World’s First Ever E-Cigarette Clinical Trial Shows Dramatic Quit Rates in Smokers with No Interest in Quitting
Ever since the debate regarding the effectiveness of electronic cigarettes as smoking cessation aids began opponents have constantly argued that small scale studies and surveys don’t offer enough proof and that a clinical trial is necessary to settle the issue. Thanks to an Italian study published at the end of last month, we now have clinical evidence that e-cigarettes can actually help people quit smoking.
The study, entitled “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 a period of 12 months. Participants were given electronic cigarettes and cartridges of e-liquid with three different levels nicotine content. By the end of the year, 13% of test subjects who had been administered cartridges with the highest nicotine content had quit smoking entirely. It may not seem like a very high percentage, but keep in mind these were all people who did not intend to quit smoking when the test began. In comparison, conventional Nicotine Replacement Therapy (patches, nicotine gum, etc.) has a 12-month smoking cessation rate of approximately 12%, and that’s in smokers with a desire to quit cigarettes. This suggests e-cigarettes could actually be more effective than traditional NRT.
Participants in the ECLAT study were provided with free e-cigarette starter kits containing two rechargeable batteries, a charger, and two atomizers and instructed on how to charge, activate and correctly use the e-cigarette. They were allowed to use the device ad libitum up to a maximum of 4 cartridges per day, as recommended by the manufacturer and were randomly divided into three groups, each with different levels of nicotine e-liquid:
A: Electronic cigarettes with 7.2 mg nicotine cartridges for 12 weeks;
B: Electronic cigarettes with 7.2 mg nicotine cartridges for 6 weeks, then 5.4 mg nicotine cartridges for 6 weeks;
C: Electronic cigarettes with 0 mg nicotine cartridges;
The smokers were invited to the researchers’ clinic in Catania Italy every two weeks for the first twelve weeks, with two additional visits at week 24 and week 52. They stocked up on new cartridges and were asked to report on their experiences, including daily use of tobacco cigarettes, withdrawal symptoms and side-effects. At the end of the trial period, 13% of the smokers in group A had completely given up smoking, and the cessation rate for all three groups combined was 7.8%. Compare that with the one-year quit rate among smokers who do want to quit, which is about 3%, and you can understand why 13%, and even 7.8% are really impressive numbers. Interestingly enough, 70% of those who quit smoking during this study also quit electronic cigarettes as well
In addition to showing the effectiveness of e-cigarettes as smoking cessation aids, the ECLAT study also reported improved respiratory function in participants, with shortness of breath reduced from 20% to 4% by week two. By my knowledge, this is the first ever study to offer solid scientific proof the using e-cigarettes can improve smokers’ health. But, as the study concludes “although these data are promising, they are not definitive and more research about long term safety of these products is still required.”
As was expected, the miraculous results of the ECLAT study didn’t sit too well with opponents of electronic cigarettes. Stan Glanz, a well-known prohibitionist was quick to discredit the research by offering two main arguments:
1. “There is not a control group of people who were not using e-cigarettes that would allow assessment of spontaneous quit rates. By not having a true control group that would account for spontaneous quitting without using e-cigarettes one cannot say anything about whether e-cigarettes affected quitting.”
2. “The problem is that the authors failed to include the required Yates correction in their calculation of the chi-square test statistic and associated p value. Recalculating the test properly yields p = 0.07, which is no longer statistically significant. Thus, the correct conclusion is that there is no statistically significant difference between the nicotine and non-nicotine e-cigarettes.”
It’s true the study did not have a control group of people with no desire to quit smoking who didn’t receive electronic cigarettes, to see if the devices actually affected the quitting rate, but as Dr. Michael Siegel of Tobacco Analysis notes, we can use the one-year quit rate among smokers who do want to quit (and try to quit), which is about 3%. Obviously, the percentage among smokers with no desire to quit is much lower. The ECLAT paper itself offers population-based data showing that in Italy, the spontaneous quit rate during the study period was 0.02%.
About the Yates correction, a method to correct for continuity in chi-squared statistics, not being used the fact is it wasn’t required because the study didn’t include a placebo. The electronic cigarettes with 0% nicotine were not a placebo because research shows that even e-cigarettes with no nicotine content can reduce the craving to smoke. The ECLAT study itself stands as proof, as 14% of the smokers in group C either quit or cut down by more than half.