New Zealand E-cigarette trial in Lancet – keeping it in perspective

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Professor Tony Blakely

A New Zealand randomized trial of e-cigarettes just published in the prestigious Lancet journal has been touted in the media as showing how good e-cigarettes are for people wanting to quit smoking.  This is overstating the study findings. And to be fair to the authors, overstating their conclusions too.

So what did the study find?  No statistically significant difference in abstinence at 6 months.

21 out of 289 people randomised to e-cigarettes were abstinent at six months, or 7.3%.  This compares to 17 out of 295 people randomised to nicotine patches, or 5.8%.  The difference in percentage points was 1.51%, with a 95% confidence interval of -2.49% (yes, negative) to 5.51%.  That is, a non-significant study finding.

Although conversely, one can conclude that e-cigarettes were at least as effective as patches, meaning they might have a place in cessation.

Similarly, the difference for ‘real’ e-cigarettes compared with placebo e-cigarettes (six month abstinence 4.1%) was 3.16%, with a 95% confidence interval -2.29% to 8.61%.

Null findings are important in research.  This study, though, due to lower than expected quit rates in all arms of the trial was under-powered to find statistically significant differences in the primary study outcome.

What Bullen and colleagues do conclude, and I agree with, is that:

E-cigarettes, with or without nicotine, were modestly effective at helping smokers to quit, with similar achievement of abstinence as with nicotine patches, and few adverse events. Uncertainty exists about the place of e-cigarettes in tobacco control, and more research is urgently needed to clearly establish their overall benefits and harms at both individual and population levels.

There are real risks that e-cigarettes may just allow people to keep smoking real tobacco, as they can use e-cigarettes at work and the pub – then smoke the real stuff elsewhere.  Conversely, maybe they are a useful cessation or substitution device.  If people truly do use only e-cigarettes, the likely harm is an order(s) of magnitude less than smoking tobacco.

But the balance of harms and benefits is still very much unknown.  Especially when you inject the fact that tobacco companies are buying e-cigarette companies and marketing them as sexy… flashback 1950s, and all the Machiavellian antics of the tobacco industry since.

In the meantime, we have a goal of a tobacco free New Zealand by 2025 – often interpreted as a prevalence less than 5%.  And we know that other policies do work, and do not hand control over to the tobacco industry.  Namely tax, mass media, Quit lines and such like.

We will need more drastic action on tobacco in due course, as we approach 5% prevalence of smoking.  It will include ongoing large increases in tobacco tax.  It might include large scale reduction of retail outlets.  It might include limiting the import quotas of tobacco at the New Zealand border.  It might include licensing of smokers (and retail outlets).  It might include regulating the removal of nicotine from cigarettes to reduce their addictiveness.  It might include removing artificial sweeteners from cigarettes.  And it might include supplying alternative nicotine delivery systems that are safer for smokers, but still give the nicotine hit – like e-cigarettes.

It almost certainly will be some combination of all these options.  We urgently need more and bigger research such as that by Bullen and co to help map out this road to the end of tobacco.  And we also need careful judgment and interpretation. Onwards.

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I am an epidemiologist and public health researcher. My research activities span mortality studies, health inequalities, healthy eating, tobacco and cancer control. I teach advanced epidemiology methods. I currently direct the Burden of Disease Epidemiology, Equity and Cost effectiveness programme (BODE3) where we are modelling the health impact, cost and cost effectiveness of preventive and cancer control interventions.

9 thoughts on “New Zealand E-cigarette trial in Lancet – keeping it in perspective

  1. Hi Tony
    I’m intersted in where this will go in terms of harm reduciton, not abstinence. I’m thinking of my patient with COPD and asthma who continues to smoke depsite mutliple intervetions of both NRT and Champix with support from practice nurses, respiratory nurses, quitline…. He has severe nicotine addiction and seems unable to quit.
    There seems to be some nonclincial cardiovascular proxies out there, but it will be years before we will see any hard data on clincial outcomes, so I think I will take a pragmatic approach that for this patient e-cigs are probably going to be less harmful than the real thing.
    Dr Medlicott, GP, Wgtn

    • Hi Richard,
      For the one-on-one patient situation in 2013, I concur that in all likelihood e-cig’s are much better than ongoing cigarette use.
      Where the uncertainty arises is – in broadbrush terms – the unintended consequences. First, if e-cigarettes are easily available it may just allow people to keep smoking at home but vaping at work – no real gain there. Second, if big tobacco has control of e-cig market…. well, a leopard only occasionally changes its spots. Third, whilst likely beneficial for many individuals (e.g. your patient), it may be counterproductive to reducing tobacco smoking prevalence across the population.
      Personally, I am sitting on the fence on e-cigs – for now. If they are made readily available in NZ, I would not want it done so by the tobacco industry. And before so doing, I would want to see some more research on these unintended conseqences and the best way to regulate/control e-cigs.

      • “if e-cigarettes are easily available it may just allow people to keep smoking at home but vaping at work – no real gain there.”

        The gain is in reduction – they’re not smoking at work. And they’re modelling the use of an e-cigarette at work rather than a real one. And they’re getting themselves used to the substitution.

        Anecdote – I’ve been using an e-cigarette for a few weeks. I wasn’t intending to give up the rollies, just cut down (I’d given up on giving up years ago). However it has turned out that I like them better than smokes, so when I ran out of rollies, I didn’t want to buy any more. I would say it’s a solid 20 years since I’ve gone this long without a smoke – and I haven’t even really been trying. That’s despite have a go with all the other stop-smoking techniques at various times over the years – patches, pills, cold turkey, the Allen Carr book…

        Some workmates and relatives have observed me and intend to give it a go themselves.

        Right now I have a couple of issues. The first is that e-cig supplies are not as easy to get as real tobacco. My order hasn’t turned up yet and I think I probably don’t have enough to see me through the weekend. There’s a good chance I’m going to have to substitute with tobacco before the weekend is out.

        The second issue is that I’m getting over the level of nicotine I’ve been taking. It felt like the perfect level a week ago, but it now feels like too much.

        I also sometimes want to have a “smoke” but don’t feel like having any nicotine in it. And I’m getting over the tobacco flavour.

        The fact that I’ll be able to vary all these things (assuming my order ever arrives) is a good thing – keeps me in control of how I want to go about this. Take it out of my control and I’m liable to not bother with it.

  2. These devices do not, for most smokers, deliver an experience quite as satisfying as a normal cigarette. Hence the relatively low success rate. However, there is a huge amount of customisation available in terms of devices which deliver different amounts of vapour, different temperature of vapour, different “draw” resistance, different nicotine levels, and then there are the different flavoured e-liquids available. Then there are the cosmetic options, allowing users to choose devices which have some visual and/or tactile appeal to them. With customisation to individual users preferences, I believe the success rate for partial or total substitution of c-cigarettes for traditional cigarettes could be greatly increased. However, all those customisation options are also risk factors in terms of un uptake of e-cigarettes by non-smokers. I would like to see e-cigarette outlets open, which would allow smokers greater ability to try out devices to try to find one which delivers an acceptable substitute experience for them, and which eliminates the problems of having to source a regular uninterupted supply of nicotine “e-juice”, but would also suggest that such outlets would need to have restrictions imposed preventing sale to minors and non-smokers, – i.e. essentially only sale to those with doctor’s referrals. Long term studies are a must, and it is criminal that none have yet been undertaken.

  3. Pity about the lack of power in the study which make it hard to draw any suitable conclusion.
    Richard may well be right on the harms issue BUT equally for all we know e-Cigs could be a lot worse than real cancer sticks, especially when you see the chemicals that go into them.
    Incidentally something’s funny about the results given the methodological failure rate in the patches group.

    • E-cigarettes haven’t been used for long enough to draw conclusions of the long term effects but they are definitely helping people quit smoking, with the nicotine and tobacco it contains and also the smoking action it provides, compared to patches for example.

  4. Ive been vaping about 3 months now and as long as e juice is readily available I cant see myself going back to smoking, I cant understand why anyone would be against it, I bet if the trial was done with the brand I imported from the states the results would be convlusive that e cigs are the best chance nz has of becoming smoke free and remaining a democracy.

  5. From my experience, I believe that vaping is a safer alternative to smoking, and that it can be an effective smoking cessation tool for many. It provides a replacement for the oral fixation many smokers have difficulty giving up, with or without the addition of nicotine replacement

  6. I believe in the ecigs totally. I smoked for 39 years and 2 and half months ago have given up with the help of ecigs. Brilliant easy products and should be encourgared in bars and workplaces. Other people I know are starting togive up now that they are seeing how easy I have found it.

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