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

BMC Complementary and Alternative Medicine

Juan Jose Garcia-Vieitez¹  Anna Anguera-Vila³  Ana M Sahagún-Prieto¹  Demetrio Carriedo-Ule²  Angela Calle-Pardo¹  M Jose Diez-Liebana¹  Matilde Sierra-Vega¹  Luis Hernandez-Echevarria²  M Nelida Fernandez-Martinez¹ 

[1] Area de Farmacologia, Instituto de Biomedicina (IBIOMED), Universidad de Leon, 24071 Leon, Spain;Complejo Hospitalario Universitario de Leon, 24071 Leon, Spain;Laboratorios Rottapharm, 08033 Barcelona, Spain

关键词: Plantago ovata husk;    Biochemical parameters;    Pharmacokinetics;    Parkinson patients;    Levodopa;   

Others  :  1086993
DOI  :  10.1186/1472-6882-14-296

 received in 2013-06-16, accepted in 2014-08-05,  发布年份 2014

【 摘 要 】

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 C_max 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

【 授权许可】

   
2014 Fernandez-Martinez et al.; licensee BioMed Central Ltd.

【 图 表 】

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