Inflammatory Bowel Diseases
Conditions
Keywords
mesotherapy, inflammatory bowel disease
Brief summary
Irritable bowel syndrome (IBS) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. Considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems. Given the complexity of this disease, no treatment has been recognized as standard treatment. The treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). In general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy. Several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. Due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of IBS symptoms.
Interventions
DRUGMesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate
4 sessions of mesotherapy (mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate), with intra-epidermal and intra-hypodermal technics.
Sponsors
Polyclinique de l'Europe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient suffering from Irritable Bowel Syndrome according to the Rome IV criteria, whose diagnosis was made by a specialist in Hepato-Gastro-Enterology, * Francis score \>75/500, i.e. minimal, moderate or severe severity, * Patient who has failed conventional treatment (treatment followed for at least 1 year and not showing an improvement in symptoms) * Absence of risk of ongoing pregnancy in women of childbearing age, validated by a urine test during the first consultation and before treatment and each month during treatment and until 1 month after the end of treatment
Exclusion criteria
* Patient with the following medical history or current pathologies: organic gastrointestinal pathology, disabling neurological pathology, disabling psychiatric pathology * Recent Post Traumatic Stress Syndrome (\<1 year), * Fibromyalgia syndrome, * Known allergy to medications used in mesotherapy treatment, * Pregnant or breastfeeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS) | day 8, day 15, day 30, day 45 | Includes 5 items regarding pain (intensity and number of days), abdominal distention, satisfaction of bowel habit, and interference of daily life of the last 10 d on a 10-point scale. Gives a score between 0 and 500, and groups of severity can be made: mild (≤175), moderate (175-300), and severe (≥300) IBS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Digestive Disorders Quality of Life questionnaire (FDDQL) | day 30, day 45 | 43 items with 8 subscales : daily activity, anxiety, nutrition, sleep, discomfort, health perception, adaptation and impact of stress Global score is between 0 and 100. |
| Pain evaluation | day 8, day 15, day 30, day 45 | Evaluation of pain with a scale from 0 (no pain) to 10 (worst pain imagined) |
| Global satisfaction | day 45 | 4 questions with Likert scale of 5 items, to not at all satisfied to very satisfied |
| Anxiety evaluation : Questionnaire Hospital anxiety and depression scale | day 30, day 45 | 14 items with 7 about depression and 7 about anxiety. Each item is noted with a Likert scale of 4 points, from 0 (no symptoms) to 3 (strong symptoms). |
Countries
France
Outcome results
None listed