title: External Chinese medical therapy for pain associated with hyperplastic disease of the breast: study protocol of a randomized, double-blind, multicenter, controlled trial.
abstract: BACKGROUND
  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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Traditional Chinese Medicine Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.
authors.forename: Xiao-hui
authors.initials: XH
authors.lastname: Sun
authors.forename: Sheng
authors.initials: S
authors.lastname: Liu
mesh_terms: D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D005260:Female; D005348:Fibrocystic Breast Disease / Q000628:therapy*; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000379:methods*; D010146:Pain / Q000188:drug therapy*; D059408:Pain Management / Q000379:methods*
chemical_list: D004365:Drugs, Chinese Herbal