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Topical NSAID for mastalgia

Background
Randomised trial [2]
Results
Comment

Bandolier is often challenged about common conditions for which there are only imperfect treatments. Mastalgia is common in women of reproductive age, with a significant impact on activities of everyday living. Use of topical NSAID appears to be effective, based on good but limited evidence.

Background

An excellent review of management of mastalgia sets the scene [1]. It tells us that breast pain is of three types, about half of patients having pain for about five days in the days before menstruation, about a quarter having non-cyclical breast pain, and the rest having some extra-mammary pain usually associated with inflammation of the chest wall.

For those women with cyclical or non-cyclical mastalgia recording of pain and reassurance, together with some lifestyle changes, can be helpful. For instance, a well-fitting brassiere will help many. Weight loss and low fat diets can reduce oestrogen production, and that will resolve the problem with more.

Some treatments are known not to work, like evening primrose oil, vitamin supplements, or caffeine reduction. Treatments that do work are primarily hormonal, like danazol, tamxofen or bromocriptine. Though effective, adverse events are major problems, resulting in high dropout rates. Two trials of topical NSAIDs, only one of which was randomised, had high levels of efficacy without adverse events or dropouts.

Randomised trial [2]

In this Turkish study, 60 women with cyclic mastalgia and 48 with non-cyclic mastalgia were separately randomised to receive topical diclofenac or a placebo of soft, white paraffin. Gel equivalent to about 50 mg of diclofenac was applied to the breast skin three times a day for six months. Randomisation was by centrally administered computer-generated list with allocation concealment, but it is not certain that the two gels were identical.

Women were all advised to reduce dietary caffeine and fat intake, and all had routine breast examination, and either sonography or mammography, depending on age. Abnormality of biochemical tests was an exclusion criterion, but all the women had to have mastalgia that affected their daily lives. Most had failed on other treatments because of adverse events or lack of efficacy.

Pain was measured on a visual analogue scale, and adverse events, particularly local effects, but also systemic effects like breathing disorders, were specifically sought.

Results

There were no differences between the groups, and the average age of the women was about 40 years. All women completed the study and there were no adverse events.

Initial pain scores were high (Figure 1) and remained high with placebo. With topical diclofenac pain scores fell from very high to very low (Figure 1). With topical NSAID, fourteen women (47%) with cyclical mastalgia and 12 (50%) with non-cyclical mastalgia had no pain after six months, compared with no woman using placebo. The relative benefit was 27 (95% CI 4 to 190) and the number needed to treat with topical diclofenac for six months for one woman to have no breast pain compared with placebo was 2.1 (1.6 to 2.9).



Figure 1: Breast pain at start of trial and after six months of topical diclofenac in women with cyclical and non-cyclical mastalgia





Comment

This is an interesting and impressive result, showing high efficacy. The fact that blinding was not explicitly described is a problem, and, of course, this is just one (small) randomised trial. On the other hand topical NSAIDs are known to be effective for a range of acute and chronic conditions, and are known to be generally safe. The result is no big surprise, therefore.

It would be good to have the result confirmed, perhaps with other topical NSAID formulations, particularly with those products that are available without prescription. Many women might then be able to become their own expert patient.

References:

  1. R Gumm et al. Evidence for the management of mastalgia. Current Medical Research and Opinion 2004 20: 681-684.
  2. T Colak et al. Efficacy of topical nonsteroidal anti-inflammatory drugs in mastalgia treatment. Journal of the American College of Surgeons 2003 196: 525-530.

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