Skin‐patch Of Ding Zi Gao on Relieving Local and Systemic Symptoms in Patients with Moderate to Severe Periodic Mastalgia: A Randomized, Double‐Blind Trial
Authors: Huan Liang , Qiao Huang , Yujian Sun , Na Fu , Wenjie Zhao , Hao Dong , Dongxiao Zhang 
Published: November 2021

Abstract
Background and purpose: The use of hormone receptor agent drugs such as androgens (tamoxifen) for the treatment of moderate and severe breast pain has limitations such as cardiac, hepatic, and nephrotoxicity and gastrointestinal side effects. Therefore, there is a need to prescribe a new safe and effective topical treatment method to reduce the use of anti-inflammatory and hormonal agent drugs, the incidence of adverse effects and the financial burden on patients. This randomized controlled clinical trial investigates the clinical efficiency and safety of Skin‐patch of Ding Zi Gao (DZG) acupoint-application therapy for the treatment of moderate to severe Periodic mastalgia (MSPM), and provides a basis for the design of an optimized, safe and effective comprehensive treatment plan for MSPM.Methods: Sixty patients with moderate to severe Periodic mastalgia (MSPM) who met the inclusion criteria were selected from the breast clinic of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University and randomly divided into 30 cases in the treatment group and 30 cases in the control group. The treatment group was treated by Skin‐patch of Ding Zi Gao (DZG) acupoint-application therapy, which was applied from the 3rd day after the end of menstruation, once a day, for 6-8 h each time, 14 times as a course of treatment, and the treatment was completed within 1 month, and the application was stopped during menstruation. The control group was treated with skin patches of placebo acupoint application, and the duration and course of treatment were the same as that of the treatment group. During the 14 day course of treatment and 2-month follow-up after the experiment, the main outcome indicators (including Breast pain improvement onset time, change in breast pain VAS score, change in patient's mood, sleep, Fullness in both flank, (McGill Pain Questionnaire) MPQ and secondary outcome indicators ( Including changes in breast nodule size and gland thickness guided by breast ultrasound, VAS pain score in the 2-month follow-up at the end of treatment, and adverse reactions), At the same time, the safety of the scheme was evaluated.RESULTS: There were no differences between the two groups in terms of age, body mass index, history of breastfeeding, family history of breast disease, history of allergies, history of breast surgery, or duration of breast pain (months) before recruitment. The comparison between pre-treatment and post-treatment showed that the time to onset of breast pain improvement, visual analogue score (VAS) of breast pain, improvement in mood, sleep, fullness in both flank and the MPQ were significantly lower in both groups after treatment, and the improvement was more significant in the treatment group than in the placebo control group (P < 0.05). Both groups showed significant reductions in improving patient mammography outcomes and VAS pain scores at two months of follow-up, but there were no significant differences between the groups. In terms of safety evaluation, no significant differences in the incidence of adverse events were found.CONCLUSION: point-application treatment with skin patches of Ding Zi Gao (DZG) therapy in patients with MSPM improved breast pain and swelling, reduced breast gland thickness, and decreased breast visual analogue pain score (VAS) and MPQ score. Its efficacy was significantly better than skin patches of placebo acupoint application therapy alone. This study provides a basis for the clinical application of DZG for MSPM.