A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation

NCT00508482 | Completed Phase 2 Results DMC

• 1 other identifier: 2006BAI12B05-1
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to re-evaluate the therapeutic superiority and safety of acupuncture treatment using high quality and large sampled clinical research. The investigators want to provide a preferred treatment protocol, which is effective, safe, and easy to use in clinical practice. This research also clarifies that the insertion depth is a key factor in the therapeutic effect of acupuncture. The results of the study will help promote the development of the standardization of acupuncture.

Conditions

Constipation

Keywords

Acupuncture; Functional constipation

Outcome Measures

Primary Outcomes (1)

• Change of Mean Weekly Spontaneous Bowel Movements

  Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries.

  over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up

Secondary Outcomes (9)

• Change of Mean Value of Straining During Defecating

  over 4 weeks of treatment

• Change of Mean Value of Incomplete Evacuation

  over 4 weeks of treatment

• Change of Mean Value of Stool Consistency

  over 4 weeks of treatment

• Change of Mean Value of Abdominal Distention

  over 4 weeks of treatment

• Change of Mean Value of Cleveland Clinic Score

  over 4 weeks of treatment

Study Arms (3)

deep needling group

EXPERIMENTAL

Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location, were used. After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 20\~60mm until piercing into the muscle layer. Paired alligator clips of the electric acupuncture (EA) apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1\~1mA. Participant's abdominal muscle twitching mildly showed the proper dose. Patients were treated once a day, five times a week for continuous 4 weeks.

Other: deep needling

lactulose group

ACTIVE COMPARATOR

Lactulose Oral Solution was taken orally at the dose of 20\~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.

Drug: Lactulose

shallow needling group

ACTIVE COMPARATOR

Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5\~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.

Other: shallow needling

Interventions

deep needling OTHER

Huatuo brand needle (0.35×75mm), LH202H electric stimulator, parameter is constant wave, 2/15Hz, and current intensity is the abdominal muscles shiver slightly and the patient feels trivial pain. Once a day, five times a week, four weeks.

Also known as: acupuncture, electroacupuncture

deep needling group

Lactulose DRUG

20-30ml, once a day before breakfast, for the whole study except the run-in period

Also known as: Lactulose produced by Solvay Pharmaceuticals BV

lactulose group

shallow needling OTHER

Huatuo brand needle (0.30×25mm). The usage of EA apparatus and treatment course were the same as deep needling group.

Also known as: acupuncture, electroacupuncture

shallow needling group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meeting the diagnosis of Rome III criteria;
• aged from 18 to 75 years old;
• no use of medicine for constipation about 2 weeks before the enrollment, no acupuncture treatment for constipation in the previous 3 months, and never joined any other trial in progress in the previous 3 months;
• volunteered to join this trial and signed the informed consent form

You may not qualify if:

• irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs;
• constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment;
• women in gestation or lactation period;
• abdominal aortic aneurysm or hepatosplenomegaly, etc.;
• blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;
• cardiac pacemaker carrier.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (1)

Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

• Wu J, Liu B, Li N, Sun J, Wang L, Wang L, Cai Y, Ye Y, Liu J, Wang Y, Liu Z. Effect and safety of deep needling and shallow needling for functional constipation: a multicenter, randomized controlled trial. Medicine (Baltimore). 2014 Dec;93(28):e284. doi: 10.1097/MD.0000000000000284.

  PMID: 25526462 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Acupuncture Therapy; Electroacupuncture; Lactulose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Limitations and Caveats

Spontaneous bowel movements were used as the primary outcome in our trial rather than complete, spontaneous bowel movements. Outcomes of follow-up were not the mean value of weekly data.

Results Point of Contact

• Title: Dr. Zhishun Liu
• Organization: Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences

liuzhishun@aliyun.com

0086-010-88001124

Study Officials

• Zhishun Liu, M.D.

  Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Acupuncture Department

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: April 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 4, 2014
• Results First Posted: March 15, 2013

Record last verified: 2014-05

Locations

CN (1)