A 12-week randomized, double-blind, placebo-controlled multicenter study of choline-stabilized orthosilicic acid in patients with symptomatic knee osteoarthritis

Abstract

BackgroundThe aim of this study was to assess the efficacy of choline-stabilized orthosilicic acid (ch-OSA) in patients with symptomatic knee osteoarthritis (OA).MethodsIn 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.ResultsA 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.ConclusionAfter 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 registrationThe study was registered retrospectively: ISRCTN88583133. Registration date: 2015-10-07.Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-016-1370-7) contains supplementary material, which is available to authorized users.

Correlations among plasma silicon, magnesium and calcium in patients with knee osteoarthritis – analysis in consideration of gender

“…According to the authors, such results might be connected with the fact that the female subjects were mostly postmenopausal, and the serum baseline estradiol in this group was much lower than in males. This made the 12-week treatment too short and consequently ineffective [31]. Such conclusions are consistent with the results reported by Macdonald et al who stated that silicon influence on bone condition was affected by oestrogen status.…”

“…Moreover, the associations between silicon metabolism and female hormones have been investigated and relationships of Si bone metabolism with oestrogen status revealed [25,29]; however, other authors did not find any correlations of its absorption and excretion with oestradiol [30]. Additionally, the differences between the male and female studied groups regarding the beneficial influence of silicon preparation treatment in knee OA patients have been reported [31]. Some interactions between silicon and other elements have also been observed [32,33].…”

Effects of Artesunate on the Expressions of Insulin-Like Growth Factor-1, Osteopontin and C-Telopeptides of Type II Collagen in a Rat Model of Osteoarthritis

“…Some papers have shown a significant correlation between radiographic progression of OA and CTX-II concentration [33]. It has been reported to be the best performing biochemical markers for OA [34]. This study revealed that the change of serum IGF-1, OPN, and CTX-II was consistent with those in SF.…”

Effectiveness of Kinesio Taping in the Management of Knee Osteoarthritis

“…Persons with OA is limited their physical activities due to this disease and their quality of life is also declined [21]. Disease modifying agents for OA is not available, treatment strategies are directed to relieve symptoms that are correlated to this disease [4]. In this study, there were three patients who reported the mild adverse effect of KT (mild itchy) but received complete intervention without requiring medical treatment.…”

“…Treatment for the course of condition of OA has not available yet. Therefore, treatment approaches are focused on relieving symptoms of disease [4]. Current OA knee treatment strategies include pharmacologic, nonpharmacologic and surgical managements [2].…”