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

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

Tablet of Ximenia Americana L. Developed from Mucoadhesive Polymers for Future Use in Oral Treatment of Fungal Infections

“…Comparing the efficacy and safety of miconazole nitrate tablets and itraconazole capsules in patients diagnosed with oral candidiasis, Yan et al (2016) found a cure rate of 51.18% for miconazole and 41.76% for itraconazole. They also observed no significant differences between these drugs regarding the safety profile of the patients [ 66 ]. Evaluating mucoadhesive tablets of nystatin in healthy volunteers, Llabot et al (2009) found that the tablets resided in the mucosa of the patients for 4.5 hours.…”

Assessment of effectiveness of fluconazole and clotrimazole in treating oral candidiasis patients: A comparative study

“…Fluconazole and clotrimazole are the two commonly used anti-fungal agents for the treatment of fungal lesions. [ 9 10 11 ] Hence, we aimed to evaluate the effectiveness of fluconazole and clotrimazole in the treatment of patients suffering from candidiasis.…”

Econazole Induces p53-Dependent Apoptosis and Decreases Metastasis Ability in Gastric Cancer Cells

“…These results indicate that econazole and miconazole dramatically inhibited the tumorigenesis of gastric cancer cells and may potentially serve as powerful anticancer drugs. Miconazole had a better inhibitory effect on cell viability but is known to cause adverse side-effects such as dizziness, hypoesthesia, and decrease white blood cell count (Yan et al, 2016). Therefore, miconazole was not tested in detail in this paper.…”