Effect of propranolol vs prednisolone vs propranolol with prednisolone in the management of infantile hemangioma: a randomized controlled study

Abstract

Aims and objectives: The purpose of this study was to compare the efficacy of orally administered propranolol versus prednisolone versus both in the treatment of potentially disfiguring or functionally threatening infantile hemangiomas.

Material and methods: A prospective study of 30 patients aged 1 week-8 months was randomized into three equal groups. These were as follows: A, propranolol (2-3 mg/kg/d); B, prednisolone (1-4 mg/kg/d); and C, receiving both for a minimum duration of 3 months. Dimensions, color, consistency, ultrasonography, photographic documentation based on Visual Analogue Scale (VAS) were recorded before and periodically after starting treatment. A minimum 75% improvement was considered as success with no regrowth up to 1 month of stopping treatment.

Results: Mean initial response time (days) in A (4.1±3.3 SD) and C (4.7±3.4SD) was significantly lower than B (9.78±7.8SD) (p<0.047). Significant change in consistency was noted very early in A (24 hours) compared to B and C (8 days). VAS results are as follows: (a) color fading--significant reduction in A within 48 hours compared to B and C (p=0.025), (b) flattening--more significant and earlier in A and C than B (p<0.05), and (c) mean reduction in size: significant in A and C at 3 months (p=0.005, p=0.005), 6 months (p=0.005, p=0.008), 12 months (p=0.005, p=0.008), and 18 months (p=0.02, p=0.04), whereas in B, it was seen only at 6 months (p=0.008).

Conclusions: Propranolol had a consistent, rapid therapeutic effect compared to prednisolone. A combination of the two had a comparable but not higher efficacy than propranolol alone. Prednisolone was associated with a higher number of complications, thereby decreasing patient compliance.

Keywords: Complications; Infantile hemangioma; Propranolol oral corticosteroid; Randomized controlled trial.