Effect of Korean Herbal Medicine Combined with a Probiotic Mixture on Diarrhea-Dominant Irritable Bowel Syndrome: A Double-Blind, Randomized, Placebo-Controlled Trial

Abstract

Introduction. Although combination therapy with herbal medicine and probiotics is gaining popularity for controlling diarrhea-dominant irritable bowel syndrome (D-IBS) symptoms, few studies have investigated its clinical effects. Materials and Methods. Fifty-three patients with D-IBS were randomly allocated into 1 of the following 4 groups: herbal medicine (Gwakhyangjeonggisan; GJS) plus probiotics (Duolac7S; DUO), GJS plus placebo DUO, placebo GJS plus DUO, and placebo GJS plus placebo DUO. The study period consisted of a 2-week run-in, 8 weeks of administration, and 2 weeks of follow-up. The primary outcomes were weekly adequate relief (AR) of overall IBS symptoms and the proportion of responders (PR) during the administration period. The secondary outcomes included individual IBS symptoms, stool assessment, and quality of life. Changes of intestinal microbiota and intestinal permeability were also analyzed. Results and Discussion. Weekly AR was not different among the 4 groups throughout the treatment period. However, the 3 treatment groups exhibited significant improvements in PR compared to the findings in the placebo group. In the intestinal microbiota assessment, herbal medicine and probiotics synergistically increased beneficial bacteria counts. Conclusion. Combination therapy with herbal medicine and probiotics appears to relieve overall IBS symptoms by synergistically increasing beneficial intestinal microbe counts.

Probiotic Therapy of the Irritable Bowel Syndrome: Why Is the Evidence Still Poor and What Can Be Done About It?

“…One study included patients with functional gastrointestinal disorders, ie, with diarrhea but not constipation and not necessarily suffering from abdominal pain, 72 one was restricted to constipation predominant IBS (IBS-C) patients 65 and 4 included only diarrhea predominant IBS (IBS-D) patients. 62,68,69,80 All studies claimed the use of Rome (II or III) criteria, nevertheless, a more detailed description of the patient population (the number of IBS-D, IBS-C, and mixed IBS [IBS-M] patients) was lacking. Treatment duration varied from 7 days to 6 months, thus not fulfilling Rome criteria for treatment duration in many cases, 17 with the majority of studies assessing treatment results after 8 weeks.…”

British Dietetic Association systematic review of systematic reviews and evidence‐based practice guidelines for the use of probiotics in the management of irritable bowel syndrome in adults (2016 update)

“…Fifteen probiotic doses in 12 RCTs showed no QoL improvements after treatment . Two RCTs gave inadequate data to assess QoL .…”

“…No probiotics improved flatulence in any IBS subtypes. Twenty‐four probiotics did not improve flatulence . Sixteen RCTs did not report or measure this outcome or present these data .…”

“…Actis BB‐12 ® , L. acidophilus LA‐5 ® , L. delbrueckii subsp. bulgaricus LBY‐27 and S. thermophilus STY‐31 , a six‐strain probiotic: B. longum , B. bifidum , B. lactis , L. acidophilus , L. rhamnosus and S. thermophilus , at 8 weeks using and S. cerevisiae CNCM I‐3856 and a two‐strain probiotic: E. faecalis (DSM 16440) and E. coli (DSM 17252) , and in IBS‐D, using a seven‐strain probiotic: L. acidophilus, L. plantarum, L. rhamnosus, B. breve, B. lactis, B. longum and S. thermophilus and, in subgroup analysis, at 8 weeks using a four‐strain probiotic: B. bifidum BGN4, B. lactis AD011, L. acidophilus AD031 and L. casei IBS041 . Marginal improvements in abdominal pain were found for five probiotics: at 4 weeks using L. acidophilus ‐SDC 2012, 2013 , B. infantis 35624 at a dose of 1 × 10 8 at 12 weeks using a four‐strain probiotic: L. rhamnosus NCIMB 30174, L. plantarum NCIMB 30173, L. acidophilus NCIMB 30175 and E. faecium NCIMB 30176 , in IBS‐D, for pain severity at 8 weeks using Bacillus coagulans GB1‐30, 6068 , and IBS‐C at 4 weeks using a three‐strain probiotic: B. lactis DN73010, S. thermophilus and L. bulgaricus and also B. infantis 35624 at a dose of 1 × 10 8 (sub‐group analysis) .…”

Irritable bowel syndrome: new and emerging treatments

“…Herbal therapies A recent trial compared the Korean herbal medicine Gwakhyangjeonggisan, with or without a probiotic supplement, with placebo in 64 patients with IBS-D. 119 The primary outcome was adequate relief from abdominal pain and discomfort. No significant difference was found between Gwakhyangjeonggisan, with or without probiotic, and placebo, although there were more responders outcome was patient reported stool form, but data were also collected on other intrusive symptoms such as urgency, pain perception, and frequency of defecation.…”