Effectiveness a herbal medicine (Sipjeondaebo-tang) on adults with chronic fatigue syndrome : A randomized, double-blind, placebo-controlled trial
© 2020 Korea Institute of Oriental Medicine. Publishing services by Elsevier B.V..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
Integrative medicine research - 10(2021), 2 vom: 16. Juni, Seite 100664 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Shin, Seungwon [VerfasserIn] |
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| Links: |
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| Themen: |
Chronic fatigue syndrome |
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| Anmerkungen: |
Date Revised 17.04.2022 published: Print-Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1016/j.imr.2020.100664 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM316707384 |
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| 100 | 1 | |a Shin, Seungwon |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effectiveness a herbal medicine (Sipjeondaebo-tang) on adults with chronic fatigue syndrome |b A randomized, double-blind, placebo-controlled trial |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Revised 17.04.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2020 Korea Institute of Oriental Medicine. Publishing services by Elsevier B.V. | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Chronic fatigue syndrome | |
| 650 | 4 | |a Complementary therapies | |
| 650 | 4 | |a Herbal medicine | |
| 650 | 4 | |a Randomized controlled trial | |
| 700 | 1 | |a Park, Soo Jung |e verfasserin |4 aut | |
| 700 | 1 | |a Hwang, Minwoo |e verfasserin |4 aut | |
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