Efficacy and safety of AnluoHuaxian pills on chronic hepatitis B with normal or minimally elevated alanine transaminase and early liver fibrosis: A randomized controlled trial.

Autor: Xiao HM; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Shi MJ; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Jiang JM; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Cai GS; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Xie YB; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Tian GJ; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Xue JD; Liver Diseases Branch, Shaanxi Provincial Hospital of Traditional Chinese Medicine, Xi'an, 710003, China., Mao DW; Hepatology Department, First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine, Nanning, 530023, China., Li Q; Department of Integration of Traditional Chinese and Western Medicine, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, 350025, China., Yang HZ; Chinese Medicine Department, Third Affiliated Hospital, SunYat-Sen University, Guangzhou, 510630, China., Guo H; Hepatology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300380, China., Lei CL; Hepatology Department, Guangzhou Eighth People's Hospital, Guangzhou, 510060, China., Lu W; Liver Diseases Branch, Tianjin Second People's Hospital, Tianjin, 300192, China., Chen L; Department of Hepatology, Shanghai Public Health Clinical Center, Shanghai, 201508, China., Liu HB; Hepatology Department, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, 400021, China., Wang J; Department of Hepatobiliary Disease, Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, 646000, China., Gao YQ; Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China., Chen JZ; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Wu SD; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Chen HJ; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Zhao PT; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Zhang CZ; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Ou-Yang WW; Key Unit of Methodology in Clinical Research, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China., Wen ZH; Key Unit of Methodology in Clinical Research, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China; National Centre for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. Electronic address: wenzh@gzucm.edu.cn., Chi XL; Hepatology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. Electronic address: bdxgy@gzucm.edu.cn.
Jazyk: angličtina
Zdroj: Journal of ethnopharmacology [J Ethnopharmacol] 2022 Jul 15; Vol. 293, pp. 115210. Date of Electronic Publication: 2022 Apr 07.
DOI: 10.1016/j.jep.2022.115210
Abstrakt: Ethnopharmacological Relevance: The AnluoHuaxian pill (AHP) is a widely used patented medicine for chronic hepatitis B (CHB) patients with advanced fibrosis or cirrhosis that has been used in China for more than 15 years. However, data are lacking on whether monotherapy with AHP can be effective in CHB patients with alanine aminotransferase (ALT) levels less than 2 times the upper limit of normal (ALT<2ULN) and early liver fibrosis (F ≤ 2).
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: Treatment of CHB patients who had ALT<2ULN and F ≤ 2 with the traditional Chinese medicine AHP for 48 weeks improves liver fibrosis. However, due to the short duration of treatment and the limited sample size of liver pathology, the long-term benefits of AHP in reducing fibrosis and the risk of cirrhosis and hepatocellular carcinoma in these patients need to be further studied in the future.
(Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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