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RCT · 2000 · n=394
Not supportedcounts toward this tierA 5-year randomized controlled, double-blind study of glycosaminoglycan polysulphuric acid complex (Rumalon) as a structure modifying therapy in osteoarthritis of the hip and knee
Pavelká K, Gatterová J, Gollerova V, Urbanová Z, Sedlácková M, Altman RD · Osteoarthritis and Cartilage
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Knee joint space narrowed 0.37 ± 0.08 mm on the extract versus 0.42 ± 0.08 mm on placebo (P = 0.68); hip 0.21 ± 0.08 versus 0.22 ± 0.08 mm (P = 0.53). Lequesne index, pain on passive motion and NSAID use did not differ. Adverse effects were 14.5% versus 15%.
- Population
- 277 patients with knee osteoarthritis and 117 with hip osteoarthritis
- Intervention
- Rumalon, an aqueous extract of bovine cartilage and bone marrow, 2 ml intramuscularly — ten 15-injection courses over five years
- Comparator
- Placebo injections on the same schedule
- Limitations
- A different product from Sigumir — injected rather than oral — so it bounds the class, not the capsule. Radiographic joint-space progression was slower than expected in both arms, which lowers the power to detect a difference. Written from the structured abstract, which reports both arms with means, SDs and P values; publisher full text is paywalled.
Cited by
1 entry references this study
- SigumirANECD.
Peptides → Bioregulators · key study