Objective

2

To evaluate the clinical effect and safety of wet hot compress of modified

Xiaohua

Plaster

（消化膏） on hyperplasia of mammary gland with moderate to severe breast pain.

Methods

2

Seventy-two patients with mammary gland hyperplasia and moderate to severe breast pain were randomly divided into treatment group of 36 cases and control group of 35 cases after excluding one case. The treatment group was given wet hot compress of modified

Xiaohua

Plaster，

and the control group was treated with wet hot compress of placebo， once daily， for 28 days. The mammary gland hyperplasia-related pain symptom score， score of breast lump size， texture， and distribution， breast pain visual analog score （VAS）， the largest diameter of the breast lump measured by hand， accompanying symptom scores， mammary gland thickness， and thickest diameter of breast duct were measured and compared before and after treatment， and the safety was evaluated.

Results

2

After treatment， the score of mammary gland hyperplasia-related pain symptoms， breast pain VAS， accompanying symptom score， as well as score of breast lump size， texture and distribution， and the largest diameter of the breast lump were significantly reduced in both groups （

P

＜0.01）， and more decreases were seen in the treatment group than in the control group （

P

＜0.05 or

P

＜0.01）. The thickest diameter of breast duct and the mammary gland thickness significantly decreased after treatment in the treatment group （

P

＜0.05）.One case in the treatment group had scattered rash on the local skin during the first treatment， which disappeared after the treatment was suspended， and no other adverse reactions were seen in the continuous treatment.There were no adverse reactions in the control group.

Conclusion

2

Wet hot compress of modified

Xiaohua Plaster

can effectively relieve the breast pain and tenderness caused by mammary gland hyperplasia， soften the lump， reduce the lump and the distribution range， and can effectively relieve the associated symptoms related to breast hyperplasia， and is of good safety.