A prospective randomized controlled trial of oral ciprofloxacin in acute ulcerative colitis.
OBJECTIVE
The aim of this prospective, randomized, controlled trial was to evaluate the role of ciprofloxacin as an adjunct to corticosteroids in acute ulcerative colitis.


METHODS
Seventy consecutive patients with mild (n = 37) or moderately active (n = 33) ulcerative colitis were randomized to receive oral ciprofloxacin (250 mg b.i.d., n = 34) or placebo (n = 36) for 14 days. In addition, they were given oral prednisolone (initial dose 20 or 40 mg for mild and moderately active ulcerative colitis, respectively) and rectal betamethasone enemas (2 g at night) for 7-9 weeks. All patients were receiving olsalazine (0.5 g twice daily). At study entry, the groups were similar with respect to age, sex, extent, duration, and severity of disease, and previous treatments. Patients were assessed clinically, endoscopically, and histologically before, at the end of the trial (day 14), and on completion of steroid treatment, or at any time worsening of symptoms or a complication of ulcerative colitis occurred.


RESULTS
At the end of the study, 24 patients (70.5%) in the ciprofloxacin group and 26 patients (72%) in the placebo group achieved remission (p > 0.1, Yates chi 2). Ten patients in each group necessitated higher doses of oral (n = 12) or intravenous (n = 8) steroids. Of the latter patients, two underwent emergency colectomy without perioperative deaths. Clostridium difficile toxin A was not detected in nonresponders to ciprofloxacin treatment.


CONCLUSIONS
A short course of oral ciprofloxacin treatment does not seem to increase the proportion of patients with active ulcerative colitis going into remission.
Mantzaris
G J
GJ
First Department of Gastroenterology, Evangelismos Hospital, Athens, Greece.
Archavlis
E
E
Christoforidis
P
P
Kourtessas
D
D
Amberiadis
P
P
Florakis
N
N
Petraki
K
K
Spiliadi
C
C
Triantafyllou
G
G
D000208:Acute Disease; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000636:Aminosalicylic Acids / Q000008:administration & dosage / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001427:Bacterial Toxins / Q000032:analysis; D001623:Betamethasone / Q000008:administration & dosage / Q000627:therapeutic use; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000627:therapeutic use*; D016360:Clostridioides difficile; D003082:Colectomy; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery; D003113:Colonoscopy; D004338:Drug Combinations; D004733:Enema; D004768:Enterotoxins / Q000032:analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011239:Prednisolone / Q000008:administration & dosage / Q000627:therapeutic use; D011446:Prospective Studies; D012074:Remission Induction
D000636:Aminosalicylic Acids; D000890:Anti-Infective Agents; D000893:Anti-Inflammatory Agents; D001427:Bacterial Toxins; D004338:Drug Combinations; D004768:Enterotoxins; D010919:Placebos; C041348:tcdA protein, Clostridium difficile; D002939:Ciprofloxacin; D001623:Betamethasone; D011239:Prednisolone; C032587:olsalazine