Abstract
Background: 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. In the long-term, reversing the fibrocystic changes is also desirable. Methods: In 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. Results: At 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). Conclusions: This 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.
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Key Points
Fibrocystic breast change is a common and benign condition which are experienced by 13.5–42% of women usually of reproductive ages. The breast fibrocystic involves both nonproliferative and proliferative changes occurred concurrently or separately. Cyclic mastalgia may occur with breast fibrocystic. However, some women experience continuous pain. 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. The purpose of medical interventions is relieving mastalgia, cessation of its progression, and finally reversing the changes. Flaxseed (Linum usitatissimium) is one of the richest sources of essential unsaturated fatty acid α-linolenic acid (55%) and lignans, well known as phytoestrogens and antioxidants. Lignans have SERMS (selective estrogen receptor modulators) properties. Flaxseed can reduce cell proliferation and growth in breast cancer.
There were few studies about the effect of flaxseed oil on breast fibrocystic. In previous studies which were conducted to evaluate the effect of flaxseed on cyclic mastalgia, a specific amount of flaxseed powder (25–30 g/d) was administered for patients. Flaxseed oil capsules formulation standardized with respect to the active chemical constituent (alfa linolenic acid) in comparison with powder of flaxseed. Moreover, most of the ingredients in the flaxseed do not enter the oil. Then, the study considers the effect of alfa linolenic acid as omega-3 fatty acid on breast fibrocystic. 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.
In this study, 51 patients received 1000 mg of flaxseed oil (two times daily) and 49 patients received vitamin E 200 units (two times daily) for 2 months. The severity of breast pain and nodularity were assessed. The results of the present study indicated that flaxseed oil and vitamin E both can reduce breast pain and improve nodularity. In most studies of breast fibrocystic, the powder of flaxseed was used to reduce mastalgia and nodularity, but in this study, flaxseed oil capsules containing about 1000 mg alfa linolenic acid as an omega-3 fatty acid were used. The results of the present study demonstrated that flaxseed oil and vitamin E both could be effective in breast pain-relieving and decreasing nodularity in comparison with the baseline. Moreover, few side effects were seen during the treatment. More studies are needed to confirm these effects in the long-term with different doses of intervention medications.