Abstract | ETHNOPHARMACOLOGICAL RELEVANCE: AIM OF THE STUDY: We aimed to investigate whether monotherapy with AHP improves liver histology in these patients. MATERIALS AND METHODS: In this double-blind, randomized, placebo-controlled trial, 270 CHB patients with ALT<2ULN and F ≤ 2 were treated in 12 hospitals in China. The patients were randomly assigned to an intervention (AHP) group and a placebo group at a ratio of 2:1. Of these 270 enrolled patients, 147 had paired liver biopsies. The primary end point was histological change after 48 weeks of treatment. RESULTS: Per-protocol analysis revealed that the rate of histologic improvement in liver fibrosis patients in the AHP group was significantly higher than that in the placebo group (37.7% vs. 19.5%, P = 0.035) after 48 weeks of treatment, which was consistent with results from intention-to-treat and sensitivity analyses. Moreover, after adjusting for baseline characteristics, AHP was superior to placebo with respect to improving liver fibrosis (odds ratio [OR] = 2.58, 95% confidence interval [CI]: (1.01, 6.63),P = 0.049) and liver histology (OR = 3.62, 95% CI: (1.42, 9.20),P = 0.007). In noninvasive measurement of liver fibrosis (FibroScan®), the level of liver stiffness measurement (LSM) had decreased significantly at 48 weeks (5.1 kPa) compared with that at baseline (5.7 kPa) (P = 0.008) in the AHP group, whereas it did not decrease significantly in the placebo group. Cirrhosis developed in one patient in the placebo group but in no patients in the AHP group. No serious side effects occurred in the AHP-treated patients. CONCLUSIONS:
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Authors | Huan-Ming Xiao, Mei-Jie Shi, Jun-Min Jiang, Gao-Shu Cai, Yu-Bao Xie, Guang-Jun Tian, Jing-Dong Xue, De-Wen Mao, Qin Li, Hong-Zhi Yang, Hui Guo, Chun-Liang Lei, Wei Lu, Liang Chen, Hua-Bao Liu, Jing Wang, Yue-Qiu Gao, Jie-Zhen Chen, Shu-Duo Wu, Hui-Jun Chen, Peng-Tao Zhao, Chao-Zhen Zhang, Wen-Wei Ou-Yang, Ze-Huai Wen, Xiao-Ling Chi |
Journal | Journal of ethnopharmacology
(J Ethnopharmacol)
Vol. 293
Pg. 115210
(Jul 15 2022)
ISSN: 1872-7573 [Electronic] Ireland |
PMID | 35398501
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved. |
Chemical References |
- Drugs, Chinese Herbal
- anluohuaxian
- Alanine Transaminase
- Alanine
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Topics |
- Alanine
(therapeutic use)
- Alanine Transaminase
- Drugs, Chinese Herbal
- Hepatitis B, Chronic
(drug therapy)
- Humans
- Liver
(pathology)
- Liver Cirrhosis
(drug therapy, pathology)
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