Effectiveness and safety of modified ‘Huoxue Shugan’ formulas on coronary heart disease combined with depression: protocol for a systematic review

OBJECTIVE: To assess the clinical effectiveness and safety of modified ‘Huoxue Shugan’ (HXSG) formulas used as Chinese herbal medicine in treating patients with coronary heart disease (CHD) and depression. METHODS: A systematic literature search of articles up to March 2018 will be performed in the following electronic databases: PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, Chinese Scientific Journals Database, Chinese Biomedical Database, Chinese Biomedical Literature Service System and Wanfang Database. Inclusion criteria are as follows: randomised controlled trials of modified HXSG formulas in patients with CHD and depression. The primary outcome measures will be CHD-related clinical evaluation (frequency of acute angina, severity of angina pectoris, ECG changes, dose of nitroglycerin) and the scores or amount of reduction in scales measuring depression (ie, the Hamilton Depression Scale or other widely used depression scales). The safety outcome measures will be adverse events, liver and kidney function. RevMan V.5.3 software will be used for data synthesis, sensitivity analyses, subgroup analyses and risk of bias assessment. A funnel plot will be developed to evaluate reporting bias. Stata V.12.0 will be used for meta-regression and Egger tests. We will use the Grading of Recommendations Assessment, Development and Evaluation system to assess the quality of evidence. ETHICS AND DISSEMINATION: This systematic review does not require ethics approval and will be submitted to a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42018089641.