title: Suspected black cohosh hepatotoxicity: no evidence by meta-analysis of randomized controlled clinical trials for isopropanolic black cohosh extract.
abstract: OBJECTIVE
  Black cohosh, a popular herbal treatment for menopausal symptoms, has been implicated in a number of hepatotoxicity case reports. The purpose of this investigation was to analyze data gained from clinical trials on the effect of black cohosh on liver function.
  
  
  METHODS
  A meta-analysis of randomized, double-blind, and controlled clinical trials was conducted. These studies primarily evaluated the efficacy and safety of the isopropanolic black cohosh extract (iCR) in perimenopausal and postmenopausal women. Raw data on liver function values of aspartate aminotransferase, alanine aminotransferase, and γ-glutamyltranspeptidase were considered in this analysis, if these data at baseline and after 3 to 6 months of treatment were available. Standard methods of descriptive statistics were used in this analysis.
  
  
  RESULTS
  Five studies involving a total of 1,117 women were included in the meta-analyses. A total of 1,020 women (test population=517 and reference population=503) completed the studies. Perimenopausal and postmenopausal women (40-60 y) were treated daily with iCR (corresponding to 40-128 mg drug) for 3 to 6 months. The meta-analyses of the standardized mean differences in the "test" versus "reference" showed no significant effects and no differences between double-blind, placebo-controlled and other trials. The overall fixed effect ± SEM was 0.055 ± 0.062 (P=0.37) for aspartate aminotransferase and 0.063 ± 0.062 (P=0.31) for alanine aminotransferase. The nonsignificant effects concerned the overall analyses of all included studies as well as the proportion of placebo-controlled studies.
  
  
  CONCLUSIONS
  The results of this meta-analysis of five randomized, double-blind, and controlled clinical trials showed no evidence that iCR has any adverse effect on liver function.
authors.affiliation: Schaper & Brümmer GmbH & Co. KG, Salzgitter, Germany. belal.naser@schaper-bruemmer.de
authors.forename: Belal
authors.initials: B
authors.lastname: Naser
authors.forename: Jörg
authors.initials: J
authors.lastname: Schnitker
authors.forename: Mary Jane
authors.initials: MJ
authors.lastname: Minkin
authors.forename: Susana Garcia
authors.initials: SG
authors.lastname: de Arriba
authors.forename: Klaus-Ulrich
authors.initials: KU
authors.lastname: Nolte
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Osmers
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000378:metabolism; D001219:Aspartate Aminotransferases / Q000378:metabolism; D056486:Chemical and Drug Induced Liver Injury / Q000201:enzymology; D031885:Cimicifuga / Q000737:chemistry*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy* / Q000201:enzymology; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000201:enzymology; D008111:Liver Function Tests; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D005723:gamma-Glutamyltransferase / Q000378:metabolism
chemical_list: D010936:Plant Extracts; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase