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. |
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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). |
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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. |
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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. |