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Original Article
A B S T R A C T
Background: Hypothyroidism is believed to be a common health issue in India, as it is worldwide. However, there is a paucity of
data on the prevalence of hypothyroidism in adult population of India. Materials and Methods: A cross-sectional, multi-centre,
epidemiological study was conducted in eight major cities (Bangalore, Chennai, Delhi, Goa, Mumbai, Hyderabad, Ahmedabad and
Kolkata) of India to study the prevalence of hypothyroidism among adult population. Thyroid abnormalities were diagnosed on the
basis of laboratory results (serum FT3, FT4 and Thyroid Stimulating Hormone [TSH]). Patients with history of hypothyroidism and
receiving levothyroxine therapy or those with serum free T4 0.89 ng/dl and TSH5.50 U/ml, were categorized as hypothyroid. The
prevalence of self reported and undetected hypothyroidism, and anti-thyroid peroxidase (anti-TPO) antibody positivity was assessed.
Results: A total of 5376 adult male or non-pregnant female participants18 years of age were enrolled, of which 5360 (mean age:
4614.68 years; 53.70% females) were evaluated. The overall prevalence of hypothyroidism was 10.95% (n587, 95% CI, 10.11-11.78)
of which 7.48% (n401) patients self reported the condition, whereas 3.47% (n186) were previously undetected. Inland cities
showed a higher prevalence of hypothyroidism as compared to coastal cities. A significantly higher (P0.05) proportion of females
vs. males (15.86% vs 5.02%) and older vs. younger (13.11% vs 7.53%), adults were diagnosed with hypothyroidism. Additionally,
8.02% (n430) patients were diagnosed to have subclinical hypothyroidism (normal serum free T4 and TSH5.50 IU/ml). Anti – TPO
antibodies suggesting autoimmunity were detected in 21.85% (n1171) patients. Conclusion: The prevalence of hypothyroidism was
high, affecting approximately one in 10 adults in the study population. Female gender and older age were found to have significant
association with hypothyroidism. Subclinical hypothyroidism and anti-TPO antibody positivity were the other common observations.
Key words: Anti-TPO positive, epidemiology, free T3, free T4, hypothyroidism, India, prevalence, subclinical hypothyroidism,
undetected hypothyroidism
Corresponding Author: Dr. Ambika Gopalakrishnan Unnikrishnan, Department of Endocrinology, Amrita Institute of Medical Sciences, Cochin,
Kerala, India. E-mail: unnikrishnanag@gmail.com
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the cluster of iodine deficient disorders (IDDs), which with the approved protocol, principles of Declaration of
were represented in terms of total goiter rates and urinary Helsinki and Good Clinical Practices. It was registered
iodine concentrations, typically assessed in school-aged with the Clinical Trials Registry India (registration no:
children.[9-11] Ever since India adopted the universal salt CTRI/2011/11/002180). All participants were required
iodization program in 1983,[12] there has been a decline to provide written informed consent before study entry.
in goiter prevalence in several parts of the country,
which were previously endemic.[13-15] In 2004, a WHO Subjects
assessment of global iodine status classified India as Enrolment of 5277 participants was planned to form a target
having ‘optimal’ iodine nutrition,[16,17] with a majority of population that constituted 0.01% of the total population
households (83.2% urban and 66.1% rural) now consuming of the eight cities. Sample size for each city was calculated
adequate iodized salt[18,19] India is supposedly undergoing by performing stratification according to the 2001 national
a transition from iodine deficiency to sufficiency state. census data. Participants were selected through a single
A recent review of studies conducted in the post-iodization visit they made to any one of the 94 general health camps
phase gives some indication of the corresponding change organized across the eight cities. For creating awareness
in the thyroid status of the Indian population.[20] However, of each general health camp, 5000-6000 invitation leaflets
most of these studies are limited to certain geographical were distributed door to door covering approximately five
areas or cities, and undertaken in children with modest kilometers area around the camp venue, banners were
sample sizes.[21-24] There have been no nationwide studies exhibited at appropriate areas and 8-10 general health
on the prevalence of hypothyroidism from India, either in camp posters were displayed in the vicinity of the camps.
the pre- or post-iodization periods. A large, cross-sectional, The general health camps were led by physicians certified
comprehensive study was required to provide a true picture in internal medicine.
of the evolving profile of thyroid disorders across the whole
country, especially as the country is in the post-iodization Study procedure
era. The aim of the present study was to estimate the Before enrolment, participants underwent medical history
prevalence of hypothyroidism among the adult population assessment, a general physical examination (including
in India. anthropometry and thyroid gland examination) and
laboratory investigations. A central certified laboratory
MATERIALS AND METHODS performed the hematological and biochemical investigations.
Assays for thyroid hormone (FT3, FT4 and TSH) were
Study design and enrollment criteria performed by the chemiluminescence method using
This was a cross-sectional, multi-centered epidemiology Advia Centaur automated immunoassay analyzer (Siemens
study conducted at eight sites in India namely Bangalore, Diagnostics Tarrytown, NY, USA). Anti-TPO antibodies
Chennai, Delhi, Goa, Ahmedabad, Hyderabad, Kolkata and were measured by the enzyme-linked immunosorbent
Mumbai. These cities were selected to ensure participation assay (ELISA) using Immulite 2000 (Siemens Diagnostics
of a diverse study population with respect to geographic Llanberis, Gwynedd, UK). Analytical sensitivity of the kit
origin, occupation, socioeconomic status and food used to measure TSH, FT3, FT4 and anti-TPO antibodies
habits. Primary outcome measure of the study was the was 0.010 IU/mL, 0.1 ng/mL, 0.3 g/dL and 5.0 IU/mL,
prevalence of hypothyroidism assessed by measurement respectively.
of thyroid hormones. Secondary outcome measures
were the prevalence of: i) self-reported and undetected Based on previous thyroid history and current thyroid
hypothyroidism, ii) sub-clinical hypothyroidism (SCH) and function test results, participants were classified
iii) anti-thyroid peroxidase (TPO) antibody positivity in using following definitions: Hypothyroid: Serum-free
the study population. All male or female natives (residing thyroxine (FT4) 0.89 ng/dL and thyroid stimulation
in that area for at least 5 years) aged 18 years, were hormone (TSH) 5.50 U/mL, Hyperthyroid: Serum
invited to participate in a general health checkup camp, FT4 1.76 ng/dL and TSH 0.35 IU/mL, Subclinical
and those willing to sign a written informed consent hypothyroidism: Normal serum FT4 and TSH5.50 IU/mL.
and provide blood sample for laboratory investigations Subclinical hyperthyroidism: Normal serum FT4 and TSH0.35
were included in the study. Participants were excluded if IU/ml, Self-reported hypothyroidism: Subjects with history of
they were pregnant, or had any acute or chronic systemic hypothyroidism and taking levothyroxine therapy. Undetected
illnesses as judged by investigator; or if they were receiving Hypothyroidism: Subjects without history of hypothyroidism
drugs (like lithium or steroids) that could interfere with and detected to have hypothyroidism through thyroid
thyroid function tests. The study was approved by a Central function tests. Anti-TPO antibody positive: Presence of
Ethics Committee (CEC) and carried out in accordance anti-TPO antibodies above 35 IU/ml.
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