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.
GLOSSARY
- AE=
- adverse event;
- AIMS=
- Abnormal Involuntary Movements Scale;
- DDCI=
- dopa-decarboxylase inhibitor;
- DSM-IV-TR=
- Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision;
- MMSE=
- Mini-Mental State Examination;
- MP=
- Mucuna pruriens variant utilis;
- MP-Hd=
- high-dose Mucuna pruriens powder;
- MP-Ld=
- low-dose Mucuna pruriens powder;
- PD=
- Parkinson disease;
- UPDRS=
- Unified Parkinson's Disease Rating Scale
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article. The Article Processing Charge was funded by the Fondazione Grigioni per il Morbo di Parkinson.
Supplemental data at Neurology.org
- Received November 7, 2016.
- Accepted in final form May 5, 2017.
- Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
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