The Effect of Catgut Embedding at Acupoints Versus Nonacupoints in Abdominal Obesity: Protocol for a Multicenter, Double-Blind, 16-Week Randomized Controlled Trial
BackgroundObesity is an increasing problem worldwide. The effective treatments for obesity mainly include diet, physical activity, behavioral intervention, pharmacotherapy, and bariatric surgery, which all have certain limitations. As a specific type of acupuncture therapy, a...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2023-07-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2023/1/e46863 |
| _version_ | 1827857321478324224 |
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| author | Qifu Li Gaoyangzi Huang Xianmei Pei Xin Tang Renrui Zhang Ya Huang Zili Liu Rong Yi Chonghui Xing Xinghe Zhang Taipin Guo |
| author_facet | Qifu Li Gaoyangzi Huang Xianmei Pei Xin Tang Renrui Zhang Ya Huang Zili Liu Rong Yi Chonghui Xing Xinghe Zhang Taipin Guo |
| author_sort | Qifu Li |
| collection | DOAJ |
| description |
BackgroundObesity is an increasing problem worldwide. The effective treatments for obesity mainly include diet, physical activity, behavioral intervention, pharmacotherapy, and bariatric surgery, which all have certain limitations. As a specific type of acupuncture therapy, acupoint catgut embedding (ACE) has gained substantial attention in the management of obesity in recent years. Previous studies suggested that ACE may be an effective obesity treatment. However, the evidence for the efficacy of ACE in abdominal obesity (AO) remains inadequate due to the paucity of high-quality studies.
ObjectiveThis study aims to investigate the difference in the effectiveness of catgut embedding at acupoints and catgut embedding at nonacupoints in patients with AO and to further validate the efficacy and safety of ACE for AO.
MethodsThis is a multicenter, double-blind, 16-week randomized controlled trial. A total of 92 eligible participants with AO will be randomly divided into 2 groups (1:1 allocation ratio). The ACE group will receive catgut embedding at acupoints and the control group will receive catgut embedding at nonacupoints. The intervention will be performed every 2 weeks for a total of 6 sessions. Follow-up will be performed every 2 weeks for a total of 2 visits. The primary outcome is waist circumference. Secondary outcomes include body weight, BMI, hip circumference, and the visual analog scale of appetite. Upon the completion of the trial, we will evaluate the effect of catgut embedding at acupoints or nonacupoints on obesity indicators in patients with AO. For treatment outcomes, an intention-to-treat analysis will be performed.
ResultsThe start of recruitment began in August 2019 and is expected to end in September 2023.
ConclusionsAlthough studies have been conducted to demonstrate the effectiveness of ACE in the treatment of obesity, the evidence for the efficacy of ACE in AO remains insufficient due to the quality of the studies. This rigorous normative randomized controlled trial will verify the effect of catgut embedding at acupoints or nonacupoints in patients with AO. The findings will provide credible evidence as to whether ACE is an effective and safe treatment for AO.
Trial RegistrationChinese Clinical Trial Registry ChiCTR1800016947; https://tinyurl.com/2p82257p
International Registered Report Identifier (IRRID)DERR1-10.2196/46863 |
| first_indexed | 2024-03-12T12:38:49Z |
| format | Article |
| id | doaj.art-dec82ea532874da1a2a6a8e1814a9902 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:38:49Z |
| publishDate | 2023-07-01 |
| publisher | JMIR Publications |
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| series | JMIR Research Protocols |
| spelling | doaj.art-dec82ea532874da1a2a6a8e1814a99022023-08-29T00:02:19ZengJMIR PublicationsJMIR Research Protocols1929-07482023-07-0112e4686310.2196/46863The Effect of Catgut Embedding at Acupoints Versus Nonacupoints in Abdominal Obesity: Protocol for a Multicenter, Double-Blind, 16-Week Randomized Controlled TrialQifu Lihttps://orcid.org/0000-0002-8823-4930Gaoyangzi Huanghttps://orcid.org/0009-0000-7516-6222Xianmei Peihttps://orcid.org/0009-0000-7125-9042Xin Tanghttps://orcid.org/0009-0000-1305-4989Renrui Zhanghttps://orcid.org/0009-0009-7715-1898Ya Huanghttps://orcid.org/0009-0006-9037-4349Zili Liuhttps://orcid.org/0009-0007-9111-4394Rong Yihttps://orcid.org/0009-0001-8320-4513Chonghui Xinghttps://orcid.org/0009-0002-0129-2327Xinghe Zhanghttps://orcid.org/0000-0001-5199-4656Taipin Guohttps://orcid.org/0000-0002-5298-8132 BackgroundObesity is an increasing problem worldwide. The effective treatments for obesity mainly include diet, physical activity, behavioral intervention, pharmacotherapy, and bariatric surgery, which all have certain limitations. As a specific type of acupuncture therapy, acupoint catgut embedding (ACE) has gained substantial attention in the management of obesity in recent years. Previous studies suggested that ACE may be an effective obesity treatment. However, the evidence for the efficacy of ACE in abdominal obesity (AO) remains inadequate due to the paucity of high-quality studies. ObjectiveThis study aims to investigate the difference in the effectiveness of catgut embedding at acupoints and catgut embedding at nonacupoints in patients with AO and to further validate the efficacy and safety of ACE for AO. MethodsThis is a multicenter, double-blind, 16-week randomized controlled trial. A total of 92 eligible participants with AO will be randomly divided into 2 groups (1:1 allocation ratio). The ACE group will receive catgut embedding at acupoints and the control group will receive catgut embedding at nonacupoints. The intervention will be performed every 2 weeks for a total of 6 sessions. Follow-up will be performed every 2 weeks for a total of 2 visits. The primary outcome is waist circumference. Secondary outcomes include body weight, BMI, hip circumference, and the visual analog scale of appetite. Upon the completion of the trial, we will evaluate the effect of catgut embedding at acupoints or nonacupoints on obesity indicators in patients with AO. For treatment outcomes, an intention-to-treat analysis will be performed. ResultsThe start of recruitment began in August 2019 and is expected to end in September 2023. ConclusionsAlthough studies have been conducted to demonstrate the effectiveness of ACE in the treatment of obesity, the evidence for the efficacy of ACE in AO remains insufficient due to the quality of the studies. This rigorous normative randomized controlled trial will verify the effect of catgut embedding at acupoints or nonacupoints in patients with AO. The findings will provide credible evidence as to whether ACE is an effective and safe treatment for AO. Trial RegistrationChinese Clinical Trial Registry ChiCTR1800016947; https://tinyurl.com/2p82257p International Registered Report Identifier (IRRID)DERR1-10.2196/46863https://www.researchprotocols.org/2023/1/e46863 |
| spellingShingle | Qifu Li Gaoyangzi Huang Xianmei Pei Xin Tang Renrui Zhang Ya Huang Zili Liu Rong Yi Chonghui Xing Xinghe Zhang Taipin Guo The Effect of Catgut Embedding at Acupoints Versus Nonacupoints in Abdominal Obesity: Protocol for a Multicenter, Double-Blind, 16-Week Randomized Controlled Trial JMIR Research Protocols |
| title | The Effect of Catgut Embedding at Acupoints Versus Nonacupoints in Abdominal Obesity: Protocol for a Multicenter, Double-Blind, 16-Week Randomized Controlled Trial |
| title_full | The Effect of Catgut Embedding at Acupoints Versus Nonacupoints in Abdominal Obesity: Protocol for a Multicenter, Double-Blind, 16-Week Randomized Controlled Trial |
| title_fullStr | The Effect of Catgut Embedding at Acupoints Versus Nonacupoints in Abdominal Obesity: Protocol for a Multicenter, Double-Blind, 16-Week Randomized Controlled Trial |
| title_full_unstemmed | The Effect of Catgut Embedding at Acupoints Versus Nonacupoints in Abdominal Obesity: Protocol for a Multicenter, Double-Blind, 16-Week Randomized Controlled Trial |
| title_short | The Effect of Catgut Embedding at Acupoints Versus Nonacupoints in Abdominal Obesity: Protocol for a Multicenter, Double-Blind, 16-Week Randomized Controlled Trial |
| title_sort | effect of catgut embedding at acupoints versus nonacupoints in abdominal obesity protocol for a multicenter double blind 16 week randomized controlled trial |
| url | https://www.researchprotocols.org/2023/1/e46863 |
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