Mucuna pruriens in untreated Parkinson's disease in sub-Saharan Africa: A 12-month, multicenter, randomized, controlled trial.

BackgroundParkinson's disease (PD) causes disability and premature mortality if untreated. Limited access to levodopa in low- and middle-income countries leaves many patients undertreated. Mucuna pruriens (MP) is a leguminous plant that contains high concentrations of levodopa.ObjectiveTo demonstrate the non-inferiority of long-term intake of MP powder in terms of safety and efficacy compared to standard levodopa plus dopa-decarboxylase inhibitor (LD + DDCI).MethodsIn this 12-month, multicenter, randomized, open-label phase 2 trial, thirty-two untreated PD patients received levodopa monotherapy with MP powder -derived from roasted seeds without pharmacological processing- or standard LD + DDCI. Dosing was adjusted for body weight and disease stage, with MP doses further calibrated to account for the absence of a DDCI. We measured quality of life using the 39-item PD Questionnaire, motor and non-motor disability using the Movement Disorders Society updated version of the Unified PD Rating Scale (MDS-UPDRS) (parts I to IV) and the Non-Motor Symptoms Questionnaire. Safety measures included recording any adverse event and laboratory test.ResultsMP powder improved quality of life, motor and non-motor symptoms over 12 months, demonstrating similar outcome to LD + DDCI on all endpoints. Adverse events were more frequent with MP (56% vs. 37.5%, p = 0.48), though the difference was not statistically significant. Most were mild, with only 12.5% leading to discontinuation.ConclusionsMP could be a cost-effective alternative for PD individuals with limited access to commercial levodopa formulations. To confirm long-term safety and efficacy, larger international multicenter, double-blind trials with extended follow-up (e.g. 24-36 months) and ethnically diverse cohorts are needed.Registered at PACTR201611001882367.