Catgut Implantation at Acupoints for the Treatment of Simple Obesity

NCT02936973 | Completed DMC

• 2 other identifiers: 201507003ChiCTR-IOR-16008384
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this multicenter randomized controlled trial is to evaluate treatment effectiveness of intervening simple obesity people with catgut implantation at preferred acupoints, which excludes placebo effect; the secondary objective is to evaluate safety and superiority of treating simple obesity with catgut implantation at acupoints to provide high-level evidence for it clinically.

Conditions

Obesity

Keywords

simple obesity; catgut implantation

Outcome Measures

Primary Outcomes (1)

• the rate of waistline reduction compared with baseline

  week4 ,week8,week12,week16,week28,week40.

Secondary Outcomes (16)

• the rate of reduction of weight compared with baseline

  week4 ,week8,week12,week16,week28,week40.

• the rate of reduction of body mass index compared with baseline

  week4 ,week8,week12,week16,week28,week40.

• the rate of reduction of hipline compared with baseline

  week4 ,week8,week12,week16,week28,week40.

• the rate of reduction of waist-hip ratio compared with baseline

  week4 ,week8,week12,week16,week28,week40.

• the rate of reduction of percentage of body fat compared with baseline

  week4 ,week8,week12,week16,week28,week40.

Study Arms (2)

Real catgut implantation

EXPERIMENTAL

Participants will receive real catgut implantation at acupoints plus lifestyle modification. Participants will receive catgut implantation treatment every two weeks to fulfill a 8-session treatment course.When the acupoints and surrounding skin are disinfected, an absorbable surgical suture of an appropriate length will be embedded into the muscular layer or subcutaneous tissue of the acupoints by the specified disposable embedding needles. The absorbable surgical suture then stimulated those points over a long period.

Device: Real catgut implantation at acupoints

sham catgut implantation

SHAM COMPARATOR

Participants will receive sham catgut implantation at acupoints and lifestyle modification every two weeks to fulfill a 8-session treatment course.The operation process will be similar to that applied in the real catgut implantation group. Empty needles without catgut will be pushed into the chosen position, to a depth equivalent to that used for catgut implantation at acupoints. The frequency and duration were the the same as the catgut embedding group.

Device: sham catgut implantation at acupoints

Interventions

Real catgut implantation at acupoints DEVICE

1. Absorbable surgical suture will be embedded in acupoints as below. Group A ：Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B ：Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40). Each group will be used alternatively and treated once every 2 weeks. 2. lifestyle intervention :Experienced nutritionists calculated every participant's basal metabolic rate,then designed a proper diet and exercise treatment for them. During the treatment, a diet and exercise diary will be distributed to the patients, and detailed guidance concerning their diet and exercise will be provided according to the diary. The patients should be encouraged to maintain the diet and exercise diary for at least 4 days per week .

Real catgut implantation

sham catgut implantation at acupoints DEVICE

Empty needles without catgut will be pushed into the chosen position as below :Group A ：1 cun lateral from the Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B ：1 cun lateral from the Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40).Those two groups of acupoints will ultimately be selected for alternative treatment. Each group will be used alternatively and treated once every 2 weeks. lifestyle intervention :It will be performed as the same as the real catgut implantation at acupoints group.

sham catgut implantation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• meeting the diagnosis standard for simple obesity in Redefinition and Processing of Obesity in Asia \& Pacific Area released by WHO in February 2000;
• age: 18-45;
• BMI: 25≤BMI\<30;
• waistline: males ≥95 cm; females ≥85 cm;
• smokers have not changed their smoking habits for at least 2 months;
• willing to accept the above-described intervention methods.

You may not qualify if:

• Patients with any of the following criteria will be excluded from the study:
• endocrine disease (such as polycystic ovarian syndrome, Cushing's Disease, and hypothyroidism, among others);
• gestational diabetes or uncontrolled hypertension (SBP ≥160 mmHg; DBP ≥100 mmHg) \[23\], or lung, heart, liver or kidney disease;
• nervous system disease or mental disorders, history of hospitalized depression, two instances of paralepsy or suicidal tendency;
• history of clinical diagnosis of an eating disorder , such as bulimia or cynorexia, anorexia; or weight changes greater than 5 kg in the previous 3 months;
• history of weight loss with surgery or a history of post-operative adhesion;
• having taken drugs with a known influence on weight or appetite in the previous 3 months, such as diet pills, corticosteroid drugs, anti-depression drugs, diazepam drugs, nonselective body antihistamine, nicotine replacements, or hypoglycaemic drugs, or planning to give up smoking and drinking;
• pregnancy, lactation, or planning to become pregnant within 40 weeks;
• received catgut implantation at acupoints;
• participated in clinical research on obesity in the previous 3 months ;
• protein allergy and scars;
• skin disease such as eczema and psoriasis;
• coagulation disorders, taking warfarin, heparin or other anticoagulant drugs;
• not cooperative or cannot maintain treatment during the study period.

Sponsors & Collaborators

• Hubei Hospital of Traditional Chinese Medicine: lead
• State Administration of Traditional Chinese Medicine of the People's Republic of China: collaborator
• Dongzhimen Hospital, Beijing: collaborator
• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Hubei Provincial Hospital of Traditional Chinese Medicine

Wuhan, Hubei, 430061, China

Location

Related Publications (3)

• Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF, RIO-Diabetes Study Group. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006;368:1660-72. Preljevic VT, Østhus TB, Sandvik L, Opjordsmoen S, Nordhus IH, Os I, et al. Screening for anxiety and depression in dialysis patients: comparison of the Hospital Anxiety and Depression Scale and the Beck Depression Inventory. J Psychosom Res. 2012;73:139-44. Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rössner S, RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant onweight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005;365:1389-97. Rosenberg M. Society and the adolescent self-image. Princeton, NJ: Princeton University Press; 1965. World Health Organization, Regional Office for the Western Pacific. The Asia-Pacific perspective: redefining obesity and its treatment. Sydney: Health Communications Australia; 2000. Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:1906-13. MacPherson H, White A, Cummings M, Jobst KA, Rose K, Niemtzow RC, et al. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. J Altern Complement Med. 2002;8:85 - 9. Ralph JL, Von Ah D, Scheett AJ, Hoverson BS, Anderson CM. Diet assessment methods: a guide for oncology nurses. Clin J Oncol Nurs. 2011;15:E114 - 21. James WP, Astrup A, Finer N, Hilsted J, Kopelman P, Rössner S, et al. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance Lancet. 2000;356:2119-25.

  BACKGROUND

• 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.

  PMID: 35265146 DERIVED

• Chen X, Huang W, Wei D, Ding DG, Jiao Y, Pan HL, Jin YT, Zheng YW, Zhang YJ, Zhang YR, Liu YR, Zhou ZY. Clinical effect of catgut implantation at acupoints for the treatment of simple obesity: A multicentre randomized controlled trial. Medicine (Baltimore). 2020 Nov 25;99(48):e23390. doi: 10.1097/MD.0000000000023390.

  PMID: 33235115 DERIVED

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhongyu Zhou, Professor

  Hubei Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2016
• First Posted: October 18, 2016
• Study Start: February 15, 2017
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

CN (1)