Zhimin Yan1, Xiaosong Liu1, Yang Liu1, Ying Han1, Mei Lin2, Wenmei Wang3, Xiaobing Guan4, Shengrong Zhu5, Handong Zhang6, Qintao Wang7, Lihong Chou8, Xinghao Zhu9, Hong Hua1. 1. Department of Oral Medicine, School and Hospital of Stomatology, Peking University, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing, China. 2. Department of Oral Medicine, West China School of Stomatology, Sichuan University, Chengdu, China. 3. Department of Oral Medicine, Institute and Hospital of Dentistry, Nanjing University Medical School, Nanjing, China. 4. Department of Periodontics & Oral Medicine, Beijing Stomatological Hospital, Capital Medical University, Beijing, China. 5. Department of Stomatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 6. Department of Stomatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 7. Department of Periodontology, School of Stomatology, The Fourth Military Medical University, Xian, China. 8. Hospital of Stomatology, China Medical University, Shenyang, China. 9. Department of Stomatology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
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. CONCLUSION: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. TRIAL REGISTRATION: Chinese Clinical Trial Register ChiCTR-TRC-13003935.
RCT Entities:
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. CONCLUSION: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. TRIAL REGISTRATION: Chinese Clinical Trial Register ChiCTR-TRC-13003935.
Authors: José A Vazquez; Lauren L Patton; Joel B Epstein; Padaruth Ramlachan; Ismail Mitha; Zoja Noveljic; Jan Fourie; Brian Conway; Rajesh V Lalla; Andrei Barasch; Pierre Attali Journal: HIV Clin Trials Date: 2010 Jul-Aug
Authors: David Moher; Sally Hopewell; Kenneth F Schulz; Victor Montori; Peter C Gøtzsche; P J Devereaux; Diana Elbourne; Matthias Egger; Douglas G Altman Journal: Int J Surg Date: 2011-10-12 Impact factor: 6.071
Authors: R C Jagat Reddy; S Jeelani; P Duraiselvi; M Kandasamy; G Suresh Kumar; R Azhal Vel Pandian Journal: J Int Soc Prev Community Dent Date: 2017-03-29