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A multicentre, double-masked, randomized, controlled trial assessing the effect of oral supplementation of omega-3 and omega-6 fatty acids on a conjunctival inflammatory marker in dry eye patients

Brignole-Baudouin F, Baudouin C, Aragona P, Rolando M, Labetoulle M, Pisella PJ, Barabino S, Siou-Mermet R, Creuzot-Garcher C

Acta ophthalmologica · 93 citas

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Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento

Quién lo pagó

Financiación
Financiación no declarada

Publicación

Publicado
2011-08-11 · Acta Ophthalmol · vol. 89 · número 7 · págs. e591–e597
Editorial
Wiley
Citado
133 citas · más que el 98% de estudios similares · 10.0× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
34 trabajos
Acceso
De pago
Áreas de investigación
Ocular Surface and Contact Lens · Fatty Acid Research and Health · Retinal Diseases and Treatments
Palabras clave
dry eye, omega-3 fatty acids, omega-6 fatty acids, dietary supplementation, HLA-DR, conjunctival inflammation, imprint cytology, conjunctival epithelium, anti-inflammatory activity
MeSH
conjunctiva, humans, dry eye syndromes, fatty acids, omega-3, fatty acids, omega-6, hla-dr antigens, antioxidants, fluorophotometry, administration, oral, double-blind method, quality of life, dietary supplements, middle aged, female, male, biomarkers, surveys and questionnaires

9 autores

  • Françoise Brignole‐Baudouin🇫🇷 · autor de correspondenciaCentre National de la Recherche Scientifique; Institut de la Vision; Inserm; Université Paris Descartes; Université Pierre-et-Marie-Curie
  • Christophe Baudouin🇫🇷Centre National de la Recherche Scientifique; Institut de la Vision; Inserm; Centre hospitalier national d'ophtalmologie des Quinze-Vingts; Université Pierre-et-Marie-Curie
  • Pasquale Aragona🇮🇹University of Messina
  • Maurizio Rolando🇮🇹University of Genoa
  • Marc Labétoulle🇫🇷Bicêtre Hospital
  • Pierre Jean Pisella🇫🇷Université de Tours; Hôpital Bretonneau
  • Stefano Barabino🇮🇹University of Genoa
  • Raphaele Siou-Mermet🇫🇷Bausch & Lomb (France)
  • Catherine P Creuzot-Garcher

Resumen

El texto original del estudio, en el idioma en que se publicó.

Purpose

To determine whether oral supplementation with omega-3 and omega-6 fatty acids can reduce conjunctival epithelium expression of the inflammatory marker human leucocyte antigen-DR (HLA-DR) in patients with dry eye syndrome (DES).

Methods

This 3-month, double-masked, parallel-group, controlled study was conducted in nine centres, in France and Italy. Eligible adult patients with mild to moderate DES were randomized to receive a placebo containing medium-chain triglycerides or treatment supplement containing omega-3 and omega-6 fatty acids, vitamins and zinc. Treatment regimen was three capsules daily. Impression cytology (IC) was performed at baseline and at month 3 to assess the percentage of cells expressing HLA-DR and to evaluate fluorescence intensity, an alternate measure of HLA-DR. Dry eye symptoms and objective signs were also evaluated. Analyses were performed on the full analysis set (FAS) and per-protocol set (PPS).

Results

In total, 138 patients were randomized; 121 patients with available IC were included in the FAS, and of these, 106 patients had no major protocol deviations (PPS). In the PPS, there was a significant reduction in the percentage of HLA-DR-positive cells in the fatty acids group (p = 0.021). Expression of HLA-DR as measured by fluorescence intensity quantification was also significantly reduced in the fatty acids group [FAS (p = 0.041); PPS (p = 0.017)]. No significant difference was found for the signs and symptoms, but there was a tendency for improvement in patients receiving the fatty acids treatment.

Conclusion

This study demonstrates that supplementation with omega-3 and omega-6 fatty acids can reduce expression of HLA-DR conjunctival inflammatory marker and may help improve DES symptoms.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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