Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin

Topical Diclofenac for the Treatment of Noncyclic Breast Pain

The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.

A prospective, randomized, double-blinded crossover trial comparing topical diclofenac and placebo for 10 weeks in the treatment of 30 women with noncyclic mastalgia and surgical scar-related breast pain.

Inclusion criteria

• Noncyclic mastalgia or surgical scar-related pain occurring at least 2 days per week and for which the patient desires treatment
• Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
• Age > 18 years
• Satisfactory breast examination and directed ultrasound at site of pain (all ages) within 12 months
• Satisfactory mammogram (all women > 30 years of age) within 12 months
• Negative pregnancy test (all women who are premenopausal and have not had hysterectomy or tubal ligation)

Exclusion criteria

• Cyclic mastalgia (as defined above)
• Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
• Abnormal breast examination or imaging (abnormality at the site of pain or for which biopsy or surgical consultation is recommended)
• Known pregnancy, lactation, positive pregnancy test, or anticipated pregnancy within 6 months
• Asthma, that has been aggravated by oral nonsteroidal antiinflammatory agents
• Allergy, to diclofenac or any nonsteroidal antiinflammatory agents
• Rash or open lesions at the site on the breast where the topical agent would be applied
• Incomplete or abnormal healing (surgical scar-related pain)
• History of gastrointestinal ulceration, renal dysfunction (creatinine > 1.5), hepatic disease (known liver disease or aspartate aminotransferase (AST) twice normal levels), congestive heart failure and uncontrolled hypertension (blood pressure > 140/90)