A Kampo medicine, <i>choreito</i>, evaluated on female lower urinary tract symptoms (<scp>LUTS</scp>) with bladder pain

Abstract Aim Choreito (CRT) is a pharmaceutical‐grade Kampo medicine and has been widely prescribed for patients with lower urinary tract symptoms (LUTS) and cystitis in Japan. The purpose of this study was to investigate the efficacy and safety of CRT in patients with persisting bladder pain. Methods This study was an open‐label, single‐arm exploratory study (Registration No. jRCTs071190017), and CRT was administered orally for eight weeks in addition to the standard therapy. The primary end‐point was the change in Core Lower Urinary Symptoms Score (CLSS) Q9 (bladder pain) from baseline to eight weeks after treatment. The secondary end‐points were all items of CLSS, International Prostate Symptom Score (IPSS), numerical rating scale of bladder pain, uroflowmetry, residual urine volume test, bladder diary and Overall Treatment Efficacy (OTE). Results In all, 13 female LUTS patients with bladder pain were enrolled. In the primary end‐point, CLSS Q9 (bladder pain) score significantly decreased at the point of week 8. Among secondary end‐points, IPSS Q7 (nocturia) has significantly decreased at weeks 4 and 8 compared with week 0. The numerical rating scale of bladder pain has significantly decreased at week 4. The 24‐hr urine volume significantly increased at week 8. However, no statistically significant changes in other subscores were observed. In satisfaction with CRT treatment according to OTE, 53.8% of patients reported “slightly improved.” There were no adverse drug reactions from CRT. Conclusion We concluded that CRT has demonstrated therapeutic efficacy for bladder pain. CRT could be potentially a useful add‐on treatment for patients persisting with bladder pain.