Statistical methods
CFS
RECRUITMENT, SENSITIVITY, SECONDARY, YANG DEFICIENCY, ATTRITION
The data was analyzed by an independent statistician. Quantitative data were described by mean with standard deviation (SD) or median with percentile (Q1, Q3). All the statistical analyses were performed with SPSS software version 25.0 (SPSS Inc, IBM Corporation, Chicago, Illinois, USA). The correlation analysis and visualization were performed with R language version 4.2.0 (R Development Core Team, Vienna, Austria). A two-sided test was applied for all available data, and a The main analysis was based on an intention-to-treat population, and missing data at random were replaced by the multiple imputation method. The primary outcome of FS-14 score was analyzed by Mann-Whitney U-test. For secondary outcomes, including the score of Symptoms Scale of Spleen-Kidney Yang Deficiency, SDS score and SAS score, we conducted independent sample T test or Mann-Whitney U test (used in non-normally distributed variables) to compare the scores after 4 -week treatment between Groups A and B.TTM analysis: Disease-related areas, specific regions or acupoints were acquired through comparing HCs with CFS patients in the whole-body thermal map. The relative thermal radiation value difference was defined as the temperature difference between the local temperature and the average temperature of the front or back of the trunk. It was automatically detected by TTM. Median differences and 95% confidence intervals of the temperature difference (ΔT) comparison between Group A or B and HCs at the end of 4-week treatment in the above area or acupoints were calculated by Hodges-Lehmann method.Attrition analyses: Considering the possible effect from visit lost on results, we added 10% more sample size for each group in recruitment to hedge against expected attrition. For incomplete outcome data, we used multiple imputation method to replace random missing data. Sensitivity analysis using the per protocol set was performed and compared with the intention-to-treat analysis results.