Evidence map›Paper›PMID 38433177›Full record

Trial reportInternational urology and nephrology2024

Evaluation of efficacy and safety profile of tadalafil 5 mg daily dose in the tablet form versus oral dispersible film in men with mild-to-moderate erectile dysfunction: a comparative placebo-controlled study.

Ahmad T Motawi, Sameh Fayek GamalEl Din, Eslam M Meatmed, Ibrahim Fahmy

Open access · hybridAbstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in International urology and nephrology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 30% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

4 authors at 1 institution in 1 country.

Ahmad T MotawiDepartment of Andrology and STDs Kasr Al-Ainy, Sexual Medicine & STIs Department, Faculty of Medicine, Cairo University, Al-Saray Street, El Manial, Cairo, 11956, Egypt.
Sameh Fayek GamalEl DinDepartment of Andrology and STDs Kasr Al-Ainy, Sexual Medicine & STIs Department, Faculty of Medicine, Cairo University, Al-Saray Street, El Manial, Cairo, 11956, Egypt. samehfayek@kasralainy.edu.eg.ORCID http://orcid.org/0000-0003-1918-5132
Eslam M MeatmedDepartment of Andrology and STDs Kasr Al-Ainy, Sexual Medicine & STIs Department, Faculty of Medicine, Cairo University, Al-Saray Street, El Manial, Cairo, 11956, Egypt.
Ibrahim FahmyDepartment of Andrology and STDs Kasr Al-Ainy, Sexual Medicine & STIs Department, Faculty of Medicine, Cairo University, Al-Saray Street, El Manial, Cairo, 11956, Egypt.
Cairo University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe aimed to compare the efficacy, safety, and compliance of tadalafil 5 mg daily dose in the tablet form versus oral dispersible film (ODF) in men with mild-to-moderate erectile dysfunction (ED).

methodsOne hundred thirty-five randomized patients were equally divided into three groups according to age where each group included forty-five patients. Within each group, 15 patients received oral tadalafil 5 mg, 15 patients received ODF tadalafil 5 mg and 15 patients received a placebo once daily for 1 month. All participants were assessed by the validated Arabic version of the international index of erectile function (ArIIEF-5) at baseline and after 1 month. Also, the efficacy of different forms of tadalafil 5 mg was assessed by responding affirmatively to a questionnaire.

resultsPatients aged > 25 to < 40 years and 40-55 years and > 55 years showed a statistically significant improvement of ArIIEF-5 scores after tadalafil 5 mg tablet and ODF tadalafil 5 mg compared to placebo ODF (23 ± 1.4; 22.7 ± 0.9; 20 ± 0.9; 20.4 ± 1.3; 20.2 ± 1.2; 16.6 ± 1.2; 18.5 ± 1.7; 19.6 ± 1.4; 16.3 ± 1.4; p < 0.001, respectively). Three patients (> 25 to < 40 years) who received tadalafil 5 mg tablet showed muscle and back pain. Gastrointestinal (GIT) upset (eight patients) followed by headache (seven patients) were the main side effects reported in patients (40-55 years) who received tadalafil 5 mg tablet. While GIT upset was the main side effect reported in patients (> 55 years) who received tadalafil 5 mg tablet.

conclusionODF tadalafil 5 mg is an effective, tolerable, and safe formulation that can be used in patients with mild-to-moderate ED.

Indexed as

Erectile DysfunctionPhosphodiesterase 5 InhibitorsTabletsTadalafilAdministration, OralAdultDouble-Blind MethodHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomePhosphodiesterase 5 InhibitorsTabletsTadalafilErectile dysfunctionOrodispersible film tadalafilTadalafil tablet

Identifiers

PMID38433177
PMCPMC11266281
OpenAlexW4392372171

What OpenQuestion holds

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LicenceCC BY
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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.