Imperial College Medical Cannabis Research Group, Department of Surgery and Cancer, Imperial College London, London, UK.
Imperial College Medical Cannabis Research Group, Department of Surgery and Cancer, Imperial College London, London, UK; Curaleaf Clinic, London, UK.
Mult Scler Relat Disord. 2024 Jul;87:105665. doi: 10.1016/j.msard.2024.105665. Epub 2024 May 6.
Whilst disease-modifying therapies are the cornerstone for treatment of multiple sclerosis (MS), there is a need to develop novel therapeutics for the symptomatic sequalae of the disease. Cannabis-based medicinal products (CBMPs) have been suggested as a potential therapy for the associated pain, spasticity, and mental health disorders. However, there is a paucity of clinical evidence on CBMPs in MS. The aim of this study is to assess changes in MS-specific and general health-related quality of life (HRQoL) outcomes alongside adverse event incidence in patients prescribed CBMPs for MS from the UK Medical Cannabis Registry (UKMCR).
Patients prescribed CBMPs for MS symptoms for longer than one month were identified from the UKMCR. The primary outcomes were changes from baseline in MS Quality of Life-54 (MSQoL-54), Generalised Anxiety Disorder-7 (GAD-7), Single-Item Sleep Quality Scale (SQS), and EQ-5D-5L scales at one month, three months and six months. p < 0.050 was defined as statistically significant.
141 patients met the inclusion criteria for the study. There was an improvement in the following subscales of the MSQoL-54 at 6 months: change in health scale, cognitive function, mental health composition, physical health, role limitations due to physical limitation and due to emotional problems, as well as social and sexual function (p < 0.050). There were also improvements in the EQ-5D-5L index value, GAD-7 and SQS (p < 0.050). 146 (103.55 %) adverse events were reported in total. Most were considered mild (n = 47; 33.33 %) and moderate (n = 72; 51.06 %).
This preliminary analysis demonstrates a possible association with improved general health-related quality of life in those prescribed CBMPs for MS. Moreover, the results suggest that CBMPs are well-tolerated in the first 6 months of treatment. However, this must be interpreted with caution considering the limitations of the observational study design.
虽然疾病修饰疗法是多发性硬化症（MS）治疗的基石，但仍需要开发新的疗法来治疗该疾病的症状后遗症。基于大麻的药用产品（CBMPs）已被提议作为治疗相关疼痛、痉挛和心理健康障碍的潜在疗法。然而，在 MS 中，关于 CBMPs 的临床证据很少。本研究的目的是评估在英国医用大麻登记处（UKMCR）中为 MS 开具 CBMP 处方的患者的 MS 特异性和一般健康相关生活质量（HRQoL）结果的变化以及不良事件发生率。
从 UKMCR 中确定了为 MS 症状开具 CBMP 处方超过一个月的患者。主要结局是在一个月、三个月和六个月时，MS 生活质量 54 项（MSQoL-54）、广泛性焦虑症 7 项（GAD-7）、单项睡眠质量量表（SQS）和 EQ-5D-5L 量表的基线变化。p < 0.050 被定义为统计学显著。
141 名患者符合研究纳入标准。在 6 个月时，以下 MSQoL-54 子量表得到改善：健康状况变化、认知功能、心理健康成分、身体健康、由于身体限制和由于情绪问题导致的角色限制、社会和性功能（p < 0.050）。EQ-5D-5L 指数值、GAD-7 和 SQS 也有所改善（p < 0.050）。总共报告了 146 例（103.55%）不良事件。大多数被认为是轻度（n = 47；33.33%）和中度（n = 72；51.06%）。
这项初步分析表明，对于为 MS 开具 CBMP 处方的患者，总体健康相关生活质量可能有所改善。此外，结果表明，在治疗的头 6 个月内，CBMPs 耐受良好。然而，考虑到观察性研究设计的局限性，必须谨慎解释这些结果。
