Newly developed antibiotic combination therapy for ulcerative colitis: a double-blind placebo-controlled multicenter trial - PubMed (original) (raw)

Randomized Controlled Trial

. 2010 Aug;105(8):1820-9.

doi: 10.1038/ajg.2010.84. Epub 2010 Mar 9.

Kimitoshi Kato, Shuichi Terao, Toshimi Chiba, Katsuhiro Mabe, Kazunari Murakami, Yuji Mizokami, Toshiro Sugiyama, Akinori Yanaka, Yoshiaki Takeuchi, Shigeru Yamato, Tetsuji Yokoyama, Isao Okayasu, Sumio Watanabe, Hisao Tajiri, Nobuhiro Sato; Japan UC Antibiotic Therapy Study Group

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Randomized Controlled Trial

Newly developed antibiotic combination therapy for ulcerative colitis: a double-blind placebo-controlled multicenter trial

Toshifumi Ohkusa et al. Am J Gastroenterol. 2010 Aug.

Abstract

Objectives: Fusobacterium varium may contribute to ulcerative colitis (UC). We conducted a double-blind placebo-controlled multicenter trial to determine whether antibiotic combination therapy induces and/or maintains remission of active UC.

Methods: Patients with chronic mild-to-severe relapsing UC were randomly assigned to oral amoxicillin 1500 mg/day, tetracycline 1500 mg/day, and metronidazole 750 mg/day, vs. placebo, for 2 weeks, and then followed up. The primary study end point was clinical response (Mayo score at 3 months after treatment completion) and secondary end points were clinical and endoscopic score improvements at 12 months. Anti-F. varium antibodies were measured by enzyme-linked immunosorbent assay.

Results: Treatment and placebo groups each had 105 subjects. At the primary end point, response rates were significantly greater with antibiotics than with placebo (44.8 vs. 22.8%, P=0.0011). Endoscopic scores significantly improved at 3 months (P=0.002 vs. placebo). Remission rates were 19.0% (antibiotics) vs. 15.8% (placebo) at 3 months (P=0.59). At the secondary end point, response rates were significantly greater with antibiotics than with placebo (49.5 vs. 21.8%, respectively, P<0.0001). Endoscopic scores were significantly improved at 12 months after antibiotic treatment (P=0.002 vs. placebo). Remission rates had improved to 26.7% with antibiotics vs. 14.9% for placebo, at 12 months (P=0.041). F. varium antibody titers decreased in responders but not in nonresponders, and more in the antibiotic than in the placebo group. More pretreatment steroid-dependent UC patients discontinued corticosteroids after treatment completion (6 months: 28.6 vs. 11.8%, respectively, P=0.046; 9 months: 34.7 vs. 13.7%, respectively, P=0.019; and 12 months: 34.7 vs. 13.7%, respectively, P=0.019). These effects were greater in the subanalysis of the active group (Mayo scores of 6-12) than in that of total cases (0-12). No serious drug-related toxicities occurred.

Conclusions: The 2-week triple antibiotic therapy produced improvement, remission, and steroid withdrawal in active UC more effectively than a placebo.

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