About this trial
Acupoint catgut embedding and laser acupuncture have each been studied as treatments for obesity in adults, but the two have not been evaluated in combination, and few trials have measured anthropometric, biochemical, and blood pressure outcomes together.
This single-center randomized sham-controlled trial plans to enroll 120 adults aged 20 to 65 years with obesity. All participants receive the same acupoint catgut embedding with poliglecaprone 25 absorbable suture at 15 acupoints, comprising 25 insertions, once every 2 weeks for 6 sessions over 12 weeks. Participants are randomly assigned in a 1:1 ratio to receive, immediately before each embedding session, either active 810 nm laser acupuncture or sham laser acupuncture delivered with a device that is identical in appearance, indicator light, and operating sound but emits no therapeutic energy. Both groups also receive standardized dietary and exercise counseling.
Because the acupoint embedding regimen is identical in both groups and the groups differ only in whether the laser emits energy, the comparison estimates the incremental effect of laser acupuncture added to acupoint embedding. Participants are treated for 12 weeks and then followed for a further 12 weeks, to Week 24.
Eligibility criteria
Qualifiers
Age 20 to 65 years
Body mass index of 27 kg/m² or greater, or body mass index of 24 kg/m² or greater together with a waist circumference of 90 cm or greater in men or 80 cm or greater in women
Able to fully understand the informed consent document and willing to give written informed consent
No use of weight-loss medication and no other weight-reduction treatment in the 3 months before enrollment
Disqualifiers
Current use of medication that may affect body weight, including corticosteroids, antipsychotics, insulin, or glucagon-like peptide-1 (GLP-1) receptor agonists
Known secondary cause of obesity, such as hypothyroidism, Cushing syndrome, or pituitary disease
Severe cardiovascular, hepatic, or renal disease, or poorly controlled diabetes defined as glycated hemoglobin (HbA1c) above 9 percent
Currently pregnant, breastfeeding, or planning pregnancy within 6 months
Trial design
Treatments tested in this trial
- Acupoint catgut embedding
- Active laser acupuncture
- Sham laser acupuncture
- Dietary and exercise counseling
Treatment groups
Sponsors and collaborators
Taipei City Hospital
Lead sponsor
Taipei City Government Department of Health
Collaborator