Evidence base: Benign breast disease

A summary of the clinical trials, guidelines, key texts and online resources to help in the management of benign breast disease

Ultrasound scan showing a simple cyst in the breast (Author image)

The evidence regarding the natural history and management of benign breast disease has been derived primarily from descriptive pathological, observational and retrospective studies. RCTs have rarely been used in this context.

The treatment of mastalgia, for example, has been subjected to such trials, whereas the management of a common condition like fibroadenoma has not been subjected to RCTs.

Clinical trials

  • Srivastava A, Mansel RE, Arvind N et al. Evidence-based management of mastalgia: a meta-analysis of randomised trials. Breast 2007; 16(5): 503-12.

These authors conducted a meta-analysis of all mastalgia trials published in the English language. The study was restricted to RCTs comparing bromo-criptine, danazol, EPO and tamoxifen with placebo. The analysis showed that EPO offered no advantage over placebo in pain relief. Bromocriptine and danazol produced a significant benefit, with a mean pain score difference. Low-dose tamoxifen (5mg daily) was effective and had fewer side-effects.

This study demonstrated that cabergoline (0.5mg weekly) is as effective as bromocriptine for the treatment of cyclic mastalgia, but has minimal side-effects compared to bromocriptine.


Key text

  • Hughes LE, Mansel RE, Webster DJT. Benign Disorders and Diseases of the Breast (third edition). Philadelphia, WB Saunders, 2009.


This is a useful overview of benign breast disease.


Contributed by Professor Kefah Mokbel, lead breast surgeon, the Princess Grace Hospital, and honorary consultant breast surgeon, St George's Hospital


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