The effect and safety of acupoint thread embedding in treatment of overweight and obese women: study protocol of a randomized controlled trial

Background: Obesity is a major health concern over the world, affecting female’s physical and psychological health. Acupoint thread embedding (ATE) treatment is an innovative method based on Traditional Chinese Medicine (TCM) theories and can provide long term stimulation on acupoints. However, its efficacy for weight-loss among female patients remains questionable primarily due to insufficient high-level evidence. Methods: This is a patient-assessor-blinded, randomized, sham controlled clinical trial that will conduct in a TCMhospital in Shanghai. A total of 132 eligible participants will be randomly assigned to either group, receiving ATE with health education or sham ATE with health education. Participants will receive 6 sessions of real or sham ATE intervention once in every 2 weeks for 12 weeks, with an additional 12 weeks of follow-upperiod. Primary outcome will be the change of body mass index between baseline and end of treatment. Secondary outcomes will include changes in the body weight, waist circumference, hip circumference, waist-to-hip ratio, waist-to-height ratio, body fat percentage measured by body composition analyzer, liver stiffness measured by liver elastography, self-rated questionnaires including Impact of Weight on Quality-of-Life-Lite Scale, Visual Analogue Scale of appetite,Well-Being Index and Hamilton Rating Scale for Anxiety, and blood tests results about glucolipid metabolism. All adverse events will be assessed by the treatment emergent symptom scale. Outcomes will be collected at baseline, week 6, week 12 and week 24 during the intervention and follow-up. Discussion: This study will investigate the effect and safety of ATE in the treatment of overweight and obesity among female patients. The findings of this study will contribute to reveal the therapeutic benefits of ATE in losing weight. Ethics and dissemination: This trial has received ethical clearance from the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine under the registration number 2024SHL-KY-10-01. All participants will provide their written informed consent prior to their enrolment. The findings will be disseminated through peer-reviewed publications and scholarly conferences. Trial registration number: ClinicalTrials.gov ID: NCT06316310