Objectives This randomized controlled trial aimed to evaluate the effects of Gui‐Shao San umbilical moxibustion on symptoms of the disease, psychological well‐being, and quality of life in patients with IBS‐D. Interventions The patients were randomly assigned to three groups: One received Gui‐Shao San umbilical moxibustion alongside conventional Western medicine treatment; one received placebo umbilical moxibustion alongside conventional Western medicine treatment; and one received only conventional Western medicine treatment for use as a positive control group. Outcomes The primary outcome measures included TCM clinical symptom score, IBS‐SSS, and grading criteria for TCM syndrome scores. Secondary outcome measures included SAS, SDS, and IBS‐QOL. The effects of the intervention on these outcomes were measured at three time points: baseline (T0), Week 2 (T1), and Week 4 (T2). At Week 8, the recurrence of patients was measured based on whether their IBS‐SSS score increased by one grade Results After 4 weeks of treatment, compared with the positive drug control group, both the Gui‐Shao San umbilical moxibustion group and the placebo umbilical moxibustion group effectively relieved patients′ symptoms, anxiety, and depression, while improving their quality of life. Significant differences were observed between groups in IBS‐SSS scores (120.61 ± 30.61 vs. 128.13 ± 41.85 vs. 161.82 ± 59.87, p < 0.001) and TCM syndrome scores (7.88 ± 1.709 vs. 8.59 ± 2.722 vs. 9.97 ± 2.099, p < 0.001). Conclusions Gui‐Shao San umbilical moxibustion is an effective method for treating IBS‐D. Further rigorous, large‐scale, long‐term trials are needed to evaluate the therapeutic effects of Gui‐Shao San umbilical moxibustion, focusing on interdisciplinary collaboration. Trial Registration The International Traditional Medicine Clinical Trial Registry (ITMCTR) Reg. No.: ITMCTR2025001072
Zhou et al. (Thu,) studied this question.