Entecavir combining Chinese herbal medicine for HBeAg-positive chronic hepatitis B patients: a randomized, controlled tr
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ORIGINAL ARTICLE
Entecavir combining Chinese herbal medicine for HBeAg‑positive chronic hepatitis B patients: a randomized, controlled trial Xiaoke Li1 · Daqiao Zhou2 · Xiaoling Chi3 · Qin Li4 · Li Wang5 · Bingjiu Lu6 · Dewen Mao7 · Qikai Wu8 · Xianbo Wang9 · Mingxiang Zhang10 · Jingdong Xue11 · Yong Li12 · Wei Lu13 · Jianchun Guo14 · Feng Jiang1 · Xinwei Zhang15 · Zhiguo Li1 · Xianzhao Yang1 · Hui Guo16 · Danan Gan1 · Liyun He17 · Lin Luo17 · Ludan Zhang1 · Hongbo Du1 · Yong’an Ye1 Received: 14 July 2020 / Accepted: 30 September 2020 © Asian Pacific Association for the Study of the Liver 2020
Abstract Background and aim Traditional Chinese medicine (TCM) is widely accepted and prescribed in China alongside Nucleoside analogs (NAs). In this double-blind, placebo-controlled, randomized, multi-center trial, we evaluated whether entecavir (ETV) plus TCM formulas Tiao-Gan-Yi-Pi granule (TGYP) and Tiao-Gan-Jian-Pi-Jie-Du granule (TGJPJD) increase the rate of hepatitis B e antigen (HBeAg) loss in Chinese patients. Methods 596 eligible participants were randomly assigned, in a 1:1 ratio, to two study groups in this 108-week trial: The experiment group was assigned ETV plus the TCM formula. The control group was assigned ETV plus a TCM placebo. We compared the rate of HBeAg loss by the end of week 108 between the two arms as the primary outcome. Secondary outcomes included hepatitis B surface antigen (HBsAg) level, proportion of undetectable HBV-DNA, and liver enzymes (ALT, AST, GGT) at week 108. Results The combination therapy achieved superior HBeAg loss at 108 weeks, without additional adverse events. The rate of HBeAg loss at week 108 was 37.54% (95% CI 31.9–43.2%) in the experiment group and 27.21% (95% CI 22.0–32.4%) in the control group. There was a statistically significant difference between the two arms of 10.33% (95% CI 8.4–12.3%, p = 0.008). The DNA loss rate, serum HBsAg level, and liver enzymes were similar between the groups by the end of 108th week. Conclusion Combining the Chinese herbal formula with ETV therapy demonstrated superior HBeAg clearance compared with ETV monotherapy. This finding indicates that this combined therapy could produce an improved therapeutic effect and safety profile. Clinical trial number ChiCTR-TRC-12002784 (Chinese Clinical Trial Registry). Keywords Chronic hepatitis B · Traditional Chinese medicine · Tiao-gan-yi-pi granule · Tiao-gan-jian-pi-jie-du granule
Introduction As one of the major global public health problems, chronic hepatitis B virus (HBV) infection has been one of the causes of mortality from cirrhosis and hepatocellular carcinoma Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12072-020-10097-z) contains supplementary material, which is available to authorized users. * Hongbo Du [email protected] * Yong’an Ye [email protected]
[1]. The prevalence of chronic HBV infection varies geographically from high (8%) to low (2%), with approximately 240 million chronic HBV surface antigen (HBsAg) carriers glo
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