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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

475 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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Functional constipation is a high morbidity disease. The life-long treatment of functional constipation can seriously impact a patient's quality of life. At present, one of the most frequently used treatment is catharsis, which deals with the symptom. There are three main problems with catharsis. First, there are no long-lasting effects once the patient stops taking medication. Second, there are many side effects, including abdominal pain with defecation and diarrhea. Third, long-term use of irritant laxatives will not only make the constipation become refractory and complex; but also, this type of medicine can harm the enteric nervous system, cause melanosis coli, or even carcinoma of colon. Therefore, a therapy that is safe with minimal side effects and good short-term and long-term effects is urgently needed in functional constipation treatment.

Clinical practice shows that acupuncture may meets this need to some extent. The acupuncture therapy is safe and effective and the therapeutic effects are still present several months after the treatment has been completed.

Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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deep needling group

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.

Group Type EXPERIMENTAL

deep needling

Intervention Type 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.

lactulose group

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.

Group Type ACTIVE_COMPARATOR

Lactulose

Intervention Type DRUG

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

shallow needling group

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.

Group Type ACTIVE_COMPARATOR

shallow needling

Intervention Type OTHER

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

Interventions

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deep needling

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.

Intervention Type OTHER

Lactulose

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

Intervention Type DRUG

shallow needling

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

Intervention Type OTHER

Other Intervention Names

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acupuncture electroacupuncture Lactulose produced by Solvay Pharmaceuticals BV acupuncture electroacupuncture

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No