Clinical trial NCT00746200: Acupuncture for Chronic Constipation
Official title: Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Constipation
Keywords: chronic constipation
electroacupuncture
randomized controlled trial
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: score of questionnaire of constipation symptoms
timeFrame: every month
Secondary outcomes:
measure: score of questionnaire of quality of life
timeFrame: every month
measure: amount of laxative use
timeFrame: every week
measure: frequency of enema/suppository use/digital maneuver
timeFrame: every week
measure: stool amount
timeFrame: every week
measure: stool consistency
timeFrame: every week
measure: overall efficacy
timeFrame: 2 month
measure: safety (adverse event)
timeFrame: every week
measure: frequency of spontaneous bowel movement
timeFrame: every week
Other outcomes:
Locations:
city: Yun-Lin
country: Taiwan
facility: National Taiwan University Hospital, Yun-Lin Branch
Study officials:
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Chien-Hsun Huang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available.