背景:透明质酸(HA),氨基葡萄糖,和硫酸软骨素被广泛用作治疗膝骨关节炎(OA)的膳食补充剂。本研究旨在探讨含HA的膳食液体补充剂混合物的有效性和安全性。氨基葡萄糖,和软骨素在患有中度膝关节疼痛的膝关节OA患者中(视觉模拟评分4-6分)。
方法:这是短期的,随机化,双盲,安慰剂对照研究。受试者被分配给一瓶20毫升的补充混合物(50毫克HA加750毫克葡糖胺加250毫克软骨素,即A+HA)或安慰剂,每天一次,持续8周。结果指标包括膝关节损伤和骨关节炎结果评分,西安大略省和麦克马斯特大学骨关节炎指数,36项简表调查(SF-36),匹兹堡睡眠质量指数中文版,不良事件的发生率在第8周结束时进行评估.在改良的意向治疗人群中进行疗效分析。
结果:在改良意向治疗人群中的80名受试者中,39人接受A+HA,41人接受安慰剂。治疗8周后,在膝关节损伤和骨关节炎结果评分方面,A+HA组未显示出显著的症状疗效和生活质量改善,西安大略省和麦克马斯特大学骨关节炎指数,与安慰剂组相比,SF-36和中国版本的匹兹堡睡眠质量指数。然而,A+HA组大多数SF-36量表评分的平均变化在数值上高于安慰剂组.两组均未报告治疗相关的不良事件。
结论:本研究发现,液体低分子量HA的组合,氨基葡萄糖,而软骨素口服补充剂不能有效改善膝关节OA中度疼痛患者短期使用后的膝关节OA疼痛和症状。然而,由于研究设计的内在局限性,这些结果应谨慎解释.
BACKGROUND: Hyaluronan (HA), glucosamine, and
chondroitin sulfate are widely consumed as dietary supplements for the treatment of knee osteoarthritis (OA). This
study aimed to explore the efficacy and safety of a dietary liquid supplement mixture containing HA, glucosamine, and
chondroitin in patients with knee OA who had moderate knee pain (visual analogue scale of 4-6 points).
METHODS: This was a short-term, randomized, double-blind, placebo-controlled
study. Subjects were allocated to administer either a bottle of 20 mL supplement mixture (50 mg HA plus 750 mg glucosamine plus 250 mg chondroitin, namely A + HA) or placebo once daily for 8 weeks. Outcome measures included the Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, 36-item Short Form Survey (SF-36), Chinese version of Pittsburgh Sleep Quality Index, and incidence of adverse event were evaluated at the end of week 8. Efficacy analyses were conducted in the modified intent-to-treat population.
RESULTS: Of the 80 subjects in the modified intent-to-treat population, 39 received A + HA while 41 received placebo. After 8 weeks of treatment, the A + HA group failed to demonstrate a significant symptomatic efficacy and quality of life improvement in terms of Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, SF-36, and Chinese version of Pittsburgh Sleep Quality Index as compared to the placebo group. However, the mean changes in most of the SF-36 scale scores were numerically higher in the A + HA group than in the placebo group. No treatment-related adverse event was reported in both groups.
CONCLUSIONS: This present
study found that the combination of liquid low molecular weight HA, glucosamine, and chondroitin oral supplement did not effectively improve knee OA pain and symptoms after short-term use in knee OA patients with moderate knee pain. However, these results should be interpreted with caution due to the intrinsic limitation of the study design.