title: Formalin dab, the effective way of treating haemorrhagic radiation proctitis: a randomized trial from a tertiary care hospital in South India.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India. vprasad285@gmail.com
authors.forename: V P
authors.initials: VP
authors.lastname: Nelamangala Ramakrishnaiah
authors.forename: T D
authors.initials: TD
authors.lastname: Javali
authors.forename: K
authors.initials: K
authors.lastname: Dharanipragada
authors.forename: K S
authors.initials: KS
authors.lastname: Reddy
authors.forename: S
authors.initials: S
authors.lastname: Krishnamachari
mesh_terms: D000287:Administration, Topical; D002277:Carcinoma / Q000532:radiotherapy; D016009:Chi-Square Distribution; D004733:Enema; D005260:Female; D005557:Formaldehyde / Q000627:therapeutic use*; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007194:India; D008875:Middle Aged; D011349:Proctitis / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D011832:Radiation Injuries / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D011878:Radiotherapy / Q000009:adverse effects*; D012720:Severity of Illness Index; D012812:Sigmoidoscopy; D018709:Statistics, Nonparametric; D013256:Steroids / Q000627:therapeutic use; D013392:Sucralfate / Q000627:therapeutic use; D002583:Uterine Cervical Neoplasms / Q000532:radiotherapy
chemical_list: D013256:Steroids; D005557:Formaldehyde; D013392:Sucralfate