Acupuncture for Breast Pain

The Safety and Efficacy of Acupuncture in Moderate to Severe Cyclic Breast Pain

This study is conducted to assess the efficacy and safety of acupuncture in moderate to severe cyclic breast pain.

Inclusion Criteria:

• Meeting the diagnosis criteria of cyclic breast pain.
• Female patients aged between 18 and 55.
• Relatively regular menstrual cycle.
• Cyclic breast pain lasting for 3 consecutive menstrual cycles or more.
• The score of worst pain ≥5 on Numerical Rating Scale and any level of breast pain lasting 5-21 days during the run-in period of one menstrual cycle.
• No previous experience of acupuncture for breast diseases.
• Willing to use nonhormonal contraceptives if any risk of pregnancy.
• Volunteer to the trial and signing written informed consent.

Exclusion Criteria:

• Noncyclic breast pain.
• Extramammary pain only.
• A history of breast cancer or suspicious of malignancy breast disease by examinations.
• The Breast Imaging Reporting and Data System (BI-RADS) category 4-6 in ultrasound or mammography examinations.
• Combined with mastitis.
• Breast pain following injury, surgery, hormones, and/or other drugs.
• Usage of hormones (including hormonal contraceptives) in the past three months.
• Combined with severe diseases in the cardiac, respiratory, renal, liver, and hematopoietic systems, psychiatric disorder and/or cognitive disorders.
• A history of bilateral ovariectomy or premature ovarian failure.
• Pregnancy, lactation, or wishing to conceive before the end of the trial.
• Poor adherence.