Status of Outcome Indicators in Randomized Controlled Trials on Traditional Chinese Medicine Intervention for Idiopathic Facial Nerve Palsy in Recent Seven Years
To evaluate the status of outcome measures in a randomized controlled trial (RCT) of traditional Chinese medicine for the treatment of idiopathic facial nerve palsy (IFP).Methods:A total of seven databases and two clinical trial registries were searched,and relevant RCTs were screened according to pre-defined selection criteria.The bias risk assessment of the included studies was performed according to the Cochrane risk bias assessment tool,and the outcome indicators,measurement time,study time,and outcome indicator levels were statistically described.Results:A total of 13 489 relevant literature was preliminary searched,and finally 45 RCTs (44 Chinese literature and one English literature) were included.95 outcome indicators were reported,with a frequency of 233 times.The study found that the overall bias of RCTs in the treatment of IFP with traditional Chinese medicine was not clear,and the outcome indicators in clinical studies involved problems such as irregular reference standards,definitions,and measurement time points,uneven selection categories,and unclear primary and secondary levels.Conclusion:The research on the RCT outcome indicator set in the treatment of IFP with traditional Chinese medicine is still in its infancy.According to international experience and practical research processes based on the characteristics of traditional Chinese medicine,it is still necessary to have accurate clinical and statistical work to construct a standardized,unified,and recognized core indicator set.