Arthritis and Traditional Chinese Medicine

关节炎与中医

• 批准号: 7020221
• 负责人: BRIAN M BERMAN
• 金额: $ 119.77万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7020221
• 关键词: Arthritis; Traditional; Chinese; Medicine

DESCRIPTION (provided by applicant): Relevance: Osteoarthritis (OA) is the most common form of arthritis and is a major cause of morbidity, limitation of activity and health care utilization, especially in the elderly. Pain and functional limitation are the primary clinical manifestations of OA. Knee OA is one of the most common joint disorders among patients with arthritis. As there are presently no curative therapies for OA of the knee, management consists of control of pain and reduction in functional limitation. However, some of the most common therapeutic approaches such as non-steroidal anti-inflammatory drugs are associated with severe side effects including gastrointestinal disturbances and cardiovascular risks. Opioids can be used to manage chronic pain, but their use is also limited by adverse effects and the risk of addiction. It has been reported that about 50% of persistent pain sufferers lack effective pain control. Traditional Chinese Medicine (TCM) is widely used to treat OA of the knee in Asian societies and is used by many in the United States. The scientific basis for its use however, is relatively sparse. Recent data suggest that inflammation plays an important role in the pathophysiology of OA with respect to both the production of pain and stiffness, and structural progression. Chinese medicine has traditionally employed mixtures of herbs in composite formulas for the treatment of various ailments. Huo-Luo-Xiao-Ling (HLXL) Dan is an ancient polyprescription that has been used for more than 400 years in the treatment of arthritis in China. We have found that an 11 herb formulation of the traditional Chinese whole herbal remedy Huo-Luo-Xiao-Ling (HLXL) Dan has significant anti-inflammatory effects in animal models. Ten of its eleven herbs are documented to have anti-inflammatory properties, and nine to have analgesic properties. Project summary: We propose to conduct a randomized, placebo-controlled, double-blind, phase II dose escalation clinical trial to find an optimally efficacious, safe, and tolerable dosage of HLXL extract as adjunctive treatment in 180 patients, aged 40 and over, diagnosed with OA of the knee. Sixty participants at each dosage level will be randomized to HLXL or placebo in a 2:1 allocation ratio. They will be treated for 6 weeks and assessed at baseline, 2, 4, and 6 weeks for the clinically important outcomes of pain and functional limitation using valid, reliable and responsive measures - the Western Ontario McMaster (WOMAC) Osteoarthritis Index, the Patient Global Assessment (PGA), and the Medical Outcomes Study Short Form 36 (MOS SF-36), among others. We will record adverse events and symptoms and conduct blood and urine analyses, ECGs, and physical examinations. We will assess adherence with the treatment regimen via pill counts and diary, and track concomitant drug and treatment use. We will assay C reactive protein and will measure cyclo-oxygenase (COX) 1 and 2 activity as biological markers of inflammation and disease.

描述（由申请人提供）： 相关性：骨关节炎 (OA) 是最常见的关节炎形式，是发病、活动受限和医疗保健利用的主要原因，特别是在老年人中。疼痛和功能受限是OA的主要临床表现。膝关节骨关节炎是关节炎患者最常见的关节疾病之一。由于目前膝关节骨关节炎尚无治愈方法，治疗方法包括控制疼痛和减少功能限制。然而，一些最常见的治疗方法（例如非甾体抗炎药）与严重的副作用相关，包括胃肠道紊乱和心血管风险。阿片类药物可用于治疗慢性疼痛，但其使用也受到不良反应和成瘾风险的限制。据报道，约50%的持续性疼痛患者缺乏有效的疼痛控制。传统中医 (TCM) 在亚洲社会广泛用于治疗膝关节骨关节炎，在美国也有许多人使用。然而，其使用的科学依据相对较少。最近的数据表明，炎症在 OA 的病理生理学中发挥着重要作用，涉及疼痛和僵硬的产生以及结构进展。中医传统上采用复合配方中的草药混合物来治疗各种疾病。火络消灵丹是一种古老的复方药物，在中国用于治疗关节炎已有 400 多年的历史。我们发现传统中草药火络消灵丹 (HLXL) 的 11 味药配方在动物模型中具有显着的抗炎作用。据记载，其十一种草药中有十种具有抗炎特性，九种具有镇痛特性。 项目摘要：我们建议开展一项随机、安慰剂对照、双盲、II 期剂量递增临床试验，以寻找 HLXL 提取物的最佳有效、安全和可耐受剂量作为辅助治疗，对 180 名 40 岁及以上患者进行辅助治疗。诊断为膝关节骨关节炎。每个剂量水平的 60 名参与者将以 2:1 的分配比例随机分配到 HLXL 或安慰剂组。他们将接受 6 周的治疗，并在基线、第 2、4 和 6 周时使用有效、可靠和反应灵敏的措施评估疼痛和功能限制的临床重要结果 - 西安大略麦克马斯特 (WOMAC) 骨关节炎指数、全球患者评估 (PGA) 和医疗结果研究简表 36 (MOS SF-36) 等。我们将记录不良事件和症状，并进行血液和尿液分析、心电图和体检。我们将通过药丸计数和日记评估对治疗方案的依从性，并跟踪伴随的药物和治疗使用情况。我们将检测 C 反应蛋白，并测量环加氧酶 (COX) 1 和 2 活性，作为炎症和疾病的生物标志物。