Comparison of the effectiveness of anti-anxiety medication (buspirone and sertraline) on anxiety and gastrointestinal symptoms of functional dyspepsia patients

Comparison of the effectiveness of anti-anxiety medication buspirone with sertraline on anxiety and gastrointestinal symptoms of functional dyspepsia patients

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 141 patients. Blocking method will be used for randomization

This study is performed in the hospital of subspecialty gastrointestinal clinics of Birjand city of South Khorasan province. 141 patients are randomly divided into three groups receiving sertraline, buspirone and PPI. Patients' anxiety and clinical symptoms are assessed by the facilitator first, one and three months after the intervention.

Patients will be referred to Birjand gastroenterology clinics in 1400. Inclusion criteria include: consent to participate in the study, not receiving psychological treatment before entering the study, not having other structural or functional gastrointestinal disorders at the same time, keeping the type and amount of drug used during the study if taking drugs, not consuming alcohol And drugs, no psychotic disorder and personality disorder, no risk symptoms such as gastrointestinal bleeding, fever, weight loss, anemia, nocturnal diarrhea, severe heartburn, no other organic disease and exclusion criteria include: having the disorder Simultaneous psychosis or other gastrointestinal disorders are the presence of danger signs in the patient and having complete criteria for personality disorder.

Intervention groups include patients receiving sertraline 50 mg, buspirone 5 mg every 8 hours and control group receiving PPI treatmen (Abidi Pharmaceutical Company, Iran) daily for three months.

Anxiety and clinical signs of patients include: bloating or abdominal distension, bowel movements such as diarrhea or constipation

Participants in the study will be randomly divided into three intervention groups: sertraline (A), buspirone (B) or antispasmodic, and Proton-pump inhibitors (PPI) (C) using the blocking method. First, various triple blocks are created using sealed envelopes (ABC, ACB, BAC, BCA, CAB, CBA). One of these blocks is selected randomly and according to the order mentioned in the selected block, patients will be divided into one of three groups A, B or C. Then randomization is performed for other patients in the same way.

Outcome Evaluator: The study facilitator (medical student) will perform the necessary evaluation without knowing the type of medication received by the patients and will be recorded in a checklist designed for this purpose. Patients: The patients participating in the study are not aware of their group, so the drugs are packaged in the same package and given to patients by the pharmacy. Data Analyzer: Data is coded to a third party (statistics expert) for analysis and the individual is unaware of the grouping.

There is no need to publish individual patient information