Clinical efficacy and safety of removing blood stasis and removing phlegm in the treatment of epilepsy with cognitive impairment: A protocol for systematic review and meta-analysis

BACKGROUND: Epilepsy is a chronic encephalopathy caused by abnormal discharge of neurons in the brain, resulting in brain dysfunction. Cognitive impairment is one of the most common complications of epilepsy. The current treatment of epilepsy in the control of symptoms at the same time cause a lot of side effects, especially the aggravation of cognitive impairment. Many literatures have stated that the efficacy and safety of integrated traditional Chinese and western medicine in the treatment of epilepsy with cognitive impairment is superior to that of western medicine alone. In this systematic review, we intend to evaluate the clinical efficacy and safety of removing stasis and resolving phlegm in the treatment of epilepsy with cognitive impairment. METHODS: We will search The Cochrane Library, EMbase, Pubmed, Web of Science, Chinese Journal Full-Text Database (CNKI), Wanfang Database, and VIP database. Simultaneously we will retrieval relevant meeting minutes, eligible research reference lists, symposium abstracts, and gray literatures. We will not apply any restrictions to the language and publication date. All randomized controlled trials about the efficacy and safety of removing blood stasis and phlegm in the treatment of epilepsy with cognitive impairment will be included. Two authors will independently carry out. Any objections will be worked out by a third author through consultation. We will use the Revman 5.3 and Stata 13.0 software for data synthesis, sensitivity analysis, meta regression, subgroup analysis, and risk of bias assessment. The grading of recommendations assessment, development, and evaluation standard will be used to evaluate the quality of evidence. RESULTS: This systematic review will synthesize the data from the present eligible high quality randomized controlled trials to assess whether the treatment of removing blood stasis and phlegm is effective and safety for epilepsy with cognitive impairment from various evaluation aspects including clinical efficacy of epilepsy, EEG improvement rate, MOCA score, QOLIE-31 cognitive function score, traditional Chinese medicine symptom score, incidence of adverse reactions, frequency of seizures of epilepsy, and duration of seizure of epilepsy. CONCLUSION: The systematic review will provide evidence to assess the efficacy and safety of removing blood stasis and phlegm in the treatment of patients with epilepsy with cognitive impairment. PROSPERO REGISTRATION NUMBER: CRD42021224893.