Summary of findings 6. 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: children with familial Mediterranean fever Settings: outpatient (Turkey) Intervention 1: colchicine single dose Intervention 2: colchicine divided dose
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Colchicine divided dose	Colchicine single dose
Number of participants experiencing an attack	Not reported.
Duration of attacksa Follow‐up: 3 and 6 months	The mean duration of attacks in the divided‐dose group was 12.35 hours during the 3‐month follow‐up.	The mean duration of attacks in the single‐dose group was 0.04 hours less (10.91 less to 10.83 more).	—	79 (1 study)	⊕⊕⊕⊝ Moderateb	—
	The mean duration of attacks in the divided‐dose group was 5.6 hours during the 6‐month follow‐up.	The mean duration of attacks in the single‐dose group was 2.80 hours longer (5.39 less to 10.99 longer).	—
Time between attacks	Not reported.
Prevention of AA amyloidosis	Not reported.
Adverse drug reactions Follow‐up: 3 and 6 months	The study reported adverse drug reactions at both 3 and 6 months as following, anorexia, nausea, diarrhea, abdominal pain, vomiting, elevated ALT and AST, but there was no evidence of a difference between single or split doses of colchicine groups.		NA	79 (1 study)	⊕⊕⊕⊝ Moderateb	—
Acute‐phase response Follow‐up: 8 months	The mean ESR was 27 mm/hour in the divided‐dose group.	Mean ESR was 2.0 mm/hour longer in the single‐dose group (4.33 less to 8.33 longer).	—	39 (1 study)	⊕⊕⊝⊝ Lowc,d	—
	The mean WBC count was 7.9 × 109/L in the divided‐dose group.	Mean WBC count was 0.6 × 109/L lower in the single‐dose group (4.06 lower to 2.86 higher).	—	39 (1 study)	⊕⊕⊝⊝ Lowc,d
	The mean fibrinogen was 414 mg/dL in the divided‐dose group.	Mean fibrinogen was 27.0 mg/dL higher in the single‐dose group (4.45 lower to 58.45 higher).	—	39 (1 study)	⊕⊕⊝⊝ Lowc,d
	The mean CRP was 4 mg/L in the divided‐dose group.	Mean CRP was 1.0 mg/L lower in the single‐dose group (2.59 lower to 0.59 higher).	—	39 (1 study)	⊕⊕⊝⊝ Lowc,d
	The mean SAA was3.28 mg/L in the divided‐dose group.	Mean SAA wasthe same in the single‐dose group (1.52 mg/L lower to 1.52 mg/L higher).	—	79 (1 study)	⊕⊕⊕⊝ Moderateb
*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; ALT: alanine aminotransferase; AST: aspartate aminotransferase; CI: confidence interval; CRP: C‐reactive protein; ESR: erythrocyte sedimentation rate; NA: not applicable; SAA: serum amyloid A protein; WBC: white blood cell.
GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: 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 certainty: we are very uncertain about the estimate.

^aAttack definition: fever ≥ 38 °C lasting < 72 hours and accompanied by abdominal pain, chest pain, erysipelas such as erythema or swelling in the joints, and laboratory findings demonstrating an acute‐phase response.
^bDowngraded one level for high risk due to lack of blinding and incomplete outcome data.
^cDowngraded one level for high risk due to other bias and unclear risk due to random sequence generation, allocation concealment and selective reporting.
^dDowngraded one level for small sample size.