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.
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Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshé SL, Perucca E, Wiebe S, French J (2010) Definition of drug resistant epilepsy: consensus proposal by the ad hoc task force of the ILAE commission on therapeutic strategies. Epilepsia 51:1069–1077
Maa E, Figi P (2014) The case for medical marijuana in epilepsy. Epilepsia 55:783–786
Whiting PF, Wolff RF, Deshpande S, Di Nisio M, Duffy S, Hernandez AV, Keurentjes JC, Lang S, Misso K, Ryder S, Schmidlkofer S, Westwood M, Kleijnen J (2015) Cannabinoids for medical use: a systematic review and meta-analysis. JAMA 313:2456–2473
Decreto Ministeriale 23 gennaio 2013 (13A00942). GU Serie Generale n.33 del 08-02-2013) http://www.gazzettauficiale.it/eli/id/2013/02/08/13A00942/sg (accessed April 10, 2019).
Saccà F, Pane C, Carotenuto A, Massarelli M, Lanzillo R, Florio EB, Brescia MV (2016) The use of medical-grade cannabis in patients non-responders to Nabiximols. J Neurol Sci. 368:349–351
Pacifici R, Marchei E, Salvatore F, Guandalini L, Busardò FP, Pichini S (2018) Evaluation of long-term stability of cannabinoids in standardized preparations of cannabis flowering tops and cannabis oil by ultra-high-performance liquid chromatography tandem mass spectrometry. Clin Chem Lab Med 56:94–96
Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshé SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM (2017) ILAE classification of the epilepsies position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 58:512–521
Sulak D, Saneto R, Goldstein B (2017) The current status of artisanal cannabis for the treatment of epilepsy in the United States. Epilepsy Behav 70(Pt B):328–333
Laux LC, Bebin EM, Checketts D, Chez M, Flamini R, Marsh ED, Miller I, Nichol K, Park Y, Segal E, Seltzer L, Szaflarski JP, Thiele EA, Weinstock A, CBD EAP study group (2019) Long-term safety and efficacy of cannabidiol in children and adults with treatment resistant Lennox-Gastaut syndrome or Dravet syndrome: expanded access program results. Epilepsy Res 154:13–20
Marsicano G, Goodenough S, Monory K, Hermann H, Eder M, Cannich A, Azad SC, Cascio MG, Gutiérrez SO, van der Stelt M, López-Rodriguez ML, Casanova E, Schütz G, Zieglgänsberger W, di Marzo V, Behl C, Lutz B (2003) CB1cannabinoid receptors and on-demand defence against excitotoxicity. Science 302(5642):84–88
Ben-Shabat S, Fride E, Sheskin T, Tamiri T, Rhee MH, Vogel Z, Bisogno T, de Petrocellis L, di Marzo V, Mechoulam R (1998) An entourage effect: inactive endogenous fatty acid glycerol esters enhance 2-arachidonoyl-glycerol cannabinoid activity. Eur J Pharmacol. 353:23–31
Marchiò M, Roli L, Lucchi C, Costa AM, Borghi M, Iughetti L, Trenti T, Guerra A, Biagini G (2019) Ghrelin plasma levels after 1 year of ketogenic diet in children with refractory epilepsy. Front Nutr 6:112. https://doi.org/10.3389/fnut.2019.00112
The authors are grateful to Ettore Brunello Florio and Annunziata Lombardi for their support on regulatory matters.
Conflict of interest
The authors report no conflict of interest for the present study.
This is a retrospective case series report, approved from our local ethics committee.
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Informed consents were obtained from patients
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Pane, C., Saccà, F. The use of medical grade cannabis in Italy for drug-resistant epilepsy: a case series. Neurol Sci 41, 695–698 (2020). https://doi.org/10.1007/s10072-019-04162-1
- Oil extract
- West syndrome