Schneider Heinz, Maheu Emmanuel, Cucherat Michel
HealthEcon AG, Steinentorstrasse 19, CH-4051 Basel, Switzerland.
Open Rheumatol J. 2012;6:183-9. doi: 10.2174/1874312901206010183. Epub 2012 Jul 25.
To perform a meta-analysis of randomized double-blind placebo-controlled clinical trials to assess the efficacy of a specific chondroitin sulfate preparation (Structum®, Laboratoires Pierre Fabre, Castres; France) as a symptom-modifying drug in osteoarthritis (OA) of the knee.
A Medline search was conducted up to October 2010 and two articles reporting two trials were identified; one additional trial was identified through contacting the producer of Structum®. There was no evidence of heterogeneity across the trials and results were pooled using a fixed effects model.
Pooled results demonstrated a modest, but significant effect of Structum® (1 g daily) over placebo on the reduction of pain during activity following a treatment period of 3-6 months of 6 mm (95% confidence interval (CI) -9.50, -1.72, p=0.005) on the visual analog scale (VAS) and a reduction in the algo-functional Index (AFI) by a weighted mean difference of -0.73 (95% CI -1.28 to -0.18, p=0.01). In addition, the pooled analysis demonstrated a statistically significant increase in OMERACT-OARSI responders in the Structum®-treated patients by 20% (RR of 1.20 (95% CI 1.06 to 1.36, p=0.003)), compared to placebo.
These results demonstrate that this chondroitin sulfate preparation (Structum®) is effective on symptoms in patients with OA of the knee compared to placebo, and may therefore have a role in the management of patients with knee osteoarthritis of Kellgren-Lawrence grades II and III.
进行一项随机双盲安慰剂对照临床试验的荟萃分析,以评估一种特定硫酸软骨素制剂(Structum®,法国卡斯特尔皮埃尔法布尔实验室)作为改善膝关节骨关节炎(OA)症状药物的疗效。
截至2010年10月进行了Medline检索,确定了两篇报告两项试验的文章;通过联系Structum®的生产商又确定了一项试验。各试验之间无异质性证据,结果采用固定效应模型进行汇总。
汇总结果显示,在3 - 6个月的治疗期后,与安慰剂相比,Structum®(每日1克)对活动期间疼痛减轻有适度但显著的效果,视觉模拟量表(VAS)上减轻6毫米(95%置信区间(CI)-9.50,-1.72,p = 0.005),算法功能指数(AFI)加权平均差异降低-0.73(95% CI -1.28至-0.18,p = 0.01)。此外,汇总分析显示,与安慰剂相比,接受Structum®治疗的患者中OMERACT - OARSI反应者的比例有统计学显著增加,增加了20%(相对危险度为1.20(95% CI 1.06至1.36,p = 0.003))。
这些结果表明,与安慰剂相比,这种硫酸软骨素制剂(Structum®)对膝关节OA患者的症状有效,因此可能在Kellgren - Lawrence II级和III级膝关节骨关节炎患者的管理中发挥作用。