Effectiveness a herbal medicine (Sipjeondaebo-tang) on adults with chronic fatigue syndrome, 2020, Shin et al

Andy · Oct 27, 2020

Full title: Effectiveness a herbal medicine (Sipjeondaebo-tang) on adults with chronic fatigue syndrome: A randomized, double-blind, placebo-controlled trial

Background
Sipjeondaebo-tang (SJDBT, Shi-quan-da-bu-tang in Chinese) is a widely prescribed herbal medicine in traditional Korean medicine. This study aimed to evaluate the effectiveness and safety of SJDBT for treating chronic fatigue syndrome (CFS).

Methods
Ninety-six eligible participants were randomly allocated to either the SJDBT or placebo groups in a 1:1 ratio. Nine grams of SJDBT or placebo granules were administered to the patients for 8 weeks. The primary outcome was the response rate, defined as the proportion of participants with a score of 76 or higher in the Checklist Individual Strength assessment. Other measurements for fatigue severity, quality of life, and qi/blood/yin/yang deficiency were included. Safety was assessed throughout the trial.

Results
At week 8, the response rate did not significantly differ between the groups (SJDBT: 35.4%; placebo: 54.2%; P =  0.101, effect size [95% confidence interval] = 0.021 [-0.177, 0.218]). However, the scores of the visual analogue scale (P =  0.001, -0.327 [-0.506, -0.128]), Fatigue Severity Scale (P =  0.020, 0.480 [0.066, 0.889]), and Chalder fatigue scale (P =  0.004, -0.292 [-0.479, -0.101]) for the SJDBT group showed significant improvements in fatigue severity at the endpoint. Quality of life was not significantly different. Furthermore, SJDBT significantly ameliorated the severity of qi deficiency compared to that in the placebo group. No serious adverse events were observed.

Conclusion
This trial failed to show a significant improvement in fatigue severity, as assessed by the CIS-deprived response rate. It merely showed that SJDBT could alleviate the severity of fatigue and qi deficiency in patients with CFS. However, the further study is needed to confirm the details.
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Open access, https://www.sciencedirect.com/science/article/pii/S2213422020303000

Trish · Oct 27, 2020

So if I read this correctly the questionnaire used as the primary outcome measure, the Checklist of individual strength, which appears to be a fatigue questionnaire, showed no significant between group difference, but other fatigue questionnaires including the Chalder one did show a significant difference.

I think the key finding from that has nothing to do with the specific medicine being tested, but the inconsistency between fatigue scales, making them all useless as measures of anything.

Creekside · Oct 27, 2020

Trish said: ↑

I think the key finding from that has nothing to do with the specific medicine being tested, but the inconsistency between fatigue scales, making them all useless as measures of anything.
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"Our research goal is to make some random numbers appear to say something we want them to say."

shak8 · Oct 27, 2020

I sure would want to know all the herb's chemical properties and any toxicities before ingesting it in a clinical trial.

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Effectiveness a herbal medicine (Sipjeondaebo-tang) on adults with chronic fatigue syndrome, 2020, Shin et al

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Effectiveness a herbal medicine (Sipjeondaebo-tang) on adults with chronic fatigue syndrome, 2020, Shin et al

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