Evidence map›Paper›PMID 27586891›Full record

Trial reportArthritis research & therapy2016

The 5-HT1A receptor agonist buspirone improves esophageal motor function and symptoms in systemic sclerosis: a 4-week, open-label trial.

George P Karamanolis, Stylianos Panopoulos, Konstantinos Denaxas, Anastasios Karlaftis, Alexandra Zorbala, Dimitrios Kamberoglou, Spiros D Ladas, Petros P Sfikakis

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Arthritis research & therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02363478 (Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 10% 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.

NCT02363478 early_phase1completednot on this map

Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)

TypeinterventionalSponsorLaikο General Hospital, AthensRan2014 to 2015Enrolled22ConditionsSystemic SclerosisArmsbuspirone
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Esophageal Manifestations of Dermatological Diseases, Diagnosis and Management.Current treatment options in gastroenterology · 2022
    Article
  11. Management of scleroderma gastrointestinal disease: Lights and shadows.Journal of scleroderma and related disorders · 2022
    Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Esophageal manifestation in patients with scleroderma.World journal of clinical cases · 2021
    Review
  17. Review
  18. Managing gastrointestinal complications in patients with systemic sclerosis.Current treatment options in gastroenterology · 2020
    Article
  19. Review
  20. Non-acid Reflux: When It Matters and Approach to Management.Current gastroenterology reports · 2020
    Review
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

8 authors at 2 institutions in 1 country.

George P KaramanolisAcademic Department of Gastroenterology, "Laiko" Hospital, Athens Medical School National and Kapodistrian University, Athens, Greece. georgekaramanolis@yahoo.co.uk.
Stylianos PanopoulosJoint Academic Rheumatology Programme, Athens Medical School National and Kapodistrian University, Athens, Greece.
Konstantinos DenaxasAcademic Department of Gastroenterology, "Laiko" Hospital, Athens Medical School National and Kapodistrian University, Athens, Greece.
Anastasios KarlaftisAcademic Department of Gastroenterology, "Laiko" Hospital, Athens Medical School National and Kapodistrian University, Athens, Greece.
Alexandra ZorbalaJoint Academic Rheumatology Programme, Athens Medical School National and Kapodistrian University, Athens, Greece.
Dimitrios KamberoglouAcademic Department of Gastroenterology, "Laiko" Hospital, Athens Medical School National and Kapodistrian University, Athens, Greece.
Spiros D LadasAcademic Department of Gastroenterology, "Laiko" Hospital, Athens Medical School National and Kapodistrian University, Athens, Greece.
Petros P SfikakisJoint Academic Rheumatology Programme, Athens Medical School National and Kapodistrian University, Athens, Greece.
Laiko General Hospital of Athens · GRNational and Kapodistrian University of Athens · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute administration of the oral 5-HT1A receptor agonist buspirone, which is commonly used as an anxiolytic drug, may improve compromised lower esophageal sphincter function. In an open-label trial we assessed the effects of buspirone on esophageal motor function and symptoms in patients with esophageal involvement associated with systemic sclerosis (SSc).

methodsThirty consecutive patients with SSc and symptomatic esophageal involvement, despite treatment with proton pump inhibitors, underwent high resolution manometry and chest computed tomography for assessment of motor function and esophageal dilatation, respectively. Regurgitation, heartburn, dysphagia, and chest pain severity was subjectively scored by visual analog scales. Manometric parameters (primary endpoint) and symptom severity (secondary endpoint) were re-examined after 4-week daily administration of 20 mg buspirone. Other medications remained unchanged.

resultsEight patients did not complete the trial because of buspirone-associated dizziness (n = 2), or nausea (n = 2), or reluctancy to undergo final manometry. In the remaining 22 patients lower esophageal sphincter (LES) resting pressure increased from 7.7 ± 3.9 to 12.2 ± 4.6 mmHg (p = 0.00002) after buspirone administration; other manometric parameters did not change. Statistical analysis revealed negative correlation between individual increases in resting LES pressure and supra-aortic esophageal diameter (r = -0.589, p = 0.017), suggesting a more beneficial effect in patients with less severely affected esophageal function. Heartburn and regurgitation scores decreased at 4 weeks compared to baseline (p = 0.001, and p = 0.022, respectively).

conclusionOur findings warrant more conclusive evaluation with a double-blind controlled study; however, buspirone could potentially be given under observation for objective improvement in all patients with SSc who report reflux symptoms despite undergoing standard treatment.

trial registrationClinicalTrials.gov Identifier: NCT02363478 Registered: 21-02-2014.

Indexed as

AdultAgedBuspironeEsophageal Motility DisordersEsophagusFemaleHumansMaleManometryMiddle AgedPeristalsisScleroderma, SystemicSerotonin 5-HT1 Receptor AgonistsBuspironeSerotonin 5-HT1 Receptor AgonistsBuspironeEsophageal motilityReflux symptomsScleroderma

Identifiers

PMID27586891
PMCPMC5009650
OpenAlexW2510187362

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.