Effect of Soy Isoflavone on hot flushes, endometrial thickness and breast clinical and sonographic features

The objective of this study is to determine the effect of Isoflavone on menopausal symptoms, breast density and endometrial thickness

In this research, 204 eligible patients referring to hot flash Association were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.

The objective of this study is to determine the effect of Isoflavone on menopausal symptoms, breast density and endometrial thickness. This study, clinical trials, double-blind, placebo- control, single center are conducted in Arash women's hospital. The patients were divided into 2 groups, the first group received soy extracts as 50 mg isoflavone in form of a tablet, one before lunch and one before dinner (soy menopause tablets – nature made) and the second group were given placebo resembling the active drug in size and shape in the same manner. Both groups had the regimen for 12 wk.patients were evaluated for breast examination (BE) and breast sonography (BS) as well as vaginal sonography at initial presentation and at 6th and 12th week follow-ups.

Women over 40 yr of age with body mass index in range of 20-35Kg/m2 who complained of hot flushes were chosen for our goals. Women with previous history of cancer,diabetes mellitus or renal, hepatic, and heart failure or abnormal uterine bleeding, mioma, ovarian cyst, Poly Cystic Ovarian syndrome(PCOS), endometriosis, hormone therapy during the last three months, consumption of drugs interacting with intestinal absorption, a known history of breast disease or the detection of breast mass or nodules in breast examination ,patients who had a suspicious history of probable sensitivity to soy products ,Patients with disability or known history of drug or alcohol consumption w, Cigarette smoking and caffeine consumption were excluded from this study

the intervention group received soy extracts as 50 mg isoflavonein form of a tablet, one before lunch and one before dinner (soy menopause tablets – nature made) and the control group were given placebo resembling the active drug in size and shape in the same manner. Both groups had the regimen for 12 wk

hot flash , breast density and endometrial thickness

Randomization is done systematically. based on days of the using the coin, it was determined that the intervention in the first day of this study was determined using the coin. Then, depending on the days of the week, the medicine or the placebo was prescribed respectively to eligible participate in the study Random allocation was performed by a methodologist. Medicines were placed in similar packets and list of random allocation of patients were not disclosed to dispensing practitioners. To conceal the random allocation process, a random 10-digit code corresponding to the identification number of the patient was written on each medicine packet. Every day epidemiologist give these packets to the dispensing nurse, who was unaware of the contents of each packet. When the doctor declared the eligibility of patients, the nurse gave packets to them according to the identification numbering.

When the doctor declared the eligibility of patients, the nurse gave packets to them according to the identification numbering.The doctor evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. To analyze the data, a statistician who is separate from the study process and who is unaware of all the processes performed will be used.