Acupuncture for Chronic Constipation

National Taiwan University Hospital80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Constipation

Interventions

(electro)acupuncturePROCEDURE

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

sham acupuncturePROCEDURE

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

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

Outcomes

Primary Outcomes

score of questionnaire of constipation symptoms

Time frame: every month

Secondary Outcomes

score of questionnaire of quality of life

Time frame: every month

amount of laxative use

Time frame: every week

frequency of enema/suppository use/digital maneuver

Time frame: every week

stool amount

Time frame: every week

stool consistency

Time frame: every week

overall efficacy

Time frame: 2 month

safety (adverse event)

Time frame: every week

frequency of spontaneous bowel movement

Time frame: every week

Data from ClinicalTrials.gov

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