Yukgunja-tang and Pyeongwi-san improve functional dyspepsia and modulate ghrelin dynamics: A multicenter randomized controlled trial

초록

Ethnopharmacological relevance: Yukgunja-tang (YGJ) and Pyeongwi-san (PWS) are traditional East Asian herbal formulations used for functional dyspepsia (FD). Aim of the study: To compare the efficacy and safety of YGJ and PWS with usual care (UC) in patients with FD and explore effects on circulating ghrelin. Materials and methods: This multicenter, assessor-blind randomized controlled trial assigned 140 patients with FD to receive YGJ (n = 56), PWS (n = 56), or UC (n = 28) for 6 weeks. The primary outcome was the change in Total Dyspepsia Symptom Scale (TDS) score at week 6. Secondary outcomes included dyspeptic symptoms, quality of life, psychological measures, pattern identification, ghrelin levels, and safety. Results: YGJ and PWS significantly reduced TDS scores compared with UC at week 6 (YGJ: MD -1.63; 95% CI, -2.94 to -0.31; PWS: MD -1.55; 95% CI, -2.98 to -0.12). YGJ showed more consistent improvements across symptom measures and improved depressive symptoms and spleen qi deficiency-related outcomes. Both groups showed exploratory, within-group reductions in des-acyl ghrelin, with PWS also increasing the acyl-ghrelin ratio. No significant differences were noted between YGJ and PWS. Drug compliance exceeded 92%, with no serious treatment-related adverse events. Conclusions: YGJ and PWS were associated with additional benefit over UC in reducing dyspeptic symptoms, with favorable safety profiles. YGJ and PWS demonstrated comparable overall efficacy but showed distinct patterns across psychological and ghrelin-related outcomes. These findings provide clinically relevant comparative evidence for the use of herbal medicines in FD, though they warrant cautious interpretation given that UC rather than placebo was the comparator.

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