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

Abstract

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

Comparing acupoint catgut embedding and acupuncture therapies for simple obesity: A systematic review and meta-analysis

“…Total effective rate. Twenty-nine studies [14,22,27,29,31,32,34,37,44,[48][49][50][51][56][57][58][60][61][62]64,69,72,73,76,84,85,[88][89][90] out of 30 including 2100 participants (1060 in the experiment group and 1040 in the comparison group) were included in the meta-analysis to synthesize the total effective rate. As shown in Figure 2A, the pooled results showed that ACE was more effective than MA (RR = 1.12 [1.07, −1.18]; P < .00001, I 2 = 45%).…”

“…Eighteen studies [14,22,29,34,37,44,45,[48][49][50]57,64,72,76,85,[88][89][90] assessed the benefit of ACE in reducing the BMI. However, the results showed serious heterogeneity (I 2 = 86%).…”

“…BW. We pooled data from 19 studies [14,22,27,31,34,37,44,45,48,49,56,57,64,72,76,85,[88][89][90] reporting on BW between the intervention and comparison groups. We found that ACE was beneficial for reducing BW (n = 1298, MD = −2.28 [−3.16, −1.41]; P < .00001, I 2 = 51%) (Fig.…”

“…WC. We included the results of 15 studies [14,27,34,37,44,48,49,56,64,72,76,85,[88][89][90] and demonstrated a significant difference in the WC data between the intervention and control groups with moderate heterogeneity (I 2 = 68%). We conducted a subgroup analysis, and the results showed that ACE was more effective than MA in reducing WC when using similar acupoints such as ST25, ST36, ST40, SP6, SP9, and CV12 (MD = −4.53 [−5.88, −3.18]; P < .00001, I 2 = 0%) (Fig.…”

“…2D). [27,34,37,48,49,72,85,[88][89][90] showed that ACE was significantly different with high heterogeneity (I 2 = 73%). When we used a similar acupoint routine as mentioned above, the results had no heterogeneity (MD, −3.08 [−5.20, −0.96]; P = .004, I 2 = 0).…”