Summary of findings 5. Colchicine single dose versus divided dose for reducing inflammation in familial Mediterranean fever.

Colchicine single dose versus divided dose for reducing inflammation in familial Mediterranean fever
Patient or population: pediatric participants with familial Mediterranean fever Settings: outpatient (Turkey) Intervention: colchicine single dose versus divided dose
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Colchicine divided dose	Colchicine single dose
Number of participants experiencing an attack	Not reported.			NA
Duration of attacks1 Follow‐up: 3 and 6 months	The mean duration of attacks in the divided‐dose group was 12.35 hours during 3 months follow up.	The mean duration of attacks in the single‐dose group was 0.04 lower (10.91 lower to 10.83 higher).	NA	79 (1 study)	⊕⊕⊕⊝ moderate2
	The mean duration of attacks in the divided‐dose group was 5.6 hours during 6 months follow up.	The mean duration of attacks in the single‐dose group was 2.8 higher (5.39 lower to 10.99 higher).	NA
Number of days between attacks	Not reported.			NA
Prevention of AA amyloidosis	Not reported.			NA
Adverse drug reactions Follow‐up: 3 and 6 months	The study reported adverse drug reactions of both 3 months and 6 months as following, anorexia, nausea, diarrhoea, abdominal pain, vomiting, elevated ALT and AST, and none of the reported adverse drug reactions between single or split doses of colchicine groups were significant.		NA	79 (1 study)	⊕⊕⊕⊝ moderate2
Acute phase response Follow‐up: 8 months	The mean ESR was 27 mm/h in the divided‐dose group.	The mean ESR was 25 mm/h in the single‐dose group.	NA	39 (1 studies)	⊕⊕⊝⊝ low3,4
	The mean WBC was 7.9×10^9/L in the divided‐dose group.	The mean WBC was 8.5×10^9/L in the single‐dose group.	NA	39 (1 studies)	⊕⊕⊝⊝ low3,4
	The mean fibrinogen was 414 mg/dL in the divided‐dose group.	The mean fibrinogen was 387 mg/dL in the single‐dose group (P = 0.09).	NA	39 (1 studies)	⊕⊕⊝⊝ low3,4
	The mean CRP was 4 mg/L in the divided‐dose group.	The mean CRP was 5 mg/L in the single‐dose group.	NA	39 (1 studies)	⊕⊕⊝⊝ low3,4
	The mean SAA was3.28 mg/L in the divided‐dose group.	The mean SAA was3.28 mg/L in the single‐dose group.	NA	79 (1 studies)	⊕⊕⊕⊝ moderate2
*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; OR: odds ratio; NA: not applicable; ESR: erythrocyte sedimentation rate; WBC: white blood cell count; CRP: C‐reactive protein; SAA: serum amyloid A.
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.

1. Attack definition: fever ≥ 38℃ lasting less than 72 h and accompanied by abdominal pain, chest pain, erysipelas such as erythema and/or swelling in the joints, and laboratory findings demonstrating an acute phase response.
2. Downgraded once for high risk due to lack of blinding and incomplete outcome data.
3. Downgraded once for high risk due to other bias and and unclear risk due to random sequence generation, allocation concealment and selective reporting.
4. Downgraded once for the small sample size.