The Efficacy and Safety of Myelophil, an Ethanol Extract Mixture of Astragali Radix and Salviae Radix, for Chronic Fatigue Syndrome: A Randomized Clinical Trial. — CFSMEATLAS
The Efficacy and Safety of Myelophil, an Ethanol Extract Mixture of Astragali Radix and Salviae Radix, for Chronic Fatigue Syndrome: A Randomized Clinical Trial.
Joung, Jin-Yong, Lee, Jin-Seok, Cho, Jung-Hyo et al. · Frontiers in pharmacology · 2019 · DOI
Quick Summary
Researchers tested a herbal supplement called Myelophil (made from two plant extracts) in 97 people with ME/CFS over 12 weeks. Overall, the supplement didn't significantly reduce fatigue compared to placebo. However, in people with severe fatigue symptoms at the start, Myelophil did show meaningful improvement in fatigue levels and quality of life. The treatment was safe with no serious side effects reported.
Why It Matters
This is one of few rigorous clinical trials testing a herbal approach for ME/CFS in a randomized controlled format. The finding that Myelophil may benefit people with severe symptoms could guide future research into patient stratification and personalized treatment approaches. Results support further investigation with adequately powered phase 3 trials.
Observed Findings
In the overall cohort (n=97), Myelophil showed no statistically significant improvement over placebo on fatigue scales (NRS, VAS, FSS) or quality of life (SF-36).
In the severe symptom subgroup (n=53), Myelophil produced statistically significant improvements in NRS fatigue scores, FSS, and SF-36 compared to placebo (p<0.05).
No significant changes in oxidative stress biomarkers or inflammatory cytokine levels were observed before or after treatment in either group.
No Myelophil-related adverse events were reported during the 12-week trial.
Inferred Conclusions
Myelophil may be beneficial specifically for people with severe ME/CFS symptoms, suggesting patient stratification by symptom severity may be important for herbal CFS therapies.
The compound appears safe and well-tolerated as an oral supplement in this population.
Results warrant progression to a larger, pre-specified phase 3 trial focusing on severely symptomatic patients.
Remaining Questions
Why did Myelophil only benefit the severe symptom subgroup and not the overall population? What are the active compounds responsible for fatigue reduction?
What is the mechanism of action if oxidative stress and cytokine biomarkers did not change significantly?
What This Study Does Not Prove
This study does not prove Myelophil is an effective treatment for all ME/CFS patients—it failed to show benefit in the overall population. The positive subgroup findings (severe symptoms only) are exploratory and require pre-specified confirmation in future trials to avoid false positives from post-hoc analysis. The lack of biomarker changes does not clarify the mechanism by which symptom improvements occurred.
Tags
Symptom:Fatigue
Biomarker:CytokinesBlood Biomarker
Phenotype:Severe
Method Flag:PEM Not DefinedWeak Case DefinitionSmall SampleExploratory Only