Clinical Assessment of Treatment Outcomes Following Borago officinalis Extract Therapy in Patients Presenting with Cyclical MastalgiaReport as inadecuate




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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. 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 statistically significant improvements in the assessments of mastalgia impact on work χ2 = 28.24; gl = 4; p < 0.0001, sleep χ2 = 14.29; gl = 4; p = 0.0006, and sexual activity χ2 = 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.

KEYWORDS

Cyclic Mastalgia, Borago officinalis, Borage Oil

Cite this paper

Gama, C. , Lasmar, R. , Gama, G. , Oliveira, L. , Naliato, E. , Ribeiro, M. , Paoli, F. , Fonseca, A. , Abreu, C. , Geller, M. and Santos, A. 2015 Clinical Assessment of Treatment Outcomes Following Borago officinalis Extract Therapy in Patients Presenting with Cyclical Mastalgia. International Journal of Clinical Medicine, 6, 363-371. doi: 10.4236-ijcm.2015.66047.





Author: Carlos Romualdo Barboza Gama1*, Ricardo Lasmar2, Gustavo Falcão Gama3, Lisa Oliveira1, Erika Cesar de Oliveira Naliato4, Marcia

Source: http://www.scirp.org/



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