Yuenyongviwat Varah, Anusitviwat Chirathit, Tuntarattanapong Pakjai, Hongnaparak Theerawit, Iamthanaporn Khanin
Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Hat Yai, 90110, Songkhla, Thailand.
Sci Rep. 2025 Sep 2;15(1):32313. doi: 10.1038/s41598-025-17505-0.
Collagen supplements have gained significant market popularity, with numerous products claiming to improve knee osteoarthritis symptoms. Previous clinical studies have primarily evaluated individual collagen formulations, with most being industry-sponsored, which raises potential bias concerns. This study aimed to evaluate the efficacy of combined undenatured type II collagen (UC-II) and hydrolysed collagen supplementation in patients with knee osteoarthritis. In this randomised, double-blind, placebo-controlled trial, 68 patients with knee osteoarthritis were divided into two groups: one receiving collagen supplements (tablets containing hydrolysed collagen and UC-II) and the other receiving a placebo. Clinical outcomes, including pain intensity (Verbal Numerical Rating Scale), functional outcomes (Knee Injury and Osteoarthritis Outcome Score [KOOS]), rescue medication consumption, and patient satisfaction, were assessed at baseline, 2, 6, and 12 weeks. Baseline demographic characteristics were comparable between the collagen and placebo groups. Both groups showed significant improvements in pain intensity (p < 0.001) and KOOS scores over time. However, no significant differences were observed between the groups in terms of pain intensity, functional outcomes, rescue medication consumption, or patient satisfaction (p > 0.05). No adverse effects were reported in either group. Combined UC-II and hydrolysed collagen supplementation over 12 weeks did not demonstrate superior efficacy compared with that of the placebo in managing knee osteoarthritis symptoms. Further research is required to explore the potential long-term benefits of combined collagen supplementation.Clinical Trial Registration: ClinicalTrials.gov (NCT06229951): registered on January 16, 2024.
胶原蛋白补充剂在市场上颇受欢迎，众多产品宣称可改善膝关节骨关节炎症状。以往的临床研究主要评估单一的胶原蛋白配方，且大多数研究由行业资助，这引发了对潜在偏倚的担忧。本研究旨在评估联合使用未变性II型胶原蛋白（UC-II）和水解胶原蛋白补充剂对膝关节骨关节炎患者的疗效。在这项随机、双盲、安慰剂对照试验中，68例膝关节骨关节炎患者被分为两组：一组接受胶原蛋白补充剂（含水解胶原蛋白和UC-II的片剂），另一组接受安慰剂。在基线、第2周、第6周和第12周评估临床结局，包括疼痛强度（语言数字评定量表）、功能结局（膝关节损伤和骨关节炎结局评分[KOOS]）、急救药物使用情况和患者满意度。胶原蛋白组和安慰剂组的基线人口统计学特征具有可比性。两组患者的疼痛强度（p < 0.001）和KOOS评分随时间均有显著改善。然而，两组在疼痛强度、功能结局、急救药物使用情况或患者满意度方面未观察到显著差异（p > 0.05）。两组均未报告不良反应。在管理膝关节骨关节炎症状方面，联合使用UC-II和水解胶原蛋白补充剂12周并未显示出优于安慰剂的疗效。需要进一步研究来探索联合补充胶原蛋白的潜在长期益处。临床试验注册：ClinicalTrials.gov（NCT06229951）：于2024年1月16日注册。
