ABSTRACT
Background
Brain tissue in Alzheimer's patients is exposed to oxidative stress. Silymarin is an adjunct drug that has anti-inflammatory and antioxidant properties.
Objective
This study aimed to evaluate the effect of silymarin on biomarkers of oxidative stress, inflammation, and disease severity in Alzheimer's patients.
Methods
This randomized, single-blind clinical trial study was performed on 33 patients with Alzheimer's disease (AD) whose disease was confirmed by DSM-5 criteria and by brain imaging. Patients in the case group received three 250 mg silymarin capsules daily (each containing 150 mg silymarin), as an adjunctive medication in addition to the routine medication regimen. In the placebo group (control), patients received the same amount of placebo. All patients underwent Mini Mental State Exam (MMSE) and a panel of blood tests including malondialdehyde, neopterin, catalase, paraoxonase-1, total oxidative status, and total antioxidant capacity to reevaluate the changes pre/postintervention at the end of the trimester.
Results
The catalase and MDA serum levels after the adjunctive silymarin treatment decreased significantly (Catalasebefore silymarin = 9.29 ± 7.02 vs Catalaseafter silymarin = 5.32 ± 2.97, p = 0.007 and MDAbefore silymarin = 4.29 ± 1.90 vs MDAafter silymarin = 1.66 ± 0.84, p < 0.001) while MMSE increased notably (MMSEbefore silymarin = 10.39 ± 6.42 vs MMSEafter silymarin = 13.37 ± 6.81, p < 0.001).
Conclusion
Silymarin can be effective as an adjunct drug and a powerful antioxidant in reducing oxidative stress and improving the course of AD.
Acknowledgements
This work was performed in partial fulfillment of the requirements for the Pharm.D thesis of Seyed Mohammad Navabi, in the School of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran. The authors gratefully acknowledge the Research Council of Kermanshah University of Medical Sciences (Grant Number: 97436) for financial support.
Author contributions
All authors contributed to the study conception and design. Material preparation, data collection, and lab works were performed by Seyed Mohammad Navabi, Daniel Elieh-Ali-Komi, Daryoush Afshari, Farjam Goudarzi, Ehsan Mohammadi-Noori, and Kiana Heydari. Data analysis was performed by Fatemeh Heydarpour and Amir Kiani. The first draft of the manuscript was written by Daniel Elieh-Ali-Komi and Amir Kiani. Daniel Elieh-Ali-Komi generated figures and graphs.
Ethics approval statement
The study was done according to the ethical committee of Kermanshah University of Medical Sciences (IR.KUMS.REC.1397.350).
Consent to participate
Informed consent to participate in the study was obtained from participants.
Consent for publication
Informed consent to publishing the results was obtained from participants.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Data availability statement
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Additional information
Funding
Notes on contributors
Seyed Mohammad Navabi
Seyed Mohammad Navabi As a member of the Students Research Committee at Kermanshah University of Medical Sciences, Seyed Mohammad does research on drug toxicity and oxidative stress.
Daniel Elieh-Ali-Komi
Daniel Elieh-Ali-Komi (Ph.D. candidate), is a researcher in the field of allergy and immunology at Charite Medical University, Berlin. He is the sole writer of the book “Evolutionary History of Immunology”. He has authored over 55 publications on mast cell biology. His background is immunology but has years of experience in Electronics and Egyptology.
Daryoush Afshari
Daryoush Afshari (MD), Neurologist, at the Neurology Department of Kermanshah University of Medical Science with more than 30 years of research in neurological disorders.
Farjam Goudarzi
Farjam Goudarzi serves as an assistant professor of clinical biochemistry at Kermanshah University of Medical Sciences. He does research mostly on regenerative medicine with a focus on wound healing, wound dressing, and adhesive hydrogels.
Ehsan Mohammadi-Noori
Ehsan Mohammadi-Noori is a member of the Students Research Committee at Kermanshah University of Medical Sciences and his fields of interest are molecular genetics and Oxidative stress.
Kiana Heydari
Kiana Heydari (Pharm. D), serves as a medical advisor and patient support consultant in public health and neurological diseases with medicoMarketing project management in pharma.
Fatemeh Heydarpour
Fatemeh Heydarpour (Ph.D. in epidemiology), serves as the assistant professor at the Department of Epidemiology Faculty of Public Health (Kermanshah University of Medical Sciences). She is interested in performing research on the effectiveness of herbal drugs in the treatment of cancer.
Amir Kiani
Amir Kiani Serving as a Professor of toxicology, Amir's fields of interest include but are surely not limited to oxidative stress, neurobiology, herbal medicine, and enzymology. He has a piling up number of registered patents mostly on translational medicine and is an Iranian well-known Innovative researcher.