Dataset Information

Effect of laser acupuncture on obesity: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Obesity-related diseases have a profound economic impact on health care systems. Laser acupuncture has been shown to have beneficial effects on obesity. However, to our knowledge, those trials were either non-randomized, non-blinded or included low-calorie diet control. We have, therefore, designed a patient-assessor-blinded, randomized, sham-controlled crossover trial to investigate the significance of laser acupuncture on obesity.

Methods/design

104 subjects above 20 years of age with a body mass index (BMI) of over 25 kg/m(2) will be divided into 2 groups: experimental and control. Each subject will receive the treatment relevant to their group 3 times a week for 8 weeks. After 8 weeks of treatment the subject will enter a 2-week washout period, after which the subjects will switch groups. Measurements will include BMI, body fat percentage, waist-to-hip ratio (WHR), waist circumference, hip circumference, skinfold thickness, thigh circumference, body fat, blood pressure, heart rate, hunger and the 36-item Short-Form Health Survey (SF-36).

Discussion

The results of this study will provide the basis for future large-scale multicenter trials investigating the effects of laser acupuncture on obesity.

Trial registration

ClinicalTrials.gov Identifier: NCT02167308 ; registration date: 14 June 2014.

SUBMITTER: Tseng CC

PROVIDER: S-EPMC4440285 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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Publications

Effect of laser acupuncture on obesity: study protocol for a randomized controlled trial.

Tseng Chi-Chuan CC Tseng Alan A Chang Chia-Hao CH

Trials 20150515

<h4>Background</h4>Obesity-related diseases have a profound economic impact on health care systems. Laser acupuncture has been shown to have beneficial effects on obesity. However, to our knowledge, those trials were either non-randomized, non-blinded or included low-calorie diet control. We have, therefore, designed a patient-assessor-blinded, randomized, sham-controlled crossover trial to investigate the significance of laser acupuncture on obesity.<h4>Methods/design</h4>104 subjects above 20 ...[more]

PMID: 25972018

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Project description:BackgroundHypnotic drugs tend to be the dominant form of treatment of insomnia, but these come with a number of reported side effects. Acupuncture has been studied as an alternative, resulting in a rising need for methodological research towards verifying its efficacy as insomnia treatment.Methods/designWe describe a proposal for a single-center, patient-assessor-blinded, randomized controlled trial with two parallel arms. A total of 38 patients complete screening tests at the first visit, are registered into the clinical trial, and then randomly assigned to the experimental or sham control groups (19 patients for each group). All subjects are clinical insomnia patients who score a 6 or above on the Pittsburgh Sleep Quality Index (PSQI) and meet all inclusion criteria. All subjects are treated with acupuncture and intradermal acupuncture (IDA) three times during the first week. Five sham acupoints are used in the control group. In the experimental group, five real acupoints (PC6, SP6, HT7, KI6, and BL62) are used unilaterally in turn. Sham acupoints are over 1 cm away from each real acupoint.The primary outcomes are the scores on the Insomnia Severity Index (ISI) and PSQI. Secondary outcomes are the sleep log, the Beck Depression Inventory (BDI), the State-Trait Anxiety Inventory (STAI), the World Health Organization Quality of Life Abbreviated Version (WHOQOL-BREF), the Korean-Auditory Verbal Learning Test (K-AVLT), the Digit Span Test (DS), Event Related Potentials (ERPs) and heart rate variability (HRV) to assess emotional states, sleep quality, cognitive functioning, and electro-physiological changes.Subjects are assessed at three time points: baseline, post-treatment and follow-up. The duration of the clinical trial is 18 days.DiscussionTo study the enhancement of the effectiveness of acupuncture for insomnia, we test the intradermal acupuncture method, which is performed continuously on the subject's skin and stimulated at home by the subject every night. In the trial, objective measurements including ERPs and HRV are used to evaluate states of cognition and autonomic nervous system functioning and subjective self-report questionnaires assess insomnia symptoms.'Sham' acupuncture points provided by STRICTA are used for the control group.Trial registrationClinicalTrials.gov: NCT01956760, registered 5 September 2013.

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Dataset Information

Effect of laser acupuncture on obesity: study protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Effect of laser acupuncture on obesity: study protocol for a randomized controlled trial.

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