OBJECTIVES: Functional dyspepsia (FD) is the most common gastrointestinal disorder, leading to significant impairment in daily life. No medicine has indication for FD by FDA yet. Yukgunja-tang (YGJ) is widely used in South Korea for managing FD, but the evidence supporting its clinical efficacy was limited. On the other hand, Pyeongwi-san (PWS) is often prescribed for gastrointestinal symptoms because it is under coverage of National Health Insurance scheme. This economic evaluation, alongside a clinical trial (KCT0006044), was performed to evaluate the cost-effectiveness of a YGJ for FD compared to an active control (PWS) and usual care (UC).

METHODS: The cost-effectiveness model was developed for three arms over a six-week period from a healthcare system perspective. Total Dyspepsia Symptom (TDS) Scale was used for the efficacy. Patients with a greater than 75% improvement in TDS were classified as treatment responders. The costs for herbal medicine occurred during the trial were input. The incremental cost-effectiveness ratios (ICER) of YGJ were estimated.

RESULTS: 119 participants were included (n=49, 44, 26 in YGJ, PWS, UC group respectively) for per protocol analysis. YGJ treatment showed slightly greater treatment response (29%) than PWS (vs. 23%, p>0.05) and UC group (vs. 8%, p<0.05). The ICER results for YGJ were KRW 7,100,000 (USD 5,100) KRW 2,100,000 (USD 1,500) compared to PWS and UC respectively.

CONCLUSIONS: While YGJ alleviates dyspepsia symptoms comparably with PWS, it is not considered a cost-effective option considering its current price not covered by insurance. However, given the limited treatment options available for FD, YGJ with comparable clinical effectiveness might be considered for the insurance coverage to increase the accessibility of FD treatments in Korea.