Evidence map›Paper›PMID 39751710›Full record

Trial reportTechniques in coloproctology2025

The use of a methylene blue and glyceryl trinitrate-based cream for the treatment of chronic anal fissures: a phase II randomized pilot trial from a referral coloproctological unit.

P Lobascio, G Tomasicchio, N Cassetta, D F Altomare, G Gallo, A Pezzolla, R Laforgia

Abstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Techniques in coloproctology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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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

7 authors.

P LobascioDepartment of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), Section of Surgery, General Surgery Unit - Hospital University of Bari, Piazza Giulio Cesare 11, 70124, Bari, SE, Italy.
G TomasicchioDepartment of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), Section of Surgery, General Surgery Unit - Hospital University of Bari, Piazza Giulio Cesare 11, 70124, Bari, SE, Italy. giovanni.tomasicchio@uniba.it.
N CassettaFarmacia Santelia, Via Antonio Santelia Architetto, N. 135, 70033, Corato - Bari, SE, Italy.
D F AltomareDepartment of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), Section of Surgery, General Surgery Unit - Hospital University of Bari, Piazza Giulio Cesare 11, 70124, Bari, SE, Italy.
G GalloDepartment of Surgery, Sapienza University of Rome, 00189, Rome, Italy.
A PezzollaDepartment of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), Section of Surgery, General Surgery Unit - Hospital University of Bari, Piazza Giulio Cesare 11, 70124, Bari, SE, Italy.
R LaforgiaDepartment of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), Section of Surgery, General Surgery Unit - Hospital University of Bari, Piazza Giulio Cesare 11, 70124, Bari, SE, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic anal fissures (CAFs) are the second most common anorectal disease. Non-surgical treatment includes several options with controversial efficacy. The aim of this study was to evaluate the efficacy and safety of a new ointment based on methylene blue in addition to glyceryl trinitrate.

methodsA phase II randomized single-centre triple-blinded study was carried out in a tertiary proctology unit on patients with CAF. The enrollment started after local ethics committee approval (study n. 6461, protocol approval n. 0045085). Eligible consecutive patients were randomized to one of three different groups, each receiving a different ointment. The efficacy of the treatment was evaluated with the REALISE score.

resultsNine patients were treated with cream A (median age 47 years, IQR 40-56, 22% female), nine with cream B (median age 52 years, IQR 49-57, 33% female), and nine with cream C (median age 58 years, IQR 46-62, 55% female). In group A, REALISE scores decreased significantly from a median of 22 (IQR 12-25) to 6 (IQR 4-8) (p < 0.05) after 40 days. In group B, REALISE scores improved significantly from a median of 20 (IQR 17-22) to 5 (IQR 4-9) (p < 0.05). In group C, REALISE scores decreased significantly from a median of 19 (IQR 19-20) to 4 (4-5) (p < 0.05). No statistically differences were recorded. The healing rate was 77% with creams A and C, while it was 44% with cream B.

conclusionMethylene blue-based ointments could be a new and innovative treatment for the non-operative management and healing of CAFs.

Indexed as

Fissure in AnoMethylene BlueNitroglycerinReferral and ConsultationAdministration, TopicalAdultChronic DiseaseDrug Therapy, CombinationFemaleHumansMaleMiddle AgedOintmentsPilot ProjectsTreatment OutcomeVasodilator AgentsMethylene BlueNitroglycerinOintmentsVasodilator AgentsAnal fissureAnal painBlue creamGlyceryl trinitrateMethylene blueREALISE scoring system

Identifiers

PMID39751710

What OpenQuestion holds

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Registered trials

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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.