Comparison of naproxen with placebo for the management of noncyclical breast pain: a randomized, double-blind, controlled trial

Abstract

Background: Breast pain is a common symptom in patients attending breast clinics. Although most patients experience mastalgia of mild to moderate severity, approximately 15% of patients suffer from severe pain that causes significant distress and some disturbance in their daily life that lead them to seek treatment. Despite a considerable number of drugs suggested for decreasing the severity of mastalgia, there is no standard treatment for the complaint. In this study, we investigated the effect of naproxen on reducing the complaint of breast pain compared with placebo.

Methods: Eighty-one women suffering from noncyclic breast pain were recruited to a randomized, double-blind, clinical trial between January 2002 and September 2004. All patients were suffering from this complaint for at least 3 months before the study. Patients were randomly assigned to two groups. Patients in the case group received naproxen 250 mg BD. Patients in the placebo group took placebo in a similar manner. The intensity of mastalgia was assessed before and twice after intervention by using a Visual Analogue Scale.

Results: Forty-two of 81 patients were recruited randomly as cases and the remaining 39 were assigned placebo. Of these 24 and 22 patients fulfilled the study protocol respectively. The mean age of patients was 35 (SD = 7.5; range, 19-55) years. The mean pain severity at the beginning of the study was 5.8 and 6.1 in naproxen and placebo groups, respectively. The severity of pain was decreased significantly at the end of the study in both groups (3.9 in patients and 3.7 in controls (P = 0.005 and 0.0001)). Although the decrease in pain severity in each individual group was statistically significant, it was not significant compared with one another (P = 0.64).

Conclusions: Breast pain is a complex symptom that can be relieved significantly with reassurance. According to the result of this study, naproxen has no superiority over placebo in reducing noncyclic breast pain.