RESUMO
ETHNOPHARMACOLOGICAL RELEVANCE: Hyangaa-Pyeongwi san is the most well known description in Traditional Chinese Medicine for treating functional gastrointestinal disorders. Functional dyspepsia (FD) is a main concern of intimidating quality of life (QoL) in recent days. Although many medicines have been developed to improve FD symptoms as well as QoL, there are no potential drugs and treatments for FD. The aim of this study is to investigate the effects of Hyangaa-Pyeongwi san (HPS) on QoL of patients with FD. METHODS: This study was designed as a randomized, double blinded, placebo controlled, and parallel group trial. Participants received either placebo or HPS (9.68g of HPS at once, three times daily) for 4-weeks, and the efficacy evaluations were performed by assessing the Nepean Dyspepsia Index (NDI) and functional dyspepsia-quality of life (FD-QoL) at 0-, 4- and 8-weeks. RESULTS: Total of 170 patients participated and were randomly allocated into placebo or HPS groups. Total symptom score of NDI decreased after 4-weeks trial in both groups (p>0.05). HPS significantly improved QoL scores, especially in the area of 'interference and eat/drink' in NDI (p=0.0031) as well as 'liveliness status', 'role-functioning status', and total score in FD-QoL (p=0.026 for liveliness status and p=0.035 for role-functioning status). This significant improvement of FD-QoL had lasted for 4-weeks. CONCLUSION: HPS treatment is markedly effective in improving QoL in patients with FD. Moreover, we observed that this improvement had lasted for 4 weeks after finishing the trial through the follow-up study.