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神經內科 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading 報告人:梁均瑜 指導臨床教師:陳彥宇醫師 日期: 2015-02-11 地點: 83 病房討論室.

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Presentation on theme: "神經內科 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading 報告人:梁均瑜 指導臨床教師:陳彥宇醫師 日期: 2015-02-11 地點: 83 病房討論室."— Presentation transcript:

1 神經內科 實 證 期 刊 閱 讀 報 告 EBM-style Journal Reading 報告人:梁均瑜 指導臨床教師:陳彥宇醫師 日期: 地點: 83 病房討論室

2 Ask

3 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

4 Acquire

5 systems summaries synopses syntheses studies Computerized decision support Evidence based textbooks Evidence based journal abstract Systemic reviews Original journal articles UpToDate DynaMed ACP PIER BMJ Clinical Evidence ACP journal club Evidencebasedmedicine.com Cochrane Library BMJ Evidence Updates Other Systemic reviews ex: PubMed systemic reivew PubMed SUMsearch TRIP Google

6 搜尋 Summaries (UpToDate) 資料庫: UpToDate 搜尋日期: 搜尋關鍵字與策略: Vestibular neuritis

7 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

8

9 經由 UpToDate 的 reference , 找到 Cochrane library 的一篇 systemic review

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 11 Lead author's name : Jonathan M Fishman

11 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)

12 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.

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 ◦ 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.

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 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

15 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

16 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

17 Moderate, Grade B High, Grade CResults-2

18 Otol Neurotol Feb;31(2): Cochrane Database Syst Rev May 11 Results-3

19 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。

20 Results-5

21 Results-6

22 Results-7

23 Results-8

24 Results-9

25 Results-10

26 Although the results were significant, the risk of bias is high (Grade C for overall methodological quality) and the patient numbers small. Results-11

27 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).

28 搜尋 Studies (PubMed) 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] 搜尋前面 Cochrane library 那篇 (2011) 之後的文章 ( 設定 5 年內 )

29 在前面 Cochrane library 那篇 (2011) 之後,並沒有 RCT 比較 corticosteroids 和 placebo 對 vestibular neuritis 的效果。

30 Appraise

31 Grade down due to small sample size and moderate to high risk of bias

32 Apply

33 綜合上述,現在並沒有很強烈的建議 corticosteroids 用在 vestibular neuritis 的病人身上。雖然在某些 trial 顯示 cortisteroids 可改善短期的 vestibular function ,但長期來講並沒 有統計上的顯著差異;且早期的研究也顯示 caloric recovery 和 recovery of clinical symptoms 並沒有相關。此外,前面提到的 4 個 clinical trials ,其 sample size 都太小且也都存在一些 bias 。  但 UpToDate 的作者還是建議 corticosteroids 的治療 病人沒有 peptic ulcer 的 history 病人在急診打了 1 支 chlorpheniramine 和 3 支 NaHCO 3 後,症狀 完全沒改善。與病人及家屬詳細討論後,病人願意嘗試 corticosteroids 的治療。  治療隔天,症狀大有改善

34 Clinical Expertise Best Research Evidence Patient Preferences

35 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: 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:

37 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

38 Audit

39 我提出的問題是否具有臨床重要性? yes 我是否明確的陳述了我的問題? yes 我的 foreground question 是否可以清楚的寫成 PICO ? yes 我是否清楚的知道自己問題的定位?(亦即可以定位自己 的問題是屬於診斷上的、治療上的、預後上的或流行病學 上的),並據以提出問題? yes 對於無法立刻回答的問題,我是否有任何方式將問題紀錄 起來以備將來有空時再找答案? yes 我是否將搜尋到的最佳證據應用到我的臨床工作中? yes 我是否因此搜尋結果而改變了原來的治療策略?做了那些 改變? Yes 這篇報告,我總共花了多少時間? 14hr 我是否覺得這個進行實證醫學的過程是值得的? yes


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