Italian study - "not harmful" and "no side effects"

[AlexTM]

I was pointed to this Italian press release, which sounds very good (although somebody who actually speaks Italian might want to confirm the Google translation):

Prof. Riccardo Polos University of Catania, international expert in the treatment of smoking, is leading the only clinical study in Europe on the effects and safety of electronic cigarettes (category).

"From the toxicological tests are not harmful - says Prof. Polos - and the study participants reported no side effects." Therefore, there remains the possibility that the electronic cigarette could be an alternative to low-risk compared to traditional cigarette smoke. "Many participants in the study have substantially reduced the use of cigarettes - continues Prof. Polos - and some have even stopped smoking." Perhaps in the near future cigarette elettronic could be used as a useful adjuvant tool to quit smoking, remains the indispensable help of medical experts. Therefore, there are certainly alarming data or negative impact on electronic cigarettes, and medical research is continuing to investigate the phenomenon. The suggestion of LIAF to consumers is to use products that they certify to the satisfaction of their safety.

This is coming after a few extremely nasty articles in the Italian press yesterday, which pretty much stated that vaping was at least as dangerous as smoking analogs. Italian forums are quite in an uproar over it.

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Here is more on this study: http://www.liaf-onlus.org/not_home.asp?id=529&tipo=1

 

[kristin]

CASAA has been in touch with Professor Polosa regarding his study. CASAA VP Elaine Keller came across the study in early November and contacted him regarding some of his testing methods and we got some interesting info on the study. He said the paper has been submitted for publication.

CASAA has also offered to assist him if he would like to complete a survey of e-cigarette users and he has indicated he would be interested. Elaine did outstanding work on this!

 

[AlexTM]

Well, at least a press release is published, and from an anti-smokers-league in favour of vaping. Which is particularly important in Italy at the moment, it seems. Mind you, we'll soon need such studies and texts in Germany, too

The set-up can be seen here: Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) - Full Text View - ClinicalTrials.gov

 

[Vocalek]

They seem to have dropped a letter off his last name. It is "Polosa". The Google translator does a pretty good job, but the meaning of one sentence got a little managled due to word-by-word translating. It should read: "...could be a low-risk alternative compared to traditional cigarettes." I have written to Dr. Polosa and invited him to send a better English translation.

 

[D103]

Thank You Elaine and Kristin!!

 

[dee5]

Very nice! More like this please, universe!

 

[rothenbj]

CASAA has been in touch with Professor Polos regarding his study. CASAA VP Elaine Keller came across the study in early November and contacted him regarding some of his testing methods and we got some interesting info on the study. He said the paper has been submitted for publication.

CASAA has also offered to assist him if he would like to complete a survey of e-cigarette users and he has indicated he would be interested. Elaine did outstanding work on this!

Must have missed the pickup of this study in the papers and the 5 o'clock news. Anything the is negative gets advertised immediately in the media before any effort to get it published. I suppose that's the advantage of knowing the results before you do any research. (sarcasm mine)

On a more direct note, will we be getting some additional information on the study Kristin?

 

[rothenbj]

I'm surprised they got any efficacy considering this statement- "Well characterized group of 100 regular smokers experimenting the E-Cigarette loaded with 7.2 mg nicotine cartridges (high nicotine group)."

Unless they were using some amazing hardware, that level of nic content wouldn't appear to deliver the goods for most smokers IMHO.

 

[wv2win]

Great work! Thank You Elaine and Kristin!!

 

[kristin]

On a more direct note, will we be getting some additional information on the study Kristin?

Elaine would probably be the better one to answer, as she has read "NCT01164072, CAT01/10, Efficacy and Safety of an Electronic Nicotine Delivery device (E-Cigarette)". I haven't had a chance to look it over thoroughly and she was the one in correspondence with him.

This was the link that brought it to her attention: Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) - Full Text View - ClinicalTrials.gov

She wrote asking him about the very low nicotine levels used and how that would affect the success rate of smoking cessation. She provided him a link to the 2009 CASAA Electronic Cigarette User Survey, which showed the various levels of nicotine most respondents used.

It seems that they did a pilot study (with smokers unwilling to quit, which is more relevant to reduced harm than studies with motivated smokers trying to quit) and he said they saw a 20% quit rate after 3 months, even with very low nicotine doses used in the e-cigarettes. He said that they believe that it has a lot to do with the "fact that e-cigs may play an important role in addressing the ritual of smoking and the behavioural component of cigarette addiction."

It was nice to hear a researcher acknowledge the importance of this, however, as Elaine pointed out to him, many e-cigarette users still need the higher nicotine - especially those who are "self-medicating" for cognitive or mood disorders - and that researchers may find the success rate doubled or even tripled if they allow for much higher doses than tested. Then she provided him with the surveys we know of, which show success rates of 60-80%, and offered for CASAA to assist him in getting e-cigarette users to participate in a survey for his research.

 

[rothenbj]

Thanks Kristin, your post explains a lot and I later saw that Elaine was in here also. That 20% sounds impressive considering the targeted participants and nic content. However, as you stated, the hand to mouth "addiction" has been underestimated for a long while, as well as the psychological effect of seeing that smoke like vapor being released.

When I vape now, it's more for effect than the manual process, my Chuck helped break that down. Plus I just love strawberry cheesecake!

 

[maclean]

I followed the link in the first post to the Italian Anti-Smoking League article.

Lega Italiana Anti Fumo

A few paragraphs caught my eye, and I've translated them into english. Overall, it's a very favorable report, especially from an anti-smoking group.

"Given that nicotine isn't the component in tobacco which provokes cancer, I'm convinced that the electronic cigarette is actually a safer alternative to cigarete smoke - above all, for those smokers who can't quit"

Original text
Dato che la nicotina non è il componente del tabacco che provoca il cancro, sono convinto che la sigaretta elettronica sia attualmente l’alternativa più sicura al fumo di sigaretta – soprattutto per quei fumatori che non riescono a smettere

The extraordinary increase in e-cig sales in many countries prompted WHO to release a paper in 2008 calling for tests on their safety. Although some studies have raised doubts about their harmlessness, producers and distributors maintain nevertheless that e-cigs constitute a low-risk alternative with respect to cigarette smoke. Furthermore, the toxological tests carried out on several brands of e-cig confirm the absence of cancerogins and substances toxic to health. Therefore, the suggestion to the consumer is to use products which certify their safety in a convincing manner.

Original text
Lo straordinario aumento nella vendita di sigarette elettroniche in diversi paesi ha indotto l’Organizzazione Mondiale per la Sanità ad emettere un esposto nel 2008 che richiama ai test sulla loro sicurezza. Se alcuni studi hanno sollevato dubbi sulla loro innocuità, produttori e distributori ribattono che le sigarette elettroniche costituiscono comunque una alternativa a basso rischio rispetto al fumo di sigaretta. Inoltre i test tossicologici effettuati su alcune marche di sigaretta elettronica confermano la assenza di sostanze cancerogene e di sostanze tossiche per la salute. Pertanto il suggerimento ai consumatori è quello di utilizzare prodotti che certificano in modo convincente la loro sicurezza

LIAF has recently conducted toxological tests on some of these products (Example: e-cig 'Category') and we are certain of the absence of significant levels of toxic substances in the products tested (as shown in the attached data). Furthermore, we didn't find any evidence of undesirable or adverse effects in the smokers who used them

Original text
La LIAF ha condotto di recente dei test tossicologici su alcuni di questi prodotti (es. sigarette elettroniche “Categoria”) e siamo sicuri della assenza di livelli significativi di sostanze tossiche nei prodotti testati (come risulta dai dati allegati). Inoltre non ci risultano segnalazioni relative ad effetti indesiderati o avversi nei fumatori che ne hanno fatto uso.

 

[maclean]

Kristin/Elaine,

By the way, if you need any italian articles translated, I'm happy to do it. You can always get me here.

maclean.d at alice dot it

mac

 

[Vocalek]

Super, Mac! Thanks, and we may be taking you up on that offer. I wrote Dr. Polosa and asked to receive a copy of the press release as sent out. This was received today.

LIAF PRESS RELEASE
Electronic Cigarettes: are safe and can help quitting
Professor Riccardo Polosa, of Catania University, leads the only clinical study in Europe, on electronic cigarette effects.

Six hundred delegates from over 170 countries have participated to the "Framework Convention for Tobacco Control”, WHO, World Health Organization (Uruguay, 15-20 November 2010).

After this event, the italian media have mounted a negative campaign against the electronic cigarette, stating that the electronic cigarette is harmful and useless for smoking cessation. To date, there is no evidence in the medical literature to support this unproven statement and WHO considers appropriate to conduct scientific studies that may clarify efficacy and long term safety of electronic cigarettes.

Prof. Riccardo Polosa, of Catania University, international expert in smoking cessation, is leading the first clinical study in Europe on the effects and safety of electronic cigarettes (CATEGORIA ELETTRONIC CIGARETTE).

<< Thorough toxicology testing conducted on these products demonstrates that they are not harmful - says Prof. Polosa - and participants using the electronic cigarette long term have never reported significant side effects>>. Therefore, electronic cigarettes may still be considered as a useful low-risk alternative compared to traditional tobacco cigarette.

<< Many participants in our pilot study have substantially reduced cigarettes consumption - continues Prof. Polosa - and some have quit smoking>>. If this will be confirmed in larger studies, the electronic cigarette could be adopted by smoking cessation specialists and used to help millions of smokers to quit. There are no sound alarming data or known negative effects of electronic cigarettes and it is hoped that medical research will soon produce data about their efficacy and safety.

The suggestion of LIAF to consumers is to use certified products.

PRESS OFFICE LIAF, ITALIAN NO SMOKING ASSOCIATION
Lega Italiana Anti Fumo
info@liaf-onlus.org

 

[Vocalek]

The original press release was, of course, in Italian. Someone translated the version I have posted here. I do not know whether that someone worked at LIAF or did the translation for LIAF. I received the English document directly from the LIAF press office. Now that I compare the two, I think that Mac's translation is probably more complete.

 

[maclean]

Thanks for posting that, Elaine. Translations are always open to a bit of liberal interpretation by the translator, so it's often the case that two people come up with slightly different versions. I certainly don't claim to be an expert. I've lived here for 28 years, but translating isn't my job or anything.

Re the italian media - Yes, there's been a spate of negative press in the last few days about e-cigs, mostly based on false information and dodgy reports. The italian forum is buzzing with it and they're all hopping mad. When I went there yesterday, there was a 54 page thread about it, which gives you an idea of how strongly they feel. E-cigs are legal in italy, although the law was passed to cover the ones sold in pharmacies. I hope the government doesn't panic and modify it to exclude imported e-cigs.

mac

 

[Vocalek]

Especially in view of the fact that Prof. Polosa's 20% success rate for smoking abstinence (using 7.5 mg of nicotine) can be tripled or quadrupled by making higher nicotine content available.