title: Adjunct antibiotic combination therapy for steroid-refractory or -dependent ulcerative colitis: an open-label multicentre study.
abstract: BACKGROUND
  We previously demonstrated that antibiotic combination therapy is effective for induction and maintenance of ulcerative colitis (UC) remission.
  
  
  OBJECTIVE
  To assess whether antibiotic combination therapy is effective for active UC refractory to or dependent on steroids in a multicentre, open-label trial.
  
  
  METHODS
  We enrolled 30 patients with steroid-refractory and 64 with steroid-dependent active UC. These patients received three-times-daily by mouth amoxicillin 500 mg, tetracycline 500 mg and metronidazole 250 mg, for two weeks, as well as conventional treatment. Symptom assessment and colonoscopic evaluation were performed before enrolment and at 3 and 12 months after treatment completion. Clinical response was defined as a Lichtiger symptom score decrease in ≥3 points and clinical remission as a score ≤4.
  
  
  RESULTS
  Nineteen of the 30 steroid-refractory (63.3%) and 47 of the 64 steroid-dependent (73.4%) patients showed a clinical response within 2 weeks. At 3 and 12 months, 60% and 66.6% of steroid-refractory patients, and 56.3% and 51.6% of steroid-dependent patients, respectively, achieved clinical remission. In the steroid-dependent group, 39 of the 64 patients (60.9%) were able to stop steroid therapy and remained in remission for 3 months. Three (10%) steroid-refractory and four (6.3%) steroid-dependent patients underwent colectomy.
  
  
  CONCLUSIONS
  This multicentre, long-term follow-up study suggests 2 week antibiotic combination therapy to be effective and safe in patients with active UC refractory to or dependent on steroids.
authors.affiliation: Division of Research Planning and Development, Nihon University School of Medicine, Tokyo, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Kato
authors.forename: T
authors.initials: T
authors.lastname: Ohkusa
authors.forename: S
authors.initials: S
authors.lastname: Terao
authors.forename: T
authors.initials: T
authors.lastname: Chiba
authors.forename: K
authors.initials: K
authors.lastname: Murakami
authors.forename: A
authors.initials: A
authors.lastname: Yanaka
authors.forename: T
authors.initials: T
authors.lastname: Uehara
authors.forename: Y
authors.initials: Y
authors.lastname: Ishii
authors.forename: M
authors.initials: M
authors.lastname: Soma
authors.forename: H
authors.initials: H
authors.lastname: Tajiri
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003082:Colectomy / Q000706:statistics & numerical data*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery; D003113:Colonoscopy; D003131:Combined Modality Therapy; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000627:therapeutic use; D008875:Middle Aged; D012720:Severity of Illness Index; D013752:Tetracycline / Q000008:administration & dosage / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D005938:Glucocorticoids; D008795:Metronidazole; D000658:Amoxicillin; D013752:Tetracycline