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

Overview

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

Full Title of Study: “Acupuncture for Functional Bowel Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2014

Detailed Description

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

Interventions

  • Other: acupuncture
    • acupuncture group1, acupoints ST25 and BL25 will be used in this trial.
  • 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: acupuncture group3
    • All acupoints used in acupuncture group1 and group2 will be used in this group.
  • Drug: Loperamide
    • Loperamide will be used in this group for a dose of 2mg a time, three time a day.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • Experimental: acupuncture group 3
    • All acupoints used in acupuncture group1 and acupuncture group2 will be used in this group.
  • Active Comparator: Loperamide
    • Loperamide will be used as an active comparator to the acupuncture groups.

Clinical Trial Outcome Measures

Primary Measures

  • Average weekly stool frequency
    • Time Frame: 4th week after inclusion
    • Average weekly stool frequency, change from baseline in 4 weeks

Secondary Measures

  • Assessment score of Bristol stool scale
    • Time Frame: 4th and 8th week after inclusion
    • 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
  • Assessment score of SF-36 scale
    • Time Frame: 4th and 8th after inclusion
    • 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.
  • Number of patients with adverse events after treatment
    • Time Frame: 4th week after inclusion
    • Number of patients with adverse events after treatment will be recorded and compared among three groups.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chengdu University of Traditional Chinese Medicine
  • Collaborator
    • Guang’anmen Hospital of China Academy of Chinese Medical Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ying Li, MD, PhD, Principal Investigator, Chengdu University of TCM

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