Efficacy of topical nonsteroidal antiinflammatory drugs in mastalgia treatment

J Am Coll Surg. 2003 Apr;196(4):525-30. doi: 10.1016/S1072-7515(02)01893-8.


Background: The aim of the study was to investigate the effects of topical nonsteroidal antiinflammatory drugs (NSAIDs) on mastalgia.

Study design: A prospective, randomized, blinded, placebo-controlled study was performed to evaluate the effects of topical NSAIDs on cyclic and noncyclic mastalgia. A total of 108 patients, 60 with cyclic (group I) and 48 with noncyclic (group II) breast pain were enrolled. Patients within each group were randomly assigned to receive either topical NSAIDs or placebo three times daily for at least 6 months. Severity of pain was measured before and after 6 months of treatment.

Results: The pain score decreased significantly when the mean initial breast pain score was compared with the sixth-month breast pain score of the treatment or the placebo group of cyclic (p = 0.0001 and p = 0.0001, respectively) or noncyclic mastalgia (p = 0.0001 and p = 0.0001, respectively). Significant differences were found when the mean within-person change in pain values in each treatment group were compared with the change in the respective placebo group for either cyclic or noncyclic mastalgia (p = 0.0001 and p = 0.0001, respectively). Changes in pain within treatment groups or placebo groups for cyclic versus noncyclic mastalgia were not found to be statistically different (p = 0.53 and p = 0.96, respectively). No side effect was seen in any group.

Conclusions: Topical application of NSAIDs was effective in both cyclic and noncyclic mastalgia with minimal side effects.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Analysis of Variance
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Breast Diseases / drug therapy*
  • Chi-Square Distribution
  • Diclofenac / administration & dosage
  • Diclofenac / therapeutic use*
  • Female
  • Humans
  • Middle Aged
  • Pain / drug therapy*
  • Pain Measurement
  • Prospective Studies
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • Diclofenac