The comparison of the effect of flaxseed oil and vitamin E on mastalgia and nodularity of breast fibrocystic: a randomized double-blind clinical trial

Gholamali Godazandeh,Adeleh Sahebnasagh,Shahram Ala,Aliyeh Bazi,Tahereh Madani Motlaq

doi:10.1186/s40780-020-00186-4

Abstract

BackgroundFibrocystic changes are a common benign condition in women aged 20–50. The medical intervention aims to stop fibrocystic disease progress and relieve the breast’s pain and tenderness. In the long-term, reversing the fibrocystic changes is also desirable.MethodsIn this randomized double-blind clinical trial, the effect of flaxseed oil on the severity of pain and breast nodularity was investigated against vitamin E. This study was conducted on 100 women with mastalgia. The intervention group received Flaxseed oil pearls and the control group received vitamin E pearl 200 IU twice a day for 2 months. The duration and severity of breast pain were evaluated by Cardiff chart and VAS (Visual Analogue Scale). The nodularity was assessed by Lucknow-Cardiff scale at baseline, then the first and second months of intervention.ResultsAt baseline, there was no statistically significant difference between the two groups in characteristics. The breast pain improved in both groups during the first and second months of intervention (P-value within group< 0.001). However, the mean breast pain was not significantly different between the two groups at the end of the first and second month (P1= 0.54, P2= 0.73). Furthermore, the breast pain during four phases of the menstrual cycle showed no difference between vitamin E and flaxseed oil groups (menstruation phase= 0.76, follicular phase= 0.48, the first week of luteal phase= 0.86, the second week of luteal phase=0.30). The breast nodularity also decreased during the first and second months of intervention, yet no significant difference between the two groups was found (p= 0.9).ConclusionsThis study showed that flaxseed oil and vitamin E both could be effective in breast pain-relieving and decreasing nodularity with minimal side effects in contrast with the baseline. But there are no significant differences between these two agents. Larger scale prospective studies are needed to evaluate these effects in the long-term.Trial registrationIRCT201612243014N18, Registration date: 2017-10-15.

Highlights

Fibrocystic changes are a common benign condition in women aged 20–50
This study aimed to evaluate the effects of flaxseed oil, capsules containing 1000 mg alfa linolenic acid, in comparison with vitamin E on breast nodularity and mastalgia of breast fibrocystic patients
The moderate to severe mastalgia was defined as the pain score above 4 in the visual analog scale (VAS) associated with breast fibrocystic and nodularity

Summary

Introduction

Fibrocystic changes are a common benign condition in women aged 20–50. The medical intervention aims to stop fibrocystic disease progress and relieve the breast’s pain and tenderness. Fibrocystic breast change is a common and benign condition which are experienced by 13.5–42% of women usually of reproductive ages. The proliferative changes include breast nodularity (presence of macro and micro cysts) which could be localized or diffused [1, 2]. It could be adenosis which means an increase in the size or number of cysts [3], or apocrine metaplasia and fibrosis. The breast pain is usually bilateral and lasts more than 5 days in a menstrual cycle This pain is more severe before menstruation and ends up after menopause [4, 6]. Other symptoms such as nipple discharge and changes in the appearance of the nipple may occur

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