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Developing a real-world evidence base for prescribed cannabis in the United Kingdom: preliminary findings from Project Twenty21
Psychopharmacology ( IF 3.5 ) Pub Date : 2021-05-10 , DOI: 10.1007/s00213-021-05855-2
C Sakal 1 , M Lynskey 2 , A K Schlag 3 , D J Nutt 3
Affiliation  

The therapeutic potential of medical cannabis to treat a variety of conditions is becoming increasingly recognised. Globally, a large number of countries have now legalised cannabis for medical uses and a substantial number of patients are able to access their medications. Yet in the UK, where medical cannabis was legalised in November 2018, only a handful of NHS prescriptions have been written, meaning that most patients are unable to access the medicine. Reasons for this are manyfold and include the perceived lack of clinical evidence due to the challenges of studying medical cannabis through randomised controlled trials. In order to develop the current evidence base, the importance of incorporating real-world data (RWD) to assess the effectiveness and efficacy of medical cannabis has gradually become recognised. The current paper provides a detailed outline of Project Twenty21 (T21), the UK’s first medical cannabis registry, launched in August 2020. We provide the rationale for T21 and describe the methodology before reporting the characteristics of the ‘first patients’ enrolled in the registry. We describe the health status of all patients enrolled into the project during its first 7 months of operation and the sociodemographic characteristics and primary presenting conditions for these patients, as well as details of the medical cannabis prescribed to these individuals. By 12th March 2021, 678 people had been enrolled into T21; the majority (64%) were male and their average age was 38.7 years (range = 18–80). The most commonly reported primary conditions were chronic pain (55.6%) and anxiety disorders (32.0%) and they reported high levels of multi-morbidity, including high rates of insomnia and depression. We also present preliminary evidence from 75 patients followed up after 3 months indicating that receipt of legal, prescribed cannabis was associated with a significant increase in self-reported health, assessed using the visual analogue scale of the EQ-5D-5L (Cohen’s d = .77, 95% CI = .51–1.03). Our initial findings complement reports from other large-scale databases globally, indicating that the current RWD is building up a pattern of evidence. With many clinicians demanding better and faster evidence to inform their decisions around prescribing medical cannabis, the current and future results of T21 will expand the existing evidence base on the effectiveness of cannabis-based medical products (CBMPs).



中文翻译:

在英国为处方大麻开发真实世界的证据基础:Twenty 项目的初步调查结果21

医用大麻治疗各种疾病的治疗潜力越来越得到认可。在全球范围内,许多国家现已将医用大麻合法化,并且大量患者能够获得药物。然而,在 2018 年 11 月医用大麻合法化的英国,只有少数 NHS 处方被开出,这意味着大多数患者无法获得这种药物。造成这种情况的原因是多方面的,包括由于通过随机对照试验研究医用大麻的挑战,人们认为缺乏临床证据。为了发展当前的证据基础,结合真实世界数据(RWD)来评估医用大麻的有效性和功效的重要性已逐渐得到认可。目前的论文提供了英国第一个医用大麻登记处 Project Twenty21 (T21) 的详细概述,该登记处于 2020 年 8 月启动。我们提供了 T21 的基本原理,并在报告登记处登记的“第一批患者”的特征之前描述了该方法. 我们描述了在该项目的前 7 个月内参与该项目的所有患者的健康状况,以及这些患者的社会人口学特征和主要表现状况,以及为这些人开具的医用大麻的详细信息。截至 2021 年 3 月 12 日,已有 678 人加入 T21;大多数(64%)为男性,平均年龄为 38.7 岁(范围 = 18-80)。最常报告的原发性疾病是慢性疼痛(55.6%)和焦虑症(32. 0%)并且他们报告了高水平的多种疾病,包括高比例的失眠和抑郁症。我们还提供了 3 个月后随访的 75 名患者的初步证据,表明接受合法的处方大麻与自我报告的健康状况显着增加有关,使用 EQ-5D-5L 的视觉模拟量表(Cohen'sd  = .77, 95% CI = .51–1.03)。我们的初步发现补充了全球其他大型数据库的报告,表明当前的 RWD 正在建立一种证据模式。由于许多临床医生需要更好、更快的证据来为他们开具医用大麻处方的决定提供信息,T21当前和未来的结果将扩大现有的基于大麻的医疗产品( CBMPs )有效性的证据基础。

更新日期:2021-05-10
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