Clinical Assessment of Treatment Outcomes Following <i>Borago officinalis</i> Extract Therapy in Patients Presenting with Cyclical Mastalgia

Abstract

In order to evaluate the safety and efficacy of Borago officinalis (900 mg borage oil capsules) in the treatment of patients presenting with cyclic mastalgia, 91 subjects were included in the study. Efficacy assessments were performed based on data obtained prior to the start of treatment (Pretreatment), and after each menstrual cycle (Assessment 2-following 45 days of treatment; and Assessment 3-at the end of the 90-day treatment period). Primary efficacy measures considered the results of the Mastalgia Questionnaire, including a 100 mm visual analog pain scale assessing mean, most intense mastalgia severity, and impact on work, sleep, and sexual activity. Safety and tolerability measures included any changes in vital signs and physical exam in relation to pretreatment, any changes in clinical laboratory exams in relation to pretreatment, and the occurrence of adverse events after the first dose of study medication. The VAS scores of the mean mastalgia and most severe mastalgia both showed statistically significant (p < 0.0001) reductions from Pretreatment to Assessment 3. Mean mastalgia scores improved among 92.3% of the treated patients, while most severe mastalgia scores improved among 93.4% of patients. There were sta-* Corresponding author. C. R. B. Gama et al. 364tistically significant improvements in the assessments of mastalgia impact on work (χ 2 = 28.24; gl = 4; p < 0.0001), sleep (χ 2 = 14.29; gl = 4; p = 0.0006), and sexual activity (χ 2 = 16.11; gl = 4; p = 0.0029) during the treatment period. The results of this study indicate a significant improvement in the mastalgia of the treated patients together with an improvement in the quality of life parameters evaluated. In terms of safety, the tolerability of the treatment was good, with the presence of some adverse events, all of which had been previously described with use of the Borago officinalis extract. No serious side effects were reported, and the events that did occur were transitory. Based on the results of this study, we concluded that the Borago officinalis extract was safe and effective in the treatment of cyclic mastalgia among the treated patients.

Plants in Menstrual Diseases: A Systematic Study from Italian Folk Medicine on Current Approaches

“…This conversion increases PGE1 production, and consequently raises intracellular cyclic adenosine monophosphate (cAMP) levels, which in turns inhibits phospholipase, thus limiting the release of arachidonic acid (AA). These metabolites could be effective in the treatment of the physical and emotional symptoms of PMS [52].…”

Borago Officinalis L.: A Review Oon Extraction, Phytochemical, and Pharmacological Activities

“…The impact of B. officinalis oil capsules (900 mg/day) was investigated on cyclical mastalgia (breast pain caused by hormones during the menstrual cycle because of the growth of breast tissue at the same time as ovulationin) in 91 women of reproductive age, with average to severe mastalgia. [149] The pain and its influence on work, sleep, and sexual activity were evaluated and showed significant reductions in both average (92.3 %) and severe mastalgia (93.4 %). Most patients recorded improvements in how mastalgia affected daily life.…”

An alternative yogic approach for cyclical mastalgia—A narrative review

“…Several alternative therapy [ Table 1 ] has been conducted through using evening primrose oil,[ 24 29 30 ] vitamin E,[ 24 30 ] Insoflavones,[ 31 ] borage oil,[ 32 ] structured exercise,[ 33 34 ] flaxseed,[ 35 ] omega-3[ 35 ] and caffeine free diet[ 36 ] including side effects. yoga therapy would be zero side effect therapy.…”