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New trial of electronic cigarettes for smoking cessation
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Jonathan Foulds, PhD posted:
The first reasonably sized randomized trial of electronic cigarettes for smoking cessation was just published online in the Lancet medical journal. The study was conducted by Dr Christopher Bullen and colleagues at the University of Aukland, New Zealand. The study randomly allocated 289 smokers to use an electronic cigarette containing around 13 mg/ml nicotine (presumably in propylene glycol solution?), 73 to receive electronic cigarettes containing a solution with no nicotine, and 295 received nicotine patches. All participants were provided with their product for 13 weeks, and were referred to a telephone quitline to provide telephone counseling support for smoking cessation, and attempts were made to contact all participants on the target quit date and 1, 3 and 6 months later. So essentially this was a randomized trial comparing the smoking cessation effects of 13 weeks of nicotine e-cig, 13 weeks of placebo e-cig and 13 weeks of the nicotine patch.
The main outcome being assessed in this trial was continuous self-reported cigarette abstinence from the first through to the sixth month, biochemically verified by a low exhaled carbon-monoxide measurement at 6 months follow-up. Only 7.3% (21/289) of those using the nicotine ecig achieved this, as did 5.8% of those using the nicotine patch (17/295) and 4.1% (3/73) of those allocated to the placebo e-cig. These small differences were not statistically significant. Given that the participants were only provided with treatment product for the first 13 weeks one might look to the 3-month follow-up point for a better chance of finding a differential effect, but there were no statistically significant differences at 3 months either. The only significant difference in continuous abstinence was found at the one month follow-up at which point 23.2% of those using nicotine e-cigs were abstinent, compared with 15.9% of those using the nicotine patches were abstinent (p=0.03). The nicotine e-cig group also had a significantly longer "time to relapse" (mean = 35 days) as compared with placebo e-cigs (12 days) and nicotine patches (14 days), and reduced their cigarette consumption by 2 cigarettes per day more than the patch group.
Overall these results, although broadly similar to those of the nicotine patch, are rather disappointing. One reason for doubting any real e-cig advantage over the nicotine patch is that there were signs that many volunteers for this study did so in the hope of receiving the electronic cigarette and very quickly did not comply with patch treatment. For example, 43/295 (15%) of the nicotine patch group dropped out prior to the quit date, compared with only 16/289 (6%) of those allocated nicotine e-cigs and 7/73 (10%) of those allocated placebo e-cigs. This "disappointment effect" may have contributed to the few early significant effects in favor of the nicotine e-cigs. This "disappointment effect" may partially explain the poor performance of the nicotine patch, but what about the poor performance of the nicotine e-cig? The most likely answer to that question is contained in the description of the nicotine delivery of the nicotine e-cig. A preliminary study of the blood nicotine concentration achieved by four experienced users, found a median increase in blood nicotine concentration 10 minutes after using the e-cig of 2.1 ng/ml. The average increase in blood nicotine from smoking a cigarette is typically 10-15 ng/ml, but smokers can easily obtain a boost of over 20 ng/ml if they desire. So it appears clear that the e-cigs used in this trial delivered a tiny amount of nicotine to the users. It is therefore not surprising that it was no more effective than the placebo e-cig in helping smokers quit, as the nicotine e-cig in this trial was little more than a placebo.
So why are e-cigs so popular? Interestingly in this trial, at the one month follow-up, 88% of those using the nicotine e-cig, 92% of those using the placebo e-cig and 56% of those using the nicotine patch, said they would recommend that product to a friend wanting to quit. It seems that people trying to quit smoking like the similarity between the behavioral and sensory aspects of e-cig use and smoking, and perceive it to be more helpful than the patch, regardless of the nicotine delivery. However, the reality was that despite that early preference, the e-cigs, all of which delivered small or no meaningful amounts of nicotine, did not provide an advantage for smoking cessation.
The authors of this research paper acknowledged that the e-cig used in this trial was "first generation" and that its nicotine delivery was likely inadequate. There is evidence to suggest that the vast majority of electronic cigarettes that consumers purchase from convenience stores and gas stations are similar to the ones used in this trial, and deliver an inadequate dose to help people quit smoking. However, more sophisticated second and third generation electronic cigarettes have been on the market for some time, and there is preliminary evidence that these products, with improved batteries, buttons to activate the heating of the coil pre-puff, and ability to control voltage and wattage, may provide improved nicotine delivery. Until we have more scientific research on electronic cigarettes I would recommend that those considering using them should go to a website frequented by experienced e-cig users to learn more about the options ( www.ecigarette-forum.com ), rather than just purchasing the cheapest e-cig from their local convenience store.

Reference:
Bullen C et al. Electronic cigarettes for smoking cessation: a randomized controlled trial. Lancet Early online oublication September 9, 2013.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61842-5/abstract

Reply
 
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Jonathan Foulds, PhD responded:
One of the links I provided had an error, it should be:
http://www.e-cigarette-forum.com/
 
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margyb replied to Jonathan Foulds, PhD's response:
Jon
You have
"electronic cigarette containing around 13 mg/ml nicotine"
I believe the study stated this was 16mg/ml
Regards
Margy
 
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Jonathan Foulds, PhD replied to margyb's response:
Margyb,
The cartridges were labelled as containing 16 mg/ml but when analyzed they were found to contain 10-16 mg/ml, so I stated the middle value. Jonathan
 
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rberezewski replied to Jonathan Foulds, PhD's response:
they are safer. Nicotine is not what makes tobacco dangerous. I read it on this review .


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