Purpose: The aims of the study were to compare the risk of complications and the quality of life in patients with corticotrope deficiency, who fasted during Ramadan. Both hydrocortisone and prednisolone were compared as treatments.
Methods: A randomized double-blind crossover clinical trial conducted in the department of Endocrinology of the University Hospital la Rabta in Tunis, during Ramadan 2018, on 53 patients with known corticotrope deficiency treated with hydrocortisone 20 mg per day and who were willing to fast during Ramadan. Patients were randomized into two groups; AB that received hydrocortisone twice daily for 14 days then prednisolone once daily with a placebo for 14 days and group BA that received the two treatments in the reverse order. Patients had to complete a daily follow-up sheet about their eating and sleeping habits, the occurrence of complications and blood glucose monitoring and also to respond to the AddiQoL questionnaire at the end of each treatment period.
Results: Fifty patients' data were analyzed; 29 men, mean age: 42.4 ± 13.3 years, mean duration of the disease: 8.1 ± 7.6 years. The frequency of complications, mean blood glucose levels and the quality of life did not differ on hydrocortisone compared to prednisolone after adjustment for the sequence of the treatment.
Conclusions: the risks of Ramadan fasting in patients with corticotrope deficiency were the same on hydrocortisone or prednisolone.
Keywords: Adrenal insufficiency; Clinical trial; Double blind; Fasting; Hormone replacement therapy; Hypoglycemia; Quality of life; Randomized.