Efficacy of Tong-Xie-Yao-Fang granule and its impact on whole transcriptome profiling in diarrhea-predominant irritable bowel syndrome patients: study protocol for a randomized controlled trial

Abstract

Background Irritable bowel syndrome (IBS) is one kind of common functional bowel disease with obscure pathogenesis, and exploration about whole transcriptome profiling in IBS-D is still negligible. Conventional medications have limited effects, which makes focus shifted to traditional Chinese medicine (TCM). Tong-Xie-Yao-Fang, as a classic herbal formula in TCM, is pretty effective and safe for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), but the underlying therapeutic mechanism remains unknown. We aim to verify the efficacy and safety of TXYF granule (the formula particles mixed together) in IBS-D and elucidate the gene-level mechanism of IBS-D and therapeutic targets of TXYF granule based on whole transcriptome analysis. Methods/design This is a randomized, double-blind, and placebo-controlled clinical trial consisting of 2 weeks of run-in period, 12 weeks of treatment period, and 8 weeks of follow-up period. We will enroll 120 participants with IBS-D, who will be randomly assigned to the TXYF granule group and the placebo group, and recruit additional 10 healthy individuals as controls for mechanistic outcome. The two groups respectively take TXYF granule or placebo orally for treatment. The primary outcome is the response rate of IBS-Symptom Severity Score (IBS-SSS). The secondary outcomes include adequate relief (AR), IBS-Quality of Life Questionnaire (IBS-QOL), and long-term efficacy. Mechanistic outcome is the whole transcriptome profiling of the intestinal mucosae from IBS participants before and after the treatment and healthy individuals. Discussion This trial will prove the effectiveness and safety of TXYF granule with high-quality evidence and provide a penetrating and comprehensive perspective on the molecular mechanism of IBS-D by whole transcriptome analysis, which makes us pinpoint specific biomarkers of IBS-D and therapeutic targets of TXYF. Trial registration Chinese Clinical Trial Registry ChiCTR-IOR-1900021785. Registered on 9 March 2019

Exploring the Molecular Mechanism of Tong Xie Yao Fang in Treating Ulcerative Colitis Using Network Pharmacology and Molecular Docking

“…There are many classical prescriptions recorded in TCM literature that are still used in China today with clinical effectiveness. TXYF, one of classical TCM prescriptions, is composed of Atractylodes macrocephala Koidz (Baizhu), Paeoniae Radix Alba (Baishao), Citrus Reticulata (Chenpi), and Saposhnikoviae Radix (Fangfeng) [ 46 ]. Our study explored possible mechanisms of TXYF related to UC using network pharmacology and molecular docking, which indicated that 7 ingredients and 15 target genes, especially PTGS2 (prostaglandin-endoperoxide synthase 2), were related to UC.…”

The efficacy of the traditional Korean herbal medicine Tongsayobang for the treatment of irritable bowel syndrome

“…[ 15 ] Conventional Western medications have shown limited efficacy for the treatment of IBS, with repeated treatments required due to high recurrence rates, which leads to socioeconomic burden. [ 16 ] Although TSYB has long been used to treat abdominal pain accompanied by diarrhea, its efficacy and safety for IBS have not been sufficiently investigated. A systematic review published in 2019 on the effect of TSYB in diarrhea-predominant IBS patients showed that TSYB was effective and safe compared to conventional medications and the placebo.…”

“…Epidemiologically, IBS affects 10% to 15% of the population [15] . Conventional Western medications have shown limited efficacy for the treatment of IBS, with repeated treatments required due to high recurrence rates, which leads to socioeconomic burden [16] . Although TSYB has long been used to treat abdominal pain accompanied by diarrhea, its efficacy and safety for IBS have not been sufficiently investigated.…”

Tong Xie Yao Fang: A Classic Chinese Medicine Prescription with Potential for the Treatment of Ulcerative Colitis

“…TXYF is composed of Rhizoma Atractylodis Macrocephalae, Paeoniae Radix Alba, Citri Reticulatae Pericarpium, and Saposhnikoviae Radix. Rhizoma Atractylodis Macrocephalae and Citri Reticulatae Pericarpium strengthen the spleen to eliminate dampness while Paeoniae Radix Alba and Saposhnikoviae Radix soothe the liver to regulate qi [ 21 ]. TXYF improves colonic mucosal pathological tissue score and disease activity in UC; it regulates the migration, proliferation, and apoptosis of epithelial cells and contributes to mucosal healing in UC [ 22 ].…”