Tags

Type your tag names separated by a space and hit enter

Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial.
Trials. 2011 Oct 06; 12:219.T

Abstract

BACKGROUND

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habits without organic disease. Many patients seek alternative IBS treatments because of the limitations of conventional treatments. Gwakhyangjeonggisan (GJS), a herbal formula, has long been used for alleviating diarrhea-predominant IBS (D-IBS) in traditional medicine. Duolac7S, which comprises 7 bacterial species as probiotics, has been frequently used for D-IBS. Although GJS and Duolac7S have been administered simultaneously in many D-IBS patients, no study has investigated the effects of GJS and Duolac7S combination therapy on D-IBS.

METHODS/DESIGN

The current trial is a randomized, double-blinded, placebo-controlled, 4-arm study. After a 2-week run-in period, 60 patients with D-IBS will be randomly assigned to one of the 4 combination groups consisting of GJS (water extract granules, 3 g/pack, 3 times a day) with Duolac7S (powder form, 1 capsule, 2 times a day) or their placebos and followed up for 2 weeks. The assigned treatments will last for 8 weeks. The primary outcomes are adequate relief of IBS pain and discomfort and the proportion of responders (on a weekly basis). The secondary outcomes are visual analog scale for IBS symptoms (on a daily basis), quality of life (at 0, 8, and 10 weeks), intestinal permeability, and composition of intestinal microbiota (at 0 and 8 weeks).

DISCUSSION

The present study is designed to examine the safety and efficacy of GJS and Duolac7S combination therapy on D-IBS. Our study provides the clinical evidence of a new therapeutic strategy for D-IBS.

Authors+Show Affiliations

Department of Internal Medicine, College of Oriental Medicine, Kyung Hee University, Seoul, Republic of Korea.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21978382

Citation

Ko, Seok-Jae, et al. "Effect of Herbal Extract Granules Combined With Probiotic Mixture On Irritable Bowel Syndrome With Diarrhea: Study Protocol for a Randomized Controlled Trial." Trials, vol. 12, 2011, p. 219.
Ko SJ, Ryu B, Kim J, et al. Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial. Trials. 2011;12:219.
Ko, S. J., Ryu, B., Kim, J., Hong, B. G., Yeo, I., Lee, B. J., Lee, J. M., & Park, J. W. (2011). Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial. Trials, 12, 219. https://doi.org/10.1186/1745-6215-12-219
Ko SJ, et al. Effect of Herbal Extract Granules Combined With Probiotic Mixture On Irritable Bowel Syndrome With Diarrhea: Study Protocol for a Randomized Controlled Trial. Trials. 2011 Oct 6;12:219. PubMed PMID: 21978382.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial. AU - Ko,Seok-Jae, AU - Ryu,Bongha, AU - Kim,Jinsung, AU - Hong,Beom-Gi, AU - Yeo,Inkwon, AU - Lee,Beom-Joon, AU - Lee,Jin-Moo, AU - Park,Jae-Woo, Y1 - 2011/10/06/ PY - 2011/08/12/received PY - 2011/10/06/accepted PY - 2011/10/8/entrez PY - 2011/10/8/pubmed PY - 2012/2/3/medline SP - 219 EP - 219 JF - Trials JO - Trials VL - 12 N2 - BACKGROUND: Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habits without organic disease. Many patients seek alternative IBS treatments because of the limitations of conventional treatments. Gwakhyangjeonggisan (GJS), a herbal formula, has long been used for alleviating diarrhea-predominant IBS (D-IBS) in traditional medicine. Duolac7S, which comprises 7 bacterial species as probiotics, has been frequently used for D-IBS. Although GJS and Duolac7S have been administered simultaneously in many D-IBS patients, no study has investigated the effects of GJS and Duolac7S combination therapy on D-IBS. METHODS/DESIGN: The current trial is a randomized, double-blinded, placebo-controlled, 4-arm study. After a 2-week run-in period, 60 patients with D-IBS will be randomly assigned to one of the 4 combination groups consisting of GJS (water extract granules, 3 g/pack, 3 times a day) with Duolac7S (powder form, 1 capsule, 2 times a day) or their placebos and followed up for 2 weeks. The assigned treatments will last for 8 weeks. The primary outcomes are adequate relief of IBS pain and discomfort and the proportion of responders (on a weekly basis). The secondary outcomes are visual analog scale for IBS symptoms (on a daily basis), quality of life (at 0, 8, and 10 weeks), intestinal permeability, and composition of intestinal microbiota (at 0 and 8 weeks). DISCUSSION: The present study is designed to examine the safety and efficacy of GJS and Duolac7S combination therapy on D-IBS. Our study provides the clinical evidence of a new therapeutic strategy for D-IBS. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/21978382/Effect_of_herbal_extract_granules_combined_with_probiotic_mixture_on_irritable_bowel_syndrome_with_diarrhea:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-12-219 DB - PRIME DP - Unbound Medicine ER -