New-ish study from new zealand: "Electronic cigarettes for smoking cessation"

[Drael]

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61842-5/fulltext

Unfortunately they did not have enough of a sample size to determine if nicotine containing e-cigs where better than patches (which I think we all know they will be). But they were able to determine that e-cigs, with or without nicotine DO have a statistically significant effect on abstinance from smoking. Bam.

That is, they have shown the e-cigs do help you quit.

Being one of the first studies of its kind, now the naysayers, who have been saying that it doesn't help people quit, or its not proven, can have their mouth shut by science

 

[SleeZy]

Bleeh must create an account to read it all.
Wanted to link this post but it's kinda useless if you've to register.

 

[Drael]

You could always register, get the full study, make a copy of it somewhere else?

 

[SleeZy]

Perhaps, not sure if that's legal / allowed though.

 

[Drael]

It is probably illegal to do that. Im nor sure who holds the copyright to the full paper, the authors or the journal, but yeah.

 

[alisa1970]

Wow, in the Lancet. Definitely some good cred.

 

[KjAthena]

would love to see the charts showing exact percentages

 

[FireDragon1138]

On its own, this is a promising, but weak study. Around 5 percent of smoker's in the study quit using the nicotine patch- that's no better than cold turkey, BTW. Hardly news but I wonder why this is never commented on. Also note that the nicotine-free e-cig did worse than the patch- perhaps the nicotine-free e-cig did not help break the smoking habit, nor did it satisfy nicotine cravings.

 

[Vocalek]

would love to see the charts showing exact percentages

From the abstract:

At 6 months, verified abstinence was 7·3% (21 of 289) with nicotine e-cigarettes, 5·8% (17 of 295) with patches, and 4·1% (three of 73) with placebo e-cigarettes (risk difference for nicotine e-cigarette vs patches 1·51 [95% CI −2·49 to 5·51]; for nicotine e-cigarettes vs placebo e-cigarettes 3·16 [95% CI −2·29 to 8·61]).

To get the U.S. version of the percents, substitute a decimal point for the hyphen.

 

[alisa1970]

I noticed after reading the summary that the results weren't that good. The methodology seemed a bit loose as well. They used 18mg nic for the ecig and 21mg for the patch, then claimed equivalence when looking at the quit rate.

 

[Vocalek]

But the worst of it was that they treated the smoking replacement as if it were just another NRT. Use for the prescribed period of time and then discontinue use.

IMHO, the biggest reason NRTs don't work is because as soon as "treatment" ends, people begin relapsing. Some people remain smoke-free for years while continuing to chew however many pieces of nicotine gum it takes to avoid relapse.

 

[aikanae1]

I thought I saw an approval for longer NRT therapy. I kinda laughed because the way it was, the box advised ppl to quit after 6 weeks. Yea, right. Do they really believe a box label will stop someone from using them longer? But I guess they believe themselves.

 

[FireDragon1138]

That's about how it worked for me. I went from cigs, to snuff (skoal and snus), to the patch and lozenges. If I had it my way I would have been on lozenges indefinitely, but the lozenge habit cost me more than snuff (I went through about 1 1/2 cans a week- not looking for a buzz, just harm reduction).

 

[Vocalek]

I thought I saw an approval for longer NRT therapy. I kinda laughed because the way it was, the box advised ppl to quit after 6 weeks. Yea, right. Do they really believe a box label will stop someone from using them longer? But I guess they believe themselves.

The problem with that labeling is that people got the impression that it would be harmful (perhaps just as hazardous as smoking?) if they used the product for any longer than the recommended time.

What people didn't realize is that the recommended duration for treatment was based on the clinical trials. The FDA didn't want to say it was safe to use the products indefinitely if the manufacturers only tested them for 12 weeks. So they were FDA-approved for a specified period of time. I believe this is sometimes called the "precautionary principle."

— n
the precept that an action should not be taken if the consequences are uncertain and potentially dangerous


The problem with applying this principle in Tobacco Control is that the consequences of continuing to smoke are certain and definitely dangerous. Duh!

Here is specific information on the proposed labeling changes:

https://www.federalregister.gov/art...-products-for-over-the-counter-human-use#h-12

IMHO, the proposed labeling change does nothing to assuage the fears of consumers about long-term use.

Accordingly, we are announcing that the statement in the labeling of OTC NRT products directing consumers to stop using the NRT product at the end of the recommended treatment period can be modified. The following specific change to the current approved “Drug Facts” labeling is recommended:

Directions. The last bullet should be revised from “it is important to complete treatment. Stop using the [NRT product] at the end of [x] weeks. If you still feel the need to use [the NRT product], talk to your doctor” to “it is important to complete treatment. If you feel you need to use [the NRT product] for a longer period to keep from smoking, talk to your health care provider.”

And what makes the FDA think that our health care provider knows more about NRT than we do? Many of us have researched and read medical journal articles on NRTs. I'll bet if you gave us a quiz based on the research, I'd get a higher score than my doctor.

 

[rolygate]

In order to provide an equivalent ecig to a cigarette, and thus a valid result, it is necessary to do three things first:

1. Refer to 'Goniewicz 2' and select a device that is efficient in transfer of nicotine to vapour.

The average transfer efficiency is about 50% and we have known this for a very long time (the ECF chemists pointed this out around 2009). Only about half the nicotine in e-liquid makes it into the vapour, and this is not news.
The range of efficiencies is between around 10% to 80% (see Goniewicz 2), so a device that is at least at the mean value, or better, needs to be identified and provided.
If the transfer efficiency is not known then the trial is worthless because the devices used might be around the 10% range, and therefore effectively useless unless a placebo result is required.


2. A refill of equivalent strength to a tobacco cigarette is required, if the trial is supposed to demonstrate the efficacy of e-cigarettes in avoidance of smoking.

Intellicig demonstrated that such a strength is 45mg (4.5%) in their clinical trials for medical licensing purposes. This is why they introduced a 45mg strength for use with their mini ecigs.
A mini ecig, used by a naive user, requires 45mg strength in order to deliver full efficacy - unless the user is unusually intolerant to nicotine and requests a lower strength.


3. Note that three separate clinical trials have clearly demonstrated that a mini ecig, with an average strength refill, with ecig-naive users isolated from expert advice, provides zero or very little measurable plasma nicotine.

Therefore a working solution must be provided or the trial qualifies as a trial of a placebo and nothing more.
A known working solution is one that is demonstrated to be capable of providing 10ng plasma level or greater at 1 hour (should the user require it).
This level could be described as the minimum usable efficiency as it is still low compared to the average smoker (especially with regard to historical plasma nic levels, of course).
The user may only self-titrate to 7 or 8ng but that is a different matter - the vaping solution must be demonstrated to work, for an ecig-naive user, or it should not be used in any trial.


Clinical trials of e-cigarettes are in effect using a placebo unless they can demonstrate that users' plasma nic levels were elevated to an effective level.

AFAIK, none do so. Most (all?) ecig trials are trials of a placebo. If they are 12-week trials then, in addition, they are trials of a placebo used for 3 months; which as not, as far as we are aware, a notably successful path to permanent cigarette avoidance.


---------
Notes

1. 'Naive' in medical terminology means 'unexposed to', so that an 'e-cigarette naive user' is a person who is not familiar with its use; it has nothing to do with any derogatory meaning.

2. Laugesen himself demonstrated that an ecig he tested had a 10% nicotine content per puff compared to a tobacco cigarette, in his earlier research (10mcg nicotine per puff vs 103mcg per puff). Therefore he should be more aware than most that some mini ecigs are in effect placebos, and that a decent solution needs to be located before trials begin.

 

[supertrunker]

So an EU-wide limit of 24mg just places further obstacles in the way of successful cessation unless one breaks the law. Lots of stick and not much carrot!


T

 

[Jman8]

All, or virtually all, clinical trials of e-cigarettes are in effect using a placebo unless they can demonstrate that users' plasma nic levels were elevated to an efficacious level.

This is interesting to me. I'm reading it as anything less than 45 mg is placebo effect at work. As many of us (I would say majority) are less than half that number, then it would clearly be placebo effect.

Related, but distinct point from above - it really appears to me, given all the available anecdotal evidence, that there is nothing around like eCigs to aid in cessation. If I had a dollar for every internet poster (on any site) that has said they went from 1+ a pack day habit, to zero, and have no desire to go back to smoking, I'd have thousands of dollars. Granted, I'm immersed to some degree in eCig culture, but it really seems highly significant on our planet in terms of mass exodus from smoking addiction.

I still think willpower is, and always will be, the number one factor. I'm one that has not quit via eCigs, nor do I intend to anytime real soon. And yet, I have quit (via cold turkey) for a very long stretch. Thus, willpower. But, it is also clear to me that it isn't just willpower. When I am vaping what is "normal" for me, and likely considered "heavy" to a non-vaper, I am able to cut back into a territory that I think most people (includes vapers) cannot relate to. I no longer have the addiction, habit to smoking. It often appears to me, like I couldn't have that same level of use smoking (1+ packs a day) by simply engaging in "normal use" of eCigs.

The whole issue of vaping nicotine as a cessation to smoking continues to fascinate me, given political history of eCigs and my own personal history. Plus, just adding in the current fight by those who are plausibly more anti-smoking that some anti-smoking vapers, and their desire to decimate the eCig industry, and it just seems like built-in endless drama for the foreseeable future.

 

[rolygate]

@Supertrunker
The limit is 20mg although it's essentially meaningless as their intention is to 99% ban ecigs. The regulations in the new TPD can be interpreted in a way that allows a country to ban ecigs if it so wishes. In places like the UK where EU law is regarded as stone tablets from god, and where pharma runs health policy, then that is the likely outcome. Down south in places like Portugal they will all but ignore the new regs, very sensibly. Eventually the trade will have to go mostly offshore in the UK, partly because pharma (sorry the government) will introduce massive fees for product registration (allowed by the new regs) that will eliminate everyone apart from the big tobacco firms.

You'll be able to get a 'Marlboro' mini ecig with a pre-filled carto of up to 20mg, costing more than cigarettes puff per puff. Everything else (about 99% of products figured by SKUs) will be black market.

 

[rolygate]

This is interesting to me. I'm reading it as anything less than 45 mg is placebo effect at work. As many of us (I would say majority) are less than half that number, then it would clearly be placebo effect.

Not really. This is an issue that concerns newbies, recruited to clinical trials, who are smokers asked if they will consider trying out an ecig for the purposes of a trial. Thus they are beginners, with no knowledge of how to use an ecig or what effective products look like, not told how to use them optimally, given a possibly very low performance device, and using a refill strength far, far too low for the combination of variables that is present.

It's already been shown that this combination results in zero or very little nic delivery. It certainly doesn't apply to any ECF members - or for long, at any rate. The point I was trying to make is that *clinical trials* end up using the most useless set of circumstances possible. You couldn't design a trial more poorly than this. They appear designed to fail from the start.

.....it just seems like built-in endless drama for the foreseeable future.

Oh yes. We will see decades of strife over this. It's always the same for new technology that promises to destroy huge incomes, so we can simply look at all the previous examples of this - there are enough of them. Basically, the people who are invested in the old ways will fight tooth and nail to block the new technology, because once the new ways take over, their huge incomes are RIP.

The most recent example I can think of is the containerisation of shipping. There was an intense fight over this for about 30 years from 1970 to 2000. The inevitable always happens, eventually, because you can't put the genie back in the bottle; but for several decades a bitter struggle takes place. You can't really see what's happening from within because of the fog of war - only with hindsight does it become clear what happened. Containerisation changed the world drastically and so will ecigs.

It's not all good, of course. With containerisation came huge job losses in the ports together with the near-destruction of Western manufacturing. The consumer got the most dramatic change in purchasing choice and price cuts that has ever occurred. Technology changes are very bloody affairs and some people gain, others are ruined. Just progress.

There will be three decades of bitter fighting over ecigs. For a lot of that time, in many countries, you won't be able to legally buy what you want. That much is obvious.
The Impact of Technology Change

 

[Traver]

So an EU-wide limit of 24mg just places further obstacles in the way of successful cessation unless one breaks the law. Lots of stick and not much carrot!


T

I am not disagreeing with you but it is not only the nicotine level but how much we vape. I for one started vaping at 24mg but soon found myself vaping more than I used to smoke. My guess is that most of the vapors on this forum had a similar experience.
I am not sure how or if this applies to the study. I would tend to agree that the amount of nicotine from the average cig-alike is not much more than a placebo. On the other hand the general population does not have the knowledge or use the same products that we use.