Internal and Emergency Medicine

, Volume 9, Issue 5, pp 537–546 | Cite as

Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study

  • Riccardo Polosa
  • Jaymin B. Morjaria
  • Pasquale CaponnettoEmail author
  • Davide Campagna
  • Cristina Russo
  • Angela Alamo
  • MariaDomenica Amaradio
  • Alfredo Fisichella


Electronic cigarettes (e-Cigarette) are battery-operated devices designed to vaporise nicotine that may aid smokers to quit or reduce their cigarette consumption. Research on e-Cigarettes is urgently needed to ensure that the decisions of regulators, healthcare providers and consumers are evidence based. Here we assessed long-term effectiveness and tolerability of e-Cigarette used in a ‘naturalistic’ setting. This prospective observational study evaluated smoking reduction/abstinence in smokers not intending to quit using an e-Cigarette (‘Categoria’; Arbi Group, Italy). After an intervention phase of 6 months, during which e-Cigarette use was provided on a regular basis, cigarettes per day (cig/day) and exhaled carbon monoxide (eCO) levels were followed up in an observation phase at 18 and 24 months. Efficacy measures included: (a) ≥50 % reduction in the number of cig/day from baseline, defined as self-reported reduction in the number of cig/day (≥50 %) compared to baseline; (b) ≥80 % reduction in the number of cig/day from baseline, defined as self-reported reduction in the number of cig/day (≥80 %) compared to baseline; (c) abstinence from smoking, defined as complete self-reported abstinence from tobacco smoking (together with an eCO concentration of ≤10 ppm). Smoking reduction and abstinence rates were computed, and adverse events reviewed. Of the 40 subjects, 17 were lost to follow-up at 24 months. A >50 % reduction in the number of cig/day at 24 months was shown in 11/40 (27.5 %) participants with a median of 24 cig/day use at baseline decreasing significantly to 4 cig/day (p = 0.003). Smoking abstinence was reported in 5/40 (12.5 %) participants while combined >50 % reduction and smoking abstinence was observed in 16/40 (40 %) participants at 24 months. Five subjects stopped e-Cigarette use (and stayed quit), three relapsed back to tobacco smoking and four upgraded to more performing products by 24 months. Only some mouth irritation, throat irritation, and dry cough were reported. Withdrawal symptoms were uncommon. Long-term e-Cigarette use can substantially decrease cigarette consumption in smokers not willing to quit and is well tolerated. (http://ClinicalTrials.govnumberNCT01195597).


Smoking cessation Smoking reduction Quit rate Adverse events Electronic cigarettes Electronic nicotine delivery devices Cigarette substitutes 



Electronic Cigarette


Electronic nicotine delivery device


Cigarettes smoked per day


Blood pressure


Millimetres of mercury


Fagerstrom test of nicotine dependence


Beck’s depression inventory


Exhaled carbon monoxide


Parts per billion




Cartridges used per day


Parts per million




Standard deviation


Interquartile range



We wish to thank Arbi Group Srl (Milano, Italy) for the free supplies of ‘Categoria’ e-Cigarette kits and nicotine cartridges as well as their support. We would also like to thank the study participants for all their time and effort and LIAF (Lega Italiana AntiFumo) for the collaboration.

Conflict of interest

JBM has received lecture fees from Pfizer. RP has received lecture fees from Pfizer and, from Feb 2011, he has been serving as a consultant for Arbi Group Srl.Arbi Group Srl (Milano, Italy), the manufacturer of the e-Cigarette supplied the product, and unrestricted technical and customer support. They were not involved in the study design, running of the study or analysis and presentation of the data. None of the authors have any competing interests to declare.


  1. 1.
    Tobacco Advisory Group of the Royal College of Physicians (2007) Harm reduction in nicotine ddiction: Helping people who can’t quit. Royal College of Physicians, LondonGoogle Scholar
  2. 2.
    Polosa R, Benowitz NL (2011) Treatment of nicotine addiction: present therapeutic options and pipeline developments. Trends Pharmacol Sci 32(5):281–289PubMedCrossRefGoogle Scholar
  3. 3.
    Casella G, Caponnetto P, Polosa R (2010) Therapeutic advances in the treatment of nicotine addiction: present and Future. Ther Adv Chronic Dis 1(3):95–106PubMedCentralPubMedCrossRefGoogle Scholar
  4. 4.
    Caponnetto P, Campagna D, Papale G, Russo C, Polosa R (2012) The emerging phenomenon of electronic cigarettes. Expert Rev Respir Med 6(1):63–74PubMedCrossRefGoogle Scholar
  5. 5.
    Etter JF (2010) Electronic cigarettes: a survey of users. BMC Public Health 10:231PubMedCentralPubMedCrossRefGoogle Scholar
  6. 6.
    Etter JF, Bullen C (2011) Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Addiction 106(11):2017–2028PubMedCrossRefGoogle Scholar
  7. 7.
    Siegel MB, Tanwar KL, Wood KS (2011) Electronic cigarettes as a smoking-cessation: tool results from an online survey. Am J Prev Med 40(4):472–475PubMedCrossRefGoogle Scholar
  8. 8.
    Caponnetto P, Polosa R, Auditore R, Russo C, Campagna D (2011) Smoking cessation with E-cigarettes in smokers with a documented history of depression and recurrign relapses. Int J Clin Med 2:281–284CrossRefGoogle Scholar
  9. 9.
    Caponnetto P, Polosa R, Russo C, Leotta C, Campagna D (2011) Successful smoking cessation with electronic cigarettes in smokers with a documented history of recurring relapses: a case series. J Med Case Rep 5(1):585PubMedCentralPubMedCrossRefGoogle Scholar
  10. 10.
    Polosa R, Caponnetto P, Morjaria JB, Papale G, Campagna D, Russo C (2011) Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study. BMC Public Health 11:786PubMedCentralPubMedCrossRefGoogle Scholar
  11. 11.
    Noel JK, Rees VW, Connolly GN (2011) Electronic cigarettes: a new ‘tobacco’ industry? Tob Control 20(1):81PubMedCrossRefGoogle Scholar
  12. 12.
    Beck A, Ward C, Mendelson M, Mock J, Erbaugh J (1987) Manual for the beck depression inventory. Harcourt Brace Jovanovich, New YorkGoogle Scholar
  13. 13.
    Fagerstrom KO, Schneider NG (1989) Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med 12(2):159–182PubMedCrossRefGoogle Scholar
  14. 14.
    Balfour D, Benowitz N, Fagerstrom K, Kunze M, Keil U (2000) Diagnosis and treatment of nicotine dependence with emphasis on nicotine replacement therapy. A status report. Eur Heart J 21(6):438–445CrossRefGoogle Scholar
  15. 15.
    Apelberg BJ, Onicescu G, Avila-Tang E, Samet JM (2010) Estimating the risks and benefits of nicotine replacement therapy for smoking cessation in the United States. Am J Public Health 100(2):341–348PubMedCentralPubMedCrossRefGoogle Scholar
  16. 16.
    Zhu SH, Lee M, Zhuang YL, Gamst A, Wolfson T (2012) Interventions to increase smoking cessation at the population level: how much progress has been made in the last two decades? Tob Control 21(2):110–118PubMedCentralPubMedCrossRefGoogle Scholar
  17. 17.
    Caponnetto P, Cibella F, Mancuso S, Campagna D, Arcidiacono G, Polosa R (2011) Effect of a nicotine-free inhalator as part of a smoking-cessation programme. Eur Respir J 38(5):1005–1011PubMedCrossRefGoogle Scholar
  18. 18.
    Bolliger CT, Zellweger JP, Danielsson T, van Biljon X, Robidou A, Westin A, Perruchoud AP, Sawe U (2000) Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety. BMJ 321(7257):329–333PubMedCentralPubMedCrossRefGoogle Scholar
  19. 19.
    Hughes JR, Carpenter MJ (2005) The feasibility of smoking reduction: an update. Addiction 100(8):1074–1089PubMedCentralPubMedCrossRefGoogle Scholar
  20. 20.
    Rennard SI, Glover ED, Leischow S, Daughton DM, Glover PN, Muramoto M, Franzon M, Danielsson T, Landfeldt B, Westin A (2006) Efficacy of the nicotine inhaler in smoking reduction: a double-blind, randomized trial. Nicotine Tob Res 8(4):555–564PubMedCrossRefGoogle Scholar
  21. 21.
    Walker N, Bullen C, McRobbie H (2009) Reduced-nicotine content cigarettes: is there potential to aid smoking cessation? Nicotine Tob Res 11(11):1274–1279PubMedCrossRefGoogle Scholar
  22. 22.
    Wennike P, Danielsson T, Landfeldt B, Westin A, Tonnesen P (2003) Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebocontrolled trial of nicotine gum with 2-year follow-up. Addiction 98(10):1395–1402PubMedCrossRefGoogle Scholar
  23. 23.
    Goniewicz ML, Kuma T, Gawron M, Knysak J, Kosmider L (2012). Nicotine Levels in Electronic Cigarettes. Nicotine Tob ResGoogle Scholar
  24. 24.
    Britton J (2003) Smokeless tobacco: friend or foe? Addiction 98(9):1199–1201 Discussion 1204–1197PubMedCrossRefGoogle Scholar
  25. 25.
    Cho JH, Shin E, Moon SS (2011) Electronic-cigarette smoking experience among adolescents. J Adolesc Health 49:542–546PubMedCrossRefGoogle Scholar
  26. 26.
    Choi K, Fabian L, Mottey N, Corbett A, Forster J (2012) Young adults’ favorable perceptions of snus, dissolvable tobacco products, and electronic cigarettes: findings from a focus group study. Am J Public Health 102(11):2088–2093PubMedCentralPubMedCrossRefGoogle Scholar
  27. 27.
    Pepper JK, Reiter PL, McRee AL, Cameron LD, Gilkey MB, Brewer NT (2013) Adolescent males’ awareness of and willingness to try electronic cigarettes. J Adolesc Health 52(2):144–150PubMedCentralPubMedCrossRefGoogle Scholar
  28. 28.
    Goniewicz ML, Zielinska-Danch W (2012) Electronic cigarette use among teenagers and young adults in Poland. Pediatrics 130(4):e879–e885PubMedCrossRefGoogle Scholar
  29. 29.
    Chen I-L (2013) FDA summary of adverse events on electronic cigarettes. Nicotine Tob Res 15(2):615–616PubMedCrossRefGoogle Scholar
  30. 30.
    U.S. Food and Drug Administration (1973) Select committee on GRAS substances (SCOGS) Opinion: propylene glycol, SCOGS report number 27Google Scholar
  31. 31.
    U.S. Food and Drug Administration (1975) Select committee on GRAS substances (SCOGS) opinion: glycerin and glycerides, SCOGS report number 30Google Scholar
  32. 32.
    Wieslander G, Norback D, Lindgren T (2001) Experimental exposure to propylene glycol mist in aviation emergency training: acute ocular and respiratory effects. Occup Environ Med 58(10):649–655PubMedCentralPubMedCrossRefGoogle Scholar
  33. 33.
    Varughese S, Teschke K, Brauer M, Chow Y, van Netten C, Kennedy SM (2005) Effects of theatrical smokes and fogs on respiratory health in the entertainment industry. Am J Ind Med 47(5):411–418PubMedCrossRefGoogle Scholar
  34. 34.
    Werley MS, McDonald P, Lilly P et al (2011) Non-clinical safety and pharmacokinetic evaluations of propylene glycol aerosol in Sprague-Dawley rats and Beagle dogs. Toxicology 287(1–3):76–90PubMedCrossRefGoogle Scholar
  35. 35.
    Vansickel AR, Cobb CO, Weaver MF, Eissenberg TE (2010) A clinical laboratory model for evaluating the acute effects of electronic “cigarettes”: nicotine delivery profile and cardiovascular and subjective effects. Cancer Epidemiol Biomarkers Prev 19(8):1945–1953PubMedCentralPubMedCrossRefGoogle Scholar
  36. 36.
    Bullen C, McRobbie H, Thornley S, Glover M, Lin R, Laugesen M (2010) Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tob Control 19(2):98–103PubMedCrossRefGoogle Scholar
  37. 37.
    Caponnetto P, Auditore R, Russo C, Cappello GC, Polosa R (2013) Impact of an electronic cigarette on smoking reduction and cessation in schizophrenic smokers: a prospective 12-month pilot study. Int J Environ Res Public Health 10(2):446–461PubMedCentralPubMedCrossRefGoogle Scholar
  38. 38.
    Caponnetto P, Campagna D, Cibella F, Morjaria JB, Caruso M, Russo C, Polosa R (2013) Efficiency and safety of an electronic cigarette (ECLAT) as tobacco cigarettes substitute: A prospective 12-month randomized control design study. Plos One (in press)Google Scholar
  39. 39.
    Caponnetto P, Keller E, Bruno CM, Polosa R (2013) Handling relapse in smoking cessation: strategies and recommendations. Intern Emerg Med 8:7–12Google Scholar

Copyright information

© SIMI 2013

Authors and Affiliations

  • Riccardo Polosa
    • 1
    • 2
  • Jaymin B. Morjaria
    • 3
  • Pasquale Caponnetto
    • 1
    Email author
  • Davide Campagna
    • 1
    • 2
  • Cristina Russo
    • 1
    • 2
  • Angela Alamo
    • 2
  • MariaDomenica Amaradio
    • 2
  • Alfredo Fisichella
    • 2
  1. 1.Centro per la Prevenzione e Cura del Tabagismo (CPCT), Azienda Ospedaliero-Universitaria “Policlinico-V. Emanuele”Università di CataniaCataniaItaly
  2. 2.Institute of Internal Medicine, Azienda Ospedaliero-Universitaria “Policlinico-V. Emanuele”Università di CataniaCataniaItaly
  3. 3.Department of Academic Respiratory Medicine, Hull York Medical School, Castle Hill HospitalUniversity of HullCottinghamUK

Personalised recommendations