Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.
Research Center for Integrative Medicine in Aging, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.
JAMA Netw Open. 2023 Apr 3;6(4):e239126. doi: 10.1001/jamanetworkopen.2023.9126.
Epilepsy is one of the most common neurologic disorders globally. Cannabidiol (CBD) has been approved for the treatment of epilepsy, but its use has been associated with several different adverse events (AEs).
To investigate the frequency and risk of AEs developing in patients with epilepsy who are using CBD.
PubMed, Scopus, Web of Science, and Google Scholar were searched for relevant studies published from database inception up to August 4, 2022. The search strategy included a combination of the following keywords: (cannabidiol OR epidiolex) AND (epilepsy OR seizures).
The review included all randomized clinical trials that investigated at least 1 AE from the use of CBD in patients with epilepsy.
Basic information about each study was extracted. I2 statistics were calculated using Q statistics to assess the statistical heterogeneity among the included studies. A random-effects model was used in cases of substantial heterogeneity, and a fixed-effects model was used if the I2 statistic for the AEs was lower than 40%. This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline.
Frequency of each AE and risk of developing each AE in patients with epilepsy using CBD.
Nine studies were included. Overall incidences of 9.7% in the CBD group and 4.0% in the control group were found for any grade AEs. The overall risk ratios (RRs) for any grade and severe grade AEs were 1.12 (95% CI, 1.02-1.23) and 3.39 (95% CI, 1.42-8.09), respectively, for the CBD group compared with the control group. Compared with the control group, the CBD group had a greater risk for incidence of serious AEs (RR, 2.67; 95% CI, 1.83-3.88), AEs resulting in discontinuation (RR, 3.95; 95% CI, 1.86-8.37), and AEs resulting in dose reduction (RR, 9.87; 95% CI, 5.34-14.40). Because most of the included studies had some risk of bias (3 raised some concerns and 3 were at high risk of bias), these findings should be interpreted with some caution.
In this systematic review and meta-analysis of clinical trials, the use of CBD to treat patients with epilepsy was associated with an increased risk of several AEs. Additional studies are needed to determine the safe and effective CBD dosage for treating epilepsy.
癫痫是全球最常见的神经疾病之一。大麻二酚（CBD）已被批准用于治疗癫痫，但它的使用与几种不同的不良事件（AE）有关。
调查使用 CBD 的癫痫患者发生 AE 的频率和风险。
从数据库建立到 2022 年 8 月 4 日，在 PubMed、Scopus、Web of Science 和 Google Scholar 上搜索了有关使用 CBD 治疗癫痫患者的相关研究。搜索策略包括以下关键词的组合：（大麻二酚或 Epidiolex）和（癫痫或癫痫发作）。
该综述包括所有至少调查了 CBD 在癫痫患者中使用的 1 种 AE 的随机临床试验。
提取了每项研究的基本信息。使用 Q 统计量计算 I2 统计量，以评估纳入研究之间的统计学异质性。如果 AE 的 I2 统计量低于 40%，则使用固定效应模型；如果存在显著异质性，则使用随机效应模型。本研究按照系统评价和荟萃分析的首选报告项目（PRISMA）指南进行。
使用 CBD 的癫痫患者中每种 AE 的发生率和发生每种 AE 的风险。
纳入了 9 项研究。CBD 组任何等级 AE 的总体发生率为 9.7%，对照组为 4.0%。与对照组相比，CBD 组任何等级和严重等级 AE 的风险比（RR）分别为 1.12（95%CI，1.02-1.23）和 3.39（95%CI，1.42-8.09）。与对照组相比，CBD 组发生严重 AE（RR，2.67；95%CI，1.83-3.88）、导致停药（RR，3.95；95%CI，1.86-8.37）和导致剂量减少（RR，9.87；95%CI，5.34-14.40）的风险更高。由于大多数纳入的研究存在一定的偏倚风险（3 项研究存在一些问题，3 项研究存在高偏倚风险），因此应谨慎解释这些发现。
在这项对临床试验的系统评价和荟萃分析中，使用 CBD 治疗癫痫患者与几种 AE 的风险增加有关。需要进一步的研究来确定治疗癫痫的安全有效的 CBD 剂量。
