This information should not be used to decide whether or not to take hydrocortisone enema or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to hydrocortisone enema. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
A 4-week single-blind, randomized, reference-controlled, parallel-group study compared the clinical efficacy and safety of glucocorticosteroid enemas in 47 children with ulcerative colitis. 23 children (range 7-15 years) were randomized and treated with Entocort Enema and 24 children (range 6 -15 years) with Pred-Clysma enema. The primary efficacy variable was remission, defined by endoscopic improvement and absence of clinical symptoms of ulcerative colitis. The remission rate after 4 weeks was 50% in the Entocort group and 71% in the Pred-Clysma group. The difference was not statistically significant. The primary safety variable was adrenal suppression, defined by changes in plasma cortisol levels after ACTH-stimulation. There was a statistically significant difference in the percentage of patients with normal adrenal function at week 4 (Entocort 73%, Pred-Clysma 33%). (Study LD-008-0003).
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