Comparison of the efficacy of once- and twice-daily colchicine dosage in pediatric patients with familial Mediterranean fever – a randomized controlled noninferiority trial

Table 2 Within-group and intergroup comparison of clinical findings

	Once-daily dosage group (n = 42)				Twice-daily dosage group (n = 37)
	Baseline	First visit	Second visit	p Value^a	Baseline	First visit	Second visit	p Value^a	p Value^b
Features of disease
Fever >38 °C, %	66.7	21.4	19	<0.001	54.1	22.2	16.7	0.001	0.272
Duration of attacks, h (mean ± SD)	48.00 ± 27.25	12.31 ± 25.18	8.4 ± 21.77	<0.001	44.57 ± 31.42	12.35 ± 24.08	5.6 ± 15.13	<0.001	0.711
Number of attacks^c	3 (3–10)^d	0 (0–1)	0 (0–1)	<0.001	3 (4–10)^d	0 (0–1)	0 (0–0)	<0.001	0.521
Erysipelas-like erythema, %	7.1	0	4.8	0.174	5.4	0	0	0.135	0.383
Skeletal system manifestations
Arthralgia, %	35.7	21.4	4.8	0.001	51.4	24.3	8.1	<0.001	0.376
Arthritis, %	26.2	2.4	2.4	<0.001	24.3	8.1	0	0.003	0.948
Serosal involvement
Abdominal pain, %	69	23.8	21.4	<0.001	64.9	24.3	21.6	<0.001	0.840
Chest pain, %	31	4.8	4.8	<0.001	18.9	2.7	2.7	0.002	0.142
Systemic manifestations
Malaise, %	64.3	26.2	14.3	<0.001	51.4	24.3	21.6	0.002	0.726
Headache, %	40.5	23.8	14.3	0.002	37.8	16.2	10.8	0.002	0.553
Confinement to bed during attacks, %	42.9	4.8	0	<0.001	37.8	0	2.7	<0.001	0.505

^aMedian (min-max)
^b p value for within-group comparison of manifestations before and after colchicine treatment
^c p value for intergroup comparison of manifestations
^dMedian number of attacks in the 6 months before admission

ISSN: 1478-6362