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E-cigarettes: an evidence update <br /> <br />47 <br />O’Brien et al., 2015 [42] conducted a secondary analysis of the RCT data from Bullen et <br />al., 2013 [43] to examine the effectiveness of EC with and without nicotine compared to <br />the nicotine patch among individuals with mental illness (MI). They identified 86 <br />participants among the original 657 participants (all motivated to quit) using secondary <br />data from the trial on reported use of any medications associated with MI. Overall, when <br />compared to participants without MI, there were no significant differences for those with <br />MI on the primary outcomes of smoking reduction and smoking cessation. One <br />exception was that the six-month quit rate was higher among participants with MI in the <br />patch condition compared to those without MI. Although not a primary outcome, there <br />was evidence of a greater rate of relapse among participants with MI. In the analysis <br />that only included participants with MI, there were no significant differences in quit rates <br />across the three conditions, however participants allocated to 16mg EC showed greater <br />smoking reduction than those allocated to patch. The authors concluded that EC <br />appear to be equally effective for smoking cessation among individuals with and <br />without MI, building on other promising research involving EC and people with MI. <br /> <br />Adriaens et al., 2014 [41] conducted an eight-week RCT in Belgium with control where <br />they randomised 48 smokers who did not want to quit to one of two conditions: (1) <br />use of tank model EC, and training on how to use, with no encouragement to quit, and <br />(2) no use of EC. Both groups attended similar periodic lab sessions over an eight -week <br />period where measurements of craving, withdrawal, saliva cotinine, and expired-air CO <br />levels were taken. Adriaens found that after eight weeks of use 34% of those given EC <br />had quit smoking compared to 0% of those not given EC, the EC group also showed <br />substantially greater cigarette reduction. After eight weeks, the group which did not <br />receive EC at baseline was given EC, but no training on how to use the products. At the <br />final eight-month follow-up, 19% of the original EC group and 25% of the control group <br />(given EC at week eight) had quit smoking. Significant reductions in cigarette <br />consumption were also found. <br /> <br />Population studies <br />One problem with RCTs is that because of the time taken to set up and implement trials, <br />the EC used in the trials are often no longer available for sale by the time the research <br />is published. This is problematic because many new EC enter onto the market and it is <br />possible they may be more effective at delivering nicotine than the products used in the <br />trial, and possibly more effective for smoking cessation. Additionally, the controlled <br />environment of RCTs is unable to provide evidence of the effectiveness of EC in the <br />real world where use is much more subject to external forces, such as availability, price <br />and social norms around use. RCTs also reveal little about the attractiveness of the <br />products and thus likely uptake of the products used and what happens after a <br />successful or failed attempt to stop smoking with an EC in the long-term. <br />