Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04276961
• Other study ID #: 2019YFC1709004
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2021
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: Min Chen, MD, PhD
• Phone: 028-87765705
• Email: cm[@]cdutcm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine	Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of participants with adverse events	Side effect of acupuncture or sham acupuncture will be recorded.	Week 4 and 12
Primary	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	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
Secondary	Weekly bowel movements	The total number of bowel movements in a week.	Baseline (week 0), week 2, 4, 6, 8
Secondary	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
Secondary	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
Secondary	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.
Secondary	Self-Rating Anxiety Scale (SAS)	The SAS is a self rating scale for the assessment of the severity of anxiety.	Baseline, weeks 2, 4.
Secondary	Self-Rating Depression Scale (SDS)	The SDS is a self rating scale for the assessment of the severity of depression.	Baseline, weeks 2, 4.