Polosa e-cig pilot study published [BMC Public Health]

[Tom09]

R Polosa, P Caponnetto, J B Morjaria, G Papale, D Campagna, C Russo: Effect of an Electronic Nicotine Delivery Device (e-Cigarette) on Smoking Reduction and Cessation: A Prospective 6-Month Pilot Study. BMC Public Health 2011, 11:786

Abstract (provisional)

Background

Cigarette smoking is a tough addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette), a battery-powered electronic nicotine delivery device (ENDD) resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. Efficacy and safety of these devices in long-term smoking cessation and/or smoking reduction studies have never been investigated.
Methods

In this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers (unwilling to quit) experimenting the 'Categoria' e-Cigarette with a focus on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product use, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed.
Results

Sustained 50% reduction in the number of cig/day at week-24 was shown in 13/40(32.5%) participants; their median of 25 cigs/day decreasing to 6 cigs/day (p<0.001). Sustained 80% reduction was shown in 5/40(12.5%) participants; their median of 30 cigs/day decreasing to 3 cigs/day (p=0.043). Sustained smoking abstinence at week-24 was observed in 9/40(22.5%) participants, with 6/9 still using the e-Cigarette by the end of the study. Combined sustained 50% reduction and smoking abstinence was shown in 22/40 (55%) participants, with an overall 88% fall in cigs/day. Mouth (20.6%) and throat (32.4%) irritation, and dry cough (32.4%) were common, but diminished substantially by week-24. Overall, 2 to 3 cartridges/day were used throughout the study. Participants' perception and acceptance of the product was good.
Conclusion

The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit (ClinicalTrials.gov number NCT01195597).

open access to pdf at the journal site



edit: find here a related interview with the leading author

 

[rolygate]

Interesting study. I seem to have seen a reference to 11mg refill liquid in there, or was that another study? If so, I'm surprised they got much in the way of success. That would be a re-run of Eissenberg #1.

 

[Tom09]

I seem to have seen a reference to 11mg refill liquid in there, or was that another study? If so, I'm surprised they got much in the way of success.

Polosa et al. used „Categoria“ e-cigarettes with „7.4 mg nicotine cartridges“ („Original“). These cartriges contain “7.4 mg (2.4 %)” nicotine (also here: Categoria labelling and classification). Somewhat unusual in the e-cig world to read “mg” in it’s actual meaning, not the often intended “mg/ml”
Anyway, liquid nicotine strengh used in this Polosa study is 2.4% or 24 mg/ml.

 

[rolygate]

Thanks!
.....

 

[Bill Godshall]

Also note that unlike Eissenberg's purported "no nicotine" study in which participants (who had never used an e-cigarette) had blood tests following their very first usage of an e-cigarette, the Polosa et al study participants were given a 4 week supply of e-cigarette cartridges and allowed to use the products ad libitum (i.e. as much as they desired).

I've become so cynical that I'll be delightfully shocked if WHO, FDA, CTFK, ACS, AHA, ALA, AAP, AMA, Legacy or others that have previously advocated banning e-cigarettes and/or claimed "there is no evidence that e-cigarettes are safe or effective for smoking cessation" issue a correction, clarification and/or public apology for their false and misleading fearmongering claims about e-cigarettes.

Unfortunately, government agencies and special interest groups are far more interested in protecting their own assess than admitting their past lies and misdeeds.

Probably the best we can hope for is that e-cigarette prohibitionists just stop advocating prohibition laws, and stop lying about the health benefits/risks of e-cigarettes. But their desire to ban tobacco products and their desire for continued drug industry funding is likely to quickly trump any concerns about public health and ethics.

 

[rothenbj]

Thanks Tom, great info. I've started to feel 24 mg/ml liquid might be the so called "sweet spot" of most smokers trying to quit once you start to break down the hand to mouth habit. I read a lot of vapers writing on low nic level liquid, but vaping 24x7. I personally prefer to take a puff here or there when I really feel a need and putting it away.

 

[kristin]

Jim, I vaped just as frequently at 18mg (24mg was always too high for me) as I do at 10mg, because I was a hand-to-mouth smoker, not a nicotine or other MAOI smoker.

Vapers are a fountain of information for smoking cessation researchers because we really highlight the WHY of smoking for individuals - something that was nearly indistinguishable for tobacco cigarette smokers. If only they would recognize that. Back when we were smoking tobacco, I never would have been able to tell you that I mostly needed the hand-to-mouth while my husband needed the nicotine and other MAOIS. We only discovered this when searching for the "right" e-cigarette combination. Knowledge like that should be a gold mine for their research, but they are mostly content to focus on studying leaky carts and mislabeling.

 

[rothenbj]

You are so spot on Kristin. The E Cig in and of itself is perfect for the group you represent. Once you give them something that imitates cigarettes they are happy campers. That group also contains those that start out at xx mg nicquid and are soon to 0mg and are delighted. The far end is the MAIO camp that you could feed nicotine to all day long and they wouldn't ever be satisfied.

I sometimes wonder how many really are satisfied just by nicotine. If I were going to make three groups, I'm almost positive the nic group would be the smaller. Once I broke down the hand to mouth, nicquid never really took the edge off. Snus, for me, was the emancipator. However, I fully know that it's only a small percent that would find that as an answer for themselves. Although, I do wonder how much of that reluctance is due to the brainwashing we got for decades.

 

[Tom09]

An interesting reference number to compare, from Michael Siegel’s recent blog on this study (The Rest of the Story):

Based on a Cochrane review of seven studies that measured smoking cessation using nicotine replacement therapy (NRT), the average 6-month point prevalence of smoking abstinence is only 17.8%, and the 6-month point prevalence of smoking abstinence in the pooled data from these studies is only 11.9%. However, these were generally studies of smokers who were motivated to quit. The fact that this trial [Polosa et al. 2011] found a 6-month abstinence rate of 22.5% [9/40] among a sample of smokers who were not motivated to quit is quite encouraging.

 

[rothenbj]

Yes that is encouraging, encouraging the ANTZ to stop at nothing to get them banned by whatever means.

 

[Valsacar]

Just saw this on the good doctors blog, very nice study.

 

[Bill Godshall]

ACSH has posted supportive comments on the publication of Polosa's clinical trial finding e-cigarettes effective for smoking cessation and for sharply reducing cigarette consumption.
Maybe new e-cigarette study will lower the heat > Facts & Fears > ACSH

 

[Vocalek]

Update from Professor Polosa:

Our BMC paper on e-cigd has been downloaded more than 4500 times since its publication. We expect this figure to rise even further because of its exposure in the NY Times column....

 

[rothenbj]

That's great! I just hope it wasn't all just E Cig users.