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Journal of Integrative Medicine ›› 2020, Vol. 18 ›› Issue (4): 319-325.doi: 10.1016.j.joim.2020.05.003

• Original Clinical Research • Previous Articles     Next Articles

Comparable effects of Jiedu granules and sorafenib for advanced hepatocellular carcinoma: A prospective multicenter cohort study

He-tong Zhaoa, Yong-bin Menga, Xiao-feng Zhaia, Bin-bin Chenga, Sha-sha Yua, Man Yaoa, Hui-xia Yina, Xu-ying Wanb, Yun-ke Yangc, Hui Liud, Feng Shend, Chang-quan Linga   

  1. a School of Traditional Chinese Medicine, Naval Medical University, Shanghai 200433, China  b Department of Integrated Traditional Chinese and Western Medicine, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai 200433, China  c Department of Integrative Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China  d The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai 200433, China
  • Received:2019-12-06 Accepted:2020-04-15 Online:2020-07-10 Published:2020-05-15
  • Contact: Feng Shen, PhD, E-mail:shenfengehbh@sina.com; Chang-quan Ling, PhD, E-mail: changquanling@smmu.edu.cn

Objective

The drug sorafenib has been extensively used for the treatment of advanced hepatocellular carcinoma (HCC). Chinese herbal medicine has also been used to manage advanced HCC. The present work evaluates the effectiveness and safety of Jiedu (JD) granules, a compound of traditional Chinese herbal medicines, side-by-side with sorafenib for the treatment of advance HCC.

Methods

Patients with advanced HCC were enrolled in this study during December 2014 and March 2018. Study patients were elected to receive treatment with JD granules or sorafenib. The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS) and safety. Propensity score matching (PSM) analysis was used to control for possible selection bias from the study group allocation process.

Results

Of the 325 patients included in this study, 161 received JD granules and 164 received sorafenib. No significant differences were found in OS or PFS among patients receiving JD granules compared to sorafenib (P > 0.05). Median OS of the two study groups was 6.83 months (95% confidence interval [CI]: 5.83–9.47) in the group receiving JD granules and 8 months (95% CI: 6.67–9.80) in the group receiving sorafenib, with half-, 1-, and 2- year survival rates of 53.6%, 31.2% and 13.2% vs 60.1%, 35.5% and 14.2%, respectively. Even after PSM, the median survival time did not differ between the JD granules group (9.03 months; 95% CI: 6.37–14.2) and the sorafenib group (7.93 months; 95% CI: 6.5–9.97), with comparable half-, 1- and 2-year survival rates. The most common adverse events (AEs) were diarrhea (13.7%) and fatigue (5.6%) in the JD granules group, and hand-foot skin reaction (46.3%) and diarrhea (36.6%) in the sorafenib group. The JD granules was more cost-effective than sorafenib treatment for advanced HCC.

Conclusion

Compared to sorafenib, JD granules provided a comparable treatment for HCC that was more cost-effective and caused fewer AEs for the treatment of Chinese patients with advanced HCC. 


Key words: Carcinoma, Hepatocellular, Jiedu granules, Sorafenib

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