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. FINDINGS: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. INTERPRETATION:Topical sodium butyrate, unlike other therapeutic regimens used so far, proved effective in the treatment of ARP.
RCT Entities:
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. FINDINGS: 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. INTERPRETATION: Topical sodium butyrate, unlike other therapeutic regimens used so far, proved effective in the treatment of ARP.
Authors: Rachel J Gibson; Dorothy M K Keefe; Rajesh V Lalla; Emma Bateman; Nicole Blijlevens; Margot Fijlstra; Emily E King; Andrea M Stringer; Walter J F M van der Velden; Roger Yazbeck; Sharon Elad; Joanne M Bowen Journal: Support Care Cancer Date: 2012-11-10 Impact factor: 3.603
Authors: Joseph Paul Weiner; Andrew Thomas Wong; David Schwartz; Manuel Martinez; Ayse Aytaman; David Schreiber Journal: World J Gastroenterol Date: 2016-08-21 Impact factor: 5.742
Authors: Andrea Hille; Markus K A Herrmann; Tereza Kertesz; Hans Christiansen; Robert M Hermann; Olivier Pradier; Heinz Schmidberger; Clemens-F Hess Journal: Strahlenther Onkol Date: 2008-12-24 Impact factor: 3.621