title: Herb-Induced Liver Injury in the Berlin Case-Control Surveillance Study.
abstract: Herb-induced liver injury (HILI) has recently attracted attention due to increasing reports of hepatotoxicity associated with use of phytotherapeutics. Here, we present data on HILI from the Berlin Case-Control Surveillance Study. The study was initiated in 2000 to investigate the serious toxicity of drugs including herbal medicines. Potential cases of liver injury were ascertained in more than 180 Departments of all 51 Berlin hospitals from October 2002 to December 2011. Drug or herb intake was assessed through a standardized face-to-face interview. Drug or herbal aetiology was assessed based on the updated Council for International Organizations of Medical Sciences scale. In ten of all 198 cases of hepatotoxicity included in the study, herbal aetiology was assessed as probable (once ayurvedic herb) or possible (Valeriana five times, Mentha piperita once, Pelargonium sidoides once, Hypericum perforatum once, Eucalyptus globulus once). Mean age was 56.4 ± 9.7 years, and the predominant pattern of liver injury was hepatocellular. No cases of acute liver failure or death were observed. This case series corroborates known risks for ayurvedic herbs, supports the suspected association between Valeriana use and liver injury, and indicates a hepatotoxic potential for herbs such as Pelargonium sidoides, Hypericum perforatum or Mentha piperita that were rarely associated with liver injury before. However, given that possible causality does not prove clinical significance, further studies in this field are needed.
authors.affiliation: Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany. antonios.douros@charite.de.
authors.forename: Antonios
authors.initials: A
authors.lastname: Douros
authors.affiliation: Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany. elisabeth.bronder@t-online.de.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Bronder
authors.affiliation: Institute for Social Medicine, Epidemiology and Health Economy, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany. frank.andersohn@charite.de.
authors.forename: Frank
authors.initials: F
authors.lastname: Andersohn
authors.affiliation: Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany. andreas.klimpel@t-online.de.
authors.forename: Andreas
authors.initials: A
authors.lastname: Klimpel
authors.affiliation: Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany. reinhold.kreutz@charite.de.
authors.forename: Reinhold
authors.initials: R
authors.lastname: Kreutz
authors.affiliation: Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany. garbe@bips.uni-bremen.de.|Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology-BIPS, 28359 Bremen, Germany. garbe@bips.uni-bremen.de.
authors.forename: Edeltraut
authors.initials: E
authors.lastname: Garbe
authors.affiliation: Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany. juliane.bolbrinker@charite.de.
authors.forename: Juliane
authors.initials: J
authors.lastname: Bolbrinker
mesh_terms: D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology*; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D028321:Plant Preparations / Q000009:adverse effects* / Q000633:toxicity
chemical_list: D028321:Plant Preparations
keywords: hepatotoxicity; pharmacovigilance; phytotherapeutics