Critical-Appraisal-Skills-Programme-(CASP)-秀传医疗社团法人秀传-

秀傳紀念醫院實證醫學中心

住院醫師升等實證醫學報告中醫部第一年住院醫師李容妙ForegroundQuestions「耳鳴患者，接受針灸治療與西醫常規治療或無治療相比，是否能使耳鳴症狀顯著改善？」現病史五十三歲男性患者，因三年前家中發生變故，開

始出現眠差情形，整日昏沉疲倦，兩年前開始出現兩耳高頻耳鳴(患者形容為金屬摩擦聲)，左耳較嚴重，整日皆有，無特殊加重或減緩因子。近四至五個月症狀加重，覺得耳鳴聲響愈大，難以忍受，經西醫耳鼻喉科檢查無異樣，並給與常規治療，但仍無明顯改善，因此前來本院針灸科求診。3過去病史Type2DM

--規律門診追蹤及服藥，控制良好無高血壓、心血管相關疾病或其他系統性疾患無開刀病史4神志清楚；頭面無明顯異常，視野無明顯缺損，眼球活動正常；呼吸平順，無喘鳴音；心跳規律，無明顯異常心音；腹部柔軟，無壓痛，無可觸及之硬塊，腹部扣診鼓音，腸音無躁進；四肢活動無限制；可觸及周邊動脈搏動無發燒，無淋巴結腫大，無水腫，無胸悶胸痛，無小便短少，無視力模糊，無感覺異常，無肌肉張力或肢體活動異常。系統性回顧理學檢查TypeofQuestion

TherapyPICOPatientorProblem耳鳴

Intervention使用針灸治療

Comparison西醫常規治療或無治療

Outcome耳鳴症狀減輕(包括客觀量表評估與主觀患者感受)

KeywordTinnitusacupunctureMeSHTinnitusacupunctureSearchStrategy文獻搜尋過程,keyword、布林邏輯Pubmed鍵入(tinnitus)AND(acupuncture)",搜尋結果共有95篇在頁面右上方頁面點選”systematicreviews”,共篩出13篇在多篇文獻中，考量能提供目前環境病患的治療方針，選擇最近期之文獻(第一篇)，作為本次可能評讀之文章CochraneLibrary使用advancedsearch

鍵入"tinnitus"inTitle,AbstractorKeywords

AND"acupuncture"inTitle,AbstractorKeywords

共有二篇文章，因皆屬於Protocol

review與我們想要的主題不符，因而捨棄不選。綜上所述，此次評讀文章選擇：Acupunctureinthetreatmentoftinnitus:asystematicreviewandmeta-analysis

LiuF1,HanX,LiY,YuS.,

EurArchOtorhinolaryngol.2014Oct25Citations標題：Acupunctureinthetreatmentoftinnitus:asystematicreviewandmeta-analysis作者：

FenyeLiu,XiuliHan,YunfengLi,ShudongYu期刊：EurArchOtorhinolaryngol,2014Oct25,DOI10.1007/s00405-014-3341-7EvidenceLevelLevel1aCriticalAppraisalSkillsProgramme

(CASP)：

SystematicReviewScreeningQuestions1.Didthereviewaskaclearly-focusedquestion?

YesConsiderifthequestionis‘focused’intermsof:thepopulationstudiedasystematicreviewandmeta-analysisofallavailablerandomizedcontrolledtrials(RCTs)usingacupuncture

totreattinnitus.theinterventiongivenorexposure

parallelRCTsoftinnituspatientswhichcomparedsubjectsreceivingacupuncture(oritsotherforms,suchaselectroacupuncture)tosubjectsreceiving

notreatment,shamtreatment,drugsorbasicmedicaltherapy.theoutcomesconsideredVisualAnalogueScale(VAS)subjectivesimplisticevaluations(better,normal,orworse)由上述各細項檢視，研究母群體、介入方式與療效指標均有明確提及，因此從本文描述中有看到一個明確焦點性問題的提出。2.Didthereviewincludetherighttypeofstudy?

YesConsideriftheincludedstudies:addressthereview’squestionOur

reviewremediedthatdeficiencybyincludingallrelevant

randomizedcontrolledtrials(RCTs)publishedinChinese

andconductingasystematicreviewandmeta-analysis,

criticallyevaluatingallofthecurrentlyavailableRCTsthat

usedacupuncturetotreattinnitus.haveanappropriatestudydesignAllthestudiesthatwereviewedincludedparallelRCTsof

acupuncture(oroneofitsotherforms,suchaselectroacupuncture)

comparedwithseveralalternatives,including

notreatment,shamtreatment,placebo,drugsorbasic

medicaltherapyinpatientswithtinnitus.RCTsthatcombined

acupuncturetreatmentwithotherinterventionsand

thencomparedthesewiththeotherinterventionsalone

werealsoincluded.Excludedfromthisstudywereanimalstudies,case–controlstudies,reviews,commentaries,letters,andstudies

thatexaminedotherassociations.Multiplepublications

reportingonthesameRCTsandthesamegroupsofparticipants

wereexcluded,aswereRCTsthatcompared

differentformsofacupunctureordifferentacupuncture

pointsandtrialsforthetreatmentofpointinjection.流程圖(見後頁)由上述各細項檢視，包含作者提出本研究收集所有(包含中、英文)的針灸治療耳鳴隨機對照試驗以及明確的納入、排除條件，並繪出清楚的研究設計流程圖，，因此本回顧文獻擁有正確的研究型態。Isitworthcontinuing?由上述兩題的檢視，合乎標準，此篇文獻值得繼續探討下去DetailedQuestions3.Didthereviewerstrytoidentifyallrelevantstudies?

YesConsider:whichbibliographicdatabaseswereusedThedatabaseswesearchedweretheChinaNetwork

KnowledgeInfrastructure(1979–2013),theChineseScientific

JournalDatabaseVIP(1989–2013),PubMed

(1966–2013),EMBASE(1974–2013)andtheCochrane

Library(Issue3,2013).iftherewasfollow-upfromreferencelists文中未提及iftherewaspersonalcontactwithexperts文中未提及ifthereviewerssearchedforunpublishedstudies文中未提及ifthereviewerssearchedfornon-English-languagestudiesOnlystudiesonhumansandineither

EnglishorChinesewereconsideredforinclusion.由上述各細項檢視，作者有提及資料庫的搜尋範圍以及語言限定(中英文皆收集)，但未針對相關文章更進一步的細節(含參考文獻的追蹤、專家的接觸面談或未出版文章的蒐集)，總結本文已有嘗試說明蒐集相關重要文獻的細部內容，但非能有完整呈現。4.Didthereviewersassessthequalityoftheincludedstudies?

YesConsider

ifaclear,pre-determinedstrategywasusedtodeterminewhichstudieswereincluded.Lookfor:ascoringsystem

Datafromthearticleswerevalidatedandextracted

usingapredefineddataextractionform.

Fortheassessmentofstudyquality,thetoolfromthe

CochraneHandbookforSystematicReviewsofInterventions

wasusedtoassessmethodologicalqualityofthe

trials.Foreachquestion,a‘yes’answerindicatedalow

riskofbias(Y),‘unclear’indicatedthattheriskofbiaswas

uncertain(U),and‘no’indicatedahighriskofbias(N).

Blindingtotheallocatedinterventionswasassessedseparately

forparticipantsandoutcomeassessors.Table3presentsasummaryoftheriskofbiaswithinthe18studiesincludedinthisreview.Biaswithinmoststudieswasofhighorofunclearrisktotheprimaryoutcome.Thiswasgenerallyduetopoorreportingofsequencegeneration,allocationconcealmentorblinding.文中有設立表格，說明偏差風險，分數的評量特別以VAS為outcome的研究，無法做到隱匿和盲性可能會影響結果之判讀，也會影響證據的等級。本研究中，也詳加描述各研究的品質程度。MorethanoneassessorThetwoauthors(SDYuandFYLiu)extracteddata

accordingtopre-definedcriteria.Discrepancieswerenoted

anddiscussedbetweentheauthorsandresolvedbyconsensus.

由上述各細項檢視，作者有提及檢視納入試驗的品質評估(有分是、未確定、否三個層級，但未有分數性的評分機制)，並經由兩位評估者進行檢視，因此回顧者有針對納入研究進行品質評估。5.Iftheresultsofthestudieshavebeencombined,wasitreasonabletodoso?

Yes

Considerwhether:theresultsofeachstudyareclearlydisplayedtheresultsweresimilarfromstudytostudy(lookfortestsofheterogeneity)舉例：The

resultsofthemeta-analysisshowedithadsignificantdifference

betweenacupunctureandshamtreatments.Analysis

oftheacupunctureandshamtreatments(measuredwith

simplyscoring)favoredtheregimen(RR=2.49,95%

CI=1.06–5.84).Thereweresignificantdifferences

betweenthesetwogroups(p=0.04),whilenoheterogeneity

existedbetweenthesetwoRCTs(I2=39.9%).thereasonsforanyvariationsinresultsarediscussedTheacupuncturepointsusedinthese18RCTsweredifferent;

thismaybebecauseofthespecificityofacupuncture

trials.Thenumberoftreatmentsessionsalsovariedfrom

studytostudy,althoughformostoftheRCTsconductedin

China,about30sessionswereheld.Thisvariablelikelyhas

aneffectontreatmenteffectivenessandfurthermorecould

bethereasonforunsatisfactoryresultsinstudiesinvolving

fewertreatmentsessions(suchasthoseEnglishstudies).由上述各細項檢視，包括各研究詳細的結果、研究之間的同質性以及可能影響分析結果的各研究變異性，作者均有提及，因此併合研究分析是合理的。6.Howaretheresultspresentedandwhatisthemainresult?Consider:howtheresultsareexpressed(e.g.oddsratio,relativerisk,etc.)由上表中可知研究結果以relativerisk作為呈現以此圖表為例，比較各研究針灸與一般西醫治療的差異性，以RR(relativerisk)為統計指標，並配合95％CI

(信賴區間)評估。各單獨研究，當RR在1的左右任何一端，且CI線不超越1的另一頭，視為有顯著差異。此外，在不同分組群裡，分別做出混合權重的統合分析，並以p-value評估顯著差異性，最後再做整體的統合分析，最終顯示RR=1.18,95%CI=1.02–1.37,p=0.03，表示針灸治療組與西醫一般醫療組相比是有顯著差異性的。howlargethissizeofresultisandhowmeaningfulitisThe18RCTsincluded1,086patients:580patientsineither

atraditionalacupunctureorelectricalacupuncturegroup

and506patientsinthecontrolgroup.Moststudieshad

relativelysmallsamplesizes.Onlytwohadmorethan100

samples.Meanageamongstudypatientswas

46years(rangingfrom18to72)and49%ofthepatients

weremales.Thecausesofthetinnitusreportedinthese

studieswerelargelyunknown.Thedurationoftinnitus

amongthepatientsvariedwidely,rangingfrom3daysto

30years.本研究完整性蒐集各國的針灸治療耳鳴臨床試驗，是至今最完整的一篇系統性回顧文章。howyouwouldsumupthebottom-lineresultofthereviewinonesentenceTheresultsofthisreviewsuggestthat

acupuncturetherapymayoffersubjectivebenefittosome

tinnituspatients.Acupuncturepointsandsessionsusedin

Chinesestudiesmaybemoreappropriate,whereasthese

studieshavemanymethodologicalflawsandriskbias,

whichpreventsusmakingadefinitiveconclusion.本系統性回顧說明針灸可能提供耳鳴患者有臨床實質性效益，但因過去臨床試驗研究存在許多方法學上的缺陷，因此未來若有更完整的臨床試驗，將提供更好的實證來說明針灸的療效性。7.Howprecisearetheseresults?Consider:ifaconfidenceintervalwerereported.Wouldyourdecisionaboutwhetherornottousethisinterventionbethesameattheupperconfidencelimitasatthelowerconfidencelimit?如右圖，表達針灸治療組與對照組是否有差異，有使用信賴區間，當在RR=1的右側側時，我們就會選擇CI的下限來看是否越過RR=1之線；當在RR=1的左側側時，我們就會選擇CI的上限來看是否越過RR=1之線，因此我們會端視情況來恰當使用信賴區間。ifap-valueisreportedwhereconfidenceintervalsareunavailable

如上圖所示，當無使用信賴區間表達時，p-value的適當統計評估，均有被使用到綜合上述，本研究的統計精準度是可被信賴的。8.Cantheresultsbeappliedtothelocalpopulation?

YesConsiderwhether:thepopulationsamplecoveredbythereviewcouldbedifferentfromyourpopulationinwaysthatwouldproducedifferentresultsIthad

differenceinacupuncturepointsandsessionsbetween

ChinesestudiesandEnglishstudies.yourlocalsettingdiffersmuchfromthatofthereviewWe

limitedoursearchtoreportswritteninChineseandEnglish,

whichmaycauseapotentialpublicationbias.Results

mighthavebeendifferentifwehadincludedreports

writteninKorean,Japaneseorotherlanguages;thiswould

haverequiredadditionallanguageskillsofourteam

members,agoalwhichwecanworktowardsforfuture

studies.youcanprovidethesameinterventioninyoursetting由以上細節檢視，本研究包含中文與英文試驗，且中文試驗多在中國執行，東西方族群的研究差異可供我們參考，這樣完整收納的文章，對應用於台灣患者的評估，是不錯的選擇，且裡面所提的研究設計也合乎台灣患者的治療模式，因此，本研究的結果，可作為我們解決臨床問題的一個良好參考。9.Wereallimportantoutcomesconsidered?

NoConsideroutcomesfromthepointofviewofthe:individualTheresultsofthisreviewsuggestthatacupuncturetherapy

mayoffersubjectivebenefittosometinnituspatients.

policymakersandprofessionals未提及

family/carers未提及widercommunityResults

mighthavebeendifferentifwehadincludedreports

writteninKorean,Japaneseorotherlanguages;thiswould

haverequiredadditionallanguageskillsofourteam

members,agoalwhichwecanworktowardsforfuture

studies由上述細節檢視，本研究結果，作者有推論於應用於個別患者的效益，並針對研究限制，推展未來的研究目標，如此可應用於更廣闊的族群上。但針對本研究可提供的醫療政策制定或對其家庭、照護的相關效益，作者並未表述，因此本研究並無將各面向之結果一一呈現。10.Shouldpolicyorpracticechangeasaresultoftheevidencecontainedinthisreview?

No

Consider:whetheranybenefitreportedoutweighsanyharmand/orcost.Ifthisinformationisnotreportedcanitbefilledinfromelsewhere?Datafromthe

articleswerevalidatedandextractedusingapredefined

dataextractionform.NearlyallofChinesestudiesreported

positiveresults,whilemostofEnglishstudiesreported

negativeresults.