Evidence map›Paper›PMID 39350142›Full record

ArticleBMC gastroenterology2024

Is chemodenervation with incobotulinumtoxinA an alternative to invasive chronic anal fissure treatments?

T Calderón, L Arriero, P Cruz, L Gómez, J Asanza, J C Santiago, R Garrido, C Bustamante, T Balsa

Abstract read
In one paragraph

Article in BMC gastroenterology, 2024. 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

9 authors.

T CalderónServicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain. ttcd01@gmail.com.
L ArrieroServicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain.
P CruzServicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain.
L GómezServicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain.
J AsanzaServicio de Cirugía General y Aparato Digestivo, Hospital Universitario de Guadalajara, Guadalajara, Castilla-La Mancha, Spain.
J C SantiagoServicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain.
R GarridoServicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain.
C BustamanteServicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain.
T BalsaServicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBotulinum toxin type A is currently strongly recommended for the treatment of anal fissures (AFs). However, there is still no consensus on dosage or injection technique. This study provides further efficacy and safety evidence in a 2-year follow-up.

methodProspective, open-label, single-arm, single-center study carried out in adult patients with AFs non-responsive to previous treatments. Patients were treated with incobotulinumtoxinA (incoBoNT/A) injected in both laterals and posterior intersphincteric groove. Healing rate at 2 years was the primary endpoint. Secondary endpoints included internal anal sphincter pressures, incontinence, and safety.

resultsA total of 49 patients were treated with a mean incoBoNT/A dose of 40.5 U (spread across three locations). Healing rate at 2 years was 83.9% with a 24.5% of recurrence throughout the study. Only 7 patients (14.3%) reported adverse events (AEs) that were mild and temporary. Mean reduction in anal resting pressure was -9.1 mmHg at 3 months (p = 0.001). Mean reduction in voluntary squeeze pressure was -27.5 mmHg at 3 months (p < 0.001). Mean pain perception measured with a visual analog scale decreased by -6.5 points at 2 years (p < 0.001). There was an incontinence increase at 1 month of 1.3 points (p = 0.006), but baseline values were restored at 6 months.

conclusionWe present results that support the use of incoBoNT/A as a second line for AFs that do not respond to ointment therapy. IncoBoNT/A injection is a less invasive treatment that should be considered before surgery due to its efficacy and its safety which includes no permanent impairment.

trial registrationISRCTN90354265; Registered on 16th February 2024. Retrospectively registered.

Indexed as

Botulinum Toxins, Type AFissure in AnoAdultAgedAnal CanalChronic DiseaseFecal IncontinenceFemaleHumansMaleMiddle AgedNeuromuscular AgentsProspective StudiesRecurrenceTreatment OutcomeWound HealingBotulinum Toxins, Type AincobotulinumtoxinANeuromuscular AgentsBotulinum toxinChronic anal fissureEfficacySafety

Identifiers

PMID39350142
PMCPMC11440925

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LicenceCC BY
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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.