title: Systematic Review of Adverse Effects from Herbal Drugs Reported in Randomized Controlled Trials.
abstract: Herbal drugs have become a popular form of healthcare, raising concerns about their safety. This study aimed to characterize the adverse effects of herbal drugs through a systematic review of results reported in randomized controlled trials (RCTs). Using eight electronic databases including PubMed, the Cochrane library and six Korean medical databases, the frequency of reported toxicity was recorded based on drug composition and indication. Among 4957 potentially relevant articles, 242 papers comprised of 244 studies met our inclusion criteria; these included 111 studies of a single herb and 133 of multiple herbs. These studies accounted for a total 15 441 participants (male = 5590; female = 9851; 7383 for single and 8058 for multiple herb studies). There were 480 cases (3.1%) of adverse events (344 for single, 136 for multiple herb studies; p < 0.01). A total of 259 cases reported blood test abnormalities, including five cases of abnormality in hepatic functional enzymes. The most frequently reported adverse event was digestive symptoms (44.3%), followed by nervous system symptoms (17.3%) and behaviors such as loss of appetite (16.3%). This is the first systematic review of adverse effects of herbal drugs among clinical studies, and the results indicate that herbal drugs are relatively safe. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Korean Medical College of Daejeon University, 22-5 Yongwoon-dong, Dong-gu, Daejeon, 301-724, Korea.
authors.forename: Ji Young
authors.initials: JY
authors.lastname: Lee
authors.affiliation: Korean Medical College of Daejeon University, 22-5 Yongwoon-dong, Dong-gu, Daejeon, 301-724, Korea.
authors.forename: Seung Ah
authors.initials: SA
authors.lastname: Jun
authors.affiliation: Korean Medical College of Daejeon University, 22-5 Yongwoon-dong, Dong-gu, Daejeon, 301-724, Korea.
authors.forename: Sung Shin
authors.initials: SS
authors.lastname: Hong
authors.affiliation: Department of Health Service Management, Daejeon University, 22-5 Yongwoon-dong, Dong-gu, Daejeon, 301-724, Korea.
authors.forename: Yo Chan
authors.initials: YC
authors.lastname: Ahn
authors.affiliation: Department of Internal Medicine, Daejeon St. Mary's Hospital of the Catholic University, Daejeon, 301-723, Korea.
authors.forename: Dong Soo
authors.initials: DS
authors.lastname: Lee
authors.affiliation: Liver and Immunology Research Center, Daejeon Oriental Hospital of Daejeon University, 22-5 Daeheung-dong, Jung-gu, Daejeon, 301-704, Korea.
authors.forename: Chang Gue
authors.initials: CG
authors.lastname: Son
mesh_terms: D000328:Adult; D064420:Drug-Related Side Effects and Adverse Reactions; D004365:Drugs, Chinese Herbal / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic
chemical_list: D004365:Drugs, Chinese Herbal
keywords: adverse drug reaction; adverse effect; herbal drug; herbal medicine