Eicosapentaenoic acid reduces rectal polyp number and size in familial adenomatous polyposis
West NJ, Clark SK, Phillips RK, Hutchinson JM, Leicester RJ, Belluzzi A, Hull MA
Gut · 174 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- National Taiwan University Hospital
- Gobierno
- Medical Research Council
Según 2 financiadores declarados.
Publicación
- Publicado
- 2010-03-26 · Gut · vol. 59 · número 7 · págs. 918–925
- Editorial
- BMJ
- Citado
- 244 citas · más que el 99% de estudios similares · 14.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 40 trabajos
- Acceso
- De pago
- Áreas de investigación
- Fatty Acid Research and Health · Genetic factors in colorectal cancer · Inflammatory mediators and NSAID effects
- Palabras clave
- eicosapentaenoic acid, familial adenomatous polyposis, rectal polyps, colorectal cancer chemoprevention, omega-3 fatty acids, polyp burden
- MeSH
- intestinal mucosa, humans, adenomatous polyposis coli, rectal neoplasms, intestinal polyps, disease progression, eicosapentaenoic acid, fatty acids, anticarcinogenic agents, sigmoidoscopy, treatment outcome, colectomy, double-blind method, patient compliance, adolescent, adult, aged, middle aged, female, male, young adult
7 autores
- Nicholas West🇬🇧St James's University Hospital; St Mark's Hospital
- Susan K. Clark🇬🇧St Mark's Hospital
- R K S Phillips🇬🇧St Mark's Hospital
- John M Hutchinson🇬🇧St James's University Hospital
- R. J. Leicester🇬🇧St George's Hospital
- Andrea Belluzzi🇮🇹IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola
- Mark A. Hull🇬🇧St James's University Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
The omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) has anticolorectal cancer activity in vitro and in preclinical models. The present study tested whether a novel, enteric-coated formulation of EPA, as the free fatty acid (EPA-FFA), has chemopreventative efficacy in patients with familial adenomatous polyposis (FAP), in a randomised, double-blind, placebo-controlled trial.
Methods
Patients undergoing endoscopic surveillance of their retained rectum postcolectomy were randomised to EPA-FFA (SLA Pharma) 2 g daily or placebo for 6 months. The number and size of polyps in an area of mucosa defined by a tattoo were determined before and after intervention. Global rectal polyp burden was scored (-1, 0, +1) by examination of video endoscopy records. Mucosal fatty acid content was measured by gas chromatography-mass spectrometry.
Results
55 patients with FAP were evaluated by an intention-to-treat analysis (EPA-FFA 28, placebo 27). Treatment with EPA-FFA for 6 months was associated with a mean 22.4% (95% CI 5.1% to 39.6%) reduction in polyp number (p=0.012) and a 29.8% (3.6% to 56.1%) decrease in the sum of polyp diameters (p=0.027). Global polyp burden worsened over 6 months in the placebo group (-0.34) unlike the EPA-FFA group (+0.09, difference 0.42 (0.10-0.75), p=0.011). EPA-FFA treatment led to a mean 2.6-fold increase in mucosal EPA levels (p=0.018 compared with placebo). EPA-FFA was well tolerated with an incidence of adverse events similar to placebo.
Conclusions
EPA-FFA has chemopreventative efficacy in FAP, to a degree similar to that previously observed with selective cyclo-oxygenase-2 inhibitors. EPA holds promise as a colorectal cancer chemoprevention agent with a favourable safety profile.
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