Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Breast Pain

Mayo Clinic

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cyclical Breast Pain

Treatments

Drug: Vitamin E, Evening Oil of Primrose, and Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00275600

1957-02

Details and patient eligibility

About

This study is being done to find out what effects Vitamin E or Evening Oil of Primrose has on cyclical breast pain.

Full description

Cyclical mastalgia is a common complaint of women presenting to their primary care physicians. Cyclical breast pain is defined as prementstrual breast discomfort associated with hormonal fluctuations during the menstrual cycle. A clinical breast examination and sometimes additional imaging, such as sonography or mammography, is required as part of the evaluation to exclude malignancy. For most women, the symptoms are effectively managed with reassurance and conservative treatment measures such as the use of a supportive bra or over the counter pain medication such as acetaminophen or anti-inflammatories. However, a small number of women will require additional drug treatment with danazol after failing to respond to conservative measures. Unfortunately, danazol is associated with significant side effects. In the Mayo Breast Clinic, women with cyclical breast pain are managed with Vitamin E and Evening oil of primrose (EOP) either as single agents or in combination. These over the counter supplements are readily available, acceptable due to minial side effects and appear to lead to significant reduction in breast pain. We propose a randomized placebo controlled trial to determine if any vitamin E or EOP or the combination of both are effective in managing cyclical breast pain.

Enrollment

82 patients

Sex

Female

Ages

18 to 56 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

18 years or older
premenopausal
cyclical breast pain
breast pain survey indicating 3 or more on scale of 1-10
if > 40 years of age, need normal mammogram and/or ultrasound if indicated and if not done within the last year
if < 40 years of age, a directed ultrasound in the area of pain
can be on oral contraceptives