Ogawa-Ochiai Keiko, Tsuji Shigetsugu, Maeda Atsuki, Ikehara Hisatomo, Kawabata Kazumi, Dohmen Takahiro, Ojima Eisuke, Nakayama Goro, Hisabe Takashi, Suenaga Masaya, Kagaya Takashi, Ishigure Kiyoshi, Okochi Osamu, Hattori Masashi, Hirai Hirokazu, Kasai Toyotaka, Takeda Toshiya, Yamada Takanori, Yoshida Isao, Sakai Mitsuru, Takehara Akira, Munemoto Yoshinori, Esaki Mitsuru, Mochizuki Yoshinari, Nishijima Koji, Kitamura Shinji, Sakai Seisho, Hara Takuo, Honyang Li, Doyama Hisashi, Uchita Kunihisa, Kodera Yasuhiro, Yoshimura Kenichi, Mori Keita, Ishikawa Hideki
Kampo Clinical Center, Hiroshima University Hospital, Kasumi 1-2-3, Minami-ku, Hiroshima, 734-8551, Japan.
Department of Gastroenterology, Ishikawa Prefectural Central Hospital, 2-1, Kuratsuki- Higashi, Kanazawa City, Ishikawa, 920-8530, Japan.
Sci Rep. 2025 Jul 1;15(1):21069. doi: 10.1038/s41598-025-07385-9.
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.
大柴胡汤（DBT）是一种传统上用于治疗肠道疾病脓肿的汉方制剂。这项双盲、多中心、随机对照试验在日本的参与医院进行。经CT证实为中度急性憩室炎的患者接受常规治疗，并同时口服DBT（治疗组）或安慰剂（对照组），每日3次，共10天（注册号：jRCTs041180063）。主要结局是治疗成功率：3天内体温降至<37.5°C或/和4天内腹痛消失。次要终点包括住院天数、炎症反应变化、开始进食前的天数、1年内的复发率和不良事件发生率。本研究纳入了171名参与者。DBT组和安慰剂组的治疗成功率无显著差异（P = 0.348）。然而，DBT组在第5天时CRP水平显著降低（P = 0.023），有脓肿的患者开始经口进食的时间明显早于安慰剂组（P = 0.046）。总之，本研究结果并不表明在中度急性憩室炎患者中加用DBT治疗能带来额外益处。然而，DBT可能在涉及脓肿或严重炎症的病例中提供临床益处。有必要针对复杂憩室炎开展进一步的前瞻性研究。
