Open Access Journal of Clinical Trials (Dec 2022)
Randomized Clinical Trial Comparing Insulin Fast Dissolving Films versus Control Group for Anosmic Patients for Improving Their Health and Social Qualities of Life
Abstract
Soad A Mohamad,1 Sara Mesbah Sayed,2 Ahmed A Sadek,3 Ahmed M Badawi3 1Department of Pharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, Deraya University, Minya, Egypt; 2Department of Occupational Medicine and Public Health, Faculty of Medicine, Minia University, Minya, Egypt; 3Department of Otorhinolaryngology, Faculty of Medicine, Minia University, Minia, EgyptCorrespondence: Soad A Mohamad, Department of Pharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, Deraya University, Minia, 61519, Egypt, Tel +1003621641, Email [email protected]: Olfactory anomalies are the most common diseases among post-COVID-19 disorders. Only 15% of patients completed their prescribed treatment plans, even though several different treatment strategies were recommended; this had a detrimental effect on the patients’ physical, social, and emotional wellbeing.Purpose: The aim of this study was approving intranasal fast-dissolving insulin films as the treatment of choice for anosmia in comparison to the control group, and the innovative treatment for anosmic post-COVID-19 is assessed in terms of the patients’ health-related quality of life (HRQoL).Methods: For therapy and evaluation, a randomized clinical trial with forty adult anosmic post-viral patients was performed. The recruited participants were recruited between October 1 and March 8 of 2021 based on predetermined criteria. A validated smell assessment questionnaire concerning the participants’ olfactory, physical, and psychological outcomes was given to them. Recruited patients were randomly subdivided into two groups: intervention and control group. Intervention was treated with insulin intranasal films, while control group took plain films (placebo).Results: The physical, emotional, and social health quality of life were significantly (p-value < 0.0001) improved after 4 consecutive weeks of treatment with the intervention group compared to the control group. The data were analyzed statistically with the aid of GraphPad Prism 9.1.0.Conclusion: The lowest HRQoLs, which significantly impact their quality of life, are found in post-COVID-19 anosmic patients treated with insulin films. It is advised to employ this new intervention (insulin films) as the main therapy approach and to gather additional industry data for its development and dissemination. Problems with self-hygiene, eating, sense of danger and emotional satisfaction were significantly enhanced with insulin intervention versus placebo.Keywords: anosmia, post-COVID syndromes, insulin, health-related quality of life, intranasal fast dissolving film, treatment outcomes
