Abstract

OBJECTIVE: To compare the effectiveness of topical versus oral Diclofenac in treatment of cyclical and non-cyclical mastalgia.
DESIGN: A prospective, parallel group, double blind, randomized clinical trial.
METHODS: From April 2011 to August 2012 female patients over age 12 who presented to surgical outpatient department with cyclical or non-cyclical mastalgia were included in the study. They were randomized to either oral diclofenac sodium or topical diclofenac gel for 7 days through computer generated block randomization. Both patients and doctors were blinded to treatment. The response to treatment was measured with Cardiff breast pain score at 7, 30 and 90 days. The effectiveness of both drugs was compared along with the need to use drugs to relieve pain after 7 days and side effects.
RESULTS: A total of 100 patients were recruited in the study. 50 patients were randomized to each group. Response rate was 62% with tab. Diclofenac sodium and 78% with Diclofenac gel at the end of first 7 days. There was no significant difference between the efficacy (P value of CBS at 7, 30 and 90 days was 0.56, 0.88 and 0.94 respectively), need to use drugs after 7 day and side effects of both drugs.
CONCLUSION: Both drugs are effective in reducing mastalgia to at least CBS II which is considered bearable by the patient. No formulation has any advantage over the other. Patient’s personal comfort level with a specific formulation can be the basis for choosing one over the other.
TRIAL REGISTRATION: Chinese trial registry: chiCTR-TRC-11001266.
FUNDING: Self funding.

Key words: Mastalgia, non-cyclical mastalgia, non-steroidal anti-inflammatory drugs