PMID- 37079302 OWN - NLM STAT- MEDLINE DCOM- 20230424 LR - 20230425 IS - 2574-3805 (Electronic) IS - 2574-3805 (Linking) VI - 6 IP - 4 DP - 2023 Apr 3 TI - Adverse Events of Cannabidiol Use in Patients With Epilepsy: A Systematic Review and Meta-analysis. PG - e239126 LID - 10.1001/jamanetworkopen.2023.9126 [doi] LID - e239126 AB - IMPORTANCE: 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). OBJECTIVE: To investigate the frequency and risk of AEs developing in patients with epilepsy who are using CBD. DATA SOURCES: 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). STUDY SELECTION: The review included all randomized clinical trials that investigated at least 1 AE from the use of CBD in patients with epilepsy. DATA EXTRACTION AND SYNTHESIS: 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. MAIN OUTCOMES AND MEASURES: Frequency of each AE and risk of developing each AE in patients with epilepsy using CBD. RESULTS: 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. CONCLUSIONS AND RELEVANCE: 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. FAU - Fazlollahi, Asra AU - Fazlollahi A AD - Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran. FAU - Zahmatyar, Mahdi AU - Zahmatyar M AD - Research Center for Integrative Medicine in Aging, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. FAU - ZareDini, Mahta AU - ZareDini M AD - Social Determinants of Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. FAU - Golabi, Behnam AU - Golabi B AD - Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran. FAU - Nejadghaderi, Seyed Aria AU - Nejadghaderi SA AD - Research Center for Integrative Medicine in Aging, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. AD - Systematic Review and Meta-analysis Expert Group, Universal Scientific Education and Research Network, Tehran, Iran. FAU - Sullman, Mark J M AU - Sullman MJM AD - Department of Life and Health Sciences, University of Nicosia, Nicosia, Cyprus. AD - Department of Social Sciences, University of Nicosia, Nicosia, Cyprus. FAU - Gharagozli, Koroush AU - Gharagozli K AD - Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. FAU - Kolahi, Ali-Asghar AU - Kolahi AA AD - Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. FAU - Safiri, Saeid AU - Safiri S AD - Neurosciences Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. AD - Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Systematic Review DEP - 20230403 PL - United States TA - JAMA Netw Open JT - JAMA network open JID - 101729235 RN - 19GBJ60SN5 (Cannabidiol) SB - IM MH - Humans MH - *Cannabidiol/adverse effects MH - *Epilepsy/drug therapy MH - Seizures/drug therapy MH - Bias PMC - PMC10119734 COIS- Conflict of Interest Disclosures: Dr Gharagozli reported receiving grants from the Brain Mapping Research Center during the conduct of the study. No other disclosures were reported. EDAT- 2023/04/20 13:41 MHDA- 2023/04/24 06:42 PMCR- 2023/04/20 CRDT- 2023/04/20 11:33 PHST- 2023/04/24 06:42 [medline] PHST- 2023/04/20 13:41 [pubmed] PHST- 2023/04/20 11:33 [entrez] PHST- 2023/04/20 00:00 [pmc-release] AID - 2803957 [pii] AID - zoi230291 [pii] AID - 10.1001/jamanetworkopen.2023.9126 [doi] PST - epublish SO - JAMA Netw Open. 2023 Apr 3;6(4):e239126. doi: 10.1001/jamanetworkopen.2023.9126.