Evidence map›Paper›PMID 27977721›Full record

Trial reportPloS one2016

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, Xiaosong Liu, Yang Liu, Ying Han, Mei Lin, Wenmei Wang, Xiaobing Guan, Shengrong Zhu, Handong Zhang, Qintao Wang and 3 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. New perspectives on the topical management of recurrent candidiasis.Drug delivery and translational research · 2021
    Review
  3. Article
  4. Tablet ofPolymers · 2019
    Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 1 country.

Zhimin YanDepartment of Oral Medicine, School and Hospital of Stomatology, Peking University, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing, China.
Xiaosong LiuDepartment of Oral Medicine, School and Hospital of Stomatology, Peking University, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing, China.
Yang LiuDepartment of Oral Medicine, School and Hospital of Stomatology, Peking University, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing, China.
Ying HanDepartment of Oral Medicine, School and Hospital of Stomatology, Peking University, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing, China.
Mei LinDepartment of Oral Medicine, West China School of Stomatology, Sichuan University, Chengdu, China.
Wenmei WangDepartment of Oral Medicine, Institute and Hospital of Dentistry, Nanjing University Medical School, Nanjing, China.
Xiaobing GuanDepartment of Periodontics & Oral Medicine, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.
Shengrong ZhuDepartment of Stomatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Handong ZhangDepartment of Stomatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Qintao WangDepartment of Periodontology, School of Stomatology, The Fourth Military Medical University, Xian, China.
Lihong ChouHospital of Stomatology, China Medical University, Shenyang, China.
Xinghao ZhuDepartment of Stomatology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Hong HuaDepartment of Oral Medicine, School and Hospital of Stomatology, Peking University, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing, China.
Peking University · CNHuazhong University of Science and Technology · CNStomatology Hospital · CNAir Force Medical University · CNCapital Medical University · CNChina Medical University · CNNanjing Medical University · CNSichuan University · CNWenzhou Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AdultAntifungal AgentsCandidiasis, OralCapsulesFemaleHumansItraconazoleMaleMiconazoleMiddle AgedTabletsAntifungal AgentsCapsulesItraconazoleMiconazoleTablets

Identifiers

PMID27977721
PMCPMC5157999
OpenAlexW2564976207

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.