Metronidazole in the treatment of chronic radiation proctitis: clinical trial

Croat Med J. 2000 Sep;41(3):314-8.


Aim: To evaluate the effectiveness of metronidazole in combination with corticosteroids in enema and mesalazine (5-aminosalicylic acid) in comparison with the same protocol without metronidazole in the treatment of chronic radiation proctitis.

Methods: Sixty patients with rectal bleeding and diarrhea were randomly divided into two groups. Patients in the first group were treated with metronidazole (3x400 mg orally per day), mesalazine (3x1 g orally per day), and betamethasone enema (once a day during 4 weeks). Patients in the second group were treated with mesalazine and betamethasone enema, but without metronidazole. The efficacy of metronidazole was assessed on the basis of rectal bleeding, diarrhea, and rectosigmoidoscopy findings in all patients.

Results: The incidence of rectal bleeding and mucosal ulcers was significantly lower in the metronidazole group, 4 weeks (p=0.009), 3 months (p=0.031), and 12 months (p=0.029) after therapy. There was also a significant decrease in diarrhea and edema in the metronidazole group, 4 weeks (p=0.044), 3 months (p=0.045), and 12 months (p=0.034) after treatment.

Conclusion: Metronidazole in combination with mesalazine and betamethasone enemas successfully treats rectal bleeding and diarrhea in chronic radiation proctitis.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Anti-Infective Agents / therapeutic use*
  • Anti-Inflammatory Agents / therapeutic use
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Betamethasone / therapeutic use
  • Chronic Disease
  • Drug Therapy, Combination
  • Enema / methods
  • Humans
  • Male
  • Mesalamine / therapeutic use
  • Metronidazole / therapeutic use*
  • Middle Aged
  • Proctitis / drug therapy*
  • Proctitis / etiology*
  • Prostatic Neoplasms / radiotherapy*
  • Radiation Injuries / drug therapy*
  • Treatment Outcome


  • Anti-Infective Agents
  • Anti-Inflammatory Agents
  • Anti-Inflammatory Agents, Non-Steroidal
  • Metronidazole
  • Mesalamine
  • Betamethasone