『퇴행성 관절염에 대한 HT008과 글루코사민의 유효성 및 안전성을 비교평가하기 위한 무작위 배정, 이중맹검 임상연구 = Efficacy and safety of HT008 and glucosamine sulfate in the treatment of knee osteoarthritis: a randomized double-blind trial

다국어 초록 (Multilingual Abstract)

The purpose of this study was to evaluate the efficacy of HT008 on pain relief and functional improvement in participants with mild knee osteoarthritis (OA) in comparison with that of glucosamine sulfate. Methods : This randomized double-blind trial was conducted at Kyung Hee University Medical Center in Seoul where participants with knee pain for more than 6 months and degenerative osteoarthritis were enrolled. The 100 participants were received either HT008 or glucosamine sulfate 750 mg twice daily for 8 weeks and evaluated at baseline, 4 and 8 weeks after the treatment. We primarily evaluated the differences between two groups with respect to changes in the visual analogue score (VAS) for pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 8. Secondarily the difference between and within two groups with respect to changes in WOMAC stiffness and physical function score, and Lequesne Functional Severity Index (LFI) were also evaluated. Results : At week 8, treatment with HT008 resulted in a significant reduction of the VAS for pain and WOMAC pain scores compared to the glucosamine sulfate (both p=0.003). Patients receiving HT008 experienced statistically significantly greater improvements in WOMAC physical function scores and LFI (p.=.0.014 and p=0.016, respectively) than glucosamine sulfate-treated group. The within-group change in WOMAC physical function and stiffness, and LFI during the 8-week intervention revealed significant improvements in HT008-treated group. Conclusions : HT008 treatment allows significant pain reduction and functional improvement compared with glucosamine sulfate. These data confirm HT008 as an effective and safe symptomatic drug for knee OA.

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