A prospective, randomized, double-blind, placebo-controlled trial of the Kampo formula daiobotanpito combined with antibiotic therapy for acute diverticulitis

Abstract

Daiobotanpito (DBT) is a Kampo formula traditionally used to treat abscesses in intestinal disorders. This double-blind, multicenter, randomized controlled trial was conducted at participating hospitals in Japan. Patients with CT-proven moderate acute diverticulitis received conventional therapy along with an oral DBT (treatment group) or placebo (control group) administered thrice a day for 10 days (Registration: jRCTs041180063). The primary outcome was the treatment success rate: fever reduction to < 37.5 °C within 3 days or/and elimination of abdominal pain within 4 days. Secondary endpoints included hospitalization days, changes in the inflammatory response, number of days before food intake, recurrence rate within 1-year, and adverse event rate. 171 participants were included in this study. No significant difference was observed in the treatment success rates between the DBT and placebo groups (P = .348). However, the DBT group showed a significant reduction in CRP levels on day 5 (P = .023), and patients with abscesses started oral intake significantly earlier than those in the placebo group (P = .046). In conclusion, the results of this study do not suggest that an add-on treatment with DBT in patients with moderate acute diverticulitis provides additional benefit., However, DBT may offer clinical benefits in cases involving abscesses or severe inflammation. Further prospective studies focusing on complicated diverticulitis are necessary.

Keywords: Abscess; Colonic diverticular disease; Da Huang Mu Dan Tang; Daiobotanpito, colon diverticulitis; Japanese traditional medicine (Kampo).

Fig. 1

CONSORT flowchart. Among the 173 patients who met the selection criteria, 171 participated in the study (86 in the DBT group and 85 in the placebo group). Among those patients, four who failed to initiate protocol treatment and eight who failed to continue were excluded, leaving 77 patients in the DBT group and 82 in the placebo group. Furthermore, seven patients could not be contacted for the evaluation of the recurrence rate after 1 year; therefore, the final analysis included 72 patients in the DBT group and 80 patients in the placebo group. DBT: daiobotanpito.