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Clinical pharmacology of daikenchuto assessed by transit analysis using radiopaque markers in patients with colon cancer undergoing open surgery: a multicenter double-blind randomized placebo-controlled study (JFMC39-0902 additional study).
J Gastroenterol 2016; 51(3):222-9JG

Abstract

BACKGROUND

This exploratory trial was conducted to investigate whether daikenchuto accelerates the recovery of gastrointestinal function in patients undergoing open surgery for sigmoid or rectosigmoid cancer.

METHODS

Eighty-eight patients who underwent colectomy at one of the 11 clinical trial sites in Japan from January 2009 to June 2011 were registered in the study. Patients received either placebo or daikenchuto (15.0 g/day, 5 g three times a day) from postoperative day 2 to postoperative day 8. The study end points included the gastrointestinal tract transit time evaluated with radiopaque markers and the time to first flatus. The safety profile of daikenchuto was also evaluated until postoperative day 8.

RESULTS

Seventy-one patients (daikenchuto, n = 38; placebo, n = 33) were statistically analyzed. Although the number of radiopaque markers in the anal side of the small intestine at 6 h was significantly greater in the daikenchuto group than in the placebo group (15.19 vs 10.06, p = 0.008), the total transit analysis results and the mean time to first flatus did not differ significantly between the two groups.

CONCLUSIONS

Daikenchuto has a positive effect on the resolution of delayed gastric emptying, but has a limited effect on the resolution of postoperative paralytic ileus after open surgery in patients with sigmoid or rectosigmoid cancer. Daikenchuto may contribute to early oral intake in the postoperative course.

Authors+Show Affiliations

Department of Surgery, Fujita Health University School of Medicine, Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, 470-1192, Japan. katsuno@fujita-hu.ac.jp.Department of Surgery, Fujita Health University School of Medicine, Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, 470-1192, Japan.Department of Surgery, Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan.Department of Surgery, Kansai Medical University Takii Hospital, Moriguchi, Japan.Department of Surgery, Kameda Medical Center, Kamogawa, Japan.Department of Surgery, Teikyo University Chiba Medical Center, Ichihara, Japan.Department of Surgery, Kyorin University Hospital, Mitaka, Japan.Department of Surgery, Hiroshima University School of Medicine, Hiroshima, Japan.Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.Nagasaki City Hospital Organization, Nagasaki, Japan.International University of Health and Welfare, Otawara, Japan.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26162646

Citation

Katsuno, Hidetoshi, et al. "Clinical Pharmacology of Daikenchuto Assessed By Transit Analysis Using Radiopaque Markers in Patients With Colon Cancer Undergoing Open Surgery: a Multicenter Double-blind Randomized Placebo-controlled Study (JFMC39-0902 Additional Study)." Journal of Gastroenterology, vol. 51, no. 3, 2016, pp. 222-9.
Katsuno H, Maeda K, Ohya M, et al. Clinical pharmacology of daikenchuto assessed by transit analysis using radiopaque markers in patients with colon cancer undergoing open surgery: a multicenter double-blind randomized placebo-controlled study (JFMC39-0902 additional study). J Gastroenterol. 2016;51(3):222-9.
Katsuno, H., Maeda, K., Ohya, M., Yoshioka, K., Tsunoda, A., Koda, K., ... Kitajima, M. (2016). Clinical pharmacology of daikenchuto assessed by transit analysis using radiopaque markers in patients with colon cancer undergoing open surgery: a multicenter double-blind randomized placebo-controlled study (JFMC39-0902 additional study). Journal of Gastroenterology, 51(3), pp. 222-9. doi:10.1007/s00535-015-1100-1.
Katsuno H, et al. Clinical Pharmacology of Daikenchuto Assessed By Transit Analysis Using Radiopaque Markers in Patients With Colon Cancer Undergoing Open Surgery: a Multicenter Double-blind Randomized Placebo-controlled Study (JFMC39-0902 Additional Study). J Gastroenterol. 2016;51(3):222-9. PubMed PMID: 26162646.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical pharmacology of daikenchuto assessed by transit analysis using radiopaque markers in patients with colon cancer undergoing open surgery: a multicenter double-blind randomized placebo-controlled study (JFMC39-0902 additional study). AU - Katsuno,Hidetoshi, AU - Maeda,Koutarou, AU - Ohya,Masatoshi, AU - Yoshioka,Kazuhiko, AU - Tsunoda,Akira, AU - Koda,Keiji, AU - Matsuoka,Hiroyoshi, AU - Ohge,Hiroki, AU - Morita,Satoshi, AU - Saji,Shigetoyo, AU - Kanematsu,Takashi, AU - Kitajima,Masaki, Y1 - 2015/07/11/ PY - 2015/04/27/received PY - 2015/06/21/accepted PY - 2015/7/12/entrez PY - 2015/7/15/pubmed PY - 2016/11/15/medline KW - Colon cancer KW - Daikenchuto KW - Herbal medicine KW - Radiopaque marker KW - Transit analysis SP - 222 EP - 9 JF - Journal of gastroenterology JO - J. Gastroenterol. VL - 51 IS - 3 N2 - BACKGROUND: This exploratory trial was conducted to investigate whether daikenchuto accelerates the recovery of gastrointestinal function in patients undergoing open surgery for sigmoid or rectosigmoid cancer. METHODS: Eighty-eight patients who underwent colectomy at one of the 11 clinical trial sites in Japan from January 2009 to June 2011 were registered in the study. Patients received either placebo or daikenchuto (15.0 g/day, 5 g three times a day) from postoperative day 2 to postoperative day 8. The study end points included the gastrointestinal tract transit time evaluated with radiopaque markers and the time to first flatus. The safety profile of daikenchuto was also evaluated until postoperative day 8. RESULTS: Seventy-one patients (daikenchuto, n = 38; placebo, n = 33) were statistically analyzed. Although the number of radiopaque markers in the anal side of the small intestine at 6 h was significantly greater in the daikenchuto group than in the placebo group (15.19 vs 10.06, p = 0.008), the total transit analysis results and the mean time to first flatus did not differ significantly between the two groups. CONCLUSIONS: Daikenchuto has a positive effect on the resolution of delayed gastric emptying, but has a limited effect on the resolution of postoperative paralytic ileus after open surgery in patients with sigmoid or rectosigmoid cancer. Daikenchuto may contribute to early oral intake in the postoperative course. SN - 1435-5922 UR - https://www.unboundmedicine.com/medline/citation/26162646/Clinical_pharmacology_of_daikenchuto_assessed_by_transit_analysis_using_radiopaque_markers_in_patients_with_colon_cancer_undergoing_open_surgery:_a_multicenter_double_blind_randomized_placebo_controlled_study__JFMC39_0902_additional_study__ L2 - https://dx.doi.org/10.1007/s00535-015-1100-1 DB - PRIME DP - Unbound Medicine ER -