Xiao 2007.
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: 37 of 62 participants in Tong‐xin‐luo group and 47 of 70 participants in control group did not undergo coronary arteriography, the occurrence of angiography restenosis for these participants was lost to follow‐up. Intention‐to‐treat analysis: not mentioned. |
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Participants | Participants were those who successfully received bare‐metal coronary stents. Tong‐xin‐luo group: 62 participants (male/female: 42/20; age: 53 ± 12 years). Control group: 70 participants (male/female: 49/21; age: 55 ± 10 years). |
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Interventions | Tong‐xin‐luo group: conventional treatment plus Tong‐xin‐luo capsules (4 capsules, tid). Control group: Conventional treatment. 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; Mortality (death) due to any cardiovascular event. |
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Notes | There were no losses to follow‐up in the outcomes measured, except angiographic restenosis. | |
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 | High risk | 37 of 62 participants in Tong‐xin‐luo group and 47 of 70 participants in control group did not undergo coronary arteriography. |
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, types of coronary pathological changes and average number of stents between the two groups (P > 0.05). The study appeared to be free of other sources of bias. |