A randomized study on a 3-month versus a 7-month prednisolone regimen for the initial episode of childhood idiopathic nephrotic syndrome at a large Saudi center

BACKGROUND AND OBJECTIVES: The standard International Study of Kidney Disease in Children (ISKDC) regimen of prednisolone of 2 months duration for the treatment of the initial episode of Idiopathic Nephrotic Syndrome (INS) was associated with a high relapse rate. The long prednisolone protocols were introduced in order to reduce the relapse rate and steroid toxicities. The main objective of this study was to assess the efficacy and safety of a 3 months protocol of prednisolone versus a 7 months protocol for the first episode of idiopathic nephrotic syndrome. DESIGN AND SETTING: The study took place in the Pediatric Nephrology Department of King Saud Medical City, Riyadh which is a large referral center all over Saudi Arabia. The study was a randomized control trial using 2 groups. Group A received the 3 months protocol and Group B received the 7 months protocol. PATIENTS AND METHODS: All children with a confirmed diagnosis of Idiopathic Nephrotic Syndrome were included. The patients were randomized by simple randomization using sealed envelopes into two groups; group A comprised of 60 children using the daily regimen prednisolone 60 mg/m(2) OD X 1 ½ months then 40mg/m(2) on alternate day for 1 ½ months (total = 3 months) and group B also comprised of 60 children using the 7 months protocol, Prednisolone 60mg/m(2) OD x 1 month then 40mg/m(2) EOD x 2 months then 30mg/m(2) EOD for 2 months then 20mg/m(2) EOD for 2 months. The efficacy and safety of these two prednisolone regimens were recorded. The follow-up period was two years. Statistical analysis was done using the SPSS progress version 16 (Chicago, USA) P < .05 was taken as a significant result. Consort guidelines for randomized controlled trials (RCTs) were followed. The hospital ethical committee approved the study. The parents gave an informed consent. RESULTS: Group B protocol was found to be significantly better than the group A protocol in both years of follow-up. The mean time of first relapse was significantly better in group B than in group A (P < .0001). The relapse rate reduced significantly in group B vs group A in both the first year (P = .0031) as well as in the second year (P = .00002). The cumulative dose of steroids was significantly less in group B vs group A both in the first year of follow-up (P = .0039) as well as in the second year (P = .0026). The incidence of frequently relapsers was significantly less (P = .049) in group B as compared to group A. The risk of relapse was better in group B as compared to group A (RR 0.8039; 95% CI 0.6566 to 0.9843 significance (P = .0346). The side effects of corticosteroids were significantly less in group B protocol as compared to group A. CONCLUSION: We concluded that the long 7 months protocol was significantly better than the 3 months prednisolone regimen in both efficacy and safety for the initial episode of childhood INS.