Chinese herbal formula Tongxie Yaofang granules for diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled, phase II trial
Objectives To assess the therapeutic effects and safety of Tongxie Yaofang (TXYF) granules vs placebo as an alternative treatment for diarrhoea-predominant irritable bowel syndrome (IBS-D). We hypothesised that TXYF would improve clinical responses among patients with IBS-D.Design A randomised, doub...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/1/e088410.full |
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| author | Nicola Robinson Mei Han Ling Yan Vincent Chi Ho Chung Jian-Ping Liu Hui-Juan Cao Shi-Bing Liang Hong-Jie Cheng Qiao-Yan Zhang Yu-Fei Li Ze-Yu Yu Ling-Yao Kong Yan-Mei Cai Li-Bao An Bao-Tuan Zhao Shan-Shan Xu Nai-Wei Zhang Bo-Yi Jia Wei-Fang Liu Fang Niu Ba-Teer Wu Jin-Ming Song Shu-Xin Jia Meng-Meng Shi Xiao-Na Zhang |
| author_facet | Nicola Robinson Mei Han Ling Yan Vincent Chi Ho Chung Jian-Ping Liu Hui-Juan Cao Shi-Bing Liang Hong-Jie Cheng Qiao-Yan Zhang Yu-Fei Li Ze-Yu Yu Ling-Yao Kong Yan-Mei Cai Li-Bao An Bao-Tuan Zhao Shan-Shan Xu Nai-Wei Zhang Bo-Yi Jia Wei-Fang Liu Fang Niu Ba-Teer Wu Jin-Ming Song Shu-Xin Jia Meng-Meng Shi Xiao-Na Zhang |
| author_sort | Nicola Robinson |
| collection | DOAJ |
| description | Objectives To assess the therapeutic effects and safety of Tongxie Yaofang (TXYF) granules vs placebo as an alternative treatment for diarrhoea-predominant irritable bowel syndrome (IBS-D). We hypothesised that TXYF would improve clinical responses among patients with IBS-D.Design A randomised, double-blind, placebo-controlled, phase II, superiority trial.Setting Outpatients attending the Fangshan Hospital, Beijing University of Chinese Medicine, Beijing, China.Participants 96 eligible participants included men and women ranging from late adolescence to middle adulthood (18–65 years), diagnosed with IBS-D according to the Rome IV criteria. In addition, they were required to have an irritable bowel syndrome symptom severity score (IBS-SSS) of at least 75.Interventions TXYF granules (3.7 g) twice daily (taken orally before meals) or placebo for 8 weeks.Primary and secondary outcomes The primary outcome was the response rate measured by the change in IBS-SSS compared with baseline at week 8. Secondary outcomes included stool frequency; stool consistency at weeks 4, 8 and 20; and quality of life, anxiety and depression at week 8; and safety was monitored throughout the trial.Results The TXYF and placebo groups each comprised 48 participants. The response rate was not significantly different at week 8 between the two groups (the unadjusted treatment effect estimate (intention-to-treat analysis) was 1.12 (95% CI (0.89, 1.41)), p=0.348). Both groups had a high and similar rate of symptom reduction (79.2% (38/48) vs 70.8% (34/48)). There were no statistically significant differences between the two groups on secondary outcomes, although both groups showed substantial improvements. Adverse events in the TXYF and placebo groups were one (sinus arrhythmia) and two (elevated transaminases, weakly positive faecal occult blood), respectively. No serious adverse events occurred.Conclusions Despite showing clinically meaningful improvements in IBS-D symptoms and a reasonable safety profile after 8 weeks, no significant differences were observed between the TXYF and placebo groups. This suggests that the severity of IBS-D symptoms in both treatment arms might have decreased over time, regardless of the treatment, and highlights the need to investigate the relationship between IBS-D and patient psychology. Future large-scale, rigorously designed trials with longer treatment and follow-up periods are essential to evaluate the therapeutic effects and safety of TXYF, and to explore the psychological factors.Trial registration number ISRCTN12453166. |
| format | Article |
| id | doaj-art-911cb418ac844d9fac8940ef907fb750 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-911cb418ac844d9fac8940ef907fb7502025-01-28T11:40:15ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-088410Chinese herbal formula Tongxie Yaofang granules for diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled, phase II trialNicola Robinson0Mei Han1Ling Yan2Vincent Chi Ho Chung3Jian-Ping Liu4Hui-Juan Cao5Shi-Bing Liang6Hong-Jie Cheng7Qiao-Yan Zhang8Yu-Fei Li9Ze-Yu Yu10Ling-Yao Kong11Yan-Mei Cai12Li-Bao An13Bao-Tuan Zhao14Shan-Shan Xu15Nai-Wei Zhang16Bo-Yi Jia17Wei-Fang Liu18Fang Niu19Ba-Teer Wu20Jin-Ming Song21Shu-Xin Jia22Meng-Meng Shi23Xiao-Na Zhang24Institute for Health and Social Care, London South Bank University, London, UKCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaThe School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, Hong KongCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaFangshan Hospital, Beijing University of Chinese Medicine, Beijing, ChinaObjectives To assess the therapeutic effects and safety of Tongxie Yaofang (TXYF) granules vs placebo as an alternative treatment for diarrhoea-predominant irritable bowel syndrome (IBS-D). We hypothesised that TXYF would improve clinical responses among patients with IBS-D.Design A randomised, double-blind, placebo-controlled, phase II, superiority trial.Setting Outpatients attending the Fangshan Hospital, Beijing University of Chinese Medicine, Beijing, China.Participants 96 eligible participants included men and women ranging from late adolescence to middle adulthood (18–65 years), diagnosed with IBS-D according to the Rome IV criteria. In addition, they were required to have an irritable bowel syndrome symptom severity score (IBS-SSS) of at least 75.Interventions TXYF granules (3.7 g) twice daily (taken orally before meals) or placebo for 8 weeks.Primary and secondary outcomes The primary outcome was the response rate measured by the change in IBS-SSS compared with baseline at week 8. Secondary outcomes included stool frequency; stool consistency at weeks 4, 8 and 20; and quality of life, anxiety and depression at week 8; and safety was monitored throughout the trial.Results The TXYF and placebo groups each comprised 48 participants. The response rate was not significantly different at week 8 between the two groups (the unadjusted treatment effect estimate (intention-to-treat analysis) was 1.12 (95% CI (0.89, 1.41)), p=0.348). Both groups had a high and similar rate of symptom reduction (79.2% (38/48) vs 70.8% (34/48)). There were no statistically significant differences between the two groups on secondary outcomes, although both groups showed substantial improvements. Adverse events in the TXYF and placebo groups were one (sinus arrhythmia) and two (elevated transaminases, weakly positive faecal occult blood), respectively. No serious adverse events occurred.Conclusions Despite showing clinically meaningful improvements in IBS-D symptoms and a reasonable safety profile after 8 weeks, no significant differences were observed between the TXYF and placebo groups. This suggests that the severity of IBS-D symptoms in both treatment arms might have decreased over time, regardless of the treatment, and highlights the need to investigate the relationship between IBS-D and patient psychology. Future large-scale, rigorously designed trials with longer treatment and follow-up periods are essential to evaluate the therapeutic effects and safety of TXYF, and to explore the psychological factors.Trial registration number ISRCTN12453166.https://bmjopen.bmj.com/content/15/1/e088410.full |
| spellingShingle | Nicola Robinson Mei Han Ling Yan Vincent Chi Ho Chung Jian-Ping Liu Hui-Juan Cao Shi-Bing Liang Hong-Jie Cheng Qiao-Yan Zhang Yu-Fei Li Ze-Yu Yu Ling-Yao Kong Yan-Mei Cai Li-Bao An Bao-Tuan Zhao Shan-Shan Xu Nai-Wei Zhang Bo-Yi Jia Wei-Fang Liu Fang Niu Ba-Teer Wu Jin-Ming Song Shu-Xin Jia Meng-Meng Shi Xiao-Na Zhang Chinese herbal formula Tongxie Yaofang granules for diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled, phase II trial BMJ Open |
| title | Chinese herbal formula Tongxie Yaofang granules for diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled, phase II trial |
| title_full | Chinese herbal formula Tongxie Yaofang granules for diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled, phase II trial |
| title_fullStr | Chinese herbal formula Tongxie Yaofang granules for diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled, phase II trial |
| title_full_unstemmed | Chinese herbal formula Tongxie Yaofang granules for diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled, phase II trial |
| title_short | Chinese herbal formula Tongxie Yaofang granules for diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled, phase II trial |
| title_sort | chinese herbal formula tongxie yaofang granules for diarrhoea predominant irritable bowel syndrome a randomised double blind placebo controlled phase ii trial |
| url | https://bmjopen.bmj.com/content/15/1/e088410.full |
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