Forgive the long silence – we’ve been locked in the cellar, working hard on researching the ins and outs, ups and downs, and twists and turns of the revisions to the Tobacco Products Directive. More to follow on this soon….
Today, though, I want to share with you the findings of a recent French study on electronic cigarettes, published at the end of November 2012. Although limited (as so many such studies are, unfortunately) to a relatively small number of smokers, it does, nevertheless, have useful information, particularly concerning the safety profile of electronic cigarettes – yet more grist to the mill for the fight against those policy makers who claim to have concerns about the safety profile of electronic cigarettes, with NO evidence to support this position.
I have only had access to the abstract, and have done my best to translate it into English, despite having forgotten how English works during the process(!), so please forgive any ‘peculiar’ turns of phrase. Also, the abstract didn’t include any graphics, but I’ve added a few pie charts, to help demonstrate the significance of the findings.
Observations on acceptance of the electronic cigarette
Results at three months
Dr Jacques Granger – Departmental Committee of Respiratory Diseases of the Dordogne
Dr Brigitte Cornette – Centre for Health Examination of Périgueux
Published 30th November 2012
The electronic cigarette or ‘e-cigarette’ replicates the sensations of tobacco smoking. The electronic cigarette only contains some nicotine, a vaporising liquid and flavourings while tobacco smoke contains approximately 4000 toxic substances, of which at least 50 are carcinogenic. It consists of an electronic vaporiser known as an ‘atomizer’, a battery and a reservoir holding the liquid (named ‘e-liquid’) for vaporisation. The mixture of vapour and air is inhaled then exhaled in a ‘cloud’, simulating tobacco smoke, which quickly dissipates. As there is no combustion thus no smoke, it is said that the consumer ‘vapes’.
The lack of clinical studies for the approval of the electronic cigarette does not allow its authorisation “as a medicinal product” for the cessation of smoking. This has not prevented numerous smokers from using it.
The Departmental Committee of Respiratory Diseases of the Dordogne therefore wished to observe the use of the electronic cigarette, in conjunction with the Centre for Health Examination of Périgueux. This Centre provides smoking cessation services and supplied, from their team, a doctor and a nurse qualified in providing prevention and educational advice on tobacco addiction.
OBJECTIVES, METHODS AND PROGRESS
The main objective was to estimate the acceptance and the tolerance of the electronic cigarette by smokers:
1. conscious of the need to reduce the risks of smoking for their health,
2. having unsuccessfully already tried to stop smoking,
3. expressing no desire to stop smoking for the moment.
The secondary objective was to get the smoker to think about their dependence and to lead them, possibly, towards a later attempt at complete smoking cessation.
It was suggested to 100 smokers, who declared they did not wish to stop smoking at the moment, to use an electronic cigarette for three months. The instruction was to ‘vape’ instead of smoking, eventually replacing their smoking with vaping.
Measurements of weight, heart rhythm, spirometry and the level of expired carbon monoxide (CO) were taken at the beginning of the study and at the end of three months by the Centre for Health Examination. A follow-up, by questionnaire and telephone, in six months then in one year is planned.
The recruitment was made by selection of smoking volunteers who:
· had benefited from a health examination at the Centre for Health Examination,
· or had participated before unsuccessfully in a program of smoking cessation,
· or were under consultation with the partner pulmonologists of the study.
In the group:
· all were smokers for more than 10 years.
· 83% were situated in the age bracket 25-59 years.
· 52% were smokers of 20 cigarettes and more a day; 98% were smokers of ten cigarettes or more.
· 70% began to smoke before the age of 18 years, and 30% before the age of 15 years.
· the Fagerström score was upper or equal to 4 for 76% of the participants; for 30%, the score was 7 or more.
Over three months, subjects were provided with different entry level e-cigarettes free of charge, generating the vapor by simple inhalation. At the beginning, the participants had disposable then later refillable models, with the flavour ‘light tobacco’ and a nicotine content of 11mg/ml (1.1%) or 16mg/ml (1.6%).
OBSERVATIONS AT THREE MONTHS
The observations below are universal and do not take into account the differences of equipment, nicotine levels and flavours.
Acceptance of the electronic cigarette
Seventy-four participants were followed over three months. The given product not satisfying them, or because they were no longer interested, 26 persons stopped participating, of which 17 stopped during the first month.
Cessation of smoking
Although it was about persons who did not initially envisage complete cessation, eight participants (11%) had stopped smoking totally during the assessment at three months. Almost all of these stopped from the first days, by using the e-cigarette until the 3rd month for 7 of them (with complete cessation of both smoking and the e-cigarette for one participant).
This total cessation of smoking is especially noticeable for the smokers of between 11 and 20 cigarettes a day, not particularly for the smokers of less than ten cigarettes. Some subjects previously smoked more than 20 cigarettes a day.
Reduction of smoking (dual use)
Among those having alternated vaping and smoking of cigarettes, all decreased their smoking:
· 45 (68%) having decreased their tobacco consumption by more than 50%
· 21 (32%) having decreased their consumption by less than 50%
Satisfaction following the use of the electronic cigarette
Concerning the sensation of cravings, with vaping:
· the sensation of cravings was not felt in 34% of the cases,
· the sensation of cravings was moderated in 38% of the cases,
· the persistence of cravings was declared in 27% of the cases.
For 91% of the participants, the handling or ‘feel’ of the electronic cigarette differed from that of the tobacco cigarette (by the weight, the feel or the texture).
The electronic cigarette achieved a majority of favourable opinions from the non-smokers, both in the family environment and in public or at work.
Effects on health
· 64% of the persons having used the electronic cigarette noticed positive effects on their health. 15% indicated minor side effects (mouth, lips or throat irritated).
· Over the 3 months, the heart rhythm of the participants decreased.
· The level of exhaled carbon monoxide (CO) decreased in every case and reduced to nil/zero for vapers having stopped smoking.
· Weight gain was moderated. In cases of complete smoking cessation with continuation of vaping, weight gain was less than is usually noticed following smoking cessation.
· The forced vital capacity (FVC) improved with the use of the electronic cigarette, especially when there was significant reduction or total cessation of smoking.
· The maximum expiratory pressure per second (MEPS) was stable or improved slightly with the use of the electronic cigarette.
After three months of regular use of the electronic cigarette (n=74):
· 8% wished to resume tobacco smoking and stop using the electronic cigarette
· 9% wished to stop smoking and continue only vaping
· 28% wished to stop both smoking and vaping
· 45% wished to continue both
Additional observations are expected in the 6th and 12th month following this study.
The average grade for satisfaction of the participants in the study is 9.5/10
Limitations of the study
In terms of the limitations of this study of the acceptance of the electronic cigarette, it is to be noted
· the number of participants was too limited to ensure statistical meaning,
· the absence of a control group for comparison,
· the variety of the supplied devices,
· and the restricted choice of flavourings and nicotine levels.
The use of the electronic cigarette achieved a significant reduction in smoking for 72% of the smokers.
Among 74 participants followed for three months, 53 strongly decreased their consumption of cigarettes (72%, confidence interval 95%: 60% – 84%), and eight (11%) totally stopped smoking. The rest of the participants also declared to have decreased, but less than 50%.
The electronic cigarette was well accepted, both by the participants and by their circle of acquaintances (family, in public or at work). Two thirds of the subjects having used the electronic cigarette noticed positive effects on their health.
Although based on a limited sample, this first study undertaken in France confirms the potential of the electronic cigarette for the protection of the health of smokers, whether they intend to quit smoking or not. We cannot recognise that tobacco smoking is the leading cause of preventable deaths in France and in the world, and at the same time, make no study of the electronic cigarette, acclaimed by millions of users concerned about their health.
This study of one hundred smokers allows us to anticipate other, more thorough studies. There was a large number of volunteers and favourable elements of health improvement were observed over three months without any significant problems.
Conflicts of interest: None.
Dr Jacques Granger
Comité Départemental des Maladies Respiratoires
Centre hospitalier – Service de Pneumologie
80, avenue Georges Pompidou
CS 61205 24019 PÉRIGUEUX Cedex
You can find the original abstract, in French, here.
I can’t help but think that by far the most significant findings of this study are the effects on health. Bear in mind that at least some of the subjects observed were currently receiving treatment from consultant pulmonologists, i.e. smokers with existing respiratory health problems. Leaving aside the rather nebulous claim of ‘64% noticing positive health effects’, the very specific measurements taken from each subject at the start of the study, and after the 3 months, show very definite health improvements, directly attributable to the use of the electronic cigarette. Just to reiterate these important findings:
- Heart rhythm decreased;
- Carbon monoxide levels decreased in every case, and reduced to zero for vapers having stopped smoking;
- For those subjects who switched from smoking to vaping, weight gain was less than is usually noticed following smoking cessation;
- Both forced vital capacity (FVC) and maximum expiratory pressure per second (MEPS) – both very significant measures for sufferers of asthma, COPD and other lung impairments – improved (and/or were stable, in the case of MEPS) with the use of the electronic cigarette.
As Michael Siegel pointed out recently:
“In my opinion, electronic cigarette companies which are claiming that use of their products reduces the health risks associated with cigarette smoking are making factual statements for which there is plentiful scientific evidence.”
“It is now clear that electronic cigarettes are reduced harm products (compared to conventional cigarettes). Anyone who continues to claim that there is no scientific basis for such a claim is either lying or living in a secluded cave without internet access.”
As far as I’m aware, at the time when Professor Siegel wrote that, he was not aware of the French study, but was discussing the Schripp study on the vapour, which also supports the safety profile of electronic cigarettes.
The evidence is mounting – and it is ALL in favour of electronic cigarettes.
Right: time to collate the evidence and write to the Commission. Watch this space!