Efficacy of Jiinshihoto on Depressive Symptoms in Patients With Pulmonary Mycobacterium avium-intracellulare Complex Disease not Receiving Standard Treatment.

Abstract

Background: Patients with pulmonary Mycobacterium avium-intracellulare complex (MAC) disease who cannot receive standard antimicrobial therapy have limited treatment options. Jiinshihoto, a Kampo formula (traditional Japanese herbal medicine) that is effective for chronic cough and depressive symptoms, has not been evaluated in this population.

Objective: To evaluate the physical, immunological, and psychiatric effects of Jiinshihoto in patients with pulmonary MAC who were ineligible for standard antimicrobial treatment.

Methods: This single-center, open-label, prospective study was conducted from March 2018 to January 2020. Patients who were not eligible for standard treatment for pulmonary MAC disease were enrolled. Jiinshihoto (3.0 g) was administered three times per day for 12 months. The primary endpoints were 3-month changes in chronic obstructive pulmonary disease assessment test (CAT) scores, body weight, and natural killer (NK) cell activity. Secondary endpoints were 3-month changes in self-rating depression scale (SDS) scores. This study was registered in the UMIN-Clinical Trials Registry (UMIN000033590).

Results: In total, 24 patients were enrolled. The mean age was 68 years, and 74% were female; the mean body mass index was 19.3 kg/m². Of these, 23 patients completed the 3-month follow-up. For the primary endpoints at 3 months, no significant changes were observed in CAT scores (from 11.2 to 11.0, P = .87), body weight (from 48.6 to 48.8 kg, P = .32), or NK cell activity (from 42.6% to 43.9%, P = .58). SDS scores showed significant improvement at 3 months (from 42.2 to 38.5, P = .032) and 12 months (from 42.2 to 40.4, P = .034).

Conclusion: Jiinshihoto did not improve respiratory symptoms, weight, or NK cell activity in patients with pulmonary MAC ineligible for standard treatment but may be beneficial for depressive symptoms.