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CONCEPT provides robust evidence that chondroitin sulfate is superior to placebo and similar to celecoxib in the symptomatic management of osteoarthritis
Annals of the Rheumatic Diseases ( IF 20.3 ) Pub Date : 2017-09-22 , DOI: 10.1136/annrheumdis-2017-212165
Jean-Yves L Reginster

We are very grateful to our distinguished colleague for his constructive comments.1 However it seems that some keypoints of our study were grossly misunderstood.2 As clearly stated, the objective of the CONCEPT study was to confirm that chondroitin sulfate (CS) is superior to placebo (PLB) in the symptomatic treatment of osteoarthritis, with the addition of a Celebrex (CLB) arm, as requested by the European Medicines Agency, to provide an external validation and to better assess the relevance of the difference in pain relief observed between the CS and PLB arms. There was no intent to demonstrate a non-inferiority of CS versus Celebrex. In such a case, a non-inferiority margin for the comparison would be mentioned in the protocol, and the power calculation would be substantially different. The use of the word similar in describing Visual Analogue Scale (VAS) and Lequesne scoring …

中文翻译:

CONCEPT 提供了强有力的证据,证明硫酸软骨素在骨关节炎的对症治疗中优于安慰剂并类似于塞来昔布

我们非常感谢尊敬的同事提出的建设性意见。1 然而,我们研究的某些关键点似乎被严重误解了。2 明确指出,CONCEPT 研究的目的是确认硫酸软骨素 (CS) 优于安慰剂 (PLB) 用于骨关节炎的对症治疗,并应欧洲药品管理局的要求增加了 Celebrex (CLB) 臂,以提供外部验证并更好地评估观察到的疼痛缓解差异的相关性CS和PLB武器。无意证明 CS 与 Celebrex 的非劣效性。在这种情况下,方案中将提及用于比较的非劣效裕度,并且功效计算将有很大不同。
更新日期:2017-09-22
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