Primary studies included in this systematic review

loading
3 articles (3 References) loading Revert Studify

Primary study

Unclassified

Long-term effects of chondroitins 4 and 6 sulfate on knee osteoarthritis: The study on osteoarthritis progression prevention, a two-year, randomized, double-blind, placebo-controlled trial

blocked
Journal Arthritis and rheumatism
Year 2009
Links Pubmed DOI

This article is included in 10 Systematic reviews Systematic reviews (10 references) 2 Broad syntheses Broad syntheses (2 references)

Loading references information
Objective. To assess the long-term effects of chondroitins 4 and 6 sulfate (CS) on the radiographic progression of, and symptom changes associated with, knee osteoarthritis (OA). Methods. We performed an international, randomized, double-blind, placebo-controlled trial in which 622 patients with knee OA were randomly assigned to receive either 800 mg CS (n = 309 patients) or placebo (n = 313 patients) once daily for 2 years. Radiographs of the target knee, using the Lyon schuss view, were obtained at the time of enrollment and at 12, 18, and 24 months. The minimum joint space width (JSW) of the medial compartment of the tibiofemoral joint was assessed by digital image analysis. The primary outcome was the loss in minimum JSW over 2 years. Results. The intent-to-treat analysis demonstrated a significant reduction (P < 0.0001) in minimum JSW loss in the CS group (mean ± SEM -0.07 ± 0.03 mm) as compared with the placebo group (-0.31 ± 0.04 mm). The percentage of patients with radiographic progression ≥0.25 mm was significantly reduced in the CS group compared with the placebo group (28% versus 41% [P < 0.0005]; relative risk reduction 33% [95% confidence interval 16-46%]). The number of patients needed to treat was 8 (95% confidence interval 5-17). Pain improved significantly faster in the CS group than in the placebo group (P < 0.01). There were no differences in safety between groups. Conclusion. The long-term combined structure-modifying and symptom-modifying effects of CS suggest that it could be a disease-modifying agent in patients with knee OA. © 2009, American College of Rheumatology.

Primary study

Unclassified

Impact of chondroitin sulphate on health utility in patients with knee osteoarthritis: Towards economic analysis

Journal Journal of medical economics
Year 2009
Links Pubmed Health Technology Assessment (HTA) DOI crd.york.ac.uk

This article is included in 1 Broad synthesis Broad syntheses (1 reference)

Loading references information
Abstract Objectives: The first objective was to assess the effect of the chondroitin 4 and 6 sulphate (CS) on health-related quality of life using utility values in patients with knee osteoarthritis (OA) during a 24-month treatment course. The second objective was, using these data, to conduct economic analyses. Methods: Data from the STOPP study was used. This study was a randomised, double-blind, placebo (PL) -controlled trial of 2-year duration. In the STOPP study, authors assessed quality of life using the Western Ontario and McMaster Osteoarthritis Index (WOMAC). WOMAC scores were translated into Health Utility Index (HUI) scores using a specific formula. Incremental cost effectiveness ratio (ICER) was calculated taking into account the cost of CS and its effect on HUI scores, compared to PL. Results: At baseline, the mean (SD) HUI scores were 0.59 (0.17), and 0.59 (0.18) for the PL and CS groups, respectively (p=0.31 between the two groups). The mean (SD) HUI scores changes from baseline to 6 months were 0.02 (0.02), and 0.05 (0.01) for the PL and CS groups, respectively (p=0.03). After 24 months of follow-up, HUI score increases by 0.04 (0.02) in the PL group and by 0.05 (0.02) in the CS group (p=0.37). Using the price bracket of CS in Europe, ICER assessment always resulted in a cost below €30,000 per QALY gained, after 6, 12 and 24 months of treatment. Conclusion: CS treatment increases health utilities in patients with knee OA compared to PL over the first 6 months of treatment. Economic evaluation based on these data suggests that CS treatment could be considered as cost-effective in patients with knee OA up to a period of 24 months. A limitation in this study is the absence of direct utility assessment as well as the absence of effective treatment as comparator. © 2009 Informa UK Ltd.

Primary study

Unclassified

A two-year prospective, randomized, double-blind, controlled study assessing the effect of chondroitin 4&6 sulfate (CS) on the structural progression of knee osteoarthritis: STOPP (STudy on osteoarthritis progression prevention)

blocked
Conference 2006 annual scientific meeting of the American College of Rheumatology (Published in: Arthritis Rheum. 2006 Nov 10;54(Suppl):93)
Year 2006

This article is included in 1 Systematic review Systematic reviews (1 reference) 1 Broad synthesis Broad syntheses (1 reference)

Loading references information
PURPOSE: STOPP was designed to evaluate the structure and modifying properties of CS in patients with knee OA by using a highly performing radiographic method (Lyon schuss view). METHODS: STOPP is a prospective, multicentre, randomized, parallel groups, double blind, study comparing orally administered chondroitin 4&6 sulfate, 800 mg and placebo over 24 months in patients with knee OA. 600 patients, from both genders, aged 45-80 years with tibio-femoral knee osteoarthritis (pain and radiological signs) were recruited in Europe and North America. A minimal level of pain of 30 mm (VAS) was requested for inclusion. Signal joint was defined as the knee with the most severe joint space narrowing (X-rays). The primary efficacy outcome was the minimal joint space narrowing (JSN) measured over two years, on digitalised X-rays (Lyon schuss view). Secondary efficacy outcomes included pain (VAS, WOMAC, intake of analgesics and NSAIDs). The digitalised X-rays were analysed blindly with respect to treatment and time, at the end of the study, and validated by an automated image analysis (E.V.). RESULTS: A total of 622 patients (CS=309; placebo=313) meeting the inclusion criteria were enrolled between the years 2000 and 2002. The study groups were balanced at baseline with respect to demographic and clinical variables, including severity of OA of the signal joint. Ninety-three patients (30.1%) of the CS group and 80 patients (25.6%) of the placebo group dropped out with no significant differences between groups regarding the reasons. Good compliance (> 80 %) was shown in both groups. In the intention-to-treat analysis, patients from the placebo group had a mean (SE) JSN of 0.24 ± 0.03 mm after 2 years, which was significantly prevented in the group treated with CS (0.10 ± 0.03 mm) (p<0.01). The per protocol analysis confirmed the results obtained in the ITT analysis. The interaction time x treatment showed a statistically significant difference in pain VAS and WOMAC (p<0.01) in favour of CS. CONCLUSIONS: Chondroitin 4&6 sulfate (CS) is able to significantly reduce the progression of joint space narrowing in patients with knee osteoarthritis compared to placebo. This structure-modifying effect is complemented by a significant difference in the clinical evolution of the disease.