Acupuncture for Chronic Constipation

Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation

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.

Study Overview

• Status: Completed
• Conditions: Chronic Constipation
• Intervention / Treatment: Procedure: (electro)acupuncture; Procedure: sham acupuncture

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
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Yun-Lin, Taiwan, 640
    • National Taiwan University Hospital, Yun-Lin branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
score of questionnaire of constipation symptoms	every month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chien-Hsun Huang, MD, MSc, National Taiwan University Hospital, Yun-Lin branch

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: August 31, 2008
• First Submitted That Met QC Criteria: August 31, 2008
• First Posted (Estimate): September 3, 2008

Study Record Updates

• Last Update Posted (Estimate): May 12, 2010
• Last Update Submitted That Met QC Criteria: May 10, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: randomized controlled trial; electroacupuncture; chronic constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 200801047R