Obesity, Obesity, Abdominal, Overweight
Conditions
Keywords
acupoint catgut embedding, thread embedding acupuncture, laser acupuncture, photobiomodulation, poliglecaprone 25, traditional Chinese medicine, weight loss
Brief summary
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.
Detailed description
Background Acupoint catgut embedding and laser acupuncture have each accumulated clinical evidence as treatments for obesity in adults, but three gaps remain. First, the two have not been evaluated in combination. Second, few published trials measure anthropometric, biochemical, and blood pressure outcomes together. Third, most existing trials are small, and systematic reviews have repeatedly noted limitations in blinding and sham control. Supporting literature is listed under Citations. Rationale for the design Acupoint embedding delivers sustained mechanical stimulation as the suture degrades over several weeks, whereas laser acupuncture delivers an energy input at the time of each session. The two therefore differ in mechanism and in time course. By giving identical acupoint embedding to both groups and varying only whether the laser emits energy, the trial estimates the incremental effect attributable to laser acupuncture rather than the combined effect of the two therapies. Masking Masking is implemented at four levels. Participants are masked because 810 nm light is outside the visible range and safety goggles are worn during treatment. The treating physician is masked because the manufacturer supplies dedicated sham pens whose housing, red indicator light, and operating sound are identical to the active pens but whose laser module is disconnected, giving an actual output of 0 milliwatts. The research assistants who perform all measurements take no part in treatment and are not informed of allocation. The statistician works from coded group labels until unmasking. Active and sham pens are managed by a study coordinator who takes no part in treatment; pens carry only a serial number with no active or sham marking, and the code list is held sealed in a safe in the principal investigator's office, to be opened only for a serious adverse event or a genuine medical emergency. Randomization A permuted block randomization sequence, with block size randomly set to 4 or 6 and an allocation ratio of 1:1, is generated in advance with the R blockrand package by an independent statistician who takes no part in enrollment or treatment, stratified by sex and by body mass index category (less than 30 versus 30 kg/m\^2 or greater). Allocation is implemented using sequentially numbered opaque sealed envelopes. Statistical analysis The primary analysis follows the intention-to-treat principle using a linear mixed-effects model containing group, time, the group-by-time interaction, the baseline value, the stratification factors, and a random participant effect. The Week 12 group-by-time contrast is reported as a least-squares mean difference with a 95 percent confidence interval. Missing data are handled by the model under a missing-at-random assumption, with last-observation-carried-forward and multiple imputation (20 imputations) as sensitivity analyses. A per-protocol analysis, defined as completion of at least 80 percent of treatment sessions with no major protocol violation, is a further sensitivity analysis. Secondary anthropometric outcomes use the same mixed-model structure. Biochemical outcomes use mixed models or analysis of covariance with the baseline value as covariate, with log transformation for skewed variables such as triglycerides and the homeostatic model assessment of insulin resistance. Blood pressure is analyzed by analysis of covariance at Week 12. Secondary outcomes are prespecified but are not adjusted for multiplicity; effect sizes and 95 percent confidence intervals are reported for each. Prespecified subgroup analyses are by sex and by body mass index category. The significance level is two-sided alpha of 0.05. Sample size The sample size is based on the primary outcome of weight change. With a standardized effect size of 0.67, two-sided alpha of 0.05, and 80 percent power, 35 participants per group are required. Allowing for 15 percent attrition and providing power for the secondary metabolic outcomes, the enrollment target is 60 participants per group, 120 in total. Safety monitoring Expected reactions to acupoint embedding include transient pain, bruising, or a mild nodule at the insertion site, usually resolving within days to two weeks. Less common events include local infection, allergic reaction, or suture extrusion. Reported adverse events from laser acupuncture are limited to transient warmth or erythema. Any serious adverse event, defined as one causing hospitalization, a life-threatening event, permanent disability, or death, is reported to the ethics committee and the principal investigator within 24 hours. Given the anticipated risk profile of the interventions, an independent safety monitor rather than a data and safety monitoring board oversees safety. The monitor reviews a safety summary monthly, the study coordinator compiles a safety data summary for the monitor every 3 months, and a formal interim safety review is conducted when enrollment reaches 60 participants. Quality control Physicians performing embedding and laser treatment must hold a license in Chinese medicine, have at least 2 years of clinical embedding experience, and complete laser acupuncture operator training, together with standard operating procedure training and simulated cases before enrollment begins. Laser output is verified monthly with an optical power meter, and a deviation of more than 10 percent triggers recalibration; the sham pens are confirmed to output 0 milliwatts. Measurement assistants complete standardized training and must reach an inter-rater intraclass correlation coefficient above 0.90.
Interventions
PROCEDUREAcupoint catgut embedding
Poliglecaprone 25 absorbable suture, in segments of approximately 1 to 1.5 cm, is implanted subcutaneously at acupoints with a disposable 22-gauge or 24-gauge embedding needle. Fifteen acupoints are treated at each session, giving 25 insertions in total: ST25, CV12, ST24, ST21, CV10, CV9, SP15, CV6, CV4, ST28, ST27, and GB26 on the abdomen, and ST40, ST36, and SP9 on the limbs, with bilateral points treated on both sides. Sessions occur once every 2 weeks at Weeks 0, 2, 4, 6, 8, and 10.
DEVICEActive laser acupuncture
An RJ Laser Pen with a gallium aluminium arsenide semiconductor laser diode, wavelength 810 nm, maximum output 500 milliwatts, continuous wave, is applied with a contact probe. Irradiation is delivered to the same acupoint sites that receive embedding, for 10 seconds per site, delivering 5 joules per site at approximately 20 joules per square centimeter, immediately before the acupoint embedding at each of the 6 sessions. Safety goggles are worn during irradiation.
DEVICESham laser acupuncture
A dedicated sham laser pen supplied by the manufacturer is applied to the same acupoints, for the same duration, and on the same schedule as the active laser. The sham pen is identical to the active pen in housing, red indicator light, and operating sound, but its laser module is disconnected so that actual output is 0 milliwatts.
BEHAVIORALDietary and exercise counseling
Standardized dietary counseling is given at baseline and at Week 6, advising a daily energy intake approximately 500 kilocalories below requirement without a prescribed menu, together with a recommendation of at least 150 minutes per week of moderate-intensity aerobic exercise. Participants complete a weekly diet and exercise log.
Sponsors
Taipei City Hospital
Taipei City Government Department of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The manufacturer supplies dedicated sham laser pens identical to the active pens in housing, red indicator light, and operating sound, but with the laser module disconnected so actual output is 0 milliwatts. Because 810 nm light is outside the visible range and safety goggles are worn, neither the participant nor the treating physician can tell the pens apart. The principal investigator personally performs the embedding and the laser application and is masked by this same mechanism, which is why the investigator role is recorded as masked. Pens are issued by serial number by a study coordinator who takes no part in treatment; the allocation code list is held sealed in the principal investigator's office and is opened only for a serious adverse event or a genuine medical emergency. Research assistants performing all measurements take no part in treatment and are not informed of allocation, and the statistician works from coded group labels until unmasking.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 20 to 65 years * Body mass index of 27 kg/m\^2 or greater, or body mass index of 24 kg/m\^2 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 * Willing to follow the dietary and exercise advice given during the trial
Exclusion criteria
* 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 * Bariatric surgery within the previous 6 months * Known allergy to absorbable suture material * Skin infection at the embedding sites, keloid tendency, or coagulation disorder * Implanted cardiac pacemaker or other electromagnetic implant * Known photosensitivity disorder or current use of photosensitizing medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Body Weight at Week 12 | Baseline and Week 12 | Body weight in kilograms, measured on a calibrated scale by a trained assessor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Body Weight at Weeks 18 and 24 | Baseline, Week 18, and Week 24 | Body weight in kilograms during the follow-up period after the end of the 12-week intervention, measured on a calibrated scale by a trained assessor. |
| Mean Change From Baseline in Body Mass Index | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Body mass index in kg/m\^2, calculated from measured height and weight. |
| Mean Change From Baseline in Waist Circumference | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Waist circumference in centimeters, measured by a trained assessor. |
| Mean Change From Baseline in Hip Circumference | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Hip circumference in centimeters, measured by a trained assessor. |
| Mean Change From Baseline in Waist-to-Hip Ratio | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Waist circumference divided by hip circumference. |
| Mean Change From Baseline in Body Fat Percentage | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Body fat expressed as a percentage of body mass, measured with a body composition analyzer. |
| Mean Change From Baseline in Periumbilical Subcutaneous Fat Thickness | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Subcutaneous fat thickness measured at the level of the umbilicus, in millimeters. |
| Mean Change From Baseline in Total Cholesterol | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Serum total cholesterol in mg/dL, drawn after at least 8 hours of fasting. |
| Mean Change From Baseline in Triglycerides | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Serum triglycerides in mg/dL, drawn after at least 8 hours of fasting. |
| Mean Change From Baseline in High-Density Lipoprotein Cholesterol | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Serum high-density lipoprotein cholesterol in mg/dL, drawn after at least 8 hours of fasting. |
| Mean Change From Baseline in Low-Density Lipoprotein Cholesterol | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Serum low-density lipoprotein cholesterol in mg/dL, drawn after at least 8 hours of fasting. |
| Mean Change From Baseline in Fasting Plasma Glucose | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Plasma glucose in mg/dL, drawn after at least 8 hours of fasting. |
| Mean Change From Baseline in Fasting Insulin | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Serum insulin in microinternational units per milliliter, drawn after at least 8 hours of fasting. |
| Mean Change From Baseline in Homeostatic Model Assessment of Insulin Resistance | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | The homeostatic model assessment of insulin resistance (HOMA-IR), calculated from fasting plasma glucose and fasting insulin. |
| Mean Change From Baseline in Glycated Hemoglobin | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Glycated hemoglobin (HbA1c), expressed as a percentage of total hemoglobin. |
| Mean Change From Baseline in Systolic Blood Pressure | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Seated systolic blood pressure in mmHg, measured with a standard sphygmomanometer. |
| Mean Change From Baseline in Diastolic Blood Pressure | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Seated diastolic blood pressure in mmHg, measured with a standard sphygmomanometer. |
| Mean Change From Baseline in Mean Arterial Pressure | Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24 | Mean arterial pressure in mmHg, calculated from systolic and diastolic blood pressure. |
| Number of Participants With Adverse Events | From the first treatment session at Week 0 up to Week 24 | Number of participants reporting any adverse event, including insertion-site pain, bruising, induration, local infection, allergic reaction, suture extrusion, transient warmth, or erythema. |
| Number of Participants With Serious Adverse Events | From the first treatment session at Week 0 up to Week 24 | Number of participants reporting any serious adverse event, defined as an event causing hospitalization, a life-threatening event, permanent disability, or death. |
Countries
Taiwan
Contacts
CONTACTChia-Lin Lin, MD
PRINCIPAL_INVESTIGATORChia-Lin Lin, MD
Taipei City Hospital, Renai Branch
Outcome results
None listed