Effects of Metformin and Theory-Based Education in Women With Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is a common condition associated with metabolic abnormalities, including insulin resistance, impaired glucose regulation, and abnormal lipid levels. Metformin is commonly used to improve metabolic outcomes in women with PCOS, while lifestyle modification and behavioral education are important components of PCOS management. This study evaluates whether metformin, alone or combined with a theory-based behavioral educational program, is associated with changes in metabolic, vitamin B12, iron-status, erythropoietin, and hematological parameters compared with matching placebo. This is a prospective, three-arm, parallel-group randomized controlled trial conducted among women aged 18-40 years with specialist-confirmed PCOS in Ministry of Health obstetrics and gynecology clinics in Jordan. A total of 900 participants were initially randomized in a 1:1:1 ratio to receive matching placebo, metformin, or metformin combined with a theory-based behavioral educational program. The metformin groups received 1500 mg/day, administered as 500 mg three times daily, for six months. The combined intervention group additionally received five structured educational sessions addressing PCOS self-management, healthy dietary practices, physical activity, weight and waist management, metformin adherence, sleep, stress management, problem solving, and maintenance of healthy behaviors. Clinical and laboratory outcomes were assessed at baseline and after six months. The primary outcomes include changes in anthropometric, metabolic, vitamin B12, iron-status, erythropoietic, and hematological parameters. Changes in PCOS-related knowledge and lifestyle practices were also evaluated among participants receiving the combined intervention.

Sex

Female

Minimum age

18 Years

Maximum age

40 Years

Inclusion Criteria:

1. Women aged 18-40 years.
2. Specialist-confirmed diagnosis of polycystic ovary syndrome (PCOS).
3. Ability and willingness to participate in the six-month study follow-up.
4. Ability to comply with the study procedures and assessments.

Exclusion Criteria:

1. Chronic hemolytic anemia.
2. Chronic kidney disease.
3. Hepatic disorders.
4. Other endocrine, metabolic, or cardiovascular conditions that could affect glucose metabolism, vitamin B12 status, iron status, erythropoietin levels, or hematological parameters.
5. Previous use of insulin-sensitizing medications other than the study metformin.
6. Current or recent hormonal therapy that could affect the study outcomes.
7. Current use of iron or vitamin B12 supplements.
8. Use of medications that could substantially affect glucose metabolism, vitamin B12 status, iron status, erythropoietin levels, or hematological parameters.
9. Any condition that could interfere with adherence to the intervention or completion of the six-month follow-up.