Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture plus usual care<br>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<br>* 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.<br>|
| Sham Comparator: Sham acupuncture plus usual care<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS symptom severity scale | 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 | The total number of bowel movements in a week. | Baseline (week 0), week 2, 4, 6, 8 | 
| Work and Social Adjustment Scale | 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 | 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 | 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) | The SAS is a self rating scale for the assessment of the severity of anxiety. | Baseline, weeks 2, 4. | 
| Self-Rating Depression Scale (SDS) | The SDS is a self rating scale for the assessment of the severity of depression. | Baseline, weeks 2, 4. |