BACKGROUND: The aim of this study was to assess the efficacy of choline-stabilized orthosilicic acid (ch-OSA) in patients with symptomatic knee osteoarthritis (OA). METHODS: In a multicenter, double-blind, placebo-controlled study, 211 patients with knee OA (Kellgren and Lawrence grade II or III) and moderate to moderately severe pain were randomly allocated to ch-OSA or placebo for 12 weeks. The primary outcome was the change in the WOMAC pain subscale from baseline to week 12. Secondary outcomes were changes from baseline to week 12 in WOMAC total, WOMAC stiffness, WOMAC physical function, Subject Global Assessment and levels of cartilage degradation biomarkers C-terminal telopeptide of collagen type II (CTX-II) and cartilage oligomeric matrix protein (COMP). Pre-specified subgroup analyses included the effect of gender. RESULTS: A total of 166 (120 women, 46 men) patients were included in the analysis (87 and 79 in the ch-OSA and placebo group, respectively). In the total study population, no differences were observed between the two treatment groups for the different outcomes but significant treatment x gender interactions were found. In men taking ch-OSA, a significant improvement in WOMAC total, WOMAC stiffness and WOMAC physical function as well as a lower increase in biomarker levels of cartilage degradation was observed, but not in women. The change in WOMAC pain showed a similar positive trend in men taking ch-OSA. CONCLUSION: After 12 weeks of treatment, no effect was found of ch-OSA in the total study population on clinical parameters and biomarkers, but a gender interaction was observed. In men, ch-OSA was found effective in reducing symptoms of knee OA, which was associated with a slight but significant reduction of biomarkers that are related to cartilage degradation. TRIAL REGISTRATION: The study was registered retrospectively: ISRCTN88583133 . Registration date: 2015-10-07.
- MeSH
- aplikace orální MeSH
- artróza kolenních kloubů farmakoterapie MeSH
- biologické markery analýza MeSH
- cholin aplikace a dávkování terapeutické užití MeSH
- chrupavka patologie MeSH
- chrupavkový oligomerní matrixový protein analýza MeSH
- dvojitá slepá metoda MeSH
- kolagen typ II analýza MeSH
- kyselina křemičitá aplikace a dávkování terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- management bolesti metody MeSH
- měření bolesti MeSH
- senioři MeSH
- sexuální faktory MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
Hearing function in the Fischer 344 (F344) albino inbred strain of rats deteriorates with aging faster than in other strains, in spite of the small hair cell loss in old F344 animals [Popelar, J., Groh, D., Pelanova, J., Canlon, B., Syka, J., 2005. Age-related changes in cochlear and brainstem auditory function. Neurobiol. Aging, in press.]. This study was aimed at elucidating the structural changes in the inner ear of this rat strain during aging. Cochlear histopathology was examined in 20-24-month-old F344 rats and compared with that of young F344 rats (4 months) and of old rats of the Long-Evans (LE) strain. Hematoxylin/eosin staining in aged F344 rats showed degenerative changes in the organ of Corti, consisting of a damaged layer of marginal cells, reduced vascularization of the stria vascularis and a distorted tectorial membrane detached from the organ of Corti. Age-related changes in collagen distribution were observed with Masson's trichrome staining in the spiral ligament of old F344 rats. The results of immunohistochemical staining for type II collagen revealed a marked decrease in collagen fibers in the area connecting the spiral ligament and stria vascularis and a decrease in area IV fibrocytes in old F344 but not in LE rats. These findings may contribute to an explanation of the substantial hearing loss found in old F344 rats.
- MeSH
- azosloučeniny analýza MeSH
- barvicí látky analýza MeSH
- Cortiho orgán chemie MeSH
- eosin analýza MeSH
- fluorescenční barviva analýza MeSH
- hematoxylin analýza MeSH
- imunohistochemie metody MeSH
- kochlea * fyziologie chemie MeSH
- kolagen typ II analýza MeSH
- kolagen * analýza MeSH
- krysa rodu rattus MeSH
- membrana tectoria chemie MeSH
- methylová zeleň analýza MeSH
- potkani inbrední F344 MeSH
- stárnutí * fyziologie MeSH
- stria vascularis chemie MeSH
- zvířata MeSH
- Check Tag
- krysa rodu rattus MeSH
- zvířata MeSH
- Publikační typ
- práce podpořená grantem MeSH