Imperial College Medical Cannabis Research Group, Department of Surgery and Cancer, Imperial College London, London, UK.
Department of Medicine, Sapphire Medical Clinics, London, UK.
Expert Rev Neurother. 2023 Jan;23(1):85-96. doi: 10.1080/14737175.2023.2174017. Epub 2023 Feb 3.
Headache disorders are a common cause of disability and reduced health-related quality of life globally. Growing evidence supports the use of cannabis-based medicinal products (CBMPs) for chronic pain; however, a paucity of research specifically focuses on CBMPs' efficacy and safety in headache disorders. This study aims to assess changes in validated patient-reported outcome measures (PROMs) in patients with headaches prescribed CBMPs and investigate the clinical safety in this population.
A case series of the UK Medical Cannabis Registry was conducted. Primary outcomes were changes from baseline in PROMs (Headache Impact Test-6 (HIT-6), Migraine Disability Assessment (MIDAS), EQ-5D-5L, Generalized Anxiety Disorder-7 (GAD-7) questionnaire and Single-Item Sleep Quality Scale (SQS)) at 1-, 3-, and 6-months follow-up. P-values <0.050 were deemed statistically significant.
Ninety-seven patients were identified for inclusion. Improvements in HIT-6, MIDAS, EQ-5D-5L and SQS were observed at 1-, 3-, and 6-months (p < 0.005) follow-up. GAD-7 improved at 1- and 3-months (p < 0.050). Seventeen (17.5%) patients experienced a total of 113 (116.5%) adverse events.
Improvements in headache/migraine-specific PROMs and general health-related quality of life were associated with the initiation of CBMPs in patients with headache disorders. Cautious interpretation of results is necessary, and randomized control trials are required to ascertain causality.
头痛障碍是全球范围内导致残疾和降低健康相关生活质量的常见原因。越来越多的证据支持使用基于大麻的药用产品(CBMP)治疗慢性疼痛;然而,针对 CBMP 在头痛障碍中的疗效和安全性的研究很少。本研究旨在评估为头痛患者开具 CBMP 后经验证的患者报告结局测量(PROM)的变化,并调查该人群的临床安全性。
对英国医用大麻登记处进行了病例系列研究。主要结局是从基线到 1、3 和 6 个月随访时 PROM(头痛影响测试-6(HIT-6)、偏头痛残疾评估(MIDAS)、EQ-5D-5L、广泛性焦虑症-7(GAD-7)问卷和单条目睡眠质量量表(SQS))的变化。p 值<0.050 被认为具有统计学意义。
确定了 97 名符合纳入标准的患者。在 1、3 和 6 个月随访时观察到 HIT-6、MIDAS、EQ-5D-5L 和 SQS 的改善(p<0.005)。GAD-7 在 1 和 3 个月时也有所改善(p<0.050)。17 名(17.5%)患者共经历了 113 次(116.5%)不良事件。
在头痛/偏头痛特定的 PROM 和一般健康相关生活质量方面的改善与头痛障碍患者开始使用 CBMP 相关。需要谨慎解释结果,需要进行随机对照试验以确定因果关系。