Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

May 6, 2021 updated by: zheng hui, Chengdu University of Traditional Chinese Medicine

Acupuncture in Addition to Usual Care for the Treatment of Refractory Irritable Bowel Syndrome: a Randomized Controlled Trial

The trial aims to examine the efficacy and safety of acupuncture in the treatment of refractory irritable bowel syndrome (IBS). The investigators will include 170 participants to receive acupuncture plus usual care or sham acupuncture plus usual care. Twelve sessions of acupuncture will be delivered to participants over a period of 4 weeks. The primary outcome is defined as proportion of participants with adequate relief of global IBS symptoms at week 8, which is defined as >50% reduction in IBS-SSS scale.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610075
        • Recruiting
        • Hospital of Chengdu University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18-70 years (either sex);
  • Fulfilled Rome IV criteria for IBS;
  • Patients with normal occult blood in stool in recent one month;
  • The age is above 50, the results of colonoscopy are normal in near year;
  • Symptoms are present for ≥12 months;
  • There is an absence of response to a minimum of 6 weeks of dietary intervention or advice;
  • There is an absence of response to an adequate dose of at least one conventional pharmacological agent tried for a minimum of 6 weeks;
  • Signed the written informed consent form.

Exclusion Criteria:

  • Previous colonoscopy, meal barium fluoroscopy, abdominal ultrasound and other examinations found severe intestinal organic lesions (including but not limited to ulcerative colitis, familial multiple intestinal polyps, colorectal cancer patients);
  • The presence of one or more of the following warning symptoms: unexplained rectal bleeding, a positive faecal occult blood test result; anaemia, abdominal mass, ascites, fever, and emaciation;
  • The presence of other severe medical conditions, such as cardiovascular disease, endocrine disorders, hepatic dysfunction, renal diseases, and cognitive disorders that can affect the outcome assessment results;
  • Unconscious, unable to express subjective symptoms of discomfort and clearly diagnosed severe mental disorders;
  • An unstable psychological state or accompanying psychological disorders (SDS>56);
  • With pregnancy or lactation;
  • Accepting acupuncture treatment in the last 3 months;
  • Difficulties in attending the trial, such as fear of acupuncture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture plus usual care
Acupuncture will be given on the basis of usual care. A total of 12 sessions of acupuncture will be given over a period of 4 weeks.
Other: Acupuncture
Acupuncture will be given for a total of 12 session over 4 weeks. Acupuncture at acupoints Tianshu (ST25), Shangjuxu (ST37), Zusanli (ST36), and Neiguan (PC6) bilaterally will be given.
Sham Comparator: Sham acupuncture plus usual care
Sham acupuncture refers to acupuncture at sham points. Sham acupuncture will be given on the basis of usual care. A total of 12 sessions of sham acupuncture will be given over a period of 4 weeks.
Other: Acupuncture
Acupuncture will be given for a total of 12 session over 4 weeks. Acupuncture at acupoints Tianshu (ST25), Shangjuxu (ST37), Zusanli (ST36), and Neiguan (PC6) bilaterally will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of participants with adequate relief of global IBS symptoms
Time Frame: 4 weeks after randomization (week 4)
Adequate relief of global IBS symptoms will be defined as a >50% reduction in the IBS symptom severity scale (IBS-SSS).
4 weeks after randomization (week 4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBS symptom severity scale
Time Frame: Baseline (week 0), week 2, 4, 6, 8
The IBS symptom severity scale (IBS-SSS) has a total of 500 points. The score ranges from 0 to 500; higher scores indicating more severe symptoms; a score over 300 indicates severe symptoms.
Baseline (week 0), week 2, 4, 6, 8
Weekly bowel movements
Time Frame: Baseline (week 0), week 2, 4, 6, 8
The total number of bowel movements in a week.
Baseline (week 0), week 2, 4, 6, 8
Work and Social Adjustment Scale
Time Frame: Baseline (week 0), week 2, 4, 6, 8
The Work and Social Adjustment Scale (WSAS) measures the effect of IBS on ability to work and manage at home, participate in social and private leisure activities and maintain relationships. It has five domains scored 0 (not affected) to 8 (severely affected), with a total possible score of 40.
Baseline (week 0), week 2, 4, 6, 8
Irritable Bowel Syndrome Quality of Life Instrument
Time Frame: Baseline (week 0), week12, and month12
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) is a condition-specific measure for assessing health-related QoL among persons with irritable bowel syndrome. The IBS-QOL had eight subscales. The IBS-QOL and its subscales were both scored on a range of 0-100 with higher scores suggestive of better QOL.
Baseline (week 0), week12, and month12
Bristol Stool Form Scale
Time Frame: Baseline, weeks 2, 4, 6 and 8.
The Bristol Stool Form Scale is a tool that is used for the assessment of stool consistency. Scores 1-2 indicate constipation, scores 3-5 indicate normal stool; scores 6-7 indicate diarrhea.
Baseline, weeks 2, 4, 6 and 8.
Self-Rating Anxiety Scale (SAS)
Time Frame: Baseline, weeks 2, 4.
The SAS is a self rating scale for the assessment of the severity of anxiety.
Baseline, weeks 2, 4.
Self-Rating Depression Scale (SDS)
Time Frame: Baseline, weeks 2, 4.
The SDS is a self rating scale for the assessment of the severity of depression.
Baseline, weeks 2, 4.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with adverse events
Time Frame: Week 4 and 12
Side effect of acupuncture or sham acupuncture will be recorded.
Week 4 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Collaborators

Beijing University of Chinese Medicine

Investigators

  • Principal Investigator: Zhi-Gang Li, MD, Beijing University of Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019YFC1709004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Conditional share, the principle investigator will ask for the reasons to use the data.

IPD Sharing Time Frame

After the completing the study for 2 years

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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