Adverse events during oral colchicine use: a systematic review and meta-analysis of randomised controlled trials

Table 2 Meta-analysis results showing pooled risk ratio of adverse events between colchicine and pooled comparator groups

	N. studies	n/N, % (95% CI) participants		Pooled risk ratio (95% CI)	I² (P value)	Overall effect, Z (P value)^a
	N. studies	Colchicine	Comparator	Pooled risk ratio (95% CI)	I² (P value)	Overall effect, Z (P value)^a
Any event	27	845/4007, 21.1% (19.9, 22.4)	784/4152, 18.9% (17.7, 20.1)	1.46 (1.20, 1.77)	58% (< 0.001)	3.82 (< 0.001)
Diarrhoea	19	420/3212, 17.9% (16.8, 19.1)	262/3142, 13.1% (11.9, 14.3)	2.44 (1.62, 3.69)	58% (< 0.001)	4.24 (< 0.001)
Gastrointestinal^b	29	729/4131, 17.6% (16.5, 18.8)	552/4213, 13.1% (12.1, 14.2)	1.74 (1.32, 2.30)	53% (< 0.001)	3.94 (< 0.001)
Liver	13	22/1150, 1.9% (1.2, 2.8)	15/1362, 1.1% (0.6, 1.8)	1.61 (0.86, 3.02)	0% (0.48)	1.50 (0.13)
Muscle^c	9	37/872, 4.2% (3.0, 5.7)	29/869, 3.3% (2.3, 4.7)	1.25 (0.80, 1.93)	0% (0.69)	0.98 (0.33)
Haematology	8	16/2878, 0.6% (0.3, 0.9)	12/2893 0.4% (0.2, 0.7)	1.34 (0.64, 2.82)	0% (0.69)	0.77 (0.44)
Sensory^d	2	3/201, 1.5% (0.4, 4.0)	2/190, 1.1% (0.2, 3.4)	1.35 (0.27, 6.74)	0% (0.58)	0.37 (0.71)
Infectious	7	105/2763, 3.8% (3.1, 4.6)	131/2997, 4.4% (3.7, 5.1)	1.03 (0.70, 1.51)	46% (0.09)	0.13 (0.90)

^aBolded P values indicate a significant overall effect in the risk ratio for an adverse event between colchicine and comparator groups
^bThe gastrointestinal category includes diarrhoea
^cThe muscle category includes myalgia, muscle cramps, myotoxicity, muscle weakness and elevated CPK. No rhabdomyolysis was assessed or reported by any study
^dThe sensory category includes dysthesia and paresthesia. No neuropathy was assessed or reported by any study

ISSN: 1478-6362