Launched by the Assistance Publique-Hôpitaux de Paris (AP-HP), the study on the effectiveness of the electronic cigarette named ECSMOKE is controversial, particularly for its cost.
12 consultations: the most extensive study ever conducted
On the day of the launch of the month(s) without tobacco, the Assistance Publique – Hôpitaux de Paris (AP-HP) announced the implementation of a large-scale national study intended to evaluate the effectiveness of the e-cigarette, with or without nicotine, as a smoking cessation aid, versus a drug, varenicline (Champix). This study, unprecedented in its scope, is based on recruiting at least 650 smokers aged 18 to 70 who consume at least 10 cigarettes daily and wish to quit smoking. Within the 12 tobacco clinic consultations in hospitals (Angers, Caen, Clamart, Clermont-Ferrand, La Rochelle, Lille Lyon, Nancy, Nîmes, Paris, Poitiers, Villejuif), participants will be monitored free of charge for 6 months after stopping tobacco. The results of the study will be known in four years.
4 years: no emergency for hospitals
Each participant will be provided with an e-cigarette with classic blond flavour e-liquids with or without nicotine (12 mg/ml). They will also be given varenicline tablets (a smoking cessation drug) or its placebo version. Divided by lottery into three groups, one taking placebo pills and nicotine-free vaping liquids. For the second, placebo tablets and liquids with nicotine will be administered, and for the third group, varenicline tablets associated with liquids without nicotine. Before the start of the study, the participants will be accompanied by a tobacco specialist six times throughout the smoking cessation.
After the study, participants will need to stop within 7-15 days. Through clinical and biological examinations and questionnaires, their addiction will be assessed. If a participant relapses, they will still be included in the study. ECSMOKE also measures the associated risks, particularly among those over 45. This age corresponds to that from which most smokers are already affected by a smoking-related health problems. On the other hand, the primary objective remains “to be sure and certain that the electronic cigarette with nicotine is an aid to quitting smoking,” as explained by Dr Ivan Berlin, addictologist and pharmacologist at the Hospital de la Pity-Salpetriere. Evidence for us which will take four long years to be born and whose price of the epidural rising between 900,000 and 1 million euros could hurt the French taxpayer to give birth on already known results.
Doctor Berlin, Addictology/drug addiction and alcoholism doctor at the Pity-Salpetriere Hospital in charge of conducting the ECSMOKE study, responded to the criticisms during an interview organized by Vaping Post. Regarding the duration of this study, they commented on the difficulty in finding volunteers: “This duration of four years is indicative. The study is being carried out in 12 hospitals of the AP-HP. To have a study speaking, we must recruit 650 to 700 volunteers. This is not massive recruitment but spread over time. For each, a period of treatment and follow-up is necessary so that the results are convincing and that the follow-up notebook for each volunteer is filled in. It is a very cumbersome operation; this notebook is very detailed. But this delay is mainly calculated by the difficulty in finding volunteers. Obviously, if we find them more quickly, they will last less. We wish to get to the end as quickly as possible by the protocol. The French are not very used to volunteer for medical studies. It may be cultural. Doctor Berlin also insists on the importance of this study, which was eagerly awaited by the scientific world at the time: “The results will be published in one of the most prestigious journals. They are eagerly awaited, including abroad. In the United States, for example, the FDA does not allow similar studies. I received messages from English colleagues, who told me that it was not worth it, that they saw that the electronic cigarette worked. I told them they replied that we had no doubts about it but that they could have taken advantage of their situation to precisely quantify all this scientifically. The health authorities in France are also waiting for it. The study will answer the question of whether e-cigarette works better than drugs, to what extent, and will open the possibility of having them prescribed by doctors, for example. But the most important thing is that this study will be the first of its kind, conducted in complete independence from the industry of pharmaceuticals, tobacco and vape industry, on rigorous scientific criteria and financed by public funds. France, in this area, will be at the forefront.”
Between 900,000 and 1 million euros invested
With results expected in 4 years and several thousand euros invested, the gestation will be long and painful to prove what we already know. The electronic cigarette is recognized by many specialists and very recently listed among the most effective means of quitting smoking by the State as part of the Tobacco-Free Me(s) approach, in the same way as other nicotine substitutes. As Marie Van der Shuren-Etway, a tobacco specialist, points out, “between 2016 and 2017, there were one million fewer smokers, a decrease of 19%. At the same time, we observe an increase in sales of electronic cigarettes of 17%. “Fortunately, the AP-HP will confirm this to us and, in addition, without the expertise of vaping professionals on using electronic cigarettes! Sebastian Bezio, the creator of the VAPYOU magazine and Vice-president of the SOVAPE association, spoke on their behalf: “Always the same remarks on this study. A single material, a single nicotine level (between 12 and 16 , so not the maximum to be effective), only one flavor. But also, a mix of “biases” which will necessarily degrade the results on weaning performance. “All that for this? However, who knows, it can probably help reassure and advance the vape’s recognition.