A randomized controlled trial comparing the efficacy of intralesional 5-fluorouracil versus triamcinolone acetonide in the treatment of keloids

Abstract

Background: Effective keloid management is still a distant dream in spite of many recent modalities being tried for the same. Although many treatment protocols have shown efficacy of varying degrees, there are few systematic randomized trials comparing them. Objective: To compare the efficacy of intralesional 5-Fluorouracil versus Triamcinolone acetonide in the treatment of Keloids. Materials and Methods: This randomized controlled trial was conducted on 30 patients with keloids, randomly divided into two groups of 15 each, treated with intralesional 5-fluorouracil (Group A) or triamcinolone acetonide (Group B). The groups were compared for reduction in the size of keloid, pain relief, and the incidence of adverse effects. Statistical analysis was done using the unpaired student t- test and test of proportion. Results: The reduction in the size of the keloid was found to be significantly better in Group B (71.23%) than in Group A (57.48%) with a P value of 0.04. The difference in the reduction of pain, as assessed by the visual analog scale, between Groups A (18%) and B (24%), was found to be insignificant (P value - 0.47). Although the incidence of complications in Group A was three times higher than those in Group B, the difference was not statistically significant (P value - 0.13). Conclusion: Reduction in the size of the keloid, which was the main aim of this study was significantly better in those treated with triamcinolone acetonide than those treated with 5-fluorouracil. The other parameters like reduction of pain and the incidence of adverse effects were comparable in both the groups.