ABSTRACT
OBJECTIVE: To evaluate whether there is equivalence between two treatments for grade I ulcers with a base of hyperoxygenated fatty acids, AGHO and Mepentol: AGHO and phytotherapy. METHOD: A randomized, controlled, triple blind clinical trial was conducted with patients admitted at the Elderly Ward at San Carlos Hospital in Madrid between November 2006 and January 2008. There were two treatment groups: Experimental and control. A theoretical limit of 15% was determined between both groups. We took a random sample of patients admitted to the Elderly Ward, which produced a sample of 151 sores. The control group received treatment with Mepentol and the experimental group received AGHO. The assignment to the group was at random. The output variable was healing of erythema within the first 72h. We calculated the absolute difference in the incidence of healing between both treatments with a level of confidence of 95%. RESULTS: The sample at the end of the study was 148 (72 control and 76 experimental). There was a healing incidence of 55.6% in the control group and 69.7% in the experimental group (p=0.074). The difference in the incidence of healing between both treatments was 14% (95% CI: 29% to -1%). The upper limit of the confidence interval of the difference is outside the margin of equivalence. CONCLUSIONS: We cannot conclude that the treatment with AGHO fatty acids is equivalent to Mepentol treatment. With both treatments the healing is clinically significant.
Subject(s)
Fatty Acids/therapeutic use , Hospitalization , Phytotherapy , Plant Extracts/therapeutic use , Pressure Ulcer/drug therapy , Aged , Double-Blind Method , Fatty Acids/pharmacokinetics , Female , Humans , Male , Plant Extracts/pharmacokinetics , Pressure Ulcer/classification , Severity of Illness Index , Therapeutic EquivalencyABSTRACT
Objetivo. Evaluar si existe equivalencia entre dos tratamientos con base de ácidos grasos hiperoxigenados, AGHO y Mepentol®: AGHO y fitoterapia. Método. Ensayo clínico aleatorizado con triple enmascaramiento, en pacientes hospitalizados en la Unidad de Geriatría del Hospital Clínico San Carlos, entre noviembre de 2006 y enero de 2008, con dos grupos de tratamiento: intervención y control. Se determinó un límite de equivalencia teórico del 15% entre ambos. El muestreo accidental de pacientes ingresados que desarrollaron úlceras grado I. La muestra calculada de 151 úlceras. Método. La intervención fue la aplicación de Mepentol® al grupo control y AGHO al grupo intervención, la asignación al grupo fue aleatoria; la variable de resultado la curación: desaparición del eritema al menos 72h. Se calcula la diferencia absoluta de incidencia de curación entre ambos tratamientos y su IC del 95%. Resultados. Finalizaron el estudio 148 úlceras (72 control y 76 intervención). Curaron 40 úlceras (55,6%) en el grupo control y 53 (69,7%) en el grupo intervención p=0,074. La diferencia de incidencia de curación entre ambos grupos de tratamiento fue del 14% (IC del 95% 29% a 1%). El límite superior del intervalo de confianza de la diferencia se encuentra fuera del margen de equivalencia. Conclusiones. No podemos concluir que el tratamiento de ácidos grasos AGHO sea equivalente al tratamiento de Mepentol®. Con ambos tratamientos la curación es clínicamente relevante(AU)
Objective.To evaluate whether there is equivalence between two treatments for grade I ulcers with a base of hyperoxygenated fatty acids, AGHO® and Mepentol®: AGHO and phytotherapy. Method. A randomized, controlled, triple blind clinical trial was conducted with patients admitted at the Elderly Ward at San Carlos Hospital in Madrid between November 2006 and January 2008. There were two treatment groups: Experimental and control. A theoretical limit of 15% was determined between both groups. We took a random sample of patients admitted to the Elderly Ward, which produced a sample of 151 sores. Method. The control group received treatment with Mepentol® and the experimental group received AGHO®. The assignment to the group was at random. The output variable was healing of erythema within the first 72h. We calculated the absolute difference in the incidence of healing between both treatments with a level of confidence of 95%. Results. The sample at the end of the study was 148 (72 control and 76 experimental). There was a healing incidence of 55.6% in the control group and 69.7% in the experimental group (p=0.074). The difference in the incidence of healing between both treatments was 14% (95% CI: 29% to −1%). The upper limit of the confidence interval of the difference is outside the margin of equivalence. Conclusions. We cannot conclude that the treatment with AGHO fatty acids is equivalent to Mepentol® treatment. With both treatments the healing is clinically significant(AU)
