Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial

الملخص 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.