Topical butyrate for acute radiation proctitis: randomised, crossover trial.
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.Method...
| Publicado en: | Lancet Vol. 356; no. 9237; pp. 1232 - 1236 |
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| Autores principales: | , , , , , , , , |
| Formato: | clinical trial research randomized controlled trial Journal Article |
| Publicado: |
Lancet
10/7/2000
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=3629283&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 3629283 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01406736 LAN jtl: Lancet issn: 01406736 maglogo: N pubinfo: dt: 10/7/2000 vid: 356 iid: 9237 pid: 1297 pub: Lancet place: Philadelphia, Pennsylvania artinfo: ui: 3629283 3629283 NLM11072942 3629283 10.1016/S0140-6736(00)02787-2 NLM11072942 3629283 ppf: 1232 ppct: 4 formats: fmt: – @attributes: type: T – @attributes: type: C – @attributes: type: P tig: atl: Topical butyrate for acute radiation proctitis: randomised, crossover trial. aug: au: Vernia, P Fracasso, P L Casale, V Villotti, G Marcheggiano, A Stigliano, V Pinnaro, P Bagnardi, V Caprilli, R sug: subj: Radiotherapy Adverse Effects Rectal Diseases Prevention and Control Butyric Acids Therapeutic Use Rectum Drug Effects Rectal Diseases Pathology Crossover Design Radiation Injuries Radiotherapy Butyric Acids Administration and Dosage Middle Age Administration, Topical Rectum Pathology Human Double-Blind Studies Treatment Outcomes Rectal Diseases Etiology Prostatic Neoplasms Radiotherapy Female Male Clinical Trials Validation Studies Comparative Studies Evaluation Research Multicenter Studies Randomized Controlled Trials Scales Middle Aged: 45-64 years Female Male ab: 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. pubtype: Academic Journal doctype: clinical trial research randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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