E-Cigarettes = Nicotine Patches for Smoking Cessation, Clinical Trial Shows

Newly published research shows that e-cigarettes are about as effective as nicotine patches in helping smokers quit. That should (but won’t) silence critics who insist that e-cigarettes are unproven and that medicinal nicotine products are the only scientifically valid cessation aids.

At New Zealand’s University of Auckland, Dr. Christopher Bullen and colleagues compared quit rates among 657 smokers treated for 12 weeks with nicotine e-cigarettes, nicotine-free e-cigarettes, or 21-mg. nicotine patches.  Their randomized study was published in the Lancet (abstract here).   

Bullen and colleagues reported continuous abstinence from smoking at 1, 3 and 6 months after the participants’ quit day.  Here is a summary of the main results:

Continuous Smoking Abstinence (%) Among Smokers Treated With Nicotine E-cigarettes, Nicotine-Free E-cigarettes and Nicotine Patches
Follow-Up (months)	Nicotine E-cigarettes	Nicotine-free E-cigarettes	Nicotine Patches
1	23	16	16
3	13	6.8	9.2
6	7.3	4.1	5.8

There were no significant differences between any of the treatments in any time period.  In other words, e-cigarettes were just as effective as nicotine patches in helping smokers quit – keeping in mind that “effective” here is only a roughly seven percent quit rate (here).  At one-year follow-up, the gold standard for cessation trials, the results would be even worse. 

This new study adds to a growing body of evidence supporting the effectiveness of e-cigarettes (here, here, and here).

A seven-percent solution is not very impressive, but if the real objective is to improve the health of smokers, the products might not be the problem.  Rather, fault may lie with the clinical trial model, in which smoking is the “illness,” 12 weeks of NRT or e-cigarettes or snus is the “therapy,” and nicotine/tobacco abstinence is the only targeted “outcome.”  Most people consider smoking a lifestyle choice, not an illness; they aren’t seeking treatment, and they are unwilling or unable to abstain.  The biggest challenge, therefore, isn’t to offer more quitting options, it is to alter the design of clinical trials to accommodate smokers’ preferences and incorporate the principles of tobacco harm reduction.  Changing the targeted outcome from nicotine/tobacco abstinence to smoking abstinence would permit ex-smokers to use alternative products at satisfying doses, indefinitely if they choose.   

Blocking the path to accomplishing this smoke-free objective is the bizarre demand by tobacco-prohibitionists that companies seeking FDA approval for harm reduction products must first prove that they will not cause population-level effects (discussed here).  Peter Hajek addressed this challenge in a Lancet commentary accompanying the Bullen study: “There is an obvious source of evidence as to whether use of e-cigarettes leads to an increase or reduction in tobacco smoking: the trajectories of sales of e-cigarettes and tobacco cigarettes.  If growing sales of e-cigarettes coincide with increased sales of tobacco cigarettes, tobacco control activists arguing for restriction of e-cigarette availability would be vindicated.  If traditional cigarette sales decline as e-cigarette sales increase, it would suggest that e-cigarettes are normalising non-smoking and that it is in the interest of public health to promote and support their development rather than try to restrict it.”

Hajek makes a legitimate case for using market data as the primary indicator of e-cigarettes’ public health impact.  An accelerating decline in cigarette consumption will confirm the positive public health impact of an e-cigarette revolution.