The Efficacy and Safety of Myelophil, an Ethanol Extract Mixture of Astragali Radix and Salviae Radix, for Chronic Fatigue Syndrome: A Randomized Clinical Trial

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: , identifier KCT0002317.

Reliability and Validity of the Modified Korean Version of the Chalder Fatigue Scale (mKCFQ11)

“…In addition, the mKCFQ11 was significantly correlated with the VAS, FSS and SF-36 on three different data points from baseline and 12 weeks ( Table 3 ). These correlations were stronger at 12 weeks than at baseline, as anticipated, because the intervention (Myelophil) showed positive effects on all scores of the mKCFQ11, FSS, VAS and SF-36 compared to the control [ 20 ]. Furthermore, these strong correlations were repeated for the altered values of the mKCFQ11 and others.…”

“…In fact, most patients with CFS have been diagnosed with the disease for many years of disease with fluctuating symptoms [ 26 ]; thus, they frequently hesitated in answering. The mKCFQ11 has been adapted well by participants, in particular RCTs because they chose to describe their condition between “no fatigue” and ”unbearable fatigue” at a certain period [ 20 ].…”

“…The study population comprised 97 patients with CFS (37 males and 60 female) between the ages of 18 and 65 years (mean age 39.6 ± 10.0 years) who were enrolled in a phase 2 trial conducted in two hospitals (Daejeon Korean Medicine Hospital of Daejeon University and Daejeon St. Mary’s Hospital of the Catholic University of South Korea) from December 2016 to November 2017 [ 20 ]. All participants met the 1994 Fukuda CFS definition, which requires clinically evaluated, unexplained, persistent, or relapsing chronic fatigue [ 7 ].…”

“…Based on the responder’s comments, specialists discussed and completed the Korean version of the CFQ with 10-point Likert scale. After repeated tests of the patients complaining of chronic fatigue, including CFS, and a pilot clinical trial for ICF [ 19 ], the final mKCFQ11 ( Table 1 ) was determined and used as a primary measurement for the above trial [ 20 ].…”

“…Therefore, we slightly modified it into a 10-point Likert scale (between normal and worst status) to describe their illness condition after treatment, called the Modified Korean Version of the Chalder Fatigue Scale (mKCFQ11). We have adapted the mKCFQ11 as a primary measurement in clinical trials using herb-derived therapeutics in both patients with idiopathic chronic fatigue (ICF) and CFS [ 19 , 20 ].…”