Oxaloacetate Treatment For Mental And Physical Fatigue In Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long-COVID fatigue patients: a non-randomized controlled clinical trial
Research abstract:
Key points:
- 6 weeks of treatment led to reduction of fatigue in Long COVID patients by up to 46.8%
- 6 weeks of treatment led to reduction of fatigue in ME/CFS patients by an average of 22.5% to 33%
- Uses Chalder Scale to measure fatigue, which is accused of having operational flaws for ME/CFS
- Compares results to control subjects from a previous study
- Not possible to buy the supplement at the same dosage researched
- Researchers say this is worth further study. Others say these results don’t support that.
Background
There is no approved pharmaceutical intervention for Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS). Fatigue in these patients can last for decades. Long COVID may continue to ME/CFS, and currently, it is estimated that up to 20 million Americans have significant symptoms after COVID, and the most common symptom is fatigue.
Anhydrous Enol-Oxaloacetate, (AEO) a nutritional supplement, has been anecdotally reported to relieve physical and mental fatigue and is diminished in ME/CFS patients. Here, we examine the use of higher dosage AEO as a medical food to relieve pathological fatigue.
Methods
ME/CFS and Long-COVID patients were enrolled in an open label dose escalating “Proof of Concept” non-randomized controlled clinical trial with 500 mg AEO capsules. Control was provided by a historical ME/CFS fatigue trial [i.e. not done at the same time] and supporting meta-analysis study, which showed average improvement with oral placebo using the Chalder Scale of 5.9% improvement from baseline.
At baseline, 73.7% of the ME/CFS patients were women, average age was 47 and length of ME/CFS from diagnosis was 8.9 years. The Long-COVID patients were a random group that responded to social media advertising (Face Book) with symptoms for at least 6 months. ME/CFS patients were given separate doses of 500 mg BID (N = 23), 1,000 mg BID (N = 29) and 1000 mg TID (N = 24) AEO for six weeks.
Long COVID patients were given 500 mg AEO BID (N = 22) and 1000 mg AEO (N = 21), again over a six-week period. The main outcome measure was to compare baseline scoring with results at 6 weeks with the Chalder Fatigue Score (Likert Scoring) versus historical placebo. The hypothesis being tested was formulated prior to data collection.
Results
76 ME/CFS patients (73.7% women, median age of 47) showed an average reduction in fatigue at 6 weeks as measured by the “Chalder Fatigue Questionnaire” of 22.5% to 27.9% from baseline (P < 0.005) (Likert scoring). Both physical and mental fatigue were significantly improved over baseline and historical placebo. Fatigue amelioration in ME/CFS patients increased in a dose dependent manner from 21.7% for 500 mg BID to 27.6% for 1000 mg Oxaloacetate BID to 33.3% for 1000 mg TID. Long COVID patients’ fatigue was significantly reduced by up to 46.8% in 6-weeks.
Conclusions
Significant reductions in physical and metal fatigue for ME/CFS and Long-COVID patients were seen after 6 weeks of treatment. As there has been little progress in providing fatigue relief for the millions of ME/CFS and Long COVID patients, anhydrous enol oxaloacetate may bridge this important medical need. Further study of oxaloacetate supplementation for the treatment of ME/CFS and Long COVID is warranted.
Authors & journal:
Alan Cash & David Lyons Kaufman in Journal of Translational Medicine volume 20, Article number: 295 (2022); publsished 28 June 2022 [doi.org/10.1186/s12967-022-03488-3]
Comments:
S4ME comment: Claims made for efficacy based on the Chalder Fatigue questionnaire were not supported by any significant improvement on the Fatigue Severity Scale, and the data used as the placebo comparator for this 6 week open label trial was from an unrelated trial over 26 weeks.
PR News Wire: New Study: Oxaloacetate Reduces Chronic Fatigue In Just Six Weeks, Promising Data for ME/CFS Patients
Currently, oxaloacetate is available over-the-counter in smaller doses as a nutritional supplement from several national brands. To obtain oxaloacetate at the doses present in this study, patients will need to utilize the medical food Oxaloacetate CFS under the supervision of a licensed healthcare provider.
Current trial (Bateman Horne Center): Medical Food – Anhydrous Enol-Oxaloacetate for Fatigue
Health rising: Oxaloacetate: the Best Mitochondrial Supplement for ME/CFS (and Long COVID?) [2021]
