Metronidazole in the treatment of chronic radiation proctitis: clinical trial.

OBJECTIVE

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.

CONCLUSIONS

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