Evaluating the effect of insulin sensitizers metformin and pioglitazone alone and in combination on women with polycystic ovary syndrome: An RCT.
BACKGROUND
Insulin resistance and hyperinsulinemia may play a role in pathogenesis of PCOS. One of the common therapeutic methods is using insulin-sensitizing drugs such as metformin and thiazolidinediones.


OBJECTIVE
The purpose was to determine the effect of metformin and pioglitazone on clinical, hormonal and metabolic parameters in women with PCOS.


METHODS
Eighty four women randomly received one of the following for 3 months: metformin (n=28) (500 mg three times a day), pioglitazone (30 mg daily) (n=28) and combination of both metformin and pioglitazone (n=28) (30 mg/day pioglitazone plus 500 mg metformin three times a day). Hormonal profile, fasting serum insulin, body weight, body mass index, menstrual status and waist to hip ratio were evaluated before and after treatment.


RESULTS
Metformin and pioglitazone and combination therapy induced favorable changes in fasting serum insulin, HOMA-IR index, QUICKI, fasting glucose to insulin ratio in women with PCOS. Body weight, BMI, and waist to hip ratio increased significantly after treatment with pioglitazone but the data were similar after administration of metformin or combination therapy. Total testosterone level decreased significantly only after treatment with metformin. After 3 months in patients who received pioglitazone or combination therapy, menstrual cycles became regular in 71.4% and 73.9% respectively. While menstrual improvement happened only in 36.4% of the patients treated with metformin.


CONCLUSIONS
These findings suggest that insulin-sensitizing drugs induce beneficial effect in insulin resistance and menstrual cyclicity but only metformin ameliorated hyperandrogenemia in women with PCOS. Treatment with combination of metformin and pioglitazone did not show more benefit than monotherapy with each drug alone.
Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.
Seyed Mojtaba
SM
Sohrevardi
Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.
Fahime
F
Nosouhi
Division of Endocrinology, Department of Internal Medicine, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.
Saeed
S
Hossein Khalilzade
Department of Dermatology, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.
Parichehr
P
Kafaie
Departments of Obstetrics and Gynecology, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.; Recurrent Abortion Research Center, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Mojgan
M
Karimi-Zarchi
Department of Anatomical Sciences, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.
Iman
I
Halvaei
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran .
Mehdi
M
Mohsenzadeh
Insulin resistance; Metformin; Pioglitazone; Polycystic ovary syndrome