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.
Highlights
Osteoarthritis is the most common form of arthritis, commonly affecting knee joints and causing pain, functional disability, and reduced quality of life [1, 2]
There was only one serious adverse event, hospitalization due to pesticide exposure, which was judged as definitely unrelated to the study drug. In this randomized-controlled trial, THF-6 offered the potential to achieve analgesic efficacy with acceptable safety profiles in patients with moderate-to-severe osteoarthritis of the knee. In both the Modified intention-to-treat (MITT) and PP analyses, the upper limit of 95% confidence interval (CI) of mean difference (MD) in visual analog scale (VAS) pain was within the predefined noninferiority margin of 10 mm. is allowed us to conclude that THF-6 was noninferior to oral diclofenac (75 mg/day) in terms of knee pain relief
Most randomized-controlled trials evaluating the effects of pharmacological interventions, especially oral Nonsteroidal anti-inflammatory drugs (NSAIDs), often last only a few weeks with only a small number of trials going beyond four weeks of treatment [26]. erefore, the present trial design, with a treatment duration of four weeks, can be considered appropriate for determining the effects of THF-6 in symptomatic osteoarthritis of the knee
Summary
Osteoarthritis is the most common form of arthritis, commonly affecting knee joints and causing pain, functional disability, and reduced quality of life [1, 2]. E efficacy of oral NSAIDs, diclofenac in particular, for symptomatic relief of knee osteoarthritis has been well established in the literature [9]. Anks to their good analgesic and antiphlogistic effects, NSAIDs are recommended by several international and national guidelines as the initial oral medication of choice in the treatment of symptomatic osteoarthritis of the knee with moderate-to-severe pain intensity [10, 11]. Is study aimed to evaluate the efficacy and safety of ai herbal formulation-6 (THF-6) in comparison with oral diclofenac in patients with moderate-to-severe osteoarthritis of the knee. Is 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. It was shown to be noninferior to oral diclofenac in relieving knee pain. is trial is registered with ChiCTR-IPR-15007213
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