title: Comparison of oral prednisolone/paracetamol and oral indomethacin/paracetamol combination therapy in the treatment of acute goutlike arthritis: a double-blind, randomized, controlled trial.
abstract: OBJECTIVE
  We compare the analgesic efficacy and adverse effects of oral prednisolone/acetaminophen and oral indomethacin/acetaminophen combination therapy in the treatment of acute goutlike arthritis in patients presenting to an emergency department (ED).
  
  
  METHODS
  This is a double-blind, randomized, controlled study in a university hospital emergency department (ED) in the New Territories of Hong Kong. Patients older than 17 years and presenting between February 1, 2003, and June 30, 2004, with a clinical diagnosis of goutlike arthritis were randomized to receive either oral prednisolone/acetaminophen or oral indomethacin/acetaminophen combination therapy. Primary outcome measures were pain scores, time to resolution of symptoms and signs, and adverse effects. Secondary outcome measures were the need for additional acetaminophen and relapse rate.
  
  
  RESULTS
  There were 90 patients randomized: 46 patients to the indomethacin group and 44 patients to the prednisolone group. Baseline characteristics, including pain scores, were similar in the 2 groups. Both treatment groups had a similar decrease in pain score in the ED. The mean rate of decrease in pain score with activity for indomethacin was -1.7+/-1.6 (SD) mm per day and for prednisolone was -2.9+/-2.0 (SD) mm per day (mean difference 1.2 mm/day; 95% confidence interval 0.4 to 2.0 mm/day; P=.0026). Although these differences were statistically significant, at no time was the difference in mean pain score greater than 13 mm. Therefore, it is unclear whether these differences are clinically significant. The mean total dose of acetaminophen consumed by the prednisolone group was significantly more than in the indomethacin group (mean 10.3 g, range 1 to 21 g versus mean 6.4 g, range 1 to 21 g). Twenty-nine patients in the indomethacin group and 12 patients in the prednisolone group experienced adverse effects (P<.05). The commonest adverse effects in the indomethacin group were nausea, indigestion, epigastric pain, dizziness, and gastrointestinal bleeding (N=5; 11%). None of the patients in the prednisolone group developed gastrointestinal bleeding. The relapse rate for both groups was similar.
  
  
  CONCLUSIONS
  In the treatment of acute goutlike arthritis, oral prednisolone/acetaminophen combination is as effective as oral indomethacin/acetaminophen combination in relieving pain but is associated with fewer adverse effects.
authors.affiliation: Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, Hong Kong, China.
authors.forename: Chi Yin
authors.initials: CY
authors.lastname: Man
authors.forename: Ian T F
authors.initials: IT
authors.lastname: Cheung
authors.forename: Peter A
authors.initials: PA
authors.lastname: Cameron
authors.forename: Timothy H
authors.initials: TH
authors.lastname: Rainer
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced; D000082:Acetaminophen / Q000008:administration & dosage* / Q000009:adverse effects; D000208:Acute Disease; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000009:adverse effects; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015210:Arthritis, Gouty / Q000188:drug therapy*; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000139:chemically induced; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced; D006074:Gout Suppressants / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010147:Pain Measurement; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome; D014987:Xerostomia / Q000139:chemically induced
chemical_list: D018712:Analgesics, Non-Narcotic; D000893:Anti-Inflammatory Agents; D006074:Gout Suppressants; D000082:Acetaminophen; D011239:Prednisolone; D007213:Indomethacin