Mastalgia and Benign Breast Lumps with Combo of Inositol, Betaine, Boswellia, NAC and B vitamins
Reviewer: Dr. Tori Hudson, ND
Author: Pasta V, Dinicola S, Giuliani A, et al.
Reference: A randomized pilot study of inositol in association with betaine and boswellia in the management of mastalgia and benign breast lump in premenopausal women. Breast Cancer (Auckl). April 20, 2016;10:37-43.
Design: Women were randomly assigned to a treatment group or placebo group and were instructed to take the capsules for 6 months. A total of 76 premenopausal women aged 22-51 years old received either a combination product called Eumastós (supplied by Lo.Li. Pharma; Rome, Italy) that includes in one capsule: boswellic acid 50 mg, betaine 175 mg, myo-inositol 200 mg, vitamin B2 2.1 mg, B6 2.1 mg, B12 0.003 mg, folic acid 0.3 mg, and N-acetylcysteine 100 mg or a placebo (containing the following per capsule: vitamin B2 2.1 mg, B6 2.1 mg, B12 0.003 mg, folic acid 0.3 mg, and N-acetylcysteine 100 mg) . Each woman took 2 capsules twice daily for 6 months or the placebo at the same 2 capsules twice daily for 6 months.
Participants: Women were included if they had mild to severe cyclic or noncyclic mastalgia for > 6 months, were premenopausal, and had not received any treatment for their mastalgia for 4 months prior to the study. Women were excluded if they had breast cancer, atypical lobular hyperplasia, sclerosing adenosis, other systemic medical problems, or were taking estrogen/progesterone hormone treatments or hormone-based contraceptives. A baseline and end of study mammogram and breast ultrasound were done to evaluate breast density and dimensions of any nodules. Breast density was categorized into one of four categories: “almost entirely fat,” “scattered fibroglandular densities,” “heterogeneously dense,” or “extremely dense.” Breast pain was reported by patients via a questionnaire at baseline and at 3 and 6 months of the study. Pain was scored from −1 (getting worse) to 2 (far better with no pain present). Other discomforts such as nausea and headaches, were also reported. A visual analog scale was used to measure the degree of pain.
Primary outcome: Cyclic and noncyclic breast pain relief, decrease in number of benign breast lumps and a decrease in breast density.
Key findings: From the 76 patients who were assigned treatment or placebo, 62 finished the trial. Four patients were lost during follow up for “nonmedical” reasons. Compliance was high with 93% in the control group and 96% in the treatment group. Significantly more women in the treatment group showed improvement in cyclic pain relief as compared to the placebo group (52.6% vs. 16.6%), and 36.8% of women in the treatment group reported “almost complete disappearance” of pain. Significantly more women with noncyclic breast pain in the treatment group reported pain relief as compared to the placebo group (61.5% vs. 16.6%). When the women with cyclic and noncyclic pain results were combined, those in the treatment group experienced greater pain relief than those in the placebo group (56.2% vs. 16.7%).
As an aside, more women in the treatment group reported improvement in anxiety (86.7% vs. 66.7%) and menstrual pain (80% vs. 10%). Related to the primary objectives of the study, a greater number of those in the treatment group showed a decrease approaching significance in benign breast lumps (40.7% vs. 16%) and a very significant decrease in breast density (60% vs. 9.1%). The only adverse side effects reported was an instance of mild diarrhea in the treatment group.
Mastalgia, aka breast pain, both cyclic and noncyclic is very common in women, and can be mild to severe such that it may adversely affect quality of life. Conventional treatments include hormonal contraception, NSAIDS and topical diclofenac gel. Alternative medicine treatments have included vitamin E, evening primrose oil, molecular iodine, and dietary changes (mostly avoid caffeine and low fat diets). Myo-inositol has been shown to impact inflammation and endocrine-related actions. Betaine has been found to attenuate inflammation and have beneficial effects on breast tissue. Previous studies have shown boswellic acid, a compound found in Boswellia, also is beneficial in decreasing inflammation. N-acetyl cysteine has been studied with success, to reduce breast density. This study suggests that Eumastós may be helpful in alleviating mastalgia. Given the reduction in breast density with this study, this combination product may have implications in reducing breast cancer risk in those with extremely dense breasts, given that breast density is a risk factor for breast cancer.