Pillai Manaswini, Erridge Simon, Bapir Lara, Nicholas Martha, Dalavaye Nishaanth, Holvey Carl, Coomber Ross, Barros Daniela, Bhoskar Urmila, Mwimba Gracia, Praveen Kavita, Symeon Chris, Sachdeva-Mohan Simmi, Rucker James J, Sodergren Mikael H
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. 2022 Nov-Dec;22(11-12):1009-1018. doi: 10.1080/14737175.2022.2155139. Epub 2022 Dec 12.
The current paucity of clinical evidence limits the use of cannabis-based medicinal products (CBMPs) in post-traumatic stress disorder (PTSD). This study investigates health-related quality of life (HRQoL) changes and adverse events in patients prescribed CBMPs for PTSD.
A case-series of patients from the UK Medical Cannabis Registry was analyzed. HRQoL was assessed at 1-, 3-, and 6-months using validated patient reported outcome measures (PROMs). Adverse events were analyzed according to the Common Terminology Criteria for Adverse Events version 4.0. Statistical significance was defined as p < 0.050.
Of 162 included patients, 88.89% (n = 144) were current/previous cannabis users. Median daily CBMP dosages were 5.00 (IQR: 0.00-70.00) mg of cannabidiol and 145.00 (IQR: 100.00-200.00) mg of Δ9-tetrahydrocannabinol. Significant improvements were observed in PTSD symptoms, sleep, and anxiety across all follow-up periods (p < 0.050). There were 220 (135.8%) adverse events reported by 33 patients (20.37%), with the majority graded mild or moderate in severity (n = 190, 117.28%). Insomnia and fatigue had the greatest incidence (n = 20, 12.35%).
Associated improvements in HRQoL were observed in patients who initiated CBMP therapy. Adverse events analysis suggests acceptability and safety up to 6 months. This study may inform randomized placebo-controlled trials, required to confirm causality and determine optimal dosing.
目前临床证据匮乏，限制了基于大麻的药用产品（CBMPs）在创伤后应激障碍（PTSD）中的应用。本研究调查了因PTSD而服用CBMPs的患者的健康相关生活质量（HRQoL）变化及不良事件。
对来自英国医用大麻注册库的一系列病例进行分析。使用经过验证的患者报告结局指标（PROMs）在1个月、3个月和6个月时评估HRQoL。根据不良事件通用术语标准第4.0版分析不良事件。统计学显著性定义为p < 0.050。
在纳入的162例患者中，88.89%（n = 144）为当前/既往大麻使用者。CBMPs的每日中位剂量为5.00（四分位间距：0.00 - 70.00）mg大麻二酚和145.00（四分位间距：100.00 - 200.00）mg Δ9 - 四氢大麻酚。在所有随访期间，PTSD症状、睡眠和焦虑均有显著改善（p < 0.050）。33例患者（20.37%）报告了220起（135.8%）不良事件，大多数严重程度为轻度或中度（n = 190，117.28%）。失眠和疲劳的发生率最高（n = 20，12.35%）。
开始CBMP治疗的患者的HRQoL有相关改善。不良事件分析表明在6个月内具有可接受性和安全性。本研究可为随机安慰剂对照试验提供参考，以确认因果关系并确定最佳剂量。
