Summary of findings for the main comparison. Colchicine (oral) versus placebo for reducing inflammation in familial Mediterranean fever.
| Colchicine (oral) versus placebo for reducing inflammation in familial Mediterranean fever | ||||||
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Participant or population: people with familial Mediterranean fever
Settings: outpatient (Israel and the USA)
Intervention: colchicine Comparison: 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 | |||||
| Placebo | Colchicine | |||||
| Number of participants experiencing an attack1,2 Follow‐up: 2 to 3 months | 1000 per 1000 | 210 per 1000 (50 to 950) | RR 0.21 (0.05 to 0.95) | 10 (1 studies) | ⊕⊕⊝⊝ low5,6 | Colchicine 0.6 mg orally 3x daily. |
| 900 per 1000 | 702 per 1000 (441 to 1000) | RR 0.78 (0.49 to 1.23) | 20 (1 studies) | ⊕⊕⊝⊝ low5,6 | Colchicine 0.5 mg orally 2x daily. | |
| Duration of attacks3,4 Follow‐up: 6 to 10 months | Wright 1977 reported that the duration of aborted attacks was less than 8 h, while all but 1 of the 18 unaborted attacks lasted more than 24 h and symptoms persisted more than 48 h in 15 of these 18 attacks. | 9 (1 studies) |
⊕⊝⊝⊝5,6,7 very low |
Data for separate treatment courses were unavailable and not analysed. | ||
| Goldstein 1974 stated there was no obvious difference in duration between 2 participants after colchicine prophylaxis. | 10 (1 studies) |
⊕⊝⊝⊝5,6,7 very low |
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| Number of days between attacks3,4 Follow‐up: 10 to 11 months | Dinarello 1974 reported the mean time between attacks was 15.1 days in the colchicine group versus 20.1 days in the placebo group. | 11 (1 studies) |
⊕⊝⊝⊝5,6,7 very low |
Data for separate treatment courses were unavailable and not analysed. No significant difference. |
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| Wright 1977 reported that the mean duration of an attack after beginning a course of placebo was 10.4 days when the preceding course was colchicine versus 11.4 days when the preceding course was placebo. | 9 (1 studies) |
⊕⊝⊝⊝5,6,7 very low |
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| Prevention of AA amyloidosis | Not reported. | NA | ||||
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Adverse drug reactions Follow‐up: 10 to 11 months |
Dinarello 1974 reported loose stools or frequent bowel movements, but no data were provided. | 11 (1 studies) |
⊕⊝⊝⊝5,6,7 very low |
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| Wright 1977 stated that 2 out of 9 participants experienced diarrhoea while taking colchicine (3.6 mg for the first day and 1.2 mg for the following 2 days), but symptoms disappeared when the dose was reduced 2.4 mg for the first day and 0.6 mg for the next 2 days in the subsequent treatment course. | 9 (1 studies) |
⊕⊝⊝⊝5,6,7 very low |
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| Acute phase response | Not reported. | NA | ||||
| *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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). AA: amyloid A; CI: confidence interval; NA: not applicable; 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. | ||||||
- Attack definition: any episode of fever and serositis reported by the participants during the study period.
- Attack definition: fever (above 38 ℃).
- Attack definition: acute, short‐lived episodes of peritonitis or pleuritis, usually with fever.
- Attack definition: symptoms of serosal inflammation accompanied by a temperature elevation to 37.8 ℃ or higher.
- Downgraded once for high risk due to incomplete outcome data and other bias, and unclear risk due to random sequence generation, allocation concealment, blinding of outcome and selective reporting.
- Downgraded once for the small sample size.
- Downgraded once for unavailable outcome data from each separate phase.