title: Safety Profiles ofTripterygium wilfordiiHook F: A Systematic Review and Meta-Analysis.
abstract: Objective:Tripterygium wilfordiiHook F (TwHF) is a widely used and effective treatment for inflammatory diseases. There have been concerns about its toxicity but no adequate synthesis of the evidence for adverse events (AEs). We aimed to undertake a clinically informative, systematic safety profile of TwHF.Methods:We undertook a systematic review and meta-analysis of experimental studies and observational studies. We searched electronic databases and conference abstracts. Safety outcomes were rates of common AEs.Results:We screened 4137 abstracts for eligibility and included 594 studies in the analysis. The overall incidence of AEs was 26.7% (95% CI 24.8%, 28.8%) in 23,256 TwHF users. The estimates did vary markedly when stratified by specific study types. The incidence of gastrointestinal symptoms, adverse reproductive outcomes, adverse skin reactions, hematologic events and cardiovascular events were 13.3% (95% CI 11.9%, 14.9%), 11.7% (95% CI 10.3%, 13.3%), 7.8% (95% CI 6.3-9.5%), 6.5% (95% CI 5.7-7.4 %) and 4.9% (95% CI 1.6 %, 14.3 %), respectively. The prevalence of irregular menstruation (IM) was increased in patients taking TwHF compared with those given control (odds ratio [OR] 4.65, 95% CI 3.08 to 7.03). TwHF use has lower risk of weight gain (OR 0.12 [95% CI 0.04 to 0.39]) and hair loss (OR 0.37 [95% CI 0.18 to 0.78]). Furthermore, long-term aspirin use (>6 months) has a higher AEs incidence (31.0% [95% CI 24.5%-38.5%]).Conclusion:Our findings suggest that more than one in four patients who were taking TwHF had experienced AEs. A clear need exists for improved understanding of contributing risk factors, as well as of prevention and management strategies to improve patients' tolerance for TwHF.
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical SciencesBeijing, China; School of Chinese Medicine, Hong Kong Baptist UniversityKowloon, Hong Kong.
authors.forename: Chi
authors.initials: C
authors.lastname: Zhang
authors.affiliation: School of Basic Medical Sciences, Beijing University of Chinese Medicine Beijing, China.
authors.forename: Ping-Ping
authors.initials: PP
authors.lastname: Sun
authors.affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine Zhengzhou, China.
authors.forename: Hong-Tao
authors.initials: HT
authors.lastname: Guo
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.affiliation: School of Basic Medical Sciences, Beijing University of Chinese Medicine Beijing, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Li
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical SciencesBeijing, China; School of Chinese Medicine, Hong Kong Baptist UniversityKowloon, Hong Kong.
authors.forename: Xiao-Juan
authors.initials: XJ
authors.lastname: He
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University Kowloon, Hong Kong.
authors.forename: Ai-Ping
authors.initials: AP
authors.lastname: Lu
keywords: Tripterygium wilfordii Hook F; adverse event; meta-analysis; safety; systematic review