Association Between Kamikihito Treatment and Nocturnal Voiding Frequency in Patients With Sleep Disturbance: A Retrospective Clinical Study

ABSTRACT Aim Sleep disturbance is an important contributing factor to nocturia, particularly in older adults. Kamikihito is a Kampo medicine traditionally prescribed for the Heart and spleen systems deficiency pattern (TM1). The aim of this study was to retrospectively evaluate the association between kamikihito treatment and nocturnal voiding frequency in patients with sleep disturbance. Methods This retrospective observational study included patients with sleep disturbance who received kamikihito between September 2023 and July 2024. Patients with untreated nocturnal polyuria or bladder storage dysfunction were excluded unless appropriately treated. The primary outcome was change in nocturnal voiding frequency (posttreatment values were defined as the lowest value observed during the treatment period). Results Thirteen patients were included in this analysis. Nocturnal voiding frequency significantly decreased after treatment (median: from 4 to 3; Wilcoxon signed‐rank test, p = 0.013). Kamikihito was generally well tolerated; only one patient discontinued treatment due to pruritus. Conclusion Kamikihito treatment was associated with reduced nocturnal voiding frequency in patients with sleep disturbance. Causality cannot be established due to the retrospective design and use of the best observed response, and the findings should be considered preliminary. Nevertheless, the results suggest a potential role for kamikihito as a complementary therapeutic option for sleep‐related nocturia.