Trial reportBMJ open2025
Chinese herbal formula Tongxie Yaofang granules for diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled, phase II trial.
Trial report in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed.
- The Potential of Complementary and Alternative Therapies in Improving Diarrhea-Predominant Irritable Bowel Syndrome: Strategies for Long-Term Efficacy.Digestive diseases and sciences · 2026Review
- Paradigm Evolution of Rome Criteria over 36 Years and Integration of Chinese and Western Medicine: From "Functional Gastrointestinal Disorders" to "Disorders of Gut-Brain Interaction".Chinese journal of integrative medicine · 2026Article
- Review
- Article
- Clinical efficacy of Xifeng Huashi and its effect on mental status in patients with diarrheal irritable bowel.World journal of psychiatry · 2026Article
- Depression and Gastrointestinal Health Abnormalities: Treatment Approaches from the Perspective of Traditional Chinese Medicine.Neuropsychiatric disease and treatment · 2026Review
- Effect of Tongxie Yaofang formula on the gut microbiota of diarrhea model mice: a combined strategy of network pharmacology, molecular docking, and 16S rRNA gene sequencing.Bioscience of microbiota, food and health · 2026Article
- Deciphering the microbiological mechanism of Tongxie Yaofang in treating IBS-D: a multimodal mechanistic study in mice integrating network pharmacology, computational simulation, and 16S rRNA sequencing.Experimental biology and medicine (Maywood, N.J.) · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo 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.
designA randomised, double-blind, placebo-controlled, phase II, superiority trial.
settingOutpatients attending the Fangshan Hospital, Beijing University of Chinese Medicine, Beijing, China.
participants96 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.
interventionsTXYF 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.
resultsThe 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)
conclusionsDespite 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.
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