A Prospective Study Comparing Two-Time Points of Thyroid Hormone Replacement during the Holy Month of Ramadan

Abstract

Background. Muslims all over the world fast during the month of Ramadan from dawn until dusk. There is little data regarding the best timing of levothyroxine intake during the month of Ramadan where taking it on an empty stomach represents a challenge to most patients. Our study aims to compare two-time points of levothyroxine intake during Ramadan in terms of change in thyroid stimulating hormone (TSH), compliance, and convenience. Study Design and Methods. This was an open-label, randomized, prospective trial. Adult patients known to have primary hypothyroidism with stable TSH for the last 6 months who intended to fast during the month of Ramadan were invited to participate in this prospective study. The study took place during Ramadan of H1438 (May-June 2017). All patients were randomly assigned to two groups. In group A (n= 50) patients took levothyroxine 30 minutes before breaking the fast at sunset (iftar), and in group B (n= 46) patients took it 30 minutes before an early morning meal before sunrise (suhour). Results. TSH levels increased in both group A (from 1.99 to 3.28 mIU/L) and group B (from 1.54 to 3.28 mIU/L) after Ramadan fasting. There was no difference between the two groups. Compliance with intake instructions, all of the time, was reported in 41.6% of group A and 35.7% of group B patients. In both the groups, 95% of patients said it was convenient for them to take the medication at the assigned time. Conclusion. Choosing an optimal time for levothyroxine intake during the month of Ramadan remains a challenge. The current study did not provide any evidence on ideal time and dose of levothyroxine administration during fasting to manage hypothyroidism. Studies with a larger number of patients need to be done to further explore this issue.

Preference, Adherence, and Maintenance of Euthyroidism Using 3 Different Regimens of Levothyroxine Intake during the Fasting Month of Ramadan

“…[14][15][16]. No recommendations exist for optimal L-T4 timing during the fasting month of Ramadan [17][18][19][20][21]. Only few studies explored the effect of fasting Ramadan on thyroid status in euthyroid and hypothyroid individuals [23][24][25].…”

“…The included patients range from 47 to 97 patients. Four studies had a prospective design, while the fifth study was a retrospective one [17][18][19][20][21].…”

“…The tested timings for L-T4 administration during Ramadan are as follows: 2 h after meal at bedtime [17], 2 h after meal and 30 min before the next meal [18], a comparison between 30 min before iftar versus 30 min before suhor [19], a comparison between 30 min before iftar versus 2 h after iftar versus 1 h before suhor after 1 h of empty stomach [20], and finally, a comparison between at iftar versus at suhor [21]. None of these regimens follow the principles of the ATA or ETA evidence-based recommendations.…”

“…None of these regimens follow the principles of the ATA or ETA evidence-based recommendations. We may conclude that the choice of these regimens or timings was based mainly on what is convenient, feasible, or accepted by the patients, rather than what is physiologic or recommended based on the available literature [17][18][19][20][21].…”

“…Based on these observations, both the American Thyroid Association (ATA) and the European Thyroid Association (ETA) recommend that L-T4 be taken after awakening from sleep -on empty stomach by defaultand 60 min before breakfast, or for those who have an early evening meal, at least 3-4 h after the last meal and before going to sleep [14][15][16]. Few studies with a limited number of patients have reported the effect of fasting during Ramadan on thyroid function in Muslim hypothyroid patients treated with L-T4 following L-T4 intake regimens that do not comply with the current recommendations by the ATA and ETA and do not guarantee optimal L-T4 absorption [17][18][19][20][21]. The present study aimed to evaluate preference, adherence, and maintenance -or attainment -of euthyroidism using 3 different regimens of administering L-T4, regimens that fulfill the 2 conditions recommended by the ATA: first, to take the L-T4 tablet at least 3-4 h after the last meal and second, to take the tablet 60 min before the next meal or beverages, during the holy month of Ramadan in fasting hypothyroid patients in Egypt.…”