BACKGROUND:Fibrocystic changes (FCC) is the most common benign breast disease. The main pathophysiologic mechanism of FCC, excessive cell proliferation in response to monthly estrogen and progesterone changes. Regarding to antiproliferative of metformin, the aim of this study is the evaluation of the effect of metformin on FCC in women who were referred to gynecology clinics of Arak METHODS: This study is a double blind placebo control randomized clinical trial. At the first among women who were referred to gynecology of Arak, 186 women with FCC between 18-40 years were selected. The women were randomly classified into three groups. The first group took metformin and the second group as placebo group took vitamin E and the third group did not take any drug during six months. All groups were compared in clinical symptoms based on visual analogue scale (VAS) and the sonographic data also were recorded and compared. Data analysis was performed by unilateral variance, student t and Chi-square. RESULTS: The three groups were not different in aspect of mean of the cysts number, cyst size, tenderness and discharge from breast before the intervention, but after the intervention, there was a significant decrease in metformin group (p value < 0.001) based on variance analysis test. There was not a meaningful difference of pain and the location of cysts between the groups after the intervention. CONCLUSIONS: The present study showed that metformin is effective in treatment of FCC and decreasing of clinical symptoms and imaging items.
RCT Entities:
BACKGROUND:Fibrocystic changes (FCC) is the most common benign breast disease. The main pathophysiologic mechanism of FCC, excessive cell proliferation in response to monthly estrogen and progesterone changes. Regarding to antiproliferative of metformin, the aim of this study is the evaluation of the effect of metformin on FCC in women who were referred to gynecology clinics of Arak METHODS: This study is a double blind placebo control randomized clinical trial. At the first among women who were referred to gynecology of Arak, 186 women with FCC between 18-40 years were selected. The women were randomly classified into three groups. The first group took metformin and the second group as placebo group took vitamin E and the third group did not take any drug during six months. All groups were compared in clinical symptoms based on visual analogue scale (VAS) and the sonographic data also were recorded and compared. Data analysis was performed by unilateral variance, student t and Chi-square. RESULTS: The three groups were not different in aspect of mean of the cysts number, cyst size, tenderness and discharge from breast before the intervention, but after the intervention, there was a significant decrease in metformin group (p value < 0.001) based on variance analysis test. There was not a meaningful difference of pain and the location of cysts between the groups after the intervention. CONCLUSIONS: The present study showed that metformin is effective in treatment of FCC and decreasing of clinical symptoms and imaging items.