Abstract
Background Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed for the treatment of symptomatic osteoarthritis (OA) of the knee. However, searching for alternatives such as locally available medicinal herbs to manage OA knee pain remains of clinical value. The objective of the present study was to evaluate the efficacy and safety of two yellow oil formulations in patients with OA of the knee. Methods This prospective, randomized, single-blind, active-controlled, noninferiority study enrolled 102 patients with OA of the knee. Eligible patients were randomly assigned to apply either yellow oil formulation 3 (YOF3), yellow oil formulation 4 (YOF4), or indomethacin solution (INDO) topically four times daily for four weeks. Outcomes were assessed on a biweekly basis. The primary efficacy outcome measure was a 100 mm visual analog scale (VAS) of pain, while secondary endpoints included knee function, physical performance assessments, and safety parameters. Modified intention-to-treat and per-protocol analyses were applied. Assessment of noninferiority was done with a prespecified margin of 10 mm for VAS pain. Results Of 102 patients enrolled, 86 completed the study: 29/34 in the YOF3 group, 25/34 in the YOF4 group, and 32/34 in the INDO group. The absolute reduction in VAS pain at the final evaluation was −25.06 ± 13.91, −18.50 ± 16.06, and −23.38 ± 10.05 mm in the YOF3, YOF4, and INDO groups, respectively (p=0.169). Only YOF3 was found to be noninferior to INDO. Other efficacy outcomes were significantly improved in all three groups. All the interventions were well tolerated; no skin rash was observed in any of the three groups. Conclusions YOF3 was shown to be noninferior to INDO in relieving knee pain and should be considered an alternative for the treatment of symptomatic OA of the knee. Further research into the mechanism of action of YOF3 and its long-term efficacy and safety is required.
Highlights
Osteoarthritis (OA) is a chronic degenerative disease characterized by a progressive loss of articular cartilage [1]
We aimed to evaluate the efficacy and safety of two yellow oil formulations–yellow oil formulation 4 (YOF4), which is a formulation included in the ai National List of Essential Medicines, and its modified formulation, that is, yellow oil formulation 3 (YOF3) in patients with OA of the knee by means of a randomized controlled trial
Six patients prematurely withdrew from the study: four in the YOF4 group during weeks 0–2, one in the YOF4 group during weeks 2–4, one in the YOF3 group during weeks 2–4, and none in the indomethacin solution (INDO) group
Summary
Osteoarthritis (OA) is a chronic degenerative disease characterized by a progressive loss of articular cartilage [1]. OA may occur in any joint but most commonly affects the knee, causing pain and functional disability [2]. E objective of the present study was to evaluate the efficacy and safety of two yellow oil formulations in patients with OA of the knee. E primary efficacy outcome measure was a 100 mm visual analog scale (VAS) of pain, while secondary endpoints included knee function, physical performance assessments, and safety parameters. E absolute reduction in VAS pain at the final evaluation was −25.06 ± 13.91, −18.50 ± 16.06, and −23.38 ± 10.05 mm in the YOF3, YOF4, and INDO groups, respectively (p 0.169). YOF3 was shown to be noninferior to INDO in relieving knee pain and should be considered an alternative for the treatment of symptomatic OA of the knee. Further research into the mechanism of action of YOF3 and its long-term efficacy and safety is required
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