Evidence map›Paper›PMID 39632750›Full record

Trial reportJournal of the International Association of Providers of AIDS Care

Efficacy and Safety of Fluconazole Mucoadhesive Patches in Human Immunodeficiency Virus-Related Oral Candidiasis.

Srikanth Deenadayalan, Ashok Shenoy, Ashwin Kamath, Mahalaxmi Rathnanand, Sheetal Ullal, Nandita Shenoy

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the International Association of Providers of AIDS Care. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Srikanth DeenadayalanMedical Affairs, Novo Nordisk, A/S Soborg R&D Centre, Soborg, Denmark.
Ashok ShenoyDepartment of Pharmacology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Ashwin KamathDepartment of Pharmacology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Mahalaxmi RathnanandDepartment of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Sheetal UllalDepartment of Pharmacology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Nandita ShenoyDepartment of Oral Medicine and Radiology, Manipal College of Dental Sciences Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.ORCID 0000-0002-4585-1357

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOpportunistic fungal infections like oral candidiasis account for a significant amount of morbidity in HIV disease and an indicator of immune suppression. Fluconazole is a broad-spectrum antifungal agent that has been extensively used in the management of oral, candidiasis. Highly efficacious fluconazole is also known to have systemic toxicity due to high drug interaction and hence the present study focuses on the formulation of bioadhesive film as a controlled release carrier for fluconazole. MATERIALS AND

methodsPatients were randomised, using a computer-generated list of random numbers, into one of the three groups: patients in group A received fluconazole mucoadhesive film 20 mg (sustained release) that was to be applied at bedtime and film 10 mg (intermediate release) to be applied during the day after lunch.

resultsThere was a significant decrease in oral discomfort, pain and clinical improvement in group A compared to group B (Fluconazole oral tablets 100 mg/day) (P = 0.005) and group C (Fluconazole Mouth rinse) (P = 0.002). The patients who received the mucoadhesive patches had a more tolerable safety profile as expected compared to the other groups.

conclusionThe bioadhesive films of fluconazole were used in HIV positive patients with oral candidiasis to overcome the problems of high dose requirement of the drug and reduce associated adverse reactions in an already immunocompromised patients and improve the quality of life.

Indexed as

Antifungal AgentsCandidiasis, OralFluconazoleAdultAIDS-Related Opportunistic InfectionsDelayed-Action PreparationsFemaleHIV InfectionsHumansMaleMiddle AgedMouth MucosaAntifungal AgentsDelayed-Action PreparationsFluconazolebioadhesive filmfluconazolegood healthlocalized deliverymucocutaneous candidiasisquality of life

Identifiers

PMID39632750
PMCPMC11618892

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.