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

Carlos Romualdo Barboza Gama^1*, Ricardo Lasmar², Gustavo Falcão Gama³, Lisa Oliveira¹, Erika Cesar de Oliveira Naliato⁴, Marcia Gonçalves Ribeiro⁴, Flavia de Paoli¹, Adenilson de Souza da Fonseca¹, Camila Sirieiro Abreu⁴, Mauro Geller^1,4,5, Alessandra Santos⁵

¹Teresópolis Medical School—UNIFESO, Rio de Janeiro, Brazil.
²Universidade Federal Fluminense—UFF, Rio de Janeiro, Brazil.
³Universidade Federal de Juiz de Fora—UFJF, Juiz de Fora, Brazil.
⁴Universidade Federal do Rio de Janeiro—UFRJ, Rio de Janeiro, Brazil.
⁵Instituto de Pós-Graduacao Médica Carlos Chagas, Rio de Janeiro, Brazil.

DOI: 10.4236/ijcm.2015.66047                

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 < 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

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	Ader, D.N. and Shriver, C.D. (1997) Cyclical Mastalgia: Prevalence and Impact in an Outpatient Breast Clinic Sample. Journal of the American College of Surgeons, 185, 466-470. http://dx.doi.org/10.1016/S1072-7515(01)00959-0
[2]	Faiz, O. and Fentiman, I.S. (2000) Management of Breast Pain. International Journal of Clinical Practice, 54, 228-232.
[3]	Leinster, S.J., Whitehouse, G.H. and Walsh, P.V. (1987) Cyclical Mastalgia: Clinical and Mammographic Observations in a Screened Population. British Journal of Surgery, 74, 220-222. http://dx.doi.org/10.1002/bjs.1800740324
[4]	Roberts, M.M., Elton, R.A., Robinson, S.E. and French, K. (1987) Consultations for Breast Disease in General Practice and Hospital Referral Patterns. British Journal of Surgery, 74, 1020-1022. http://dx.doi.org/10.1002/bjs.1800741121
[5]	Kataria, K., Dhar, A., Srivastava, A., et al. (2014) A Systematic Review of Current Understanding and Management of Mastalgia. Indian Journal of Surgery, 76, 217-222. http://dx.doi.org/10.1002/bjs.1800741121
[6]	Davies, E.L., Gateley, C.A., Miers, M. and Mansel, R.E. (1998) The Long-Term Course of Mastalgia. Journal of the Royal Society of Medicine, 91, 462-464.
[7]	Das, U.N. (2008) Essential Fatty Acids and Their Metabolites Could Function as Endogenous HMG-CoA Reductase and ACE Enzyme Inhibitors, Anti-Arrhythmic, Anti-Hypertensive, Anti-Atherosclerotic, Anti-Inflammatory, Cytoprotective, and Cardioprotective Molecules. Lipids in Health and Disease, 15, 37.
[8]	Huang, Y.S. and Ziboh, V.A. (2001) Gamma Linolenic Acid: Recent Advances in Biotechnology and Clinical Applications. AOCS Publishing, 259 p.
[9]	Gama, C.R.B., Lasmar, R., Gama, G.F., et al. (2014) Premenstrual Syndrome: Clinical Assessment of Treatment Outcomes Following Borago officinalis Extract Therapy. RBM, 71, 211-217.
[10]	Ramirez, A.J., Jarret, S.R., Hamed, H., Smith, P. and Fentiman, I.S. (1994) Psychosocial Distress Associated with Severe Mastalgia. In: Mansel, R.E., Ed., Recent Developments in the Study of Benign Breast Disease, Parthenon, London.
[11]	Scurr, J., Hedger, W., Morris, P., et al. (2014) The Prevalence, Severity, and Impact of Breast Pain in the General Population. The Breast Journal, 20, 508-513. http://dx.doi.org/10.1111/tbj.12305
[12]	Ader, D.N., South-Paul, J., Adera, T. and Deuster, P.A. (2001) Cyclical Mastalgia: Prevalence and Associated Health and Behavioral Factors. Journal of Psychosomatic Obstetrics & Gynecology, 22, 71-76. http://dx.doi.org/10.3109/01674820109049956
[13]	Millet, A.V. and Dirbas, F.M. (2002) Clinical Management of Breast Pain: A Review. Obstetrical & Gynecological Survey, 57, 451-61. http://dx.doi.org/10.1097/00006254-200207000-00022
[14]	Furse, R.K., Rossetti, R.G., Seiler, C.M., et al. (2002) Oral Administration of Gammalinolenic Acid, an Unsaturated Fatty Acid with Anti-Inflammatory Properties, Modulates Interleukin-1Beta Production by Human Monocytes. Journal of Clinical Immunology, 22, 83-91. http://dx.doi.org/10.1023/A:1014479702575
[15]	Kast, R.E. (2001) Borage Oil Reduction of Rheumatoid Arthritis Activity May Be Mediated by Increased cAMP That Suppresses Tumor Necrosis Factor-Alpha. International Immunopharmacology, 1, 2197-2199. http://dx.doi.org/10.1016/S1567-5769(01)00146-1
[16]	Sweetman, S.C. (2011) Martindale: The Complete Drug Reference. 37th Edition, Pharmaceutical Press, London.
[17]	Srivastava, A., Mansel, R.E., Arvind, N., Prasad, K., Dhar, A. and Chabra, A. (2007) Evidence-Based Management of Mastalgia: A Meta-Analysis of Randomised Trials. The Breast, 16, 503-512. http://dx.doi.org/10.1016/j.breast.2007.03.003
[18]	Bendich, A. (2000) The Potential for Dietary Supplements to Reduce Premenstrual Syndrome (PMS) Symptoms. Journal of the American College of Nutrition, 19, 3-12. http://dx.doi.org/10.1080/07315724.2000.10718907
[19]	Foster, S. and Tyler, V.E. (1999) Tyler’s Honest Herbal. 4th Edition, Haworth Press, New York.