The safety and efficacy of prednisolone in preventing re-accumulation of ascites among emf patients at mulago hospital: a randomised clinical trial (pilot).

Abstract

Introduction: Endomyocardial fibrosis is the commonest restrictive cardiomyopathy worldwide and is of unknown origin. Ongoing inflammation and fibrosis in the heart and other parts of the body like the peritoneum may explain the commonest presentation in Uganda of exudative ascites found in these patients. Ascites causes acute discomfort and pain in these patients yet medical treatment is disappointing. This pilot study, set out to determine the efficacy and safety of prednisolone in preventing re-accumulation of ascites from grade 2 to grade 3 among these patients attending Mulago hospital cardiology service. Methods: This was a randomised placebo controlled trial with a 1:1 parallel design. Over a period of ten months, patients were screened, recruited and randomised to receive 1mg/Kg of either prednisolone or placebo if they met the eligibility criteria. They were followed every four weeks for a period of up to two months. The primary outcome variables were; the proportion of patients receiving prednisolone prevented from re- accumulating ascites from grade 2 to grade 3 at the end of two months of treatment and, time to re-accumulation of ascites from grade 2 to grade 3(requirement for paracentesis). The safety profile of prednisolone was assessed using a questionnaire containing questions on particular side effects as well as physical examination every four weeks for 2 months. Results: Sixteen patients were randomised to and received prednisolone, while nineteen were randomised to and received placebo. Six patients were lost to follow up (1-prednisolone arm, 5-placebo). There were no statistically significant differences in the baseline demographic, clinical and laboratory characteristics in the two arms of the study. The efficacy of prednisolone was found to be 0.7 (95% confidence interval 0.439-1.114) and P-value 0.121. On survival analysis, the probability of progression to grade 3 ascites was found to be the same in both arms of the study. Prednisolone was found to be relatively safe when used on these patients with no statistically significant difference in the occurrence of the different side effects monitored. Conclusion: Prednisolone was found to be relatively safe to use among EMF patients with ascites and can be safely used in this patient population even if there was no statistically significant evidence of efficacy. We recommend a bigger study to confirm these results. Trial registration number: ISRCTN 63999319 Contact the authors for the trial protocol at ynabunnya@yahoo.com. Source of funding: MEPI-CVD-Linked program (Makerere College of Health Sciences)