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CLINICAL TRIAL article

Front. Med.
Sec. Ophthalmology
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1359463

Effect of Low Dose Honey on the Apoptosis and Inflammation Gene Expression in Corneal Limbal Stem Cells and Keratocytes and Its Efficacy as an Ophthalmic Formulation in the Treatment of Dry Eye: In-Vitro and Clinical Study Provisionally Accepted

 Fatemeh Sanie-Jahromi1 Mehdi Khaki1  Mojtaba Heydari1  Mohammad H. Nowroozzadeh1 Amin Reza Akbarizadeh1 Saeid Daneshamouz1 Yaser NejatyJahromy1 Maryam Nejabat1  Ahmad Mahmoudi1 Athar Zareei1 Mahmood Nejabat1*
  • 1Shiraz University of Medical Sciences, Iran

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Background: The use of honey as an eye treatment encounters challenges due to its high osmolarity, low pH, and difficulties in sterilization. This study addresses these issues by employing a low concentration of honey, focusing on both in-vitro experiments and clinical trials for treating dry eye disease in corneal cells.
Methods: In the in-vitro experiment, we investigated the impact of a 1% honey-supplemented medium (HSM) on limbal stem cells (LSCs) and keratocytes using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-2H-tetrazolium bromide (MTT) assay and real-time Polymerase chain reaction (PCR) for BCL-2, BAX, and IL-1β gene expression. Simultaneously, in the clinical trial, 80 participants were divided into two groups, receiving either a 1% w/v honey ophthalmic formulation or a placebo for 3 months. Study outcomes included subjective improvement in dry eye symptoms, tear break-up time (TBUT), and Schirmer’s test results.
Results: MTT results indicated that 1% HSM did not compromise the survival of corneal cells and significantly reduced the expression of the IL-1β gene. Additionally, participants in the honey group demonstrated a higher rate of improvement in dry eye symptoms and a significant enhancement in TBUT values at the three-month follow-up. However, there was no significant difference between the study groups in terms of Schirmer's test values. No adverse events were observed or reported.
Conclusion: In conclusion, 1% honey exhibits anti-inflammatory and anti-infective properties, proving effective in ameliorating dry eye symptoms and enhancing tear film stability in patients with dry eye disease.

Keywords: dry eye, Honey, Apoptosis, Inflammation, Corneal limbal stem cell, keratocytes BAX: Bcl-2-associated X protein Bcl-2: B-cell lymphoma 2 HSM: Honey-supplemented-medium IL: Interleukin LSC: Limbal stem cells MTT: 3-(4, 5-dimethylthiazol-2-yl)-2, 5-diphenyl-2H-tetrazolium bromide PCR: Polymerase chain reaction

Received: 21 Dec 2023; Accepted: 29 Apr 2024.

Copyright: © 2024 Sanie-Jahromi, Khaki, Heydari, Nowroozzadeh, Akbarizadeh, Daneshamouz, NejatyJahromy, Nejabat, Mahmoudi, Zareei and Nejabat. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Dr. Mahmood Nejabat, Shiraz University of Medical Sciences, Shiraz, Iran