The use of medical grade cannabis in Italy for drug-resistant epilepsy: a case series
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The use of medical grade cannabis in Italy for drug-resistant epilepsy: a case series Chiara Pane 1
&
Francesco Saccà 1
Received: 11 July 2019 / Accepted: 15 November 2019 # Fondazione Società Italiana di Neurologia 2019
Abstract In Italy, medical grade cannabis (MGC) can be prescribed for different medical conditions, including drug-resistant epilepsy (DRE), once standard and approved therapies have failed, or caused non-tolerable side effects. Here, we present a retrospective case series report of five patients with DRE who started therapy with MGC. Authorized ISO 9001:2008 pharmacies prepared MGC according to Italian laws. Olive oil extracts (OOEs) were prepared following standard extraction protocols, and cannabinoids were measured on each OOE to check for successful extraction.After treatment with MGC, all patients reported a reduction in seizure frequency and severity, and some reported improved mood, sleep quality, and general well-being without relevant side effects. Despite the small sample size and open-label nature of the data, we show that MGC may be successfully used to treat DRE. This is especially true when considering that no valid therapeutic option exists for these patients and that MGC was extremely well tolerated. Keywords Cannabis . Oil extract . Absence . West syndrome
Introduction Epilepsy affects over 50 million people worldwide, and onethird of patients have drug-resistant epilepsy (DRE) [1]. Ninedelta-tetrahydrocannabinol (THC) and cannabidiol (CBD) have received the greatest attention as potential antiepileptic agents [2]. In Italy, medical grade cannabis (MGC) can be prescribed for recommended medical conditions [3] (i.e., pain, spasticity, untreatable vomiting, appetite stimulation in anorexia, glaucoma, and Gilles de la Tourette Syndrome) or whatever condition may benefit from MGC in the opinion of the prescribing physician. Failure of approved therapies, or non-tolerable side effects, is a pre-requisite for MGC prescription [4]. No approved dose exists for MGC, leaving the decision to the physician’s discretion. As of July 2019, nine MGC variants are available in Italy (Table 1). MGC can be inhaled, ingested as an oral-non-
activated (-ONA) compound [5], or can be administered orally as an olive oil extract (-OOE) [6].
Methods This is a retrospective case series report, approved from our local ethics committee. Epilepsy syndrome and seizure types were recorded according to the International League Against Epilepsy classification [7]. Informed consents were obtained from patients. Seizure frequency was measured through patients’ self-recordings using paper charts. Authorized ISO 9001:2008 pharmacies prepared MGC according to Italian laws, using standard extraction protocols [6]. Cannabinoids were measured on each OOE to check for successful extraction. MGC was administered BID orally for convenience.
Results * Francesco Saccà [email protected] 1
Department of Neurosciences and Reproductive and Odontostomatological Sciences, University “Federico II”,
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