A Pilot Study of the Government Pharmaceutical Organization (GPO) Cannabis Extract for Multiple Sclerosis (MS) Spasticity Treatment in Thailand

Abstract

Background: The prevalence of spasticity in multiple sclerosis (MS) patients is nearly 90%. Most patients do not respond to current anti-spastic medications. Objective: To evaluate the efficacy and safety of Government Pharmaceutical Organization cannabis extract (GPOCE) in the treatment of spasticity in MS patients in Thailand. Materials and Methods: This prospective pilot study in patients diagnosed with MS whose spasticity was not relieved under current spasticity treatments, was performed between November 2019 and June 2020. The GPOCE formulation of THC:CBD 1:1 was administered to all patients. The treatment outcomes were determined at 12 weeks and compared with their baseline. Results: Seven patients participated in the present study. Among these, two patients withdrew after receiving only a small dose of GPOCE. Finally, five patients were included in the final analysis. The primary outcome was a reduction in the Modified Ashworth Score (MAS), which decreased among participants from a baseline of 15 (IQR 12 to 19) to 6 (IQR 1 to 12) (p=0.043). The key secondary outcome was a clinically relevant response (CRR), which was defined as a reduction of the spasticity Numeric Rating Scale (NRS) of more than thirty percent compared to baseline. Four patients (80%) achieved CRR. Moreover, the overall spasticity NRS decreased from a median of 6 (IQR5 to 7) to 2 (IQR2 to 3). A reduction of other NRS parameters, including fatigue, pain, tremor, sleep, spasm, anxiety, and depression, was also observed after treatment. Moreover, GPOCE was generally well tolerated. Conclusion: GPOCE is useful in treating spasticity in patients with MS. The safety profile is acceptable under the supervision of a health care provider. Keywords: Multiple sclerosis (MS), Cannabis extract, Spasticity