Chen 2011.
Methods | Study design: randomised controlled trial.
Method of randomisation: random number table.
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 | Patients were all diagnosed as having ACS based on coronary arteriography, and in accordance with the diagnostic criteria formulated by the European Society of Cardiology in September 2000. Tong‐xin‐luo group: 80 patients (male/female: 48/32; age: 71.5 ± 5.6 years). Control group: 80 patients (male/female: 46/34; age: 70.7 ± 5.8 years). |
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Interventions | Control: conventional treatment (pre‐operation: aspirin 100 mg qd, clopidogrel 75 mg qd; post‐operation: aspirin, clopidogrel, nitroglycerin, low molecular weight heparin, ACEI, atorvastatin). Tong‐xin‐luo group: conventional treatment plus Tong‐xin‐luo capsules (4 capsules tid; 0.26 g/capsule). Duration of intervention: 6 months. |
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Outcomes | Occurrence of angiographic restenosis; Occurrence of heart failure and angina. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised, random number table was used. |
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 | Low risk | Same numbers of participants randomly assigned and analysed. No missing outcome data. |
Incomplete outcome data (attrition bias) Outcomes other than angiographic restenosis | Low risk | Same numbers of participants randomly assigned and analysed. No missing outcome data. |
Selective reporting (reporting bias) | Unclear risk | The study protocol is not available. |
Other bias | Low risk | Baseline characteristics (sex, age, type of angina, disease severity, disease duration, comorbidities, blood glucose, blood pressure, serum lipoid, etc.) were comparable between the two groups (P > 0.05). The study appeared to be free of other sources of bias. |