Evidence map›Paper›PMID 31690286›Full record

Observational studyBMC urology2019

Clinical and morphological effects of hyperbaric oxygen therapy in patients with interstitial cystitis associated with fibromyalgia.

Gerardo Bosco, Edoardo Ostardo, Alex Rizzato, Giacomo Garetto, Matteo Paganini, Giorgio Melloni, Giampiero Giron, Lodovico Pietrosanti, Ivo Martinelli, Enrico Camporesi

Registry-linked trialOpen access · goldAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMC urology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03693001 (Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With Fibromyalgia), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 20% 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.

NCT03693001 nacompletednot on this map

Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With Fibromyalgia

TypeinterventionalSponsorUniversity of South FloridaRan2016 to 2018Enrolled12ConditionsFibromyalgia, Interstitial CystitisArmsIntermittent Exposure to Oxygen via Oro-Nasal Mask
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. 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

10 authors at 4 institutions in 2 countries.

Gerardo BoscoEnvironmental and Respiratory Physiology Laboratory, Department of Biomedical Sciences, University of Padova, Padova, Italy.
Edoardo OstardoUnità Operativa di Urologia, Azienda Ospedaliera Santa Maria degli Angeli, Pordenone, Italy.
Alex RizzatoEnvironmental and Respiratory Physiology Laboratory, Department of Biomedical Sciences, University of Padova, Padova, Italy.
Giacomo GarettoATIP Centro di Medicina Iperbarica, Padova, Italy.
Matteo PaganiniEnvironmental and Respiratory Physiology Laboratory, Department of Biomedical Sciences, University of Padova, Padova, Italy. paganini.mtt@gmail.com.ORCID http://orcid.org/0000-0002-7556-6928
Giorgio MelloniDepartment of Statistics, Harvard School of Medicine, Boston, MA, USA.
Giampiero GironOTI Services, Centro di Medicina Iperbarica, Venezia, Italy.
Lodovico PietrosantiOTI Services, Centro di Medicina Iperbarica, Venezia, Italy.
Ivo MartinelliOTI Services, Centro di Medicina Iperbarica, Venezia, Italy.
Enrico CamporesiTEAMHealth Research Institute, TGH, Tampa, Florida, USA.
University of Padua · ITAzienda Ospedaliera Santa Maria Degli Angeli · ITHarvard University · USHonorHealth · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInterstitial Cystitis (IC) is a debilitating disorder of the bladder, with a multifactorial and poorly understood origin dealing with microcirculation repeated damages. Also Fibromyalgia (FM) is a persistent disorder whose etiology is not completely explained, and its theorized alteration of pain processing can compromise the quality of life. Both these conditions have a high incidence of conventional therapeutic failure, but recent literature suggests a significant beneficial response to Hyperbaric Oxygen Therapy (HBOT). With this study, this study we evaluated the effects of HBOT on quality of life, symptoms, urodynamic parameters, and cystoscopic examination of patients suffering from both IC and FM.

methodsWe structured an observational clinical trial design with repeated measures (questionnaires, urodynamic test, and cystoscopy) conducted before and 6 months after a therapeutic protocol with hyperbaric oxygen for the treatment of patients suffering from both IC and FM. Patients were exposed to breathing 100% oxygen at 2 atm absolute (ATA) in a multiplace pressure chamber for 90 min using an oro-nasal mask. Patients undertook a cycle of 20 sessions for 5 days per week, and a second cycle of 20 sessions after 1 week of suspension.

resultsTwelve patients completed the protocol. Changes after HBOT were not significant, except for hydrodistension tolerance (mean pre-treatment: 409.2 ml; mean post-treatment: 489.2 ml; p < 0.05). A regression of petechiae and Hunner's ulcers was also noted 6 months after the completion of HBOT.

conclusionsOur study showed no improvement of symptoms, quality of life, and urodynamic parameters, except for hydrodistension, and a slight improvement in cystoscopic pattern. However, to date, we could not demonstrate the significance of overall results to justify the use of HBOT alone in patients with IC and FM. This observation suggests that additional studies are needed to better understand if HBOT could treat this subset of patients.

trial registrationNCT03693001 ; October 2, 2018. Retrospectively registered.

Indexed as

Hyperbaric OxygenationAgedCystitis, InterstitialFemaleFibromyalgiaHumansMaleMiddle AgedQuality of LifeFibromyalgiaHyperbaric medicineInterstitial cystitis

Identifiers

PMID31690286
PMCPMC6833196
OpenAlexW2985098132

What OpenQuestion holds

Textmetadata
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.