Effectiveness a herbal medicine (<i>Sipjeondaebo-tang</i>) on adults with chronic fatigue syndrome: A randomized, double-blind, placebo-controlled trial. — CFSMEATLAS
Effectiveness a herbal medicine (Sipjeondaebo-tang) on adults with chronic fatigue syndrome: A randomized, double-blind, placebo-controlled trial.
Shin, Seungwon, Park, Soo Jung, Hwang, Minwoo · Integrative medicine research · 2021 · DOI
Quick Summary
This study tested whether a traditional Korean herbal medicine called Sipjeondaebo-tang could help people with ME/CFS feel less tired. Ninety-six patients took either the herbal medicine or a placebo (fake medicine) for 8 weeks. While the herbal medicine did not meet the study's main success measure, it did help reduce fatigue severity on several fatigue rating scales and was safe to use.
Why It Matters
This study addresses the need for evidence-based treatment options for ME/CFS, a condition with limited approved therapies. The findings suggest SJDBT may have modest benefits for fatigue symptoms and warrants further investigation into traditional medicine approaches for ME/CFS management.
Observed Findings
The primary endpoint (CIS response rate ≥76) did not significantly differ between SJDBT (35.4%) and placebo (54.2%) groups (P=0.101).
Visual analogue scale fatigue scores improved significantly in the SJDBT group compared to placebo (P=0.001).
Fatigue Severity Scale and Chalder fatigue scale both showed statistically significant improvements in the SJDBT group (P=0.020 and P=0.004, respectively).
SJDBT significantly reduced qi deficiency severity compared to placebo.
No serious adverse events were observed in either group during the 8-week treatment period.
Inferred Conclusions
SJDBT did not significantly improve the primary CFS outcome measure despite showing improvements on secondary fatigue severity scales.
SJDBT may have modest effects in alleviating fatigue severity and qi deficiency symptoms in CFS patients.
SJDBT appears to be a safe intervention with no serious adverse events observed.
Further research is needed to clarify the clinical significance and mechanism of action of SJDBT in CFS.
Remaining Questions
Why did the primary outcome (CIS response rate) fail to show benefit while secondary fatigue measures showed improvement—is this clinically meaningful or a statistical artifact?
What This Study Does Not Prove
This study does not prove that Sipjeondaebo-tang is an effective primary treatment for ME/CFS, as it failed to meet its main outcome measure. The results cannot establish optimal dosing, duration, patient subgroups most likely to benefit, or mechanisms of action. The discrepancy between the primary outcome and secondary measures raises questions about clinical meaningfulness of the observed effects.
Tags
Symptom:Fatigue
Method Flag:Weak Case DefinitionSmall SampleExploratory Only
About the PEM badge: “PEM required” means post-exertional malaise was an explicit required diagnostic criterion for participant inclusion in this study — not that PEM was studied, observed, or discussed. Studies using criteria that do not require PEM (e.g. Fukuda, Oxford) are tagged “PEM not required”. How the atlas works →