Summary of findings 4. Low‐dose colchicine versus NSAIDs.
Low‐dose colchicine versus NSAIDs | ||||||
Patient or population: people with acute gout Settings: 100 GPs across England Intervention: low‐dose colchicine versus naproxen | ||||||
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 (NSAIDs) | Low‐dose colchicine | |||||
Pain NRS Scale from 0 to 10, 0 is no pain. Follow‐up: 7 days |
1.4 points | Mean pain was 0.1 points worse (0.29 better to 0.49 worse) | Not estimable | 399 (1 study) |
⊕⊕⊝⊝ Lowa,b | Low‐dose colchicine may have little or no effect on pain when compared to NSAIDs. Absolute difference: 1% worse pain (3% better to 5% worse). Relative percentage change: 1.4% worse (4% better to 7% worse)c |
Participant global assessment of treatment success: Completely better/much better Follow‐up: 7 days |
570 per 1000 | 553 per 1000 (467 to 655) | RR 0.97 (0.82 to 1.15) | 399 (1 study) |
⊕⊕⊝⊝ Lowa,b | Low‐dose colchicine may have little or no effect on the number of people reporting treatment success. Absolute difference: 1.7% fewer people reported treatment success as completely better or much better with low‐dose colchicine (10.3% fewer to 8.5% more), compared to NSAIDs. Relative percentage change: 3% fewer (18% fewer to 15% more) |
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 Follow‐up: 4 weeks |
See comment | See comment | Not estimable | ‐ | See comment | There were three serious adverse events (2 from the NSAIDs group and 1 from low‐dose colchicine group), none related to study interventions, and no deaths. |
Total number of participants reporting adverse events Follow‐up: 4 weeks |
500 per 1000 | 535 per 1000 (440 to 645) | RR 1.07 (0.88 to 1.29) | 399 (1 study) |
⊕⊕⊝⊝ Lowa,b | Low‐dose colchicine may have little or no difference to the number of adverse events compared to NSAIDs. Absolute difference: 3.5% more people reported adverse events (6% fewer to 14.5% more), compared to NSAIDs. Relative percentage change: 7% (12% fewer to 29% more) |
Withdrawals due to adverse events | See comment | See comment | Not estimable | ‐ | See comment | There was one withdrawal from the low‐dose colchicine group with the reason unreported. |
*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; GPs: general practices; NRS: numeric rating scale; NSAIDs: non‐steroidal anti‐inflammatory drugs; 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 performance and detection bias. bDowngraded one level for imprecision as the number of events was small (< 200) and 95% CI includes no effect, or appreciable benefit. Data were from a single study only, which may have been inadequately powered to detect a clinically important change in pain between groups (defined as 1.5 points on the 0 to 10 NRS pain scale). cRelative change was calculated as absolute change (mean difference) divided by mean at baseline in the NSAIDs group from Roddy 2020 (mean NRS baseline value was 7.1).