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Chinese herbal formula Tongxie Yaofang granules for diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled, phase II trial

Chinese Herbal Formula for IBS-D: Study Overview

Purpose of the Study

This study aimed to evaluate how effective and safe Tongxie Yaofang (TXYF) granules are compared to a placebo for treating diarrhoea-predominant irritable bowel syndrome (IBS-D).

Study Design

The research was a phase II trial, which was randomised, double-blind, and placebo-controlled, ensuring unbiased results.

Location and Participants

The study took place at Fangshan Hospital, Beijing University of Chinese Medicine, involving 96 adults aged 18-65 with IBS-D symptoms.

Intervention Details

Participants received either TXYF granules (3.7 g) or a placebo twice daily for 8 weeks, taken before meals.

Outcomes Measured

The main outcome was the reduction in IBS symptoms after 8 weeks. Secondary outcomes included stool frequency and consistency, quality of life, anxiety, and depression.

Results Summary

Both TXYF and placebo groups showed similar rates of symptom reduction. No significant differences were found in the primary and secondary outcomes, although both groups experienced substantial symptom improvements. The safety profile was acceptable, with few adverse events reported.

Conclusions

While TXYF showed promise for improving IBS-D symptoms, no significant differences from the placebo were observed. Ongoing research is necessary to better understand the psychological factors impacting IBS-D and to further investigate TXYF’s effects.

Future Research Directions

More extensive trials with longer follow-up are needed to confirm these findings and explore the psychological aspects of IBS-D.

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