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Updated: Aug 1, 2026
Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
Published on: September 19, 2013
Efficacy and Safety of Modified Sishen Decoction for Tyrosine Kinase Inhibitor-Induced Diarrhea in Hepatocellular
Jingwen Cao1, Shengli He1, Song Yu2
1Integrated Traditional Chinese and Western Medicine Department, Minhang Branch of Fudan University Cancer Hospital (Shanghai Minhang Cancer Hospital), Shanghai, 200240, People's Republic of China.
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.
Insights
Modified Sishen Decoction (MSD) effectively treated tyrosine kinase inhibitor-induced diarrhea in hepatocellular carcinoma patients. This Traditional Chinese Medicine formula improved symptoms and showed a comparable safety profile to montmorillonite powder.
Area of Science:
- Oncology
- Gastroenterology
- Traditional Chinese Medicine
Background:
- Diarrhea is a common, dose-limiting side effect of tyrosine kinase inhibitors (TKIs) in hepatocellular carcinoma (HCC) patients.
- Current treatments for TKI-induced diarrhea are often insufficient, necessitating novel therapeutic strategies.
Purpose of the Study:
- To evaluate the efficacy and safety of Modified Sishen Decoction (MSD), a Traditional Chinese Medicine formula, for managing TKI-induced diarrhea in HCC patients.
- To compare MSD with montmorillonite powder in controlling diarrhea and improving systemic symptoms.
Main Methods:
- A single-blind, randomized controlled trial was conducted with 60 HCC patients experiencing TKI-induced diarrhea.
- Participants were randomized to receive either MSD capsules or montmorillonite powder capsules for 7 days.
- Primary outcome was the change in diarrhea grade (NCI CTCAE v4.0); secondary outcomes included symptom scores and safety.
Main Results:
- The MSD group showed a significantly greater reduction in diarrhea grade compared to the montmorillonite group (P=0.008).
- MSD demonstrated a higher overall effective rate for diarrhea control (90% vs. 20%; P<0.001).
- Patients receiving MSD experienced significant improvement in systemic symptoms like fatigue and poor appetite (P<0.001), with comparable adverse event rates.
Conclusions:
- Modified Sishen Decoction is more effective than montmorillonite powder for TKI-induced diarrhea in HCC patients.
- MSD effectively reduces diarrhea severity and alleviates associated systemic symptoms.
- MSD presents a valuable and safe therapeutic option for managing this challenging clinical issue.
