The Therapeutic Effect of Catgut Embedding in Obesity

The Therapeutic Effect of Catgut Embedding in Obesity-A Randomized, Double-blind, Placebo-controlled Clinical Trial

The aim of this double-blind, randomized, placebo-controlled trial is to evaluate the therapeutic effects of acupoint stimulation by catgut embedding on complexion, quality of life, lipid profile, inflammatory markers, and obesity-related hormone peptide of obese women.

Study Overview

• Status: Unknown
• Conditions: Obese Women
• Intervention / Treatment: Device: Catgut embedding group; Device: sham catgut embedding group

Detailed Description

We will recruit 90 females aged from 16 year-old to 65 year-old with body mass index(BMI) 27㎞/㎡ and waist circumference≧80cm. After inform consent, they will be randomly assigned into two groups. In group A, catgut embedding will be applied to six acupuncture points on the abdomen including Qihai (Ren-6), Shuifen (REN-9), bilateral shuidao (ST-28) and Siman (ST-26), which have been proved to be effective on obesity in our previous study, once each week for six times. In group B, sham catgut embedding will be applied on the same acupoints once each week for six weeks. This trial will go on for six weeks with six course of treatment.

Our primary outcome measurements is complexion which included body mass index(BMI),waist circumstances, and waist-hip ratio. In our second outcome measurments, we will evaluate the life quality of these patients using 12-Item Short Form Health Survey (SF-12) which developed for the Medical Outcomes Study (MOS) and also using questionnaire of quality of life that was designated by World Health Organization. We will also classify the patients by questionnaire designed for TCM syndrome of obesity. We will check blood test included lipid profile (TG, Chol, HDL-C, LDL-C), inflammatory markers, and hormone peptide related to obesity such as insulin,leptin,ghrelin,adiponectin. Each enrolling patients will be evaluated at the baseline before treatment and after 6 times treatments completed by above parameters to find out the therapeutic effects and mechanism of catgut embedding in acupoints in obese women.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 886
    • Branch of Chinese Medicine, Taipei City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• body mass index (BMI) ≥ 27 kg/m2 waist circumference (WC) ≥ 80 cm and willing to participate in and fill out the questionnaires for this trial.

Exclusion Criteria:

• Endocrine disease(Thyroid disease, pituitary disease, diabetes mellitus) Autoimmune disease（SLE、SSS、RA） Heart disease(Heart failure, arrhythmia etc.） Abnormal liver function（GOT>80U/L、GPT>80U/L） Abnormal kidney function（serum creatinine>2.5 mg/dL） Stroke disease in past one year Under breast feeding or pregnancy Coagulation disorder Subjects with keloid disorder Accept weight reduction treatment in last two months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: catgut embedding group; Catgut will be embedding in acupoints as below. Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26) Frequency: one time per week Duration: 6 weeks	Device: Catgut embedding group; An extensive form of acupuncture that involves weekly infixing self-absorptive chromic catgut sutures into acupoints with a specialised needle under antiseptic precautions. The catgut then stimulate those points over a long period. The stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger with chromic catgut in front of the syringe needle. Catgut will be embedding in acupoints as below. Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26); Other Names: acupoint catgut embedding
SHAM_COMPARATOR: sham catgut embedding group; The stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger without chromic catgut in front of the syringe needle. All the procedure will be performed as in catgut embedding group. Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26) The other procedure were the same as catgut embedding group Frequency: one time per week Duration: 6 weeks	Device: sham catgut embedding group; The stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger without chromic catgut in front of the syringe needle. Catgut will be embedding in acupoints as below. Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26); Other Names: sham acupoint catgut embedding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
body weight	assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
body mass index	assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
waist circumference	assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks
hip circumference	assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cholesterol	cholesterol (Chol),	Assess at baseline and after 6 weeks of treatment
triglyceride (TG)	triglyceride (TG),	Assess at baseline and after 6 weeks of treatment
low-density lipoprotein cholesterol (LDL-C)	low-density lipoprotein cholesterol (LDL-C)	Assess at baseline and after 6 weeks of treatment
High-density lipoprotein cholesterol(HDL-C)	High-density lipoprotein cholesterol(HDL-C)	Assess at baseline and after 6 weeks of treatment
Quality of life	short-form 12 items and WHOQOLBREF	Assess at baseline and after 6 weeks of treatment
Questionnaire on traditional Chinese medicine syndrome groups	Obesity subjects will be classified into six groups including stomach heat, yin deficiency, qi stagnation, qi deficiency, kidney deficiency and blood stasis With more than two "yes"in items, patient will be classified to that kind of syndrome	Assess at baseline and after 6 weeks of treatment
sugar	AC sugar,	Assess at baseline and after 6 weeks of treatment
glycohemoglobin	glycohemoglobin (HbA1c),	Assess at baseline and after 6 weeks of treatment
liver function	ALT	Assess at baseline and after 6 weeks of treatment
kidney function	Cr	Assess at baseline and after 6 weeks of treatment
inflammatory markers	hsCRP	Assess at baseline and after 6 weeks of treatment

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Collaborators: National Yang Ming University

Publications and helpful links

General Publications

• Huang CY, Choong MY, Li TS. Treatment of obesity by catgut embedding: an evidence-based systematic analysis. Acupunct Med. 2012 Sep;30(3):233-4. doi: 10.1136/acupmed-2012-010176. Epub 2012 Jul 7. No abstract available.
• Liao JQ, Song X, Chen Y, Liang LC, Wang SX. [Clinical randomized controlled trials of acupoint catgut-embedding for simple obesity: a meta-analysis]. Zhongguo Zhen Jiu. 2014 Jun;34(6):621-6. Chinese.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (ESTIMATE): October 28, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 23, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: obese women; catgut embedding; obesity-related hormones
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 101XDAA00024