Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

NCT04276961 | Unknown DMC

• 1 other identifier: 2019YFC1709004
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• The proportion of participants with adequate relief of global IBS symptoms

  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 Outcomes (7)

• IBS symptom severity scale

  Baseline (week 0), week 2, 4, 6, 8

• Weekly bowel movements

  Baseline (week 0), week 2, 4, 6, 8

• Work and Social Adjustment Scale

  Baseline (week 0), week 2, 4, 6, 8

• Irritable Bowel Syndrome Quality of Life Instrument

  Baseline (week 0), week12, and month12

• Bristol Stool Form Scale

  Baseline, weeks 2, 4, 6 and 8.

Other Outcomes (1)

• Proportion of participants with adverse events

  Week 4 and 12

Study Arms (2)

Acupuncture plus usual care

EXPERIMENTAL

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

Sham acupuncture plus usual care

SHAM COMPARATOR

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

Interventions

Acupuncture OTHER

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.

Acupuncture plus usual care; Sham acupuncture plus usual care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead
• Beijing University of Chinese Medicine: collaborator

Study Sites (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

RECRUITING

Related Publications (1)

• Zhao J, Chen M, Wang X, Ye K, Shi S, Li H, Wang J, Chen X, Ni J, Wei Q, Shi Y, Hu Y, Sun J, Li D, Liu S, Li Z, Zheng H, Yu SG. Efficacy of acupuncture in refractory irritable bowel syndrome: study protocol for a randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e045655. doi: 10.1136/bmjopen-2020-045655.

  PMID: 34518248 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Zhi-Gang Li, MD

  Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Chen, MD, PhD

CONTACT

028-87765705; cm@cdutcm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 19, 2020
• Study Start: October 15, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the completing the study for 2 years

Locations

CN (1)