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氨基葡萄糖对膝骨关节炎症状的有效性:一项基于互联网的随机双盲对照试验结果

Effectiveness of glucosamine for symptoms of knee osteoarthritis: results from an internet-based randomized double-blind controlled trial.

作者信息

McAlindon Timothy, Formica Margaret, LaValley Michael, Lehmer Melissa, Kabbara Karim

机构信息

Division of Rheumatology, Tufts-New England Medical Center, Boston, Massachusetts 02111, USA.

出版信息

Am J Med. 2004 Nov 1;117(9):643-9. doi: 10.1016/j.amjmed.2004.06.023.

Abstract

PURPOSE

To present the safety and effectiveness results of a prototypical 12-week, double-blind, randomized placebo-controlled trial of glucosamine among subjects with knee osteoarthritis who were recruited and followed entirely over the Internet.

METHODS

The study comprised 205 subjects aged 45 years or older with symptomatic knee osteoarthritis who were recruited over the Internet; eligibility was authenticated through medical record review. Participants were assigned randomly to 1.5 g/d of glucosamine (n = 101) or placebo (n = 104), of whom 108 completed the intervention (93 in each arm). The primary outcome measure was the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (Likert version). Additional outcome measures included the physical function and stiffness subscales and overall score of the questionnaire, and analgesic use.

RESULTS

There was no difference between treatment and control groups in terms of change in pain score (2.0 +/- 3.4 vs. 2.5 +/- 3.8, P = 0.41), stiffness (0.7 +/- 1.6 vs. 0.8 +/- 1.5, P = 0.52), physical function (5.2 +/- 9.5 vs. 4.6 +/- 9.6, P = 0.49), overall score (7.8 +/- 13.1 vs. 7.8 +/- 13.5, P = 0.81), and analgesic use (133 +/- 553 vs. -88 +/- 755, P = 0.12). Stratification by osteoarthritis severity, glucosamine product, and use of a nonsteroidal anti-inflammatory drug, as well as exclusion of opiate users, did not alter the results. The number and type of adverse events reported was similar between the groups.

CONCLUSION

Our results suggest that although glucosamine appears to be safe, it is no more effective than placebo in treating the symptoms of knee osteoarthritis.

摘要

目的

呈现一项典型的为期12周的双盲、随机、安慰剂对照试验的安全性和有效性结果,该试验针对通过互联网招募并全程跟踪的膝骨关节炎患者使用氨基葡萄糖进行研究。

方法

该研究纳入了205名年龄在45岁及以上、有症状的膝骨关节炎患者,他们通过互联网招募;通过病历审查确认 eligibility。参与者被随机分配至每日1.5克氨基葡萄糖组(n = 101)或安慰剂组(n = 104),其中108人完成了干预(每组93人)。主要结局指标是西安大略和麦克马斯特大学骨关节炎指数(李克特版)的疼痛子量表。其他结局指标包括问卷的身体功能和僵硬子量表及总分,以及镇痛药使用情况。

结果

治疗组和对照组在疼痛评分变化(2.0±3.4对2.5±3.8,P = 0.41)、僵硬程度(0.7±1.6对0.8±1.5,P = 0.52)、身体功能(5.2±9.5对4.6±9.6,P = 0.49)、总分(7.8±13.1对7.8±13.5,P = 0.81)和镇痛药使用情况(133±553对 -88±755,P = 0.12)方面无差异。按骨关节炎严重程度、氨基葡萄糖产品、非甾体抗炎药的使用情况进行分层,以及排除阿片类药物使用者,均未改变结果。两组报告的不良事件数量和类型相似。

结论

我们的结果表明,虽然氨基葡萄糖似乎是安全的,但在治疗膝骨关节炎症状方面,它并不比安慰剂更有效。

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