Effects of mokuboito, a Japanese Kampo medicine, on long‐term clinical outcomes in patients with heart failure

Aim We previously reported that oral administration of mokuboito (a Japanese Kampo medicine) significantly improved symptoms in hospitalized patients with heart failure (HF). However, it remains unclear whether mokuboito treatment affects the long‐term clinical prognosis in patients with HF. Methods We retrospectively investigated the long‐term prognosis in 40 patients who participated in our previous study. Patients were allocated randomly to Group S (standard therapy alone) or Group M (oral administration of mokuboito plus standard therapy). The primary outcome was the composite endpoint of major adverse cardiovascular events (MACE; death from any cause, myocardial infarction or unstable angina, and readmission due to worsening HF) during 2 years. Results MACE were respectively observed in 13 and 5 patients in Group S and Group M (incidence rate per 100 person‐years, 57.7 versus 17.3; P = 0.02), and the hazard ratio (HR) was 0.32 (95% CI 0.12–0.91; P = 0.02). Death from any cause was respectively observed in seven and three patients in Group S and Group M (incidence rate per 100 person‐years, 22.6 versus 9.00; P = 0.18), and the HR was 0.41 (95% CI 0.11–1.58; P = 0.18). Readmission due to worsening HF was respectively observed in 11 and 5 in Group S and Group M (incidence rate per 100 person‐years, 44.4 versus 16.8; P = 0.08), and the HR was 0.39 (95% CI 0.13–1.12; P = 0.07). Conclusions Oral administration of mokuboito significantly improved long‐term clinical outcomes in patients hospitalized for HF during 2 years after discharge.