Wu 2010.
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 unstable angina based on the Unstable Angina Diagnosis and Treatment Guidelines formulated by the Chinese Society of Cardiology of the Chinese Medical Doctors Associations in 2007, and underwent PCI successfully. Tong‐xin‐luo group: 57 patients (male/female: 32/25; age: 71.4 ± 4.5 years). Control group: 53 patients (male/female: 31/22; age: 69.8 ± 4.3 years). |
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Interventions | Control: conventional treatment:
• Pre‐operation: aspirin 100 mg qd, clopidogrel 75 mg qd for more than 7 days.
• Post‐operation: aspirin, clopidogrel, nitroglycerin, low molecular weight heparin, ACEI, etc. Tong‐xin‐luo group: conventional treatment plus Tong‐xin‐luo capsules (4 capsules, tid; 0.38 g/capsule) Duration of intervention: 6 months. Co‐intervention: none. |
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Outcomes | Occurrence of angiographic restenosis; Occurrence of myocardial infarction, heart failure and angina; Use of revascularisation, including PCI and coronary artery bypass graft surgery. |
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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 | Whether all participants were brought back for angiography 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 showed no statistical differences in sex, age, comorbidities, number and distributions of coronary pathological changes, blood pressure, levels of blood glucose and levels of blood lipoid between the two groups (P > 0.05). The study appeared to be free of other sources of bias. |