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World J Hepatol. 2017 Oct 18;9(29):1141-1157. doi: 10.4254/wjh.v9.i29.1141.

Herbal Traditional Chinese Medicine and suspected liver injury: A prospective study.

Author information

Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, CH-8091 Zurich, Switzerland.
Hospital for Traditional Chinese Medicine, D-93444 Bad Kötzting, Germany.
Competence Centre for Complementary Medicine and Naturopathy (CoCoNat), University Hospital Munich rechts der Isar, Technical University of Munich, D-80801 Munich, Germany.
Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Teaching Hospital of the Medical Faculty of the Goethe University, D-63450 Hanau, Frankfurt/Main, Germany.



To analyze liver tests before and following treatment with herbal Traditional Chinese Medicine (TCM) in order to evaluate the frequency of newly detected liver injury.


Patients with normal values of alanine aminotransferase (ALT) as a diagnostic marker for ruling out pre-existing liver disease were enrolled in a prospective study of a safety program carried out at the First German Hospital of TCM from 1994 to 2015. All patients received herbal products, and their ALT values were reassessed 1-3 d prior to discharge. To verify or exclude causality for suspected TCM herbs, the Roussel Uclaf Causality Assessment Method (RUCAM) was used.


This report presents for the first time liver injury data derived from a prospective, hospital-based and large-scale study of 21470 patients who had no liver disease prior to treatment with herbal TCM. Among these, ALT ranged from 1 × to < 5 × upper limit normal (ULN) in 844 patients (3.93%) and suggested mild or moderate liver adaptive abnormalities. However, 26 patients (0.12%) experienced higher ALT values of ≥ 5 × ULN (300.0 ± 172.9 U/L, mean ± SD). Causality for TCM herbs was RUCAM-based probable in 8/26 patients, possible in 16/26, and excluded in 2/26 cases. Bupleuri radix and Scutellariae radix were the two TCM herbs most commonly implicated.


In 26 (0.12%) of 21470 patients treated with herbal TCM, liver injury with ALT values of ≥ 5 × ULN was found, which normalized shortly following treatment cessation, also substantiating causality.


Herb induced liver injury; Herbal medicine; Liver injury; Roussel Uclaf Causality Assessment Method; Traditional Chinese Medicine

Conflict of interest statement

Conflict-of-interest statement: Albrecht, Hager and Dai belong to the medical personnel of the TCM hospital in Bad Kötzting. Melchart is head of the scientific board of the TCM hospital in Bad Kötzting taking part in voluntary service. None financial disclosure of all authors is declared.

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