ArticleJournal of hepatocellular carcinoma2026
Efficacy and Safety of Modified Sishen Decoction for Tyrosine Kinase Inhibitor-Induced Diarrhea in Hepatocellular Carcinoma: A Randomized Controlled Trial.
Article in Journal of hepatocellular carcinoma, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Diarrhea is a common and dose-limiting toxicity of tyrosine kinase inhibitors (TKIs) in patients with hepatocellular carcinoma (HCC), for which current treatments are often insufficient. This study aimed to evaluate the efficacy and safety of Modified Sishen Decoction (MSD), a Traditional Chinese Medicine formula, for TKI-induced diarrhea. Methods: We conducted a single-blind, randomized controlled trial involving 60 HCC patients with TKI-induced diarrhea. Patients were randomly assigned (1:1) to receive either MSD capsules or montmorillonite powder capsules for 7 days. The primary outcome was the change in diarrhea grade (NCI CTCAE v4.0) from baseline to day 8. Secondary outcomes included changes in TCM-related symptom scores and safety. Results: At day 8, the MSD group demonstrated a significantly greater reduction in diarrhea grade compared to the montmorillonite group (OR=4.75, 95% CI: 1.50-15.05, P=0.008). The overall effective rate for diarrhea control was significantly higher in the MSD group (90% vs. 20%; P<0.001). Patients receiving MSD also reported greater improvement in systemic symptoms, including fatigue and poor appetite (total symptom score reduction, P<0.001). Adverse event rates were comparable between the two groups. Conclusion: In this trial, Modified Sishen Decoction was more effective than montmorillonite powder in reducing the severity of TKI-induced diarrhea and alleviating associated systemic symptoms in HCC patients, with a comparable safety profile. MSD may be a valuable therapeutic option for this challenging clinical problem. Clinical Trial Number: ChiCTR1900023194.
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