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1.
Parkinsonism Relat Disord ; 49: 60-66, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29352722

RESUMO

BACKGROUND: Thousands of individuals with Parkinson's disease (PD) in low-income countries have limited access to marketed levodopa preparations. Mucuna pruriens (MP), a levodopa-containing leguminous plant growing in tropical areas, may be a sustainable alternative therapy for indigent patients. Single-dose intake of MP proved noninferior to marketed levodopa preparations. METHODS: Fourteen PD patients with motor fluctuations and dyskinesias received MP powder (obtained from roasted seeds) and marketed levodopa/carbidopa (LD/CD) in a randomized order and crossover design over a 16-week period. Efficacy measures were changes in quality of life, motor and non-motor symptoms, and time with good mobility without troublesome dyskinesias. Safety measures included tolerability, frequency of adverse events, changes in laboratory indices and electrocardiogram. RESULTS: Daily intake of MP was associated with a variable clinical response, especially in terms of tolerability. Seven patients (50%) discontinued MP prematurely due to either gastrointestinal side-effects (n = 4) or progressive worsening of motor performance (n = 3), while nobody discontinued during the LD/CD phase. In those who tolerated MP, clinical response to MP was similar to LD/CD on all efficacy outcome measures. Patients who dropped out entered a study extension using MP supernatant water (median[IQR], 16 [7-20] weeks), which was well tolerated. CONCLUSIONS: The overall benefit provided by MP on the clinical outcome was limited by tolerability issues, as one could expect by the relatively rapid switch from LD/CD to levodopa alone in advanced PD. Larger parallel-group studies are needed to identify appropriate MP formulation (e.g. supernatant water), titration scheme and maintenance dose to minimize side-effects in the long-term. CLINICAL TRIALS. GOV IDENTIFIER: NCT02680977.


Assuntos
Antiparkinsonianos/farmacologia , Levodopa/farmacologia , Mucuna , Avaliação de Resultados em Cuidados de Saúde , Doença de Parkinson/tratamento farmacológico , Fitoterapia , Preparações de Plantas/farmacologia , Sementes , Idoso , Antiparkinsonianos/administração & dosagem , Antiparkinsonianos/efeitos adversos , Carbidopa/farmacologia , Estudos Cross-Over , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Humanos , Levodopa/administração & dosagem , Masculino , Pessoa de Meia-Idade , Mucuna/efeitos adversos , Projetos Piloto , Preparações de Plantas/administração & dosagem , Preparações de Plantas/efeitos adversos , Sementes/efeitos adversos
2.
Neurology ; 89(5): 432-438, 2017 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-28679598

RESUMO

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. CLINICALTRIALSGOV IDENTIFIER: NCT02680977.


Assuntos
Antiparkinsonianos/uso terapêutico , Mucuna , Doença de Parkinson/tratamento farmacológico , Fitoterapia , Antiparkinsonianos/efeitos adversos , Antiparkinsonianos/farmacocinética , Benserazida/efeitos adversos , Benserazida/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Estudos Cross-Over , Relação Dose-Resposta a Droga , Método Duplo-Cego , Discinesia Induzida por Medicamentos , Feminino , Frequência Cardíaca/efeitos dos fármacos , Humanos , Levodopa/efeitos adversos , Levodopa/farmacocinética , Levodopa/uso terapêutico , Masculino , Pessoa de Meia-Idade , Atividade Motora/efeitos dos fármacos , Fitoterapia/efeitos adversos , Pós , Sementes , Resultado do Tratamento
3.
J Neurol Sci ; 365: 175-80, 2016 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-27206902

RESUMO

BACKGROUND: Parkinson's disease (PD) is a progressive neurological condition. Levodopa (LD) is the gold standard therapy for PD patients. Most PD patients in low-income areas cannot afford long-term daily Levodopa therapy. The aim of our study was to investigate if Mucuna pruriens (MP), a legume with high LD content that grows in tropical regions worldwide, might be potential alternative for poor PD patients. METHODS: We analyzed 25 samples of MP from Africa, Latin America and Asia. We measured the content in LD in various MP preparations (dried, roasted, boiled). LD pharmacokinetics and motor response were recorded in four PD patients, comparing MP vs. LD+Dopa-Decarboxylase Inhibitor (DDCI) formulations. RESULTS: Median LD concentration in dried MP seeds was 5.29%; similar results were obtained in roasted powder samples (5.3%), while boiling reduced LD content up to 70%. Compared to LD+DDCI, MP extract at similar LD dose provided less clinical benefit, with a 3.5-fold lower median AUC. CONCLUSION: Considering the lack of a DDCI, MP therapy may provide clinical benefit only when content of LD is at least 3.5-fold the standard LD+DDCI. If long-term MP proves to be safe and effective in controlled clinical trials, it may be a sustainable alternative therapy for PD in low-income countries.


Assuntos
Antiparkinsonianos/sangue , Antiparkinsonianos/uso terapêutico , Levodopa/sangue , Levodopa/uso terapêutico , Mucuna/química , Doença de Parkinson/sangue , Doença de Parkinson/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Inibidores das Descarboxilases de Aminoácidos Aromáticos/sangue , Inibidores das Descarboxilases de Aminoácidos Aromáticos/uso terapêutico , Composição de Medicamentos/economia , Composição de Medicamentos/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fitoterapia/métodos , Extratos Vegetais/química , Sementes/química
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