Outcome measures
shortness of breath, loose stool, depression/anxiety, anxiety, fatigue, TCM syndrome, depression, lassitude, Self-rating depression, lumbar cold pain, abdominal fullness, weakness, CFS, Fatigue
YANG DEFICIENCY, SECONDARY, COLD, GROUP B
Primary outcome: In this trial, the improvement in fatigue severity assessed by Fatigue scale-14 (FS-14) was set as the primary outcome. FS-14 is a standardized questionnaire reflecting physical and mental fatigue and comprises 14 questions. Each question has two options (yes or no) and a score of 0 to 1 (0 = no, 1 = yes), resulting in a total score ranging from 0 to 14 [Secondary outcome: The secondary outcome measures included the scores of the Symptoms Scale of Spleen-Kidney Yang Deficiency, the Self-rating depression scale (SDS), and the Self-rating anxiety scale (SAS). The Symptoms Scale of Spleen-Kidney Yang Deficiency is a 4-rate scale designed to evaluate symptoms based on TCM syndrome differentiation. It consists of primary symptoms with scores ranging from 0 to 6, including fear of cold and cold extremities, lassitude and lack of strength, shortness of breath and laziness to speak, reduced food intake, soreness and weakness of waist and knees. It also includes secondary symptoms with scores ranging from 0 to 3, including lumbar cold pain, abdominal fullness and distention, loose stool, cold and more urine volume during night. Higher scores indicate a higher level of Spleen-Kidney Yang Deficiency. Both the SDS and SAS are 20-item scales designed to measure depression/anxiety with scores ranging from 20 to 80. Higher scores indicate a higher level of depression and anxiety. All secondary outcomes were assessed at baseline and at the end of the 4-week treatment period (week 4).TTM scanning: 90 eligible participants (30 female CFS patients in Group A, 30 female CFS patients in Group B, and 30 HCs) received TTM (Digital Medical Infrared Imaging System, MTI-ex pro-2013, Chongqing, China) scanning at baseline, and only patients in Groups A and B received a second TTM scanning after the 4-week treatment period. To weaken the influence of external thermo-source on the moxibustion effect assessment, the second TTM scanning was employed 5 days after the end of treatment. To minimize the impact of outside temperature, all the scanning was executed in the morning at the health examination center of the Affiliated Hospital of Chengdu university of TCM. The scanning room was maintained at a controlled temperature of 21℃ ± 2℃ and a humidity level of 50% ± 10%. The subjects were positioned in an environment with no direct ventilation, sunlight, or infrared radiation source [
The process and relevant precautions of TTM
The definition of Three-Jiao in TTM image