Common problems and solutions in sample size estimation of acupuncture clinical trials

Sample size estimation is a crucial step in clinical trial design, directly impacting the reliability and reproducibility of research findings. Researchers currently face several methodological challenges when estimating sample sizes for acupuncture clinical trials, such as: whether sample size estimation is necessary for pilot trial; what parameters are required for sample size estimation; whether sample size estimation methods differ among various types of hypothesis tests; how to perform sample size estimation with multiple primary outcomes or multiple groups; and how to standardize the reporting of sample size estimation. Based on these, this article addressed common problems of sample size estimation in acupuncture pilot trial and confirmatory trial, put forward solving strategies accordingly, in order to provide reference for clinical researchers in acupuncture clinical trial sample size estimation.