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Abstract
Background: Bias is easily generated if the design is not proper. Placebo design is a key factor to determine whether the trial result will bear bias. Objectives: To review placebo-controlled trials of traditional Chinese herbal medicine (TCHM) to find out the current situation of placebo design in the herbal medicine area; to study how to improve the quality of placebo-controlled RCTs of TCHM. Method: Asearchof EMBASE and MEDLINE was conducted to identify placebo-controlled RCTs of TCHM. A checklist was used to extract the relevant data. The data extracted were analysed using Excel. Results: The search identified 211 placebo-controlled trials of TCHM. Based on the analysis, the results showed that: i) the commonest four types of placebo are capsule, tablet, liquid and granule form; ii) no RCT performed the pharmacological test about the placebo’s effects before the start of the trial; iii) the majority of the RCTs of TCHM (72%) did not state clearly the component of the placebo; iv) only a few studies (3%) did a quality check of the placebo before the trial; v) the majority of studies (76%) did not state the concern of the physical appearance of placebo; vi) 3% were open-label, 22% single-blinded, 74% double-blinded; one RCT was triple-blinded; and vii) only 2% tested if blinding was done successfully. Conclusions: The quality of placebo design should be improved, otherwise it will generate bias in the results. More efforts should be paid to the quality control of placebo, involving the physical appearance and pharmacological effects. These characteristics should be reported in the report. Further, the design of RCTs should be improved as a whole, otherwise it is meaningless to improve placebo design only.