Comparative Efficacy of Modafinil and Methylphenidate in Managing Excessive Daytime Sleepiness in Parkinson’s Disease: Results from a Randomized Controlled Trial
Notice bibliographique
Résumé
Background: Excessive daytime sleepiness (EDS) is a prevalent and debilitating non-motor symptom of Parkinson's disease (PD), yet treatment alternatives are still constrained. This study aimed to evaluate the efficacy and safety of modafinil against methylphenidate in mitigating excessive daytime sleepiness in people with Parkinson's disease. Methods: In this double-blind, randomized, placebo-controlled trial, 110 patients with idiopathic Parkinson's disease and an Epworth Sleepiness Scale (ESS) score of 10 or above were recruited from two neurology clinics in Quetta, Pakistan, between December 2023 and February 2025. Participants were randomly assigned to receive modafinil (200 mg/day, n = 44), methylphenidate (10–20 mg/day, n = 52), or a placebo (n = 14) for six weeks, with optional follow-up assessments at 12 and 24 weeks. The primary outcome was the alteration in the Epworth Sleepiness Scale (ESS) score at six weeks. Secondary objectives encompassed sleep quality (Pittsburgh Sleep Quality Index, PSQI), cognitive function (Montreal Cognitive Assessment, MoCA), quality of life (PDQ-39), and motor symptoms (UPDRS-III). Safety and tolerability were evaluated using adverse event surveillance. Subgroup and multivariate analyses investigated predictors of treatment response. Results: Both modafinil and methylphenidate markedly decreased ESS scores relative to placebo at six weeks (mean change: -6.6 for modafinil, -4.4 for methylphenidate against -0.3 for placebo; p < 0.001). Modafinil exhibited a significant enhancement in sleep quality (PSQI), with a substantial effect size (Cohen’s d = 0.91). PDQ-39 scores showed substantial enhancement in both active groups, especially with modafinil (mean: 35.6 compared to 48.2 in placebo; p = 0.003). Cognitive function and motor symptoms exhibited stability between groups. Adverse events occurred more frequently in the methylphenidate group (32.7%) compared to the modafinil (18.2%) and placebo (7.1%) groups, although the majority were mild to moderate in severity. Longitudinal follow-up revealed a progressive reduction in treatment efficacy. Subgroup analysis indicated enhanced advantages in people with milder disease (Hoehn & Yahr stage ≤2). The baseline ESS score and disease severity independently forecast treatment response. Conclusions: Modafinil and methylphenidate both significantly reduced excessive daytime sleepiness in Parkinson's disease, with modafinil demonstrating enhanced efficacy and tolerance. These data suggest the prospective efficacy of modafinil as a secure and successful treatment alternative for addressing excessive daytime sleepiness in Parkinson's disease, especially in the first phases of the disorder.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,007 | 0,007 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,002 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».