Individually integrated traditional Chinese medicine approach in the management of knee osteoarthritis: study protocol for a randomized controlled trial.
Individually integrated traditional Chinese medicine approach in the management of knee osteoarthritis: study protocol for a randomized controlled trial.
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治疗膝骨关节炎的个体化综合中医方法：随机对照试验的研究方案。
DOI：
10.1186/1745-6215-12-160
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发表时间：
2011-06-22
期刊：
影响因子：
2.5
通讯作者：
Shi Y
中科院分区：
文献类型：
--
作者：
Cao Y;Zhan H;Pang J;Li F;Xu S;Gao J;Xu Z;Li G;Liu T;Guo C;Shi Y
膝关节骨关节炎（OA）被认为是一个主要的公共卫生问题，造成慢性残疾的世界范围内，随着越来越多的老年人。在中国和越来越多的世界范围内，许多膝关节OA患者正在使用补充和替代药物，包括草药，草药贴片，针灸和推拿等，以缓解他们的症状。然而，从系统评价或随机对照试验（RCT）中收集的证据仅证实了针灸对骨关节炎疼痛的治疗。此外，上述这些中医方法通常以综合方式使用。本试验旨在比较单独综合中医治疗膝关节OA与其他单一治疗作为平行随机对照的疗效。五所教学医院将参与本随机对照试验。500名参与者，每家医院100人，将被随机分配接受口服中草药（抗骨癣胶囊），局部使用中草药贴片（妇纳紫金贴片），针灸，推拿和个别综合中医方法。单独整合的中医方法包括口服抗骨癣胶囊的基本治疗，根据患者症状的严重程度可变地使用推拿，针灸和草药贴片。干预的时间为4周。主要结果测量是使用西安大略麦克马斯特大学骨关节炎指数（WOMAC）的自我报告总分。次要结局指标包括患者和研究者对治疗反应的总体评估，患者和研究者对OA状况的总体评估，WOMAC疼痛、僵硬和身体功能亚量表，短表36 （SF-36）和中医对OA状况的评估。统计分析将采用混合模型和敏感性分析。该试验旨在验证一个假设，即单独整合中医方法比单独使用四种治疗方式更有效。本研究的主要局限性是缺乏安慰剂对照和双盲。中国科克伦中心ChiCTR-TRC-00000176
Knee osteoarthritis (OA) is considered a major public health issue causing chronic disability worldwide with the increasing number of aging people. In China and increasingly worldwide, many sufferers with knee OA are using complementary and alternative medicine including herbal drug, herbal patch, acupuncture and Tuina etc., to alleviate their symptoms. However, evidence gathered from systematic reviews or randomized controlled trials (RCT) has only validated acupuncture for the management of osteoarthritic pain. Moreover, such Traditional Chinese Medicine (TCM) methods above are commonly used in an integrative way. This trial is aimed to compare the efficacy of an individually integrated TCM approach in the management of knee OA with other single treatments as parallel randomized controls. Five teaching hospitals will participate in this randomized controlled trial. 500 participants, 100 in each hospital, will be randomly assigned to receive oral administration of a Chinese herbal drug (counter osteophytes capsule), topical use of a Chinese herbal patch (Fufnag Zijin patch), acupuncture, Tuina and the individually integrated TCM approach. The individually integrated TCM approach consists of basic treatment of oral counter osteophytes capsule, variable use of Tuina, acupuncture and a herbal patch based on the severity of the patient's symptoms. The interventions are given for a period of 4 weeks. The primary outcome measure is the self-reported total score using the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures include patient and investigator global assessment of response to treatment, patient and investigator global assessment of OA condition, WOMAC pain, stiffness, and physical function subscales, short-form 36 (SF-36) and TCM assessment of OA condition measured by syndromes questionnaire. Mixed models and sensitivity analysis will be used for the statistical analysis. The trial is designed to test the hypothesis that an individually integrated TCM approach is more effective than four treatment modalities used separately. The major limitation of this study is lack of placebo control and of double blinding. Chinese Cochrane Center ChiCTR-TRC-00000176
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影响因子：
4.9
作者：
Felson DT
通讯作者：
Felson DT
影响因子：
5.5
作者：
Berman, BM;Singh, BB;Hochberg, M
通讯作者：
Hochberg, M
DOI：
10.1093/ecam/neh104
发表时间：
2005-09
期刊：
Evidence-based complementary and alternative medicine : eCAM
影响因子：
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作者：
Cao Y;Shi Y;Zheng Y;Shi M;Lo SK
通讯作者：
Lo SK
影响因子：
4.2
作者：
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通讯作者：
Wells, Christopher W.
影响因子：
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作者：
Perlman, Adam I.;Sabina, Alyse;Katz, David L.
通讯作者：
Katz, David L.