Effect of chondroitin sulfate on soluble biomarkers of osteoarthritis: a method to analyze and interpret the results from an open-label trial in unilateral knee osteoarthritis patients

Abstract

BackgroundThe aim of this study was to investigate the effects of chondroitin sulfate (CS) on the serum levels of Coll2-1 in patients with knee OA.MethodsSeventy two patients with unilateral symptomatic knee OA were involved in a post-authorization open-label study evaluating CS (800 mg/day). The primary outcome was the % relative change in serum Coll2-1 (sColl2-1). The secondary outcomes were the evaluation of pain (VAS) and function (Lequesne’s Index). Responders and non-responders were classified according to OMERACT-OARSI recommendations. Finally, an original cut-off method was applied to categorize patients and interpret individual variations in serum levels of Coll2-1.ResultsPatients showed no difference in the sColl2-1 levels at baseline. When considering responders and non-responders from the ITT population, a significant difference was found for Coll2-1 at 3 months (p = 0.030) and 6 months (p = 0.038). A decrease in pain (VAS) and an improvement in function (LI) were recorded throughout the visits (p < 0.01). Considering an intra-batch cut-off of 21 %, CS decreased Coll2-1 serum levels between baseline and 1-month visit compared to the value of Coll2-1 before treatment (screening visit) which can be interpreted as a drastic reduction of the proportion of patients with an increase of Coll2-1 over 21 % (reduction from 13 to 3 %). It also consisted in a more important proportion of patients with a decrease in Coll2-1 (from 5 to 10 %).ConclusionThis study proposes a new approach for the analysis and the interpretation of the individual variation in biomarker levels and introduces the notion of metabolic responders.Trial registrationID ISRCTN63795830. The trial was retrospectively registered on 2 October, 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-016-1268-4) contains supplementary material, which is available to authorized users.

Molecular Effects of Chondroitin Sulfate in Osteoarthritis and Herniated Discs

“…A number of clinical trials performed with CS-BIOACTIVE© substance-based medicines have been conducted [64][65][66]. It has been demonstrated that the efficacy of the treatment with oral administration of CS (1200 mg/day, orally, 24 months) in patients with OA of knee joints was comparable to that of nonsteroidal anti-inflammatory celecoxib (200 mg/day, n = 62).…”

“…It has been demonstrated that the efficacy of the treatment with oral administration of CS (1200 mg/day, orally, 24 months) in patients with OA of knee joints was comparable to that of nonsteroidal anti-inflammatory celecoxib (200 mg/day, n = 62). The action of CS-BIOACTIVE© was associated with a decrease in the activity of MMP1 and MMP3 [64], and with reduced levels of biomarkers of inflammation (soluble collagen type 2, Coll2-1) in blood serum [65]. In addition, the use of CS-BIOACTIVE© is promising to treat various inflammatory processes that are comorbid with diseases accompanied by damage to the cartilaginous tissue [67][68][69][70][71].…”

Molecular effects of chondroguard in osteoarthritis and herniated discs

“…(Испания) [64][65][66]. Показано, что при приеме внутрь (1200 мг/сут, внутрь, 24 мес) эффективность лечения паци-ентов с ОА коленных суставов была сравнимой с таковой при использовании нестероидного противовоспалительно-го препарата целекоксиба (200 мг/сут, n=62).…”

“…Действие суб-станции CS-BIOACTIVE©Биоиберика С.А.У. (Испания) со-провождалось снижением активности ММП1 и ММП3 [64], уровня биомаркера воспаления (растворимого коллагена 2-го типа, Coll2-1) в сыворотке крови [65]. Кроме того, показана перспективность применения субстанции CS-BIOACTIVE© Биоиберика С.А.У.…”

New possibilities of treatment of low back pain

“…Одно из клинических исследований [39] было посвящено изучению влияния приема ХС на течение ОА. В исследование были включены 72 больных с односторонним ОА коленного сустава, которые на протяжении 6 мес ежедневно получали по 800 мг ХС.…”