Randomized Controlled Trials (RCT) often provide rather reliable and reproducible results. Thus they are considered the Gold standard. They are very useful when you want to evaluate a few clearly defined distinct options. Like the efficacy of medical therapies.
The problems
are in the design and interpreting the meaning of the results. E.g.:
There was a RCT comparing the efficacy of NRT, ecigs, and “cold turkey” [ https://www.ncbi.nlm.nih.gov/pubmed/24029165 ]. While technically solid, the problem is: This trial wasn’t modelled on reality. The results, good as they are, were still disappointing and don’t seem to match with the abundant anecdotes. The explanation is simple. The scientists appearently started with erroneous assumptions:
“All ecigs are basically the same.”
Well, they aren’t. Picking just one model with a specific liquid cripples the results so that they simply can’t match the reality, where ecigs users usually have to try several devices and many liquids before they find combinations they are comfortable with. ->Pleasure Principle ->Don’t Dismiss Differences
“Ecigs are just like any other NRT.”
Some people might use them this way. If you prescribe a regime for the use of ecigs like for NRTs, you get nice reproduceable data. On the downside this tight control also has a demolishing influence on exactly what you are looking for. ->Vaping vs.NRT
Suggestion:
The next time you do a RCT to evaluate the efficacy of ecigs used for cessation, simply add another group. A group without any of these restrictions. On the contrary! Try to give them the best case scenario:
- Get them in contact with experienced vapers. Personal contact would be best. But contacts via internet would help, too.
- Give them a reasonable budget to buy what they decide after consultation. Including a set of liquids.
Ok, the numbers of this group won’t be reliable and reproducible because of all the uncontrolled variables. But it would serve as a control on how much “damage” the study design did to the applicability of the results. And please be explicit about your ->Definition of “cessation” Better yet: Differentiate which levels of cessations where reached.
Please consider, what a real scientist – Carl V. Phillips – has to say: http://antithrlies.com/tag/rcts/
Heisenberg’s uncertainty principle
also is relevant for RCTs. It’s rather easy and efficient when you only have just a few distinct option you want to evaluate. But when you try to evaluate a multifactorial phenomenon like the success of vaping you have a Heisenberg problem. The nicotine content is just one of many factors for the appeal and success of vaping vs smoking. Not even the major factor for most (ex-)smokers. You can get a hint about that when you examine the internet surveys of mostly successful switchers from this point of view. They too often are flippantly dismissed because of their Selection Bias.
For a RCT to realistically model vaping as an alternative to smoking you either have to build an extremely complex (and expensive) RCT that examines the many factors or relax the control and allow the participants lots of choices (like nicotine level, flavors, devices). You’ll have to chose a compromise between these mutually exclusive properties for this RCT: cost efficiency, applicability, reliability.
Update:
Effectiveness of the Electronic Cigarette: An Eight-Week Flemish Study with Six-Month Follow-up on Smoking Reduction, Craving and Experienced Benefits and Complaints
DOI: doi:10.3390/ijerph111111220
http://www.mdpi.com/1660-4601/11/11/11220/htm
This is a nice example of a study that avoided some of the pitfalls of control I mention. But still they encouraged the limitation to a single type of liquid. But anyway the results are very encouraging. Just imagine how much better the results might have been for a group where the smokers were allowed to chose and change the device and the liquids ad lib, too. My “theory”. That is what happened with the “smokers” group when they were properly presented with the vaping option after the last lab session, when the limiting restrictions wwere removed. It might explain why this this group hat the best switch rate in the end. I suspect that some in the ecigs groups were conditioned by the limitations of the lab period and simply didn’t consider exploring other possibilities.
More about this study and models in general: Carl V Phillips: This works in practice, now we just need to see if it works in theory
Update:
Bias in public health research: with examples from e-cigarette research
Robert West
https://youtu.be/uiBwjv13IJs
Norbert Zillatron 
could not agree more with this post. RCT can never capture the diversity which I’d critical to the success of vaping. In fact I would go one step further and say that using a clinical/medical tool could be damaging to our cause. In the first instance I feel it takes us a step nearer to medical regs creating a division between “tested” and untested products. Secondly I feel that the cessation argument is a red herring. E cigarettes are not an improved alternative to NRT, they are an improved alternative to smoked tobacco, as such there efficacy as a cessation device is irrelevant. When I first became engaged in this debate, ANTZ were arguing about direct physical harm caused by vaping. This has been roundly refuted
Goal posts were shifted and now we are onto cessation and gateways. However the simple fact is that if e cigs did not help current smokers quit but we’re taken up by only future smokers, this is still a win. By engaging and trying to argue the cessation efficacy of ecigs we are allowing the terms of reference to be dictated by ANTZ. The terms of reference should be this and this alone. ANTZ lie, here us the proof. This study is useful as further proof that ANTZ lie
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I tend to agree with the points that Mark makes in the above post, research should not solely be undertaken to demonstrate efficacy and destroy the ANTZ shoddy arguments that largely went back to the Bullen trial comparing 1st Gen to NRT where results were inconclusive .
However a trial comparing cigarettes to Gen1-2-3 (a virtual impossibility given the huge variations in products) would be good to see in the public domain to help to encourage smokers to convert NOT to satisfy the ever more bizarre and tenuous ANTZ arguments
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Excellent post and comments Norbert, Alan and Mark! Getting the ANTZ to read science is going to be hard.
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Yes. Not much chance for the ANTZ to listen. But we need to alert real scientists to what is happening and to take a closer look. And avoid the mistakes due to faulty assumptions. They are human, too …
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I agree the Red Herring is exactly that!
Most vapers don’t want to quit,they wish to continue in their habit of inhaling and getting pleasure without the extreme dangers posed by using tobacco from the major suppliers’ of cigarettes!
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Reblogged this on artbylisabelle and commented:
You must ask for what you want, LOUDLY & OFTEN!
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[…] Crippling Control. […]
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Very well said, Zillatron! And I agree fully with Mark. Including this: “E cigarettes are not an improved alternative to NRT, they are an improved alternative to smoked tobacco”
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1st link doesn’t work. I assume it’s the Bullen trial. What’s seldom mentioned in that trial is that ecigs were only used for 3 months, then cessation was measured at 6 months, at a time long ago when it was very difficult to get ecigs outside of the trial.
The same team are starting a new big trial soon using 3rd gen gear and most importantly, although they will still only supply for 3 months, participants are free to continue using them and they will be aware of how to get more e-liquid and coils, so when they measure cessation at 6 months, it will reflect the reality that vapers most often continue vaping. I expect much better results with this one.
Traditional quitting methods achieve roughly 5% success at 6 months/1 year. Even if the results are not as high as we see anecdotally, the results are still likely to be much higher than 5%.
It’s always good to have RCT evidence. But we know from Sweden and snus that some zealots will still refuse to budge even with the best evidence. Hopefully our movement and sheer commonsense will marginalise these zealots and they will eventually be ignored to rant to each other in dark rooms while the rest of the world celebrates the obsolescence of smoking.
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Thanks for the feedback. Link fixed. Yes, it’s the Bullen study. Interresting additional information.
I already heard about the upcoming study. I hope the participants will also get support from experienced vapers. But this still won’t fix the major problem of RCTs: Too much control.
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Norbert, I can’t believe how many blogs I have missed of yours… 🙂
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They are all linked on the front page. 😉
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