Breast gel based on Boswellia serrata, Betaine and myo-Inositol improves cyclic mastodynia in fertile women: A retrospective clinical study

Abstract

Background: The management of mastodynia plays a central role in improving women quality of life. Despite its high occurrence, specific therapeutic guidelines for mastalgia are still lacking. Available therapies include unspecific anti-inflammatories, even though they may often expose to undesirable effects and low compliance.

Objective: The aim of this study was to highlight the efficacy of the topical application of combined natural molecules including Boswellia serrata, Betaine and myo-Inositol in improving cyclic mastalgia.

Methods: In this retrospective pilot clinical study, patients with cyclic mastalgia applied a specific breast gel for three months. The severity of the pain was measured through the Visual Analogue Score (VAS) in the treated group compared to untreated one. Treated patients also filled in a questionnaire evaluating acceptance and safety of the breast gel.

Results: This pilot clinical study demonstrated for the first time the efficacy of the topical application of a breast gel based on Betaine, Boswellia serrata, and myo-Inositol in improving cyclic mastodynia. The completed questionnaires also revealed high levels of acceptance, as both safety and compliance.

Conclusions: Besides confirming the positive effects of these natural molecules in the management of conditions affecting breast physiology - so far evaluated as oral supplementation - the obtained results pave the way for further studies supporting the use of such molecules as a tailored medical device in the management of breast pain, thus also opening toward a combined oral and topical approach.

Keywords: Betaine; Boswellia serrata; Myo-Inositol; breast gel; mastalgia; medical device.

Fig. 1.

Flow chart of the retrospective study. The flow chart represents the two groups of the study and the timing of using the breast gel.

Fig. 2.

VAS records at the baseline and throughout the application of the gel. Records of the Visual Analogue Scale (VAS) evaluation throughout the period of breast gel application. At T1, T2 and T3 patients using Eumastos^® gel experienced a significant improvement in breast pain compared to the untreated group (Ctrl) (*p value < 0.01).

Fig. 3.

Patients’ compliance and perception of efficacy and safety of the medical device. At T3 patients expressed their thoughts about efficacy (A) and safety (B) of the medical device and reported their compliance to the treatment (C).