Efficacy and Safety of the Japanese Herbal Medicine Daikenchuto (DKT) Elderly Fecal Incontinence Patients: A Prospective Study

Objectives: This study has investigated the efficacy and safety of daikenchuto (DKT) in elderly patients with fecal incontinence (FI). Methods: This was an open-label, single-arm study (UMIN Clinical Trials Registry as UMIN000030252). DKT at 15 glday was orally administered to patients for 28 days. Patients over 70 years old with FI, who scored over 11 in the Mini-Mental State Examination, are capable of oral intake, and provided written informed consent, were enrolled in this study. Changes in abdominal pain and bloating, Cleveland Clinic Incontinence Score (CCIS), FI Quality of Life Scale (FIQI,S), maximum resting pressure (MRP), FI frequency, and stool form were evaluated. Results: In total, 21 patients (1 requested to withdraw) were enrolled in this study. The compliance rate was 95.2%, and no serious adverse drug reactions were observed. Improvements in terms of abdominal pain and bloating were observed at 2 weeks (p < 0.01). In the CCIS, the total score, leakage of solid stool, and leakage of liquid stool improved after 2 weeks (p < 0.01), while pad use and lifestyle alteration improved after 4 weeks (p < 0.05). Improvement in FIQLS was also observed at 2 weeks (p < 0.01). MRP demonstrated significant improvement at 2 weeks (p < 0.01). Eleven (52.4%) patients had no Fl during the study period. Conclusions: DKT improves MRP and quality of life in patients with abdominal symptoms; moreover, it is considered to be a safe and effective drug for elderly patients with FI.