TY - JOUR
T1 - Mucuna pruriens in Parkinson disease
T2 - A double-blind, randomized, controlled, crossover study
AU - Cilia, Roberto
AU - Laguna, Janeth
AU - Cassani, Erica
AU - Cereda, Emanuele
AU - Pozzi, Nicolò G.
AU - Isaias, Ioannis U.
AU - Contin, Manuela
AU - Barichella, Michela
AU - Pezzoli, Gianni
N1 - Ricercatore distaccato presso IRCCS a seguito Convenzione esclusiva con Università di Bologna (Contin Manuela)
PY - 2017/8/1
Y1 - 2017/8/1
N2 - 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 (LD1DDCI; 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 (LD2DDCI; 17.5 mg/kg); (5) MP plus benserazide (MP1DDCI; 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 LD1DDCI, 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 LD1DDCI and LD2DDCI. 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.
AB - 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 (LD1DDCI; 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 (LD2DDCI; 17.5 mg/kg); (5) MP plus benserazide (MP1DDCI; 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 LD1DDCI, 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 LD1DDCI and LD2DDCI. 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.
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U2 - 10.1212/WNL.0000000000004175
DO - 10.1212/WNL.0000000000004175
M3 - Article
C2 - 28679598
AN - SCOPUS:85026546181
VL - 89
SP - 432
EP - 438
JO - Neurology
JF - Neurology
SN - 0028-3878
IS - 5
ER -