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. 2015 May 21;2015(5):CD010237. doi: 10.1002/14651858.CD010237.pub2

Li 2004.

Methods Study design: randomised controlled trial.
 Method of randomisation: no description.
 Concealment of allocation: no description.
 Exclusions post randomisation: none.
Length of follow‐up: 6 months.
 Losses to follow‐up: none.
 Intention‐to‐treat analysis: not mentioned.
Participants Participants were those who underwent PTCA and stenting successfully.
Tong‐xin‐luo group: 38 participants (age: 56.6 ± 11.2 years).
Control group: 38 participants (age: 54.9 ± 11.8 years).
Interventions Conventional treatment:
 • Pre‐operation (from 3 days before operation): aspirin 300 mg qd, clopidogrel 250 mg bid.
• Intra‐operation: heparin 10000 IU, then 1000 IU/hour during operation.
• Post‐operation: aspirin 300 mg qd, then reduced to 100 mg qd after 2 weeks; clopidogrel 250 mg bid, reduced to 250 mg qd after 4 weeks and applied for 3 months. ACEI, nitroglycerin and statin, were selectively applied.
Tong‐xin‐luo group: conventional treatment plus Tong‐xin‐luo capsules (4 capsules, tid).
 Control: conventional treatment.
 Duration of intervention: 6 months.
 Co‐intervention: none.
Outcomes Occurrence of myocardial infarction and angina.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomised, but detailed information on the randomisation method was not provided.
Allocation concealment (selection bias) Unclear risk No description about the allocation procedure.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No description about blinding. No placebo.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No description about blinding. No placebo.
Incomplete outcome data (attrition bias) 
 Angiographic restenosis Unclear risk The outcome was not reported.
Incomplete outcome data (attrition bias) 
 Outcomes other than angiographic restenosis Low risk There was no loss to follow‐up.
Selective reporting (reporting bias) Unclear risk The study protocol is not available.
Other bias Low risk Baseline information between groups showed no statistical differences in age, number of stents implanted, types of CHD and distributions of coronary pathological changes between the two groups (P > 0.05). The study appeared to be free of other sources of bias.