Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (4): 384-389.doi: 10.3736/jcim20120406

Previous Articles     Next Articles

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

Xiao-hui Sun, Sheng Liu()   

  1. Department of Traditional Chinese Medicine Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
  • Received:2011-10-18 Accepted:2011-12-28 Online:2012-04-20 Published:2018-04-15

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 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.
Trial registration: ChiCTR-TRC-11001297.

Key words: external therapies, fibrocystic breast disease, randomized controlled trial, clinical protocols

Figure 1

Flow diagram of this clinical trial"

[1] Lu DM, He QH. Traditional Chinese medicine surgery. Beijing: China Press of Traditional Chinese Medicine. 2004: 55. Chinese.
陆德铭, 何清湖 . 中医外科学.北京: 中国中医药出版社. 2004: 55.
[2] Lin Y, Tang HJ. Contemporary traditional Chinese medicine on breast diseases. Beijing: People’s Medical Publishing House. 2003: 102, 107, 108, 114, 118. Chinese.
林毅, 唐汉钧 . 现代中医乳房病学.北京: 人民卫生出版社.2003: 102, 107, 108, 114, 118.
[3] Cao XL, Liu C, Sun GJ, Chen CY, Lu WP Wang Z. Short-term tamoxifen therapy for mammary hyperplasia. Shi Yong Zhong Liu Xue Za Zhi. 1995; 9(4): 75-76. Chinese.
曹秀兰, 刘春, 孙桂娟, 陈纯义, 卢伟平, 王众 . 乳腺增生症短程三苯氧胺治疗.实用肿瘤学杂志. 1995; 9(4):75-76.
[4] Song AL, Yang Y Sun YA. Clinical research on Runing cream for mammary hyperplasia. Shandong Zhong Yi Za Zhi. 1997; 16(12): 537-539. Chinese.
宋爱莉, 杨毅, 孙贻安 . 乳宁霜治疗乳腺增生病临床研究.山东中医杂志. 1997; 16(12):537-539.
[5] Tang XH. Traditional Chinese medicine in the treatment of 20 patients with mammary hyperplasia. Sichuan Zhong Yi. 1996; 14(7): 391. Chinese.
唐晓华 . 中医周期疗法治疗乳腺增生症20例.四川中医. 1996; 14(7):391.
[6] Wu KR, Guo Y, Wu ZJ . Study of staircase method of combined traditional Chinese and Western medicine therapy in mammary hyperplasia. Zhejiang Zhong Xi Yi Jie He Za Zhi. 2000; 10(12): 736-737. Chinese.
吴可人, 郭勇, 吴钟玖 . 中西医结合阶梯法治疗乳腺增生病.浙江中西医结合杂志. 2000; 10(12):736-737.
[7] Zhao MY, Wu GB Zhao ML. Observation of Chinese medicine in the treatment of 100 patients with mammary hyperplasia. Shaanxi Zhong Yi. 2004; 25(6): 505-506. Chinese.
赵敏怡, 吴光波, 赵敏莉 . 药物导入治疗乳腺增生100 例.陕西中医. 2004; 25(6):505-506.
[8] Gao MR, Ma J Wang SH. Clinical observation of magnetic brassiere in 96 patients with mammary hyperplasia. Xin Zhong Yi. 2001 ; 33(4) : 53. Chinese.
高美荣, 马杰, 王松鹤 . 药磁乳罩治疗乳腺增生症96 例临床观察.新中医. 2001; 33(4):53.
[9] Tian Y, Lin Y . Study of therapy based on channels and collaterals theory in mammary hyperplasia. Xian Dai Zhong XiYi Jie He Za Zhi. 2005; 14(11): 1417-1419. Chinese.
田莹, 林毅 . 乳癖从经论冶.现代中西医结合杂志. 2005; 14(11) : 1417-1419.
[10] Yuan YX, Shen YK Meng YJ. Magnetic sticker treatment for 50 cases of lobular hyperplasia. Shanghai Zhen Jiu Za Zhi. 1996; 15(3): 44. Chinese.
袁永熙, 沈玉琨, 孟永济 . 曼格磁贴治疗小叶增生 50例.上海针灸杂志. 1996; 15(3):44.
[11] Klimberg VS . Etiology and management of breast pain, part II . In: Copeland EM, Bland KI. The breast. Philadelphia: WB Saunders Co. 1998: 27-260.
[12] Cao ZH . Traditional Chinese and Western medicine therapy in treatment of middle-stage or severe mammary adenosis. Zhongguo Shi Yong Wai Ke Za Zhi. 2000; 20(10): 620-621. Chinese.
曹钟华 . 中西医结合治疗中、重度乳腺腺病的探讨.中国实用外科杂志. 2000; 20(10):620-621.
[13] Wang J . Differential acupuncture treatment of hyperplasia of mammary glands.J Tradit Chin Med. 2002 ; 22(3):184-186.
[14] Lii X, Shen C . 42 cases of hyperplasia of mammary glands treated with Chaihu Sanjie decoction.J Tradit Chin Med. 1996; 16(4):270-272.
[15] Egarter C, Eppel W, Vogel S, Wolf G . A pilot study of hormone replacement therapy with tibolone in women with mastopathic breasts. Maturitas. 2001 ; 40(2):165-171.
doi: 10.1016/S0378-5122(01)00235-3
[1] Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[2] Gerli E.G. Herr, Fábio Goulart da Silva, Francisco José Cidral-Filho, Fabricia Petronilho, Lucinéia Gainski Danielski, Mariana Pereira de Souza Goldim, Afonso Shiguemi Inoue Salgado, Franciane Bobinski, Daniel Fernandes Martins, Eliane R. Winkelmann. Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial. Journal of Integrative Medicine, 2020, 18(1): 27-.
[3] Xin-yu Yue, Zhuo-qi Feng, Xi-yi Yu, Jia-min Hu, Xiao-Jing He, Shi Shu. Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 167-172.
[4] Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei, Liu, Hui Zheng, You-ping Hu. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 161-167.
[5] Pádraic J.Dunne, Julie Lynch, Lucia Prihodova, Caoimhe O'Leary, Atiyeh Ghoreyshi, Sharee A. Basdeo, Donal J.Cox, Rachel Breen, Ali Sheikhi, Áine Carroll, Cathal Walsh, Geraldine McMahon, Barry White. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. Journal of Integrative Medicine, 2019, 17(3): 173-180.
[6] J.M. Oliver-Baxter, H.S. Whitford, D.A. Turnbull, M.J. Bond. Effects of vitamin supplementation on inflammatory markers and psychological wellbeing among distressed women: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(5): 322-328.
[7] Parunkul Tungsukruthai, Preecha Nootim, Wiwan Worakunphanich, Nareerat Tabtong. Efficacy and safety of herbal steam bath in allergic rhinitis: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(1): 39-44.
[8] Zahra Hajmohammadi, Mojtaba Heydari, Majid Nimrouzi, Pouya Faridi, Mohammad Javad Zibaeenezhad, Gholamhossein Ranjbar Omrani, Mesbah Shams . Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: A double-blind placebo-controlled randomized clinical trial. Journal of Integrative Medicine, 2018, 16(1): 45-50.
[9] Laura Belland, Laura Rivera-Reyes, Ula Hwang. Using music to reduce anxiety among older adults in the emergency department: A randomized pilot study. Journal of Integrative Medicine, 2017, 15(6): 450-455.
[10] Hilal Yuksel, Yasemin Cayir, Zahide Kosan, Kenan Tastan. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: A randomized controlled trial. Journal of Integrative Medicine, 2017, 15(6): 456-461.
[11] Yoshiharu Motoo, Takashi Hakamatsuka, Nobuo Kawahara, Ichiro Arai, Kiichiro Tsutani. Standards of Reporting Kampo Products (STORK) in research articles. Journal of Integrative Medicine, 2017, 15(3): 182-185.
[12] Maria T.Chao, AlexandraChang, SanjayReddy, James D.Harrison, JosephAcquah, MiriaToveg, TrilceSantana, Frederick M.Hecht. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study. Journal of Integrative Medicine, 2016, 14(3): 228-238.
[13] Nouran A. Aleyeidi, Khaled S. Aseri, Shadia M. Matbouli, Albaraa A. Sulaiamani, Sumayyah A. Kobeisy. Effects of wet-cupping on blood pressure in hypertensive patients: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(6): 391-399.
[14] Maria Sousa Cláudia, Coimbra Daniela, Machado Jorge, J. Greten Henry. Effects of self-administered exercises based on Tuina techniques on musculoskeletal disorders of professional orchestra musicians: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(5): 314-318.
[15] Marco Gemma, Elisa Nicelli, Luigi Gioia, Elena Moizo, Luigi Beretta, Maria Rosa Calvi. Acupuncture accelerates recovery after general anesthesia: A prospective randomized controlled trial. Journal of Integrative Medicine, 2015, 13(2): 99-104.
Full text



[1] Yi-ting He, Qing-lin Zha, Jian-ping Yu, Yong Tan, Cheng Lu, Ai-ping Lv. Principal factor analysis of symptoms of rheumatoid arthritis and their correlations with efficacy of traditional Chinese medicine and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 32-36
[2] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[3] Dong Yang, Yong-ping Du, Qing Shen, Wei Chen, Yan Yu, Guang-lei Chen. Expression of alpha-smooth muscle actin in renal tubulointerstitium in patients with kidney collateral stasis. Journal of Chinese Integrative Medicine, 2008, 6(1): 41-44
[4] Min Cheng, Qiong Feng, Shu-wen Qian, Hui Gao, Cui-qing Zhu. Preliminary assay of p-amyloid binding elements in heart-beneficial recipe. Journal of Chinese Integrative Medicine, 2008, 6(1): 68-72
[5] Hai-feng Wei, Bai-liu Ya, Ling Zhao, Cui-fei Ye, Li Zhang, Lin Li. Evaluation of tongue manifestation of blood stasis syndrome and its relationship with blood rheological disorder in a rat model of transient brain ischemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 73-76
[6] Xi Lin, Jian-ping Liu. Tai chi for treating rheumatoid arthritis. Journal of Chinese Integrative Medicine, 2008, 6(1): 82
[7] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88
[8] Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. Guiding principles of clinical research on mild cognitive impairment (protocol). Journal of Chinese Integrative Medicine, 2008, 6(1): 9-14
[9] Ning-qun Wang, Liang-duo Jiang, Zong-xing Li. Research progress in asthma-related quality of life. Journal of Chinese Integrative Medicine, 2008, 6(1): 93-97
[10] Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022