ABSTRACT
Background: Fasting during Ramadan may be challenging for patients on levothyroxine (LT4), as the drug has a narrow therapeutic index and is administered on an empty stomach. The majority of Muslims who fast in Ramadan have two meals per day, iftar immediately after sunset and suhoor just before dawn. This study aimed at evaluating the impact of LT4 timing during Ramadan on thyrotropin (TSH) levels in patients who underwent total thyroidectomy to determine the best timing for intake and identify the predictors of TSH level changes. Methods: We conducted a parallel, double-blind, randomized controlled trial on Saudi patients diagnosed with hypothyroidism who underwent total thyroidectomy. Patients were required to have stable thyroid function for 6 months before the study period and fast ≥20 days of Ramadan. Participants were randomized to one of three times for LT4 administration: Group A, 30 minutes pre-iftar (n = 48); Group B, 3 hours post-iftar (n = 47); or Group C, 1 hour pre-suhoor (n = 47). The number of participants in the final analysis (excluding patients who dropped out) was as follows: Group A, (n = 31); Group B, (n = 34); and Group C, (n = 22). The changes in TSH and free thyroxine (fT4) levels two weeks before and after Ramadan were compared. Factors associated with a change in TSH levels were examined through multivariable analysis. Results: The TSH levels significantly increased in Group B (1.7 ± 1.8 mU/L vs. 3.1 ± 3.9 mU/L, p = 0.003) and Group C (2 ± 1.7 mU/L vs. 5.5 ± 10 mU/L, p = 0.011), but not Group A (1.8 ± 1.6 mU/L vs. 3.3 ± 4.2 mU/L, p = 0.158). The change in fT4 levels was comparable among the groups: Group A, 16.5 ± 2.7 mcg/dL vs. 15.9 ± 3.2 mcg/dL, p = 0.144; Group B, 15.8 ± 3.8 mcg/dL vs. 16.3 ± 3.6 mcg/dL, p = 0.620; and Group C, 17.5 ± 2.8 mcg/dL vs. 17.3 ± 3.9 mcg/dL, p = 0.770. In multivariable linear regression analysis, the following variables were significantly independently associated with TSH level change: age, weight gain, and the number of nonadherence days to LT4, where ß = -0.2, p = 0.026; ß = + 0.2, p = 0.026; and ß = + 0.5, p < 0.0001, respectively. Conclusions: Fasting patients who took LT4 pre-iftar did not experience significant changes in TSH, whereas those who took LT4 post-iftar or pre-suhoor did. The TSH changes during Ramadan may be associated with age (inverse association), weight gain, and the number of non-adherence to LT4 days. Trial Registration: SCTR Application no. 21122002.
Subject(s)
Fasting , Hormone Replacement Therapy , Thyroidectomy , Thyroxine , Humans , Religion , Thyroid Hormones , Thyrotropin , Thyroxine/therapeutic use , Weight GainABSTRACT
BACKGROUND: Anal fissure (AF) in children is usually treated with laxatives and/or topical agents such as calcium channel blockers. We hypothesize that owing to the superior efficacy of Polyethylene glycol (PEG) in treating constipation in children, adding diltiazem (DTZ) might not improve healing of AF. METHODS: Children ≤14â¯years with anal fissure presented to the pediatric surgery clinic between November 2014 and March 2016 were recruited. Randomization was performed to either PEG with DTZ or PEG with placebo. Study personnel, patients, and their families were blinded. Primary outcome was resolution of symptoms. Secondary outcomes were constipation and treatment complications at 12-week follow up. RESULTS: 48 patients were randomized: 24 to PEG + DTZ and 24 to PEG + placebo. Both groups were similar in their baseline characteristics. At week 12, majority of patients' symptoms have improved without significant difference between groups; painful defecation at week 12: 20.8% and 8.3% (p-value 0.41), blood per rectum at week 12: 4.2% and 8.3% (p value 0.58) in the DTZ and placebo groups, respectively. Additionally, there was similar improvement in constipation in both groups. CONCLUSION: PEG alone was associated with similar improvement in anal fissure symptoms in children compared to PEG and topical diltiazem combined. LEVEL OF EVIDENCE: I.
