Clinical efficacy of Daikenchuto for gastrointestinal dysfunction following colon surgery: a randomized, double-blind, multicenter, placebo-controlled study (JFMC39-0902)

Published on Jul 1, 2015in Japanese Journal of Clinical Oncology1.914
· DOI :10.1093/JJCO/HYV056
Hidetoshi Katsuno11
Estimated H-index: 11
(Fujita Health University),
Koutarou Maeda19
Estimated H-index: 19
(Fujita Health University)
+ 9 AuthorsMasahiko Watanabe53
Estimated H-index: 53
(Kitasato University)
Sources
Abstract
Objective This exploratory trial was performed to determine whether Daikenchuto accelerates recovery of gastrointestinal function in patients undergoing open colectomy for colon cancer.
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Background This multi-center, phase III trial assesses the efficacy of daikenchuto (TU-100) on gastrointestinal disorders after hepatic resection (UMIN Registration No. 000003103).
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We constructed population pharmacokinetic (PK) models for the five constituents of daikenchuto (DKT), a traditional Japanese herbal medicine. Data were collected from two randomized PK studies conducted in Japan and the US. Participants received single oral doses of 2.5 g, 5 g, and 10 g of DKT. The plasma concentrations of five DKT constituents, hydroxy-α-sanshool (HAS), hydroxyl-β-sanshool (HBS), 6-shogaol(6S), 10-shogaol(10S), and ginsenoside Rb1 (GRB1) were determined by LC-MS/MS. A total of ...
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The functional roles of transient receptor potential (TRP) channels in the gastrointestinal tract have garnered considerable attention in recent years. We previously reported that daikenchuto (TU-100), a traditional Japanese herbal medicine, increased intestinal blood flow (IBF) via adrenomedullin (ADM) release from intestinal epithelial (IE) cells (Kono T et al. J Crohns Colitis 4: 161–170, 2010). TU-100 contains multiple TRP activators. In the present study, therefore, we examined the involvem...
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Purposes The inflammatory response after surgery is associated with various postoperative complications. The aim of the present prospective study was to evaluate the effects of Daikenchuto (DKT) (a Japanese herbal medicine) on the inflammatory response in patients following laparoscopic colorectal resection.
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The pharmacokinetics of daikenchuto (TJ-100), a pharmaceutical-grade traditional Japanese medicine, were investigated in healthy Japanese volunteers after a single oral administration of 2.5-, 5-, and 10-g doses. Six ingredients [hydroxy-α-sanshool (HAS), hydroxy-β-sanshool (HBS), [6]-shogaol (6S), [10]-shogaol (10S), ginsenoside Rb1(GRB1), and ginsenoside Rg1(GRG1)] of TJ-100 were determined by using liquid chromatography-tandem mass spectrometry. The results indicated that HAS, an ingredient d...
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Daikenchuto (TU-100) is a traditional Japanese (Kampo) medicine used to treat postoperative ileus. TU-100 dose dependently increases gastrointestinal (GI) motility by modulating cholinergic and serotonergic mechanisms in animal studies. The aim of this study was to evaluate the effects of orally administered TU-100 on GI and colonic transit and bowel function in healthy humans. In a randomized, parallel-group, double-blind, placebo-controlled, dose-response study, 60 healthy subjects were random...
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ALTHOUGH HERBAL MEDICINE has been used throughout the world since time immemorial, its utilization in the Western World remains within the limited scope of practice largely of complementary and alternative medicine (CAM), the epicenter of so-called allopathic medicine. According to the data from 2007 National Health Interview Survey of 24,000 people conducted by the Center for Disease Control and Prevention’s National Center for Health Statistics, approximately 20% of U.S. adults reported use of...
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Abstract null null We conducted a prospective randomized study to investigate the effect of daikenchuto (DKT) on abdominal symptoms following laparoscopic colectomy in patients with left-sided colon cancer. Patients who suffered from abdominal pain or distention on postoperative day 1 were randomized to either the DKT group or non-DKT group. The primary endpoints were the evaluation of abdominal pain, abdominal distention, and quality of life. The metabolome and gut microbiome analyses were cond...
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