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Eumastós® Supplement Decreases Breast Density in Women with Extremely Dense Breasts on Mammogram

Date 10-14-2016
HC# 031655-554
Keywords:
Boswellia (Boswellia serrata, Burseraceae)
Betaine
Myo-inositol
Breast Density

Pasta V, Gullo G, Giuliani A, et al. An association of boswellia, betaine and myo-inositol (Eumastós®) in the treatment of mammographic breast density: a randomized, double-blind study. Eur Rev Med Pharmacol Sci. 2015;19(22):4419-4426.

Breast cancer risk is increased 4- to 6-fold in women with radiologically dense breast tissue. It is proposed that "a treatment strategy to reduce the mammary density may bring about very relevant clinical outcomes in breast cancer prevention." Eumastós® (Lo.Li. Pharma s.r.l.; Rome, Italy) is a blend of myo-inositol, betaine, and boswellic acid (from boswellia [Boswellia serrata, Burseraceae] resin). Myo-inositol modulates inflammatory, metabolic, and endocrine pathways involved in disease pathogenesis, including cancer. Betaine and boswellia also have anti-inflammatory activity and exert protective effects against cancer. The authors hypothesized that Eumastós may reduce breast density by exerting synergistic effects on inflammatory, metabolic, and endocrine processes. The purpose of this randomized, double-blind, placebo-controlled study was to investigate the effect of Eumastós on breast density in women with high breast density.

Premenopausal women (n = 76, aged 22-51 years) with high breast density participated in this 6-month study conducted in Rome, Italy. Excluded patients had breast treatments 4 months prior to the trial, breast cancer, bloody nipple discharge, premalignant lesions (carcinoma in situ), or other diseases. Patients received either placebo or Eumastós twice daily for 6 months. The placebo contained 2.1 mg vitamin B6, 0.3 mg folic acid, 2.1 mg vitamin B2, 0.003 mg vitamin B12, and 100 mg N-acetylcysteine. The Eumastós supplement contained the same nutrient mix (2.1 mg vitamin B6, 0.3 mg folic acid, 2.1 mg vitamin B2, 0.003 mg vitamin B12, and 100 mg N-acetylcysteine) plus 200 mg myo-inositol, 175 mg betaine, and 50 mg boswellic acid. The primary endpoint was change in breast density on mammogram and ultrasound from baseline to study end. Breast density was evaluated by 2 independent expert radiologists and subclassified as (1) almost entirely fat, (2) scattered fibroglandular densities, (3) heterogeneously dense, or (4) extremely dense.

A total of 62 patients completed the trial (n = 30, placebo and n = 32, Eumastós); reasons for the 14 dropouts were not given. The authors state that compliance in both groups was higher than expected and that "treatment was discontinued only in a few cases and for less than few days."

Results data are given only for patients with extremely dense (grade 4) breasts (n = 22 in the placebo group and n = 25 in the Eumastós group). It is unclear why this was not an inclusion/exclusion criterion; the post-hoc exclusion of the data for 15 patients raises the question of potential bias in the reporting.

After 6 months, at study end, 9.1% (n = 2) of the patients in the placebo group and 60% (n = 15) of patients in the Eumastós group had a decrease in breast density compared with baseline as recorded by mammography. The decrease in breast density for the Eumastós group was significant (P = 0.001). The reduction in breast density in the Eumastós group was accompanied by a reduction in pain for 13/15 patients. The protocol for assessing pain was not reported. The only adverse event was 1 case of mild transient diarrhea in the Eumastós group.

The authors conclude that Eumastós provided a clinical benefit in women with high breast density. They state that there are no conflicts of interest. The study was funded by the Deanship of Scientific Research at King Saud University, Riyadh, Saudi Arabia.

Data for only 47 of the 76 enrolled patients (62%) is reported; therefore, the results may be biased. Additional limitations include the small sample size, lack of between-group baseline statistical comparisons, and no discussion of whether the adverse event was treatment-related. These data should be viewed as preliminary; the results must be confirmed by a larger trial employing a more rigorous study design and robust reporting.

—Heather S. Oliff, PhD