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Mucuna pruriens in Parkinson disease: A double-blind, randomized, controlled, crossover study
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 prepar...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5539737/ https://www.ncbi.nlm.nih.gov/pubmed/28679598 http://dx.doi.org/10.1212/WNL.0000000000004175 |
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author | Cilia, Roberto Laguna, Janeth Cassani, Erica Cereda, Emanuele Pozzi, Nicolò G. Isaias, Ioannis U. Contin, Manuela Barichella, Michela Pezzoli, Gianni |
author_facet | Cilia, Roberto Laguna, Janeth Cassani, Erica Cereda, Emanuele Pozzi, Nicolò G. Isaias, Ioannis U. Contin, Manuela Barichella, Michela Pezzoli, Gianni |
author_sort | Cilia, Roberto |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5539737 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-55397372017-08-24 Mucuna pruriens in Parkinson disease: A double-blind, randomized, controlled, crossover study Cilia, Roberto Laguna, Janeth Cassani, Erica Cereda, Emanuele Pozzi, Nicolò G. Isaias, Ioannis U. Contin, Manuela Barichella, Michela Pezzoli, Gianni Neurology Article 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. Lippincott Williams & Wilkins 2017-08-01 /pmc/articles/PMC5539737/ /pubmed/28679598 http://dx.doi.org/10.1212/WNL.0000000000004175 Text en Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. |
spellingShingle | Article Cilia, Roberto Laguna, Janeth Cassani, Erica Cereda, Emanuele Pozzi, Nicolò G. Isaias, Ioannis U. Contin, Manuela Barichella, Michela Pezzoli, Gianni Mucuna pruriens in Parkinson disease: A double-blind, randomized, controlled, crossover study |
title | Mucuna pruriens in Parkinson disease: A double-blind, randomized, controlled, crossover study |
title_full | Mucuna pruriens in Parkinson disease: A double-blind, randomized, controlled, crossover study |
title_fullStr | Mucuna pruriens in Parkinson disease: A double-blind, randomized, controlled, crossover study |
title_full_unstemmed | Mucuna pruriens in Parkinson disease: A double-blind, randomized, controlled, crossover study |
title_short | Mucuna pruriens in Parkinson disease: A double-blind, randomized, controlled, crossover study |
title_sort | mucuna pruriens in parkinson disease: a double-blind, randomized, controlled, crossover study |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5539737/ https://www.ncbi.nlm.nih.gov/pubmed/28679598 http://dx.doi.org/10.1212/WNL.0000000000004175 |
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