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. 2015 May 21;2015(5):CD010237. doi: 10.1002/14651858.CD010237.pub2

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.
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).
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.
Outcomes Occurrence of angiographic restenosis;
Occurrence of myocardial infarction, heart failure, and angina;
Mortality (death) due to any cardiovascular event.
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.