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Effect of Electronic Cigarettes on Smoking Reduction and Cessation in Korean Male Smokers: a Randomized Controlled Study

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Effect of Electronic Cigarettes on Smoking Reduction and Cessation in Korean Male Smokers: a Randomized Controlled Study J Am Board Fam Med: first published as 10.3122/jabfm.2019.04.180384 on 12 July 2019. Downloaded from ORIGINAL RESEARCH Effect of Electronic Cigarettes on Smoking Reduction and Cessation in Korean Male Smokers: A Randomized Controlled Study Seung-Hwa Lee, MD, Sang-Hyun Ahn, and Yoo-Seock Cheong, MD, PhD Introduction: New approaches to electronic cigarettes (e-cigarettes) as a form of nicotine replacement therapy (NRT) may reduce the rates of tobacco-related disease and mortality. Therefore, we investigated the effect of e-cigarettes on smoking cessation compared with nicotine gum. Methods: A total of 150 subjects were randomly assigned to 2 groups and each was allocated a 12- week supply of either e-cigarettes or nicotine gum. The continuous abstinence rate, 7-day point preva- lence of abstinence, smoking reduction rate and amount, and tolerability were evaluated. Results: There were no statistically significant differences in the effectiveness-related parameters of smoking cessation, such as 9- to 12-week, 9- to 24-week, and 12- and 24-week point prevalence of ab- stinence, between the 2 groups. However, although the reduction in cigarette smoking was similar, the proportion of subjects who showed smoking reduction at 24 weeks was higher in the e-cigarette group than the nicotine gum group. In addition, adverse events were significantly less frequent in the e-ciga- rette group than in the nicotine gum group. Conclusions: In our study, the effect of e-cigarettes on smoking cessation was similar compared with that of nicotine gum, a well-documented NRT. In addition, e-cigarettes were well tolerated by the study population. Therefore, the use of e-cigarettes as an NRT may be considered for smoking-cessation pur- copyright. poses. A large-scale prospective randomized controlled trial is necessary to clarify our results. (J Am Board Fam Med 2019;32:567–574.) Keywords: Cigarette Smoking, Electronic Nicotine Delivery Systems, Korea, Nicotine Chewing Gum, Smoking Cessation, Smoking Reduction, Tobacco Products The electronic cigarette (e-cigarette) is a battery- combustible cigarette. In its third report on the http://www.jabfm.org/ powered device that delivers nicotine in a warm scientific basis of tobacco-product regulation, the vapor.1,2 It seems and feels similar to a traditional World Health Organization (WHO) defined e-cig- arettes as electronic nicotine delivery systems.3,4 E-cigarette companies advertise their products as This article was externally peer reviewed. being effective for smoking cessation or reduction Submitted 24 December 2018; revised 28 March 2019; and ecologically friendly.5 A recent article found accepted 1 April 2019. on 25 September 2021 by guest. Protected From Department of Family Medicine, Seohae Hospital, that although the long-term effects of e-cigarette Seocheon, Republic of Korea (S-HL); Department of Fam- use are not known, these devices are probably safer ily Practice and Community Health, Smoking Cessation 6 Center, Ajou University School of Medicine, Suwon, Re- than combustible tobacco products. Indeed, most public of Korea (S-HL); Department of Family Medicine, people who purchase e-cigarettes report doing so as Seoul National University Hospital, Seoul, Republic of Korea (S-HA); Department of Family Medicine, Smoking part of an attempt to quit smoking altogether or to Cessation Center, Dankook University College of Medicine, reduce their combustible cigarette consumption.3,5 Cheonan, Republic of Korea (Y-SC). Funding: none. Thus, e-cigarettes may be considered to be lower Conflict of interest: none declared. risk substitutes for traditional cigarettes.7 More- Corresponding author: Yoo-Seock Cheong, MD, PhD, De- partment of Family Medicine, Smoking Cessation Center, over, new approaches to e-cigarettes as a nicotine Dankook University College of Medicine, 201 Manghyang- replacement therapy (NRT) and as fast-acting nic- ro, Dongnam-gu, Cheonan, Chungcheongnam-do, 31116 Republic of Korea ͑E-mail: [email protected]). otine inhalation devices may help to reduce the *S-H Lee and S-HA contributed equally to this work. burden of tobacco-related disease and mortality in doi: 10.3122/jabfm.2019.04.180384 Electronic Cigarettes and Smoking Reduction 567 J Am Board Fam Med: first published as 10.3122/jabfm.2019.04.180384 on 12 July 2019. Downloaded from current smokers. However, the efficacy of the e- allocation. The protocol and study design are pre- cigarette as an aid in smoking cessation or reduc- sented in Figure 1. tion is still controversial. Few studies have focused on the relationship between e-cigarette use and smoking cessation.8–12 Therefore, the purpose of Ethics Statement this study was to evaluate the effectiveness of e-cig- This study was conducted in accordance with the arettes in smoking cessation compared with that of Declaration of Helsinki,13 and is consistent with nicotine gum, a well-documented NRT. the guidelines of Good Clinical Practice.14 The study was approved by the Institutional Review Board of Dankook University Hospital (approval Methods no. 1101–008). In addition, the study was regis- Study Population tered with the Clinical Research Information Ser- This study was a single-center, prospective, open- vice, number KCT0001277, the Korean national label, randomized controlled, clinical pilot trial. clinical trial registry in the WHO International From January to September 2012, 218 Korean Clinical Trials Registry Platform. Written in- male adults over 18 years of age were recruited formed consent was obtained from all subjects be- from a motor company in Cheonan, Republic of fore enrollment in the study. Korea. Because most employees of this company were male, we recruited only male employees in the study. Eligible subjects had smoked at least 10 cig- arettes per day during the preceding year, had Interventions smoked for at least 3 years, and were motivated to Fifty-minute education sessions on smoking cessa- stop smoking entirely or to reduce their cigarette tion and the use of smoking-cessation aids were consumption. Among the initial 218 subjects, 68 conducted in the medical office where the e-ciga- were excluded for the following reasons: (1) de- rette and nicotine gum were distributed. At enroll- copyright. clined to participate (n ϭ 26); (2) had a past medical ment, we collected subject information, which in- history of serious clinical diseases (n ϭ 38) such as cluded age, sex, education, marriage status, alcohol malignancy, cardiovascular disease, cerebrovascular consumption (Ն70 g/week or Ն10 g/day), exercise disease, pulmonary disease, and significant hepatic (at least once per week on a regular basis), and or renal impairment; and (3) had attempted to stop detailed data regarding cigarette smoking habits smoking in the past 12 months by using other (cumulative smoking amount, cigarettes smoked NRTs (n ϭ 4). Finally, 150 participants were in- per day, duration of smoking, confidence in the http://www.jabfm.org/ cluded in the study. ability to quit smoking, Fagerstro¨m test for nico- tine dependence, and prior attempts to quit). After completion of a basic questionnaire, follow-up Study Design questionnaires were administered at weeks 12 and The 150 enrolled subjects were randomly assigned 24. The subjects were instructed to visit the med- to 2 groups according to a computer-generated ical office every 4 weeks for evaluation and coun- randomization sequence with a block size of 2. The on 25 September 2021 by guest. Protected seling by an independent health practitioner. The e-cigarette (EC) group (n ϭ 75) and the nicotine gum (NG) group (n ϭ 75) received e-cigarettes or end-expiratory carbon monoxide (Micro-4 smoker- nicotine gum, respectively. A total of 132 subjects lyzer; Bedfont Scientific Ltd., NJ) and urine coti- received treatment and completed the study; 4 and nine (AccuSign nicotine; Princeton Biomeditceh 14 subjects originally assigned to the EC and NG Co., Princeton, NJ) levels were measured at base- groups, respectively, withdrew before treatment. line, and at the final visit (24-week). We used an Those 18 subjects who did not receive treatment e-cigarette (eGO-C Ovale, nicotine 0.01 mg/mL; were included in the analyses on an intention-to- Janty-Korea Co., Janty-Asia Co., Seoul, Republic treat basis. The enrollment and assignment of all of Korea) and nicotine gum (Nicoman, nicotine 2 subjects were performed by a clinical research co- mg/tablet; Daewoong Pharmaceuticals, Seongnam, ordinator not involved in the study. All investiga- Republic of Korea) (Figure 2), both of which were tors involved in the study were blinded to group distributed in 12-week supplies. 568 JABFM July–August 2019 Vol. 32 No. 4 http://www.jabfm.org J Am Board Fam Med: first published as 10.3122/jabfm.2019.04.180384 on 12 July 2019. Downloaded from Figure 1. Consolidated Standards of Reporting Trials flow chart detailing conduct of the study. MHx., medical history; ds., disease; NRT, nicotine replacement therapy; NG, nicotine gum; EC, e-cigarette. copyright. http://www.jabfm.org/ Efficacy Outcomes rette, and analysis of adverse events (AEs) for tol- Primary End Points erability assessment. on 25 September 2021 by guest. Protected In our study, the primary outcomes were 9- to 12-week and 9- to 24-week continuous abstinence Statistical Analysis rates (CARs). They were verified not only by self- All continuous variables were expressed as means Ϯ reported questionnaires but also by means of urine standard deviations and categorical variables as cotinine (negative) and end-expiratory carbon numbers and percentages. Differences in continu- monoxide (Ͻ10 ppm) measurements. ous variables between the EC and NG groups were analyzed using the independent t test, and categor- Secondary End Points ical variables were analyzed using the ␹2 test or The secondary outcomes were the 7-day point Fisher-Freeman-Halton extension of Fisher’s pro- prevalence (PP) of abstinence at weeks 12 and 24, bability test, as appropriate. We conducted multi- an evaluation of the decrease in smoking as an variable logistic regression analyses controlling for estimation of the harm-reduction effect of e-ciga- possible confounders in both groups.
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