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Effects of Topical Vitamin E Mouthwash in Preventing Oral Mucositis in Allogenic Hematopoietic Stem Cell Transplant Patients: A Double-Blind, Placebo-Controlled Trial



Solduzian M1 ; Babaei MH2, 3 ; Goodarzi N4 ; Honarmand H2 ; Shabanir N5 ; Motlagh ZL2 ; Taghvayemasoumi H6 ; Jahangardrafsanjani Z2 ; Zadeh HK7 ; Sadeghi K2
Authors
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Authors Affiliations
  1. 1. Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Science, Tabriz, Iran
  2. 2. Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Science, Tehran, Iran
  3. 3. Research Center for Rational Use of Drugs, Tehran University of Medical Science, Tehran, Iran
  4. 4. Nanotechnology Research Centre, Tehran University of Medical Sciences, Tehran, Iran
  5. 5. Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
  6. 6. Department of Clinical Pharmacy, Faculty of Pharmacy, Guilan University of Medical Science, Guilan, Iran
  7. 7. Hematology-Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran

Source: Iranian Journal of Blood and Cancer Published:2021

Abstract

Background: Oral mucositis is considered a frequent complication of conditioning regimen in patients undergoing hematopoietic stem cell transplantation (HSCT). Mucositis develops due to direct and indirect damage to the epithelial cells and production of reactive oxygen species (ROS). Vitamin E has shown positive effects in reducing production of ROS or improving its elimination. The aim of this study was to evaluate the effects of vitamin E mouthwash in lowering the incidence and severity of acute mucositis in patients undergoing allogenic HSCT. Methods: The current study was designed as a double bind, placebo controlled randomized clinical trial. Eighty patients were randomized in a 1 to 1 method to receive either placebo or vitamin E mouthwash. Patients in vitamin E group received 400 International Units of vitamin E in form of mouthwash twice daily and placebo group received a mouthwash with equal composition but without vitamin E, starting the day of the chemotherapy initiation and continuing it for 14 days. Results: Vitamin E mouthwash effectively reduced the duration of oral mucositis compared to placebo (P-value 0.02). The difference between placebo and vitamin E groups in terms of mucositis severity did not reach statistical significance (P=0.35). No difference in length of hospital stay was observed (P=0.46). Conclusion: Vitamin E mouthwash could effectively reduce the duration of oral mucositis in allogenic HSCT patients. Further studies are required to show the effects of topical vitamin E in preventing the development of oral mucositis. © 2021, Iranian Pediatric Hematology and Oncology Society. All rights reserved.