The impact of silymarin on the symptom severity in pediatric patients with Inflammatory Bowel Disease: A randomized clinical trial

Document Type : original article

Authors

1 Clinical Research Development Unit of Akbar Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

2 Department of Gastroenterology,Faculty of medicine,Mashhad university of medical sciences,Mashhad,Iran

3 Department of Pediatrics, School of Medicine, Akbar hospital, Mashhad University of Medical Sciences, Mashhad, Iran

4 Department of Pediatrics, School of Medicine, Antimicrobial Resistance Research Center, Basic Sciences Research Institute, Akbar hospital, Mashhad University of Medical Sciences, Mashhad, Iran

5 Department of Pediatrics, School of Nursing and Midwifery, Nursing and Midwifery Care Research Center, Akbar hospital, Mashhad University of Medical Sciences, Mashhad, Iran

6 Department of Pharmaceutical Nanotechnology, School of Pharmacy, Nanotechnology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

10.22038/ijp.2023.75325.5373

Abstract

Introduction: Inflammatory bowel disease (IBD) is a multifactorial disease, posing significant challenges to public health. The aim of this study is to determine the effect of silymarin on the symptom severity in pediatric patients with IBD.

Methods & Materials: This randomized clinical trial study was conducted on children aged 5-18 diagnosed with IBD referred to the GI clinic at Akbar Children's Hospital in Mashhad. Those who met the inclusion criteria were randomly allocated into either the intervention group or placebo group, with each group consisting of 20. In the intervention group, silymarin were administered three times daily at divided doses for three months. The control group received a placebo. To assess the efficacy of silymarin, PUCAI and PCDAI were evaluated for all patients at three different time points: before the intervention, during the first visit, and after the intervention. Data were analyzed utilizing the SPSS version 25, with a significance level set at p < 0.05.

Results: The comparison of the disease activity index scores in patients with IBD between the silymarin and placebo groups revealed during the initial evaluation, no significant difference was observed in the disease activity index score between the two groups before the intervention (p>0.05). However, a statistically significant difference was observed in the disease activity index score between the two groups during the second, and third evaluations (p<0.05).

Conclusion: The findings indicate that silymarin has a significant effect on alleviating the symptom severity in pediatric patients with IBD.

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