Effectiveness of Jiedu granule on gut microbiota in patients with advanced hepatocellular carcinoma: a randomized controlled trial.

OBJECTIVE
To observe whether Jiedu granule (, JDG) modulates the composition of the gut microbiota during advanced hepatocellular carcinoma (HCC).


METHODS
A randomized controlled trial was conducted. Sixty-two advanced HCC participants were randomly allocated to receive JDG or placebo. The median overall survival (OS) times of patients and the variation of relative abundance of bacteria over time were used as main outcome measures.


RESULTS
Patients who received JDG demonstrated significantly longer median OS times compared with the placebo group. Pyrosequencing of the V3 regions of 16S rRNA genes revealed a dose dependent deviation of gut microbiota in response to JDG treatment. Redundancy analysis identified and Peptostre-ptococcaceae which related to the onset of liver cancer disappeared after 1-month and 2-month JDG treatment, while in control group, no significant changes of these two bacteria were found. The variation tendency of relative abundance of (essential in immunoblocking therapy of tumor) in JDG group was not obvious while in control group, it was decreased significantly with time. The relative abundance of (correlated with the occurrence of liver cancer) was increased in JDG group and was decreased in control group over time.


CONCLUSION
Changes in the gut microbiota may be associated with the efficiency of JDG on survival period of advanced HCC patients. Trial registration：Chinese Clinical TRIAL Registry ChiCTR-OOC-16008002.