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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. Ef- ficacy assessments were performed based on data obtained prior to the start of treatment (Pre- treatment), 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 pre- treatment, any changes in clinical laboratory exams in relation to pretreatment, and the occur- rence of adverse events after the first dose of study medication. The VAS scores of the mean mas- talgia 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.

international journal of clinical medicine

Clinical Assessment of Treatment Outcomes Following &amp;lt;i&amp;gt;Borago officinalis&amp;lt;/i&amp;gt; Extract Therapy in Patients Presenting with Cyclical Mastalgia