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局部红车轴草油治疗膝骨关节炎的疗效:一项前瞻性随机三盲安慰剂对照临床试验。

The efficacy of topical red clover oil on knee osteoarthritis: A pilot prospective randomized triple-blind placebo-controlled clinical trial.

机构信息

Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

Department of Community Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

出版信息

Phytother Res. 2020 Jul;34(7):1687-1695. doi: 10.1002/ptr.6650. Epub 2020 Mar 12.

Abstract

A triple-blind placebo-controlled clinical trial was performed to evaluate the efficacy of topical red clover oil (containing standardized red clover extract in olive oil) on knee osteoarthritis (OA). A total of 80 patients, 50-80 years old, with primary knee OA were randomly allocated to two groups. The study group used topical red clover oil and the control group used olive oil for 4 weeks (20 drops twice a day). Both groups adhered to nonpharmacological American College of Rheumatology recommendations and took meloxicam tablets during the study (0-8 weeks), and were followed up from Week 4 to 8. Efficacy measures were evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale and Visual Analogue Scale (VAS). At baseline, both groups were homogeneous regarding demographic characteristics. In addition, they were asked about the side effects during the intervention. The results showed that the WOMAC score and its subscales of pain and stiffness and function scores and VAS significantly increased over time in both groups (p < .001). The study group showed a significant increase regarding pain (p = .001), function (p = .010), VAS (p < .001), and the WOMAC total score (p = .018). No serious drug side effects were observed. Red clover oil may have positive effects on symptoms of knee OA and can be considered as a complementary treatment.

摘要

一项三盲安慰剂对照临床试验评估了局部施用红车轴草油(含标准化红车轴草提取物的橄榄油)对膝骨关节炎(OA)的疗效。共 80 例 50-80 岁的原发性膝 OA 患者随机分为两组。研究组使用局部红车轴草油,对照组使用橄榄油,持续 4 周(每天 2 次,每次 20 滴)。两组均遵循非药物性美国风湿病学会建议,并在研究期间服用美洛昔康片(0-8 周),并在第 4 周到第 8 周进行随访。使用 Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)量表和视觉模拟量表(VAS)评估疗效。基线时,两组在人口统计学特征方面具有同质性。此外,还询问了干预过程中的副作用。结果显示,两组 WOMAC 评分及其子量表(疼痛、僵硬和功能评分)和 VAS 评分随时间均显著增加(p<0.001)。研究组疼痛(p=0.001)、功能(p=0.010)、VAS(p<0.001)和 WOMAC 总分(p=0.018)均有显著增加。未观察到严重的药物副作用。红车轴草油可能对膝骨关节炎症状有积极影响,可以考虑作为一种补充治疗。

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