@article{ref1,
title="Herbal traditional Chinese medicine and suspected liver injury: a prospective study",
journal="World journal of hepatology",
year="2017",
author="Melchart, Dieter and Hager, Stefan and Albrecht, Sabine and Dai, Jingzhang and Weidenhammer, Wolfgang and Teschke, Rolf",
volume="9",
number="29",
pages="1141-1157",
abstract="AIM: 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. <br><br>METHODS: 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. <br><br>RESULTS: 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. <br><br>CONCLUSION: 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.<p /> <p>Language: en</p>",
language="en",
issn="1948-5182",
doi="10.4254/wjh.v9.i29.1141",
url="http://dx.doi.org/10.4254/wjh.v9.i29.1141"
}