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Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized Trial.

Abstract：

BACKGROUND:Two recent double-blind, randomized, controlled trials (RCTs) showed that oral steroids and nonsteroidal anti-inflammatory drugs have similar analgesic effectiveness for management of gout, but the trials had small sample sizes and other methodological limitations. OBJECTIVE:To compare the effectiveness and safety of oral prednisolone versus oral indomethacin in patients presenting to emergency departments (EDs) with acute gout. DESIGN:Multicenter, double-blind, randomized equivalence trial. Patients were randomly assigned (1:1 ratio) to receive either indomethacin or prednisolone. (ISRCTN registry number: ISRCTN45724113). SETTING:Four EDs in Hong Kong. PARTICIPANTS:416 patients aged 18 years or older. MEASUREMENTS:Analgesic effectiveness was defined as changes in pain (at rest or with activity) greater than 13 mm on a 100-mm visual analogue scale. Outcomes were measured during the first 2 hours in the ED and from days 1 to 14. RESULTS:376 patients completed the study. Equivalent and clinically significant within-group reductions in mean pain score were observed with indomethacin and prednisolone in the ED (approximately 10 mm [rest] and 20 mm [activity]) and from days 1 to 14 (approximately 25 mm [rest] and 45 mm [activity]). No major adverse events occurred during the study. During the ED phase, patients in the indomethacin group had more minor adverse events than those in the prednisolone group (19% vs. 6%; P < 0.001). During days 1 to 14, 37% of patients in each group had minor adverse events. LIMITATION:Diagnosis of gout was usually based on clinical criteria rather than examination of joint fluid. CONCLUSION:Oral prednisolone and indomethacin had similar analgesic effectiveness among patients with acute gout. Prednisolone is a safe, effective first-line option for treatment of acute gout. PRIMARY FUNDING SOURCE:Health and Health Services Research Grant Committee of the Hong Kong Government.

journal_name

Ann Intern Med

journal_title

Annals of internal medicine

authors

Rainer TH,Cheng CH,Janssens HJ,Man CY,Tam LS,Choi YF,Yau WH,Lee KH,Graham CA

doi

10.7326/M14-2070

subject

Has Abstract

pub_date

2016-04-05 00:00:00

pages

464-71

issue

eissn

0003-4819

issn

1539-3704

pii

2494539

journal_volume

164

pub_type

杂志文章,多中心研究

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Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized Trial.