Formalin dab, the effective way of treating haemorrhagic radiation proctitis: a randomized trial from a tertiary care hospital in South India

Abstract

Aim: Chronic radiation proctitis with bleeding is a common problem encountered following radiotherapy for pelvic malignancy. Sucralfate-steroid enema and formalin dab are two common nonsurgical treatments. A randomized trial was conducted to compare the efficacy of these two methods.

Method: This was a prospective randomized controlled trial conducted in the Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) from August 2005 to May 2007. One-hundred and two patients with chronic radiation proctitis, presenting as rectal bleeding after radiotherapy for carcinoma of the cervix, were recruited and randomly allocated into two treatment groups: Group 1, formalin dab; and Group 2, sucralfate-steroid retention enema. The mean age of the patients was 51.3 ± 5.1 years. The mean interval between the end of radiotherapy and the onset of bleeding was 12.3 ± 3.5 months. Symptom score and sigmoidoscopic grade were assessed before, and at 1 month after, treatment.

Results: Ninety per cent of patients in Group 1 and 74.5% of patients in Group 2 responded to treatment (P = 0.038). In spite of having a higher median symptom score before treatment, patients in Group 1 demonstrated a marked decrease in symptom score after treatment compared with patients in Group 2 and the difference once again was statistically significant (P = 0.000). Similarly, the median sigmoidoscopic grade was significantly lower for patients in Group 1 compared with patients in Group 2 after treatment (P = 0.000). There were no specific treatment-related complications in either group.

Conclusions: Formalin (4%) dab is superior to sucralfate-steroid retention enema for treatment of chronic haemorrhagic radiation proctitis.