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Efficacy of Combined Cabergoline and Metformin Compared to Metformin Alone on Cycle Regularity in Patients with Polycystic Ovarian Disease with Hyperprolactinemia: A Randomized Clinical Trial

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Abstract

Purpose

Polycystic ovarian syndrome (PCOS) is a common reproductive disorder. Increasing serum prolactin in these patients could be detected in both follicular and luteal phase of the normal and stimulated cycles. Hyperprolactinemia affects the hypothalamic–pituitary–ovarian axis causing anovulation and abnormal uterine bleeding. In this study, the efficacy of combined cabergoline and metformin therapy was compared to metformin therapy alone in patients with PCOS on the body mass index, androgen profile and menstrual cycle regulation.

Methods

Two hundred and fifty patients with polycystic ovarian syndrome (PCOS) with increased serum prolactin were randomly allocated into two groups: group (1) received oral metformin tablet 1000 mg per day and cabergoline 0.5 g tablet weekly for 3 months as a case group, and group (2) received oral metformin tablet 1000 mg per day and a placebo tablet weekly for 3 months as the control group (n = 123). Body mass index (BMI), menstrual cycle regularity, serum testosterone, serum prolactin and dehydroepiandrosterone sulfate (DHEAS) level were compared before and after treatment in both groups.

Results

There was significant decrease in body mass index and improvement of androgenic profile in both groups after treatment. In group (1), there was significant improvement in cycle regularity and significant decrease in serum prolactin level post-treatment.

Conclusions

The use of cabergoline in addition to metformin had more favorable effect on cycle regularity and prolactin level in patients with polycystic ovarian syndrome with hyperprolactinemia than the use of metformin alone.

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Acknowledgements

I would like to thank Dr. Mahmoud Hamdy the chemical pathology consultant for his help to complete of this work. Also I would like to thank all participants.

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Correspondence to Mervat Ali Mohamed Elsersy.

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Conflicts of interest

The author declares that she has no conflict of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Informed Consent

The study protocol was approved by the ethics committee of Hai Jamma hospital. All participants were counseled and informed about the trial protocol and a written informed consent according to declaration of Helsinki was signed. A randomized clinical study approved that the use of combined cabergoline and metformin had a better impact on the control of prolactin level and cycle regulation in patients with both PCO and hyperprolactinemia.

Additional information

Mervat Ali Mohamed Elsersy is a Lecturer in Department of Obstetrics and Gynecology, Faculty of Medicine, Alexandria University, Egypt.

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Elsersy, M.A.M. Efficacy of Combined Cabergoline and Metformin Compared to Metformin Alone on Cycle Regularity in Patients with Polycystic Ovarian Disease with Hyperprolactinemia: A Randomized Clinical Trial. J Obstet Gynecol India 67, 363–369 (2017). https://doi.org/10.1007/s13224-017-1022-3

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  • DOI: https://doi.org/10.1007/s13224-017-1022-3

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