A Randomised Double Blind Control Trial of Add-on Duloxetine on Symptom Severity and Quality of Life in Irritable Bowel Syndrome: Protocol of a Proof-of- Concept Study

Background: Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), which has been approved in the United States and Europe for the treatment of the major depressive disorder, generalized anxiety disorder, peripheral neuropathy in patients with diabetes and fibromyalgia, but it has not been approved for the treatment of irritable bowel syndrome. In an open-label study on the duloxetine impact on symptoms of irritable bowel syndrome, duloxetine resulted in significant improvement in the severity of pain, the severity of illness, quality of life, anxiety, and disability at work and life, but this study was conducted on small sample size. This study aims to investigate the effectiveness of duloxetine on Symptom Severity And Quality Of Life In Irritable Bowel Syndrome. Methods: A total of 62 patients will be enrolled in the study and will be randomized into two groups (cases and control). Randomisation will be done using a computer generated random number table. Rome IV Criteria will be applied for diagnosis of Irritable Bowel Syndrome. Informed consent will be taken. Severity will be assessed by IBS Severity Scoring System. Screening for psychiatric disorders will be done following a clinical interview. Diagnosis will be confirmed as per ICD-10. Socio-demographic and clinical details of patients will be recorded on the semi-structured proforma. Specified rating scales (IBS-SSS, IBS-QOL) will be applied appropriately. The clinician can change the dosages as per the tolerability within the range. Control group shall receive treatment as usual only. Both the cases and controls will not be given any other psychotropic medications in addition to Duloxetine during the study period. Both cases and controls shall be assessed on the start of the treatment and by 2nd, 4th and 8th week. Drug adverse effects and compliance to treatment will be evaluated every 2 weeks after starting the treatment. Data obtained will be analysed statistically with appropriate statistical tools. The trial has been registered in the Clinical Trials Registry, India (CTRI/2023/04/051948). Result: After the collection of data, statistical analysis will be done by using a computerized statistical program, Statistical Package for Social Sciences. Mean changes in the rating scale scores will be compared after each assessment and between the groups. Conclusion: The findings will help to assess the efficacy of Add-On Duloxetine On Symptom Severity And Quality Of Life In Irritable Bowel Syndrome