Acupuncture for Chronic Constipation

Chronic Constipation Clinical Trial

Official title:

Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746200
• Other study ID #: 200801047R
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2008
• Last updated: May 10, 2010
• Start date: October 2008
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Procedure:
• (electro)acupuncture
Frequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min;
• sham acupuncture
Superficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Yun-Lin Branch	Yun-Lin

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	score of questionnaire of constipation symptoms		every month	No
Secondary	score of questionnaire of quality of life		every month	No
Secondary	amount of laxative use		every week	No
Secondary	frequency of enema/suppository use/digital maneuver		every week	No
Secondary	stool amount		every week	No
Secondary	stool consistency		every week	No
Secondary	overall efficacy		2 month	No
Secondary	safety (adverse event)		every week	Yes
Secondary	frequency of spontaneous bowel movement		every week	No