Sep 222013
E-Cigarettes Shown Effective as Smoking Cessation Aids

Electronic cigarettes or e-cigarettes use battery power to vaporize a solution, usually containing nicotine dissolved in propylene glycol, glycerin, or polyethylene glycol, creating a puff of "smoke" that dissipates harmlessly. E-cigarettes deliver a hit of nicotine (about 1/4 to 1/2 that of a cigarette puff), but their vapor lacks the 250 known poisons and 69 carcinogens in real cigarette smoke, except in trace amounts not believed to be harmful.

Most smokers want to quit, and they have flocked to electronic cigarettes or e-cigarettes as a way to reduce or stop smoking. E-cigarettes were introduced in 2004, and today people are buying them so fast that some analysts predict e-cigarette sales will surpass real cigarette sales within 10 years.

These numbers could be seen as an emphatic answer to the question, do e-cigarettes work to help people quit smoking? If smokers are buying e-cigarettes en masse, and are using them instead of smoking cigarettes, what other definition of "working" do we need?

Well, some randomized controlled trials would help. To date, there have been none of any meaningful size. In one well-publicized case series, authors enrolled 40 smokers recruited from their own hospital staff, and showed that giving them free e-cigarette cartridges led to voluntary reductions in cigarettes smoked by almost 90%.

Very interesting -- but with 443,000 annual deaths from smoking in the U.S. alone, and billions of dollars at stake on e-cigarettes (both in health care and commerce), I don't know whether to laugh or cry that after 9 years on the market, all the science we have to guide us on e-cigarettes are the experiences of 40 Italian gli operatori sanitari.

Christopher Bullen et al help remedy this sad shortfall with a nicely done randomized trial testing e-cigarettes against nicotine patches and placebo e-cigarettes for smoking cessation. Their results are published in the online September 7, 2013 issue of The Lancet.

What They Did

Authors randomized 657 smokers in New Zealand desiring to quit to receive either e-cigarettes with nicotine, nicotine patches, or placebo e-cigarettes for 12 weeks after starting their quit attempt. Participants were followed for 6 months, at which time their exhaled breath was checked for carbon monoxide to verify smoking cessation. The New Zealand Health Research Council funded the study.

What They Found

During the first month after starting a quit attempt, nicotine-charged e-cigarettes helped smokers stay away from real cigarettes: 23% using nicotine-charged e-cigarettes reported being completely tobacco smoke-free, compared to 16% of those using patches or placebo e-cigarettes.

This advantage steadily declined, though, and at 6 months, those using e-cigarettes reported similar continuous abstinence rates as those using nicotine patches (7% vs 6% for patches, and 4% for placebo e-cigarettes). After excluding protocol violations, e-cigarettes and nicotine patches appeared equal at supporting smoking cessation -- about 9% of smokers using either method stayed quit for 6 months. Only 4-5% of placebo e-cigarette users successfully quit smoking for 6 months. These differences were not statistically significant (because fewer people successfully quit than anticipated, reducing the study's power), but the trends were strongly in favor of nicotine replacement (e-cigarettes or patches) over placebo, and indeterminate for nicotine e-cigarettes over nicotine patches.

As in all smoking cessation trials, most people failed to quit smoking and relapsed within 7 weeks. But e-cigarettes also helped this larger group of backsliders hold out from resuming smoking (median 5 weeks without smoking) compared to those wearing nicotine patches (median 2 weeks), which were hardly better than placebo (median time to relapse 12 days). People using e-cigarettes who relapsed also smoked fewer cigarettes -- 2 fewer daily than those wearing nicotine patches, and many more who reduced their smoking by at least half -- and more people consistently used the e-cigarette (82%) than the patch (46%).

E-cigarettes appeared safe in the short-term; there were no observed adverse events that were attributable to e-cigarettes.

What It Means

E-cigarettes with nicotine appear to be effective smoking cessation aids, and may be as effective or more than nicotine patches at improving smokers' ability to quit cigarettes. In past studies, nicotine patches have tended to double smokers' quit rates at one year from 3-5% by going "cold turkey" to 9% with patches. E-cigarettes with nicotine equaled that efficacy in this well-conducted randomized trial. Although this study turned out to be underpowered, it's safe to conclude that e-cigarettes do help people reduce and quit smoking.

So why are we not handing free e-cigarette cartridges to every smoker on every clinic visit? Why not convert primary care and pulmonary clinics to the equivalent of methadone clinics for nicotine-addicted smokers?

E-cigarettes are virtually unregulated, and have been giving fits to the public health community (governmental and non-governmental) since their launch in 2004. In 2008 the FDA banned importation of e-cigarettes, classifying them as drug-delivery devices and requiring further review before U.S. sales could resume. A federal judge overruled the ban in 2010, saying e-cigarettes are tobacco products, over which the FDA has limited authority (but is seeking more). As e-cigarette use soared, FDA and anti-tobacco organizations began fear-mongering through a non-science-based public relations campaign, trying to create a public perception that e-cigarettes are unsafe.

The FDA posted on its website that e-cigarettes' vapor may contain "carcinogens and toxic chemicals". An article in Chest showed that smoking an e-cigarette  increased airway resistance. Huffington Post and other news outlets dutifully parroted the message that e-cigarettes are harmful.

Are E-cigarettes Safe?

The truth is, there is no good evidence that e-cigarettes are harmful to adults. Propylene glycol, the vaporized inhalant solution in most e-cigarettes, is classified as GRAS (generally recognized as safe) by the FDA: we eat it in cake frosting, and physicians inject it into their patients' veins as the solvent for lorazepam (Ativan). There's currently no reason to believe propylene glycol is harmful when inhaled as a vapor. Anti-tobacco activists know all this, but like to scare people by referring to propylene glycol as "the ingredient in antifreeze" (which it is -- nontoxic antifreeze). Glycerin and polyethylene glycol (the other common solvents in e-cigarettes) are also nontoxic.

Nicotine itself is not harmful to adults in small amounts (that's why it's sold over the counter). And as for the Chest study, increased airway resistance is a well-known, temporary effect of nicotine. There was no basis in the study for postulating long-term lung damage, but the play for headlines carried the story far and wide, reported as "e-cigarettes cause breathing problems."

Most of the controversy surrounding e-cigarettes has centered on the FDA's detection of diethylene glycol in one sample, and carcinogenic nitrosamines in several others. Diethylene glycol appeared to have been an isolated finding not present other products tested by FDA or independent labs, and at any rate has low toxicity when inhaled (it's present in cleaning products).

The "cancer-causing chemicals" were likewise overhyped. Nitrosamines are carcinogenic by-products of extracting nicotine from tobacco, but were described as "below the limit of quantitation" in Table 1 of FDA's report (they didn't include that in their press release). Other labs found carcinogens in e-cigarettes only at trace levels (parts per trillion) -- about the same concentration as in nicotine patches. These are “about one million times lower concentrations than are conceivably related to human health,” according to Dr. Brad Rodu of the University of Louisville in Harm Reduction Journal.

A French consumer magazine claimed recently to have discovered formaldehyde and another carcinogen at higher levels than anyone else has reported before in 3 of 10 e-cigarettes tested; however, they used an apparently unique testing method whose validity remains in question.

Instead of biased press releases from antismoking groups and the FDA, read Medscape's "The Emerging Phenomenon of Electronic Cigarettes" by Pasquale Caponetto et al, for a more objective take on the safety and efficacy of electronic cigarettes.

Why Does the "Anti-Smoking Establishment" Hate E-Cigarettes?

For adult smokers who use them instead of smoking real cigarettes, e-cigarettes are almost certainly health-promoting, relatively speaking. Every puff on an e-cigarette is one less puff on a real cigarette and its incredibly toxic, cancer/cardiovascular/lung disease-causing chemical brew. The idea that a smoker would light a cigarette rather than puff an "unsafe" e-cigarette, thanks to a belief created by public health groups, seems positively Orwellian. With the publication of the Lancet article reviewed here, and the known extreme health risks from smoking, it now seems ethically questionable to suggest that e-cigarettes are unsafe and don't help people reduce and quit smoking.

“It boggles my mind why there is a bias against e-cigarettes among antismoking groups,” Dr. Michael Siegel of Boston University told a reporter in 2011. “E-cigarettes could replace much or most of cigarette consumption in the U.S. in the next decade,” William T. Godshall, executive director of Smokefree Pennsylvania added.

And that may be precisely the problem, from anti-tobacco advocates' tactical point of view. E-cigarettes have thus far been a niche product sold by small companies, but e-cigarettes' $1.7 billion in sales for 2013 has drawn Big Tobacco into the market. The leading U.S. tobacco companies are all launching or buying e-cigarette brands, some of whose sales may surpass certain tobacco cigarette brands within the decade, one analyst predicts.

Anti-tobacco groups worry that if e-cigarettes become a blockbuster product, Big Tobacco's marketing prowess and deep pockets will unravel years of progress in creating smoke-free public spaces and building a social stigma around smoking. More reason to fret: e-cigarettes are often sold with kid-friendly flavorings like bubblegum, and surveys show that 10% of high-school students reported trying e-cigarettes in 2012, double the 2011 rate. E-cigarette use doubled among middle-school kids as well, from 1.3% to 2.4%. There's no proof yet that e-cigarettes are a "gateway" product for kids leading to lifelong smoking as adults, but there's cause for concern (remember Joe Camel?)

E-Cigarettes Are Here To Stay. Now What?

Because e-cigarettes are likely a safe option for adult smokers, they replace an existing legal product, and they probably can help smokers cut back and quit, there is no reason to believe e-cigarettes will be banned. The FDA is expected to announce its proposal for regulation of e-cigarettes in October, which will be unlikely to take effect for at least a year, observers believe. Rational rules from the FDA governing e-cigarette ingredients, advertising, flavorings and online sales could reduce lingering concerns about safety and access to e-cigarettes by minors. At that point, perhaps the campaign of official disinformation can give way to a constructive dialogue in the public health and medical care communities on how best to conduct future research, and on how we should recommend responsible use of e-cigarettes as a legitimate smoking cessation aid to the millions of people desperate to quit smoking. Their health suffers every day we don't.

Christopher Bullen et al. Electronic cigarettes for smoking cessation: a randomised controlled trial. The Lancet, Early Online Publication, 9 September 2013.

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E-cigarettes prove effective for smoking cessation