TITLE:
Clinical Assessment of Treatment Outcomes Following Borago officinalis Extract Therapy in Patients Presenting with Cyclical Mastalgia
AUTHORS:
Carlos Romualdo Barboza Gama, Ricardo Lasmar, Gustavo Falcão Gama, Lisa Oliveira, Erika Cesar de Oliveira Naliato, Marcia Gonçalves Ribeiro, Flavia de Paoli, Adenilson de Souza da Fonseca, Camila Sirieiro Abreu, Mauro Geller, Alessandra Santos
KEYWORDS:
Cyclic Mastalgia, Borago officinalis, Borage Oil
JOURNAL NAME:
International Journal of Clinical Medicine,
Vol.6 No.6,
June
3,
2015
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