Acupuncture for Chronic Constipation

Phase 3

Completed

• Conditions: Chronic Constipation
• Interventions: Procedure: (electro)acupuncture; Procedure: sham acupuncture

• Registration Number: NCT00746200
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2008-08-31
• Study First Submitted QC: 2008-08-31
• Study First Posted: 2008-09-03
• Study Start: 2008-10
• Primary Completion: 2010-04
• Status Verified: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2010-05-10
• Last Update Posted: 2010-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	(electro)acupuncture	-
S	sham acupuncture	-

Primary Outcome Measures

Name	Time	Method
score of questionnaire of constipation symptoms	every month

Secondary Outcome Measures

Name	Time	Method
score of questionnaire of quality of life	every month
amount of laxative use	every week
frequency of enema/suppository use/digital maneuver	every week
stool amount	every week
stool consistency	every week
overall efficacy	2 month
safety (adverse event)	every week
frequency of spontaneous bowel movement	every week

Trial Locations

Locations (1)

National Taiwan University Hospital, Yun-Lin Branch; 🇨🇳 Yun-Lin, Taiwan