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Table 1 Characteristics of included studies

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

Reference

Country

Disease state

Intervention

Comparator

Daily dose of colchicine (mg)

Cumulative dose of colchicine (mg)

Length of intervention

Length of follow-up for AE assessment

Total sample size

Participant characteristics

Aran 2011 [16]

USA

Knee osteoarthritis

Colchicine, 0.5 mg twice daily

Placebo

1

91

3 months

3 months

61

Mean age 60.2 years

0% males

Batezzati 2001 [7]

Italy

Primary biliary cirrhosis

Colchicine, 1 mg daily + ursodeoxycholic acid, 250 mg daily

Placebo + ursodeoxycholic acid, 250 mg daily

1

3650

10 years

10 years

44

Mean age 56.5 years

14% males

Bessissow 2018 [17]

Canada

Lung resection surgery

Colchicine, 0.6 mg 3 times daily for first day, then twice daily

Placebo

1.26

12.6

10 days

30 days

100

Mean age 69 years

45% males

Borstad 2004 [18]

USA

Chronic gouty arthritis

Colchicine, 0.6 mg twice daily

Placebo

1.2

219.0

6 months

6 months

43

Mean age 63 years

86% males

Cohen 1991 [19]

USA

COPD in ex-cigarette smokers

Colchicine, 0.6 mg 3 times daily

Placebo

1.8

25.2

2 weeks

2 weeks

16

Mean age 65.9 years

% males NR

Cortez-Pinto 2002 [8]

Portugal

Alcoholic cirrhosis

Colchicine, 1 mg daily, 5 days/week

Placebo

0.714

901.3

41.5 months (mean)

41.5 months (mean)

55

Mean age 53.8 years

89% males

Das 2002 [20]

India

Knee osteoarthritis

Colchicine, 0.5 mg twice daily + Piroxicam, 20 mg once daily

Placebo + Piroxicam, 20 mg once daily

1

152

5 months

5 months

39

Mean age 53 years

33% males

Davatchi 2009 [21]

Iran

Behcet’s disease

Colchicine, 1 mg daily

Placebo

1

122

4 months

4 months

282

Mean age 32.1 years

32% males

Deftereos 2013 [22]

Greece

Bare-metal stent restenosis in people with diabetes

Colchicine, 0.5 mg twice daily

Placebo

1

182

6 months

6 months

222

Mean age 63.6 years

65% males

Demidowich 2019 [23]

USA

Metabolic syndrome

Colchicine, 0.6 mg twice daily

Placebo

1.2

36.6

3 months

3 months

40

Mean age 45.8 years

23% males

Dinarello 1974 [12]

USA

Familial Mediterranean fever

Colchicine, 0.6 mg 3 times daily

Placebo

1.8

602.3

11 months

11 months

11

Mean age NR

% males NR

Fish 1997 [24]

USA

Asthma

Colchicine, 0.6 mg twice daily

Placebo

1.2

50.4

6 weeks

6 weeks

71

Mean age 34 years

48% males

Imazio 2010 [25]

Italy

Post-periocardiotomy syndrome

Colchicine, 1 mg daily for first day then 0.5 mg daily for 1 month (<  70 kg) or 1 mg twice daily for first day then 0.5 mg twice daily for 1 month (≥70 kg)

Placebo

0.5 to 1

15 to 30

1 month

1 month

360

Mean age 66 years

66% males

Imazio 2011 [26]

Italy

Recurrent pericarditis

Colchicine, 1 mg daily for first day then 0.5 mg daily for 1 month (< 70 kg) or 1 mg twice daily for first day then 0.5 mg twice daily for 1 month (≥ 70 kg)

Placebo

0.5 to 1

91 to 182

6 months

18 months

120

Mean age 47.6 years

53% males

Imazio 2013 [27]

Italy

Acute pericarditis

Colchicine, 0.5 mg daily (< 70 kg) or 0.5 mg twice daily (≥ 70 kg)

Placebo

0.5 to 1.0

46 to 91

3 months

22 months (mean)

240

Mean age 52.1 years

60% males

Imazio 2014a [28]

Italy

Post-periocardiotomy syndrome and postoperative atrial fibrillation

Colchicine, 0.5 mg daily (<  70 kg) or 0.5 mg twice daily (≥ 70 kg)

Placebo

0.5 to 1.0

15 to 30

1 month

3 months

360

Mean age 67.5 years

69% males

Imazio 2014b [29]

Italy

Pericarditis

Colchicine, 0.5 mg daily (<  70 kg) or 0.5 mg twice daily (≥ 70 kg)

Placebo

0.5 to 1.0

91 to 182

6 months

18 months

240

Mean age 48.7 years

50% males

Kaplan 1986 [6]

USA

Primary biliary cirrhosis

Colchicine, 0.6 mg twice daily

Placebo

1.2

876.0

24 months

24 months

60

Mean age NR

5% males

Kershenobich 1979 [9]

Mexico

Cirrhosis

Colchicine, 1 mg daily, 5 days/week

Placebo

0.714

1042.4

48 months

48 months

43

Mean age 55.6 years

58% males

Kershenobich 1988 [10]

Mexico

Cirrhosis

Colchicine, 1 mg daily, 5 days/week

Placebo

0.714

1224.9

14 years (mean 4.7 years)

14 years (mean 4.7 years)

100

Mean age 50.3 years

49% males

Leung 2018 [30]

Singapore

Knee osteoarthritis

Colchicine, 0.5 mg twice daily

Placebo

1

112

16 weeks

16 weeks

109

Mean age 58.5 years

29% males

Liebenburg 2016 [31]

South Africa

Tuberculous pericarditis

Colchicine, 1 mg daily

Placebo

1

42

6 weeks

6 weeks

33

Mean age 31 years

33% males

Masuda 1989 [32]

Japan

Behcet’s disease

Colchicine, 1 mg daily

Cyclosporin, 10 mg/kg daily

1

112

16 weeks

16 weeks

96

Mean age NR

% males NR

McKendry 1993 [13]

Canada

Psoriatic arthritis

Colchicine, 0.6 mg daily for first week, 0.6 mg twice daily for second week, 0.6 mg 3 times daily for 6 weeks

placebo

1.575

88.2

8 weeks

8 weeks

25

Mean age 40.7 years

56% males

Olsson 1995 [11]

Sweden

Primary sclerosing cholangitis

Colchicine, 1 mg daily

placebo

1

1095

36 months

36 months

84

Mean age 41.6 years

67% males

Pakfetrat 2010 [33]

Iran

Recurrent aphthous stomatitis

Colchicine, 0.5 mg daily

Prednisolone, 5 mg/d daily

0.5

47

3 months

6 months

34

Mean age 31.5 years

35% males

Paulus 1974 [34]

USA

Gout

Colchicine, 0.5 mg 3 times daily + probenecid 500 mg 3 times daily

Probenecid, 500 mg 3 times daily

1.5

274

6 months

6 months

52

Mean age 52.5 years

100% males

Roche 1995 [14]

France

Allergic rhinitis

Colchicine, 1 mg twice daily for 3 days then once daily for 5 days

Placebo

1.375

11

8 days

8 days

16

Age range 20 to 30 years

100% males

Schlesinger 2011 [15]

USA

Gout

Colchicine, 0.5 mg daily

Canakinumab dose ranging: single dose of 25 mg, 50 mg, 100 mg,200 mg, 300 mg or four doses at four-weekly intervals (50 mg, 50 mg, 25 mg, 25 mg)

0.5

56

16 weeks

24 weeks

432

Mean age 52.4 years

94% males

Schnebel 1988 [35]

USA

Low back pain

Colchicine, 0.6 mg hourly for 8 h then 0.6 mg every fourth day

Placebo

2.1

191.6

3 months

3 months

34

Mean age 69.1 years

63% males

Seideman 1987 [36]

Sweden

Psoriatic arthritis

Colchicine, 0.5 mg up to 3 times daily increased over 6 days

Placebo

0.5 to 1.5

30 to 91

2 months

2 months

15

Age range 20 to 65 years

% males NR

Tardif 2019 [37]

Canada

Myocardial Infarction

Colchicine, 0.5 mg daily

Placebo

0.5

640.5

42 months

42 months

4745

Mean age 60.6 years

81% males

Terkeltaub 2010 [38]

USA

Gout

Colchicine, 1.2 mg followed by 0.6 mg in 1 h (low dose) or 1.2 mg followed by 0.6 mg hourly for 6 h (high dose)

Placebo

1.8 to 4.8

1.8 to 4.8

1–6 h

7 days

185

Mean age 51.5 years

95% males

Wang 2014 [39]

China

Gout

Colchicine, 0.5 mg twice daily for 3 days then once daily

Chuanhu anti-gout mixture, 250 ml daily

0.65

6.5

10 days

13.4 weeks

176

Mean age 52.8 years

94% males

Yurdakul 2001 [40]

Turkey

Behcet’s syndrome

Colchicine, 0.5 mg twice daily (≤50 kg), 0.5 mg alternating twice and 3 times daily (50–49 kg), 0.5 mg 3 times daily (60–75 kg), 0.5 mg alternating 3 and 3 times daily (76–84 kg), 0.5 mg 4 times daily (≥ 85 kg)

Placebo

1 to 2

730 to 1460

24 months

24 months

116

Mean age 27 years

52% males

  1. NR Not reported