Prospective Observational Study: The Role of a Bergamot Based Nutraceutical in Dyslipidaemia and Arthralgia for Subjects Undergoing Aromatase Inhibitors Based Therapy

Author(s):

Annamaria Izzo, Michele D’Arienzo, Paolo Sergiacomi, Cinzia Marrese, Massimo Bonucci and Costanza Riccioni*

Introduction: The aromatase inhibitors (Als) constitute hormonal therapy in post-menopausal women with ER+ breast carcinoma. The most common side effects of these medicines are arthralgia and dyslipidaemia. Given the increase of cardiovascular risk associated with dyslipidaemia (high levels of LDL-C and TG, low levels of HDL-C), the principal aim of the study is to describe the efficacy of a nutraceutical containing extract of bergamot and artichoke, phytosterols and vitamin C on the parameters of the lipid profile in women undergoing hormone therapy (TC, HDL-C, LDL-C, TG). The secondary aim is to evaluate the possible effect of the nutraceutical on arthralgia pain, given the anti-inflammatory properties of the active natural ingredients of the product. Materials and Methods: The study was carried out on a total of 41 female subjects who suffered from arthralgia from aromatase inhibitors and druginduced dyslipidaemia. The subjects’ levels of TC, LDL-C, HDL-C, TG, Homocysteine, and uric acid were tested upon enrollment (t0) and thereafter at 3 (t1) and 6 months (t2) of observation. The study lasted 12 months from enrollment to follow-up. Participants took 2 tablets daily of the supplement after dinner for 6 months. Participants did not take any other medicines with the exception of 250 mg of paracetamol twice daily if required. Results: Subjects showed a normalisation of their lipid profile, together with some relief from pain, measured using the VAS. The increase of HDL-C (p<0.001) levels was of particular note. No side-effects relative to the use of this product were reported. Conclusion: The results obtained open new therapeutic scenarios for the use of nutraceuticals in cancer patients, and especially in subjects exposed to a multiple pharmaceutical treatments, as a possible adjuvant tool and as natural device to limit side effects to a minimum.