Promising Clinical Trial Results: Advancing ME/CFS and Long COVID Treatment
by Suzanne Vernon, PhD,
Director of Research
At the Bateman Horne Center (BHC), we are committed to finding effective treatments for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Long COVID. Randomized Controlled Trials (RCTs), the gold standard of medical research, help us test whether treatments truly work. We conducted two investigator-initiated RCTs this year, and the findings are encouraging.
RESTORE ME Trial: A Step Forward for ME/CFS Fatigue
The RESTORE ME trial explored whether oxaloacetate, a medical food, could reduce fatigue—a primary symptom of ME/CFS. Here’s what we did:
- Participants: 82 individuals with ME/CFS.
- Treatment Groups: Half took 2,000 mg/day of oxaloacetate capsules, and the other half took control capsules (rice flour) for 90 days. There were monthly in-person visits and weekly surveys that included the Chalder Fatigue Scale to assess fatigue.
- Results:
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- Fatigue decreased by 27% in the oxaloacetate group compared to 10% in the control group.
- Notably, almost half of those receiving oxaloacetate had an “enhanced response” and experienced significant fatigue improvement.
- While some improvements in the control group were due to the placebo effect (common in all trials), the results clearly show oxaloacetate can help. Ongoing analysis will determine if it also improves cognition and physical function. Results can be viewed here.
Long COVID Trial: Insights on Valacyclovir and Celecoxib
We also tested whether a combination of valacyclovir (an antiviral) and celecoxib (an anti-inflammatory) could reduce fatigue in Long COVID patients. Participants took the treatment twice daily for 12 weeks, attended four in-person visits, and completed online surveys each week to assess fatigue, sleep, and pain.
Here’s what we found:
- Groups and Dosage: Participants were divided into:
- Low-dose group (750 mg valacyclovir + celecoxib).
- High-dose group (1,500 mg valacyclovir + celecoxib).
- Placebo group.
- Results:
- The low-dose group showed meaningful fatigue reduction.
- he high-dose group experienced more gastrointestinal side effects and less fatigue reduction.
- The placebo group also improved but to a lesser extent than the low-dose group.
We’re still analyzing these results and look forward to publishing them soon.
Why Your Support Matters
BHC is dedicated to conducting clinical trials that advance research and clinical care. Each study generates crucial insights that guide better care for ME/CFS, Long COVID, fibromyalgia, and other chronic illnesses linked to infections. But none of this is possible without your support.
Lucinda Bateman, MD, is a renowned clinician, researcher, and educator. Her Johns Hopkins University Medical School training instilled an approach to care that she has employed throughout her career - the patient comes first and the unknown or unexplained does not equate to a lack of proper and compassionate care. Since starting her own practice in 2000, she has served on six boards or committees, been the principal investigator for 45 studies, authored/coauthored 40 journal articles, served as adjunct instructor and adjunct assistant professor in the University of Utah Departments of Preventative Medicine, Internal Medicine, and Anesthesiology, and lectured around the world.