Functional symptoms in UC patients in remission: a comparison of two antidepressants, Gabapentin and paroxetine, in the alleviating of functional gastrointestinal symptoms, psychological symptoms and quality of life

Comparison of gabapentin and paroxetine in alleviating functional gastrointestinal symptoms, psychological symptoms, and quality of life in UC patients who are in remission

This study will be conducted with parallel groups, one side blind in phase 3 on 100 patients. Patients will be randomly divided into two groups

This is a single-blind study on 100 UC patients who are recovering based on laboratory (normal stool calprotectin and CRP), endoscopy (zero Mayo) and clinical diagnosis (absence of abdominal cramps and bowel movements less than 6 times a day). will be done. But they have digestive functional symptoms such as bloating, abdominal pain, functional constipation, etc. Before starting the intervention, patients will complete questionnaires on quality of life, anxiety and depression, IBS symptoms and IBD symptoms. Then the patients are randomly divided into two groups of 50 people. Paroxetine (20 mg - flexible) - Exir - is prescribed to the first group and gabapentin (100 mg BD - flexible) - Exir - to the second group. 45 days after the start of treatment, patient's adherence to medication is followed up by phone calls. After the completion of the treatment period (3 months), the patients will be examined again with the mentioned questionnaires.

inclusion: patients with functional gastrointestinal disorder exclusion: Coexistence of gastrointestinal problems other than UC, Drug sensitivity, gfr<30 in the gabapentin group, serotonin syndrome in the paroxetine group

The first group: patients receiving paroxetine at a dose of 20 mg The second group: patients receiving gabapentin at a dose of 100 mg

Treatment of gastrointestinal functional symptoms, quality of life, anxiety and depression

Patients are assigned to two groups using the random block method. The number of blocks will be 22 and in each block two, four or six patients according to the order of entry are studied. Random allocation of blocks of patients to two treatment groups receiving paroxetine and receiving gabapentin It will be done through Sealed Envelope online software. With reference to the site https://www.sealedenvelope.com/simple-randomiser/v1/lists By specifying the total number of samples, the number of possible samples in each random block (2, 4 and 6 patients), randomization is performed by online software. For example, like the following output: block identifier block size sequence within block treatment 1 2 1 Group B 1 2 2 Group A 2 4 1 Group A 2 4 2 Group B 2 4 3 Group B 2 4 4 Group A 3 2 1 Group A 3 2 2 Group B ... which is the block number, the number of patients in the block, and the random assignment of each patient (with the corresponding number) to the treatment group. The randomized list of blocks will be placed in sealed envelopes and will be provided to the gastroenterologist on a daily basis.

To prevent abuse, the researcher investigating the results and the data analyst are not aware of the allocation of the groups.

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Statistical analysis map, study design, clinical study report and codes used in the analysis will be made available

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