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.

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: P Vernia, P L Fracasso, V Casale, G Villotti, A Marcheggiano, V Stigliano, P Pinnaro, V Bagnardi, R Caprilli
• Journal: Lancet (London, England) (Lancet) Vol. 356 Issue 9237 Pg. 1232-5 (Oct 07 2000) ISSN: 0140-6736 [Print] England
• PMID: 11072942 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Butyrates

Topics

• Administration, Topical
• Butyrates (administration & dosage, therapeutic use)
• Cross-Over Studies
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Proctitis (etiology, pathology, prevention & control)
• Prostatic Neoplasms (radiotherapy)
• Radiation Injuries (radiotherapy)
• Radiotherapy (adverse effects)
• Rectum (drug effects, pathology)
• Treatment Outcome