氨基葡萄糖和软骨素治疗骨关节炎:系统质量评估与荟萃分析。
Glucosamine and chondroitin for treatment of osteoarthritis: a systematic quality assessment and meta-analysis.
作者信息
McAlindon T E, LaValley M P, Gulin J P, Felson D T
机构信息
The Arthritis Center, Boston University School of Medicine, Mass 02118, USA.
出版信息
JAMA. 2000 Mar 15;283(11):1469-75. doi: 10.1001/jama.283.11.1469.
CONTEXT
Glucosamine and chondroitin preparations are widely touted in the lay press as remedies for osteoarthritis (OA), but uncertainty about their efficacy exists among the medical community.
OBJECTIVE
To evaluate benefit of glucosamine and chondroitin preparations for OA symptoms using meta-analysis combined with systematic quality assessment of clinical trials of these preparations in knee and/or hip OA.
DATA SOURCES
We searched for human clinical trials in MEDLINE (1966 to June 1999) and the Cochrane Controlled Trials Register using the terms osteoarthritis, osteoarthrosis, degenerative arthritis, glucosamine, chondroitin, and glycosaminoglycans. We also manually searched review articles, manuscripts, and supplements from rheumatology and OA journals and sought unpublished data by contacting content experts, study authors, and manufacturers of glucosamine or chondroitin.
STUDY SELECTION
Studies were included if they were published or unpublished double-blind, randomized, placebo-controlled trials of 4 or more weeks' duration that tested glucosamine or chondroitin for knee or hip OA and reported extractable data on the effect of treatment on symptoms. Fifteen of 37 studies were included in the analysis.
DATA EXTRACTION
Reviewers performed data extraction and scored each trial using a quality assessment instrument. We computed an effect size from the intergroup difference in mean outcome values at trial end, divided by the SD of the outcome value in the placebo group (0.2, small effect; 0.5, moderate; 0.8, large), and applied a correction factor to reduce bias. We tested for trial heterogeneity and publication bias and stratified for trial quality and size. We pooled effect sizes using a random effects model.
DATA SYNTHESIS
Quality scores ranged from 12.3% to 55.4% of the maximum, with a mean (SD) of 35.5% (12%). Only 1 study described adequate allocation concealment and 2 reported an intent-to-treat analysis. Most were supported or performed by a manufacturer. Funnel plots showed significant asymmetry (P< or =.01) compatible with publication bias. Tests for heterogeneity were nonsignificant after removing 1 outlier trial. The aggregated effect sizes were 0.44 (95% confidence interval [CI], 0.24-0.64) for glucosamine and 0.78 (95% CI, 0.60-0.95) for chondroitin, but they were diminished when only high-quality or large trials were considered. The effect sizes were relatively consistent for pain and functional outcomes.
CONCLUSIONS
Trials of glucosamine and chondroitin preparations for OA symptoms demonstrate moderate to large effects, but quality issues and likely publication bias suggest that these effects are exaggerated. Nevertheless, some degree of efficacy appears probable for these preparations.
背景
氨基葡萄糖和软骨素制剂在大众媒体中被广泛吹捧为骨关节炎(OA)的治疗方法,但医学界对其疗效仍存在不确定性。
目的
通过荟萃分析并结合对这些制剂用于膝关节和/或髋关节OA临床试验的系统质量评估,来评估氨基葡萄糖和软骨素制剂对OA症状的益处。
数据来源
我们在MEDLINE(1966年至1999年6月)和Cochrane对照试验注册库中检索了人类临床试验,检索词为骨关节炎、骨关节病、退行性关节炎、氨基葡萄糖、软骨素和糖胺聚糖。我们还手动检索了风湿病学和OA期刊的综述文章、手稿及增刊,并通过联系内容专家、研究作者以及氨基葡萄糖或软骨素制造商来获取未发表的数据。
研究选择
纳入的研究需为已发表或未发表的双盲、随机、安慰剂对照试验,试验持续时间不少于4周,测试氨基葡萄糖或软骨素用于膝关节或髋关节OA,并报告有关治疗对症状影响的可提取数据。37项研究中有15项被纳入分析。
数据提取
评审人员进行数据提取,并使用质量评估工具对每项试验进行评分。我们根据试验结束时组间平均结果值的差异计算效应量,再除以安慰剂组结果值的标准差(效应量为0.2表示小效应;0.5为中等效应;0.8为大效应),并应用校正因子以减少偏倚。我们对试验异质性和发表偏倚进行了检验,并按试验质量和规模进行分层。我们使用随机效应模型汇总效应量。
数据综合
质量得分在最大值的12.3%至55.4%之间,平均(标准差)为35.5%(12%)。只有1项研究描述了充分的分配隐藏,2项报告了意向性分析。大多数研究由制造商资助或进行。漏斗图显示出与发表偏倚相符的显著不对称性(P≤0,01)。剔除1项离群试验后,异质性检验无显著性。氨基葡萄糖的汇总效应量为0.44(95%置信区间[CI],0.24 - 0.64),软骨素为0.78(95%CI,0.60 - 0.95),但仅考虑高质量或大型试验时,效应量会减小。疼痛和功能结局的效应量相对一致。
结论
氨基葡萄糖和软骨素制剂治疗OA症状的试验显示出中度至较大的效应,但质量问题和可能存在的发表偏倚表明这些效应被夸大了。尽管如此,这些制剂似乎可能有一定程度的疗效。