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Randomised clinical trial: Tong-Xie-Yao-Fang granules versus placebo for patients with diarrhoea-predominant irritable bowel syndrome.
Aliment Pharmacol Ther. 2018 07; 48(2):160-168.AP

Abstract

BACKGROUND

Tong-Xie-Yao-Fang (TXYF) is a Chinese herbal formula for treating chronic diarrhoea accompanied by abdominal pain. The results were inconsistent in previous trials examining its effect.

AIM

To study the efficacy of TXYF granules for treating diarrhoea-predominant irritable bowel syndrome (IBS-D).

METHODS

We performed a double-blind, placebo-controlled randomised trial and enrolled 160 participants with IBS-D. The participants had VAS scores ≥3 cm in IBS-D global symptoms and ≥2 days in a week with abdominal pain and loose stools (Bristol score 5, 6 or 7). They were randomly assigned to received TXYF or placebo during a treatment period of 4 weeks, and they were followed up for 8 weeks after treatment. The primary outcome was adequate relief of IBS-D global symptoms for at least 2 of 4 weeks during weeks 1-4. Secondary outcomes included mean weekly VAS scores of IBS-D major symptoms, mean weekly stool frequency, mean weekly Bristol score, and adverse events.

RESULTS

155 of 160 patients completed the trial. We found a significantly higher rate of adequate relief of global symptoms in TXFY group during weeks 1 to 4 (57.5% vs 37.5%, χ2 = 5.6391, P = 0.017); logistic regression analysis showed a similar result (OR 2.2, 95% CI 1.2-4.4, P = 0.016). Most of the secondary outcomes showed superiority of TXYF over placebo in weekly assessment from week 3 to week 7. The adverse event rate was low in both groups (3.8% vs 3.8%, P = 1.000).

CONCLUSION

During a 4 week trial, TXFY granules were superior to placebo in controlling symptoms of IBS-D.

Authors+Show Affiliations

Clinical Medicine College/Teaching hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.Clinical Medicine College/Teaching hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.Colorectal Department, Luzhou People's Hospital, Luzhou, Sichuan, China.Clinical Medicine College/Teaching hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.Clinical Medicine College/Teaching hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.Clinical Medicine College/Teaching hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.Clinical Medicine College/Teaching hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.Clinical Medicine College/Teaching hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.Colorectal Department, Luzhou People's Hospital, Luzhou, Sichuan, China.Colorectal Department, Luzhou People's Hospital, Luzhou, Sichuan, China.Acupuncture and Tuina School/3rd Teaching Hosptial, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.Clinical Medicine College/Teaching hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.

Pub Type(s)

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

Language

eng

PubMed ID

29856472

Citation

Chen, M, et al. "Randomised Clinical Trial: Tong-Xie-Yao-Fang Granules Versus Placebo for Patients With Diarrhoea-predominant Irritable Bowel Syndrome." Alimentary Pharmacology & Therapeutics, vol. 48, no. 2, 2018, pp. 160-168.
Chen M, Tang TC, Wang Y, et al. Randomised clinical trial: Tong-Xie-Yao-Fang granules versus placebo for patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2018;48(2):160-168.
Chen, M., Tang, T. C., Wang, Y., Shui, J., Xiao, X. H., Lan, X., Yu, P., Zhang, C., Wang, S. H., Yao, J., Zheng, H., & Huang, D. Q. (2018). Randomised clinical trial: Tong-Xie-Yao-Fang granules versus placebo for patients with diarrhoea-predominant irritable bowel syndrome. Alimentary Pharmacology & Therapeutics, 48(2), 160-168. https://doi.org/10.1111/apt.14817
Chen M, et al. Randomised Clinical Trial: Tong-Xie-Yao-Fang Granules Versus Placebo for Patients With Diarrhoea-predominant Irritable Bowel Syndrome. Aliment Pharmacol Ther. 2018;48(2):160-168. PubMed PMID: 29856472.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised clinical trial: Tong-Xie-Yao-Fang granules versus placebo for patients with diarrhoea-predominant irritable bowel syndrome. AU - Chen,M, AU - Tang,T-C, AU - Wang,Y, AU - Shui,J, AU - Xiao,X-H, AU - Lan,X, AU - Yu,P, AU - Zhang,C, AU - Wang,S-H, AU - Yao,J, AU - Zheng,H, AU - Huang,D-Q, Y1 - 2018/06/01/ PY - 2018/02/17/received PY - 2018/03/17/revised PY - 2018/04/30/accepted PY - 2018/6/2/pubmed PY - 2019/8/20/medline PY - 2018/6/2/entrez SP - 160 EP - 168 JF - Alimentary pharmacology & therapeutics JO - Aliment Pharmacol Ther VL - 48 IS - 2 N2 - BACKGROUND: Tong-Xie-Yao-Fang (TXYF) is a Chinese herbal formula for treating chronic diarrhoea accompanied by abdominal pain. The results were inconsistent in previous trials examining its effect. AIM: To study the efficacy of TXYF granules for treating diarrhoea-predominant irritable bowel syndrome (IBS-D). METHODS: We performed a double-blind, placebo-controlled randomised trial and enrolled 160 participants with IBS-D. The participants had VAS scores ≥3 cm in IBS-D global symptoms and ≥2 days in a week with abdominal pain and loose stools (Bristol score 5, 6 or 7). They were randomly assigned to received TXYF or placebo during a treatment period of 4 weeks, and they were followed up for 8 weeks after treatment. The primary outcome was adequate relief of IBS-D global symptoms for at least 2 of 4 weeks during weeks 1-4. Secondary outcomes included mean weekly VAS scores of IBS-D major symptoms, mean weekly stool frequency, mean weekly Bristol score, and adverse events. RESULTS: 155 of 160 patients completed the trial. We found a significantly higher rate of adequate relief of global symptoms in TXFY group during weeks 1 to 4 (57.5% vs 37.5%, χ2 = 5.6391, P = 0.017); logistic regression analysis showed a similar result (OR 2.2, 95% CI 1.2-4.4, P = 0.016). Most of the secondary outcomes showed superiority of TXYF over placebo in weekly assessment from week 3 to week 7. The adverse event rate was low in both groups (3.8% vs 3.8%, P = 1.000). CONCLUSION: During a 4 week trial, TXFY granules were superior to placebo in controlling symptoms of IBS-D. SN - 1365-2036 UR - https://www.unboundmedicine.com/medline/citation/29856472/Randomised_clinical_trial:_Tong_Xie_Yao_Fang_granules_versus_placebo_for_patients_with_diarrhoea_predominant_irritable_bowel_syndrome_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=29856472.ui DB - PRIME DP - Unbound Medicine ER -