Comparing the effect of metformin with vitamin E in improving mastalgia and breast fibroadenoma size:(Randomized clinical trial)

Determining the comparison of the effect of metformin with vitamin E in improving breast pain and breast fibroadenoma size

The present study is a clinical trial with a control group, with parallel groups, randomized (using block randomization), phase 3 on 72 patients.

In this double-blind randomization clinical trial, patients with a definitive diagnosis of breast fibroadenoma referred to Waliasr Hospital in Arak will be divided into three equal groups of metformin, vitamin E and control by means of block randomization. In this study, patients (by placebo pills) and outcome assessors (by patient coding) will be blinded. In each group, drug treatment will be prescribed daily for 24 weeks. Finally, three groups will be evaluated in terms of study results.

Inclusion Criteria: definitive diagnosis of breast fibroadenoma; unilateral or bilateral fibroadenoma less than 3 cm in size; Consent to participate in the study; age 18-45; Body mass index above 30 Exclusion Criteria: suffering from metabolic and endocrinological diseases; Presence of pregnancy and breastfeeding; history of malignant breast masses; Use of anti-diabetic, hypoglycemic and anti-fat drugs

In the metformin group, patients will receive 1000 mg metformin tablets (Esveh Pharmaceutical Company, Tehran, Iran) once a day for 24 weeks. In the vitamin E group, vitamin E tablets will be taken once a day (400 units each time) for 24 weeks. Tablets will be taken orally in both groups. In the placebo group, patients will receive a starch tablet similar to metformin and a vitamin E tablet made of gelatin.

Breast fibroadenoma size, mastalgia pain score

The participants will be assigned to three groups of Metformin, vitamin E and placebo based on the order of arrival and based on the randomization sequence that will be produced in advance. This sequence is unpredictable, and its arrangement is completely random. Block randomization method with 9 blocks will be used to allocate the samples. In this way, by using the block method random number generation software, the randomization sequence will be produced according to the required sample size for two groups. In the beginning, all the modes that can arrange 3 letters A, B and C in a block of 9 are produced. Then a block will be selected randomly and by placement among the blocks, and the arrangement pattern in that block will be used to allocate the participants. Then this block will be placed in the main container and another block will be selected again. All these works will be done with a software called Sealed Envelope.

This study is double blind. In this way, for Metformin, vitamin E tablets, starch tablets similar to Metformin, vitamin E will be prepared, which will be given to the opposite group and the placebo group. Therefore, each person in the study receives one pill from the supervisor, one of which is the drug in question and the other is a placebo, and in the placebo group, the person will take two placebo pills. For the second type of blinding, the drugs are prescribed by the relevant supervisor (principal guide) and are provided to the patients. The assistant of the relevant specialty does not know the type of prescription drugs of the patients and will only be responsible for collecting their clinical information through the checklist and file number.

After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.

Access will be from 2024/06/20 to 2027/09/20 for 3 years.

University researchers

Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.

Academic researchers and university professors can request Dr. Reza Shojaei to use the data after contacting the relevant professor via message or email. Dr. Reza Shojaei: Phone: 09123700960 Email: R.shojaei@arak.mu.ac.ir Address: Valiasr Hospital, Arak, Vice-Chancellor of Hospital Education

Letter writing should be done with professors and universities.