Efficacy of clotrimazole for the management of oral candidiasis: A meta-analysis of randomized clinical trials

Thamer A Almangour; Keith S Kaye; Mohammed Alessa; Khalid Eljaaly; Fadilah Sfouq Aleanizy; Aynaa Alsharidi; Fahad M Al Majid; Naif H Alotaibi; Abdullah A Alzeer; Faris S Alnezary; Abdullah A Alhifany

doi:10.1016/j.jsps.2021.03.003

Efficacy of clotrimazole for the management of oral candidiasis: A meta-analysis of randomized clinical trials

Saudi Pharm J. 2021 Apr;29(4):315-323. doi: 10.1016/j.jsps.2021.03.003. Epub 2021 Mar 24.

Authors

Affiliations

¹ Department of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
² Director of Clinical Research, Division of Infectious Diseases, University of Michigan Medical School, 5510A MSRB I, SPC 5680, 1150 W. Medical Center Drive, Ann Arbor, MI 48109-5680, United States.
³ Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
⁴ Pharmacy College, University of Arizona, Tucson, AZ, United States.
⁵ Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 22452, Riyadh 11495, Saudi Arabia.
⁶ Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, King Saud University, PO Box 7805, Riyadh 11472, Saudi Arabia.
⁷ Department of Clinical and Hospital Pharmacy, College of Pharmacy, Taibah University, Medinah, Saudi Arabia.
⁸ University of Houston College of Pharmacy, Pharmacy Practice and Translational Research, 4901 Calhoun Rd #3044, Houston, TX 77204, United States.
⁹ Department of Clinical Pharmacy, College of Pharmacy, Umm Al-Qura University P.O. Box 13578 Makkah 21955, Saudi Arabia.

Abstract

Purpose: To assess the efficacy and safety of topical application of clotrimazole versus others in the treatment of oropharyngeal candidiasis (OPC).

Method: Four electronic databases, registries of ongoing trials, and manual search were used to identify randomized controlled trials (RCTs) that compared the efficacy of clotrimazole to other antifungal agents in patients who were clinically diagnosed with oral candidiasis up to November 1st, 2019. Primary outcomes were clinical response and mycological cure rates. Secondary outcomes include relapse rate, incidence of systemic infections, and compliance. Adverse effects were also evaluated.

Results: Sixteen RCTs with a total of 1685 patients were included. Half of the eligible studies were considered at high risk of performance bias and more than a third, at high risk of reporting bias. Our analysis showed no significant difference in clinical response between clotrimazole and all other antifungal agents. However, clotrimazole was less effective in terms of mycologic cure and relapse rate. Sensitivity analysis comparing clotrimazole to other topical antifungal agents only showed no differences in clinical response, microbiologic cure or relapse. Further sensitivity analysis showed significant efficacy of fluconazole over clotrimazole.

Conclusion: This meta-analysis indicated that clotrimazole is less effective than fluconazole but as effective as other topical therapies in treating OPC. Well-designed high-quality RCT is needed to validate these findings.

Keywords: CI, confidence interval; Clotrimazole; HIV, human immunodeficiency virus; Meta-analysis; OPC, oropharyngeal candidiasis; OR, odds ratio; Oral candidiasis; Systematic review.