EMPATHY Questionnaire as a Tool for Better Personalization of Levothyroxine Doses in Patients with Primary Hypothyroidism?
The therapy for hypothyroidism consists of substitution with levothyroxine (L-T4). Failure to achieve the target thyrotropin hormone (TSH) level can be due to non-compliance (in 60% of cases) or malabsorption of the drug (in 40%). The aim of the presented Italian study was the validation of the EMPATHY questionnaire for better personalization of therapy.
Study Methodology and Population
A total of 300 patients (100 men and 200 women) with newly diagnosed primary hypothyroidism based on autoimmune thyroiditis were included in the study. They were randomized into 2 groups in a ratio of 1:1 – patients in group 1 (average age 37 years) completed the EMPATHY questionnaire (Evaluation of Malabsorption in Patients with Hypothyroidism), group 2 (average age 39 years) was the control group.
The EMPATHY questionnaire consists of the following 7 questions:
- Do you have a drug/food allergy or intolerance?
- Have you been diagnosed with gastritis, gastroesophageal reflux, or Helicobacter pylori infection?
- Have you been diagnosed with an inflammatory bowel disease such as ulcerative colitis or Crohn's disease?
- Do you follow any diet (e.g., vegan, vegetarian)?
- Do you consume soy products?
- Do you have health problems after consuming alcoholic beverages?
- Do you have health problems after consuming the foods listed below?
The last question includes a list of foods divided into subgroups to identify patients with allergies to nickel or corn starch and with intolerance to lactose, histamine, citric acid, gluten, or celiac disease.
At baseline and then every 2 months for 6 months, serum levels of thyroid hormones (fT3, fT4, TSH) and antibodies (anti-TPO, anti-TG) were measured. The initial dose and form of the drug (tablets, soft capsules, or oral suspension) were chosen based on the responses to the EMPATHY questionnaire or anamnesis. In case of a positive response to questions no. 1–3, soft capsules, or oral suspension were administered; when consuming soy, oral suspension was given; in case of alcohol intolerance, tablets or soft capsules were provided; with suspected nickel allergy, or histamine or gluten intolerance, oral suspension was used. In case of suspected lactose, citric acid intolerance, or corn starch allergy, it is advisable to avoid these excipients.
The inclusion criteria for the study were:
- age < 60 years
- TSH level > 10 mIU/l
- decreased/normal fT3 and fT4 levels
Patients who had undergone thyroidectomy for thyroid cancer, those with central hypothyroidism, diabetes, obesity, pregnant women, or individuals taking levothyroxine or drugs affecting L-T4 absorption were excluded from the study.
Study Findings
Most patients (60% in group 1 and 64% in group 2) took levothyroxine in tablet form.
After 6 months of substitution therapy, a total of 6 (4%) patients from group 1 and 17 (11%) from group 2 did not reach the target TSH value (0.4–2.5 mIU/l; p = 0.03). A total of 21 (14%) patients in group 1 and 42 (28%) in group 2 required more than 2 dose adjustments of levothyroxine during the first 6 months of therapy, with a higher number of dose adjustments necessary in group 2 (272 vs. 203; p < 0.001).
Conversely, after the second visit, the target TSH level was achieved in 91 (60%) patients in group 1 and 62 (42%) in group 2 (p = 0.001). The final target dose of levothyroxine was higher in group 2 (148 ± 33 μg/day vs. 136 ± 28 μg/day in group 1; p = 0.003). Drug or food allergy/intolerance based on the EMPATHY questionnaire was suspected in 45 patients (30%).
Conclusion
The EMPATHY questionnaire allows for the personalization of levothyroxine substitution (including the selection of the appropriate drug form) and faster achievement of the target TSH level with fewer dose adjustments in patients with primary hypothyroidism. It is also suitable for the preliminary identification of patients with food allergies or intolerances. Malabsorption should be considered especially if the target TSH level is not achieved despite high doses of L-T4.
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Source: Bellastella G., Caputo M., Maiorino M. I. et al. EMPATHY: a new tool for identifying the most suitable thyroxine formulation in hypothyroid patients. Thyroid 2019; 29 (7): 928–933, doi: 10.1089/thy.2018.0493.
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