Claudio Lucchiari1, Marianna Masiero2, Ketti Mazzocco3, Giulia Veronesi4, Patrick Maisonneuve5, Costantino Jemos6, Emanuela Omodeo Salè6, Stefania Spina4, Raffaella Bertolotti7, Gabriella Pravettoni3. 1. Department of Philosophy, University of Milan, Milan, Italy. 2. Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy; Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, IRCCS, Milan 20141, Italy. Electronic address: Marianna.masiero@unimi.it. 3. Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, IRCCS, Milan 20141, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy. 4. Humanitas Research Hospital, Division of Thoracic and General Surgery, Milan, Italy. 5. Division of Epidemiology and Biostatistics, European Institute of Oncology, IRCCS, Milan 20141, Italy. 6. Division of Pharmacy, European Institute of Oncology, IRCCS, Milan 20141, Italy. 7. Division of Thoracic Surgery, European Institute of Oncology, IRCCS, Milan 20141, Italy.
Abstract
INTRODUCTION:Electronic cigarettes (e-cigarettes) might be a valid and safe device to support smoking cessation. However, the available evidence is divergent. The aim of the present work was to assess the effects of an e-cigarette program on pulmonary health (cough, breath shortness, catarrh) and to evaluate the effectiveness of e-cigarettes in reducing tobacco consumption. METHODS: The study is a double-blind randomized controlled trial. Two hundred and ten smokers were randomized into three groups: nicotine e-cigarette (8 mg/mL nicotine concentration), nicotine-free e-cigarettes (placebo), and control with 1:1:1 ratio. All participants received a 3 months cessation program that included a cognitive-behavioral intervention aimed at supporting people in changing their behavior and improving motivation to quit. RESULTS:Pulmonary health, assessed with self-reported measures, clinical evaluations and the Leicester Cough Questionnaire, improved in participants who stopped smoking compared to their own baseline. No differences in pulmonary health were found between groups. Statistical tests showed a significant effect of Group (F (2, 118) = 4.005, p < .020) on daily cigarette consumption: after 6 months participants in the nicotine e-cigarette group smoked fewer cigarettes than any other group. Moreover, participants in this group showed the lowest level of exhaled carbon monoxide (CO) (M = 12.012, S.D. = 8.130), and the lowest level of dependence (M = 3.12, S.D. = 2.29) compared to the nicotine-free e-cigarette and control conditions. CONCLUSIONS: After 6 months about 20% of the entire sample stopped smoking. Participants who used e-cigarettes with nicotine smoked fewer tobacco cigarettes than any other group after 6 months (p < .020). Our data add to the efficacy and safety of e-cigarettes in helping smokers reducing tobacco consumption and improving pulmonary health status.
RCT Entities:
INTRODUCTION: Electronic cigarettes (e-cigarettes) might be a valid and safe device to support smoking cessation. However, the available evidence is divergent. The aim of the present work was to assess the effects of an e-cigarette program on pulmonary health (cough, breath shortness, catarrh) and to evaluate the effectiveness of e-cigarettes in reducing tobacco consumption. METHODS: The study is a double-blind randomized controlled trial. Two hundred and ten smokers were randomized into three groups: nicotine e-cigarette (8 mg/mL nicotine concentration), nicotine-free e-cigarettes (placebo), and control with 1:1:1 ratio. All participants received a 3 months cessation program that included a cognitive-behavioral intervention aimed at supporting people in changing their behavior and improving motivation to quit. RESULTS: Pulmonary health, assessed with self-reported measures, clinical evaluations and the Leicester Cough Questionnaire, improved in participants who stopped smoking compared to their own baseline. No differences in pulmonary health were found between groups. Statistical tests showed a significant effect of Group (F (2, 118) = 4.005, p < .020) on daily cigarette consumption: after 6 months participants in the nicotine e-cigarette group smoked fewer cigarettes than any other group. Moreover, participants in this group showed the lowest level of exhaled carbon monoxide (CO) (M = 12.012, S.D. = 8.130), and the lowest level of dependence (M = 3.12, S.D. = 2.29) compared to the nicotine-free e-cigarette and control conditions. CONCLUSIONS: After 6 months about 20% of the entire sample stopped smoking. Participants who used e-cigarettes with nicotine smoked fewer tobacco cigarettes than any other group after 6 months (p < .020). Our data add to the efficacy and safety of e-cigarettes in helping smokers reducing tobacco consumption and improving pulmonary health status.
Authors: Jonathan Foulds; Caroline O Cobb; Miao-Shan Yen; Susan Veldheer; Phoebe Brosnan; Jessica Yingst; Shari Hrabovsky; Alexa A Lopez; Sophia I Allen; Christopher Bullen; Xi Wang; Chris Sciamanna; Erin Hammett; Breianna L Hummer; Courtney Lester; John P Richie; Nadia Chowdhury; Jacob T Graham; Le Kang; Shumei Sun; Thomas Eissenberg Journal: Nicotine Tob Res Date: 2022-06-15 Impact factor: 5.825
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