METHODS: This study aimed to investigate the effect of an oral low molecular weight liquid hyaluronic acid supplement in the treatment of knee OA patients with mild knee pain (visual analogue scale [VAS] ≤ 3) in Taiwan population. This was a randomized, double-blind, placebo-controlled study. Forty-seven subjects were enrolled and randomly allocated to either the A+HA or the placebo groups. The subjects were required to drink a bottle contained 20 mL of A+HA or placebo daily throughout an 8-week study period. The efficacy was assessed by using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the 36-item Short Form Survey (SF-36).
RESULTS: At Week 8, significant reductions from baseline in the WOMAC pain (-2.6 ± 1.68, P < .0001), stiffness (-1.2 ± 1.50, P = .007), physical function (-5.8 ± 4.39, P < .0001), and total (-9.4 ± 5.82, P < .0001) scores were observed in the A+HA group but not in the placebo group. Significant differences in the mean change of WOMAC scores from baseline at Week 8 between groups were detected (P < .01). At Week 8, the A+HA group also showed significant improvements in SF-36 physical functioning (2.7 ± 3.10, P = .001) and bodily pain (0.7 ± 1.50, P < .05) domains. Although the A+HA group had a higher increase in the SF-36 total score than the placebo group but the difference was not statistically significant (2.1 ± 12.75 vs 0.3 ± 19.66, P = .12).
CONCLUSIONS: Oral administration of low molecular weight liquid HA appeared to be effective for knee OA patients with mild knee pain (VAS ≤ 3) in the relief of knee OA symptoms, particularly in pain and physical function.Clinical Trial Registration: NCT04352322.
方法:本研究旨在探讨口服低分子量液体透明质酸补充剂治疗台湾人群轻度膝关节疼痛(视觉模拟评分[VAS]≤3)的膝关节OA患者的疗效。这是一个随机的,双盲,安慰剂对照研究。纳入47名受试者并随机分配到A+HA或安慰剂组。在整个8周的研究期间,要求受试者每天饮用含有20mL的A+HA或安慰剂的瓶子。通过使用西安大略省和麦克马斯特大学骨关节炎指数(WOMAC)和36项简短形式调查(SF-36)评估疗效。
结果:在第8周时,WOMAC疼痛从基线显着降低(-2.6±1.68,P<0.0001),刚度(-1.2±1.50,P=.007),物理功能(-5.8±4.39,P<0.0001),在A+HA组中观察到总分(-9.4±5.82,P<0.0001),但在安慰剂组中没有。在第8周,检测到组间WOMAC评分从基线的平均变化的显著差异(P<0.01)。在第8周,A+HA组还显示SF-36身体功能(2.7±3.10,P=.001)和身体疼痛(0.7±1.50,P<.05)域的显著改善。虽然A+HA组SF-36总分的增加高于安慰剂组,但差异无统计学意义(2.1±12.75vs0.3±19.66,P=.12)。
结论:口服低分子量液体HA似乎对具有轻度膝关节疼痛(VAS≤3)的膝关节OA患者有效缓解膝关节OA症状,特别是在疼痛和身体机能方面。临床试验注册:NCT04352322。