Evidence map›Paper›PMID 18923838›Full record

Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2009

Rheopheresis for idiopathic sudden hearing loss: results from a large prospective, multicenter, randomized, controlled clinical trial.

Ralph Mösges, Juliane Köberlein, Andreas Heibges, Bernard Erdtracht, Reinhard Klingel, Walter Lehmacher, RHEO-ISHL Study Group

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
4.1field-weighted citation impact, top 8% 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

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Guideline
  2. Pentoxifylline uses in inner ear diseases.European journal of clinical pharmacology · 2025
    Pooled it
  3. Intratympanic corticosteroids for sudden sensorineural hearing loss.The Cochrane database of systematic reviews · 2022
    Pooled it
  4. Steroids for idiopathic sudden sensorineural hearing loss.The Cochrane database of systematic reviews · 2013
    Pooled it
  5. Randomized, placebo-controlled study on efficacy, safety and tolerability of drug-induced defibrinogenation for sudden sensorineural hearing loss: the lessons learned.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023
    Trial
  6. Hyperbaric oxygen therapy as salvage treatment for sudden sensorineural hearing loss: a prospective controlled study.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2015
    Trial
  7. Trial
  8. Prospective, randomized, controlled clinical study evaluating the efficacy of Rheopheresis for dry age-related macular degeneration. Dry AMD treatment with Rheopheresis Trial-ART.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2009
    Trial
  9. Observational
  10. Review
  11. Review
  12. Article
  13. Rheopheresis in treatment of idiopathic sensorineural sudden hearing loss.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale · 2017
    Observational
  14. Article
  15. Diagnostics and therapy of sudden hearing loss.GMS current topics in otorhinolaryngology, head and neck surgery · 2017
    Review
  16. Characteristics and Spontaneous Recovery of Tinnitus Related to Idiopathic Sudden Sensorineural Hearing Loss.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2016
    Article
  17. Fibrinogen is not a prognostic factor for response to HELP-apheresis in sudden sensorineural hearing loss (SSHL).European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2015
    Observational
  18. Article
  19. Therapeutic apheresis in peripheral and retinal circulatory disorders.Clinical research in cardiology supplements · 2012
    Article
  20. 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

7 authors at 3 institutions in 3 countries.

Ralph MösgesInstitute of Medical Statistics, Informatics und Epidemiology, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany. Ralph@Moesges.DE
Juliane Köberlein
Andreas Heibges
Bernard Erdtracht
Reinhard Klingel
Walter Lehmacher
RHEO-ISHL Study Group
University of Cologne · DEGenesis Research Institute · JPMax Planck Institute for Metabolism Research · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Idiopathic sudden hearing loss (ISHL) has been suggested to precipitate as final common pathway of microcirculatory impairment of the inner ear associated with a variety of etiologies and characterized by a local hyperviscosity syndrome in cochlear vessels. Therefore, we investigated the effect of Rheopheresis, a method of therapeutic apheresis reducing plasma viscosity and improving microcirculation on hearing recovery. Patients were randomly assigned to receive two Rheopheresis treatments, or treatment according to current German guidelines consisting either of i.v. corticosteroids (methylprednisolon 250 mg for 3 days and subsequent oral dosing with tapering to zero) or i.v. hemodilution (500 mL 6% hydroxyethyl starch plus 600 mg pentoxifylline per day), each applied for 10 days. The primary outcome parameter was absolute recovery of hearing as measured by pure tone audiometry 10 days after the start of treatment. Secondary outcomes were recovery of hearing at day 42, the improvement of speech audiometry, tinnitus and feeling of pressure and the frequency of adverse events. In total, 240 patients with sudden hearing loss were enrolled from otorhinolaryngological departments at hospitals as well as out-patient clinics in Germany. Analysis was performed for the intention-to-treat as well as per protocol population. Mean absolute recovery of hearing on day 10 within the intention-to-treat population (ITT, n = 193) was 23.95 dB (SD 15.05) in the Rheopheresis group and 24.29 dB (SD 15.48) in the control group. Equal efficacy of Rheopheresis and tested standard treatments was demonstrated (P = 0.00056). Single Rheopheresis led to a higher recovery of hearing after 48 h in patients with high plasma viscosity (>1.8 mPas s; P = 0.029) or high total protein (>74 g/dL; P = 0.02). However, an overall good recovery of ISHL was observed with none of the tested therapies being superior regarding the primary outcome parameter. Improvement of health-related quality of life as documented by the SF36 was higher in the Rheopheresis group, exhibiting a significant difference for the physical summary scale at the final follow-up at day 42 (P = 0.006). In conclusion, Rheopheresis proved to be an effective treatment option within the ENT armamentarium for ISHL. Two Rheopheresis treatments within 3 days lasting for about 2 h each could be used to replace a 10-day infusion regimen, especially in patients who desire fast recovery from acute hearing loss. Also, this may be a second line treatment option for patients refractory to i.v. corticosteroids or hemodilution.

Indexed as

Blood Component RemovalAdultAudiometry, Pure-ToneBlood ViscosityEar, InnerFemaleFluid TherapyGlucocorticoidsHearing Loss, SuddenHumansMaleMethylprednisoloneMicrocirculationMiddle AgedProspective StudiesRecovery of FunctionGlucocorticoidsMethylprednisolone

Identifiers

PMID18923838
OpenAlexW1979791904

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.