Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial. (9th December 2020)

• Record Type: Journal Article
• Authors: Koonrungsesomboon, Nut; Nopnithipat, Saowaros; Teekachunhatean, Supanimit; Chiranthanut, Natthakarn; Sangdee, Chaichan; Chansakaow, Sunee; Tipduangta, Pramote; Hanprasertpong, Nutthiya
• Other Names: Shabbir Arham Academic Editor.
• Is Part Of: Evidence-based complementary and alternative medicine. Volume 2020(2020)
• Publication Date: 2020-12-09
• Subjects: Alternative medicine -- Periodicals; 615.505
• DOI: 10.1155/2020/8817374
• Languages: English
• ISSNs: 1741-427X

Abstract

Abstract : 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 .