Objectives: Frail patients with chronic obstructive pulmonary disease (COPD) have a higher risk of mortality, mood disorder, and poor quality of life (QOL). There are few intervention studies in frail patients with COPD, and there is a need for an effective therapy. Ninjin'yoeito (NYT) is a Kampo medicine that has been reported to improve fatigue, psychosomatic vulnerability, and respiratory symptoms. We examined the efficacy of NYT in frailty or prefrailty patients with COPD. Design: Prospective, single-center, open-label, randomized controlled trial. Location: Showa University Hospital, Tokyo, Japan. Subjects: Sixty-two patients (53 males and 9 females) with a mean age of 76 ± 6 years were included in the analysis. Interventions: The patients were divided into two groups: the NYT group (n = 31) and the control (standard treatment) group (n = 31). Outcome measures: The primary outcome was changes in Kihon checklist (KCL) scores at week 24, which reflect changes in frailty. The secondary outcomes were changes in the following assessment scores at week 24: Simplified Nutritional Appetite Questionnaire (SNAQ) scores, which reflect changes in appetite; COPD Assessment Test (CAT) scores, which reflect changes in QOL in patients with COPD; Hospital Anxiety and Depression Scale (HADS)-Anxiety scores, which reflect changes in anxiety; and HADS-Depression scores, which reflect changes in depression. Results: There was a slight but not significant difference in changes in KCL scores between the NYT and control groups (p = 0.09). However, there were statistically significant differences in changes in SNAQ (p = 0.03), CAT (p = 0.03), HADS-Anxiety (p < 0.01), and HADS-Depression (p = 0.02) scores between the two groups. Conclusions: Our results suggest that NYT is an effective and promising drug with various effects in patients with COPD who are frail, despite conventional treatment.
Keywords: Ninjin'yoeito; chronic obstructive pulmonary disease; frailty; prefrailty.