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聚合草根提取物(药用聚合草)与单宁酸乳膏混合剂治疗膝骨关节炎的效果:随机、安慰剂对照、双盲、多临床试验

Effect of a blend of comfrey root extract (Symphytum officinale L.) and tannic acid creams in the treatment of osteoarthritis of the knee: randomized, placebo-controlled, double-blind, multiclinical trials.

作者信息

Smith Doug B, Jacobson Bert H

机构信息

Associate Professor, Health and Human Performance, AB Harrison Exercise Physiology Lab, Oklahoma State University, Stillwater, OK 74078.

出版信息

J Chiropr Med. 2011 Sep;10(3):147-56. doi: 10.1016/j.jcm.2011.01.003. Epub 2011 Jul 22.

Abstract

OBJECTIVE

The purpose of this study was to determine the effect of 2 concentrations of topical, comfrey-based botanical creams containing a blend of tannic acid and eucalyptus to a eucalyptus reference cream on pain, stiffness, and physical functioning in those with primary osteoarthritis of the knee.

METHODS

Forty-three male and female subjects (45-83 years old) with diagnosed primary osteoarthritis of the knee who met the inclusion criteria were entered into the study. The subjects were randomly assigned to 1 of 3 treatment groups: 10% or 20% comfrey root extract (Symphytum officinale L.) or a placebo cream. Outcomes of pain, stiffness, and functioning were done on the Western Ontario and MacMaster Universities Osteoarthritis Index. Participants applied the cream 3× a day for 6 weeks and were evaluated every 2 weeks during the treatment.

RESULTS

Repeated-measures analyses of variance yielded significant differences in all of the Western Ontario and MacMaster Universities Osteoarthritis Index categories (pain P < .01, stiffness P < .01, daily function P < .01), confirming that the 10% and 20% comfrey-based creams were superior to the reference cream. The active groups each had 2 participants who had temporary and minor adverse reactions of skin rash and itching, which were rapidly resolved by modifying applications.

CONCLUSION

Both active topical comfrey formulations were effective in relieving pain and stiffness and in improving physical functioning and were superior to placebo in those with primary osteoarthritis of the knee without serious adverse effects.

摘要

目的

本研究旨在确定两种含有鞣酸和桉树叶混合成分的外用紫草科植物乳膏以及一种桉树叶对照乳膏对膝原发性骨关节炎患者疼痛、僵硬和身体功能的影响。

方法

43名符合纳入标准、确诊为膝原发性骨关节炎的男性和女性受试者(45 - 83岁)进入本研究。受试者被随机分配至3个治疗组中的1组:10%或20%的紫草提取物(药用聚合草)乳膏或一种安慰剂乳膏。疼痛、僵硬和身体功能的评估采用西安大略和麦克马斯特大学骨关节炎指数。参与者每天涂抹乳膏3次,持续6周,并在治疗期间每2周进行一次评估。

结果

重复测量方差分析显示,西安大略和麦克马斯特大学骨关节炎指数的所有类别均存在显著差异(疼痛P < .01,僵硬P < .01,日常功能P < .01),证实10%和20%的紫草科植物乳膏优于对照乳膏。两个活性组各有2名参与者出现皮疹和瘙痒的暂时轻微不良反应,通过调整涂抹方式后迅速缓解。

结论

两种活性外用紫草科植物配方在缓解疼痛和僵硬以及改善身体功能方面均有效,且在膝原发性骨关节炎患者中优于安慰剂,无严重不良反应。

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