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Newly Developed Antibiotic Combination Therapy for Ulcerative Colitis: A Double-Blind Placebo-Controlled Multicenter Trial
| Content Provider | Semantic Scholar |
|---|---|
| Author | Ohkusa, Toshifumi Kato, Kimitoshi Terao, Shuichi Chiba, Toshimi Mabe, Katsuhiro Murakami, Kazunari Mizokami, Yuji Sugiyama, Toshiro Yanaka, Akinori Takeuchi, Yoshiaki Yamato, Shigeru Yokoyama, Tetsuji Okayasu Watanabe, Sumio Tajiri, Hisao Sato, Nobuhiro |
| Copyright Year | 2010 |
| 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. |
| Starting Page | 1820 |
| Ending Page | 1829 |
| Page Count | 10 |
| File Format | PDF HTM / HTML |
| PubMed reference number | 20216533 |
| Journal | Medline |
| Volume Number | 105 |
| Alternate Webpage(s) | http://gi.org/wp-content/uploads/2011/07/media-ajg201084a_ucantibiotics.pdf |
| Alternate Webpage(s) | https://doi.org/10.1038/ajg.2010.84 |
| Journal | The American Journal of Gastroenterology |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
