Avon and Wiltshire Mental Health Partnership NHS Trust, Colston Fort, Montague Pl, Bristol, BS6 5UB, UK.
King's College London, Strand, London, WC2R 2LS, UK.
Psychopharmacology (Berl). 2022 May;239(5):1147-1155. doi: 10.1007/s00213-021-05855-2. Epub 2021 May 10.
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).
医用大麻治疗多种疾病的治疗潜力正日益受到认可。在全球范围内，许多国家已经将大麻合法化用于医疗用途，大量患者能够获得药物。然而，在英国，医用大麻于 2018 年 11 月合法化，但只有少数 NHS 处方，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有很多，包括由于通过随机对照试验研究医用大麻存在挑战，因此临床证据不足。为了建立目前的证据基础，人们逐渐认识到采用真实世界数据（RWD）来评估医用大麻的有效性和疗效的重要性。本文详细介绍了 2021 年项目（T21），这是英国首个医用大麻注册处，于 2020 年 8 月启动。我们提供了 T21 的基本原理，并描述了方法，然后报告了该注册处首批入组患者的特征。我们描述了项目运行的头 7 个月内所有入组患者的健康状况，以及这些患者的社会人口统计学特征和主要表现疾病，以及为这些个体开出的医用大麻的详细信息。截至 2021 年 3 月 12 日，已有 678 人入组 T21；其中大多数（64%）为男性，平均年龄为 38.7 岁（范围 18-80 岁）。报告的主要疾病最常见的是慢性疼痛（55.6%）和焦虑症（32.0%），他们报告了多种疾病，包括失眠和抑郁的高发病率。我们还介绍了 75 名随访 3 个月后的患者的初步证据，表明接受合法处方大麻与自我报告健康状况显著改善相关，使用 EQ-5D-5L 的视觉模拟量表评估（Cohen's d =.77，95%CI =.51-1.03）。我们的初步发现与全球其他大型数据库的报告相补充，表明目前的 RWD 正在建立证据模式。由于许多临床医生要求更好、更快的证据来为他们开具医用大麻处方的决策提供信息，因此 T21 的当前和未来结果将扩大基于大麻类药物的医疗产品（CBMPs）有效性的现有证据基础。
