Cancer chemoprevention by Metformin Hydrochloride compared to placebo in oral potentially malignant lesions : A randomized clinical trial (part I) /
الوِقايَةٌ الكِيمْيائِيَّة من السرطان بواسطة هيدروكلوريد الميتفورمن مقارنة بالغُفْل في آفات الفم القابلة للتسرطن : دراسة إكلينيكيّة على عينات مختارة عشوائياً - الجزء الأول
Ahmed Adel Mohamed Abdelazim ; Supervised Fatheya Mohamed Zahran , Gihane Gharib Madkor , Heba Ahmed Farrag
- Cairo : Ahmed Adel Mohamed Abdelazim , 2021
- 201 P. : charts , facsimiles ; 25cm
Thesis (Ph.D.) - Cairo University - Faculty of Oral and Dental Medicine - Department of Periodontology
Aim: The aim of this study was to compare the effect of metformin hydrochloride on potentially malignant to placebo regarding its efficacy in regression or suppression of the progress into frank cancer. Methodology: This trial was a multicentre, tripleblind, placebocontrolled, randomized phase II trial. 40 nondiabetic adult patients clinically and histologically diagnosed with OPMD were enrolled into the study. Eligible patients were randomly assigned (1:1) to receive oral met formin (500 mg daily) or identical placebo tablets by a stratified computerbased randomization method for a duration of 3 months. All patients, clinicians, and outcome assessors were masked to drug allocation until the end of the trial. Recommended standard health and dental care were given to both groups.Clinical data, biopsies, immunohistochemical staining of cyclin D1, and RTqPCR quantification of tissue and salivary miRNA21 were performed for all groups at baseline and at three months point. Results: The current study showed that metformin was effective as a cancer chemopreven tive agent in controlling some of the molecular mechanisms that could lead to the the malignant transformation of OPMDs. Clinical lesion size, nuclear expression of cyclin D1, and tissue and salivary levels of cancerassociated miRNA21 showed a statistically significant reduction in the metformin group compared to the placebo group. Cyclin D1 and miRNA21 correlated well to the degree of epithelial dysplasia, while toluidine blue color intensity was of limited value as a prognostic aid in OPMD. miRNA21 demonstrated a positive correlation between tissue and saliva levels, highlighting the emerging role of salivary transcriptomics in the field of OPMDs and oral cancer
Cancer chemoprevention Metformin Hydrochloride Potentially malignant