Effect of Evening Primrose Oil and Vitamin B6 on Pain Control of Cyclic Mastalgia Associated with Fibrocystic Breast Changes: A Triple-Blind Randomized Controlled Trial

Abstract

Background: Mastalgia is the most common symptom of fibrocystic breast changes. It causes concern and fear of breast cancer and has negative effects on quality of life. The study aimed to compare the effectiveness of evening primrose oil (EPO) and vitamin B6 in the pain control of cyclic mastalgia. Methods: This triple-blind randomized controlled clinical trial was conducted on 94 patients with mastalgia referring to the breast clinic of Milad hospital, Tehran, Iran. The participants were randomly assigned to three groups: EPO (n = 33), vitamin B6 (n = 31), and placebo (n = 30). The mastalgia severity in the three groups was measured using Visual analogue scale (VAS) before intervention and at the first, second, and third months after the beginning of the intervention using SPSS 18. Results: The results of this study showed that the mean severity of breast pain significantly reduced at the first, second, and third months after the intervention in the EPO (2.61 ± 2.35) and vitamin B6 groups (2.81 ± 1.97) (P < 0.001). However, the mean score of pain severity in the placebo group before and after the intervention did not show a statistically significant difference (5.38 ± 2.28) (P = 0.815). In addition, the difference in the mean score of pain severity between the two groups of EPO and vitamin B6 was not statistically significant (P = 0.999). Conclusions: The results of this study showed that vitamin B6 and EPO have the same therapeutic effects in the treatment of cyclic mastalgia. Because of the low cost and more availability of vitamin B6 compared to EPO, it can be used in the first line of treatment.

Vitamin B6 Effects on Breast Pain in Women of Reproductive Age: A Systematic Review

“…The results showed that both evening primrose oil (EPO) and vitamin B6 decreased breast pain, but vitamin B6, as a cheaper and more easily available agent, was shown to have significantly better pain-reducing effects (P < 0.001 and CI = 95%). In the placebo group, there was no significant reduction in breast pain (P = 0.815) (21). Paine score (0-3)…”

“…Mean baseline pain scores were 1.51 in control and 1.67 in the intervention group, showing 0.75 and 0.61 reduction after treatments, respectively (P < 0.01) (20). Jahdi et al (2018) compared the effects of vitamin B6 and evening primrose. Thirty-one women (18 -50 years old) received 50 mg vitamin B6 twice daily for three months.…”

“…The effect of vitamin B6 on reducing breast pain has been compared with vitamin E and a herbal medicine (i.e., EPO), revealing the same efficacy for all three agents (21,22). In the study of Jahdi et al, vitamin B6 was tested against EPO, suggesting vitamin B6 as a more widely available and cheaper pain-reducing compound (21).…”

“…The effect of vitamin B6 on reducing breast pain has been compared with vitamin E and a herbal medicine (i.e., EPO), revealing the same efficacy for all three agents (21,22). In the study of Jahdi et al, vitamin B6 was tested against EPO, suggesting vitamin B6 as a more widely available and cheaper pain-reducing compound (21). Other studies have also compared the analgesic effects of vitamin E with that of EPO (27)(28)(29)(30)(31)(32)(33), and some have reported comparable effects for the two agents in reducing breast pain (27,29,31,33).…”

Effect of evening primrose oil on postoperative pain after appendectomy: A double-blind, randomized, clinical trial

“…Some sources consider right daily intake of evening primrose oil about 8 g for adults and 4 g for children [ 22 , 23 , 25 , 38 , 39 ]. In terms of side effects and safety of evening primrose in humans, although it is usually well tolerated and no significant side effects have been documented in the medical literature, it has been recommended that using evening primrose oil during pregnancy should be avoided [ 14 , 40 ].…”