Short summary

In this study we investigate how treatment with the dietary supplement myoinositol (MI) affects women with PCOS compared to standard treatment with metformin. Both MI and metformin are known to decrease insulin resistance, but the effect on other symptoms of PCOS is still scarcely clarified. We want to investigate if myoinositol has an equal effect on anthropometric values, glucose metabolism, menstrual pattern and quality of life compared to the standard treatment with metformin. The trial includes 2x20 patients with PCOS. The patients will be randomized to MI or metformin for 6 months. Follow up will be after 6 months of inclusion. 

Rationale

PCOS affects more than 10% of fertile women. The symptoms of PCOS usually appear in puberty and continue in varying degrees until the menopause. The most common symptoms are hirsutism, irregular menstruation and infertility. Furthermore, there is a higher prevalence of insulin resistance and hyperinsulinemia among women with PCOS. Studies have shown that women with PCOS have up to 10 times higher risk of developing both type 2 diabetes and cardio-vascular diseases compared to healthy women with same age, high and weight.

Many women with PCOS suffer from decreased quality of life due to overweight and unwanted hair. Furthermore they have a higher risk of developing depression, anxiety and obsessive-compulsive disorder. Side effects like abdominal pain, bloated stomach, diarrhea and nausea are quite common during treatment with metformin, which may further decrease quality of life. We believe there is a need of additional treatments of PCOS, in particular to women who experience gastrointestinal side effects of metformin. Both MI and metformin are believed to be safe treatments without any severe side effects. 

Description of the cohort

Patients will be included through the outpatient clinic at Department of Gynaecology at Odense University Hospital.

To be included, women must

• Be aged between 18-50 years
• Be diagnosed with PCOS or meet the diagnostic criteria
• Be generally healthy and not be diagnosed with diabetes  
• Not be post menopausal
• Not take any medicine that can interfere with the results 

Data and biological material

Blood samples and urine samples will be analysed immediately. No biological material in a bio-bank.

Information about PCOS symptoms as well as data from the objective examination will be collected from the patient file. The objective examination does not include any extra measures. The examination includes height, weight, state of hirsutism, waist and hip measures, vaginal ultrasound and a pregnancy test.

Besides the standard procedure, an ExtremeCT and a DEXA-scan will be performed at baseline and at 6 months follow-up.

Quality of life is surveyed by Major Depression Score, SF-36 Health survey and VAS-score. 

Collaborating researchers and departments

Department of Gynaecology and Obstetrics, Odense University Hospital

• Undergraduate medical student Sophie Jørgensen

• Professor Marianne Andersen, MD
• Consultant Dorte Glintborg, MD