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A five-year, first-in-Canada study, led by McGill cardiologist Dr. Mark Eisenberg, is exploring whether vaping really is the magic ticket to finally breathing free and easy.
By James Martin
Although the holidays may seem like a distant memory, statistically speaking, most of us are still sticking with our New Year’s resolutions. (For now. Let’s not talk about how many of us last until July.) For many, that means quitting smoking — and they’re hoping that electronic cigarettes will help. According to the U.S. Centers for Disease Control and Prevention, nearly half of all American smokers have tried e-cigarettes to help them kick the habit. But Dr. Mark Eisenberg wants to know: Is vaping really the magic ticket to breathing free and easy?
Dr. Eisenberg is passionate about getting people to butt out. He gives a lot of smoking cessation talks — just last month, he spoke at the Jewish General Hospital, where he is staff cardiologist — and has noticed that, invariably, reformed smokers come up to him afterward to sing the praises of e-cigarettes, those increasingly popular handheld battery-operated vaporizers that mimic conventional cigarettes.
“They say, ‘I smoked for decades and I’ve tried everything — nicotine gum, patches, Zyban, Champix — and I couldn’t stop. Then I picked up an e-cigarette and I never smoked again,’” recalls Eisenberg, who is also a professor in McGill’s Faculty of Medicine and director of the Joint MD/PhD program. “Anecdotally, we have many, many cases like this.”
What doctors don’t have, however, is hard data to back it up. That’s why, this month Eisenberg will start a five-year clinical trial to look at how effective e-cigarettes are at aiding smoking cessation. It’s not just smokers and physicians who are interested in such clarity — so are lawmakers. Under Canada’s Food and Drug Act, e-cigarettes containing nicotine cannot be imported, advertised or sold without Health Canada’s approval; nicotine-free e-cigarettes are not restricted. Although Health Canada has yet to grant such approval, nicotine-loaded e-cigarettes are nevertheless widely and openly available in Canada.
The study, which is funded by the Canadian Institutes of Health Research (CIHR), will follow 486 outpatient smokers at 19 sites across Canada. The smokers will be randomized into three groups. One group will be given e-cigarettes that contain nicotine and counselling. The second group will receive e-cigarettes that do not contain nicotine, and counselling. The third group will only receive counselling. The researchers will supply the smokers with e-cigarettes for 12 weeks, and then follow up with them after six months and a year, observing whether they graduate to total non-smoking, continue with the e-cigarettes, or return to conventional cigarettes. Although some reformed smokers may fall off the wagon after a smoke-free year, Eisenberg clarifies that “statistically significant results at 12 months would still be important evidence” for the efficacy of e-cigarettes as a cessation aid. All 486 patients will not be enrolled simultaneously, with the study expected to roll out over the course of five years.
“The ultimate goal is to use the e-cigarette as a transitional tool in going from smoking conventional cigarettes to not smoking at all,” says Eisenberg. He notes that, at least in the early stages, e-cigarettes are about “transferring the addiction. You’re getting people onto something else that is giving them their nicotine, so they may never quit. E-cigarettes also provide other physical and social aspects because they feel like a cigarette; a pack-a-day smoker makes that hand-to-mouth motion more than 70,000 times a year, for example. That’s a difficult thing to break away from, and a nicotine patch doesn’t provide it.
“We have great hopes that e-cigarettes will be helpful for people trying to quit smoking,” he adds. “Even if they just switch to smoking e-cigarettes that would be better than continuing to smoke conventional cigarettes for decades. I’m not saying that e-cigarettes are safe, but they’re much safer than conventional cigarettes. They’re not going to give you lung cancer. They’re not going to give you heart disease. They’re not going to give you emphysema.
“But what we’re really hoping for is that e-cigarettes lead people to not smoking altogether.”
(This particular study, Eisenberg notes, is not designed to investigate safety concerns, such as whether e-cigarette vapour contains trace elements of harmful substances. Other than their smoking habits, the trial’s participants are healthy, he explains, “so the chances that they’d have adverse effects over a short time like the course of one year are quite low.” The researchers will, however, track whether the smokers are hospitalized for any cardiopulmonary issues. They will also gather data about benign side effects, such as throat irritation.)
E-cigarettes are already big business, ringing up an estimated $500-plus million in sales in the U.S. alone — and that’s without being able to make any claims about helping smokers kick their habits. Eisenberg says that the e-cigarette industry itself isn’t clamouring to make such claims: “They don’t want to be regulated by the Food and Drug Administration [in the U.S.] and Health Canada, so they don’t want to support clinical trials,” he says. “And they don’t need to: Smokers are voting with their feet by buying e-cigarettes to help them quit smoking.” Governments, however, want more than anecdotal evidence.
“This study alone would not be enough for Health Canada to allow companies to market e-cigarettes as smoking cessation aids,” explains Eisenberg. “That said, if this trial shows that there is a substantial reduction in smoking traditional cigarettes, then Health Canada will have to rethink their policy.
“This is just a first step. Then we would need multiple big trials in multiple populations. We would need to use tapering [of nicotine levels] studies, and we would need to use interventions that are longer than 12 weeks. But the fact is that smoking is still the single most reversible cause of mortality in Canada — so it’s an important first step.”
People trying to give up smoking often use e-cigarettes to help wean themselves off tobacco. Most experts think they are safer than cigarettes but a surprising paper was published recently – it suggests that people who use e-cigarettes are less successful at giving up smoking than those who don’t.
The study causing the fuss was written by researchers at the Center for Tobacco Control Research and Education at the University of California, and published in one of the Lancet’s sister journals, Lancet Respiratory Medicine.
It is a meta-analysis, which means the authors reviewed the academic literature already available on the topic. They sifted out the weaker papers – ones that didn’t have control groups, for example – and were left with 20.
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The conclusion? Smokers who use e-cigarettes have a 28% lower chance of quitting than smokers who don’t use them, according to Prof Stanton Glantz, one of the authors.
But while the conclusion is surprising, so is the number of academics who have criticised the paper.
One was Ann McNeill, professor of tobacco addiction at Kings College London, whose own research is included in Glantz’s analysis.
“The information… about two studies that I co-authored is either inaccurate or misleading… I believe the findings should therefore be dismissed.
“I am concerned at the huge damage this publication may have – many more smokers may continue smoking and die if they take from this piece of work that all evidence suggests e-cigarettes do not help you quit smoking; that is not the case.”
Prof Peter Hajek, director of the Tobacco Dependence Research Unit at the Wolfson Institute also called the findings “grossly misleading”.
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The critics are making three main points. First, the definition of e-cigarettes is a bit loose. There are many different types – some look like cigarettes, others have tanks for the vaping liquid, some are disposable and other are multi-use. They all deliver different doses of nicotine. Many of the papers included in the analysis don’t specify which type people are using, according to Linda Bauld, professor of health policy at the University of Stirling.
Another point is that the studies vary in the way they measure how often people use e-cigarettes. “Some only assessed whether a person had ever tried an e-cigarette or if they had tried one recently, not whether they were using it regularly or frequently,” Bauld says.
Even the paper’s author admits it’s possible that in some of the studies e-cigarettes may only have been used once, which he says would not be a good predictor of whether they had affected people’s ability to stop smoking.
And there is another problem. You might expect, if you were going to draw conclusions about how useful e-cigarettes are in helping people quit, to focus on studies looking at people who are trying to give up.
Prof Robert West, who heads a team at University College London researching ways to help people stop smoking, says this analysis mashed together some very different studies – only some of which include people using e-cigarettes to help them quit.
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“To mix them in with studies where you’ve got people using an e-cigarette and are not particularly trying to stop smoking is mixing apples and oranges,” he says.
Some of the studies track smokers who use e-cigarettes for other reasons – perhaps because smoking a cigarette in a bar or an office is illegal and they want a nicotine hit.
“With the studies where people are using electronic cigarettes specifically in a quit attempt the evidence is consistent,” says West, referring to two randomised control trials.
Both are quite small and one was funded by the e-cigarette industry. They took two groups of smokers, and gave one real e-cigarettes, and the other a placebo. The studies reach a broadly similar conclusion to a large, real-world study called the Smoking Toolkit run by West.
West’s investigation follows people in their daily lives and assesses how successful various methods of giving up smoking are – this includes nicotine patches, medicines and going cold turkey.
These studies suggest that people using e-cigarettes to help them quit are 50% to 100% more successful than those who use no aids at all.
In his paper, Glantz acknowledges there are limitations to the research that he analysed. He agrees there are problems with the way the use of e-cigarettes is measured and accepts it’s not clear which devices people are using. But he is sticking by his analysis because he believes he has taken these factors into account.
The editor of Lancet Respiratory Medicine, Emma Grainger, defends the article too. She says she does not see a problem with the paper and that it has been through the normal peer-review process.
~Vapelounge~ 
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