Objectives To discuss the methodology of evaluation of traditional Chinese medicine (TCM) placebo simulation effects and the problems of blind implementation and so as to improve the quality of double-blind clinical trials of TCM. Methods Focusing on case of placebo preparation of TCM investigational new drug, simulation effects of the placebo were evaluated in terms of shape, color, taste and smell. The possibility of placebo be a drug and the similarity between placebo and drug were tested. Results There was no significant difference between placebo and investigational new drug to be judged as a drug (P>0.05). As for the similarity between placebo and drug, there was no significantly difference of the shape (P>0.05), for which the similarity was 100%. The color, taste and smell were significant different between placebo and drug (P<0.05), for which the similarity were 50%, 10% and 15% respectively. Conclusions It is very difficult to simulate TCM based on its certain color, taste or smell. Therefore, the subjects and the investigators’ compliance should be kept to avoid breaking the blind intentionally in the process of the trial and the influence of unblinding should be estimated at the end of the trial.
Aiming at the problems of uneven reporting quality and lack of unified standards in SMART in the context of personalized medicine, this paper analyzes the application and reporting status of SMART, and summarizes the key problems of current research reporting. These include unclear description of core design elements, missing information on randomization and blinding, insufficient reporting of phase transition rules, opaque sample size estimation and multiple comparisons, and lack of detailed description of data processing procedures. Based on the CONSORT standard, this paper proposed to expand the reporting specifications for SMART design methodology. By adding and elaborating items, the standardized description of multi-stage randomization process, decision nodes, embedded dynamic treatment regimes comparison framework and dedicated flow chart are emphasized to enhance the transparency, reproducibility and reliability of the results of SMART study. This study aims to provide structured and standardized reporting recommendations for SMART trials, and promote the output of high-quality evidence and clinical transformation of dynamic treatment strategies.