title: 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: BACKGROUND
  Oral 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.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  Miconazole 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.
  
  
  BACKGROUND
  Chinese Clinical Trial Register ChiCTR-TRC-13003935.
authors.affiliation: Department of Oral Medicine, School and Hospital of Stomatology, Peking University, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing, China.
authors.forename: Zhimin
authors.initials: Z
authors.lastname: Yan
authors.affiliation: Department of Oral Medicine, School and Hospital of Stomatology, Peking University, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing, China.
authors.forename: Xiaosong
authors.initials: X
authors.lastname: Liu
authors.affiliation: Department of Oral Medicine, School and Hospital of Stomatology, Peking University, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Oral Medicine, School and Hospital of Stomatology, Peking University, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Han
authors.affiliation: Department of Oral Medicine, West China School of Stomatology, Sichuan University, Chengdu, China.
authors.forename: Mei
authors.initials: M
authors.lastname: Lin
authors.affiliation: Department of Oral Medicine, Institute and Hospital of Dentistry, Nanjing University Medical School, Nanjing, China.
authors.forename: Wenmei
authors.initials: W
authors.lastname: Wang
authors.affiliation: Department of Periodontics & Oral Medicine, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.
authors.forename: Xiaobing
authors.initials: X
authors.lastname: Guan
authors.affiliation: Department of Stomatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Shengrong
authors.initials: S
authors.lastname: Zhu
authors.affiliation: Department of Stomatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Handong
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Department of Periodontology, School of Stomatology, The Fourth Military Medical University, Xian, China.
authors.forename: Qintao
authors.initials: Q
authors.lastname: Wang
authors.affiliation: Hospital of Stomatology, China Medical University, Shenyang, China.
authors.forename: Lihong
authors.initials: L
authors.lastname: Chou
authors.affiliation: Department of Stomatology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
authors.forename: Xinghao
authors.initials: X
authors.lastname: Zhu
authors.affiliation: Department of Oral Medicine, School and Hospital of Stomatology, Peking University, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Hua
mesh_terms: D000328:Adult; D000935:Antifungal Agents / Q000627:therapeutic use*; D002180:Candidiasis, Oral / Q000188:drug therapy*; D002214:Capsules / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D017964:Itraconazole / Q000627:therapeutic use*; D008297:Male; D008825:Miconazole / Q000627:therapeutic use*; D008875:Middle Aged; D013607:Tablets / Q000627:therapeutic use*
chemical_list: D000935:Antifungal Agents; D002214:Capsules; D013607:Tablets; D017964:Itraconazole; D008825:Miconazole