A New Anxiolitic Approach With Passiflora Incarnata L., Herba In Patients With Irritable Bowel Syndrome And Comorbidy For Mild Anxiety Disorders: A Prospective, Observational, Real-Life Setting Study On 112 Patients

Background: Irritable Bowel Syndrome (IBS) is a common disorder of gut-brain axis interaction associate with significant disease trouble. Visceral pain represents the cardinal symptom of patients with I.B.S. and has been attribuited to the malfunction of the brain-gut axis in the nervous system. A mood-modifier approach has been evaluated in multiple cinical trials on IBS. Our real life setting observational study aiming both to evaluate the activity of a new anxiolitic drug cointaning Passiflora Incarnata L., Herba on visceral pain sensation (abdominal pain) and on quality of stool. Adherence to treatment has also been evaluated in this setting of patients. Methods: One hundred twelve (112) patients diagnosed with IBS according to Rome IV criteria and mild anxiety (Hamilton Anxiety Rating Scale between 8 – 14) have been enrolled in this prospective, real world, open clinical study. Every patient has been treated with two tablets daily (200 mg x 2) of a new drug (TRACTANA™) containing as active principle a dry extract of Passiflora Incarnata L., Herba. All the patients have been treated only with the test drug plus mediterranean diet. Two months after baseline evaluation (VAS for visceral pain and BFSF for stool formation) a second visit has been made to reasses visceral pain and stool formation and to evaluate adherence to treatment. Results: After two months of treatment all the patients returned to the final control visit with a 100% of adherence to treatment. The medium score of BFSF statistically decreased from 4.88 to 4.29 (p<0.006) while visceral pain sensation median value at VAS also statistically decreased from 8.25 to 4.53 (p<0.000). All the patients reported an increase of their well being during the treatment period an no patient withdrawal the study during the treatment period. No patient developed adverse events to the study drug. Conclusion: This real world study suggested that patients affected by IBS according to Rome IV criteria in comorbidity with mild anxiety disorders can improve both quality of stool and visceral pain sensation after two months of treatment with 2 tablets daily of a drug containing as active principle a dry extract of Passiflora Incarnata L., Herba. The adherence to treatment (100% of the patients returned to the final visit after two months), the improvement of well-being and the absence of adverse effects to the treatment seems to point out the role of Passiflora Incarnata L., Herba in the management of IBS patients with mild anxiety disorders. Keywords : Irritable Bowel Syndrome (I.B.S.), Mild Anxiety Disorders, Passiflora Incarnata L., Herba, Bristol Stool Form Scale (BSFS), Abdominal Pain.