Ebastine in combination with low-dose antidepressants for refractory irritable bowel syndrome: A randomized controlled trial

Background Drug treatment of refractory irritable bowel syndrome (IBS) is not satisfactory at present. This study investigated the clinical effects of ebastine combined with low-dose antidepressants on refractory IBS. Methods A total of 105 patients with refractory refractory IBS were randomly assigned to two different treatment groups after signing informed consent. And they didn't know about the treatment group they were in. They were administered with ebastine (Group A) or ebastine combined with flupentixol and melitracen (Group B) for 4 weeks. Drug efficacy was evaluated using scales before and after treatment. In addition, serum D-lactate (D-LAC) and human intestinal fatty acid binding protein (I-FABP) level were measured to assess intestinal permeability. Results Significant improvements were observed in IBS Quality of Life (IBS-QOL) score, IBS Symptom Severity Scale (IBS-SSS) score, and total sleep quality score. Patients in Group A showed no improvements in anxiety (44.83 ± 9.62 vs. 43.92 ± 10.43, P = 0.415) and depression (39.08 ± 9.34 vs. 38.75 ± 9.35, P = 0.674) compared with the baseline level, while those in Group B improved significantly on anxiety (52.12 ± 8.19 vs. 39.28 ± 9.88) and depression (47.64 ± 9.53 vs. 38.24 ± 9.41) status. After treatment, the serum levels of D-LAC and I-FABP were significantly lower in Group B than in Group A. Conclusion Refractory IBS patients showed certain psychological abnormalities. Ebastine combined with antidepressants exhibited more obvious benefits on QOL, sleep quality, and SSS, with significant improvements in psychological status and intestinal permeability in refractory IBS patients.