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美国国立卫生研究院氨基葡萄糖/软骨素关节炎干预试验(GAIT)。

The NIH Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT).

出版信息

J Pain Palliat Care Pharmacother. 2008;22(1):39-43. doi: 10.1080/15360280801989351.

Abstract

Americans continue to spend millions of dollars annually on glucosamine and chondroitin for symptoms of osteoarthritis. These agents are classified as dietary supplements, not as drugs, per se. Therefore, they do not meet the requirements of the FDA to be classified as drugs. This study was designed to determine if glucosamine and chondroitin are effective for osteoarthritis pain. This report was adapted from an online publication by the National Center for Complimentary and Alternative Medicine of the National Institutes of Health to inform the general public about the GAIT trial and its findings. Participants taking the positive control, celecoxib, experienced statistically significant pain relief versus placebo, about 70% of those taking celecoxib had a 20% or greater reduction in pain versus about 60% for placebo. Overall, there were no significant differences between the other treatments tested and placebo. For a subset of participants with moderate-to-severe pain, glucosamine combined with chondroitin sulfate provided statistically significant pain relief compared with placebo, about 79% had a 20% or greater reduction in pain versus about 54% for placebo. According to the researchers, because of the small size of this subgroup these findings should be considered preliminary and need to be confirmed in further studies. For participants in the mild pain subset, glucosamine and chondroitin sulfate together or alone did not provide statistically significant pain relief.

摘要

美国人每年仍花费数百万美元用于购买葡萄糖胺和软骨素,以缓解骨关节炎症状。这些制剂本身被归类为膳食补充剂,而非药物。因此,它们不符合美国食品药品监督管理局(FDA)对药物的分类要求。本研究旨在确定葡萄糖胺和软骨素对骨关节炎疼痛是否有效。本报告改编自美国国立卫生研究院补充和替代医学国家中心的一篇在线出版物,旨在向公众介绍“葡萄糖胺/软骨素关节炎干预试验”(GAIT)及其研究结果。服用阳性对照药塞来昔布的参与者与服用安慰剂的参与者相比,在统计学上有显著的疼痛缓解,服用塞来昔布的参与者中约70%的人疼痛减轻了20%或更多,而服用安慰剂的这一比例约为60%。总体而言,所测试的其他治疗方法与安慰剂之间没有显著差异。对于一部分中度至重度疼痛的参与者,与安慰剂相比,葡萄糖胺与硫酸软骨素联合使用在统计学上有显著的疼痛缓解效果,约79%的人疼痛减轻了20%或更多,而服用安慰剂的这一比例约为54%。研究人员表示,由于这一亚组规模较小,这些发现应被视为初步结果,需要在进一步研究中得到证实。对于轻度疼痛亚组的参与者,葡萄糖胺和硫酸软骨素单独或联合使用均未提供统计学上显著的疼痛缓解效果。

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