Acupoint Catgut Embedding With Laser Acupuncture for Weight Loss in Adults With Obesity
Acupoint Embedding Combined With Laser Acupuncture for Obesity: A Randomized, Double-Blind, Sham Laser-Controlled Trial Evaluating Anthropometric, Biochemical, and Hemodynamic Outcomes
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.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Chia-Lin Lin, MD
- Número de telefone: 886-905-211-208
- E-mail: DBB10@tpech.gov.tw
Locais de estudo
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Taipei, Taiwan, 106
- Taipei City Hospital, RENAI Branch
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Contato:
- Chia-Lin Lin, MD
- Número de telefone: 886-905-211-208
- E-mail: DBB10@tpech.gov.tw
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Investigador principal:
- Chia-Lin Lin, MD
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Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
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Experimental: Acupoint catgut embedding plus active laser acupuncture
Participants receive acupoint catgut embedding at 15 acupoints (25 insertions) once every 2 weeks for 6 sessions, at Weeks 0, 2, 4, 6, 8, and 10.
Immediately before each embedding session, active 810 nm laser acupuncture is applied to the same acupoints for 10 seconds per point, delivering 5 joules per point.
All participants also receive standardized dietary and exercise counseling.
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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.
Outros nomes:
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.
Outros nomes:
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.
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Comparador Falso: Acupoint catgut embedding plus sham laser acupuncture
Participants receive exactly the same acupoint catgut embedding regimen at the same 15 acupoints on the same schedule.
Immediately before each embedding session, a sham laser pen is applied to the same acupoints for the same duration.
The sham pen is identical in appearance, indicator light, and operating sound, but its laser module is disconnected and actual output is 0 milliwatts.
All participants also receive standardized dietary and exercise counseling.
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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.
Outros nomes:
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.
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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Mean Change From Baseline in Body Weight at Week 12
Prazo: Baseline and Week 12
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Body weight in kilograms, measured on a calibrated scale by a trained assessor.
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Baseline and Week 12
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Change From Baseline in Body Weight at Weeks 18 and 24
Prazo: Baseline, Week 18, and Week 24
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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.
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Baseline, Week 18, and Week 24
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Mean Change From Baseline in Body Mass Index
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Body mass index in kg/m^2, calculated from measured height and weight.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Waist Circumference
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Waist circumference in centimeters, measured by a trained assessor.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Hip Circumference
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Hip circumference in centimeters, measured by a trained assessor.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Waist-to-Hip Ratio
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Waist circumference divided by hip circumference.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Body Fat Percentage
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Body fat expressed as a percentage of body mass, measured with a body composition analyzer.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Periumbilical Subcutaneous Fat Thickness
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Subcutaneous fat thickness measured at the level of the umbilicus, in millimeters.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Total Cholesterol
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Serum total cholesterol in mg/dL, drawn after at least 8 hours of fasting.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Triglycerides
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Serum triglycerides in mg/dL, drawn after at least 8 hours of fasting.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in High-Density Lipoprotein Cholesterol
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Serum high-density lipoprotein cholesterol in mg/dL, drawn after at least 8 hours of fasting.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Low-Density Lipoprotein Cholesterol
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Serum low-density lipoprotein cholesterol in mg/dL, drawn after at least 8 hours of fasting.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Fasting Plasma Glucose
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Plasma glucose in mg/dL, drawn after at least 8 hours of fasting.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Fasting Insulin
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Serum insulin in microinternational units per milliliter, drawn after at least 8 hours of fasting.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Homeostatic Model Assessment of Insulin Resistance
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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The homeostatic model assessment of insulin resistance (HOMA-IR), calculated from fasting plasma glucose and fasting insulin.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Glycated Hemoglobin
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Glycated hemoglobin (HbA1c), expressed as a percentage of total hemoglobin.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Systolic Blood Pressure
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Seated systolic blood pressure in mmHg, measured with a standard sphygmomanometer.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Diastolic Blood Pressure
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Seated diastolic blood pressure in mmHg, measured with a standard sphygmomanometer.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean Change From Baseline in Mean Arterial Pressure
Prazo: Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Mean arterial pressure in mmHg, calculated from systolic and diastolic blood pressure.
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Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24
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Number of Participants With Adverse Events
Prazo: From the first treatment session at Week 0 up to Week 24
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Number of participants reporting any adverse event, including insertion-site pain, bruising, induration, local infection, allergic reaction, suture extrusion, transient warmth, or erythema.
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From the first treatment session at Week 0 up to Week 24
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Number of Participants With Serious Adverse Events
Prazo: From the first treatment session at Week 0 up to Week 24
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Number of participants reporting any serious adverse event, defined as an event causing hospitalization, a life-threatening event, permanent disability, or death.
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From the first treatment session at Week 0 up to Week 24
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Outras medidas de resultado
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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James Blinding Index
Prazo: Week 12
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Participants are asked at Week 12 to guess which group they were assigned to.
The James blinding index is calculated from these guesses and ranges from 0 to 1, where higher values indicate that participants were less able to identify their assignment.
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Week 12
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Bang Blinding Index
Prazo: Week 12
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Participants are asked at Week 12 to guess which group they were assigned to.
The Bang blinding index is calculated separately for each group and ranges from -1 to 1, where values closer to 0 indicate that participants were less able to identify their assignment.
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Week 12
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Chia-Lin Lin, MD, Taipei City Hospital, RENAI Branch
Publicações e links úteis
Publicações Gerais
- 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.
- Chen IJ, Yeh YH, Hsu CH. Therapeutic Effect of Acupoint Catgut Embedding in Abdominally Obese Women: A Randomized, Double-Blind, Placebo-Controlled Study. J Womens Health (Larchmt). 2018 Jun;27(6):782-790. doi: 10.1089/jwh.2017.6542. Epub 2018 May 3.
- Chen LS, Li YY, Chen H, Liu BW, Wang DW, Zhao YH. Polyglycolic acid sutures embedded in abdominal acupoints for treatment of simple obesity in adults: a randomized control trial. Chin Med. 2019 Sep 18;14:32. doi: 10.1186/s13020-019-0258-5. eCollection 2019.
- Yang Q, Xu N, Guo L, Li H, Li X, Zeng Q, Zhang W, Li S, Yi W. Effect of acupoint catgut embedding for simple obesity in adults: A randomized controlled double-blind trial. Integr Med Res. 2025 Jun;14(2):101151. doi: 10.1016/j.imr.2025.101151. Epub 2025 May 14.
- Guo T, Ren Y, Kou J, Shi J, Tianxiao S, Liang F. Acupoint Catgut Embedding for Obesity: Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2015;2015:401914. doi: 10.1155/2015/401914. Epub 2015 Aug 31.
- Razzaghi M, Akbari Z, Mokmeli S, Razzaghi Z, Rezaei-Tavirani M, Afzalimehr M, Kamani E. Laser Diode - GaAlAs Acupuncture in the Treatment of Central Obesity: a Randomized Clinical Trial. J Acupunct Meridian Stud. 2023 Dec 31;16(6):255-262. doi: 10.51507/j.jams.2023.16.6.255.
- Kamal WM, Maged AM, AbdelAziz S, Mahmoud SI, Mohsen RA. The effects of laser acupuncture on metabolic syndrome in obese postmenopausal women: a randomized controlled study. Lasers Med Sci. 2024 Aug 14;39(1):215. doi: 10.1007/s10103-024-04158-0.
- Sun W, Zhuang Z, Yang L, Zhou J, Zhang L, Yuan J. Effectiveness of photobiomodulation therapy in improving health indicators in obese patients: a systematic review and meta-analysis of RCTs. BMC Complement Med Ther. 2025 Apr 11;25(1):133. doi: 10.1186/s12906-025-04874-2.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios Nutricionais
- Supernutrição
- Peso corporal
- Alterações de Peso Corporal
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Excesso de peso
- Obesidade
- Perda de peso
- Obesidade Abdominal
- Terapêutica
- Dieta, comida e nutrição
- Fenômenos fisiológicos
- Fenômenos fisiológicos nutricionais
- Terapia a laser
- Fototerapia
- Dieta
- Terapia com luz de baixo nível
Outros números de identificação do estudo
Outros números de identificação do estudo
- TCHIRB-11505001
- 115XDAA00074 (Número de outro subsídio/financiamento: Taipei City Government Department of Health)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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