Risk of Bias and Brand Explain the Observed: Inconsistency in Trials on Glucosamine Symptomatic Relief of Osteoarthritis: A Meta-Analysis of Placebeo-Controlled Trials
Risk of Bias and Brand Explain the Observed: Inconsistency in Trials on Glucosamine Symptomatic Relief of Osteoarthritis: A Meta-Analysis of Placebeo-Controlled Trials
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DOI：
10.1002/acr.22376
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发表时间：
2014-12-01
影响因子：
4.7
通讯作者：
Christensen, Robin
中科院分区：
文献类型：
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作者：
Eriksen, Patrick;Bartels, Else M.;Christensen, Robin
目的：确定研究申办者、化学制剂、葡萄糖胺品牌和/或偏倚风险是否可以解释葡萄糖胺治疗骨关节炎（OA）疼痛疗效试验中观察到的不一致性。对随机安慰剂对照试验进行了系统综述和分层荟萃分析，并应用随机效应模型，分别使用Review Manager和SAS估计不一致性（I-2）和异质性（tau（2））。主要结局是疼痛减轻;标准化平均差异（SMD [95%置信区间（95% CM）]）作为效应量。入选标准产生了25项试验（3，458例患者）。氨基葡萄糖可中度减轻疼痛（SMD-0. 51 [95% CI-0. 72，-0. 30]），但观察到试验间不一致性水平较高（I-2 = 88%）。唯一最重要的解释（即，协变量）为品牌，异质性降低41%（P = 0.00032）。十二试炼（1，437名患者）使用Rottapharm/Madaus产品导致疼痛显著减轻（SMD 1.07 [95% CI-1.47，-0.67]），尽管使用Rottapharm/Madaus产品的3项低偏倚风险试验的敏感性分析显示结果不太有希望（SMD-0.27 [95% CI-0.43，-0.12]），这只是一个小的效应量。使用非Rottapharm/Madaus产品的13项试验（1，963例患者）始终未能显示疼痛减轻（SMD-0.11 [95% CI-0.46，0.24]）。第二个最重要的解释是偏倚的总体风险（异质性降低32%）。在氨基葡萄糖试验中观察到的大多数异质性可通过品牌来解释。与其他葡萄糖胺制剂相比，使用Rottapharm/Madaus葡萄糖胺产品的试验在OA疼痛方面具有上级结局。然而，发现了很大的不一致性。使用Rottapharn/Madaus产品的低偏倚风险试验显示了较小的效应量。
Objective, To determine whether study sponsor, chemical formulation, brand of glucosamine, and/or risk of bias explain observed inconsistencies in trials of glucosa.mine's efficacy for treating pain in osteoarthritis (OA).Methods. A systematic review and stratified meta-analysis of randomized placebo-controlled trials was performed, and random-effects models were applied with inconsistency (I-2) and heterogeneity (tau(2)) estimated using Review Manager and SAS, respectively. The major outcome was reduction of pain; the standardized mean difference (SMD [95% confidence interval (95% CM) served as effect size.Results. The inclusion criteria yielded 25 trials (3,458 patients). Glucosamine moderately reduced pain (SMD -0.51 [95% CI -0.72, -0.30]), although a high level of between-trial inconsistency was observed (I-2 = 88%). The single most important explanation (i.e., covariate) was brand, reducing heterogeneity by 41% (P = 0.00032). Twelve trials (1,437 patients) using the Rottapharm/Madaus product resulted in significant pain reduction (SMD 1.07 [95% CI -1.47, -0.67]), although a sensitivity analysis of 3 low risk of bias trials using the Rottapharm/Madaus product showed less promising results (SMD -0.27 [95% CI -0.43, -0.12]), which is only a small effect size. Thirteen trials (1,963 patients) using non-Rottapharm/Madaus products consistently failed to show a reduction in pain (SMD -0.11 [95% CI -0.46, 0.24]). The second most important explanation was overall risk of bias (reducing heterogeneity by 32%).Conclusion. Most of the observed heterogeneity in glucosamine trials is explained by brand. Trials using the Rottapharm/Madaus glucosamine product had a superior outcome on pain in OA compared to other preparations of glucosamine. Large inconsistency was found, however. Low risk of bias trials, using the Rottapharrn/Madaus product, revealed a small effect size.