Ma 2019.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel trial Total N randomised: 312 Length of follow‐up: no follow‐up Analysis: per‐protocol (3 dropouts in treatment group, 2 dropouts in control group) |
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| Participants | Location: China Number of study centres and settings: patients who were in hospital cardiac centre CAD criteria: CAD confirmed by coronary angiography Depression entry criteria: HADS Anxiety or HADS Depression score ≥ 8 Other entry criteria: Han ethnicity, at least junior middle school level of education Exclusion criteria: chest pain originating from a stomach complaint; sympathetic ganglia compression in the neck; atrial fibrillation; rapid arrhythmia; ejection fraction < 35% by echocardiography; severe liver, kidney, nerve, or coagulation dysfunction; pregnant or lactating women; suspected aortic dissection; previously diagnosed psychiatric patients (including bipolar disorder, manic depression, psychosis, schizophrenia, suicidal tendencies); allergy to Xinkeshu Treatment: 30 (66.67% male, mean age: 61 (SD: 11)) Control: 30 (56.67% male, mean age: 66 (SD: 11)) Comparability of groups: no significant baseline differences |
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| Interventions | Treatment: Xinkeshu (4 tablets, 3 times a day) Control: placebo Duration of treatment: 12 weeks |
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| Outcomes | Review outcomes: depression symptoms (HADS Depression, PHQ‐9), platelet biomarkers, pharmacological side effects Other outcomes: HADS Anxiety, cytokine levels |
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| Funding | National Natural Science Fund and Guangdong Provincial People’s Hospital Fund | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Comment: Conflicting report of randomization in the study "random number table" and trial registration "expert bronze camel random envelope method" |
| Allocation concealment (selection bias) | Unclear risk | Comment: Insufficient information provided on allocation concealment Quote: "Randomization was blinded to both the patient and investigator" (pg. 2) |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Insufficient information provided on performance bias |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Depression outcome is self‐reported. Otherwise, insufficient information provided on outcome assessment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Out of 60 patients, 2 patients did not complete the intervention (1 patient in each group). 3 patients did not complete the intervention (2 patients in the intervention group, and 1 patient in the control group. The reasons for patients who did not complete the intervention were stated in the result section |
| Selective reporting (reporting bias) | High risk | Comment: drug safety data reported inadequately and cytokine data not reported as either per protocol or ITT |
| Other bias | High risk | Comment: this trial was registered retrospectively after recruitment had commenced ChiCTR‐IPR‐17010940 |