DR Madhushree Pahari Ambicon2021, PPT

PREVALENCE OF SUBCLINICAL
HYPOTHYROIDISM IN
UNTREATED PCOS PATIENTS
AND PCOS PATIENTS ON
METFORMIN AT A TERTIARY
CARE HOSPITAL OF EASTERN
INDIA
Dr.Madhushree Pahari
3rd-year PGT, Dept. of Biochemistry, IPGME&R,KOLKATA
GUIDE:
DR. MOUSUMI MUKHOPADHYAY
PROFESSOR AND HEAD
DEPARTMENT OF BIOCHEMISTRY
IPGME&R, KOLKATA
CO-GUIDE:
DR. SAMBHUNATH BANDOPADHYAY
ASSOCIATE PROFESSOR
DEPARTMENT OF GYNAECOLOGY AND OBSTETRICS
IPGME&R, KOLKATA
CO-GUIDE:
DR. KASTURI MUKHERJEE
ASSISTANT PROFESSOR
DEPARTMENT OF BIOCHEMISTRY
IPGME&R, KOLKATA
INTRODUCTION
• Polycystic ovary syndrome (PCOS) is one of the most common
endocrine disorders characterized by anovulation, hyperandrogenism
and polycystic ovaries.
• affect up to 15–20% of women of reproductive age.
• These patients are at risk of a range of metabolic and endocrinological
disturbances that include infertility, obesity, insulin resistance, and
metabolic syndrome .
• In addition, there is also increasing evidence suggesting that PCOS
links to the increased prevalence of thyroid diseases
• Although SCH is a mild form, it also results in anovulatory cycles, sex
hormone imbalances, subfertility, and adverse pregnancy outcomes,
which are also features of women with PCOS.
• In addition, patients with SCH have an increased risk of obesity,
insulin resistance and hyperlipidemia similar to those with PCOS .
• The prevalence of SCH in women with PCOS is variable, ranging
from 11 to 36%.
• The reported prevalence of SCH in the Indian PCOS population was
nearly 22.5%.
• Hyperandrogenism in PCOS is aggravated in the presence of
hypothyroidism.
• Screening for hypothyroidism in PCOS patients in our population
gives a better idea about the epidemiology of this disorder and the
importance of evaluating thyroid function status in them .
• Metformin may be a beneficial choice for PCOS women with SCH.
• Metformin is considered one of the safest antihyperglycemic agents,
that activates AMP-activated protein kinase (AMPK), an intracellular
sensor of nutrient availability and regulator of energy homeostasis.
• Activation of AMPK by metformin results in a strong reduction of
iodide uptake through thyroidal sodium iodide symporter.
• . The pharmacological activation of AMPK in normal thyrocytes
results in decreased iodide uptake counterbalancing TSH action .
• Meanwhile, metformin also plays a role in improving the ovulation
rate and reproductive outcomes in women with PCOS .
• Hypothyroidism is definitely an important contributing factor for
hyperandrogenism, menstrual irregularities, infertility among females
of the reproductive age group.
• In previous studies, a significant reduction in serum TSH levels was
observed in patients with SCH after treatment with metformin and the
effect was not related to its dose.
• hence the presence of subclinical hypothyroidism in PCOS imparts a
higher risk of reproductive problems. This study suggests that
screening for hypothyroidism along with reproductive hormone profile
should be evaluated in PCOS/infertile women for early diagnosis and
management.
AIMS AND OBJECTIVES OF THE
STUDY
• General objectives:
1. To measure the serum TSH, serum FT4, Serum FT3 level in
diagnosed untreated PCOS patients.
2. To measure the serum TSH, serum FT4, Serum FT3 level in

diagnosed untreated PCOS patients on metformin therapy for >6
months.
3.To measure the serum LH, serum FSH, serum Insulin, FBS and the
BMI of untreated PCOS patients and PCOS patients on metformin for
>6 months
• Specific objective:
To compare the prevalence of subclinical hypothyroidism in
untreated PCOS patients with age-matched, diagnosed PCOS
patients on metformin therapy for >6 months, in order to
establish the effect of metformin on thyroid hormone status
in patients with PCOS patients on metformin therapy for >6
months
MATERIALS AND METHODS
• EXPERIMENT/STUDY DESIGN - Cross-sectional, observational
hospital-based study.
• PLACE OF STUDY-Dept.of Biochemistry,Dept. of Gynaecology and
Obstetrics,IPGME&R, KOLKATA
• SAMPLE SIZE-100 patients clinically diagnosed with PCOS on

metformin therapy>6 months and the same number of age-matched
diagnosed PCOS patients according to Rotterdam criteria were
selected as cases and controls respectively for the study.
• INCLUSION CRITERIA, EXCLUSION CRITERIA
• Inclusion criteria for cases: Patients with diagnosed PCOS according

to Rotterdam criteria, on metformin therapy >6 months, of age group
18-44 years, signed the informed consent form.
• Inclusion criteria for controls: Patients with diagnosed PCOS

according to Rotterdam criteria, untreated patients of age group 18-44
years, signed informed consent form.
• Exclusion criteria:
• 1. Patients with diseases other than PCOS and taking any other kind of
medicine could have influenced the test result.
• 2. Patients with a previous history of hypothyroidism.
• 3. PCOS patients on hormone therapy.
• 4. Patients on drugs affecting the thyroid profile[Lithium, Amiodarone], OCP,

hormone replacement therapy using oral Estrogen, PPI, etc.
LABORATORY INVESTIGATION PARAMETERS-
1. Serum TSH ,2. Serum FT4 ,3. Serum FT3,4. Serum LH,5. Serum
FSH,6. Serum FBS,7. Serum Insulin
STATISTICAL SOFTWARE-SPSS (Statistical Package for Social
Sciences) version 24
RESULTS: comparison of parameters
MEAN±SD CASE CONTROL P VALUE
(parameters)
LH 6.29±1.91 9.81±1.48 p<0.0001
FSH 6.34±1.29 3.71±0.66 p<0.0001
TSH 3.29±2.73 4.15±3.28 p=0.022
FT4 1.08±0.25 1.04±0.20 p=0.35
FT3 2.15±0.55 2.11±0.52 p=0.12
FBS 79.06±6.02 85.37±9.14 p<0.0001

FASTING 10.56±1.32 11.44±2.80 p=0.005
INSULIN
Mean (±s.d.)TSH (in mIU/L)
12
0
4
8
Case
Control
DISCUSSION
• A high prevalence of obesity had been observed in PCOS patients,

although the cause of association remains unknown.
• Obese PCOS patients are characterized by a worsened
hyperandrogenic and metabolic state, poorer menses and ovulatory
performance, poorer pregnancy rates, higher abortion rates and a low
live birth rate.
• In this study most patients of two groups were overweight and the rest
were obese.
• Our study revealed that the mean BMI, mean FBS and mean fasting Insulin
of controls were higher than the cases, results were statistically significant.
• The study found that the mean LH was significantly higher among controls
than cases and mean FSH was significantly higher among cases than
controls, thus LH :FSH ratio was higher among controls than cases.
• Metformin works in PCOS by reducing the circulating insulin levels.
• metformin can directly affect ovarian steroidogenesis [Mansfield et al.
2003; Arlt et al. 2001].
• Several effects have been reported metformin in PCOS patients include
restoring ovulation, reducing weight, reducing circulating androgen
levels, reducing the risk of miscarriage, and reducing the risk of
gestational diabetes mellitus (GDM). Other studies have reported that the
addition of metformin to the ovarian stimulation regime in in-vitro
fertilization (IVF) improves the pregnancy outcome.
• This study unveiled that the mean level of TSH of the patients of the controls
was significantly higher than that of cases (t198=2.02;p=0.022).The mean
TSH of controls was 4.15±3.28 and the mean TSH of cases was 3.29±2.73.
• In previous studies, a significant reduction in serum TSH levels was
observed in patients with SCH after treatment with metformin and the effect
was not related to its dose. Several mechanisms have been hypothesized for
explaining this effect:
(a) a change in the affinity or number of TSH receptors;
(b) an increase in the central dopaminergic tone;
or (c) an interaction
between metformin and TSH
CONCLUSION
• The study concluded that the control group who were not on
metformin had significantly higher BMI, mean FBS, mean fasting
Insulin, mean LH and LH:FSH ratio than the case group.
• Thus the study concluded that metformin as one of the 1 st line
treatments for PCOS patients was significantly associated with long
term better health outcome for treating PCOS patients.
• As well as this study unveiled the mean TSH value significantly low
among cases who were on metformin therapy for >6 months than the
control group, the prevalence of subclinical hypothyroidism, as well as
overt hypothyroidism, were more among controls, who were not on
metformin therapy
• This study suggests that screening for hypothyroidism along with
reproductive hormone profile should be evaluated in PCOS/infertile
women for early diagnosis and management.
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DR Madhushree Pahari Ambicon2021, PPT

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PREVALENCE OF SUBCLINICAL

2. To measure the serum TSH, serum FT4, Serum FT3 level in

• SAMPLE SIZE-100 patients clinically diagnosed with PCOS on

• Inclusion criteria for cases: Patients with diagnosed PCOS according

• Inclusion criteria for controls: Patients with diagnosed PCOS

• 2. Patients with a previous history of hypothyroidism.

• 3. PCOS patients on hormone therapy.

• 4. Patients on drugs affecting the thyroid profile[Lithium, Amiodarone], OCP,

FSH 6.34±1.29 3.71±0.66 p<0.0001

TSH 3.29±2.73 4.15±3.28 p=0.022

FT4 1.08±0.25 1.04±0.20 p=0.35

FT3 2.15±0.55 2.11±0.52 p=0.12

FBS 79.06±6.02 85.37±9.14 p<0.0001

• A high prevalence of obesity had been observed in PCOS patients,

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