Cash Alan, Vernon Suzanne D, Rond Candace, Bateman Lucinda, Abbaszadeh Saeed, Bell Jennifer, Yellman Brayden, Kaufman David L
Terra Biological LLC, San Diego, CA, United States.
Bateman Horne Center, Salt Lake City, UT, United States.
Front Neurol. 2024 Nov 27;15:1483876. doi: 10.3389/fneur.2024.1483876. eCollection 2024.
The energy metabolite oxaloacetate is significantly lower in the blood plasma of ME/CFS subjects. A previous open-label trial with oxaloacetate supplementation demonstrated a significant reduction in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)-related fatigue.
In this follow-up trial, 82 ME/CFS subjects were enrolled in a 3-month randomized, double-blinded, controlled study, receiving either 2,000 mg of oxaloacetate or control per day. The primary endpoints were safety and reduction in fatigue from baseline. Secondary and exploratory endpoints included functional capacity and general health status.
Anhydrous enol-oxaloacetate (oxaloacetate) was well tolerated at the tested doses. Oxaloacetate significantly reduced fatigue by more than 25% from baseline, while the control group showed a non-significant reduction of approximately 10%. Intergroup analysis showed a significant decrease in fatigue levels in the oxaloacetate group ( = 0.0039) with no notable change in the control group. A greater proportion of subjects in the oxaloacetate group achieved a reduction in fatigue greater than 25% compared to the control group ( < 0.05). Additionally, 40.5% of the oxaloacetate group were classified as "enhanced responders," with an average fatigue reduction of 63%. Both physical and mental fatigue improved with oxaloacetate supplementation.
Oxaloacetate is well tolerated and effectively helps reduce fatigue in ME/CFS patients.
能量代谢物草酰乙酸在肌痛性脑脊髓炎/慢性疲劳综合征（ME/CFS）患者的血浆中显著降低。先前一项关于补充草酰乙酸的开放标签试验表明，与肌痛性脑脊髓炎/慢性疲劳综合征（ME/CFS）相关的疲劳显著减轻。
在这项随访试验中，82名ME/CFS患者参与了一项为期3个月的随机、双盲、对照研究，每天接受2000毫克草酰乙酸或对照治疗。主要终点是安全性和与基线相比疲劳程度的降低。次要和探索性终点包括功能能力和总体健康状况。
在测试剂量下，无水烯醇式草酰乙酸（草酰乙酸）耐受性良好。草酰乙酸使疲劳程度较基线显著降低超过25%，而对照组则有大约10%的非显著性降低。组间分析显示草酰乙酸组的疲劳水平显著下降（P = 0.0039），而对照组无明显变化。与对照组相比，草酰乙酸组中更大比例的患者疲劳程度降低超过25%（P < 0.05）。此外，草酰乙酸组40.5%的患者被归类为“增强反应者”，平均疲劳减轻63%。补充草酰乙酸后，身体和精神疲劳均有所改善。
草酰乙酸耐受性良好，有效帮助减轻ME/CFS患者的疲劳。
