“中药敷贴治疗乳腺增生疼痛的随机、双盲、安慰剂对照多中心临床试验”的研究方案(英文)

External Chinese medical therapy for pain associated with hyperplastic disease of the breast:study protocol of a randomized,double-blind,multicenter,controlled trial

背景:乳腺增生疼痛并非是真正的乳房疾病,而是女性达到一定年龄,因激素失调所致。许多女性在经前期可以出现轻度的乳腺痛,并不需要治疗,如果疼痛的程度和发作次数均增加,发展到中至重度的疼痛,则会给患者带来痛苦。因此,积极有效地防治该病具有重要的临床意义。方法与设计:本研究根据循证医学原则,采取随机、对照、双盲、多中心试验的设计方法,根据乳腺增生病中、西医病因以及发病机制、预后转归等特点,进行辨证,采用中医外治药散结止痛膏治疗,以安慰剂为对照,以缓解疼痛为主要目的,评价中医药治疗的有效性、安全性。在进行设计时考虑到试验过程中可能出现的偏倚因素,并采用相应措施加以防范。试验过程中可能出现的一些药物不良反应将采取相关应对措施。讨论:散结止痛膏治疗乳腺增生病疼痛是以中医药理论为指导,在保留传统用药的基础上,发挥中医外治法的优势。本研究根据乳腺增生病的主要病因病机和乳房疼痛、肿胀、结块的临床特点,结合长期临床实践经验,提出温经活血、理气止痛、散结消肿的治疗原则,使药物直接作用于病变部位,通过皮肤渗透吸收和对经络腧穴的刺激作用,改善乳房血运,以止痛为主,散结为辅,减轻症状,并反射性调节内分泌功能。

Hyperplastic disease of the breast （HDB） is caused by a hormone imbalance experienced among women at a certain age. Slight breast pain is common in women before menstruation without need of treatment; however, if the pain becomes severe, it can cause physical and mental suffering. Therefore, it is of great clinical significance to control this disease. METHODS AND DESIGN： This study will follow the principle of evidence-based medicine and adopt various design methods, being conducted as a randomized, controlled, double-blind and multicenter trial based on the cause of HDB defined in Chinese and Western medicine. According to the cause of HDB in Chinese and Western medicine and its pathogenesis and prognosis, this study will conduct syndrome differentiation, adopt external therapy of Chinese medicine by using Sanjie Zhitong plaster as the intervention, take placebo as the control method and aim at relieving pain. The effectiveness and safety of Chinese medicine therapy will be evaluated. During the design process, some confounding factors will be taken into consideration and prevented with corresponding measures. We will also discuss the side effects of the medicine used and corresponding countermeasures to be taken. DISCUSSION= On the basis of traditional Chinese medicine （TCM） theory, Sanjie Zhitong plaster takes the advantage of external therapy of TCM. According to the main etiology and pathogenesis of HDB, the treatment principles of warming the meridians and activating blood, smoothing circulation and relieving pain, and removing swelling and dissipating stagnation are put forward. The medicine exerts its effects directly on the lesion site by permeating into the skin and stimulating the meridians, thus improving blood supply to the breast and relieving pain.