The effect of duloxetine on symptoms and quality of life in patients with irritable bowel syndrome with moderate to severe symptoms

The effect of duloxetine on symptoms and quality of life in patients with irritable bowel syndrome with moderate to severe symptoms

Clinical trial with control group with parallel, randomized, phase 3 groups on 40 patients A random number table was used for randomization.

This intervention is performed in Khorshid Hospital in Isfahan. Patients with irritable bowel syndrome are admitted and randomly divided. Intervention group, patients will receive duloxetine and the second group will receive a placebo. Before and one week after the interventions, the level of depression, anxiety and stress, as well as the quality of life of patients and the severity of their disease are measured by special questionnaires.

Inclusion criteria: Men and women aged 18 to 65 years, diagnosis of irritable bowel syndrome by a gastroenterologist, moderate to severe symptoms, informed consent to participate in the study, no depressive disorders, bipolar disorder or Exclusion criteria: diagnosis of any organic disease, failure to take medication regularly, failure to complete a questionnaire, severe side effects, patient request to be excluded from the study

Intervention group: Patients in this group will be treated with duloxetine daily at a target dose of 60 mg per day for three months. The severity of symptoms, quality of life and the level of stress, anxiety and depression of patients are measured by special questionnaires and by a gastroenterologist before and after the interventions and are compared with each other. Control group: Patients in this group will be given placebo capsules daily for three months. The mentioned factors of patients are and by a gastroenterologist before and after the interventions and are compared with each other.

Anxiety, depression and stress and quality of life

Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group . The researcher begins to read the numbers in a predetermined manner and the patients are divided.

Patients are blinded according to the intervention or control treatment groups of the type of drug used. Also, the drugs are prepared in separate containers with numbering and the nurse who used the drug for the patients has no information about its type. Patients are seen by a specialist doctor and evaluated for symptoms and quality of life. Doctors and health evaluators are also unaware of the type of medication used. After collecting information, it enters the software with numbering, and after performing statistical analysis and completing the work, the codes are determined. Until then, the data analyzer and the data safety and monitoring committee do not know the patient groups. .

All data can be shared after people have requested.

Six months after publishing the results

Academic researchers

Scientific uses

Isfahan University of Medical Sciences website

Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.