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Journal of Endocrinological Investigation

, Volume 42, Issue 12, pp 1451–1458 | Cite as

Effect of metformin on thyroid function tests in patients with subclinical hypothyroidism: an open-label randomised controlled trial

  • R. Palui
  • J. Sahoo
  • S. KamalanathanEmail author
  • S. S. Kar
  • K. Sridharan
  • H. Durgia
  • H. Raj
  • M. Patil
Original Article

Abstract

Purpose

Though most of the observational studies have shown that metformin can reduce serum thyroid stimulating hormone (TSH) level in patients of hypothyroidism with diabetes or polycystic ovarian disease, randomised controlled trials are sparse. The primary objective of this study was to evaluate the effect of metformin on thyroid function tests (TSH, free T4, and free T3) in patients with subclinical hypothyroidism (SCH).

Methodology

In this open label, parallel arm, randomised controlled trial, 60 patients of SCH (TSH 5.5–10 mIU/L) were randomised to either metformin group (1500 mg/day) or control group.

Result

A total of 46 patients (23 in each group) completed the study and no significant difference in serum TSH, free T4 or free T3 was found in between the 2 groups. Neither there was any significant change in serum TSH, free T4 or free T3 (pre and post 6 months) within the individual groups. However, the rate of normalisation of serum TSH in patients with negative thyroid antibody was significantly higher than patients with positive thyroid antibody (71.4% vs. 18.8%; P = 0.026) in metformin group in post hoc analysis. Fasting plasma glucose, serum high-density lipoprotein and indices of insulin sensitivity significantly improved in metformin group. Four patients (17%) had mild gastrointestinal adverse effects in the metformin group.

Conclusion

We did not find any significant change in thyroid function test in patients with SCH with metformin therapy.

Keywords

Adipokines Insulin resistance Metformin Subclinical hypothyroidism 

Abbreviations

Anti-Tg Ab

Anti-thyroglobulin antibody

Anti-TPO Ab

Anti-thyroid peroxidase antibody

BMI

Body mass index

CI

Confidence interval

DBP

Diastolic blood pressure

DM

Diabetes mellitus

fT3

Free T3

fT4

Free T4

HDL

High-density lipoprotein

HOMA2-IR

Homeostasis Model Assessment for 2 Insulin Resistance

IQR

Inter-quartile range

IR

Insulin resistance

LDL

Low-density lipoprotein

PCOD

Polycystic ovarian disease

QUICKI

Quantitative Insulin Sensitivity Check Index

RCT

Randomised controlled trial

SBP

Systolic blood pressure

SCH

Subclinical hypothyroidism

SD

Standard deviation

TFT

Thyroid function test

TSH

Thyroid stimulating hormone

VLDL

Very-low-density lipoprotein

WC

Waist circumference

Notes

Acknowledgements

This study was done from intramural research fund (Grant number: JIP/Res/Intra-DM-MCH/phs1/01/2016-17 Project number 37) of Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), India.

Compliance with ethical standards

Conflict of interest

The authors declare that there is no conflict of interests.

Ethical approval

This study was done with approval of Institute ethical committee.

Informed consent

Informed consent was obtained from all individual human participants included in the study.

Supplementary material

40618_2019_1059_MOESM1_ESM.docx (19 kb)
Supplementary material 1 (DOCX 19 kb)

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Copyright information

© Italian Society of Endocrinology (SIE) 2019

Authors and Affiliations

  1. 1.Department of EndocrinologyJIPMERPuducherryIndia
  2. 2.Department of Preventive and Social MedicineJIPMERPuducherryIndia
  3. 3.Inlaks Budhrani HospitalPuneIndia

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