[Pharmacological properties as criterion of demarcation]. / Pharmakologische Wirkung als Abgrenzungskriterium.

Because of the growing healthcare market and the increasing health consciousness of the population, more and more food supplements are being placed on the market in addition to medicinal products. Concerning the demarcation of medicinal products to food supplements, not only is the intended purpose of the product critical, but the mode of action of the respective preparation also plays an important role. Following the legal definition, a drug has a pharmacological effect, without it being further defined. Therefore, many courts have already tried to interpret the term pharmacological effect, including the terms metabolic or immunologic effect, and try to describe this in more detail.It should be noted that the pharmacological effect, which means an interaction of the substance of a medicinal product with cellular constituent of the human body - unlike the effect of a foodstuff - must significantly affect the physiological functions and must therefore exert targeted effects on the human body and its functions, more than with the consumption of a conventional quantity of a food would be possible. These modifying physiological functions of the body must be addressed positively, which means beneficial to human health. Products which are consumed only for euphoria purposes, or even have a harmful effect, shall not be classified as medicinal products, despite their pharmacological mechanism of action.

Impact of biofeedback on self-efficacy and stress reduction in obesity: a randomized controlled pilot study.

Biofeedback application is an evidence-based technique to induce relaxation. A primary mechanism of action is the improvement of self-efficacy, which is needed to facilitate the translation of health behavioral intentions into action. Obesity is often associated with low self-efficacy and dysfunctional eating patterns, including comfort eating as an inexpedient relaxation technique. This is the first study investigating the effects of biofeedback on self-efficacy and relaxation in obesity. In the present experiment, 31 women, mean body mass index 35.5 kg/m², were randomized to a food-specific biofeedback paradigm, a non-specific relaxation biofeedback paradigm, or a waiting list control. Eight sessions of biofeedback of the electrodermal activity were performed while presenting either a challenging food stimulus or a non-specific landscape stimulus. Self-efficacy, stress, ability to relax, eating behavior, and electrodermal activity were assessed before, directly after, and 3 months after the intervention. The food-specific biofeedback predominantly showed effects on food-related self-efficacy and perceived stress. The non-specific relaxation biofeedback showed effects on the ability to relax. Self-reported improvements were confirmed by corresponding decrease in the electrodermal reaction to food stimuli. Biofeedback treatment is effective in improving self-efficacy in individuals with obesity and might therefore be a valuable additional intervention in obesity treatment.