{"title":"麝香草与常规左旋多巴治疗帕金森病的比较疗效:一项来自亚洲的药代动力学和临床观点的随机对照试验","authors":"Thanatat Boonmongkol, Onanong Phokaewvarangkul, Sornkanok Vimolmangkang, Thitima Wattanavijitkul, Virunya Komenkul, Roongroj Bhidayasiri","doi":"10.1007/s00702-025-02914-2","DOIUrl":null,"url":null,"abstract":"<p><p>Levodopa remains central to Parkinson's disease (PD) treatment, but long-term use can cause motor complications, highlighting the need for additional therapies. Mucuna pruriens (MP), a natural source of levodopa, shows potential in managing these complications. Further research is needed to compare its pharmacokinetics (PK) and clinical outcomes with traditional levodopa formulations. This randomised, single-blind, crossover trial compared the PK, clinical outcomes, and safety of MP powder against levodopa/benserazide dispersible tablets (Levodopa DT) in PD patients with motor complications. Twelve participants were recruited to receive either 30 g of MP powder or two 100/25 levodopa DT in separate sessions with a two-week washout between sessions. Key PK parameters (AUC, Cmax, Tmax, and t<sub>½</sub>) were measured. Clinical assessments used standard rating scales and adverse events were recorded. Data from 11 participants were analysed after one withdrawal. MP powder demonstrated significantly higher overall drug exposure, with a geometric mean AUC<sub>0-∞</sub> of 12,424.81 compared to 7981.69 ng·h/mL for levodopa DT. The geometric mean ratio was 155.67% (90% CI 134.59-180.04), exceeding the bioequivalence acceptance range of 80-125%. However, the two treatments exhibited similar Tmax and t₁/₂ values, indicating comparable rates of absorption and elimination. Clinically, MP provided a longer ON state without dyskinesia-232.2 min versus 161.8 min for levodopa DT (p = 0.01). Mild and transient adverse events, such as nausea and dizziness, were more frequently associated with MP. MP offers superior drug exposure and extends the ON state without increasing dyskinesia, positioning it as a promising alternative to synthetic levodopa for managing motor symptoms. These findings support MP's potential role in alleviating motor complications in PD treatment.</p>","PeriodicalId":16579,"journal":{"name":"Journal of Neural Transmission","volume":" ","pages":""},"PeriodicalIF":3.2000,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative efficacy of Mucuna pruriens and conventional levodopa in Parkinson's disease: a randomized controlled trial on pharmacokinetics and clinical perspectives from Asia.\",\"authors\":\"Thanatat Boonmongkol, Onanong Phokaewvarangkul, Sornkanok Vimolmangkang, Thitima Wattanavijitkul, Virunya Komenkul, Roongroj Bhidayasiri\",\"doi\":\"10.1007/s00702-025-02914-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Levodopa remains central to Parkinson's disease (PD) treatment, but long-term use can cause motor complications, highlighting the need for additional therapies. Mucuna pruriens (MP), a natural source of levodopa, shows potential in managing these complications. Further research is needed to compare its pharmacokinetics (PK) and clinical outcomes with traditional levodopa formulations. This randomised, single-blind, crossover trial compared the PK, clinical outcomes, and safety of MP powder against levodopa/benserazide dispersible tablets (Levodopa DT) in PD patients with motor complications. Twelve participants were recruited to receive either 30 g of MP powder or two 100/25 levodopa DT in separate sessions with a two-week washout between sessions. Key PK parameters (AUC, Cmax, Tmax, and t<sub>½</sub>) were measured. Clinical assessments used standard rating scales and adverse events were recorded. Data from 11 participants were analysed after one withdrawal. MP powder demonstrated significantly higher overall drug exposure, with a geometric mean AUC<sub>0-∞</sub> of 12,424.81 compared to 7981.69 ng·h/mL for levodopa DT. The geometric mean ratio was 155.67% (90% CI 134.59-180.04), exceeding the bioequivalence acceptance range of 80-125%. However, the two treatments exhibited similar Tmax and t₁/₂ values, indicating comparable rates of absorption and elimination. Clinically, MP provided a longer ON state without dyskinesia-232.2 min versus 161.8 min for levodopa DT (p = 0.01). Mild and transient adverse events, such as nausea and dizziness, were more frequently associated with MP. MP offers superior drug exposure and extends the ON state without increasing dyskinesia, positioning it as a promising alternative to synthetic levodopa for managing motor symptoms. These findings support MP's potential role in alleviating motor complications in PD treatment.</p>\",\"PeriodicalId\":16579,\"journal\":{\"name\":\"Journal of Neural Transmission\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2025-03-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Neural Transmission\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00702-025-02914-2\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Neural Transmission","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00702-025-02914-2","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Comparative efficacy of Mucuna pruriens and conventional levodopa in Parkinson's disease: a randomized controlled trial on pharmacokinetics and clinical perspectives from Asia.
Levodopa remains central to Parkinson's disease (PD) treatment, but long-term use can cause motor complications, highlighting the need for additional therapies. Mucuna pruriens (MP), a natural source of levodopa, shows potential in managing these complications. Further research is needed to compare its pharmacokinetics (PK) and clinical outcomes with traditional levodopa formulations. This randomised, single-blind, crossover trial compared the PK, clinical outcomes, and safety of MP powder against levodopa/benserazide dispersible tablets (Levodopa DT) in PD patients with motor complications. Twelve participants were recruited to receive either 30 g of MP powder or two 100/25 levodopa DT in separate sessions with a two-week washout between sessions. Key PK parameters (AUC, Cmax, Tmax, and t½) were measured. Clinical assessments used standard rating scales and adverse events were recorded. Data from 11 participants were analysed after one withdrawal. MP powder demonstrated significantly higher overall drug exposure, with a geometric mean AUC0-∞ of 12,424.81 compared to 7981.69 ng·h/mL for levodopa DT. The geometric mean ratio was 155.67% (90% CI 134.59-180.04), exceeding the bioequivalence acceptance range of 80-125%. However, the two treatments exhibited similar Tmax and t₁/₂ values, indicating comparable rates of absorption and elimination. Clinically, MP provided a longer ON state without dyskinesia-232.2 min versus 161.8 min for levodopa DT (p = 0.01). Mild and transient adverse events, such as nausea and dizziness, were more frequently associated with MP. MP offers superior drug exposure and extends the ON state without increasing dyskinesia, positioning it as a promising alternative to synthetic levodopa for managing motor symptoms. These findings support MP's potential role in alleviating motor complications in PD treatment.
期刊介绍:
The investigation of basic mechanisms involved in the pathogenesis of neurological and psychiatric disorders has undoubtedly deepened our knowledge of these types of disorders. The impact of basic neurosciences on the understanding of the pathophysiology of the brain will further increase due to important developments such as the emergence of more specific psychoactive compounds and new technologies.
The Journal of Neural Transmission aims to establish an interface between basic sciences and clinical neurology and psychiatry. It intends to put a special emphasis on translational publications of the newest developments in the field from all disciplines of the neural sciences that relate to a better understanding and treatment of neurological and psychiatric disorders.