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Soy Isoflavones Supplementation for Patients with Irritable Bowel Syndrome: A Randomized Double Blind Clinical Trial.

ABSTRACT: BACKGROUND Irritable bowel syndrome (IBS) is one of the common gastrointestinal disorders with unknown etiology. In experimental models, it is proposed that soy isoflavones may suppress the clinical and psychological symptoms of IBS by alteration of gut barrier tight junctions. METHODS We conducted this study to evaluate the effects of soy isoflavones on IBS symptoms and patients' quality of life. In a randomized double blind placebo-controlled clinical trial, 67 patients with IBS were allocated to consume either soy isoflavones capsules or a placebo for 6 weeks. The primary outcome was a significant reduction in symptoms severity score and the secondary outcome was a significant improvement in quality of life. RESULTS 45 participants completed the study. There was no significant changes in mean differences of symptoms severity score between the two groups; however soy isoflavone supplementation could significantly improve the quality of life scores (p=0.009). CONCLUSION Soy isoflavones supplementation could improve the quality of life in patients with IBS; however it did not suppress the symptoms severity in 6 weeks. Further research with a longer duration is needed to determine the sustained clinical efficacy. This study was registered at clinicaltrials.gov as NCT02026518.

SUBMITTER: Jalili M

PROVIDER: S-EPMC4560632 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Soy Isoflavones Supplementation for Patients with Irritable Bowel Syndrome: A Randomized Double Blind Clinical Trial.

Jalili Mahsa M Vahedi Homayoon H Janani Leila L Poustchi Hossein H Malekzadeh Reza R Hekmatdoost Azita A

Middle East journal of digestive diseases 20150701

BACKGROUND Irritable bowel syndrome (IBS) is one of the common gastrointestinal disorders with unknown etiology. In experimental models, it is proposed that soy isoflavones may suppress the clinical and psychological symptoms of IBS by alteration of gut barrier tight junctions. METHODS We conducted this study to evaluate the effects of soy isoflavones on IBS symptoms and patients' quality of life. In a randomized double blind placebo-controlled clinical trial, 67 patients with IBS were allocated ...[more]

PMID: 26396720

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Project description:AimTo examine the efficacy and safety of otilonium bromide (OB) in treatment-sensitive functional irritable bowel syndrome (IBS) clinical parameters.MethodsNinety-three patients (44.8 ± 12.6 years, 69% female) with IBS symptoms complying with Rome II criteria participated in this double-blind, placebo-controlled, randomised, dose-ranging phase I/II study. Patients were administered OB 20 mg (n = 24), 40 mg (n = 23) and 80 mg (n = 23) tid or placebo (n = 23) in 4 parallel groups for 4 wk. Primary efficacy variables included abdominal discomfort, intestinal habits, number of daily evacuations and stool consistency. Secondary efficacy measures included return to regular intestinal habits and global discomfort. Safety was also assessed.ResultsBaseline clinical characteristics were similar among the 4 groups. Although individual parameters such as intensity and frequency of abdominal discomfort, bloating or pain were reduced by OB over the 4 wk, no significant differences were observed between groups. Similarly, no difference was observed between OB treatment or placebo for mucus in stool and incomplete or difficulty of evacuation. However, evacuation frequency was significantly reduced after 4 wk by 80 mg OB compared to placebo (-8.36% for placebo vs -41.9% for 80 mg OB, P < 0.01). While 21.7% of patients in the placebo group experienced regular intestinal habits after 4 wk, this improvement was greater for patients treated with 40 mg OB (P < 0.01 vs placebo). Furthermore, a dose-dependent reduction in frequency of diarrhoea (χ(2)-test for trend = 11.5, P < 0.001) and an increase in normal stool frequency was observed. Combining individual variables into a global discomfort index revealed significant improvement among increasing OB doses, favouring 40 mg (P = 0.013) and 80 mg OB (P = 0.001) over placebo. No difference was observed between frequency of adverse events for placebo vs OB.ConclusionThis dose-ranging study demonstrates that OB at 40 and 80 mg can improve individual and global clinical symptoms of IBS compared to placebo over a 4-wk period.

Project description:Background & aimsWe sought to determine the efficacy of psyllium fiber treatment on abdominal pain and stool patterns in children with irritable bowel syndrome (IBS). We evaluated effects on breath hydrogen and methane production, gut permeability, and microbiome composition. We also investigated whether psychological characteristics of children or parents affected the response to treatment.MethodsWe performed a randomized, double-blind trial of 103 children (mean age, 13 ± 3 y) with IBS seen at primary or tertiary care settings. After 2 weeks on their habitual diet, children began an 8-day diet excluding carbohydrates thought to cause symptoms of IBS. Children with ≥75% improvement in abdominal pain were excluded (n = 17). Children were assigned randomly to groups given psyllium (n = 37) or placebo (maltodextrin, n = 47) for 6 weeks. Two-week pain and stool diaries were compared at baseline and during the final 2 weeks of treatment. We assessed breath hydrogen and methane production, intestinal permeability, and the composition of the microbiome before and after administration of psyllium or placebo. Psychological characteristics of children were measured at baseline.ResultsChildren in the psyllium group had a greater reduction in the mean number of pain episodes than children in the placebo group (mean reduction of 8.2 ± 1.2 after receiving psyllium vs mean reduction of 4.1 ± 1.3 after receiving placebo; P = .03); the level of pain intensity did not differ between the groups. Psychological characteristics were not associated with response. At the end of the study period, the percentage of stools that were normal (Bristol scale scores, 3-5), breath hydrogen or methane production, intestinal permeability, and microbiome composition were similar between groups.ConclusionsPsyllium fiber reduced the number of abdominal pain episodes in children with IBS, independent of psychological factors. Psyllium did not alter breath hydrogen or methane production, gut permeability, or microbiome composition. ClinicalTrials.gov no: NCT00526903.

Project description:Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo. However, several recent RCTs, including patients with irritable bowel syndrome (IBS), chronic low back pain, and episodic migraine, have demonstrated that individuals receiving open-label placebo (OLP) can still experience symptomatic improvement and benefit from honestly described placebo treatment.This paper describes an innovative multidisciplinary trial design (n?=?280) that attempts to replicate and expand upon an earlier IBS OLP study. The current study will compare OLP to double-blind placebo (DBP) administration which is made possible by including a nested, double-blind RCT comparing DBP and peppermint oil. The study also examines possible genetic and psychological predictors of OLP and seeks to better understand participants' experiences with OLP and DBP through a series of extensive interviews with a randomly selected subgroup.OLP treatment is a novel strategy for ethically harnessing placebo effects. It has potential to re-frame theories of placebo and to influence how physicians can optimize watch-and-wait strategies for common, subjective symptoms. The current study aims to dramatically expand what we know about OLP by comparing, for the first time, OLP and DBP administration. Adopting a unique, multidisciplinary approach, the study also explores genetic, psychological and experiential dimensions of OLP. The paper ends with an extensive discussion of the "culture" of the trial as well as potential mechanisms of OLP and ethical implications.ClinicalTrials.gov, identifier: NCT02802241 . Registered on 14 June 2016.

Dataset Information

Soy Isoflavones Supplementation for Patients with Irritable Bowel Syndrome: A Randomized Double Blind Clinical Trial.

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Soy Isoflavones Supplementation for Patients with Irritable Bowel Syndrome: A Randomized Double Blind Clinical Trial.

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