一项关于益气化瘀通髓颗粒治疗轻中度脊髓型颈椎病的随机、双盲、安慰剂对照试验。
A randomized, double-blind, placebo-controlled trial for Yi-Qi Hua-Yu tong-sui granule in the treatment of mild or moderate cervical spondylotic myelopathy.
作者信息
Xu Chongqing, Zhou Xiaoning, Tong Zhengyi, Ma Junming, Ye Jie, Xu Jinhai, Mo Wen
机构信息
Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
出版信息
Medicine (Baltimore). 2020 Aug 14;99(33):e21776. doi: 10.1097/MD.0000000000021776.
BACKGROUND
Neck pain, sensory disturbance and motor dysfunction in most patients suffered cervical spondylotic myelopathy (CSM). However, some conservative treatments are limited by their modest effectiveness. In the other hand, surgical treatment is necessary when symptoms are refractory to conservative treatments and neurological function of the patients has deteriorated. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine effectiveness and safety of Yiqi-Huayu-Tongsui (YQHYTS) granule, a compound traditional Chinese herbal medicine, on symptoms in patients with mild or moderate CSM.
METHODS/DESIGN: A randomized, double blinded, placebo-controlled clinical trial to evaluate the efficacy and safety of YQHYTS granule is proposed. 72 patients in Longhua Hospital with the diagnosis of mild or moderate CSM will be randomly allocated into 2 groups, and treated with YQHYTS granule or placebo. The prescription of the trial drugs (YQHYTS granule/placebo) is 20 grams twice a day for 3 months. The primary outcome measurements include visual analog scale, Japanese Orthopedic Association, and Neck Disability Index score. The secondary outcome measurements are electromyogram and Pfirrmann classification.
DISCUSSION
YQHYTS granule has been established and applied in Longhua Hospital for many years. As it has a potential benefit in treating mild or moderate CSM, we designed a double-blind, prospective, randomized controlled trial and would like to publish the results and conclusions later. If YQHYTS granule can alleviate neck pain, sensory disturbance, and even motor dysfunction without adverse effects, it may be a unique strategy for the treatment of mild or moderate CSM.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ID: ChiCTR1900028192. Registered 15 December 2019, Available at: http://www.chictr.org.cn/edit.aspx?pid=46913&htm=4.
背景
大多数脊髓型颈椎病（CSM）患者存在颈部疼痛、感觉障碍和运动功能障碍。然而，一些保守治疗的效果有限。另一方面，当症状对保守治疗无效且患者神经功能恶化时，手术治疗是必要的。许多患者使用包括中药在内的补充和替代医学来缓解症状。本研究的目的是检验益气化瘀通髓（YQHYTS）颗粒（一种复方中药）对轻中度CSM患者症状的有效性和安全性。
方法/设计：拟进行一项随机、双盲、安慰剂对照临床试验，以评估YQHYTS颗粒的疗效和安全性。龙华医院72例诊断为轻中度CSM的患者将被随机分为两组，分别接受YQHYTS颗粒或安慰剂治疗。试验药物（YQHYTS颗粒/安慰剂）的处方为每日2次，每次20克，共3个月。主要结局指标包括视觉模拟量表、日本骨科学会评分和颈部功能障碍指数评分。次要结局指标为肌电图和Pfirrmann分级。
讨论
YQHYTS颗粒在龙华医院已应用多年。由于其在治疗轻中度CSM方面具有潜在益处，我们设计了一项双盲、前瞻性、随机对照试验，并希望随后公布结果和结论。如果YQHYTS颗粒能够缓解颈部疼痛、感觉障碍甚至运动功能障碍且无不良反应，它可能是治疗轻中度CSM的一种独特策略。
试验注册
中国临床试验注册中心标识符：ChiCTR1900028192。于2019年12月15日注册，可在以下网址查询：http://www.chictr.org.cn/edit.aspx?pid=46913&htm=4。
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