Huoxiang Zhengqi oral liquid for irritable bowel syndrome with diarrhea: a multicenter, double-blind, randomized controlled trial

Abstract

Background: Both preclinical and clinical studies have suggested Huoxiang Zhengqi (HXZQ) oral liquid's effect on gastrointestinal disease. However, robust evidence in patients with irritable bowel syndrome with diarrhea (IBS-D) is still lacking.

Purpose: The aim of this study was to assess the efficacy and safety of HXZQ oral liquid for IBS-D patients.

Methods: This two-arm, multicenter, double-blind randomized controlled trial assessed HXZQ oral liquid's superiority over a placebo in IBS-D patients. Adults aged 18-70 years with IBS-D from 14 hospitals in China were randomly assigned to receive either HXZQ (20 ml) or a placebo (20 ml), twice a day for 4 weeks. Based on a patient-centered research approach, the primary outcome was binary adequate relief (AR) responder rates. Secondary outcomes were the IBS symptom severity scale (IBS-SSS) score, the IBS quality of life (IBS-QOL) score, and the visual analogue scale (VAS) and utility values on the EuroQol-5-Dimensions-5-Level (EQ-5D-5 L).

Results: 108 of the 212 eligible participants were randomly assigned to the HXZQ group and 104 to the placebo group. At the end of the 4th week, the response rate in the HXZQ group was significantly higher than that in the placebo group, exceeding the efficacy margin of 10% (rate difference: 0.29; 95% CI: 0.14, 0.43). The fragility index (FI) values of AR for the two groups were 13 at 4 weeks and 8 at 8 weeks, respectively. The IBS-SSS score showed a greater reduction in the HXZQ group compared to the placebo group (mean difference: -10.92, 95% CI: -18.93, -2.90). No serious adverse events were reported.

Conclusion: HXZQ oral liquid may be an alternative option for IBS-D patients in clinical practice.

Keywords: Adequate relief; Huoxiang Zhengqi oral liquid; Irritable bowel syndrome; Randomized controlled trial.