Colchicine lack of effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): a randomized controlled trial
作者： Y.Y. Leung , B. Haaland , J.L. Huebner , S.B.S. Wong , M. Tjai
DOI: 10.1016/J.JOCA.2018.01.026
关键词:
摘要: Summary Objectives Uric acid may activate an innate immune response in osteoarthritis (OA), contributing to disease pathology and progression. We evaluated the effectiveness of colchicine on pain function symptomatic knee OA (KOA) underlying mechanism action. Methods Colchicine symptoms inflammation modification (COLKOA) was a double-blind, placebo-controlled, randomized trial comparing 16 weeks treatment with 0.5 mg twice-daily oral placebo for (KOA). The primary endpoint ≥30% improvement total Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) score at week 16. Secondary endpoints included (0–10 Likert scales); WOMAC pain; patient global assessment (0–100); physical function; OARSI-OMERACT response; quality life; change serum, urine, synovial fluid (SF) biomarkers cartilage metabolism inflammation, plasma/SF concentrations. Results Of 109 randomly assigned participants, 39% (95% confidence interval (CI) 27–52%) 49% CI 36–62%) arms respectively met study end ( P = 0.284, odds ratio 0.66, 95% 0.31–1.41). No strong evidence differences identified clinical secondary endpoints. Treatment significantly reduced mean serum hs-CRP = 0.008) SF CTXI = 0.002); tended reduce inflammatory markers (SF IL-6, IL8, TNFα, CD14 IL-18), but these were not statistically significant. Conclusion (0.5 mg orally) high bone turnover known be associated severity progression risk, did KOA over 16-week period. A longer-term evaluate slow-acting modifying effects is warranted. Trial registration has been registered clinicaltrials.gov as NCT02176460. Date registration: June 26, 2014.
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