3 Foreground question Clinical Uncertainty → PICO 問題 臨床個案的PICO Are corticosteroids more effective then placebo for improving vestibular function and relieving symptoms such as vertigo in patients with vestibular neuritis?Clinical Uncertainty → PICO 問題臨床個案的PICOPatient / ProblemPatients with vestibular neuritisInterventionCroticosteroidsComparisonPlaceboOutcomeVestibular function;Symptomatic improvement (vertigo)Type of Question: Therapy
7 Best available evidence: （挑選可獲得之最佳研究證據） Citation/s:Vestibular neuritis and labyrinthitisUpToDate Literature review current through: Jan 2015.| This topic last updated: Aug 09, 2013.Lead author's name : Joseph M Furman, MD, PhD
10 Best available evidence: （挑選可獲得之最佳研究證據） Citation/s: Corticosteroids for the treatment of idiopathic acute vestibular dysfunction (vestibular neuritis) Cochrane Database Syst Rev May 11Lead author's name :Jonathan M Fishman
11 Methods-1 Types of studies: Randomized controlled trials Types of participants:Inclusion criteriaAdults(> 16 y/o) of either gender, diagnosed with vestibular neuritis (idiopathic acute peripheral vestibular dysfunction/ vestibulopathy, rather than acute cochleo-vestibular dysfunction), as defined by the following criteria:First episode of sudden onset sustained vertigo measured in daysAbsence of auditory symptoms or findings suggestive of alternative diagnosesAbsence of neurological signs other than spontaneous nystagmus (unidirectional, horizontal, obeying Alexander’s Law and enhancing with removal of optic fixation), a positive head-thrust test or a positive Romberg’s testAbsence of neurological symptoms or findings suggestive of alternative diagnosesTreatment must be initiated within seven days of the onset of symptoms.Exclusion criteriaExclude patients with any other cause of acute vertigo (e.g. Benign paroxysmal positional vertigo, Ménière’s disease)
12 Methods-2 Types of interventions Types of outcome measures Any corticosteroids (any timing, any dose, by oral/intravenous/intramuscular/ intratympanic route and of any duration), including medications such as prednisolone, dexamethasone, methylprednisolone, etc.Corticosteroids were compared to placebo, no treatment, any active intervention and/or any active comparator.Types of outcome measuresPrimary outcomesProportion of patients that recoverDegree of recovery (if appropriate) of peripheral vestibular function in patients with idiopathic acute vestibular dysfunction, through subjective patient reporting of symptoms, use of validated questionnaires, or objective evidence of recovery (e.g. electronystagmography, caloric testing and other vestibular function and balance tests), as defined by the authors.Secondary outcomesTime to recovery, including a return to normal activities and health-related quality of life measures (generic, or disease specific, or both).Patient-reported adverse events: severe and minor.A severe adverse event is defined as resulting in a patient discontinuing the medication and withdrawing from the study. A minor adverse event is defined as a side effect experienced by the patient but where they continue to take the medication.
13 Methods-3 Search methods for identification of studies Systematic searches for randomized controlled trials. There were no language, publication year or publication status restrictions. We contacted original authors for clarification and further data if trial reports were unclear. The date of the most recent search was 28 December 2010.Electronic searchesWe identified published, unpublished and ongoing studies by searching the following databases from their inception: the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 4); PubMed; EMBASE; CINAHL; LILACS; KoreaMed; IndMed; PakMediNet; CAB Abstracts; Web of Science; BIOSIS Previews; CNKI; mRCT; ClinicalTrials.gov; ICTRP and Google.Searching other resourcesWe scanned reference lists of identified publications for additional trials and contacted authors as necessary.
14 Methods-4 Data collection and analysis Selection of studies Two authors (JMF and CB)Data extraction and management Two authors (JMF and CB)Assessment of risk of bias in included studiesMeasures of treatment effectRisk ratio (RR) with 95% confidence intervals (CI)Mean differences (MD) and standardized mean differences (SMD) with 95% CIDealing with missing data intention-to-treat basisAssessment of heterogeneity Chi2 test and I2 statistic available in RevMan 5.1Assessment of reporting biasesData synthesis Review Manager 5.1Subgroup analysis and investigation of heterogeneitySensitivity analysis NOT appropriate if the number of included trials is low
15 本篇文獻的PICO(T) Patient / Problem Intervention Comparison Outcome Time Patients with vestibular neuritisInterventionCroticosteroidsComparisonPlaceboOutcomeComplete caloric recovery; The extent of caloric recovery; Symptomatic recovery of vestibular function (vertigo); Dizziness Handicap Inventory scoreTime24 hrs, one, three, six and 12 months
16 Results-1 RCT Total (corticosteroids/placebo) Ariyasu 1990 20 (10/10) 32 mg methylprednisolone/PO on the first day and then decreased to 4 mg graduallyover the next seven daysRezaie 200640 (20/20)18 mg dexamethasone daily/PO (6 mg TID/PO) for three days +100 mg dimenhydrinate daily for three days/ Placebo + dimenhydrinateShupak 200830 (15/15)Prednisolone 1 mg/kg daily/PO for five days, followed by reducing regimen for the next 15 days + Famotidine 20 mg dailyStrupp 200473 (35/38) 59 (29/30)100 mg methylprednisolone QD/PO, for three days, then tapered off to 10 mg over the next 19 days149 (74/75)
17 Results-2 Moderate, Grade B High, Grade C Moderate, Grade B
26 Results-11Although the results were significant, the risk of bias is high (Grade C for overall methodological quality) and the patient numbers small.
27 ConclusionsBased on the currently available data, there is insufficient evidence to support the use of corticosteroids in the management of patients with idiopathic acute vestibular dysfunction(vestibular neuritis).
28 搜尋Studies (PubMed) 資料庫： PubMed 搜尋日期：2015-02-09 搜尋關鍵字與策略： 搜尋前面Cochrane library那篇(2011)之後的文章(設定5年內)資料庫： PubMed搜尋日期：搜尋關鍵字與策略：(("Steroids"[Mesh]) OR "Glucocorticoids"[Mesh]) AND "Vestibular Neuronitis/therapy"[Mesh]
35 Clinical bottom line 臨床決策底線 回到臨床個案情境Clinical bottom line 臨床決策底線Overall, there is insufficient evidence from these trials to support the administration of corticosteroids to patients with idiopathic acute vestibular dysfunction (vestibular neuritis).使用類固醇與否，應考慮其可能的副作用，也應詳細 的與病人及家屬討論。
36 References:Fishman JM1, Burgess C, Waddell A. Corticosteroids for the treatment of idiopathic acute vestibular dysfunction (vestibular neuritis). Cochrane Database Syst Rev 2011;5:CDGoudakos JK1, Markou KD, Franco-Vidal V, Vital V, Tsaligopoulos M, Darrouzet V. Corticosteroids in the treatment of vestibular neuritis: a systematic review and meta-analysis. Otol Neurotol 2010;31:183-9.Strupp M, Zingler VC, Arbusow V, et al. Methylprednisolone, valacyclovir, or the combination for vestibular neuritis. N Engl J Med 2004;351:Shupak A, Issa A, Golz A, et al. Prednisone treatment for vestibular neuritis. Otol Neurotol 2008;29:
37 Kill or Update By（下次更新日期）: 結 論（臨床底線的精要敘述）There is insufficient evidence from these trials to support the administration of corticosteroids to patients with idiopathic acute vestibular dysfunction (vestibular neuritis).Kill or Update By（下次更新日期）:2016年 02月 11日