The product is formulated with key ingredient Berberine Phytosome, which has been developed using technology to enhance absorption, which the company says makes it 10 times more effective than berberine alone.
The product was chosen by the judges' panel, who said: “PCOS affects millions of women worldwide and requires comprehensive understanding and tailored treatment approaches. Sophy had the ‘X-factor’ in serving this often overlooked condition.”
Elena Fava, international product manager at PharmExtracta SpA, thanked the judges, stating: “This is a great recognition that gives value to our daily work and our great dedication to the innovation in this field.”
Improved bioavailability
PCOS is a prevalent endocrine disorder that affects 5% to 15% of women of reproductive age and can contribute to infertility, type-2 diabete, and mental health disorders such as anxiety and depression.
Diagnosis requires two out of three features: menstrual disturbance, hyperandrogenism and multifollicular ovarian morphology. Hyperandrogenism is a hormonal imbalance that is key to PCOS and can lead to various reproductive, dermatologic, metabolic and psychological symptoms.
Current treatment goals focus on enhancing fertility, regulating menstruation and managing metabolic issues, using lifestyle changes and medications.
However, botanical extracts and particularly berberine have shown effectiveness in improving PCOS symptoms by addressing insulin resistance and androgen levels. However, berberine’s poor bioavailability has limited its use.
Berberine Phytosome has been found to significantly improve absorption, featuring phospholipids that incorporate berberine and enhance its absorption, overcoming glycoprotein-P blockage.
PCOS results
Sophy aims to alleviate PCOS symptoms such as irregular menstrual cycles, ovarian polycystosis and acne and improve overall quality of life. Recent research found the Berberine Phytosome ingredient had positive effects in women with PCOS.
In a recent randomized controlled trial, the effect of daily Sophy supplementation was assessed in 106 women between the ages of 18.5 and 35 diagnosed with PCOS. They were divided into two groups; 51 women treated with diet + Sophy (two tablets/day) for three months, and 55 women on diet alone (control) for three months.
Results showed that the Sophy group experienced an 80% decrease in the number of participants with menstrual disorders, a 70% decrease in the number of patients with ovarian polycystosis and a 55% decrease in the number of patients with acne.
As Fava explained, there were no significant difference in side effects between the treated group and the control.
She added that while the product has the potential to offer solutions to consumers with PCOS, PharmExtracta must be careful about the promotion of Sophy due to claim regulation.
“We are promoting a food supplement, not a drug, and we depend on medical professionals to recommend it,” she noted.
“The only approved claim for Berberine is that it promotes cardiometabolic health, so we emphasize that this product is not an alternative to standard therapy but can be used as a complementary or alternative option if standard care is ineffective.”