Abstract | BACKGROUND: METHODS: This was a pilot randomised placebo controlled trial with a 1:1 parallel design. Over a period of 10 months, participants were recruited and randomized to receive 1 mg/kg per day of prednisolone or placebo and were followed for a maximum of 8 weeks. The primary outcome was re-accumulation of ascites from baseline (grade 2) to grade 3. Safety was assessed by self-reported side effects, physical exam, and laboratory assessment. RESULTS: Sixteen study participants were randomised to prednisolone, while nineteen were randomised to placebo. Six were lost to follow up (1-prednisolone arm, 5-placebo). Baseline characteristics were similar between groups. Prednisolone was safely administered in this setting. There was no statistically significant difference in the overall risk of developing grade 3 ascites over 8 weeks. RR (95 % confidence interval) 0.70 (0.43-1.11), P value 0.12. The rate of the primary outcome per 1000 person days of follow-up was also similar in both arms P value 0.63. CONCLUSION: Short term prednisolone use was generally safe and did not prevent reaccumulation of ascites in this study population. TRIAL REGISTRATION NUMBER: ISRCTN63999319, 28/03/2013.
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Authors | Yvonne Brenda Nabunnya, James Kayima, Chris T Longenecker, Richard A Josephson, Juergen Freers |
Journal | BMC research notes
(BMC Res Notes)
Vol. 8
Pg. 783
(Dec 15 2015)
ISSN: 1756-0500 [Electronic] England |
PMID | 26666319
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
- Glucocorticoids
- Prednisolone
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Topics |
- Abdominal Pain
(chemically induced)
- Adolescent
- Adult
- Ascites
(prevention & control)
- Double-Blind Method
- Endomyocardial Fibrosis
(drug therapy)
- Female
- Follow-Up Studies
- Glucocorticoids
(adverse effects, therapeutic use)
- Humans
- Kaplan-Meier Estimate
- Male
- Myalgia
(chemically induced)
- Pilot Projects
- Prednisolone
(adverse effects, therapeutic use)
- Treatment Outcome
- Uganda
- Young Adult
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