title: Topical butyrate for acute radiation proctitis: randomised, crossover trial.
abstract: BACKGROUND
  No available therapy has, as yet, proven effective to treat acute radiation proctitis (ARP) following radiation therapy for malignant pelvic disease. We assessed whether sodium butyrate enemas, at a dose of 80 mmol/L (80 mL/24 h), might offer effective treatment for this condition.
  
  
  METHODS
  20 patients presenting with ARP after completing a cycle of 35-52 Gy external-beam radiation therapy for pelvic malignant disease, were treated for 3 weeks with topical sodium butyrate and saline enemas according to a randomised, double-blind, crossover protocol. Clinical, endoscopic, and histological findings were assessed at enrollment, at week 3, and then at the end of the study. Data were analysed by two-tailed t test for paired data (continuous variables) and a logistic-regression model with variable multiple response for ordered categorical data.
  
  
  RESULTS
  Topical butyrate, but not saline, led to remission of symptoms (clinical score from 8.2 [SE 1.6] to 1.5 [0.7] vs 7.9 [1.8] to 8.1 [3.4]). When the treatment regimen was switched, eight out of nine of the previously placebo-treated patients went into remission, whereas three patients relapsed when switched to saline. The advantage of butyrate over placebo, expressed as CI, odds ratio, and p value was significant for almost all the clinical, endoscopic and histological factors taken into consideration.
  
  
  CONCLUSIONS
  Topical sodium butyrate, unlike other therapeutic regimens used so far, proved effective in the treatment of ARP.
authors.affiliation: Cattedra di Gastroenterologia 1, Università La Sapienza, Roma, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Vernia
authors.forename: P L
authors.initials: PL
authors.lastname: Fracasso
authors.forename: V
authors.initials: V
authors.lastname: Casale
authors.forename: G
authors.initials: G
authors.lastname: Villotti
authors.forename: A
authors.initials: A
authors.lastname: Marcheggiano
authors.forename: V
authors.initials: V
authors.lastname: Stigliano
authors.forename: P
authors.initials: P
authors.lastname: Pinnaro
authors.forename: V
authors.initials: V
authors.lastname: Bagnardi
authors.forename: R
authors.initials: R
authors.lastname: Caprilli
mesh_terms: D000287:Administration, Topical; D002087:Butyrates / Q000008:administration & dosage / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011349:Proctitis / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D011471:Prostatic Neoplasms / Q000532:radiotherapy; D011832:Radiation Injuries / Q000532:radiotherapy; D011878:Radiotherapy / Q000009:adverse effects*; D012007:Rectum / Q000187:drug effects / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D002087:Butyrates