Summary of findings 1. Low‐dose colchicine versus placebo for acute gout.
Low‐dose colchicine versus placebo for acute gout | ||||||
Patient or population: people with acute gout Settings: outpatient Intervention: low‐dose colchicine versus placebo | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Control (placebo) | Low‐dose colchicine | |||||
Pain ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | Not reported |
Participant global assessment of treatment success: proportion with 50% or greater decrease in pain score from baseline ‐ 32 to 36 hours | 172 per 1000 | 418 per 1000 (181 to 970) | RR 2.43 (1.05 to 5.64) | 103 (1 study) | ⊕⊕⊝⊝ Lowa,b | Low‐dose colchicine may slightly increase the number of people who report treatment success. Absolute difference: 25% more reported success (7% more to 42% more); relative percentage change: 143% (5% more to 464% more) NNTB 5 (2 to 39)3 |
Reduction of inflammation ‐ not measured | See comment | See comment | Not estimable | ‐ | See comment | Not measured |
Function of target joint ‐ not measured | See comment | See comment | Not estimable | ‐ | See comment | Not measured |
Serious adverse events | ‐ | ‐ | Not estimable | 133 (1 study) |
See comment | Participants reported no serious adverse events. |
Total adverse events | 276 per 1000 | 364 per 1000 (188 to 706) | RR 1.32 (0.68 to 2.56) | 103 (1 study) | ⊕⊕⊝⊝ Lowa,b | Low‐dose colchicine may have little or no effect on the number of people reporting adverse events. Absolute difference: 9% more events with low‐dose colchicine (11% fewer to 29% more), compared to placebo. Relative percentage change: 32% more events (32% fewer to 156% more) |
Withdrawals due to adverse events | ‐ | ‐ | Not estimable | 133 (1 study) |
See comment | No participants withdrew due to adverse events in either study arm. |
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; NNTB: number needed to treat for an additional beneficial outcome; RR: risk ratio | ||||||
GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. |
aDowngraded one level due to a risk of selection bias from unclear reporting of the method of randomisation, and a risk of reporting bias. bDowngraded one level for imprecision as the number of events was small (< 200) and 95% CI includes no effect, or appreciable benefit. cNote: number needed to treat for an additional beneficial (NNTB) or harmful outcome (NNTH) is not reported when result is not statistically significant. Number needed to treat for dichotomous outcomes calculated using 1/risk difference for single studies and Cates NNT calculator for meta‐analyses (www.nntonline.net/visualrx).