The Efficacy and Safety of Miconazole Nitrate Mucoadhesive Tablets versus Itraconazole Capsules in the Treatment of Oral Candidiasis: An Open-Label, Randomized, Multicenter Trial.

Zhimin Yan,Ying Han,Hong Hua,Wenmei Wang,Xiaobing Guan,Yang Liu,Handong Zhang,Shengrong Zhu,Xiaosong Liu,Xinghao Zhu,Mei Lin,Qintao Wang,Lihong Chou

doi:10.1371/journal.pone.0167880

Abstract

BackgroundOral candidiasis (OC) is a common oral fungal infection. Recently, miconazole mucoadhesive tablets have been gaining attention for OC treatment. Despite trials in patients with human immunodeficiency virus and cancer, evidence of its application in the large-scale, general population with OC is lacking. This study aimed to evaluate the efficacy and safety of miconazole nitrate mucoadhesive tablets in comparison with itraconazole capsules for OC treatment.MethodsThe study was a randomized, open-label, parallel-armed, multicenter clinical trial. Totally, 343 patients diagnosed with OC, who met the inclusion criteria, were randomly assigned to either a treatment group that received miconazole nitrate mucoadhesive tablets (10 mg) once daily or a control group that received itraconazole capsules (100 mg QD) for 2 weeks, and were followed up for 2 weeks. The clinical cure, improvement of clinical symptoms/signs, mycologic cure, and safety were evaluated.ResultsThe mucoadhesive tablets (n = 171) did not show inferiority to itraconazole (n = 172) in the treatment of OC. At the end of the 14-day treatment, the clinical cure rates were 45.29% and 41.76% in the miconazole and itraconazole groups, respectively (P = 0.3472). At the end of the 14-day follow-up, the clinical cure rates were 51.18% and 41.76% in the miconazole and itraconazole groups, respectively (P = 0.0329). Adverse events occurred in 53 subjects (33 in the miconazole group and 20 in the itraconazole group). There was no statistical difference in the safety profile between miconazole and itraconazole (P = 0.0533). Thrombocytopenic purpura, although rare, occurred in one patient in the miconazole group and was considered a drug-related, severe adverse event.ConclusionMiconazole nitrate mucoadhesive tablets may be as effective as systemic itraconazole capsule for OC treatment. Physicians should be cautious about thrombocytopenic purpura occurring as a rare and serious adverse event of miconazole nitrate.Trial RegistrationChinese Clinical Trial Register ChiCTR-TRC-13003935

Highlights

Oral candidiasis (OC) is the most common human fungal infection of the oral cavity [1]
Adverse events occurred in 53 subjects (33 in the miconazole group and 20 in the itraconazole group)
343 patients were enrolled in the study as the intent-to-treat population, and 3 of them were eventually excluded due to insufficient diagnosis, which resulted in a final population of 340 subjects as the full-analysis set/modified intentto-treat population

Summary

Introduction

Oral candidiasis (OC) is the most common human fungal infection of the oral cavity [1]. Previous studies have evaluated the effect of mucoadhesive tablets in the treatment of special subgroups of patients with HIV infection [9, 10] or head and neck cancer [11], the knowledge of its effectiveness and safety in the general management of patients with OC, which is a rather larger group, is still insufficient. This study aimed to evaluate the effectiveness and safety of miconazole mucoadhesive tablets in the treatment of OC and establish a standard therapeutic program for its application. This study aimed to evaluate the efficacy and safety of miconazole nitrate mucoadhesive tablets in comparison with itraconazole capsules for OC treatment

Objectives

Methods

Results

Conclusion