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Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial
Joint Authors
Sangdee, Chaichan
Chiranthanut, Natthakarn
Chansakaow, Sunee
Koonrungsesomboon, Nut
Nopnithipat, Saowaros
Tipduangta, Pramote
Hanprasertpong, Nutthiya
Teekachunhatean, Supanimit
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2020, Issue 2020 (31 Dec. 2020), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2020-12-09
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
Background.
Osteoarthritis of the knee is the most common form of arthritis.
Identifying effective and safe herbal formulations that are locally available is viewed as a priority for sustainable development in a region.
This study aimed to evaluate the efficacy and safety of Thai herbal formulation-6 (THF-6) in comparison with oral diclofenac in patients with moderate-to-severe osteoarthritis of the knee.
Methods.
This randomized, double-blind, active-controlled, noninferiority trial randomly assigned patients with osteoarthritis of the knee to receive either THF-6 or diclofenac for four weeks.
The primary outcome measure was the change from baseline in knee pain as measured by a 100 mm visual analog scale (VAS).
Secondary outcome measures included knee stiffness, a stair climb test, the Knee Injury and Osteoarthritis Outcome Score, and safety parameters.
Outcomes were assessed on a biweekly basis.
Modified intention-to-treat (MITT) and perprotocol (PP) analyses were applied.
Results.
A total of 200 patients were enrolled of whom 175 (87.5%) were included in the MITT analysis and 153 (76.5%) in the PP analysis.
The mean change in VAS pain did not differ between the two groups, and the upper limit of the two-sided 95% confidence interval (CI) for comparison between the two groups was within the prespecified margin of 10 mm for noninferiority (MITT analysis: mean difference = 0.86, 95% CI = -4.39 to 6.10, p=0.748; PP analysis: mean difference = 1.98, 95% CI = -3.61 to 7.56, p=0.486).
Significant improvement was observed in all the efficacy parameters in both groups.
Dyspepsia was the most common adverse event: 23 patients in the THF-6 group and 28 in the diclofenac group p=0.417.
Conclusions.
THF-6 offers an alternative to oral diclofenac for the short-term treatment of osteoarthritis of the knee.
It was shown to be noninferior to oral diclofenac in relieving knee pain.
This trial is registered with ChiCTR-IPR-15007213.
American Psychological Association (APA)
Koonrungsesomboon, Nut& Nopnithipat, Saowaros& Teekachunhatean, Supanimit& Chiranthanut, Natthakarn& Sangdee, Chaichan& Chansakaow, Sunee…[et al.]. 2020. Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial. Evidence-Based Complementary and Alternative Medicine،Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1158001
Modern Language Association (MLA)
Koonrungsesomboon, Nut…[et al.]. Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial. Evidence-Based Complementary and Alternative Medicine No. 2020 (2020), pp.1-9.
https://search.emarefa.net/detail/BIM-1158001
American Medical Association (AMA)
Koonrungsesomboon, Nut& Nopnithipat, Saowaros& Teekachunhatean, Supanimit& Chiranthanut, Natthakarn& Sangdee, Chaichan& Chansakaow, Sunee…[et al.]. Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial. Evidence-Based Complementary and Alternative Medicine. 2020. Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1158001
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1158001