Authors' objectives:

The authors consider the effectiveness of evening primrose oil (EPO) in the treatment of cyclical mastalgia (breast pain which varies with the menstrual cycle), taking into account that exclusion of malignancy and reassurance are the main stays in the management of patients with mastalgia.

Authors' results and conclusions: The interpretation of treatments for cyclical mastalgia is complicated by possible confounding effects. Firstly cyclical mastalgia is considered to have a natural history of spontaneous remission usually related to hormonally related events such as pregnancy or the menopause and a placebo response as high as 94%. Secondly the inclusion criteria, study design and response to treatment measures differ in all of the randomised controlled trials and it is not possible to combine results nor make direct comparisons between the studies. Two partially unblinded randomised controlled trials have concluded that cyclical breast pain is improved by EPO. Three other trials, two fully blinded, randomised and placebo controlled, did not detect any difference between placebo and treatment effects.

Authors' recommendations: EPO has not been shown to be more effective than placebo in any trial that has been double blind control throughout. Other treatments may be effective and less expensive but have more side effects, and it is this last factor which has ensured that many consider EPO a first line treatment. The authors conclude that all of the studies suffer from shortcomings, and that there is no current good evidence to recommend the use of EPO for cyclical mastalgia. This will not change unless larger robust controlled trials produce positive results. However EPO may be an effective placebo.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.wihrd.soton.ac.uk

Year Published: 1996

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England

Organisation Name: Wessex Institute for Health Research and Development

Contact Address: Pauline King. Wessex Institute for Health Research and Development, Boldrewood Medical School, Bassett Crescent East, Highfield, Southampton. SO16 7PX Tel. +44 1703 595661 Fax +44 1703 595662

Copyright: Wessex Institute for Health Research and Development (WIHRD)