Potential Modulation of Disease Activity Indices and Inflammatory Biomarkers in Patients With Active Inflammatory Bowel Disease on Melatonin Adjuvant Therapy

Abstract

Objective: The objective of this study was to explore the benefits of melatonin supplementation in the active stage of moderate to severe inflammatory bowel diseases (IBDs) as an adjuvant to the standard immunosuppressant and biological targeting therapy in both Crohn's disease (CD) and ulcerative colitis (UC) patients.Methods: This is an interventional prospective randomized controlled, open-label, single-center study was carried out on 50 patients visiting the inpatient biology unite diagnosed as moderate-severe active IBD. Melatonin adjuvant was added to the standard treatment.Results: Disease activity indices showed significant improvement in both diseases after melatonin adjuvant therapy compared to the standard treatment alone (CD −61.80 vs. 36.48%), (UC −74.48% vs. −46.66%) (p<0.01). The erythrocyte sedimentation rate (ESR) level showed higher percent of reduction after melatonin adjuvant in both diseases (p<0.05). CD patients presented with slight reduction in matrix metalloproteinases-9 (MMP-9) level following on melatonin adjuvant therapy compared to standard therapy (p˃0.05). At baseline, a significant correlation between severity scores of both diseases and both ESR and MMP-9 in UC patients, but after treatment, only the ESR level was correlated to the improvement in disease score in CD patients. Conclusion:Melatonin produced marked improvement in the disease activity status in both CD and UC after receiving melatonin adjuvant in active stage of disease, and notable modulation of inflammatory biomarkers with no clear role on MMP-9 expression.