Yao 2006.
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 patients with CHD, with evidence of coronary arteriography showing stenosis ≥ 70%, who successfully received stenting. Tong‐xin‐luo group: 38 participants (age: 56.6 ± 10.9 years). Control group: 38 participants (age: 50.1 ± 12.4 years ). |
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Interventions | Control group: conventional treatment:
• Pre‐operation(3 days before operation): aspirin 300 mg qd, clopidogrel 75 mg qd, simvastatin 20 mg qd.
• Intra‐operation: heparin 10000 IU/kg, then 1000 IU/hour during operation.
• Post‐operation: low molecular weight heparin 600 ml subcutaneous injection bid for 5 days; aspirin 300 mg qd, clopidogrel 75 mg qd. Tong‐xin‐luo group: conventional treatment plus Tong‐xin‐luo capsules (4 capsules, tid). Duration of intervention: 6 months. Co‐intervention: none. |
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Outcomes | Occurrence of 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 sex, age, length of lesions, distributions of coronary pathological changes and severity of stenosis between the two groups (P > 0.05). The study appears to be free of other sources of bias. |