Foreground question Are corticosteroids more effective then placebo for improving vestibular function and relieving symptoms such as vertigo in patients with vestibular neuritis? Patient / Problem Patients with vestibular neuritis Intervention Croticosteroids Comparison Placebo Outcome Vestibular function; Symptomatic improvement (vertigo) 臨床個案的 PICO Type of Question: Therapy Clinical Uncertainty → PICO 問題
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Best available evidence: （挑選可獲得之最佳研究證據） Citation/s: Vestibular neuritis and labyrinthitis UpToDate Literature review current through: Jan 2015.| This topic last updated: Aug 09, Lead author's name : Joseph M Furman, MD, PhD
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 11 Lead author's name : Jonathan M Fishman
Methods-1 Types of studies: Randomized controlled trials Types of participants: ◦ Inclusion criteria Adults(> 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 days Absence of auditory symptoms or findings suggestive of alternative diagnoses Absence 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 test Absence of neurological symptoms or findings suggestive of alternative diagnoses Treatment must be initiated within seven days of the onset of symptoms. ◦ Exclusion criteria Exclude patients with any other cause of acute vertigo (e.g. Benign paroxysmal positional vertigo, Ménière’s disease)
Methods-2 Types of interventions ◦ 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 measures ◦ Primary outcomes Proportion of patients that recover Degree 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 outcomes Time 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.
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 ◦ Electronic searches We 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 resources We scanned reference lists of identified publications for additional trials and contacted authors as necessary.
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 studies ◦ Measures of treatment effect Risk ratio (RR) with 95% confidence intervals (CI) Mean differences (MD) and standardized mean differences (SMD) with 95% CI ◦ Dealing with missing data intention-to-treat basis ◦ Assessment of heterogeneity Chi 2 test and I 2 statistic available in RevMan 5.1 ◦ Assessment of reporting biases ◦ Data synthesis Review Manager 5.1 ◦ Subgroup analysis and investigation of heterogeneity ◦ Sensitivity analysis NOT appropriate if the number of included trials is low
本篇文獻的 PICO(T) Patient / Problem Patients with vestibular neuritis Intervention Croticosteroids Comparison Placebo Outcome Complete caloric recovery; The extent of caloric recovery; Symptomatic recovery of vestibular function (vertigo); Dizziness Handicap Inventory score Time 24 hrs, one, three, six and 12 months
RCT Total (corticosteroids/placebo) Ariyasu (10/10)32 mg methylprednisolone/PO on the first day and then decreased to 4 mg gradually over the next seven days Rezaie (20/20)18 mg dexamethasone daily/PO (6 mg TID/PO) for three days mg dimenhydrinate daily for three days/ Placebo + dimenhydrinate Shupak (15/15)Prednisolone 1 mg/kg daily/PO for five days, followed by reducing regimen for the next 15 days + Famotidine 20 mg daily Strupp (35/38) 59 (29/30)100 mg methylprednisolone QD/PO, for three days, then tapered off to 10 mg over the next 19 days 149 (74/75) Results-1
Otol Neurotol Feb;31(2): Cochrane Database Syst Rev May 11 Results-4 因使用 fixed-effect model ，而使統計上有顯著差異；但 I 2 =79% >50% ， 有 significant heterogeneity ，應使用 random-effects model 分析， 若改用 random-effects model 分析，就沒有統計上的顯著差異了。
Although the results were significant, the risk of bias is high (Grade C for overall methodological quality) and the patient numbers small. Results-11
Conclusions Based 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).
Clinical Expertise Best Research Evidence Patient Preferences
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。
References: 1. Fishman JM1, Burgess C, Waddell A. Corticosteroids for the treatment of idiopathic acute vestibular dysfunction (vestibular neuritis). Cochrane Database Syst Rev 2011;5:CD Goudakos 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: 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:
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