title: Preventive effect of Kampo medicine (Hangeshashin-to) against irinotecan-induced diarrhea in advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  TJ-14 was effective in preventing and controlling CPT-11-induced diarrhea.
authors.affiliation: Department of Thoracic Diseases, Tochigi Cancer Center, 4-9-13 Yonan, Utsunomiya, 320 Tochigi, Japan. kmori@tcc.pref.tochigi.jp
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Mori
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Kondo
authors.forename: Yukari
authors.initials: Y
authors.lastname: Kamiyama
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Kano
authors.forename: Keigo
authors.initials: K
authors.lastname: Tominaga
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects* / Q000627:therapeutic use; D002166:Camptothecin / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000627:therapeutic use; D003967:Diarrhea / Q000139:chemically induced* / Q000517:prevention & control*; D004365:Drugs, Chinese Herbal / Q000494:pharmacology*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D020835:Medicine, Kampo; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D004365:Drugs, Chinese Herbal; C088236:hange-shashinto; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin