Guidelines for the clinical application of the Xihuang pill for the prevention and treatment of breast hyperplasia diseases

Figures & data

Table 1. Members of the guideline develop team.

	Work unit	Title
Consultant
Zhihua Zheng	Guangdong Pharmaceutical Association	Vice Chairman and Secretary-General, Chief Pharmacist
Writing member
Lizhu Lin	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Professor
Hongmei Tang	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Chief Pharmacist of Traditional Chinese Medicine
Shiyin Feng	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Supervising Pharmacist of Traditional Chinese Medicine
Member
Tianqi Yu	The Third Affiliated Hospital of Guangzhou University of Chinese Medicine	Chief Physician of Traditional Chinese Medicine
Li Deng	The Affiliated Traditional Chinese Medicine Hospital of Guangzhou Medical University	Chief Physician
Tao Liu	Sun Yat-sen University Cancer Center	Chief Pharmacist
Zhenwen Qiu	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Chief Pharmacist of Traditional Chinese Medicine
Cuiling Liu	Shenzhen Bao’an Traditional Chinese Medicine Hospital Group	Associate Chief Pharmacist of Traditional Chinese Medicine
Junyan Wu	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Chief Pharmacist
Liming Li	The Affiliated Traditional Chinese Medicine Hospital of Guangzhou Medical University	Chief Pharmacist of Traditional Chinese Medicine
Yuzhen Li	The Eighth Affiliated Hospital, Sun Yat-sen University	Chief Pharmacist
Lixia Zhu	The Eighth Affiliated Hospital, Sun Yat-sen University	Associate Chief Pharmacist
Zhiwei Xiao	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Associate Chief Physician of Traditional Chinese Medicine
Wanyin Wu	Guangdong Provincial Hospital of Chinese Medicine	Chief Physician
Gaofeng Chen	Guangdong Second Traditional Chinese Medicine Hospital	Chief Physician of Traditional Chinese Medicine
Bo Ji	Chinese PLA General Hospital of Southern Theater Command	Chief Pharmacist
Chengguang Zhang	Guangdong Second Traditional Chinese Medicine Hospital	Chief Pharmacist of Traditional Chinese Medicine
Jun Chen	Shenzhen Traditional Chinese Medicine Hospital	Chief Pharmacist of Traditional Chinese Medicine
Hua Lin	Guangdong Provincial Hospital of Chinese Medicine	Chief Pharmacist of Traditional Chinese Medicine
Jietao Lin	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Chief Physician
Yong Ouyang	Guangzhou Hospital of Integrated Traditional and Western Medicine	Chief Pharmacist of Traditional Chinese Medicine
Qi Liang	Shenzhen Bao’an Traditional Chinese Medicine Hospital Group	Chief Pharmacist of Traditional Chinese Medicine
Weiwen Peng	Zhongshan Hospital of Traditional Chinese Medicine	Chief Pharmacist of Traditional Chinese Medicine
Kaijun Lei	Foshan Hospital of Traditional Chinese Medicine	Chief Pharmacist of Traditional Chinese Medicine
Qingqun Cai	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Chief Pharmacist of Traditional Chinese Medicine
Secretary
Qin Lu	The First Clinical Medical School of Guangzhou University of Chinese Medicine	Master’s student
Xueting Liu	The First Clinical Medical School of Guangzhou University of Chinese Medicine	Master’s student
Zexin Zhang	The First Clinical Medical School of Guangzhou University of Chinese Medicine	Master’s student

Table 2. Summary of clinical studies of xihuang pill.

Type of Research	Number of patients	Medications	Results	Reference
Case Report	1	Oral Xihuang pill+ Jiawei Xiaoyao Pill	Stabilized mood stability, increased menstrual flow, decreased blood clots.	Shao JF. 2018. Clinical application of Xihuang pill. Smart Healthcare. 4(09):119-120. (Chinese).
	1	Oral Xihuang pill	Soften lumps in both breasts and reduce pain	Zhu DS. 2009. A case of breast hyperplasia treated with Xihuang pill. In: Beijing Tongrentang Science and Technology Development Co., Chinese Journal of Traditional Chinese Medicine, editors. [Proceedings of the Research on Clinical Application of Xihuang Pills]. Beijin(China): Chinese Association of Chinese Medicine. p.127. (Chinese).
	1	Oral Xihuang pill	Improve the degree of glandular disorder, without pain and discomfort	Zhu DS. 2009. A case of breast atypical hyperplasia treated with Xihuang pill. In: Beijing Tongrentang Science and Technology Development Co., Chinese Journal of Traditional Chinese Medicine, editors. [Proceedings of the Research on Clinical Application of Xihuang Pills]. Beijin(China): Chinese Association of Chinese Medicine. p.128. (Chinese).
	1	Oral Xihuang pill	Glands of both breasts showed no significant abnormality after treatment	Zhang DX. 2009. Report of a case of cystic hyperplasia of the breast treated with Xihuang pill. In: Beijing Tongrentang Science and Technology Development Co., Chinese Journal of Traditional Chinese Medicine, editors. [Proceedings of the Research on Clinical Application of Xihuang Pills]. Beijing (China): Chinese Association of Chinese Medicine. p.148-149. (Chinese).
	1	Oral Xihuang pill + Prescription based on differential diagnosis	Breast swelling and pain improved and the lumps shrunk.	Liu L. 2009. Xihuang pill Clinical Experiments. In: Beijing Tongrentang Science and Technology Development Co., Chinese Journal of Traditional Chinese Medicine, editors. [Proceedings of the Research on Clinical Application of Xihuang Pills]. Beijing (China): Chinese Association of Chinese Medicine. p.91. (Chinese).
Clinical Observation/Trials	58	Intervention: Oral Xihuang pills Control group: Oral Rupi Xiao tablet	Xihuang pills were more effective than Rupi xiao tablet in treating breast hyperplasia	Chen ZH, Chen ZR, Zeng LH, Yang HC, Lu FH. 2010. Observation on the efficacy of Xihuang pill in treating 58 cases of breast hyperplasia. Chinese Journal of Traditional Chinese Medicine and Pharmacy. 25(11):1919-1920. (Chinese).
	132	Oral Xihuang Pills + Tamoxifen Control Group: Rupi Xiao tablet	Combination of Xihuang pill and tamoxifen was more effective than Rupi Xiao tablet	Zeng LZ, Ding ZS. 2003. Clinical observation on 132 cases of breast hyperplasia treated by Xihuang pill with tamoxifen. Chinese Journal of Primary Medicine and Pharmacy. (02):77. (Chinese).
	118	Oral Xihuang Pills + Xiaoyao Pills	Combination of two drugs was simple and effective in treating breast hyperplasia.	Zhang Q, Wen HB. 2006. Clinical observation on the treatment of breast hyperplasia by Xihuang pill together with Xiaoyao Pills. Journal of Practical Medical Technology. (14):2448-2449. (Chinese).
	120	Oral Xihuang Pills	More effective in treating breast enlargement disease	Gao YH, Tian Z, Wang XX, Yuan HE, Gao QZ. 2009. Observation on the therapeutic effect of Xihuang pill in the treatment of breast hyperplasia disease. In: Beijing Tongrentang Science and Technology Development Co., Chinese Journal of Traditional Chinese Medicine, editors. [Proceedings of the Research on Clinical Application of Xihuang Pills]. Beijin(China): Chinese Association of Chinese Medicine. p.114. (Chinese).
	160	External application of Xihuang Pills + oral administration of Rupi Xiao Tablets Control group: Oral Rupi Xiao tablet	External application of Xihuang pill in the treatment of breast hyperplasia with good clinical efficacy.	Han T, Lan YM, Han P, Cheng ZQ. 2009. Clinical study on the treatment of breast hyperplasia by external application of Xihuang pill. Journal of Chinese Medicinal Materials. 32(11):1793-1794. (Chinese).
	56	Oral Xihuang Pills Control group: Oral Rupi Xiao tablet	Xihuang Pills were more effective than Rupi Xiao tablet in treating breast hyperplasia.	Sui YB. 2010. Clinical observation on the treatment of breast hyperplasia disease by Xihuang pill. Chinese Journal of Traditional Chinese Medicine and Pharmacy. 25(04):618-619. (Chinese).
	98	Oral Xihuang Pills + Xiaoyao pills	Combination of two drugs was simple and effective in treating breast hyperplasia.	Jin J. 2009. Clinical study on the treatment of breast hyperplasia by Xihuang pill together with Xiaoyao Pill. In: Beijing Tongrentang Science and Technology Development Co., Chinese Journal of Traditional Chinese Medicine, editors. [Proceedings of the Research on Clinical Application of Xihuang Pills]. Beijin(China): Chinese Association of Chinese Medicine. p.79. (Chinese).

Table 3. The syndrome differentiation based on concurrent clinical and relevant symptoms.

Combination of symptoms	Clinical symptom	Tongue Diagnosis	Pulse
Concurrent Blood Stasis Syndrome	Breast soreness, delayed menstruation, dark menstrual blood with clots, and premenstrual abdominal pain.	The tongue may appear dark with stasis spots or ecchymosis.	The pulse may be tight or astringent.
Concurrent Phlegm-Stasis Syndrome	An overweight body, less prominent breast pain, and a tough lump texture. They may also show fatigue, phlegm presence, poor appetite, and symptoms of chest congestion, hypochondriac fullness, irritability, and restlessness.	The tongue coating could be thin or greasy.	With a yellow coating and a slippery pulse.
Concurrent Liver-Fire Syndrome	Breast swelling and pain, possibly with the sensation of burning heat. Other symptoms include irritability, early menstruation with dark and heavy flow, dry and bitter mouth.	A red tongue, yellow or greasy coating.	A wiry or rapid pulse.

Jin J. 2009. Clinical study on the treatment of breast hyperplasia by Xihuang pill together with Xiaoyao Pill. In: Beijing Tongrentang Science and Technology Development Co., Chinese Journal of Traditional Chinese Medicine, Editors. [Proceedings of the Research on Clinical Application of Xihuang Pills]. Beijing (China): Chinese Association of Chinese Medicine. p. 79. (Chinese).

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