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Translation of a-t 2019; 50: 120, 129



The only mildly psychoactive cannabis component cannabidiol (a-t 2017; 48: 91-2) has been available as a medicinal product to treat rare forms of epilepsy since October 2019 (EPIDYOLEX; see e a-t 12/2019a). It has been available since 2011 in combination with delta-9-tetrahydrocannabinol as an oral spray (SATIVEX) to treat spasticity in patients with multiple sclerosis (a-t 2011; 42: 57-9). Advantages of cannabidiol have, however, also been postulated for a large number of areas of application for which the active substance is not authorised. In this context, the US Food and Drug Administration (FDA) warned in 2019 providers several times for making illegal advertising statements about efficacy for example in cancer, ALZHEIMER's disease or autism (1,2). The benefits of taking this cannabinoid in those non-authorised indications have either been insufficiently proven through randomised studies or have not been proven at all:

For the treatment of secondary generalised seizures, we were only able to find an older randomised study (3) on just 15 patients, which is insufficient to prove a benefit. There are several two-week to eight-week investigations on patients with schizophrenia, but with 29 to 88 participants they are also small and insufficient to prove a benefit (4-7). The results are contradictory, and one of the studies (5) was also only published as a conference abstract and does not indicate the dose of cannabidiol.

Eight further small placebo-controlled studies lasting a maximum of 13 weeks with up to 62 participants look at the active substance in various areas of application and doses (up to 800 mg per day). There were no significant advantages compared to placebo for the treatment of CROHN's disease, hyperlipidaemia in patients with type 2 diabetes, PARKINSON's disease, HUNTINGTON's chorea, chronic pain, fatty liver and increased intraocular pressure (8). Only one small, methodologically deficient study of 24 patients with social phobia (9) described a decrease in anxiety symptoms in simulated public speaking.

Three further small placebo-controlled studies (n = 24 to 42) investigated a possible benefit in smoking cessation and in abstinent heroin addicts to decrease symptoms of craving. These only looked at short-term or single use and did not focus on clinical endpoints (10-13), with the exception of one (10) in which the number of cigarettes consumed was investigated.

As far as we know, only small or very small, in some cases uncontrolled observational studies are available for other claimed indications, for example to prevent a graft-versus-host reaction (14) and to treat epileptic seizures caused by tuberous sclerosis (15) or the studies are merely cell experiments or animal studies, as is the case for cancer or ALZHEIMER's disease (16-17).

We advise against use of cannabidiol in non-authorised indications outside of clinical trials due to a lack of or insufficient evidence of a benefit.

(R = randomised trial)
1FDA: press release, 23. Juli 2019; http://www.a-turl.de/?k=tras
2FDA: press release, 22. Okt. and 25. Nov. 2019; http://www.a-turl.de/?k=hors, http://www.a-turl.de/?k=ffen
R3CUNHA, J.M. et al.: Pharmacology 1980; 21: 175-85
R4LEWEKE, F.M. et al.: Transl. Psychiatry 2012; 2: e94 (7 pages)
R5LEWEKE, M.: Schizophrenia Bulletin 2013; 39: S341
R6McGUIRE, P. et al.: Am. J. Psychiatry 2018; 175: 225-31
R7BOGGS, D.L. et al.: Psychopharmacology 2018; 235: 1923-32
8MILLAR, S.A. et al.: Br. J. Clin. Pharmacol. 2019; 85: 1888-900
R9BERGAMASCHI, M.M. et al.: Neuropsychopharmacol. 2011; 36: 1219-26
R10MORGAN, C.J. et al.: Addict. Behav. 2013; 38: 2433-6
R11HINDOCHA, C. et al.: Addiction 2018; 113: 1696-1705
R12HINDOCHA, C. et al.: Sci. Rep. 2018; 8: 7568 (7 pages)
R13HURD, Y.L. et al.: Am. J. Psychiatry; publ. online 21 May 2019, doi: 10.1176/appi.ajp.2019.18101191 (12 pages)
14YESHURUN, M. et al.: Biol. Blood Marrow Transplant. 2015; 21: 1770-5
15HESS, E.J. et al.: Epilepsia 2016; 57: 1617-24
16National Academies of Sciences, Engineering, and Medicine: The Health Effects of Cannabis and Cannabinoids, Jan. 2017; http://www.a-turl.de/?k=einb
17WATT, G., KARL, T.: Front. Pharmacol. 2017; 8: 20 (7 pages)

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