Published online Oct 18, 2017. doi: 10.4254/wjh.v9.i29.1141
Peer-review started: May 27, 2017
First decision: July 11, 2017
Revised: July 26, 2017
Accepted: August 16, 2017
Article in press: August 17, 2017
Published online: October 18, 2017
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.
Core tip: Worldwide research on herbal medicine safety is still limited. Adverse effects are range from clinically not relevant to more severe ones including suspected liver injury. We conducted a prospective hospital-based study to report the number of new liver injury in patients with no liver disease prior to treatment with herbal Traditional Chinese Medicine. Liver injury was detected in 26/21470 patients (0.12%) with alanine aminotransferase values of ≥ 5 × upper limit normal. The Roussel Uclaf Causality Assessment Method assessed the causality of suspected cases and showed a causality level of “possible” for the majority of the liver injury cases.