Herbal medicine Sihogayonggolmoryeo-tang or Chai-Hu-Jia-Long-Gu-Mu-Li-Tang for the treatment of post-stroke depression: A protocol for a systematic review and meta-analysis

INTRODUCTION: This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of herbal medicine Sihogayonggolmoryeo-tang (SGYMT) or Chai-Hu-Jia-Long-Gu-Mu-Li-Tang for the treatment of post-stroke depression. METHODS AND ANALYSIS: The following electronic databases will be searched up to July 2018 without language or publication status restrictions: MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing, and Allied Health Literature (CINAHL), and PsycARTICLES. We will also search Korean and Chinese databases. Any clinical randomized controlled trials related to SGYMT treatment for post-stroke depression will be included. Changes in the degree of depression and adverse events will be assessed as primary outcomes. The total effective rate and changes in neurological function, activities of daily living, and quality of life will be evaluated as secondary outcomes. Study selection, data extraction, assessment of study quality, and evaluation of the quality of evidence for the main findings will be performed independently by 2 researchers. The data synthesis and analysis will be performed using RevMan version 5.3. The results will be expressed as a risk ratio for dichotomous data and as the mean difference or standardized mean difference for continuous data. Data will be synthesized by either a fixed-effects or random-effects model according to a heterogeneity test or the number of studies included in the meta-analysis. The methodological quality of the included studies will be evaluated using the Cochrane Collaboration's risk of bias tool. The quality of evidence for each main outcome will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. ETHICS AND DISSEMINATION: Ethical approval is not required because individual patient data are not included. The findings of this systematic review will be disseminated through a peer-reviewed publication or conference presentations. PROSPERO REGISTRATION NUMBER: CRD42018102939