Efficacy of Abdominal Catgut Embedding Combined With Auricular Acupressure Therapy for Obese Patients

Objective: obesity is an important risk factor of chronic diseases, which not only threatens people's health, but also an important topic of public health. The purpose of this study is to define obesity according to the norms of the World Health Organization, and to explore whether combined weight loss methods have an impact on weight loss.

Methods:

In this study, Combined treatment of abdominal acupoint catgut embedding was combined with auricular pellet acupressure, The wire used for catgut embedding in the experiment was polydioxanone (PDO) 。 This experiment was divided into two groups: the experimental group A and the control group B 。 The reference measurement basis is the data obtained by "Inbody" instrument, including height and weight, body mass index (BMI), basic metallic rate (BMR), Body Fat Percentage BFP) , waist hip ratio and the data of total cholesterol (TC) and triglycerides (TG) obtained from biochemical blood examination, through the comparison before and after the test, we can judge whether the method of this test can achieve a certain degree of curative effect on weight loss.

Study Overview

• Status: Completed
• Conditions: Acupuncture
• Intervention / Treatment: Other: Catgut Embedding at acupoints

Detailed Description

Objective: obesity is an important risk factor of chronic diseases, which not only threatens people's health, but also an important topic of public health. The purpose of this study is to define obesity according to the norms of the World Health Organization, and to explore whether combined weight loss methods have an impact on weight loss.

Methods:

In this study, This study is a random Single Blind Random Blind Trial conducted at Acupuncture and Moxibustion department of China Medical University hospital, Taichung city, Taiwan. The study involved 2 groups divided in 1:1 ratio to an intervention group and a control group. The study Combined treatment of abdominal acupoint catgut embedding was combined with auricular pellet acupressure, The wire used for catgut embedding in the experiment was polydioxanone (PDO) 。 This experiment was divided into two groups: the experimental group and the control group。The reference measurement basis is the data obtained by "Inbody" instrument, including height and weight, body mass index (BMI), basic metallic rate (BMR), Body Fat Percentage BFP), waist hip ratio and the data of total cholesterol (TC) and triglycerides (TG) obtained from biochemical blood examination, through the comparison before and after the test, we can judge whether the method of this test can achieve a certain degree of curative effect on weight loss.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

A. Age 25 to 45 years old B. In line with the World Health Organization's BMI standard diagnosis ≥ 25 C. Waist circumference of men ≥90 cm or waist circumference of women ≥80 cm D. Body fat rate of men>25%, body fat rate of women>30% E. The above B, C, D can be included if they meet one of them F. Complete written informed consent

Exclusion Criteria:

• A. Pregnant, breastfeeding, menopausal women B. There are malignant tumors of the heart, liver and kidneys C. Diagnosed with mental illness D. Participated in another study within three months E. There are people who are taking diet pills

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; In both groups, catgut embedding using disposable single-strand surgical suture Polydioxanone threads was embedded to the following abdominal acupoints: ST-24 (Huaroumen), ST-25 (Tianshu), ST26 (Wailing), REN-12 (Zhongwan), REN-9 (Shuifen), REN-6 (Qihai), REN-4 (Guanyuan) as baseline treatment. Patients in this arm also received auricular acupressure using ear seeds (Vaccaria seeds) in the following auricular acupoints: Shen Men, Stomach, Endocrine. Those points were chosen due to function that are related to weight loss.	Other: Catgut Embedding at acupoints; Supplemented by auricular point therapy, can increase the effect of catgut embedding therapy.
Sham Comparator: sham group; In both groups, catgut embedding using disposable single-strand surgical suture Polydioxanone threads was embedded to the following abdominal acupoints: ST-24 (Huaroumen), ST-25 (Tianshu), ST26 (Wailing), REN-12 (Zhongwan), REN-9 (Shuifen), REN-6 (Qihai), REN-4 (Guanyuan) as baseline treatment. Patients in this arm also received auricular acupressure using ear seeds (Vaccaria seeds) in the following auricular acupoints:Lung, Eye, Ear Apex. The points were selected as control points as there is no clear indication on their ability to contribute to weight loss.	Other: Catgut Embedding at acupoints; Supplemented by auricular point therapy, can increase the effect of catgut embedding therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	body weight in kilograms measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument	12 weeks
BMI	Body mass index (BMI) measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument	12 weeks
basal metabolic rate	basal metabolic rate measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument	12 weeks
Body fat percentage	Body fat percentage measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglycerides	Triglycerides levels in blood measured by blood tests on inclusion and at 12 weeks	12 weeks
Total cholesterol	Total cholesterol levels in blood measured by blood tests on inclusion and at 12 weeks	12 weeks
WHOQOL	WHOQOL numerical assessment of quality of life, fill in the questionnaire before the first treatment.	12 weeks
Skeletal muscle weight	Skeletal muscle weight measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument	12 weeks
waist hip ratio	waist hip ratio measured at inclusion and at 12 weeks measured by "InBody" body	12 weeks

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CMUH110-REC3-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No