Efecto de un suplemento nutricional específico (Balnimax®) en la cicatrización de úlceras de la extremidad inferior de etiología venosa y úlceras por presión

  1. José Verdú Soriano 3
  2. Teresa Segovia Gómez 1
  3. Mariano Bermejo Martínez 2
  4. Pablo López Casanova 4
  5. Josefina Arboledas Bellón 5
  6. José M. Carrasco Herrero 6
  7. Elodia Dumont Lupiáñez 6
  8. Francisco de Haro Fernández 7
  9. Estrella Perdomo Pérez 8
  10. Justo Rueda López 9
  11. Núria Serra Perucho 10
  12. José Luis Higuera Bombin 11
  13. Tania Sáez Gúzman 12
  1. 1 Hospital Universitario Puerta de Hierro. Madrid.
  2. 2 Hospital Universitario Ramón y Cajal. Madrid.
  3. 3 Universitat d'Alacant
    info

    Universitat d'Alacant

    Alicante, España

    ROR https://ror.org/05t8bcz72

  4. 4 Departamento de Salud Alcoi. Alicante
  5. 5 Enfermera. AGS Norte. Jaén
  6. 6 Área Sanitaria de la Serranía de Ronda. Málaga.
  7. 7 Hospital G.U. San Cecilio. Granada
  8. 8 Centro de Salud Miller Bajo. Las Palmas de Gran Canaria
  9. 9 Consorci Sanitari de Terrassa Barcelona
  10. 10 Clínica Sagrada Familia. Barcelona.
  11. 11 Complejo Hospitalario Donostia. Guipukoa.
  12. 12 Hospital Universitario de Álava. Vitoria
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Journal:
Gerokomos: Revista de la Sociedad Española de Enfermería Geriátrica y Gerontológica

ISSN: 1134-928X

Year of publication: 2016

Volume: 27

Issue: 1

Pages: 27-32

Type: Article

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More publications in: Gerokomos: Revista de la Sociedad Española de Enfermería Geriátrica y Gerontológica

Abstract

Objective: To evaluate a specific oral nutritional supplement, Balnimax® (alfa-lipoic acid, L-arginine, L-methionine, vitamin B complex, vitamin E and selenium) along with daily clinical practice on the healing of pressure and venous leg ulcers. Method: a multicentre, prospective, single-group, repeated measures and post-authorization study was carried out with pressure and venous leg ulcers' patients without signs of local infection, to be treated for up to 8 weeks. Measures were recorded at baseline, 2, 4, 6 and 8 weeks. The patients received a tablet orally twice daily with meals. The primary outcome variable was the percentage of wound size reduction. We also analysed the complete healing. The sample size calculation was determined to compare the results against a reference value. 127 subjects would be required to detect a difference equal to or above 15%. It was assumed that the percentage of wound reduction was 57%. We estimated a loss rate of up to 10%. Results: 112 patients with 133 wounds were included and finished the study (16.0% had 2 or more wounds), with a mean age of 74.2±12.0 (median: 77, extremes: 35-94). 69.8% were women, most of them ambulatory patients (98.4%). In 9% proteases modulators were used and in only 27.2% was applied a multilayer compression therapy. 58 (43.6%) ulcers healed during the study period. The evolution of wound size and percentage reduction was, statistically significant (p ≤ 0.001), decreasing over time period. It was a statistical significant difference (p ≤ 0.001) between the results and the reference value. Conclusions: Despite the possible methodological flaws due to a single-group study, the supplement studied seems to be an effect over healing. The results are better than previous published with other nutritional supplements or with moist wound healing only.

Bibliographic References

  • Alleva R, Nasole E, Di Donato F, Larrick J. α-Lipoic acid supplementation inhibits oxidative damage, accelerating chronic wound healing in patients undergoing hyperbaric oxygen therapy. Biochem Biophys Res Commun. 2005;333:404-10.
  • Alleva R, Tomasetti M, Sartini D, Emanuelli M, Nasole E, Di Donato F, et al. α-Lipoic acid modulates extracellular matrix and angiogenesis gene expression in non-healing wounds treated with hyperbaric oxygen therapy. Mol Med. 2008;14(3-4):175-83
  • Armstrong M. Obesity as an intrinsic factor affecting wound healing. J Wound Care. 1998;7(5):220-1
  • Butler JA, Hagen TM, Moreau R. Lipoic acid improves hypertriglyceridemia by stimulating triacylglycerol clearance and downregulating liver triacylglycerol secretion. Arch Biochem Biophys. 2009;485:63-71
  • Cereda E, Gini A, Pedrolli C, Vanotti A. Disease-Specific, versus standard, Nutritional support for the Treatment of Pressure Ulcers in Institutionalized Older Adults: A Randomized Controlled Trial. J Am Geriatr Soc. 2009;57(8):1395-402
  • Collins C. Nutrition and wound care. Clin Nutr Highlights. 2006;2:2-7.
  • CONUEI. Conferencia Nacional de Consenso Sobre Úlceras de la Extremidad Inferior. Documento de Consenso. Madrid: Edikamed; 2009
  • Curran JN, Winter DC, Bouchier-Hayes D. Biological fate and clinical implications of arginina metabolism in tissue healing. Wound Rep Reg. 2006;14:376-86.
  • Desneves KJ, Todorovic BE, Cassar A, Crowe TC. Treatment with supplementary arginine, vitamin C and zinc in patients with pressure ulcers: A randomised controlled trial. Clin Nutr. 2005;24:979-87
  • Documento técnico GNEAUPP n.o XII. Nutrición y Heridas Crónicas. Abril, 2011. Disponible en: http://gneaupp.info/wp-content/uploads/2014/12/59_pdf1.pdf.
  • Drugs.com. Alpha-Lipoic Acid. (visitado el 29/11/2011). Disponible en: http://www.drugs.com/npp/alpha-lipoic-acid.html.
  • Heinen MM, van Achterberg T, op Reimer WS, van de Kerkhof PCM, de Laat E. Venous leg ulcer patients: a review of the literature on lifestyle and pain-related interventions. J Clin Nurs. 2004;13:355-66.
  • Heyman H, Van De Looverbosch DEJ, Meijer EP, Schols JMGA. Benefits of an oral nutritional supplement on pressure ulcer healing in long-term care. J Wound Care. 2008;17(11):476-80.
  • Hunt TK, Ehrlich HP, Garcia JA, Dunphy JE. Effect of vitamin A on reversing the inhibitory effect of cortisone on healing of open wounds in animals and man. Ann Surg. 1969;170:633-41
  • Legendre C, Debure C, Meaume S, Lok C, Golmard JL, Senet P. Impact of protein deficiency on venous ulcer healing. J Vasc Surg. 2008;48(3):688-93
  • Lewis B. Nutrition and wound healing. En: McCulloch JM, Kloth LC, Feeder JA, eds. Wound healing: alternatives in management. 3.a ed. Cap. 2. Philadelphia PA: Davis Company; 2002. p. 35-67.
  • Maklebust JA, Sieggreen M. Pressure Ulcers. Guidelines for prevention and management. Pennsylvania: Springhouse Corporation; 2000.
  • Pinchcofsky-Devin GD, Kaminski MV Jr. Correlation of pressure sores and nutritional status. J Am Geriatr Soc. 1986;34:435-40
  • Redd LJ, DeBusk BG, Gunsalus IC, Hornberger CS Jr. Crystalline alpha-lipoic acid; a catalytic agent associated with pyruvate dehydrogenase. Science.1951;114(2952):93-4
  • Rojas AI, Phillips TJ. Patients with chronic leg ulcers show diminished levels of vitamin A, and E, carotenes and zinc. Dermatol Surg. 1999;25:601-4.
  • Shay KP, Moreau RF, Smith EJ, Smith AR, Hagen TM. Alpha-lipoic acid as a dietary supplement: Molecular mechanisms and therapeutic potential. Biochim Biophys Acta. 2009;1790:1149-60.
  • Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999;341:738-46.
  • Stratton RJ, Ek AC, Engfer M, Moore Z, Rigby P, Wolfe R, et al. Enteral nutritional support in prevention and treatment of pressure ulcers: A systematic review and meta-analysis. Ageing Res Rev. 2005;4:422-50.
  • Thomas DR. The role of nutrition in prevention and healing of pressure ulcers. Clin Geriatr Med. 1997;13:497-511
  • Tobón J, Whitney JD, Jarrett M. Nutritional status and wound severity of overweight and obese patients with venous leg ulcers: a pilot study. J Vasc Nurs. 2008;26(2):43-52.
  • Todorovic V. Food and wounds: nutritional factors in wound formation and healing. Clin Nutr Update. 2003;8(2):6-9
  • van Anholt RD, Sobotka L, Meijer EP, Heyman H, Groen HW, Topinková E, et al. Specific nutritional support accelerates pressure ulcer healing and reduces wound care intensity in non-malnourished patients. Nutrition. 2010;26:867-72
  • Verdú J, Nolasco A, López P, Torra JE. Estudio "Auriga-04". Aplicación y utilidad de los resultados de la investigación con la gama de apósitos Allevyn en Atención Primaria. Rev Enf Rol. 2006;29(4):283-9.
  • Verdú J. Apósitos hidrocelulares en heridas crónicas de diversa etiología. Rev Enf Rol. 2003;26(5):15-20
  • Zaloga GP. Nutrition in Critical Care. St Louis: Mosby; 1994
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