Wang 2020.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 280 Length of follow‐up: 4 weeks after the 8‐week intervention Analysis: per‐protocol (27 dropouts from intervention group, 25 dropouts from control group) |
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| Participants | Location: China Number of study centres and setting: outpatient clinic and hospitalised patients from the Cangzhou Center Hospital, the Tangshan Hospital of Traditional Chinese Medicine, and the Beijing Huilongguan Hospital CAD criteria: angina pectoris diagnosed according to the ACC/AHA 2002 guidelines for the management of patients with chronic stable angina, and standardisation of diagnosis and treatment of unstable angina pectoris published by the Chinese Medical Association in 2000 Depression criteria: depression was diagnosed according to the Chinese Classification and Diagnostic Criteria of Mental Disorders, Third Edition, and depression symptoms were assessed with the HAM‐D, total score 20 or higher CAD and depression standardised in Guidelines for Diagnosis and Treatment of Common Disease in Traditional Chinese Internal Medicine, First Edition: “Xiong Bi and Xin Tong syndrome”, “palpitation”, “insomnia”, “hysteria”, “depressive psychosis”, “consumptive disease”, and “sweating syndrome” Other entry criteria: age 40 years or older; TCM criteria for "Qi deficiency and blood stasis"; not yet received antidepression drugs, or received antidepression treatment but discontinued for at least 1 month; agreement to participate in the study; without any other acute diseases and severe complications Exclusion criteria: MI or acute or severe heart failure; advanced malignancy; a physical impairment that would prevent participation; cognitive impairment, comorbid major psychiatric disorders, psychosis, a high risk of suicide or current substance abuse; severe arrhythmia such as atrial fibrillation, atrial flutter, high atrioventricular block, sick sinus syndrome, frequent ventricular premature or ventricular tachycardia; history of epilepsy; current use of an antidepressant or anticonvulsant; patient with a HAM‐D score of > 35; physician or patient refusal |
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| Interventions | Intervention 1: flexible doses of daily escitalopram (Lexapro): 5 mg/d for mild depression HAM‐D 20 to 23, and 10 mg/d for moderate depression HAM‐D > 24 Intervention 2: Bu Xin Qi herbal decoction 400 mL orally (2 times per day); Dang shen Codonopsis pilosula (root) 15 mg/d, Fu lin Poria cocos 15 mg/d, Bai zhu Bighead atractylodes rhizome (rhizome) 15 mg/d, Huang qi Astragalus membranaceus (Fisch) Bge. (root) 12 mg/d, Dang gui Angelica sinensis (root) 20 mg/d, Gui zhi Cassia twig (dried twigs) 10 mg/d, Gan cao Radix liquiritiae (root) 18 mg/d Duration of treatment: 8 weeks |
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| Outcomes | Review outcomes: depression symptoms (HAM‐D), cardiac events, pharmacological side effects | |
| Funding | Supported by the Scientific Research Plan Project of Administration of Traditional Chinese Medicine of Hebei Province of China (Project No. 2016117) and Scientific Research Plan Project of Cangzhou City of Hebei Province of China (Project No. 151302047) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: Randomization was carried out by using random‐number tables with a block size of 4. The assignment was carried out at the trial coordination center. |
| Allocation concealment (selection bias) | High risk | Comment: Described as an open‐label trial |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Described as an open‐label trial |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: blinding not described for depression, major adverse cardiac events or biomarkers; described as open‐label trial |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: per‐protocol analysis that excluded patients for non‐compliance, adverse events Comment: reason for drop‐out described ‐ 27 drop‐outs in escitalopram and 25 in Bu Xin Qi decoction |
| Selective reporting (reporting bias) | Unclear risk | Comment: no trial protocol paper available |
| Other bias | Unclear risk | Comment: unclear how study drugs were obtained Comment: p values for between group baseline differences in comorbidities were not reported |