www.medscape.com
Clinicians should not routinely recommend electronic nicotine delivery devices (ENDS), such as ecigarettes, to their patients
who smoke. The wisdom of this evidencedbased recommendation stems from 4 key issues: inadequate safety, poor
effectiveness, little regulation, and an ethical framework to do no harm.
First, we lack strong evidence in regard to the safety of ENDS, and evidence exists about potential and real harms. While
many studies report lower levels of toxicants in ENDS compared with conventional cigarettes,
[1]
the belief that ENDS are thus
safe is false. ENDS appear to deliver a similar number of particulate matter as cigarettes,
[2] and exposure to particles
increases risks for cardiovascular and respiratory disease,
[3,4]
raising concern that particulate matter in ENDS may have similar
adverse effects. Potentially cytotoxic or nephrotoxic effects of ENDS are also emerging.
[5,6] Finally, virtually all ENDS products
utilize flavorings, and the inhalation of flavor additives, such as diacetyl, is a recognized health hazard associated with
respiratory disease, including bronchiolitis obliterans, commonly known as “Popcorn Lung”.
[7,8] Longterm inhalation of
flavorings and other chemicals found in ENDS, even at low concentrations, is a safety concern.
[9]
Second, the effectiveness of ENDS as a smoking cessation aid is questionable at best, potentially ineffective at worst, and
significantly poorer than existing FDAapproved optimal therapies, such as combined nicotine replacement therapy (NRT) or
varenicline, with intensive behavioral treatment. Results from 2 randomized controlled trials suggest that ENDS may help some
smokers stop smoking, but the quality of evidence was rated as low.
[10] On the contrary, a metaanalysis of 4 populationbased
longitudinal studies and 1 crosssectional study indicated ENDS use is associated with significantly lower odds of quitting
smoking cigarettes.
[9] Whether ENDS help or hurt a patient’s chances of quitting, as of today, they are significantly less
effective than existing best practices.
[11]
Third, until regulations are approved by authorities, clinicians should pause for thought before recommending ENDS. Lack of
regulation has resulted in battery and other safety concerns, resulting in overheating, fire, and explosions, with damaging,
disfiguring, and lifethreatening consequences to users and nonusers.
[12] Poisonings from ENDS exposure, particularly for
young children, has increased exponentially in the last 5 years.
[13] From a regulatory approach, nicotine concentrations found in
ENDS can be markedly different than the labeled content, and some supposedly nicotinefree products contain varying
concentrations of nicotine.
[1] Finalizing pending FDA regulations of ENDS in the United States would be a significant step
forward.
Finally, the ethical duty of medicine is to do no harm. Jumping from the 10th floor of a burning building rather than the 15th
floor offers no real benefit. If a clinician recommends penicillin for a resistant infection in the face of more effective therapy,
they would face an uncertain defense in front of their colleagues or courts. For clinicians that do recommend ENDS, do they
document such in the medical record? Given the rise in medical lawsuits related to ENDS side effects or injuries,
[14,15] until
such time that medical evidence supports ENDS safety and effectiveness, and robust regulatory frameworks exist, clinicians
who recommend ENDS to patients in favor of more effective and safe products
[16] may face medicolegal risks.
Some clinicians may be tempted to recommend ENDS for certain subgroups of smokers, but this approach is problematic.
Pregnant women may think ENDS use in pregnancy is safe and avoid quitting tobacco entirely in pregnancy in favor of
switching to ENDS.
[17] No trials, however, have evaluated the safety of ENDS use during pregnancy
[18] and cells from embryos
and newborns have shown greater cytoxicity to ENDS fluid than adult cells.
[19]
It is problematic to recommend ENDS for
asthmatic tobacco users, as immediate reduction in lung function is observed when using ENDS.
[20,21] Perhaps most
importantly, the impact of increased ENDS use among youth has generated national and international concern.
[22,23]
In
adolescents, ENDS use is associated with increased odds of being diagnosed with asthma and increased asthma severity
[24]
and is also associated with lower cigarette smoking abstinence.
[25]
One thing perhaps all clinicians can agree on is that patients need more help from providers in quitting tobacco use. The good
news is that clinicians already have adequate tools at their disposal. Best practices (ie, combined behavioral support and FDAapproved
pharmacotherapy) provide safe and effective treatment for smoking cessation, increasing quit rates by two to
threefold.
[11] Encouraging clinicians to utilize such best practices should be a priority. Until more independent data on ENDS
Should Clinicians Recommend Ecigarettes
to Their Patients Who Smoke? No.
Clare Meernik, MPH; Adam O. Goldstein, MD, MPH
Ann Fam Med. 2016;14(4):302303.
threefold.
[11] Encouraging clinicians to utilize such best practices should be a priority. Until more independent data on ENDS
safety and effectiveness emerges, clinicians should be advised against routinely recommending ENDS to their patients who
smoke.
References
1. Pisinger C, Døssing M. A systematic review of health effects of electronic cigarettes. Prev Med. 2014;69:248–260.
2. Fuoco FC, Buonanno G, Stabile L, Vigo P. Influential parameters on particle concentration and size distribution in the
mainstream of ecigarettes. Environ Pollut. 2014;184:523–529.
3. Pope CA III, Burnett RT, Krewski D, et al. Cardiovascular mortality and exposure to airborne fine particulate matter and
cigarette smoke: shape of the exposureresponse relationship. Circulation. 2009;120(11):941–948.
4. Mehta S, Shin H, Burnett R, North T, Cohen AJ. Ambient particulate air pollution and acute lower respiratory infections:
a systematic review and implications for estimating the global burden of disease. Air Qual Atmos Health. 2013;6(1):69–
83.
5. Jensen RP, Luo W, Pankow JF, Strongin RM, Peyton DH. Hidden formaldehyde in ecigarette aerosols. N Engl J Med.
2015;372(4):392–394.
6. Golli NE, JradLamine A, Neffati H, et al. Impact of ecigarette refill liquid exposure on rat kidney. Regul Toxicol
Pharmacol. 2016;77:109–116.
7. Allen JG, Flanigan SS, LeBlanc M, et al. Flavoring chemicals in ecigarettes: diacetyl, 2,3pentanedione, and acetoin in
a sample of 51 products, including fruit, candy, and cocktailflavored ecigarettes. Environ Health Perspect.
2015;124(6):733–739.
8. National Institute for Occupational Safety and Health. Occupational Exposures to Diacetyl and 2, 3pentanediione.
Cincinnati, OH: National Institute for Occupational Safety and Health; 2013.
9. Grana R, Benowitz N, Glantz SA. Ecigarettes: a scientific review. Circulation. 2014;129(19):1972–1986.
10. McRobbie H, Bullen C, HartmannBoyce J, Hajek P. Electronic cigarettes for smoking cessation and reduction.
Cochrane Database Syst Rev. 2014;12(12):CD010216. 10.1002/14651858.CD010216.pub2.
11. Fiore MCJC, Baker TB. Clinical Practice Guideline: Treating Tobacco Use and Dependence: 2008 Update. Washington,
DC: US Department of Health and Human Services Public Health Service; 2008.
12. Rudy SF, Durmowicz EL. Electronic nicotine delivery systems: overheating, fires and explosions [published online ahead
of print March 9, 2016]. Tob Control. doi: 10.1136/tobaccocontrol2015–052626.
13. ChathamStephens K, Law R, Taylor E, et al. Notes from the field: calls to poison centers for exposures to electronic
cigarettes—United States, September 2010February 2014. MMWR Morb Mortal Weekly Rep. 2014;63(13):292–293.
14. BransonPotts H. Ecigarette explosions promot three lawsuits in California. Los Angeles Times. November 19, 2015.
http://www.latimes.com/local/lanow/lameecigarettelawsuits20151119story.html. Accessed Mar 23, 2016.
15. Ovalle D. Ecigarette exploded in Florida man’s mouth, lawsuit contends. Miami Herald. January 28, 2016.
http://www.miamiherald.com/news/local/community/miamidade/article57037303.html. Accessed Mar 23, 2016.
16. Kandra KL, Ranney LM, Lee JG, Goldstein AO. Physicians’ attitudes and use of ecigarettes as cessation devices,
North Carolina, 2013. PLoS One. 2014;9(7):e103462.
17. Meernik C, Goldstein AO. A critical review of smoking, cessation, relapse and emerging research in pregnancy and postpartum.
Br Med Bull. 2015;114(1):135–146.
Ann Fam Med. 2016;14(4):302303. © 2016 Annals of Family Medicine, Inc.
18. Coleman T, Chamberlain C, Davey MA, Cooper SE, LeonardiBee J. Pharmacological interventions for promoting
smoking cessation during pregnancy. Cochrane Database Syst Rev. 2015;12(12):CD010078.
19. Bahl V, Lin S, Xu N, Davis B, Wang YH, Talbot P. Comparison of electronic cigarette refill fluid cytotoxicity using
embryonic and adult models. Reprod Toxicol. 2012;34(4):529–537.
20. Vardavas CI, Anagnostopoulos N, Kougias M, Evangelopoulou V, Connolly GN, Behrakis PK. Shortterm pulmonary
effects of using an electronic cigarette: impact on respiratory flow resistance, impedance, and exhaled nitric oxide.
Chest. 2012;141(6):1400–1406.
21. Marini S, Buonanno G, Stabile L, Ficco G. Shortterm effects of electronic and tobacco cigarettes on exhaled nitric
oxide. Toxicol Appl Pharmacol. 2014;278(1):9–15.
22. Arrazola RA, Singh T, Corey CG, et al.; Centers for Disease Control and Prevention (CDC). Tobacco use among middle
and high school students United States, 2011–2014. MMWR Morb Mortal Wkly Rep. 2015;64(14):381–385.
23. Dutra LM, Glantz SA. High international electronic cigarette use among never smoker adolescents. J Adolesc Health.
2014;55(5):595–597.
24. Cho JH, Paik SY. Association between electronic cigarette use and asthma among high school students in South
Korea. PLoS One. 2016;11(3):e0151022. 10.1371/journal.pone.0151022.
25. Dutra LM, Glantz SA. Electronic cigarettes and conventional cigarette use among U.S. adolescents: a crosssectional
study. JAMA Pediatr. 2014;168(7):610–617.