Intake of coffee in early morning is a social habit in this part of the country, which may interfere with the absorption of levothyroxine [ 9 ]. So as convention the drug is given at least half an hour before breakfast, and failure to follow this advice results in variable absorption of levothyroxine sodium. However, many patients with hypothyroidism find it inconvenient to take the drug on an empty stomach in the morning because of their lifestyle, and intake of multiple other drugs which they are regularly consuming and often request their treating physicians to prescribe the drug at some alternate time of the day.
The results of the study conducted by Bolk et al. They found it to be safe and well tolerated. They found out that changing the timings of thyroxine ingestion does not affect the circadian rhythm of TSH and iodothyronine secretion, and hence, testing the thyroid profile of the patients in the morning after ingesting levothyroxine at night bears no significance in the outcome of the study. Keeping these facts in mind, this study was planned to compare the efficacy of morning versus bedtime dose of thyroxine in patients of hypothyroidism.
All patients were having Hashimoto's thyroiditis as underlying cause of hypothyroidism. A written consent was taken from all patients. Patients in group 1 were given levothyroxine in the morning minimum half an hour before breakfast, and in group 2 the drug was given minimum 2 hours after dinner. None of the patients used medication known to interfere with levothyroxine absorption, nor were they known to have gastro-intestinal disease.
Pregnant and postpartum patients with hypothyroidism were not included in either group. Initial dosage was calculated as 1. The study was carried for a time period of 12 weeks, and assessment of quality of life by RAND- Research and Development 36 scoring system [ 11 ] and clinical profile according to the clinical scores given by Billewicz et al.
Biochemical parameters were assessed at baseline before start of treatment and at the end of six, and 12 weeks. TSH normal range 0. Lipid profile was assessed by Konelab 30i using analyzing kits by Randox. Patients were studied on the basis of change in clinical symptoms at presentation, improvement in Quality of life and change in the biochemical parameters with special reference to thyroid function tests and lipid profile. Clinical symptoms were scored according to the scoring system given by Billewicz et al.
The scale score ranged from 0 to for every subscale, with a higher outcome meaning a better health status. Primary end point was a change in the thyroid profile of the subjects and achievement of euthyroidism in each group measured at the end of six and 12 weeks. Secondary end points of the study were change in QoL, thyroid symptom score, and lipid profile.
For calculation of sample size, results from the pilot study conducted by Bolk et al. Z test was used to compare the difference in mean of free T3, free T4, and lipid profile between each group at the beginning, six and 12 weeks.
Paired t -test was used to assess the intragroup change at six and 12 weeks. The value of TSH in either group did not follow Gaussian data distribution on followup as most of the data were clustered in a narrow range in both the groups at 6 weeks and 12 weeks. Hence, nonparametric tests: Wilcoxon two-sample test was applied for intergroup comparison and Wilcoxon sign-rank test was applied for intragroup comparison.
For intergroup comparison of total score of clinical signs and symptoms and QoL, Wilcoxon two-sample test was applied. For intragroup comparison of total score of clinical signs and symptoms and QoL, Wilcoxon sign-rank test was applied.
The mean age of patients in group 1 was At the end of 12 weeks the mean weight was It was seen that at the end of 6 weeks, 32 At the end of 12 weeks, 70 No patient in either group had a low serum TSH at either 6 or 12 weeks. We also analyzed the secondary outcomes of the study in both of the groups. However, when Group 1 was compared to Group 2, there was no significant statistical difference. Serum triglyceride levels were reduced by However, there was no statistical significant improvement in LDL and serum triglyceride levels when intragroup and intergroup comparison was made Table 1.
In our study we observed that physical tiredness, followed by mental lethargy, muscle pain, and increase in body weight were the most common symptoms in patients of group 1, whereas periorbital puffiness was the most common sign.
Similarly in group 2, physical tiredness was the most common presenting symptom, followed by mental lethargy, muscle pain, and dryness of hair, while slowing of ankle jerk and slow movements were the most common signs observed.
The total clinical scores decreased significantly in both the groups showing improvement P value of. Physical tiredness was the most common symptom to be resolved after 12 weeks of therapy, and periorbital puffiness in Group1 and slowness of movement in Group 2 were the most common signs which had maximum improvement after 12 weeks of therapy.
On evaluation of the results of assessment of quality of life by RAND scoring system, it was seen that all the parameters decreased in both the groups. It was noticed that there was a significant improvement in terms of physical functioning and role limitation due to physical health in both the groups at the end of 12 weeks when compared to its baseline.
It was also found that there was a significant improvement in the role limitation due to emotional problems in group 2 at the end of 12 weeks when compared to its baseline.
No significant results were found in group 1. Improvement in the rest of the parameters was found to be statistically insignificant in both the groups. Levothyroxine sodium or thyroxine is the most commonly prescribed thyroid hormone replacement medication in Australia. But is first thing in the morning really the best time to take your thyroid medication? As mentioned above, thyroxine absorption can be impacted by many things, such as food, nutritional supplements and other medications.
Certain supplements, such as calcium tablets, antacids and iron supplements have such a strong effect on thyroid hormone absorption that you should wait at least hours between taking your thyroxine and using these agents. Many of these substances bind with thyroxine, preventing it from diffusing across the gut wall and into the blood. A common situation I see in clinic is patients who are unintentionally reducing their thyroxine absorption by taking their tablet with a cup of tea!
This allows more time for the thyroxine to be absorbed, unaffected by other substances in the digestive tract theoretically enabling a greater percentage of the medication to be taken up into the blood. The aim of taking thyroxine in the morning is to maximise your absorption of the drug, whilst also maintaining steady thyroid hormone levels by taking the medication under the same conditions each day.
This means if you choose to take it at another time of day, you should do so under the same conditions every day. For example, some patients find it easier and more convenient to take their thyroxine at bedtime, ideally at least three to four hours after their last meal. Many patients report feeling better when taking their thyroxine at bedtime, and appreciate the convenience of not having to wait for their morning coffee! This can also be a good option for patients who have to take other medications early in the morning.
This is especially true with calcium and iron pills. Consequently, many patients are instructed to take their levothyroxine on an empty stomach before breakfast and to wait up until an hour before eating.
Some patients find this timing inconvenient. A prior study suggested that taking levothyroxine at bedtime was equally as effective in providing stable thyroid hormone levels. The goal of this study was to compare the effect of taking levothyroxine at bedtime as opposed to taking it before breakfast. Effects of evening vs.
Arch Intern Med. After three months, they switched the timing of levothyroxine to the alternate time either pre-breakfast or bedtime for another 3 months, such that all patients experienced both schedules of levothyroxine ingestion.
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