CATANIA, ITALY — The results from the first-ever clinical electronic cigarette trial further suggest the product’s potential to improve public health. Published last week in the PLoS One journal, the “Efficiency and Safety of an Electronic Cigarette (ECLAT) as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study” followed 300 smokers with no intention of quitting over 12 months, finding a high rate of both cessation and an improvement in negative respiratory symptoms associated with tobacco consumption.
"Electronic cigarettes are becoming increasingly popular with smokers worldwide," the study said. "Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms and to continue having a ‘smoking’ experience, but with reduced health risks. Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators, healthcare providers and consumers are based on science."
Trial participants were broken up into three groups and consumed either: electronic cigarettes with 7.2 mg nicotine cartridges for 12 weeks, electronic cigarettes with 7.2 mg nicotine cartridges for six weeks followed by electronic cigarettes with 5.4 mg nicotine cartridges for six weeks, or electronic cigarettes with 0 mg nicotine cartridges. The study consisted of nine visits throughout the 12-month period, during which participants reported the amount of cigarettes they were consuming on a daily basis and had their exhaled carbon monoxide levels measured to verify the rate of cigarette reduction.
After 12 weeks, 22.3% of all participants reported that they were smoking fewer cigarettes, with 10.7% reporting that they had stopped smoking tobacco cigarettes altogether; at the end of the 12 month study, 10.3% said they were continuing to reduce the amount they smoked, with an 8.7% total cessation rate. Not surprisingly, the group who received the highest level of nicotine cartridges had the highest cessation rate at the end of the trial, at 13%.
During the year-long trial, researchers also kept track of common “adverse events”—or side effects—associated with cigarette use, including cough, dry mouth, throat irritation, shortness of breath and headaches. The study found that while the amount of nicotine participants consumed through electronic cigarettes did not have an effect on the frequency of these symptoms, all participants reported fewer symptoms than the baseline that was established at the beginning of the trial. The authors noted that “of all symptoms that progressively decreased throughout the study with the use of e-cigarettes, shortness of breath was substantially reduced from 20 to 4% already by week two.”
"The results of this study demonstrate that e-cigarettes hold promise in serving as a means for reducing the number of cigarettes smoked, and can lead to enduring tobacco abstinence," the study concludes. "In view of the fact that subjects in this study had no immediate intention of quitting, the reported overall abstinence rate of 8.7% at 52-week was remarkable. … Moreover, these positive results were obtained together with an important reduction in frequency of reported symptoms. Although, these data are promising, they are not definitive and more research about long term safety of these products is still required."