A randomised clinical trial to evaluate the effects of Plantago ovata husk in Parkinson patients: changes in levodopa pharmacokinetics and biochemical parameters.

BACKGROUND: Plantago ovata husk therapy could be used in patients with Parkinson disease to reduce the symptoms of gastrointestinal disorders, but it is important to know whether this compound modifies levodopa pharmacokinetics. The maintenance of constant plasma concentrations of levodopa abolishes the clinical fluctuations in parkinsonian patients. The aim of this randomised clinical trial was to establish the influence of the fiber Plantago ovata husk in the pharmacokinetics of levodopa when administered to Parkinson patients well controlled by their oral medication. METHODS: To evaluate the effects of this fiber on several biochemical parameters. 18 volunteers participated in the study and received alternatively two treatments (Plantago ovata husk or placebo) with their usual levodopa/carbidopa oral dose. On days 0 (initial situation), 14 and 35 of the study, blood samples were taken to assess levodopa pharmacokinetics and to determine biochemical parameters. RESULTS: Levodopa Cmax was very similar in the initial situation (603.2 ng/ml) and after placebo administration (612.0 ng/ml), being slightly lower (547.8 ng/ml) when Plantago ovata husk was given. AUC was very similar in the three groups: initial situation.- 62.87 µg.min/ml, fiber treatment.- 64.47 µg.min/ml and placebo treatment.- 65.10 µg.min/ml. Fiber reduced significantly the number of peaks observed in the levodopa concentrations, maintaining concentrations more stable. No significant differences were found in total cholesterol, LDL-cholesterol and triglycerides with the administration of Plantago ovata husk. CONCLUSIONS: Plantago ovata husk administration caused a smoothing and homogenization of levodopa absorption, providing more stable concentrations and final higher levels, resulting in a great benefit for patients. TRIAL REGISTRATION: EudraCT2006-000491-33.

Nutritional profile of multiple sclerosis.

INTRODUCTION: Background: multiple sclerosis (MS) is an inflammatory, neurodegenerative disease of the central nervous system. Weight loss and malnutrition are prevalent in advanced stages of MS. Objective: the aim of this study was to define the nutritional profile in moderate-advanced MS (especially by documenting malnutrition) and its evolution. Methods: a case-control study was designed; cross-sectional observational study was complemented by a 12-month prospective longitudinal observational study of MS patients. Nutritional status was evaluated by collecting clinical, anthropometric, dietary and analytical data. Results: one hundred and twenty-four patients with MS and 62 controls were recruited; 8% of the patients were malnourished or at risk of malnutrition. Only MS patients with advanced disability needed nutritional support. During the follow-up, five patients died and four of them received nutritional support. Conclusions: malnutrition was unusual in our sample of patients with moderate-advanced MS. The need for nutritional support is related to dysphagia in patients with advanced neurological disability. The nutritional status of patients with moderate-advanced MS is defined by a tendency to overweight and by the decrease in basal energy expenditure and handgrip strength test in relation to the loss of muscle mass. The deficient intake of polyunsaturated fatty acids, fiber and vitamin D is exacerbated in the evolution of the disease.

INTRODUCCIÓN: Introducción: la esclerosis múltiple (EM) es una enfermedad inflamatoria y neurodegenerativa del sistema nervioso central. La pérdida de peso y la malnutrición son frecuentes en fases avanzadas de la EM. Objetivo: el objetivo de este estudio fue definir el perfil nutricional de la EM en estadio moderado-avanzado (especialmente, documentando la malnutrición) y su evolución a 12 meses. Métodos: se realizó un estudio de casos-controles; el estudio observacional transversal se complementó con un estudio observacional longitudinal prospectivo a 12 meses de los pacientes con EM. El estado nutricional se evaluó mediante la recogida de datos clínicos, antropométricos, dietéticos y analíticos. Resultados: se incluyeron en el estudio 124 pacientes con EM y 62 controles. El 8% de los pacientes estaban desnutridos o en riesgo de desnutrición. Solo los pacientes con EM con discapacidad avanzada necesitaban soporte nutricional. Durante el seguimiento, cinco pacientes fallecieron y cuatro de ellos estaban recibiendo soporte nutricional. Conclusiones: la desnutrición es infrecuente en nuestra muestra de pacientes con EM moderada-avanzada. La necesidad de apoyo nutricional está relacionada con la disfagia en pacientes con discapacidad neurológica avanzada. El estado nutricional de los pacientes con EM moderada-avanzada se define por una tendencia al sobrepeso y por valores bajos en el gasto energético basal y en la dinamometría manual en relación con la pérdida de masa muscular. La ingesta deficiente de ácidos grasos poliinsaturados, fibra y vitamina D se acentúa en la evolución de la enfermedad.