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Mucuna pruriens in Parkinson disease: A double-blind, randomized, controlled, crossover study
- Source :
- Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid, Consejería de Sanidad de la Comunidad de Madrid
- Publication Year :
- 2017
-
Abstract
- Objective:To investigate whether Mucuna pruriens (MP), a levodopa-containing leguminous plant growing in all tropical areas worldwide, may be used as alternative source of levodopa for indigent individuals with Parkinson disease (PD) who cannot afford long-term therapy with marketed levodopa preparations.Methods:We investigated efficacy and safety of single-dose intake of MP powder from roasted seeds obtained without any pharmacologic processing. Eighteen patients with advanced PD received the following treatments, whose sequence was randomized: (1) dispersible levodopa at 3.5 mg/kg combined with the dopa-decarboxylase inhibitor benserazide (LD+DDCI; the reference treatment); (2) high-dose MP (MP-Hd; 17.5 mg/kg); (3) low-dose MP (MP-Ld; 12.5 mg/kg); (4) pharmaceutical preparation of LD without DDCI (LD−DDCI; 17.5 mg/kg); (5) MP plus benserazide (MP+DDCI; 3.5 mg/kg); (6) placebo. Efficacy outcomes were the change in motor response at 90 and 180 minutes and the duration of on state. Safety measures included any adverse event (AE), changes in blood pressure and heart rate, and the severity of dyskinesias.Results:When compared to LD+DDCI, MP-Ld showed similar motor response with fewer dyskinesias and AEs, while MP-Hd induced greater motor improvement at 90 and 180 minutes, longer ON duration, and fewer dyskinesias. MP-Hd induced less AEs than LD+DDCI and LD−DDCI. No differences in cardiovascular response were recorded.Conclusion:Single-dose MP intake met all noninferiority efficacy and safety outcome measures in comparison to dispersible levodopa/benserazide. Clinical effects of high-dose MP were similar to levodopa alone at the same dose, with a more favorable tolerability profile.ClinicalTrials.gov identifier:NCT02680977.
- Subjects :
- 0301 basic medicine
Male
Levodopa
Dyskinesia, Drug-Induced
Blood Pressure
Pharmacology
Motor Activity
Placebo
Antiparkinson Agents
03 medical and health sciences
Benserazide
0302 clinical medicine
Double-Blind Method
Heart Rate
medicine
Humans
Adverse effect
Cross-Over Studies
biology
Dose-Response Relationship, Drug
business.industry
digestive, oral, and skin physiology
food and beverages
Parkinson Disease
Middle Aged
biology.organism_classification
Crossover study
Mucuna
nervous system diseases
030104 developmental biology
Treatment Outcome
Dyskinesia
Tolerability
Seeds
Female
Neurology (clinical)
medicine.symptom
Powders
business
030217 neurology & neurosurgery
Mucuna pruriens
medicine.drug
Phytotherapy
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid, Consejería de Sanidad de la Comunidad de Madrid
- Accession number :
- edsair.doi.dedup.....b1a01e482050e98890adbbc8e93a46d0