INTRODUCTION: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for the treatment of acute gouty arthritis but have the risk of gastrointestinal bleeding and cardiovascular toxicity. Glucocorticoid was as effective as oral NSAIDs in the initial treatment of gout arthritis of patients intolerant of NSAIDs. However, whether glucocorticoid has the same or preferable effect as oral NSAIDs on patients with acute gouty arthritis irrespective of gastrointestinal and cardiovascular risks factor remains unknown. This study was to compare the efficacy, safety and tolerance of compound betamethasone (diprospan) 7 mg intramuscular injection (i.m.) once for all during the study with diclofenac sodium 75 mg twice a day in the treatment of acute gouty arthritis. METHODS:Sixty patients with acute gouty arthritis were randomised (1 : 1) to receive compound betamethasone 7 mg i.m. once for all during the study or diclofenac sodium 75 mg twice a day for 7 days in this open-label study. Pain intensity, tenderness, swelling and global assessment of response to therapy were collected as end-points for the treatment. RESULTS: The mean change in pain intensity from baseline to Day 3 and Day 7 in both treatment groups demonstrated that compound betamethasone had preferable efficacy over diclofenac sodium on Day 3 and comparable efficacy on Day 7. The compound betamethasone group had fewer adverse effects (AEs) than diclofenac sodium group. No statistically significant differences were observed about serum uric acid levels at different pain intensity at baseline. CONCLUSIONS: A single dose of compound betamethasone may be better than diclofenac sodium for the treatment of acute gouty arthritis.
RCT Entities:
INTRODUCTION: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for the treatment of acute gouty arthritis but have the risk of gastrointestinal bleeding and cardiovascular toxicity. Glucocorticoid was as effective as oral NSAIDs in the initial treatment of gout arthritis of patients intolerant of NSAIDs. However, whether glucocorticoid has the same or preferable effect as oral NSAIDs on patients with acute gouty arthritis irrespective of gastrointestinal and cardiovascular risks factor remains unknown. This study was to compare the efficacy, safety and tolerance of compound betamethasone (diprospan) 7 mg intramuscular injection (i.m.) once for all during the study with diclofenac sodium 75 mg twice a day in the treatment of acute gouty arthritis. METHODS: Sixty patients with acute gouty arthritis were randomised (1 : 1) to receive compound betamethasone 7 mg i.m. once for all during the study or diclofenac sodium 75 mg twice a day for 7 days in this open-label study. Pain intensity, tenderness, swelling and global assessment of response to therapy were collected as end-points for the treatment. RESULTS: The mean change in pain intensity from baseline to Day 3 and Day 7 in both treatment groups demonstrated that compound betamethasone had preferable efficacy over diclofenac sodium on Day 3 and comparable efficacy on Day 7. The compound betamethasone group had fewer adverse effects (AEs) than diclofenac sodium group. No statistically significant differences were observed about serum uric acid levels at different pain intensity at baseline. CONCLUSIONS: A single dose of compound betamethasone may be better than diclofenac sodium for the treatment of acute gouty arthritis.