Abstract:
Objective To summarize and evaluate the clinical research evidence of antihypertensive Chinese patent medicine. Methods Eight major Chinese and English databases were searched to identify all clinical studies(including secondary studies) of antihypertensive Chinese patent medicine in the treatment of essential hypertension listed on the 2020 Directory of Insured Medicine. The retrieval time was from the establishment of the database to July 2020.The evidence was graded according to the evidence classification and recommendation standard of Oxford University Evidence-Based Medicine Center. The methodological quality of clinical research was evaluated using Cochrane’s risk of bias tool, and the reporting quality was evaluated using consolidated standards for reproting trials of traditional Chinese medicine(CONSORT for TCM). Results A total of 66 Chinese patent medicines with evidence-based support for reducing blood pressure were retrieved, and a large amount of clinical evidence was accumulated for some Chinese patent medicines. Randomized controlled trials were the main clinical research, followed by non-randomized controlled trials. Some studies still had clinical evidence for the treatment of hypertension with clinical symptoms/comorbidities and target organ damage. Fifty drugs had level 1 evidence. The low quality of methodology was mainly reflected in the absence of "double blind" application. The report quality was not high, mostly in the absence of traditional Chinese medicine syndrome description and detailed description of intervention measures. Conclusions Clinicians pay high attention to the role of proprietary Chinese medicines in the prevention and treatment of hypertension, but the overall legal quality of all clinical studies is not high, and the report is not standardized, which will affect the reliability of research results. Relevant research lack traditional Chinese medicine characteristics.