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由順勢療法研究所院 (HRI) 回應澳洲NHMRC報告

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由順勢療法研究所院 (HRI) 回應澳洲NHMRC報告            
Response by the Homeopath Research Institute to Australian NHMRC report
Effectivenessof         Homeopathyfor Clinical Conditions:Evaluation of the Evidence’.
Overview Reportprepared for the National Health and Medical Research Council (NHMRC) Homeopathy Working Committee by Optum,October 2013
順勢療法對於臨床狀況的有效性:證據評估」。
為國家衛生與醫學研究評議會 (NHMRC)順勢療法工作委員會準備的概述報告
Optum,2013年10月

The Homeopathy ResearchInstitute (HRI) welcomes attempts to critically evaluate the evidence base for homeopathy,providing this is done accurately and objectively. Unfortunately the recently published‘Overview Report’ by Australia’s National Health and Medical Research Council (NHMRC)fails on both counts: it does not accurately reflect the findings of the originalresearch studies in homeopathy and its conclusion that the evidence ‘fails to demonstratethat homeopathy is an effective treatment for any of the reported clinical conditions’is seriously misleading. Responses in the media have further misconstrued this conclusion,implying either that there are no positive studies showing that homeopathy is effective,or that the evidence shows homeopathy is no better than placebo – neither of whichare true.
順勢療法研究所 (Homeopathy Research Institute, HRI)歡迎同行嘗試審慎評估順勢療法的實證資料庫,只要符合精確和客觀這兩項條件。不幸的是,最近由澳洲國家衛生和醫學研究評議會(NHMRC) 出版的「概述報告」,未能在準確性及客觀性這兩方面達到合理標準:它不能準確地反映原本研究報告在順勢療法的調查結果,而且在結論中聲稱:證據「不能證明順勢療法是一種對任何記錄在案的臨床狀況有效之治療方法」,此結論會嚴重誤導讀者。而媒體的反應更進一步曲解這個結論,暗示著「沒有正面研究結果顯示順勢療法有效」,或暗示「有證據指出順勢療法比不上安慰劑」——然而兩者都不是真實的。

HRI applauds theNHMRC’s decision to assess the evidence by individual clinical condition – an approachwhich makes this report far more useful than the negative pseudo-­‐scientific ‘EvidenceCheck 2’ report in 2010 published by the UK House of Commons Science and TechnologySelect Committee1. The report is needed and timely, following on fromthe Swiss HTA report in 20062,3, which concluded in favour of the existenceof clinical effects of homeopathy but was criticised, by some, on methodologicalgrounds.  
  HRI讚揚NHMRC以個別臨床情況來評估證據的決定,這種方法可以令該報告比那份負面的偽科學報告(2010年由英國下議院科技特別委員會出版的「實證檢查2」報告)有用得多。此報告是必要和切合時宜的,由於瑞士在2006年HTA的報告2,3中,贊同順勢療法存在臨床效果,但卻被某些人以方法論的理由予以批評。

However, sadly theNHMRC made a critical mistake in the way they analysed the evidence, which explainshow they reached their inaccurate conclusion that there is no ‘reliable’ evidencethat homeopathy is effective for any of the 61 conditions under consideration. Inthis systematic review of systematic reviews, the NHMRC have considered the resultsof all trials for one condition togetheras a whole, despite the fact that the individual studies were testing differenttypes of homeopathic treatment.
  然而,可悲的是NHMRC在分析證據時犯了一個關鍵性錯誤,這能夠解釋為何他們會得出那不準確的結論——就是斷定沒有「可靠」證據證明,順勢療法對被審視的61個疾病情況有效。這是一個針對多個系統評審 (Systematic Review)而進行的系統評審,儘管事實上每個獨立的研究,正在測試不同類型的順勢療法處理,NHMRC卻把針對一種疾病狀況的所有試驗結果視為一個整體

The NHMRC reviewersasked, “Is homeopathy effective for condition Y?’, working from the premisethat a positive trial showing that one homeopathic treatment is effective is somehownegated by a negative trial which shows that a completely different homeopathictreatment for that same condition is ineffective.
  NHMRC的評審問道:「順勢療法在疾病Y中是否有效?」,而他們工作的前提是,如果有一個正面的試驗顯示順勢療法治療有效,有時卻為了某些原因,在同一疾病上出現負面的試驗結果,他們就會否定該疾病的其他正面試驗之有效性;然而,那些負面試驗中所使用的順勢療法處理,與在正面試驗中使用的,卻可以是完全不同。

This is a bizarreand unprecedented way of assessing scientific evidence. In conventional researchthe question asked would be, “Is treatment X effective for condition Y?”,not “Is conventional medicine effective for condition Y?” based on combiningthe results of all drug trials together.
  這種評估科學證據的方式,是相當離奇和前所未見的。在傳統醫藥的研究中,要探討的問題是:「藥物X對疾病Y是否有效?」,而不是把所有藥物試驗的結果集合在一起,然後評論傳統醫學對於疾病Y是否有效?」

Some treatments work,some don’t. The whole point of medical research is to establish which treatmentsare useful and which are of no value. This is no different in homeopathy.  
  有些治療有效,但有些則不然。醫學研究的根本意義,就是在於確定哪些治療有用,而哪些是沒有價值的。在順勢療法領域之中也當然無異。

Unfortunately thisbasic error by the NHMRC means that their findings tell us nothing about which homeopathictreatments do and don’t work for specific conditions, making this whole exerciseof questionable value.
不幸的是,NHMRC犯下如此基本的錯誤,意味著他們的研究結果,並不能告訴我們順勢療法在特定疾病狀況中,到底有沒有效,致使這整份報告的價值成疑。

When one looks atthe evidence appropriately – by specific treatment – there is evidence which meetsthe NHMRC’s inclusion criteria (good quality prospective, controlled studies), whichdemonstrates effectiveness for certain homeopathic treatments for several conditionse.g.  
只要正確地閱讀實證數據——以獨有的處理方式——也就可以找出符合NHMRC納入條件的數據(高質素、前膽性、對照實驗),足以證明某些特定順勢療法藥物,對於好些疾病有正面療效,例如:

•        individualised homeopathic treatmentfor diarrhoea4 and otitis media5,6 in children,
•        個人化的順勢療法治療對於兒童腹瀉4和中耳炎5,6有正面療效,
•        two different non-individualisedtreatments for allergic rhinitis – the homeopathic medicine Galphimia glauca7and the isopathic medicine Pollen 30c,8  and  
•        兩種不同的非個人化順勢療法治療對於過敏性鼻炎有正面療效——分別是順勢療法療劑金英樹  (Galphimia glauca) 7以及同源療劑藥花粉 (Pollen)30c8,以及
•        the non-individualised complex homeopathicmedicine Vertigoheel for vertigo.9
•        非個人化的順勢療法成藥Vertigoheel治療眩暈9有正面療效。

Itis imperative that the NHMRC either acknowledge the serious error they have madeby analysing mixed data sets in this way and amend their Overview Report accordingly,or provide justification as to the scientific validity of their work. Without this,it is hard to see any value in their findings concerning effectiveness of homeopathy.
最重要的是,NHMRC既不承認他們在分析混合數據集的方式上出了嚴重錯誤,並且根據此分析來修改他們的概述報告;亦沒有提供他們研究結果的科學有效認證。如果沒有這些,就很難在他們的研究結果(關注順勢療法有效性)中找到任何價值。

A second key reasonwhy the NHMRC reviewers found ‘no reliable evidence’ that homeopathy is effective,is the definition they used for ‘reliable evidence’.
  NHMRC評審發現「沒有可靠證據」證明順勢療法有效的第二個重要原因是,他們對「可靠證據」所下的定義。

Although certainelements of their definition are reasonable e.g. flaws in poor quality studies,the NHMRC also dismissed high quality positive studies as being ‘unreliable’ ifeither of the following applied:  
  雖然他們的定義中,有某些元素是合理的,例如:低質素研究中存在缺點,但是,NHMRC卻以「不可靠」為名,同時把高質素的正面研究也拒於門外,只要符合下列任何一項就會被他們定義為「不可靠」:

•      The number of participants in the trial was less than 150 (even in instanceswhere the results were statistically significant, in which case the number of participantswas sufficient)
•      The study had been repeated multiple times by one research team, butnot yet been repeated by another independent team, or a single study had not yetbeen repeated.
•      該試驗的參與者人數少於150(即使研究結果在統計學上已相當明顯,而且參與者數目在這情況下也是足夠的)。
•      該研究經由同一個研究團隊重複多次,但卻未經另一個獨立團隊重複,或者是尚未被重複的單一研究。
The NHMRC need tojustify their use of n=150 as a line between reliable and unreliable and they certainlyneed to explain why size is relevant at all when the findings are statisticallysignificant.
  NHMRC有必要說明他們使用N=150作為可靠和不可靠之界線,是有甚麼根據?他們當然也須要解釋,在統計學上已有顯著結果的研究中,規模大小有甚麼關係?

The HRI does notdispute the fact that positive studies should be replicated (ideally by multipleindependent research team), but we do dispute the NHMRC’s failure to identify thesepositive studies in their Information Paper as promising studies which should berepeated.  
  HRI並不反對「正面研究應該被複製」的事實(最理想是由多個獨立的研究團隊來進行),然而我們反對的是——NHMRC並沒有在他們的資料文件中向公眾提出這些正面研究,這些都是最有潛力的研究方向,應該要被重複測試。

The NHMRC have draftedan Information Paper, based on the findings of their Overview Report, targeted atthe general public. In this document they again state that they found “no reliableevidence” for the conditions considered. As the public are likely to interpret thisas meaning that there are either no trials for that medical condition, or that thetrials that exist are flawed in some way, the NHMRC has severely mislead the publicon this issue.  
NHMRC根據他們概述報告中的調查結果起草了資料文件,目標是廣大市民。在這份文件中,他們再次指出,他們在那些疾病中發現「沒有可靠證據」。公眾很可能會將此解釋為,這意味著(1)沒有那疾病的臨床試驗,或(2)在某種程度上,現存的試驗是有缺陷的,NHMRC在這個問題上已經嚴重誤導公眾。

A more transparentappraisal would have identified the conditions for which good quality studies existshowing that certain homeopathic treatments are effective, but stating that thesestudies need to be repeated to confirm the findings before definitive conclusionscan be drawn. The NHMRC conducted a public consultation on this draft InformationPaper, inviting external input as to whether the information provided clearly outlineshow the evidence was reviewed and interpreted. HRI gave input to this consultationidentifying various concerns, most of which can be summarised by our recommendationsregarding amendment of the Overall Finding paragraph. This currently reads as follows:
  一份更加透明的評估,會指出現時在甚麼疾病中,已有高質素研究存在,展示某些順勢療法處理是有效的,同時亦指出:在獲得最終結論之前,這些研究需要被反複進行以確認結果。為了該資料文件的草案,NHMRC曾進行公眾諮詢,說要聆聽外部意見,看看資料是否能夠明確概括,要如何評審和解釋當中的實證數據。HRI曾於諮詢中提供了意見,指出種種問題,其中大部分可以由我們對「總結研究」那段落的修正建議中反映出來。

內容如下:

‘There wereno health conditions for which there was reliable evidence that homeopathy was effective.No good-quality, well‐designed studies with enough participants for a meaningful resultreported either that homeopathy caused greater health improvements than a substancewith no effect on the health condition (placebo), or that homeopathy caused healthimprovements equal to those of another treatment.’
  「沒有任何疾病狀態,有可靠的證據表明順勢療法有效。沒有高質素、設計良好、有足夠參與者的研究能夠得到有意義結果,以證明順勢療法與在健康狀況上無效果的物質(安慰劑)相比,可造成更大的健康改善,或順勢療法引起的健康改善,會等同於另一種治療方法。」

In order for thisOverall Finding to clearly reflect how the evidence was reviewed and interpreted,HRI has suggested that it be changed to read as follows:  
  為了使整體研究可清楚地反映證據是如何被評審和詮釋,HRI已建議將以上內容改為如下:

‘For the 61 health conditions considered, if we consideronly prospective, controlled trials published in English, and discount all trialswith less than 150 participants (even if they had positive statistically significantresults), and if we discount positive trials that have not yet been repeated byother teams of researchers, and if we then combine all trial results for each condition,we can say that there was no reliable evidence demonstrating that homeopathy waseffective.’
「於那61個受審查的疾病中,如果我們只考慮以英文出版的、前瞻性的、對照試驗,再減除了所有少於150人的試驗(即使它們有顯著的正面統計學結果),以及減除了所有正面的、只是未及被其他研究團隊重複的試驗,還有,我們要為每個疾病結合所有不同處理方式的試驗結果,那我們可以說,沒有可靠的證據表明,順勢療法是有效的。
Having alerted theNHMRC to these concerns via the public consultation process, we look forward tohearing their response, along with either justifications for their approach or detailsas to how these problems will be corrected before the Information Paper is finalised.
  在公眾諮詢的過程中,已經提醒了NHMRC必須關注這些問題,我們期待聽到他們的回應,無論是為他們的做法加以辯解,又或者是如何在資料文件定稿之前,糾正這些問題細節。

Overall, the factthat the reviewers found a lack of definitive positive evidence of effectivenessfor homeopathy in specific conditions is not surprising, as this is a common resultwith systematic reviews: for example, 49% of systematic reviews on conventionalmedicine reach similar ‘inconclusive’ conclusions and 96% recommend further research.10Furthermore, of 2500 treatments with good evidence used within the NHS, only 15%have been shown to be clearly ‘beneficial’, showing that the evidence base for mosttreatments needs further development.11  
  總體而言,評審員發現到,順勢療法在特定疾病下缺乏確定性正面證據是不足為奇的,因為這是系統評審的常見結果:例如,在傳統醫學的系統評審中,有49% 達到類似這般「非確定性」結論,有96% 建議應該要進一步研究10。此外,在NHS內有2,500種治療擁有「可靠證據」,卻只有15% 已被清楚證明是「有助益的」,可見對於大部分的治療而言,實證數據都需要進一步發展。

The HRI does howeveragree with the NHMRC’s conclusion that,  
不過,HRI對於NHMRC以下這句結論,確實表示同意,

“There isa paucity of good-­‐quality studies of sufficient size that examine the effectivenessof homeopathy….”.  
就探討順勢療法有效性的研究而言,現時高質素、規模充分的研究並不足夠.....。」

Due to a lack of funding, most homeopathy researchstudies involve small numbers of participants and, as we have seen here, many positivestudies are dismissed on this basis alone. As the funding available for researchin homeopathy is minuscule compared to that dedicated to conventional medical research,homeopathy finds itself in a Catch 22situation – critics say there is a lack of evidence of effectiveness because theexisting trials are too small, then use this ‘lack of evidence’ to say funding shouldnot be provided for future studies. As for raising standards in research, this isan issue across the board. Only one study has ever looked directly at the qualityof trials, comparing matched studies of homeopathy and conventional medicine, andthe results showed that the homeopathy studies were, in fact, of higher qualitythan  comparable trials from conventionalmedicine (19% of the homoeopathy trials were assessed as ‘higher quality’ comparedto 8% of the conventional-­‐medicine trials).12
由於缺乏資金,大多數順勢療法臨床研究都只能包括少數的參與者,正如我們在這裡看到的,許多正面研究就是單單由於這個原因而被剔除。提供順勢療法研究的資金,與分配給主流醫學研究的相比,實在有著天淵之別,順勢療法處於一個兩難境地——批評者說缺乏有效證據,因為現有的試驗規模太小了,然後利用這個「缺乏證據」的原因,去說服社會不應為今後的研究提供資金。至於提高研究標準,這是一個人人有責的問題。過去就只有一份研究直接針對探討試驗的質素,比較主流醫學與順勢療法的相對應研究,結果顯示:順勢療法研究事實上是比傳統藥物試驗的質素更高(19%的順勢療法試驗被評為「較高質素」,而主流醫學試驗中只有8% 達此水平)。12

In short, the NMHRCreport has highlighted the need for a level playing field i.e.
•      Sufficient funds need to be made available to conduct high quality, large-scale trials to test the most promising homeopathic treatments (suchas those identified above), and  
•      The existing evidence base needs to be assessed using the same scientificmethods used to assess conventional treatments.
總之,NMHRC報告突顯出必須要有一個公平的競爭環境,即是:
•     提供足夠資金以進行高質素、大規模試驗,以測試最有潛力的順勢療法治療(例如以上提及的),以及
•     評估現有實證數據庫的方法,必須與用於評估主流醫療的科學方法相同。

Only by taking thisfresh, fair approach can we move past the current impasse in the decades-old debate surrounding homeopathy and conduct research which providesthe public, healthcare providers and decision-makers with truly useful information about the clinical value of homeopathy.
  唯有採取這種嶄新、公平的方法,我們才可走出圍繞順勢療法數十年的爭辯僵局,進行研究以向公眾、醫療服務提供者和決策者,提供關於順勢療法臨床應用價值真正有用的信息。

References

1.     Great Britain, Parliament, House of Commons &Science and Technology Committee. Evidencecheck 2:       homeopathy. (TSO, 2010).
2.     Bornhöft, G. et al. Effectiveness, safety and cost-­‐effectiveness of homeopathyin general practice -­‐  
   summarizedhealth technology assessment. Forsch. Komplementärmedizin2006 13 Suppl 2, 19–29  
    (2006).
3.     Bornhöft, G. & Matthiessen, P. Effectiveness, safety and cost-­‐effectivenessof homeopathy in general       practice. (Springer, 2011).
4.     Jacobs et al, Homeopathy for childhood diarrhea:combined results and metaanalysis from three
    randomized,controlled clinical trials, Pediatr Infect Dis J, 2003;22:229–34
5.     Jacobs, J., Springer, D. A., et al. (2001). "Homeopathictreatment of acute otitis media in children: a
      preliminary randomized placebo-­‐controlled trial."The Pediatric infectious disease journal 20(2): 177-­‐
183.
6.     Sinha et al. Randomised controlled pilot study tocompare Homeopathy and conventional therapy in        AcuteOtitis Media. Homeopathy 2012, 101: 5-­‐12.
7.     Wiesenauer and Lüdtke. A meta analysis of the homeopathictreatment of pollinosis with Galphimia       glauca. Forsch. Komplementärmed. 1996;3: 230-­‐234
8.     Reilly, D. T., Taylor, M. A., et al. (1986). "Ishomoeopathy a placebo response? Controlled trial of   
      homoeopathic potency, with pollen in hayfever asmodel." Lancet 2(8512): 881-­‐886.
9.     Schneider et al. Treatment of vertigo with a homeopathiccomplex remedy compared with usual  
      treatments – a meta-­‐analysis of clinical trials,Arzneim.-­‐Forschung 2005, 55(1) 23-­‐29.
10.  El Dib, R. P., Atallah,A. N. & Andriolo, R. B. Mapping the Cochrane evidence for decision making inhealth  
   care. J. Eval.Clin. Pract. 13, 689–692 (2007).
11.  Garrow, J. S. Howmuch of orthodox medicine is evidence based? BMJ 335, 951–951 (2007).
12.  Shang, A. et al. Are the clinical effects of homoeopathyplacebo effects? Comparative study of placebo-­‐       controlled trials of homoeopathy and allopathy.Lancet 366, 726–732 (2005).
Authors: Rachel Roberts,Dr Alexander Tournier, Alastair Gray
For further informationplease contact us at info@HRI-­‐research.org or visit www.HRI-­‐research.org.







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