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Efficacy of colchicine versus placebo for the treatment of pericardial effusion after open-heart surgery : A randomized , placebo-controlled trial . BACKGROUND Pericardial effusion ( PE ) , a common complication after open-heart surgery , accounts for 50 % to 85 % of patients . Although reversible in most of the cases , it could be life threatening in the occurrence of tamponade in large effusions . We aimed to determine the therapeutic efficacy of colchicine on PE after open-heart surgery . METHODS The study is a prospective , randomized , triple-blind , placebo-controlled single-center trial at Tehran Heart Center . A total of 149 patients with mild or moderate PE in transthoracic echocardiography were randomly assigned to receive 1 mg/d colchicine ( n = 74 ) or 1 tablet of placebo ( n = 75 ) for 2 weeks and then underwent follow-up echocardiography . RESULTS Baseline and clinical characteristics were not significantly different between the 2 study groups except for age ( P = .02 ) and graft numbers ( P = .005 ) . There was no significant difference in pretreatment and posttreatment PE sizes between the 2 study groups ( P = .440 and .844 , respectively ) . Median ( 25th-75th percentiles ) of effusion changes was 5 mm ( 1-7.6 mm ) in the colchicine group and 5 mm ( 1-6.6 mm ) in the placebo group ( P = .932 ) . Intervention had no significant impact on pretreatment and posttreatment effusion values and changes in isolated coronary artery bypass graft surgery patients ( P = .607 , .539 , and .628 , respectively ) . After adjustment for possible confounders , there was still no significant difference in postoperative PE between the 2 study groups ( t = -0.285 , P = .776 ) . CONCLUSION We concluded that prescription of colchicine does not seem to be effective in treatment of asymptomatic postoperative PE . This could be justified in case that the etiology of most of the PEs might be contribution of noninflammatory factors which are better to be dealt with observational approaches .
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Intervention_Pharmacological
colchicine
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Intervention_Control
placebo
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
1 mg/d colchicine ( n = 74 )
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Intervention_Control
placebo
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Intervention_Physical
echocardiography
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Intervention_Pharmacological
colchicine
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Intervention_Control
placebo
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Intervention_Pharmacological
colchicine
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Outcome_Physical
Pericardial effusion ( PE )
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Outcome_Physical
PE
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Outcome_Physical
PE sizes
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Outcome_Physical
effusion changes
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Outcome_Physical
posttreatment effusion values and changes
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Outcome_Physical
isolated coronary artery bypass graft surgery patients
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Outcome_Physical
PE
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Outcome_Physical
asymptomatic postoperative PE .
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Participant_Condition
pericardial effusion
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Participant_Condition
open-heart surgery
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Participant_Condition
Pericardial effusion ( PE )
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Participant_Condition
PE
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Participant_Condition
open-heart surgery
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Participant_Sample-size
149
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Participant_Condition
mild or moderate PE
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Participant_Condition
PE
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Participant_Condition
PEs