{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T12:49:05Z","timestamp":1774010945683,"version":"3.50.1"},"reference-count":30,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2024,8,29]],"date-time":"2024-08-29T00:00:00Z","timestamp":1724889600000},"content-version":"unspecified","delay-in-days":28,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001826","name":"ZonMw","doi-asserted-by":"publisher","award":["10140022110009"],"award-info":[{"award-number":["10140022110009"]}],"id":[{"id":"10.13039\/501100001826","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,7,26]]},"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Intratympanic corticosteroids are commonly used in the treatment of Meni\u00e8re\u2019s disease (MD). However, few and small randomised controlled trials (RCT) on the effectiveness of intratympanic corticosteroids have been performed. A recent Cochrane review suggested that a well-conducted placebo-controlled RCT with a large study population is required to evaluate the effectiveness of the use of intratympanic corticosteroids in MD. The following protocol describes a phase-3 multicentre, double-blinded, randomised, placebo-controlled trial to compare the effectiveness of methylprednisolone (62.5 mg\/mL) to a placebo (sodium chloride 0.9%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>We aim to recruit 148 patients with unilateral MD from six hospitals in the Netherlands. Patients will be randomly assigned to either the methylprednisolone or the placebo group. Two injections will be given, one at baseline and one after 2 weeks. Follow-up assessments will be done at 3, 6, 9 and 12 months. The primary outcome will be the frequency of vertigo attacks. Attacks will be evaluated daily with the DizzyQuest app. Secondary outcomes include hearing loss, tinnitus, health-related quality of life, use of co-interventions and escape medication, (serious) adverse events and cost-effectiveness. These will be evaluated with audiometry and multiple commonly used, validated questionnaires. For the primary and secondary outcomes mixed model analysis, generalised estimating equation analysis and logistic regression analysis will be used.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study was submitted via the Clinical Trials Information System, reviewed and approved by the Medical Research Ethics Committee Leiden The Hague Delft and the local institutional review board of each participating centre. All data will be presented ensuring the integrity and anonymity of patients. Results will be published in scientific journals and presented on (inter)national conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      This study is registered at ClinicalTrials.gov Protocol Registration and Results System, with the registration ID:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05851508\">NCT05851508<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-076872","type":"journal-article","created":{"date-parts":[[2024,8,29]],"date-time":"2024-08-29T22:40:39Z","timestamp":1724971239000},"page":"e076872","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["The effectiveness of intratympanic injections with methylPREDnisolon versus placebo in the treatment of vertigo attacks in MENi\u00e8re\u2019s disease (PREDMEN trial): a study protocol for a phase-3 multicentre, double-blinded, randomised, placebo-controlled trial"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05851508","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05851508","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5451-4611","authenticated-orcid":false,"given":"Maud Martina Emilie","family":"Boreel","sequence":"first","affiliation":[{"name":"Department of Otorhinolaryngology\u2014Head and Neck Surgery, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands"},{"name":"Apeldoorn Dizziness Centre, Gelre Ziekenhuizen, Apeldoorn, Gelderland, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0419-5760","authenticated-orcid":false,"given":"Babette","family":"van Esch","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2014Head and Neck Surgery, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tjard R","family":"Schermer","sequence":"additional","affiliation":[{"name":"Apeldoorn Dizziness Centre, Gelre Ziekenhuizen, Apeldoorn, Gelderland, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Berber M","family":"Mol","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2014Head and Neck Surgery, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter Paul","family":"van Benthem","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2014Head and Neck Surgery, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5955-8453","authenticated-orcid":false,"given":"Tjasse D","family":"Bruintjes","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2014Head and Neck Surgery, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands"},{"name":"Apeldoorn Dizziness Centre, Gelre Ziekenhuizen, Apeldoorn, Gelderland, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,8,29]]},"reference":[{"key":"2025121605094656000_14.8.e076872.1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599820909438"},{"key":"2025121605094656000_14.8.e076872.2","doi-asserted-by":"publisher","DOI":"10.1097\/00129492-200211000-00022"},{"key":"2025121605094656000_14.8.e076872.3","doi-asserted-by":"crossref","unstructured":"Lahiji MR , Akbarpour M , Soleimani R , et al . 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