title: The mystery of the Hawaii liver disease cluster in summer 2013: A pragmatic and clinical approach to solve the problem.
abstract: OBJECTIVE
  In the fall of 2013, the US Centers for Disease Control and Prevention (CDC) published a preliminary report on a cluster of liver disease cases that emerged in Hawaii in the summer 2013. This report claimed a temporal association as sufficient evidence that OxyELITE Pro (OEP), a dietary supplement (DS) mainly for weight loss, was the cause of this mysterious cluster. However, the presented data were inconsistent and required a thorough reanalysis.
  
  
  METHODS
  To further investigate the cause(s) of this cluster, we critically evaluated redacted raw clinical data of the cluster patients, as the CDC report received tremendous publicity in local and nationwide newspapers and television. This attention put regulators and physicians from the medical center in Honolulu that reported the cluster, under enormous pressure to succeed, risking biased evaluations and hasty conclusions.
  
  
  RESULTS
  We noted pervasive bias in the documentation, conclusions, and public statements, also poor quality of case management. Among the cases we reviewed, many causes unrelated to any DS were evident, including decompensated liver cirrhosis, acute liver failure by acetaminophen overdose, acute cholecystitis with gallstones, resolving acute hepatitis B, acute HSV and VZV hepatitis, hepatitis E suspected after consumption of wild hog meat, and hepatotoxicity by acetaminophen or ibuprofen. Causality assessments based on the updated CIOMS scale confirmed the lack of evidence for any DS including OEP as culprit for the cluster.
  
  
  CONCLUSIONS
  Thus, the Hawaii liver disease cluster is now best explained by various liver diseases rather than any DS, including OEP.
authors.affiliation: Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Teaching Hospital of the Medical Faculty, Goethe University Frankfurt/ Main, Germany.
authors.forename: Rolf
authors.initials: R
authors.lastname: Teschke
authors.affiliation: Institute of Industrial, Environmental and Social Medicine, Medical Faculty, Goethe University Frankfurt/Main, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Schwarzenboeck
authors.affiliation: Institute of Industrial, Environmental and Social Medicine, Medical Faculty, Goethe University Frankfurt/Main, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Frenzel
authors.affiliation: Institute of Industrial, Environmental and Social Medicine, Medical Faculty, Goethe University Frankfurt/Main, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Schulze
authors.affiliation: Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Teaching Hospital of the Medical Faculty, Goethe University Frankfurt/ Main, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Eickhoff
authors.affiliation: Department of Internal Medicine II, Division of Gastroenterology, Hepatology and Infectious Diseases, Friedrich Schiller University Jena, Germany.
authors.forename: Albrecht
authors.initials: A
authors.lastname: Wolff
mesh_terms: D000328:Adult; D019440:Anti-Obesity Agents / Q000009:adverse effects*; D015982:Bias; D002487:Centers for Disease Control and Prevention, U.S.; D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy; D016000:Cluster Analysis; D000068598:Data Accuracy; D016208:Databases, Factual; D019587:Dietary Supplements / Q000009:adverse effects*; D005260:Female; D006254:Hawaii / Q000453:epidemiology; D006801:Humans; D008107:Liver Diseases / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D033262:Narration; D011379:Prognosis; D012107:Research Design; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012621:Seasons; D013997:Time Factors; D014481:United States
chemical_list: D019440:Anti-Obesity Agents