Industrial Hemp Association Safety and Side Effects of Cannabidiol

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Industrial Hemp Association Safety and Side Effects of Cannabidiol ( industrial-hemp-association-safety-and-side-effects-cannabid )

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European Industrial Hemp Association (EIHA) review on: Safety and Side Effects of Cannabidiol – A review of clinical data and relevant animal studies by Kerstin Iffland and Dr. med. Franjo Grotenhermen, nova-Institut (www.nova-institut.eu) Hürth (Germany), October 2016 The study was commissioned by the European Industrial Hemp Association. Download this paper and further documents at: www.eiha.org Responsible under press legislation (V.i.S.d.P.): Michael Carus | EIHA co/ nova-Institut GmbH | Industriestraße 300 | 50354 Hürth | Germany | michael.carus@eiha.org | www.eiha.org Abstract This literature survey aims to provide an update of the extensive survey performed by Bergamaschi and colleagues in 2011. Apart from updating the literature, this paper focuses on clinical studies and CBD’s potential interactions with other drugs. In general, the often described excellent safety profile of CBD in humans was confirmed and extended by the reviewed research. The majority of studies were performed for treatment of epilepsy and psychotic disorders. Here, the most commonly reported side effects were tiredness, diarrhea and changes of appetite/ weight. In comparison with other medicinal drugs used for the treatment of these medical conditions, CBD has a very favorable side effect profile, which may improve compliance and adherence to treatment. Up until now, CBD was mainly used as adjunct therapy. Therefore, more clinical research is warranted in CBD’s action on hepatic enzymes and drug-transporters and interactions with other drugs. This can have positive or negative effects, e.g. reducing the needed clobazam doses in epilepsy and therefore this drug’s side effects. A third result of this survey was, that some of the parameters summarized by Bergamaschi et al. (2011), which were observed in animal experiments, have not been studied in humans, yet. This is the case, for example, for several hormones (e.g. luteinizing hormone). Given that the endocannabinoid system also plays an important role in endocrine regulation, further research of CBD’s off-target effects in this area is needed, e.g. by including the measurement of endocrine parameters in upcoming clinical trials with CBD. Introduction Since several years other pharmacologically relevant constituents of the Cannabis plant, apart from THC, have come into the focus of research and legislation. The most prominent of those is Cannabidiol (CBD). In contrast to THC, it is non-psychotropic, but exerts a number of pharmacological effects, which may be of therapeutic interest. For instance, it is anxiolytic, anti-inflammatory, anti-emetic and anti-psychotic. Moreover, neuroprotective properties have been shown. Consequently, it could be used at high doses for the treatment of a variety of conditions ranging from psychiatric disorders such as schizophrenia and dementia, as well as diabetes and nausea (Bergamaschi et al., 2011; for a complete and up-to-date review please refer to Grotenhermen et al., 2016). At lower doses it has beneficial physiological effects which promote and maintain health (anti-oxidative, anti-inflammatory, neuroprotection). For instance, CBD is more effective than vitamin C and E as a neuroprotective antioxidant and can ameliorate skin conditions such as acne (Hampson et al., 1998; Olah et al., 2014). The comprehensive review by Bergamaschi and colleagues describes the safety profile of CBD, mentioning several properties: catalepsy is not induced and physiological parameters are not altered (heart rate, blood pressure and body temperature). Psychological and psychomotor functions are not adversely affected. The same holds true for gastrointestinal transit, food intake, and absence of toxicity for non-transformed cells. Chronic use and high doses of up to 1,500 mg per day have been repeatedly shown to be well tolerated by humans. Nonetheless, some side effects have been reported for CBD, but mainly in vitro or in animal studies. They include alterations of cell viability, reduced fertilization capacity, inhibition of hepatic drug metabolism and drug transporters (e.g. p-glycoprotein; Bergamaschi et al., 2011). On May 3rd, 2016, the German Federal Institute for Drugs and Medical Devices (BfArM) advised that CBD should be legislated as a prescription-only drug (Sachverständigenausschuss Verschreibungspflicht, 2016). They argued, that the safety and side effects of CBD were not studied enough. On October 1st, 2016 CBD became a prescription-only drug in Germany. This paper will demonstrate, that numerous clinical studies have been performed on CBD and that its safety, even at high doses, has been proven in the context of various medical conditions. Already in 2011, Bergamaschi and colleagues reviewed 132 original studies on CBD’s safety and side effects. This review will build on the clinical studies mentioned there and update it with new studies published until September 2016. 1

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