Acupuncture for Chronic Constipation

NCT ID: NCT00746200

Last Updated: 2010-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-05-31

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.

Conditions

Chronic Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

Group Type: EXPERIMENTAL

(electro)acupuncture

Intervention Type: PROCEDURE

Frequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min;

S

Group Type: SHAM_COMPARATOR

sham acupuncture

Intervention Type: PROCEDURE

Superficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds

Interventions

(electro)acupuncture

Frequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min;

Intervention Type: PROCEDURE

sham acupuncture

Superficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds

Intervention Type: PROCEDURE

Other Intervention Names

electroacupuncture

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Hospital

Principal Investigators

Chien-Hsun Huang, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, Yun-Lin Branch

Locations

National Taiwan University Hospital, Yun-Lin Branch

Douliu, , Taiwan

Countries

Taiwan

References

Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available.

Reference Type: BACKGROUND

PMID: 14523145 (View on PubMed)

Other Identifiers

200801047R

Identifier Type: -

Identifier Source: org_study_id