Study on intestinal flora of acupoint catgut embedding intervention in female patients with abdominal obesity: Study protocol for a randomized controlled trial

Background With high morbidity, and many complications, obesity has become a global public health problem, and attracted extensive attention from the medical community. Previous studies have suggested that acupoint catgut embedding (ACE) is a safe and effective therapy for abdominal obesity (AO). However, the investigation of its mechanisms remains limited. The purpose of this study is to observe the effect of ACE intervention in AO on the intestinal flora, to reveal its site of action and therapeutic mechanisms, and provide further theoretical support for ACE in the clinical treatment of AO. Methods/design: A total of 60 eligible female participants diagnosed with AO will be recruited in this study. They will be blinded to group assignment and randomized to either ACE group, sham ACE group, and waiting list (WL) group, with 20 patients in each group. Each patient in the two ACE-based groups will receive one ACE treatment per week for 12 consecutive weeks. This study will focus on analyzing the intestinal flora changes elicited by ACE treatment. The body mass index (BMI), waist circumference (WC), body weight (BW), blood pressure (BP), heart rate (HR), total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), and high-density lipoprotein (HDL), visual analogue score (VAS) of appetite, and the Gastrointestinal Symptom Rating Scale (GSRS) will be used to evaluate the clinical efficacy of ACE treatment by making assessments before and after treatment. High-throughput 16S ribosomal ribonucleic acid (rRNA) gene sequencing will be used to detect changes in the intestinal flora composition before and after treatment. The repeated measures analysis of variance (3 groups × 2-time points ANOVA) will be employed to analyze numerical variables of the clinical and intestinal flora data generated in the study. Discussion The results of this trial are expected to further confirm that ACE can effectively relieve AO and verify the intervention mechanisms of ACE on intestinal flora in patients with AO. Trial registration: Chinese Clinical Trial Registry, ChiCTR2100048853. Registered on July 19, 2021. https://www.chictr.org.cn/showproj.aspx?proj=130531