Preventive effect of Kampo medicine (Hangeshashin-to) against irinotecan-induced diarrhea in advanced non-small-cell lung cancer

Cancer Chemother Pharmacol. 2003 May;51(5):403-6. doi: 10.1007/s00280-003-0585-0. Epub 2003 Apr 9.


Purpose: Kampo medicine Hangeshashin-to (TJ-14) which contains baicalin, a beta-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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents, Phytogenic / adverse effects*
  • Antineoplastic Agents, Phytogenic / therapeutic use
  • Camptothecin / adverse effects*
  • Camptothecin / analogs & derivatives*
  • Camptothecin / therapeutic use
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Cisplatin / therapeutic use
  • Diarrhea / chemically induced*
  • Diarrhea / prevention & control*
  • Drugs, Chinese Herbal / pharmacology*
  • Female
  • Humans
  • Irinotecan
  • Lung Neoplasms / drug therapy*
  • Male
  • Medicine, Kampo*
  • Middle Aged
  • Treatment Outcome


  • Antineoplastic Agents, Phytogenic
  • Drugs, Chinese Herbal
  • hange-shashinto
  • Irinotecan
  • Cisplatin
  • Camptothecin