Abstract
BackgroundWhile electronic cigarettes are forbidden in several countries, their sales are exploding in many others. Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation, very scarce data are available on their efficacy and safety.We describe the protocol of a 5-year multicentric prospective study aimed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking. The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking.Methods/designFrom June to December 2013, we will enroll adult smokers of: (EC) e-cigarettes (self-reported inhaling ≥ 50 puffs per week since ≥ 6 months); (TC) traditional cigarettes (≥ 1 per day since ≥ 6 m); (Mixed) both electronic and traditional cigarettes (≥1 per day since ≥ 6 m). Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops. Each subject will have to compile a structured questionnaire at enrolment and after 6, 12, 24, 36 and 60 months. The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase, using portable carbon monoxide analyzers. The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes. Secondary outcomes include adherence to e-cigarettes, self-reported adverse events, quality of life, and time to hospital admission for one among cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Admissions will be checked using official discharge data of the Abruzzo Region. A minimum of 500 subjects in each group will be enrolled, for a total of 1500 participants. Cox proportional hazards analysis will be used to calculate adjusted relative hazards of smoking cessation by each variable.DiscussionData on long-term efficacy and safety of e-cigarettes will be of utmost importance to form the basis for guidelines and regulatory decisions on e-cigarettes.Trial registrationThe protocol has been registered (NCT01785537) and approved by the Ethics Committee of the University of Chieti (Record n. 6; 25-03-2013).
Highlights
While electronic cigarettes are forbidden in several countries, their sales are exploding in many others
Data on long-term efficacy and safety of e-cigarettes will be of utmost importance to form the basis for guidelines and regulatory decisions on e-cigarettes
The product has been proposed as a longterm substitute for traditional smoking or as a tool for smoking cessation [10,11], some authorities are opposing the recreational use of nicotine because there are concerns about both safety and efficacy, and about the potential risk of e-cigarettes to play as a promoter of smoking for never or ex-smokers [10,12,13,14]
Summary
While electronic cigarettes are forbidden in several countries, their sales are exploding in many others. E-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation, very scarce data are available on their efficacy and safety. The product has been proposed as a longterm substitute for traditional smoking or as a tool for smoking cessation [10,11], some authorities are opposing the recreational use of nicotine because there are concerns about both safety and efficacy, and about the potential risk of e-cigarettes to play as a promoter of smoking for never or ex-smokers [10,12,13,14]. The sale of e-cigarettes market is subject to limitations in many countries (i.e. USA and Germany) and is forbidden in several others (i.e. China, Brazil) [14]. No data are available on long-term efficacy and safety and, most importantly, no ongoing study has been designed to collect data on hard outcomes (smoking-related cancer, major cardiovascular events and chronic obstructive pulmonary disease – COPD) over a long follow-up period [11,24]
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