Abstract
Background: There is a strong demand for therapeutics to treat chronic fatigue syndrome (CFS), although there are limitations. Myelophil, which is a combination of extracts from Astragali Radix and Salviae Miltiorrhizae Radix, has been clinically used to treat fatigue-related disorders in South Korea. We conducted a randomized controlled clinical trial of Myelophil in patients with CFS and evaluated its efficacy and safety in two hospitals. Methods: We enrolled 98 participants (M: 38, F: 60) with CFS in a phase 2 trial of oral Myelophil (2 g daily) or placebo for 12 weeks. The primary end point was a change in the Chalder fatigue scale, as scored by a numeric rating scale (NRS). The secondary end points included changes in the visual analogue scale, fatigue severity scale (FSS), and 36-item short-form health survey (SF-36). Biomarkers of oxidative stress and cytokines were evaluated by blood tests. Results: Ninety-seven participants (48 in the Myelophil group and 49 in the placebo group) completed the trial. An analysis of all participants showed that Myelophil slightly improved fatigue symptoms compared with those of the placebo, but this effect was not statistically significant (p > 0.05 for the NRS, VAS, FSS, and SF-36). By contrast, an analysis of the subpopulation (53 participants, M: 24, F: 29) with severe symptoms (≥63, median NRS value of total participants) showed a statistically significant improvement in fatigue symptoms in the Myelophil group compared with the placebo (p < 0.05 for NRS, FSS, and SF-36). There were no significant changes in the biomarkers for oxidative stress and cytokines before or after the treatment. No Myelophil-related adverse response was observed during the trial. Conclusion: These results support the hypothesis that Myelophil can be a therapeutic candidate to manage CFS and provide the rationale for its progression to a phase 3 clinical trial. Clinical Trial Registration: www.ClinicalTrials.gov, identifier KCT0002317.
Highlights
Chronic fatigue syndrome (CFS) is a complicated disease that is characterized by extreme fatigue with substantial symptoms that are associated with neurological, cognitive, and immune abnormalities for at least 6 months (Wyller, 2007; Moss-Morris et al, 2013)
To emphasize the medical impact of CFS, the Institute of Medicine in the USA suggested changing the name of CFS to systemic exertion intolerance disease without the word “fatigue” and asked the US government to accelerate the research progress for CFS treatment by raising funds in 2015 (Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome et al, 2015)
98 consecutive participants who fulfilled the inclusion criteria were enrolled in this study
Summary
Chronic fatigue syndrome (CFS) is a complicated disease that is characterized by extreme fatigue with substantial symptoms that are associated with neurological, cognitive, and immune abnormalities for at least 6 months (Wyller, 2007; Moss-Morris et al, 2013). Altered serotonergic and muscarinic neurotransmitter systems (Katafuchi et al, 2006; Yamamoto et al, 2012), immunological dysfunction (Kennedy et al, 2005; Morris et al, 2013; Nijs et al, 2014), and disruption of the hypothalamic–pituitary–adrenal (HPA) axis (Papadopoulos and Cleare, 2011; Tomas et al, 2013) were reported to contribute to CNS impairment in CFS patients Based on this finding, antidepressants, immunomodulatory agents, and corticosteroids were studied as therapeutic agents, but no clear effects of these treatments were observed (Castro‐Marrero et al, 2017). We conducted a randomized controlled clinical trial of Myelophil in patients with CFS and evaluated its efficacy and safety in two hospitals
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