Level 2: Mid-level evidence
Gout flares are commonly treated with colchicine, which can provoke GI side effects, particularly diarrhea. The Acute Gout Flare Receiving Colchicine Evaluation (AGREE) trial investigated the efficacy and safety of higher and lower doses of colchicine in 184 patients with acute gout flare. The researchers found low-dose colchicine to be effective without a high rate of adverse events. Patients were randomized to one of three treatments: Low-dose colchicine (1.2 mg orally followed by 0.6 mg one hour later), high-dose colchicine (1.2 mg orally followed by 0.6 mg hourly for six hours), or placebo. Outcomes were assessed after 24 hours. The low-dose colchicine group had a higher proportion of patients with at least 50% pain reduction without rescue medication compared to placebo (37.8% vs. 15.5%, P=0.005, NNT 5). Low-dose colchicine was also associated with reduced rescue medication use (31.1% vs. 50%, P=0.027, NNT 6). There were no significant differences in adverse events between low-dose colchicine and placebo (36.5% vs. 27.1%). All adverse events with low-dose colchicine were mild to moderate in intensity. High-dose colchicine was also more effective than placebo (≥50% reduction in pain in 32.7% vs. 15.5%, P=0.034, NNT 6), but was associated with a higher rate of adverse events compared with both placebo (76.9% vs. 27.1%, P <0.05, NNH 3) and with low-dose colchicine. Severe diarrhea occurred in 19% of patients in the high-dose group (Arthritis Rheum. 2010;62:1060-1068).