Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial

Acupuncture for Functional Bowel Disease

This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control.

Study Overview

• Status: Completed
• Conditions: Diarrhea-predominant Irritable Bowel Syndrome; Functional Diarrhea
• Intervention / Treatment: Other: acupuncture; Other: acupuncture group2; Other: acupuncture group3; Drug: Loperamide

Detailed Description

Outcome measurements:

The frequency of bowel movement; The bristol stool scale; SF-36 evaluation

• Study Type: Interventional
• Enrollment (Actual): 449
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610075
      • First affiliated hospital of Chengdu university of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosed as diarrhoea-predominant irritable bowel syndrome according to Rome III criteria;
2. Age between 18 and 65 years old;
3. Did not take any medicine for bowel symptoms and attend other clinical research;
4. Have inform consent signed.

Exclusion Criteria:

1. Diarrhea caused by diseases such as infection, etc.
2. Patients can't express himself clearly or with mental diseases;
3. Tumor and other infectious diseases;
4. With other serious diseases of Cardiovascular, liver, kidney, digestive or blood system; Pregnant women or planned to be pregnant.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture group 1; Acupoints ST25 and BL25 will be used in the group. ST25 locate at the abdomen, while BL25 locate at the back.	Other: acupuncture; acupuncture group1, acupoints ST25 and BL25 will be used in this trial.; Other Names: Acupuncture at Shumu acupoints
Experimental: acupuncture group 2; Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.	Other: acupuncture group2; Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.; Other Names: Acupuncture at He acupoints
Experimental: acupuncture group 3; All acupoints used in acupuncture group1 and acupuncture group2 will be used in this group.	Other: acupuncture group3; All acupoints used in acupuncture group1 and group2 will be used in this group.; Other Names: Acupuncture at Shumu and He acupoints
Active Comparator: Loperamide; Loperamide will be used as an active comparator to the acupuncture groups.	Drug: Loperamide; Loperamide will be used in this group for a dose of 2mg a time, three time a day.; Other Names: Luopaidingan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average weekly stool frequency	Average weekly stool frequency, change from baseline in 4 weeks	4th week after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment score of Bristol stool scale	Bristol stool scale was designed to classify the human stool into 7 categories. The seven types of stool are: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid	4th and 8th week after inclusion
Assessment score of SF-36 scale	The Short Form (36) Health Survey (SF-36) is a survey of patient health. The SF-36 is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The chinese version of SF-36 was validated and has been widely used in acupuncture studies.	4th and 8th after inclusion
Number of patients with adverse events after treatment	Number of patients with adverse events after treatment will be recorded and compared among three groups.	4th week after inclusion

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Collaborators: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Ying Li, MD, PhD, Chengdu University of TCM

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 6, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimate): May 10, 2011

Study Record Updates

• Last Update Posted (Estimate): April 10, 2015
• Last Update Submitted That Met QC Criteria: April 9, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: IBS; acupuncture; loperamide; functional diarrhea
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Diarrhea; Gastrointestinal Agents; Loperamide; Antidiarrheals
• Other Study ID Numbers: 2011CB5200-Fd