Irritable Bowel Syndrome
Conditions
Keywords
moxibustion, irritable bowel syndrome, Magnetic Resonance Imaging
Brief summary
To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel syndrome and evaluation by Magnetic Resonance Imaging (MRI), Event related potential (ERP).
Detailed description
1. A randomized controlled trial 2. Moxibustion treatment, sham control 3. To observe the safety and efficacy of moxibustion treatment versus placebo control 4. Evaluation by intestinal microbial structural and diversity changes using 16S rDNA sequencing 5. Evaluation by structural MRI and resting state-functional MRI 6. Evaluation by ERP
Interventions
DEVICEmoxibustion
Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral). using mild-warm moxibustion，the surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.
DEVICESham moxibustion
Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral); using sham mild-warm moxibustion，the surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.
Sponsors
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Diarrhea-predominant IBS patients who met the Rome III diagnostic criteria; 2. Age 18-65 years old, male or female; 3. Volunteered for the trial, signed the informed consent
Exclusion criteria
1. Intestinal organic disease; 2. Constipation-predominant IBS; 3. Alternating diarrhea and constipation IBS; 4. Unstructured IBS; 5. At the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine; 6. Combined liver, kidney, heart or mental disease patients; 7. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total efficacy (Adequate relief responder) | Week 6 | The ratio of the number of responders and the total number of participants in each group. Adequate relief responder is the participant who considered effective treatment in the self-assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bristol stool form scale (BSS) | Week 6, 12, 18 and 24 | Differences in the mean changes of BSS score from baseline between groups |
| hospital anxiety and depression score (HADS) | Week 6 | Differences in the mean changes of HADS score from baseline between groups |
| Self-rating anxiety scale (SAS) | Week 6 | Differences in the mean changes of SAS score from baseline between groups |
| Self-rating Depression Scale (SDS) | Week 6 | Differences in the mean changes of SDS score from baseline between groups |
| Diarrhea frequency per day | Week 6, 12, 18 and 24 | Differences in the mean changes of Diarrhea frequency per day from baseline between groups |
| Urgency of defecation | Week 6, 12, 18 and 24 | Differences in the mean changes of Urgency of defecation from baseline |
| Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0) | Week 6, 12, 18 and 24 | Eg.moxibustion related burns, blistering, etc |
| Total efficacy (Adequate relief responder) | Week 12, 18 and 24 | Differences in Adequate relief responder between groups |
| Symptom severity score (SSS) | Week 6, 12, 18 and 24 | Differences in the mean changes of SSS score from baseline between groups |
| The proportion of responder to SSS | Week 6, 12, 18 and 24 | The differences of the proportion of responders between groups. Defined the SSS score decreased more than 50 points from baseline as responder. |
| Quality of life questionnaire (IBS-QOL) | Week 6 | Differences in the mean changes of IBS-QOL score from baseline between groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Magnetic Resonance Spectroscopy (MRS) | Week 6 | The ratio of glutamate complex (Glx) peak area and creatine ratio (Cr) of the cingulate cortex and insula. |
| Event-related potentials (ERP) | Week 6 | Measurement of brain resting state energy atlas and the amplitude changes of each major components during the task and latency. |
| Intestinal microbiota changes | Week 6 | Fecal microbial structural and diversity changes |
| Brain-gut microbiota interaction | Week 6 | Multiple regression analysis to establish the association between intestinal microbiota and brain |
| resting-state functional MRI | Week 6 | Analysis with methods of regional homogeneity，ALFF/fALFF，functional connectivity. |
| Brain structures （gray matter, white matter）MRI | Week 6 | — |
Countries
China
Outcome results
None listed