Abstract
Purpose
Kampo medicine Hangeshashin-to (TJ-14) which contains baicalin, a β-glucuronidase inhibitor, alleviates diarrhea induced by irinotecan (CPT-11). We conducted a randomized comparative trial to investigate whether support with TJ-14 would prevent and control CPT-11-induced diarrhea.
Methods
Of 44 previously untreated patients with advanced non-small-cell lung cancer randomized, 41 (18 TJ-14 group, 23 control group) were available for evaluation. The chemotherapy regimen consisted of a combination of cisplatin and CPT-11. TJ-14 (7.5 g/day) was administered orally.
Results
Of the 41 patients, 39 experienced diarrhea. Compared with the control group, the TJ-14 group showed a significant improvement in diarrhea grades (P=0.044) as well as a reduced frequency of diarrhea grades 3 and 4 (one patient versus ten patients; P=0.018). However, the two groups showed no differences in the frequency of diarrhea or the number of days the symptoms continued. This study was stopped at an interim evaluation.
Conclusion
TJ-14 was effective in preventing and controlling CPT-11-induced diarrhea.
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This work was supported in part by a Grant-in Aid for Cancer Research from the Ministry of Health, Labour and Welfare, the Foundation for the Promotion of Cancer Research, and the Second Term Comprehensive 10-Year Strategy for Cancer Control.
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Mori, K., Kondo, T., Kamiyama, Y. et al. Preventive effect of Kampo medicine (Hangeshashin-to) against irinotecan-induced diarrhea in advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 51, 403–406 (2003). https://doi.org/10.1007/s00280-003-0585-0
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DOI: https://doi.org/10.1007/s00280-003-0585-0