A Pilot Study of the Effect of Daikenchuto on Rectal Sensation in Patients with Irritable Bowel Syndrome

Abstract

Background/AimsDaikenchuto (TU 100), a botanical agent that modulates gastrointestinal nerves, is used in the treatment of motility and functional disorders. Our aim was to study the effects of TU-100 on rectal compliance and sensation in patients with irritable bowel syndrome (IBS). MethodsIn 20 patients per treatment arm, we conducted a single-center, randomized, parallel-group, double-blind, placebo-controlled, singledose pharmacodynamics study evaluating the effects of TU-100, 15 g (5 g t.i.d. [means 3 times a day]), for 14-16 consecutive days on rectal compliance and rectal sensation (thresholds and sensation ratings), all measured at baseline and on the last day of medication treatment. The primary endpoint was rectal sensation thresholds and sensation ratings in response to balloon distension at 32 mmHg. Secondary endpoints were rectal compliance, sensation thresholds, ratings and tone (fasting and postprandial), bowel pattern, abdominal pain (average and worst severity) and bloating scores, IBS quality of life and safety profile. ResultsRectal sensation ratings post-treatment were significantly associated with baseline (pre-treatment) ratings and with level of anxiety or stress recorded at the time of the sensation testing. There were no effects of TU-100 treatment on rectal sensation ratings, sensation thresholds, rectal fasting or postprandial tone, rectal compliance, bowel function, abdominal pain or bloating scores, or IBS quality of life. Conclusions

Effects of Cannabidiol Chewing Gum on Perceived Pain and Well-Being of Irritable Bowel Syndrome Patients: A Placebo-Controlled Crossover Exploratory Intervention Study with Symptom-Driven Dosing

“…Sample size calculation was based on a published pilot study that used a VAS score for pain after rectal distension. 50 Sample size was calculated with the formula n = ((Z a + Z b ) 2 • SD 2 )/D 2 with n as total sample size, D as the difference between treatments, and standard deviation (SD) for the treatment effects To detect a minimal treatment effect of 20% (D = 2.0, difference on a VAS of 0.0-10.0), with a power of 80% (1 À b = 0.8416) and a twosided significance level of 5% (a = 1.9600), assuming an SD of difference in VAS score of 4.0 [SD pilot study = 28 on a VAS of 0-100, so 2.8 on a scale of 0.0-10.0; SD of difference between 2 measurements = O(+SD 2 of each measurement ) = O(2(SD 2 )) = 4], calculated sample size (n) for this study is 32. Taking into account a dropout rate of 25%, the initial number of subjects to be included was 40.…”

A review of frequently used Kampo prescriptions part 1. Daikenchuto

“…Although there are no randomized controlled trials (RCTs) of DKT in patients with IBS with clinical symptoms as endpoints, the number of cases has been accumulated through clinical reports. In an RCT of rectal sensation as an endpoint in patients with IBS, DKT did not significantly affect the urgency of defecation and pain threshold for rectal distension pressure [23].…”

“…Accordingly, a meta‐analysis of DKT was conducted. As shown in Table 2, previous studies by RCTs and meta‐analysis on DKT have been reported [17, 20–60]. These studies are categorized according to the underlying disease and the targeted condition, and the main ones are described below.…”

New therapeutic perspectives in irritable bowel syndrome: Targeting low-grade inflammation, immuno-neuroendocrine axis, motility, secretion and beyond

“…Recently, however, Acosta et al[ 212 ] did not report any significant effects of TU-100 on rectal sensation ratings, sensation thresholds, rectal fasting or postprandial tone, rectal compliance, bowel function, abdominal pain or bloating scores, or IBS quality of life. Further randomized controlled trials in patients with IBS-C or functional constipation using both clinical and validated biomarkers are required.…”