Some studies have found that CEs are effective in controlling craving , as well as other withdrawal symptoms. The study by Bullen et al. showed that the use of a CE with 16Nicotine mg for one hour by a group of 40 smokers produced a significant reduction in craving compared to those in which placebo was used (p=0.006). In a more recent study by Vansickel in which a small group of habitual “vapers” was analyzed, it was found that after inhalation of the EC with nicotine, the different symptoms of withdrawal syndrome were significantly reduced.
Another important aspect that requires analysis is to know if the ECs are effective in releasing sufficient amounts of nicotine so that they can be used as nicotine replacement therapy devices. A recent study has shown that in order to obtain adequate levels of nicotine through the use of an EC it is essential to use a correct “vaping” technique. Those who “vape” properly can reach up to 25ng / ml quickly; while those who do not know how to do it only reach up to 3ng / ml.
So far, only 2 randomized and placebo-controlled studies have been conducted to evaluate the efficacy and safety of using CE as a smoking cessation treatment: the ECLAT study and that of Bullen et al.
The ECLAT study was a prospective randomized study of 12Months of follow-up that evaluated the effectiveness of the EC to achieve abstinence or reduction in a group of 300 smokers who did not want to stop being. A group of subjects received for 12EC weeks containing 7.2Nicotine mg, another received the same pattern followed by 6more weeks with 5.4 CEnicotine mg and another group received EC without nicotine for 12weeks The results showed that in all groups there was a reduction in the number of cigarettes consumed per day, which was observed in 22.3 and 10.3% of subjects after 12 and 52weeks of follow-up Complete withdrawal was verified in 10.7 and 8.7% of subjects at follow-up times of 12 and 52weeks, respectively. The acceptance of the EC by the participants in the study was satisfactory.
In the study by Bullen et al. the authors randomized a group of 657 smokers who wanted to cease to be 3 treatment arms: a)CE with 16mg of nicotine; b)21 patchesmg of nicotine, and c)EC without nicotine. Subjects used treatment from one week before D-day until 12weeks after that day. As results, after 6Months of follow-up the withdrawal rate for the EC group with nicotine was 7.3%, for patches it was 5.8% and for EC without nicotine, 4.1%. The authors explain that the study does not have enough statistical power to conclude that ECs with nicotine are more effective than nicotine patches.
However, they claim that the effectiveness of the EC with nicotine in helping to quit smoking was similar to that of the patches. In addition, they do not find that the use of EC with nicotine is accompanied by more frequent or serious adverse effects than those that occur with the treatment of nicotine patches.
These studies seem to show promising results. However, they suffer from significant methodological weaknesses that make their conclusions not definitive. In both studies there is no blind arm. All subjects who used the EC knew that they were using a new form of treatment and that could give them more chances of success than those who were randomized to the nicotine patch group, some of whom had already used them without success. previously. On the other hand, the number of drop-outs and follow-up losses was higher in the group of subjects that used patches than in the one that used CE.
There are 3 possible categories for EC regulation: as a medicinal product, as a tobacco product or as a consumer product. The most reasonable thing is that the EC is regulated as a medicinal product.
The regulation of the EC as a medicinal product is defined by 2 fundamental reasons: its presentation and its function. The usual presentation of the EC is as products that help not only to quit smoking but also to reduce the number of cigarettes consumed and even to relieve the symptoms of withdrawal symptoms.
EC presentations containing different amounts of nicotine contribute even more to recommending that the regulation of these devices be as a medicinal product. But in addition, from a functional point of view, ECs that contain nicotine, regardless of the amount they contain, also require regulation as medications. Nicotine produces pharmacological and toxic effects on the body.
The regulation of the EC as a medicine would facilitate the scientific evaluation of its efficacy and its safety in treating withdrawal symptoms. It would also force greater quality control in production and limit the indiscriminate access to it that is currently taking place, especially among young people, who can use them as a way to start smoking. Then, the EC should be regulated according to Directive 2001/83 / EC of the European Union, which regulates medicinal products.
It is important to note that the regulation of the EC as medicinal products should be accompanied by adequate regulations that control not only the consumption of these devices in public places, but also their advertising, promotion, distribution and sale. In this way, the process of backward movement in the social non-acceptance of tobacco consumption in public places, which had been an achievement of the anti-smoking regulation, can be stopped.
Up to 12 countries in the European Union support the EC to be regulated as medicinal products: Austria, Denmark, Estonia, Finland, Germany, Hungary, Holland, Portugal, Romania, Slovenia, Sweden and France. A good number of scientific institutions are also in favor of this type of categorization. These include the English agency Medicines and Healthcare Products Regulatory Agency (MHRA), which plans that as of 2016 the EC will be regulated as medicines in the United Kingdom the International Union against Tuberculosis and Pulmonary Diseases (IUTLD) the German Cancer Research Center the WHO working group on the regulation of tobacco products , and some pharmaceutical companies.