Jugl Sebastian, Okpeku Aimalohi, Costales Brianna, Morris Earl J, Alipour-Haris Golnoosh, Hincapie-Castillo Juan M, Stetten Nichole E, Sajdeya Ruba, Keshwani Shailina, Joseph Verlin, Zhang Yahan, Shen Yun, Adkins Lauren, Winterstein Almut G, Goodin Amie
Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, Florida, USA.
Center for Drug Evaluation and Safety (CoDES), University of Florida, Gainesville, Florida, USA.
Med Cannabis Cannabinoids. 2021 Feb 25;4(1):21-42. doi: 10.1159/000515069. eCollection 2021 Jun.
In 2017, a National Academies of Sciences, Engineering, and Medicine (NASEM) report comprehensively evaluated the body of evidence regarding cannabis health effects through the year 2016. The objectives of this study are to identify and map the most recently (2016-2019) published literature across approved conditions for medical cannabis and to evaluate the quality of identified recent systematic reviews, published following the NASEM report. Following the literature search from 5 databases and consultation with experts, 11 conditions were identified for evidence compilation and evaluation: amyotrophic lateral sclerosis, autism, cancer, chronic noncancer pain, Crohn's disease, epilepsy, glaucoma, human immunodeficiency virus/AIDS, multiple sclerosis (MS), Parkinson's disease, and posttraumatic stress disorder. A total of 198 studies were included after screening for condition-specific relevance and after imposing the following exclusion criteria: preclinical focus, non-English language, abstracts only, editorials/commentary, case studies/series, and non-U.S. study setting. Data extracted from studies included: study design type, outcome definition, intervention definition, sample size, study setting, and reported effect size. Few completed randomized controlled trials (RCTs) were identified. Studies classified as systematic reviews were graded using the Assessing the Methodological Quality of Systematic Reviews-2 tool to evaluate the quality of evidence. Few high-quality systematic reviews were available for most conditions, with the exceptions of MS (9 of 9 graded moderate/high quality; evidence for 2/9 indicating cannabis improved outcomes; evidence for 7/9 indicating cannabis inconclusive), epilepsy (3 of 4 graded moderate/high quality; 3 indicating cannabis improved outcomes; 1 indicating cannabis inconclusive), and chronic noncancer pain (12 of 13 graded moderate/high quality; evidence for 7/13 indicating cannabis improved outcomes; evidence from 6/7 indicating cannabis inconclusive). Among RCTs, we identified few studies of substantial rigor and quality to contribute to the evidence base. However, there are some conditions for which significant evidence suggests that select dosage forms and routes of administration likely have favorable risk-benefit ratios (i.e., epilepsy and chronic noncancer pain). The body of evidence for medical cannabis requires more rigorous evaluation before consideration as a treatment option for many conditions, and evidence necessary to inform policy and treatment guidelines is currently insufficient for many conditions.
2017年,美国国家科学院、工程院和医学院(NASEM)发布了一份报告,全面评估了截至2016年有关大麻对健康影响的证据。本研究的目的是识别和梳理2016年至2019年期间发表的关于医用大麻获批适用病症的最新文献,并评估在NASEM报告发布后发表的已识别近期系统评价的质量。在对5个数据库进行文献检索并咨询专家后,确定了11种病症进行证据汇编和评估:肌萎缩侧索硬化症、自闭症、癌症、慢性非癌性疼痛、克罗恩病、癫痫、青光眼、人类免疫缺陷病毒/艾滋病、多发性硬化症(MS)、帕金森病和创伤后应激障碍。在根据病症特异性相关性进行筛选并应用以下排除标准后,共纳入了198项研究:临床前研究重点、非英语语言、仅摘要、社论/评论、病例研究/系列以及非美国研究背景。从研究中提取的数据包括:研究设计类型、结果定义、干预定义、样本量、研究背景以及报告的效应量。几乎没有发现完整的随机对照试验(RCT)。被归类为系统评价的研究使用“系统评价方法学质量评估 - 2”工具进行分级,以评估证据质量。对于大多数病症,几乎没有高质量的系统评价,多发性硬化症(9项中有9项评为中等/高质量;9项中有2项表明大麻改善了结果;9项中有7项表明大麻效果不明确)、癫痫(4项中有3项评为中等/高质量;3项表明大麻改善了结果;1项表明大麻效果不明确)和慢性非癌性疼痛(13项中有12项评为中等/高质量;13项中有7项表明大麻改善了结果;7项中有6项表明大麻效果不明确)除外。在RCT中,我们发现很少有具有足够严谨性和质量的研究能为证据库做出贡献。然而,在某些病症方面,有重要证据表明特定剂型和给药途径可能具有有利的风险效益比(即癫痫和慢性非癌性疼痛)。在将医用大麻考虑作为许多病症的治疗选择之前,其证据主体需要更严格的评估,而且目前许多病症缺乏为政策和治疗指南提供信息所需的证据。