Clinical implications of dual therapy in thyroid profile of PCOS

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J. Pharm. Pharmacogn. Res., vol. 12, no. 6, pp. 1187-1195, Nov-Dec 2024. DOI: https://doi.org/10.56499/jppres24.2001_12.6.1187 Original Article Clinical implications of dual therapy of acarbose plus myo-inositol on the thyroid profile in women with polycystic ovary syndrome [Implicaciones clínicas de la terapia dual de acarbosa más mioinositol sobre el perfil tiroideo en mujeres con síndrome de ovario … Continue reading Clinical implications of dual therapy in thyroid profile of PCOS

J. Pharm. Pharmacogn. Res., vol. 12, no. 6, pp. 1187-1195, Nov-Dec 2024.

DOI: https://doi.org/10.56499/jppres24.2001_12.6.1187

Original Article

Clinical implications of dual therapy of acarbose plus myo-inositol on the thyroid profile in women with polycystic ovary syndrome

[Implicaciones clínicas de la terapia dual de acarbosa más mioinositol sobre el perfil tiroideo en mujeres con síndrome de ovario poliquístico]

Marina Andavar1, Raju Kamaraj2*, Thangavel Mahalingam Vijayakumar1, Anuradha Murugesan3

1Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu - 603 203, India.

2Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu - 603203, India.

3Department of Obstetrics and Gynaecology, Faculty of Medicine, SRM Medical College Hospital and Research Centre, Kattankulathur, Tamil Nadu - 603203, India.

*E-mail: kamarajr@srmist.edu.in

Abstract

Context: Polycystic ovary syndrome (PCOS) and thyroid are the most common endocrine disorders affecting women of childbearing age, causing anovulation and infertility. There is an increased prevalence of thyroid dysfunction reported among PCOS women.

Aims: To evaluate the benefits of acarbose plus myo-inositol therapy on the thyroid profile of PCOS.

Methods: An open-labelled, parallel randomised clinical trial on 80 PCOS women based on inclusion and exclusion criteria was performed at the Department of Gynaecology, SRM Medical College Hospital and Research Centre, Kattankulathur. Institutional ethics committee approval and prior informed consent were obtained. The trial was registered in CTRI (No: CTRI/2022/04/041877). Group A (n = 38) received metformin 500 mg TID, and group B (n = 39) received acarbose 50 mg TID along with myoinositol 1000 mg BID. Assessment of metabolic and hormonal profile was done at baseline and at the end of six months.

Results: Both groups showed significant reductions in luteinising hormone (p <0.0001), total testosterone (p<0.05), thyroid stimulating hormone (p<0.05), fasting insulin (p<0.05), and homeostatic model assessment for insulin resistance (p<0.0001). The follicle-stimulating hormone was increased only in the metformin group. No significant changes in body mass index, free triiodothyronine, free tetraiodothyronine, and fasting glucose were observed in any group. Both therapies were safe, and no side effects or hypoglycaemia were recorded.

Conclusions: In consideration of the beneficial effects of the study, we conclude that the administration of acarbose plus myo-inositol exerts positive effects on the thyroid and other endocrinological profiles in PCOS women.

Keywords: acarbose plus myoinositol; excess androgen; insulin resistance; polycystic ovary syndrome; thyroid stimulating hormone.

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Resumen

Contexto: El síndrome de ovario poliquístico (SOP) y la tiroides son los trastornos endocrinos más comunes que afectan a las mujeres en edad fértil, causando anovulación e infertilidad. Se ha informado una mayor prevalencia de disfunción tiroidea entre las mujeres con SOP.

Objetivos: Evaluar los beneficios del tratamiento con acarbosa más mio-inositol en el perfil tiroideo del SOP.

Métodos: En el Departamento de Ginecología del SRM Medical College Hospital and Research Centre, Kattankulathur, se llevó a cabo un ensayo clínico aleatorizado, paralelo y de etiqueta abierta en 80 mujeres con SOP basado en criterios de inclusión y exclusión. Se obtuvo la aprobación del comité ético institucional y el consentimiento informado previo. El ensayo se registró en el CTRI (nº: CTRI/2022/04/041877). El grupo A (n = 38) recibió metformina 500 mg TID, y el grupo B (n = 39) recibió acarbosa 50 mg TID junto con mioinositol 1000 mg BID. Se evaluó el perfil metabólico y hormonal al inicio y a los seis meses.

Resultados: Ambos grupos mostraron reducciones significativas de la hormona luteinizante, la testosterona total, la hormona estimulante del tiroides, la insulina en ayunas y la evaluación del modelo homeostático de resistencia a la insulina. La hormona foliculoestimulante se incrementó sólo en el grupo de metformina. No se observaron cambios significativos en el índice de masa corporal, la triyodotironina libre, la tetrayodotironina libre y la glucosa en ayunas en ningún grupo. Ambas terapias fueron seguras y no se registraron efectos secundarios ni hipoglucemias.

Conclusiones: Considerando los efectos beneficiosos del estudio, concluimos que la administración de acarbosa más mio-inositol ejerce efectos positivos sobre el tiroides y otros perfiles endocrinológicos en mujeres con SOP.

Palabras Clave: acarbosa más mioinositol; exceso de andrógenos; hormona estimulante del tiroides; resistencia a la insulina; síndrome de ovario poliquístico.

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Citation Format: Andavar M, Kamaraj R, Vijayakumar TM, Murugesan A (2024) Clinical implications of dual therapy of acarbose plus myo-inositol on the thyroid profile in women with polycystic ovary syndrome. J Pharm Pharmacogn Res 12(6): 1187–1195. https://doi.org/10.56499/jppres24.2001_12.6.1187
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