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Efficacy and safety of SKCPT in patients with knee osteoarthritis: A multicenter, randomized, double-blinded, active-controlled phase III clinical trial

Authors
 Sung Ii Bin  ;  Myung Chul Lee  ;  Seung-Baik Kang  ;  Young-Wan Moon  ;  Kyoung Ho Yoon  ;  Seung-Beom Han  ;  Yong In  ;  Chong Bum Chang  ;  Ki-Cheor Bae  ;  Jae-Ang Sim  ;  Jong-Keun Seon  ;  Kwan Kyu Park  ;  Sang Jin Lee  ;  Young-Mo Kim 
Citation
 JOURNAL OF ETHNOPHARMACOLOGY, Vol.337(Pt 2) : 118843, 2025-01 
Journal Title
JOURNAL OF ETHNOPHARMACOLOGY
ISSN
 0378-8741 
Issue Date
2025-01
MeSH
Adult ; Aged ; Anti-Inflammatory Agents, Non-Steroidal / adverse effects ; Anti-Inflammatory Agents, Non-Steroidal / therapeutic use ; Celecoxib / adverse effects ; Celecoxib / therapeutic use ; Clematis / chemistry ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Osteoarthritis, Knee* / drug therapy ; Pain Measurement / drug effects ; Plant Extracts* / administration & dosage ; Plant Extracts* / adverse effects ; Plant Extracts* / pharmacology ; Plant Extracts* / therapeutic use ; Treatment Outcome
Keywords
Celecoxib ; Elderly ; Knee osteoarthritis ; Pain ; SKCPT ; Treatment
Abstract
Ethnopharmacological relevance: Osteoarthritis (OA) is the most prevalent type of arthritis worldwide and a leading cause of years lost to pain and disability. Among the current pharmacological treatments for OA, symptomatic slow-acting drugs for OA (SYSADOA) induce pain relief and aim to improve joint function by relieving inflammation while causing fewer gastrointestinal and cardiovascular adverse events than non-steroidal anti-inflammatory drugs (NSAIDs). SKCPT is a herbal SYSADOA formulated from Clematis mandshurica, Trichosanthes kirilowii, and Prunella vulgaris powdered extracts. This preparation has been shown to induce cartilage protection and anti-inflammatory effects in preclinical studies and inhibit glycosaminoglycan degradation and catabolic gene expression in human OA chondrocytes and cartilage.

Aim of the study: We aimed to evaluate the non-inferiority of SKCPT to celecoxib and safety for treating knee OA.

Materials and methods: This multicenter, randomized, double-blind, phase III clinical trial enrolled adults with primary knee OA who were randomized (1:1) to SKCPT 300 mg twice daily or celecoxib 200 mg once daily for 12 weeks.

Results: In total, 278 patients were assigned to treatment (SKCPT, 136; celecoxib, 142) for approximately 12 weeks. The primary endpoint was the mean change of Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC) pain subscale scores from baseline to Day 84. The mean change (least squares [LS] mean ± standard error) from baseline to Day 84 was -23.74 ± 1.48 for SKCPT and -25.88 ± 1.44 for celecoxib. The two-sided 95% confidence interval of the difference (LS mean) between groups was [-1.94, 6.20], confirming that the upper limit was less than the non-inferiority margin of 10. Additionally, there were no significant differences in the secondary endpoints (mean changes of K-WOMAC pain, physical, stiffness subscale, and total score, and the frequency and number of doses of rescue medications) between groups at all time points. Differences between groups in adverse events and adverse drug reactions were not significant, and no serious adverse events occurred.

Conclusions: SKCPT efficacy was non-inferior, and its safety profile was similar, to celecoxib. Building on previous results showing that SYSADOA reduce NSAID intake, the present results suggest that the SYSADOA SKCPT could effectively replace NSAIDs in knee OA treatment while avoiding long-term side effects.
Files in This Item:
T202406604.pdf Download
DOI
10.1016/j.jep.2024.118843
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
Yonsei Authors
Park, Kwan Kyu(박관규) ORCID logo https://orcid.org/0000-0003-0514-3257
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/201518
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