Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

Not Applicable

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Acupuncture

• Registration Number: NCT04276961
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-19
• Study Start: 2020-10-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10
• Primary Completion: 2021-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham acupuncture plus usual care	Acupuncture	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.
Acupuncture plus usual care	Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
The proportion of participants with adequate relief of global IBS symptoms	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).

Secondary Outcome Measures

Name	Time	Method
IBS symptom severity scale	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.
Self-Rating Depression Scale (SDS)	Baseline, weeks 2, 4.	The SDS is a self rating scale for the assessment of the severity of depression.
Weekly bowel movements	Baseline (week 0), week 2, 4, 6, 8	The total number of bowel movements in a week.
Irritable Bowel Syndrome Quality of Life Instrument	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.
Self-Rating Anxiety Scale (SAS)	Baseline, weeks 2, 4.	The SAS is a self rating scale for the assessment of the severity of anxiety.
Bristol Stool Form Scale	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.
Work and Social Adjustment Scale	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.

Trial Locations

Locations (1)

Hospital of Chengdu University of Traditional Chinese Medicine; 🇨🇳 Chengdu, Sichuan, China