This is a qualitative–quantitative study based on hospital records of female patients of reproductive age, presenting sexual dysfunction, and treated with 250 mg Tribulus terrestris extract (1 tablet thrice daily for 90 days). Safety monitoring included vital signs, physical examination, laboratory tests, and occurrence of adverse events. Efficacy analysis included results of the Female Sexual Function Index (FSFI), dehydroepiandrosterone (DHEA) levels together with total and free testosterone, and the patient and physician assessments. There was a statistically significant improvement in total FSFI scores (P < 0.0001) post-treatment, with improvement among 106 (88.33%) subjects. There was a statistically significant (P < 0.0001) increase in the level of DHEA, while the levels of both serum testosterone (P = 0.284) and free testosterone decreased (P < 0.0001). Most adverse events recorded were related to the gastrointestinal tract. Physical examination showed no significant changes post-treatment. Based on the results, it is concluded that the T. terrestris extract is safe and effective in the treatment of female sexual dysfunction.

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.

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