nicotine. NRTs do not cause cancer. The gum, patch, and lozenge do not require inhalation, thereby lessening respiratory effects. Abstinence success rates of combination NRT plus counseling is found to be most helpful. E-juice vials should offer a quit plan in reduction of mg/ml and pair the current traditional smoking habit with the level of nicotine in e-juice. Currently JUUL, a popular US product only offers one-step reduction in two flavors (tobacco and mint). The most popular flavor among youth, mango, remains at the highest level of nicotine.
3. E-cigarettes are harm reduction, but not harm-free. Currently, there is not enough research for us to advocate for these products.
4. E-juice contains propylene glycol and/or glycerin as propellants, both of concern. Some studies have indicated carcinogens in the vapor.
5. Successful quit attempts using vape devices has been noted. Follow up of this study’s participants is important to determine if they were able to wean off the e-cigarettes/NRT.
6. E-cigarettes and NRT both have negative side effects. In this study, throat or mouth irritation were reported more frequently in the e-cigarette group (65.3% vs 51.2% in the NRT group) and nausea more frequently in the NRT group (37.9% vs 31.3% in the e-cigarette group).
7. 18 mg/ml liquid nicotine provided initially in this study would be appropriate for an individual who smokes one-half a pack a day. After week one, these study participants were allowed to purchase their own e-juice of varying concentrations. This makes it difficult from a research perspective to compare products. Current research on vials indicates varying levels among vials; partly due to lack of regulation and quality control.
8. Although we can encourage patients to quit smoking, follow up of recidivism rates back to traditional smoking is important to know if the products are actually successful in long term quit. Is cost a barrier to quitting? In this study, a three month supply of NRT cost $159 and the cost of the e-cigarette kit was $40. How much out of pocket did the participants pay and how many vials e-juice were consumed? In this study, the participants were middle-aged and 41% socially disadvantaged receiving free prescriptions.
9. There are no FDA approved methods for teen vapors. In discussion forums, such as ATTUD (association for the treatment of tobacco use and dependence) and AARC’s Tobacco Free Lifestyle Digest, cessation specialists are having constant dialogue about the best products for teens and current research in the area of cessation.
10. Deaths related to e-cigarettes gain media attention. Mostly these explosive deaths are related to irregular batteries and inconsistent battery to device alterations resulting in bodily harm and fires. We must take into consideration the media deaths as compared to the number of deaths of individuals who will continue to smoke traditional cigarettes. American Cancer Society position: offer FDA approved products/medications and counseling as a first line method. For those who fail to quit using this method, consider a harm reduction strategy.

References

1. Hemphill TA. Electronic cigarettes at a regulatory crossroads. Regulation. 2013;36(3):10.
2. Lanza HI, Teeter H. Electronic Nicotine Delivery Systems (E-cigarette/Vape) use and Co-Occurring Health-Risk Behaviors Among an Ethnically Diverse Sample of Young Adults. Substance use & misuse. 2018;53(1):154-61.
3. Vallone DM, Bennett M, Xiao H, Pitzer L, Hair EC. Prevalence and correlates of JUUL use among a national sample of youth and young adults. Tobacco control. 2018:tobaccocontrol-2018-054693.
4. Institute NC. Nicotine and Addiction 2019 [cited 2019 February 3]. Available from: https://teen.smokefree.gov/the-risks-of-tobacco/nicotine-addiction.
5. Hajek P, Phillips-Waller A, Przulj D, Pesola F, Myers Smith K, Bisal N, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy. New England Journal of Medicine. 2019.
6. Fagerstrom K-O, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. Journal of behavioral medicine. 1989;12(2):159-82.
7. Patnode CD, Henderson JT, Thompson JH, Senger CA, Fortmann SP, Whitlock EP. Behavioral counseling and pharmacotherapy interventions for tobacco cessation in adults, including pregnant women: a review of reviews for the US Preventive Services Task Force. Annals of internal medicine. 2015;163(8):608-21.

Email newsroom@aarc.org with questions or comments, we’d love to hear from you.

Heather Willden is the Director of Governance and Strategic Initiatives for the AARC where she works with state affiliates as the HOD liaison. She also manages DEI efforts and strategic initiatives. Connect with her about these topics by email, AARConnect or LinkedIn. When she's not working, you can find her podcasting with her husband, exploring new hiking trails, photographing, and spending time with her family.