Comparison of the effects of pramipexole and gabapentin on the treatment of restless leg syndrome in end-stage chronic renal failure patients undergoing hemodialysis

Introduction: Despite the high prevalence of restless legs syndrome (RLS) in hemodialysis patients, few studies have investigated the effect of pramipexole and gabapentin on the severity of RLS in these patients. Objectives: The study aimed to evaluate the effects of pramipexole and gabapentin on the treatment of RLS in end-stage chronic renal failure patients undergoing hemodialysis. Patients and Methods: Using the diagnostic criteria the presence of RLS was investigated in all hemodialysis patients admitted to the dialysis ward of Bu Ali Sina and Velayat hospitals in Qazvin, Iran. Out of 162 patients, 96 patients had RLS and 60 patients with moderate to severe RLS were enrolled in the study. The selected patients were randomly divided into two groups including pramipexole (0.18 mg daily) and gabapentin (100 mg daily). The two groups were treated for 4 weeks. Results: The prevalence of RLS was 59% (96 out of 162 patients). After the intervention, the severity of RLS was significantly decreased in all patients and also in each of the pramipexole and gabapentin groups (P<0.001). Moreover, after the intervention, the rate of improvement in RLS severity in the pramipexole group (16.8 ± 6.5) was significantly higher than that in the gabapentin group (13.0 ± 7.3; P=0.036). Conclusion: The findings of the study showed that the severity of RLS in hemodialysis patients undergoing 4 weeks of treatment with pramipexole or gabapentin was significantly reduced; in addition, the rate of improvement in RLS severity was higher in pramipexole group

Cyclosporine-A versus prednisolone for induction of remission in auto-immune hepatitis : interim analysis report of a randomized controlled trial

Background: Corticosteroids are used to induce remission in auto-immune hepatitis.They are not universally effective; therefore, alternative treatments are needed.In this study Cysclosporine-A has been compared with prednisolone as an alternativetreatment in a randomized controlled trial. This paper is an interimanalysis of an ongoing clinical trial. Methods: Sixteen years and older consenting patients were enrolled. Group-A receivedprednisolone and group-B cyclosporine-A according to a preset protocoland followed at regular intervals for 48 weeks. Final assessment was doneat week 48. Primary outcome was response rate as defined below. "Completeresponse" was defined as achieving AST and ALT in the normal range andabsence of any clinical signs of deterioration, and partial response was definedas a decrease in AST and ALT by less than half of their original values but notto within normal limit. Non-responding ones at week eight were switched tothe other arm. Results: Thirty-nine patients were enrolled (24 group-A, 9 male). Mean AST andALT at baseline were higher in group-B, but other variables were comparable.At week 12, 34.8% and 64.3% of group-A and B had achieved AST and ALTin the normal range (less than 40 IU/L) respectively (p=0.081). Correspondingfigures at week 48 were 50.0% and 47.6% (p=0.62 & 0.48 respectively).At week 12, 86.9% and 85.7% of patients had AST and ALT levels less thantwice upper normal limit in groups-A and B respectively (p=0.54 & 0.42).Corresponding figures at week 48 were 90.0% for both groups. There was onetreatment failure in group-B which did not respond to prednisolone either.Serious adverse events (death and liver transplantation) occurred in group-Aonly. Serum creatinine did not change during the study period in either group. Conclusion: According to our data, Cyclosporine-A is as effective as prednisolone forinduction of remission in AIH. Adverse events and serious adverse events weremore common with prednisolone