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The Clinical Efficacy and Safety of Gumiganghwal-Tang in Knee Osteoarthritis: A Phase II Randomized Double Blind Placebo Controlled Study
Joint Authors
Chang, Sung Hae
Song, Yun-Kyung
Nah, Seong-Su
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2018, Issue 2018 (31 Dec. 2018), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2018-11-14
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
Background.
Gumiganghwal-tang (GMGHT) is a traditional herbal medicine consisting of nine different herbs.
GMGHT inhibits the mRNA expression and production of inflammatory cytokines tumor necrosis factor-α (TNF- α), interleukin-6 (IL-6), and TNF- β on lipopolysaccharide- (LPS-) stimulated peritoneal macrophages in a dose-dependent manner.
It is empirically used for the treatment of inflammatory disease, but there are few reports of clinical trials that investigate its efficacy and safety.
The current study aimed to investigate the clinical efficacy and safety of GMGHT in patients with knee osteoarthritis (OA).
Methods.
This was a multicenter, two-armed, double-blinded, randomized, placebo controlled study of GMGHT over 6 weeks.
Eligible patients who fulfilled the American College of Rheumatology criteria for OA were randomized to receive either GMGHT or the placebo.
Clinical assessments included measurement of knee pain and function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), patient global assessment (PGA), and knee pain scores every 2 weeks.
Results.
A total of 128 patients were enrolled (91.4% female; mean age, 58.7 ± 8.1 years).
At baseline, pain visual analogue score (VAS) was 67.2 ± 1.4, resp.
71.3 ± 1.6 (treatment, resp.
placebo group, p=0.84), and total WOMAC score was 55.2 ± 1.6, resp.
55.6 ± 1.5 (p = 0.84).
After 6 weeks, the pain VAS was 43.0 ± 2.5, resp.
61.6 ± 2.5 (p < 0.01) and the total WOMAC score was 34.1 ± 2.4, resp.
46.9 ± 1.8 (p < 0.01).
No patients withdrew because of treatment emergent adverse events.
Expected adverse events including dyspepsia, liver function abnormality, and lower extremity edema were comparable between both groups.
Conclusions.
Treatment with GMGHT resulted in significant improvement in pain, function, and global assessment, and it was generally safe and well tolerated in patients with OA.
American Psychological Association (APA)
Chang, Sung Hae& Song, Yun-Kyung& Nah, Seong-Su. 2018. The Clinical Efficacy and Safety of Gumiganghwal-Tang in Knee Osteoarthritis: A Phase II Randomized Double Blind Placebo Controlled Study. Evidence-Based Complementary and Alternative Medicine،Vol. 2018, no. 2018, pp.1-8.
https://search.emarefa.net/detail/BIM-1154790
Modern Language Association (MLA)
Chang, Sung Hae…[et al.]. The Clinical Efficacy and Safety of Gumiganghwal-Tang in Knee Osteoarthritis: A Phase II Randomized Double Blind Placebo Controlled Study. Evidence-Based Complementary and Alternative Medicine No. 2018 (2018), pp.1-8.
https://search.emarefa.net/detail/BIM-1154790
American Medical Association (AMA)
Chang, Sung Hae& Song, Yun-Kyung& Nah, Seong-Su. The Clinical Efficacy and Safety of Gumiganghwal-Tang in Knee Osteoarthritis: A Phase II Randomized Double Blind Placebo Controlled Study. Evidence-Based Complementary and Alternative Medicine. 2018. Vol. 2018, no. 2018, pp.1-8.
https://search.emarefa.net/detail/BIM-1154790
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1154790