Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity

NCT06091761 | Completed

• 1 other identifier: 700/HDDD-DHYD
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Overweight and obesity are chronic non-communicable diseases with a rapidly increasing global prevalence. They constitute risk factors for various chronic conditions, including cardiovascular diseases, type 2 diabetes, chronic kidney disease, cancer, as well as musculoskeletal disorders and numerous other disorders, significantly impacting the quality of life. Numerous non-pharmacological interventions have been employed in the management of these conditions. Particularly, Auricular acupuncture (AA) has been a widely used and established method for weight management, owing to its effectiveness, safety, and convenience. Recently, a novel therapy known as Thread embedding acupuncture (TEA) has also demonstrated efficacy in weight reduction. Several studies have shown a substantial increase in treatment effectiveness when combining TEA with other acupuncture therapies. However, there is currently no available data on the combination of TEA with AA. This study is conducted to assess the efficacy and safety of combining TEA with AA compared with AA monotherapy in overweight and obesity.

Conditions

Overweight or Obesity

Keywords

overweight; obesity; auricular acupuncture; thread embedding acupuncture; traditional medicine

Outcome Measures

Primary Outcomes (1)

• Changes in body weight

  The body weight of the participants will be collected by investigators in the morning after the participants' personal hygiene routine and before breakfast, with measurements in kilograms (kg).

  Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

Secondary Outcomes (7)

• Changes in Body Mass Index (BMI)

  Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

• Changes in waist circumference

  Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

• Changes in hip circumference

  Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

• Changes in waist-hip ratio

  Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

• Changes in the Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score

  Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

Study Arms (2)

AA + TEA

EXPERIMENTAL

Auricular acupuncture (AA) every week in eight weeks (eight sessions). Combined with Thread embedding acupuncture (TEA) every two weeks in eight weeks (four sessions).

Other: Auricular acupuncture; Other: Thread embedding acupuncture

AA + Sham-TEA

SHAM COMPARATOR

Auricular acupuncture (AA) every week in eight weeks (eight sessions). Combined with Sham Thread embedding acupuncture (Sham-TEA) every two weeks in eight weeks (four sessions).

Other: Auricular acupuncture; Other: Sham Thread embedding acupuncture

Interventions

Auricular acupuncture OTHER

Auricular acupuncture is conducted weekly in eight weeks using patches, each with a square shape and a side length of 10 mm, along with sterilized needles measuring 0.25 x 1.3 mm. Five acupoints on one ear are selected, which included Shen-men (TF4), Stomach (CO4), Spleen (CO13), Endocrine (CO18), and Hunger point. The patch with the needle will remain in place for one week.

AA + Sham-TEA; AA + TEA

Thread embedding acupuncture OTHER

Thread embedding acupuncture is performed every two weeks in eight weeks using a single Polydioxaone thread. Needles has a gauge size of 29G, a shaft length of 38mm, and a thread length of 50mm, folded in half, and are applied to ten acupoints, including Qihai (CV6), Shuifen (CV9), and Tianshu (ST25), Shuidao (ST28), Daheng (SP15), Siman (KI14) on both sides of the body. Needles with a gauge size of 30G, a shaft length of 25mm, and a thread length of 30mm, folded in half, are used for five acupoints, which included Zhongwan (CV12) and Zusanli (ST36), Pishu (BL20) on both sides of the body. After the thread being inserted into the body, the needle will be withdrawn immediately.

AA + TEA

Sham Thread embedding acupuncture OTHER

Sham Thread embedding acupuncture is performed every two weeks in eight weeks. Needles without threads has a gauge size of 29G, and a shaft length of 38mm, are applied to ten acupoints, including Qihai (CV6), Shuifen (CV9), and Tianshu (ST25), Shuidao (ST28), Daheng (SP15), Siman (KI14) on both sides of the body. Needles without threads with a gauge size of 30G, and a shaft length of 25mm, are used for five acupoints, which included Zhongwan (CV12) and Zusanli (ST36), Pishu (BL20) on both sides of the body. After the needle being inserted into the body, it will be withdrawn immediately.

AA + Sham-TEA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Simple overweight or obesity with a Body Mass Index (BMI) of 23 kg/m2 or higher, following the criteria of The World Health Organization Regional Office for the Western Pacific Region.
• Waist circumference of 90 cm or more for males, or 80 cm or more for females.
• Voluntary informed consent.

You may not qualify if:

• Secondary obesity resulting from endocrine diseases or medication.
• Presence of severe medical conditions (e.g., cardiovascular, hepatic, renal or others) that could potentially affect treatment outcomes as per researchers' assessments.
• Current use of weight-affecting medications, including diabetes medications, endocrine medications, and medications for neurological psychiatric disorders.
• Pregnancy, lactation, or recent childbirth within the past 6 months.
• Severe mental and neurological conditions that may impact treatment compliance.
• Alcohol or substance addiction.
• History of hypersensitivity reactions to any form of acupuncture with needles or to Polydioxanone.
• Existing injuries or lesions at the acupoints under investigation in this study.
• Concurrent participation in other clinical trials or utilization of other weight reduction therapies.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University of Medical Center HCMC - Branch no.3

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (11)

• Lillingston F, Fields P, Waechter R. Auricular Acupuncture Associated with Reduced Waist Circumference in Overweight Women-A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2019 Dec 18;2019:6471560. doi: 10.1155/2019/6471560. eCollection 2019.

  PMID: 31929817 BACKGROUND

• Yasemin C, Turan S, Kosan Z. The Effects of Auricular and Body Acupuncture in Turkish Obese Female Patients: A Randomized Controlled Trial Indicated Both Methods Lost Body Weight But Auricular Acupuncture Was Better Than Body Acupuncture. Acupunct Electrother Res. 2017 Jan;42(1):1-10. doi: 10.3727/036012917x14908026364990.

  PMID: 29772131 BACKGROUND

• Sheng J, Jin X, Zhu J, Chen Y, Liu X. The Effectiveness of Acupoint Catgut Embedding Therapy for Abdominal Obesity: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2019 Jun 23;2019:9714313. doi: 10.1155/2019/9714313. eCollection 2019.

  PMID: 31341504 BACKGROUND

• Wang ZY, Li XY, Gou XJ, Chen CL, Li ZY, Zhao C, Huo WG, Guo YH, Yang Y, Liu ZD. Network Meta-Analysis of Acupoint Catgut Embedding in Treatment of Simple Obesity. Evid Based Complement Alternat Med. 2022 May 23;2022:6408073. doi: 10.1155/2022/6408073. eCollection 2022.

  PMID: 35656457 BACKGROUND

• Zhao HY, Kim S, Son MJ. Comparing acupoint catgut embedding and acupuncture therapies for simple obesity: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2022 Dec 23;101(51):e31531. doi: 10.1097/MD.0000000000031531.

  PMID: 36595747 BACKGROUND

• Yan RH, Liu XM, Bai J, Hou BB, Yu J, Gu JS. Clinical efficacy of simple obesity treated by catgut implantation at acupoints. Chin J Integr Med. 2015 Aug;21(8):594-600. doi: 10.1007/s11655-012-1215-7. Epub 2012 Dec 3.

  PMID: 23212565 BACKGROUND

• Wujie YE, Jingyu X, Zekai YU, Xingang HU, Yan Z. Systematic review and Meta-analysis of acupuncture and acupoint catgut embedding for the treatment of abdominal obesity. J Tradit Chin Med. 2022 Dec;42(6):848-857. doi: 10.19852/j.cnki.jtcm.2022.06.002.

  PMID: 36378041 BACKGROUND

• Chen X, Huang W, Wei D, Zhao JP, Zhang W, Ding DG, Jiao Y, Pan HL, Zhang JJ, Zhong F, Gao F, Jin YT, Zheng YW, Zhang YJ, Huang Q, Zeng XT, Zhou ZY. Effect of Acupoint Catgut Embedding for Middle-Aged Obesity: A Multicentre, Randomised, Sham-Controlled Trial. Evid Based Complement Alternat Med. 2022 Feb 27;2022:4780019. doi: 10.1155/2022/4780019. eCollection 2022.

  PMID: 35265146 BACKGROUND

• Jiali W, Lily L, Zhechao L, Jianping L, Mei H. Acupoint catgut embedding versus acupuncture for simple obesity: a systematic review and Meta-analysis of randomized controlled trials. J Tradit Chin Med. 2022 Dec;42(6):839-847. doi: 10.19852/j.cnki.jtcm.2022.06.001.

  PMID: 36378040 BACKGROUND

• Dai L, Wang M, Zhang KP, Wang L, Zheng HM, Li CB, Zhou WJ, Zhou SG, Ji G. Modified acupuncture therapy, long-term acupoint stimulation versus sham control for weight control: a multicenter, randomized controlled trial. Front Endocrinol (Lausanne). 2022 Jul 28;13:952373. doi: 10.3389/fendo.2022.952373. eCollection 2022.

  PMID: 35966092 BACKGROUND

• Trinh DT, Kieu QV, Tran AH, Bui MP, Vuong NL. Adding thread-embedding acupuncture to auricular acupuncture enhances short-term weight reduction in overweight and obesity: A double-blinded, randomized, sham-controlled trial. Integr Med Res. 2024 Sep;13(3):101050. doi: 10.1016/j.imr.2024.101050. Epub 2024 Jun 1.

  PMID: 38911552 DERIVED

Related Links

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MeSH Terms

Conditions

Overweight; Obesity

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be unaware of their random allocation into either the intervention or placebo group. Sham Thread embedding acupuncture (Sham-TEA) will be administered in a manner similar to TEA, but without the insertion of threads, ensuring that no threads are left at the acupoints after the procedure. The physician responsible for administering the treatments will be aware of the group assignments but remain uninvolved in the evaluation of outcomes and subsequent data analysis. Those responsible for outcome assessment and data analysis will be kept blinded to the treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 19, 2023
• Study Start: October 30, 2023
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

VN (1)