Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Completed

Conditions: Overweight or Obesity

Treatments: Other: Thread embedding acupuncture; Other: Sham Thread embedding acupuncture; Other: Auricular acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06091761

700/HDDD-DHYD

Details and patient eligibility

About

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.

Full description

Eligible participants with overweight or obesity, defined according to the criteria set by The World Health Organization Regional Office for the Western Pacific Region (Body Mass Index [BMI] of 23 kg/m² or higher), will be enrolled and subsequently randomized into two groups: the intervention group (AA + TEA group) and the placebo group (AA + Sham-TEA group), with a 1:1 allocation ratio.

In both groups, the intervention duration is eight weeks, with Auricular acupuncture (AA) administered weekly, along with recommended lifestyle modifications. For the intervention group, Thread embedding acupuncture (TEA) therapy will be added every two weeks, totaling four sessions during the eight-week period. Meanwhile, Sham-TEA will be administered in the placebo group.

Data regarding body weight, BMI, waist circumference, hip circumference, appetite, and adverse effects will be recorded immediately following randomization and weekly thereafter over the eight-week duration.

Enrollment: 66 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups

AA + TEA

Experimental group

Description:

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

Treatment:

Other: Auricular acupuncture

Other: Thread embedding acupuncture

AA + Sham-TEA

Sham Comparator group

Description:

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).

Treatment:

Other: Auricular acupuncture

Other: Sham Thread embedding acupuncture