Institute of Medicine, China Medical University, Taichung.
Department of Orthopaedics, China Medical University Hospital, Taichung.
Medicine (Baltimore). 2021 Feb 5;100(5):e24252. doi: 10.1097/MD.0000000000024252.
BACKGROUND: The popularity of dietary supplements for knee osteoarthritis (OA) management is on the rise; however, their effects are still debated. 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.
背景：膳食补充剂在膝骨关节炎（OA）管理中的应用日益普及，但它们的效果仍存在争议。
方法：本研究旨在调查口服低分子液态透明质酸补充剂对台湾地区轻度膝关节疼痛（视觉模拟评分[VAS]≤3）的膝骨关节炎患者的治疗效果。这是一项随机、双盲、安慰剂对照研究。47 名受试者入组并随机分配至 A+HA 组或安慰剂组。受试者需在 8 周的研究期间每天饮用 20 毫升 A+HA 或安慰剂。采用 Western Ontario and McMaster Universities Osteoarthritis Index（WOMAC）和 36-Item Short Form Survey（SF-36）评估疗效。
结果：第 8 周时，A+HA 组 WOMAC 疼痛评分（-2.6±1.68，P<0.0001）、僵硬评分（-1.2±1.50，P=0.007）、躯体功能评分（-5.8±4.39，P<0.0001）和总分（-9.4±5.82，P<0.0001）均较基线显著降低，但安慰剂组无明显变化。组间 WOMAC 评分在第 8 周的变化有显著差异（P<0.01）。第 8 周时，A+HA 组在 SF-36 躯体功能（2.7±3.10，P=0.001）和躯体疼痛（0.7±1.50，P<0.05）领域也有显著改善。尽管 A+HA 组 SF-36 总分增加幅度高于安慰剂组，但差异无统计学意义（2.1±12.75 与 0.3±19.66，P=0.12）。
结论：口服低分子液态 HA 对 VAS 评分≤3 的轻中度膝骨关节炎患者缓解膝关节疼痛症状，特别是疼痛和躯体功能，似乎是有效的。
临床试验注册号：NCT04352322。
Mediterr J Rheumatol. 2024-12-31
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