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. 2021 Dec 15;2021(12):CD008012. doi: 10.1002/14651858.CD008012.pub4

Liu 2016.

Study characteristics
Methods RCT design: 2‐arm parallel‐group trial
Total N randomised: 149
Length of follow‐up: no follow‐up
Analysis: unclear (27 dropouts in the treatment group, 28 dropouts in the control group)
Participants Location: China
Number of study centres and setting: single centre, Cardiology of Harbin Medical University Hospital Department
CAD criteria: MI in the past month (diagnosis of acute MI according to the Braunwald standard of cardiology); MI patients must comply with symptomatic myocardial ischaemia, and the ECG appears to ischaemic ST‐segment decline or the ST segment elevation or the new pathological Q wave, myocardial enzyme changing observed, such as elevated serum creatine kinase CK‐MB, increased lactate dehydrogenase (LDH1), increased CK (CPK)
Depression criteria: depression score HAM‐D ≥ 18
Other entry criteria: none
Exclusion criteria:
(1) Those suffering from cardiovascular disease: (1.1) acute MI caused by non‐atherosclerotic disease; (1.2) uncontrollable hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); (1.3) less than 3 months after arterial bypass surgery; (1.4) suffering from arrhythmia; (1.5) suffering from non‐arterial sclerosis (such as anaemia).
(2) Those suffering from other somatic diseases: (2.1) an obvious laboratory examination exception; (2.2) distinct hepatic and renal dysfunction; (2.3) with a history of allergies to sertraline, hyperforin, and acanthopanax.
(3) Those suffering from mental illness: (3.1) with alcohol or other substance abuse in the last 6 months; (3.2) with psychotic symptoms, psychiatric history or suffering from bipolar disorder, organic mental disorder, dementia, and other diseases; (3.3) frequently receiving benzodiazepines; (3.4) receiving psychological treatment in the last 3 months; (3.5) with suicide attempts; (3.6) receiving monoamine oxidase inhibitor in the last 4 weeks; (3.7) if the patient has a suicide attempt or the depressive symptoms are aggravated in the course of treatment, the psychiatrist would advise the patient to quit the experiment; (3.8) with a history of depression and the HAM‐D24 score higher than 35 before MI.
Treatment N: 73 (43.4% female, mean age: 53.4 (SD: 10.3))
Control N: 76 (41.1% female, mean age: 54.1 (SD: 10.8))
Comparability of groups: no significant baseline differences
Interventions Treatment: sertraline + placebo of Shugan Jieyu capsule treatment
Control: Shugan Jieyu capsule + sertraline placebo
Duration of treatment: 24 weeks
Outcomes Review outcomes: depression symptoms (HAM‐D), all‐cause mortality, cardiovascular vital signs (BP, HR), ECG waves, pharmacological side effects
Other outcomes: clinical global impression, number needed to treat for non‐inferiority
Funding None
Notes Inconsistency in HAM‐D change scores. No significant differences between trial arms were reported, but the data suggest otherwise (likely standard error instead of standard deviation reported). No contact possible in order to clarify results.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "...patients were numbered chronologically and then labeled by a random number." (p.535)
Comment: Group allocation via odd or even number
Allocation concealment (selection bias) Unclear risk Comment: No sufficient information provided
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: No sufficient information provided
Quote: "We used the double‐blind experiment..." (pg. 537)
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: No sufficient information provided
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comment: data‐analysis paragraph is missing, insufficient information on data‐analysis (ITT/per protocol) and missing data handling procedure
Selective reporting (reporting bias) Unclear risk Comment: No study protocol available; assessment points described (see below) do not correspond with results
Other bias High risk Comment: data on assessments at 4, 8 and 24 weeks are missing; available results are based on week 12 (middle of the treatment). End of treatment (week 24) not reported