The SPIOMET treatment, which groups low doses of spironolactone (SPI), pioglitazone (PIO) and metformin (MET), has offered encouraging results against the polyendocrine metabolic ovarian syndrome (SOMP) in the phase II clinical trial "SPIOMET4HEALTH", in which 316 young women from six European countries were involved.
The research, aimed at an innovative approach that focuses on the endocrine and metabolic mechanisms that give rise to SOMP, has been developed in seven centers in Italy, Denmark, Turkey, Austria, Norway and Spain, with the participation of Hospital Sant Joan de Déu of Barcelona and of Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta.
According to the data obtained, the women treated with SPIOMET showed more stable ovulations and menstrual cycles, along with a reduction in excess body hair and acne, as well as a decrease in blood androgen concentrations.
All participants, aged between 12 and 24, also followed a structured program to promote healthy lifestyle habits. The work notes that quality of life improved in all the groups analyzed.
"The results open up new hopes for women with SOMP: combining SPIOMET with an intervention on lifestyle habits could allow us to address the syndrome itself, not just its symptoms. It is an important step towards better care for millions of women", highlighted the project coordinator, Lourdes Ibáñez, of Hospital Sant Joan de Déu.
The findings achieved now make it possible to propose a phase III trial to further analyze in depth the efficacy and safety of SPIOMET.
Recognize SOMP as a public health priority
The University of Bologna, in Italy, was the setting on November 6 for the closing event of "SPIOMET4HEALTH", which brought together specialists, healthcare staff and patient representatives to review the project’s conclusions and its potential impact on clinical practice and health policies, with the attendance of the European MPs Sirpa Pietikäinen and Billy Kelleher.
At this meeting, several demands were raised by patients and professionals, starting with the urgency of positioning SOMP as a public health priority, strengthening public awareness, early diagnosis, systematic data collection and stable funding for research.
It was also demanded to ensure a real involvement of patients, integrating their experiences and priorities into clinical trials and into health-care decision-making. In this regard, the representative of Young Women’s Health Group, Martina Alberani, emphasized that "patient involvement is not an optional extra", as it contributes to improving both the quality of research and health care.
Likewise, the need was highlighted to maintain support for clinical development to transform promising results into new therapeutic alternatives, while at the same time strengthening European coordination and long-term commitment.
At the same time, it was insisted on the appropriateness of establishing specific, adequate, and sustained funding for research on women’s health, together with simplifying regulatory processes and a greater consideration of women’s health needs in European research and health policies.
Carolina Bucalo, one of the women who participated in the trial, called for more attention to women’s health problems. "This experience taught me something very important: we don’t have to resign ourselves to our symptoms or suffer in silence. We deserve research that takes our health seriously," she asserted.