Corticosteroid plus glycyrrhizin therapy for chronic drug‐ or herb‐induced liver injury achieves biochemical and histological improvements: a randomised open‐label trial

• DOI: 10.1111/apt.16902
• Publication Date: 2022-04-01T02:51:44Z
• Authors: Jia‐Bo Wang; Ang Huang; Yijin Wang; Dong Ji; Qing‐Sheng Liang; Jun Zhao; Guangde Zhou; Shuhong Liu; Ming Niu; Ying Sun; Hui Tian; Guang‐Ju Teng; Bin‐Xia Chang; Jing‐Feng Bi; Xiao‐Xia Peng; Shaojie Xin; Huan Xie; Xiong Ma; Yi‐Min Mao; Suthat Liangpunsakul; Romil Saxena; Guruprasad P. Aithal; Xiao‐He Xiao; Jingmin Zhao; Zhengsheng Zou
• Keywords: Glycyrrhizin; Open label

Summary Background Treatment of chronic drug‐induced liver injury (DILI) or herb‐induced injury(HILI) is an important and unresolved challenge. There no consensus regarding the indications for corticosteroids DILI/HILI. Aims To investigate efficacy safety corticosteroid plus glycyrrhizin patients with Methods This was a randomised open‐label trial. Eligible causality assessment using updated RUCAM were randomly assigned (1:1) either to steroid treatment group (48‐week stepwise dose reduction methylprednisolone glycyrrhizin) control (glycyrrhizin alone). Liver biopsies performed at baseline end 48‐week period. The primary outcome proportion sustained biochemical response (SBR). secondary outcomes improvement in histology, time normalisation safety. Results Of 80 participants, 70 (87.5%) completed predominantly female (77.5%), aged >40 years (77.5%) had hepatocellular pattern DILI (71.2%). Compared group, showed higher SBR (94.3% vs. 71.4%, p = 0.023), shorter histological improvements both activity fibrosis. HILI subgroups, as well autoimmune hepatitis (AIH)‐like non‐AIH‐like comparable responses. No severe adverse events observed during Conclusion study provides first clinical evidence that therapy without AIH‐like features can achieve good ( ClinicalTrials.gov , NCT 02651350).