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

• 作者: Adenilson de Souza da Fonseca Alessandra Santos Camila Sirieiro Abreu Carlos Romualdo Barboza Gama Erika Cesar de Oliveira Naliato Flavia de Paoli Gustavo Falc?o Gama Lisa Oliveira Marcia Gon?alves Ribeiro Mauro Geller Ricardo Lasmar
• 来源期刊: 临床医学国际期刊(英文)
• 学科: 医学
• 关键词: CYCLIC MASTALGIA Borago OFFICINALIS Borage Oil
• 年，卷（期）: 2015,（6）
• 页码范围: 363-371
• 页数: 9页
• 分类号: R73

摘要

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