Randomized controlled trials （RCT） belong to the first level of clinical study designed scheme

while the result of Meta-analysis on RCTs is the best evidence accepted in evaluating the effect of medical intervention.But there is certain limitation in RCT.Single case randomized controlled trials （N-of-1） is a special type of RCT.It takes the single case itself as comparison to identify the difference between observed medicine and controlled measures.TCM is characterized by individualized diagnosis and treatment under the guidance of its wholism concept

therefore the TCM clinical studies will never leave individualization.The current situation is that the characteristic of TCM individualization is not fully manifested

this calls for corresponding research methods to match with it.N-of-1 is combining organically the scientific clinical research technique with the inherent laws of TCM.It is simple in implementation process and practical in clinical work.Its study procedure is exactly of the same mode of diagnosis and treatment of TCM

and the selection of effect evaluation indicators meets the TCM characteristics.As for its method of effect evaluation

each patient’s N-of-1 data is weighted and merged

using systematic evaluation to evaluate flexibly the curative effect of traditional Chinese medicine.Thus

N-of-1 can be used for the studies on different treating principles of TCM

different medicines’ dosages

different modification of medicines

and carrying forward the famous TCM doctors’ experiences

etc.It has a bright future in TCM clinical researches.