Propranolol Versus corticosteroids for Infantile Hemangiomas: A Randomized Control Trial in a Tertiary care Hospital

Abstract

Infantile hemangiomas are the most common vascular tumor of infancy and childhood. Sometimes these lesions interfere with normal function & produce serious disfigurement that is unlikely to resolve on its own and then treatment is required. While evidence most supports the use of corticosteroids, there is no well- studied or Federal Drug Administration (FDA) approved systemic therapy for haemangiomas of Infancy. Dramatic improvement of complicated haemangioma by propranolol has recently been reported, but to date, details for initiating therapy, monitoring and potential risks in relation to Corticosteroids were not compared in a large scale. This research was designed to observe the effectiveness of oral propranolol compared to oral corticosteroid aimed at treatment of clinically important groups of infantile hemangiomas that require aggressive treatment. We conducted a randomized control study among the diagnosed case of infantile hemangiomas, age of <10 years. The total sample size was 60 (30 for propranolol group i.e. in group A, and 30 for corticosteroid group i.e. in group B) & grouping was done with the simple random technique. A clinical & photograph based VAS (Visual Analogue Scale) scale with a defined monitoring schedule was used for evaluation of treatment response. Our study result showed, (3.33%) patients of group A, response to color change (red-purple-grey) within 1st month of treatment whereas none of the patient (0.00%) of group B had any response to color by this time. Patients response to propranolol therapy was also continued even up to 5^th month (3.33%) but it was absent (0.00%) in corticosteroid therapy even after 4^th month & p= 0.025, that was statistically significant. Regarding the mean size (diameter) of the tumor, most of the tumor size reduced and near to stabilize at 4^th month in group A, but in group B, the rate was slower and needed longer time (5-6 month), the p value was 0.030. Again 60% of tumor became non-palpable at 3^rd week of treatment in group A patients, but in group B, 70% of tumor was still remain palpable on that time & p=0.001, that was statistically significant. Again, in Propranolol therapy group, the rate of complications was (24%) whereas in Corticosteroid therapy group, it was (76%).The p value was 0.020 that was also statistically significant. Hence, the present study results denote that, oral propranolol can be considered as an emerging and effective treatment over oral corticosteroid therapy for infantile hemangiomas.