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Acupuncture for Chronic Constipation

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ClinicalTrials.gov Identifier: NCT00746200
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : May 12, 2010
Information provided by:
National Taiwan University Hospital

Brief Summary:
Since there have been few advances for constipation in laxative treatment in the last 50 years, this study is designed to evaluate the efficacy and safety of acupuncture for patients with chronic constipation based on the theory of traditional Chinese Medicine.

Condition or disease Intervention/treatment Phase
Chronic Constipation Procedure: (electro)acupuncture Procedure: sham acupuncture Phase 3

Detailed Description:

Although many people regard regular defecation as important factor to maintain healthy, constipation is still a common problem in general population. Because the symptoms cause serious impairment of life quality, laxatives are commonly prescribed for people and over prescribing of laxatives is also common. Despite the large sums spent on laxatives, there have been few advances in laxative treatment in the last 50 years and there have been minimal research addressing the problem.

Since there is unsatisfactory effect by current pharmacologic therapies and preventive strategies, we look forward to the practice of traditional Chinese medicine, which had abundant clinical experiences and medical records in the past of thousands years ago. Therefore we aim to do the research to create the evidence of acupuncture on the safety, efficacy and quality of life for chronic constipation.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation
Study Start Date : October 2008
Primary Completion Date : April 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Procedure: (electro)acupuncture
Frequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min;
Other Name: electroacupuncture
Sham Comparator: S Procedure: sham acupuncture
Superficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds

Primary Outcome Measures :
  1. score of questionnaire of constipation symptoms [ Time Frame: every month ]

Secondary Outcome Measures :
  1. score of questionnaire of quality of life [ Time Frame: every month ]
  2. amount of laxative use [ Time Frame: every week ]
  3. frequency of enema/suppository use/digital maneuver [ Time Frame: every week ]
  4. stool amount [ Time Frame: every week ]
  5. stool consistency [ Time Frame: every week ]
  6. overall efficacy [ Time Frame: 2 month ]
  7. safety (adverse event) [ Time Frame: every week ]
  8. frequency of spontaneous bowel movement [ Time Frame: every week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • men or non-pregnant women who are at least 20 years old
  • who meet any one of the following three criteria: 1.the one who meets RomeIII criteria; 2.at least once a week of enema/suppository in past three months; 3.laxative use in more than half time of last three months

Exclusion Criteria:

  • known colorectal cancer, anal abscess, anal fissure, rectocele, inflammatory bowel disease, megacolon or mechanical bowel obstruction
  • unknown cause of gastrointestinal bleeding or acute infection
  • history of alcohol or drug abuser
  • women who are pregnant, as determined by a urine pregnancy test
  • history of adverse reaction to (electro)acupuncture
  • received herb or acupuncture therapy within one month prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746200

National Taiwan University Hospital, Yun-Lin Branch
Yun-Lin, Taiwan, 640
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Chien-Hsun Huang, MD, MSc National Taiwan University Hospital, Yun-Lin Branch

Responsible Party: Chien-Hsun Huang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00746200     History of Changes
Other Study ID Numbers: 200801047R
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: May 12, 2010
Last Verified: May 2010

Keywords provided by National Taiwan University Hospital:
chronic constipation
randomized controlled trial

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms