Abstract:

Objectives: Hange-Shashin-To (HST), which is a combination of seven herbs, has previously been used in the treatment of inflammatory or ulcerative gut disease. The aim of this study was to evaluate the safety and efficacy of HST for the treatment of chronic pouchitis. Methods: Nineteen patients with chronic pouchitis, defined as either frequent episodes (≥ three episodes per six months) of pouchitis or persistent symptoms that required continuous antibiotic therapies, were selected and treated with ciprofloxacin (CPFX) 600 mg/day for 2 weeks (week 0~2) and HST 3,750 mg/day for 32 weeks (week 0~32). The Pouchitis Disease Activity Index (PDAI) score was measured at week 0 and 6 for short-term evaluation. For long-term evaluation, total CPFX dose in the 26-week period prior to study entry (from 30 weeks before study entry to 5 weeks before study entry) was compared with the total CPFX dose during the 26-week study period (week 7~32). Although no concomitant administration of CPFX was permitted from week 2-6, patients whose condition deteriorated were prescribed CPFX from week 7 to week 32. Results: Fourteen patients completed this 32-week study. The PDAI scores of eight patients decreased below seven. The mean total PDAI scores decreased significantly from 11 ± 2.5 to 6.5 ± 2.5 (P < 0.001). The mean value of total CPFX dose decreased significantly from 491.6 ± 182.4 mg/kg to 392.5 ± 184.0 mg/kg (P < 0.05). No severe adverse events were noted. Conclusions: Our data suggest that HST has a positive effect on chronic pouchitis with no adverse effects.