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A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue

Received: 2 November 2020    Accepted: 17 November 2020    Published: 27 November 2020
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Abstract

Purpose: To observe and evaluate the clinical efficacy of the Wisconsin ginseng (Panax quinquefolius) herbal botanical adjunctive treatment to improve Rheumatoid Arthritis (RA) fatigue. A secondary aim was to observe RA related biomarkers and evaluate the safety of the treatment. Methods: Eligible adult patients with RA were enrolled between September 2019 and January 2020 at a multisite in a double-blind randomized trial with each intervention lasting 8 weeks with prescription medications, diet, and lifestyle kept constant. Interventions consisted of Wisconsin ginseng in doses of 3,000, or 6,000 mg/day or placebo given in twice daily dosing over 8 weeks. Primary endpoint outcome measures were changes from baseline at 4 and 8 weeks utilizing the Visual analogue scale to evaluate fatigue severity (VAS-F) and Disease activity score 28-joint count erythrocyte sedimentation rate & C-reactive protein (DAS28 ESR & CRP), secondary objectives included The health assessment questionnaire disability index (HAQ-DI), Cyclic adenosine monophosphate (cAMP), and Cyclic guanosine monophosphate (cGMP). Safety parameters included complete blood count (CBC), liver, kidney and function. Results: A total of 17 individuals with well-controlled RA that complained of fatigue completed the study. The safety profiles were unaffected. Kruskal-Wallis test was used to compare the efficacy at 4 weeks and 8 weeks after treatment, there was no significant difference in efficacy between the groups 4 weeks after treatment (Z=2.914, P=0.233). After 8 weeks of treatment, there was a significant difference in efficacy between the groups (Z=6.753, P=0.034). Further pair comparison showed that the effect of the high-dose 6,000 mg/day group demonstrated greater efficacy than the control group (Z=6.325, P=0.01). Conclusions: Addition of Wisconsin ginseng to conventional therapy in RA with fatigue, thus warrants further investigation to guide the role of Wisconsin ginseng to improve fatigue associated with autoimmune disorders as an adjunct treatment. Trial registration: Chinese Clinical Trials Registry. Identifier: ChiCTR1900026257; Registration Date: 2019-09-28.

Published in International Journal of Chinese Medicine (Volume 4, Issue 4)
DOI 10.11648/j.ijcm.20200404.11
Page(s) 71-81
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This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Rheumatoid Arthritis, Fatigue, Panax quinquefolius, Wisconsin Ginseng, Complementary and Integrative Health

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    Vandenhouten Eric Eugene, Song Xinwei. (2020). A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue. International Journal of Chinese Medicine, 4(4), 71-81. https://doi.org/10.11648/j.ijcm.20200404.11

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    Vandenhouten Eric Eugene; Song Xinwei. A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue. Int. J. Chin. Med. 2020, 4(4), 71-81. doi: 10.11648/j.ijcm.20200404.11

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    AMA Style

    Vandenhouten Eric Eugene, Song Xinwei. A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue. Int J Chin Med. 2020;4(4):71-81. doi: 10.11648/j.ijcm.20200404.11

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  • @article{10.11648/j.ijcm.20200404.11,
      author = {Vandenhouten Eric Eugene and Song Xinwei},
      title = {A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue},
      journal = {International Journal of Chinese Medicine},
      volume = {4},
      number = {4},
      pages = {71-81},
      doi = {10.11648/j.ijcm.20200404.11},
      url = {https://doi.org/10.11648/j.ijcm.20200404.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijcm.20200404.11},
      abstract = {Purpose: To observe and evaluate the clinical efficacy of the Wisconsin ginseng (Panax quinquefolius) herbal botanical adjunctive treatment to improve Rheumatoid Arthritis (RA) fatigue. A secondary aim was to observe RA related biomarkers and evaluate the safety of the treatment. Methods: Eligible adult patients with RA were enrolled between September 2019 and January 2020 at a multisite in a double-blind randomized trial with each intervention lasting 8 weeks with prescription medications, diet, and lifestyle kept constant. Interventions consisted of Wisconsin ginseng in doses of 3,000, or 6,000 mg/day or placebo given in twice daily dosing over 8 weeks. Primary endpoint outcome measures were changes from baseline at 4 and 8 weeks utilizing the Visual analogue scale to evaluate fatigue severity (VAS-F) and Disease activity score 28-joint count erythrocyte sedimentation rate & C-reactive protein (DAS28 ESR & CRP), secondary objectives included The health assessment questionnaire disability index (HAQ-DI), Cyclic adenosine monophosphate (cAMP), and Cyclic guanosine monophosphate (cGMP). Safety parameters included complete blood count (CBC), liver, kidney and function. Results: A total of 17 individuals with well-controlled RA that complained of fatigue completed the study. The safety profiles were unaffected. Kruskal-Wallis test was used to compare the efficacy at 4 weeks and 8 weeks after treatment, there was no significant difference in efficacy between the groups 4 weeks after treatment (Z=2.914, P=0.233). After 8 weeks of treatment, there was a significant difference in efficacy between the groups (Z=6.753, P=0.034). Further pair comparison showed that the effect of the high-dose 6,000 mg/day group demonstrated greater efficacy than the control group (Z=6.325, P=0.01). Conclusions: Addition of Wisconsin ginseng to conventional therapy in RA with fatigue, thus warrants further investigation to guide the role of Wisconsin ginseng to improve fatigue associated with autoimmune disorders as an adjunct treatment. Trial registration: Chinese Clinical Trials Registry. Identifier: ChiCTR1900026257; Registration Date: 2019-09-28.},
     year = {2020}
    }
    

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  • TY  - JOUR
    T1  - A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue
    AU  - Vandenhouten Eric Eugene
    AU  - Song Xinwei
    Y1  - 2020/11/27
    PY  - 2020
    N1  - https://doi.org/10.11648/j.ijcm.20200404.11
    DO  - 10.11648/j.ijcm.20200404.11
    T2  - International Journal of Chinese Medicine
    JF  - International Journal of Chinese Medicine
    JO  - International Journal of Chinese Medicine
    SP  - 71
    EP  - 81
    PB  - Science Publishing Group
    SN  - 2578-9473
    UR  - https://doi.org/10.11648/j.ijcm.20200404.11
    AB  - Purpose: To observe and evaluate the clinical efficacy of the Wisconsin ginseng (Panax quinquefolius) herbal botanical adjunctive treatment to improve Rheumatoid Arthritis (RA) fatigue. A secondary aim was to observe RA related biomarkers and evaluate the safety of the treatment. Methods: Eligible adult patients with RA were enrolled between September 2019 and January 2020 at a multisite in a double-blind randomized trial with each intervention lasting 8 weeks with prescription medications, diet, and lifestyle kept constant. Interventions consisted of Wisconsin ginseng in doses of 3,000, or 6,000 mg/day or placebo given in twice daily dosing over 8 weeks. Primary endpoint outcome measures were changes from baseline at 4 and 8 weeks utilizing the Visual analogue scale to evaluate fatigue severity (VAS-F) and Disease activity score 28-joint count erythrocyte sedimentation rate & C-reactive protein (DAS28 ESR & CRP), secondary objectives included The health assessment questionnaire disability index (HAQ-DI), Cyclic adenosine monophosphate (cAMP), and Cyclic guanosine monophosphate (cGMP). Safety parameters included complete blood count (CBC), liver, kidney and function. Results: A total of 17 individuals with well-controlled RA that complained of fatigue completed the study. The safety profiles were unaffected. Kruskal-Wallis test was used to compare the efficacy at 4 weeks and 8 weeks after treatment, there was no significant difference in efficacy between the groups 4 weeks after treatment (Z=2.914, P=0.233). After 8 weeks of treatment, there was a significant difference in efficacy between the groups (Z=6.753, P=0.034). Further pair comparison showed that the effect of the high-dose 6,000 mg/day group demonstrated greater efficacy than the control group (Z=6.325, P=0.01). Conclusions: Addition of Wisconsin ginseng to conventional therapy in RA with fatigue, thus warrants further investigation to guide the role of Wisconsin ginseng to improve fatigue associated with autoimmune disorders as an adjunct treatment. Trial registration: Chinese Clinical Trials Registry. Identifier: ChiCTR1900026257; Registration Date: 2019-09-28.
    VL  - 4
    IS  - 4
    ER  - 

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Author Information
  • International Education College, Zhejiang Chinese Medical University, Hangzhou, China; Ginseng Board of Wisconsin Medical Research Committee, Marathon, USA

  • The First School of Medicine, Zhejiang Chinese Medical University, Hangzhou, China; Department of Rheumatism and Immunology, Zhejiang Provincial Hospital of Chinese Medicine, Hangzhou, China; Rheumatism Professional Committee of Zhejiang Association of TCM, Hangzhou, China; Rheumatism Professional Committee of Zhejiang Association of Integrative Medicine, Hangzhou, China; Rheumatism Professional Committee of Zhejiang Medical Association, Hangzhou, China; Rheumatism Professional Committee of Zhejiang Medical Doctors Association, Hangzhou, China

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