順勢療法討論區 Homeopathy Discuss!

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admin 發表於 2017-7-7 23:01:04 | 顯示全部樓層 |閱讀模式
Complaintto the Commonwealth Ombudsman regarding the National Health and MedicalResearch Council (NHMRC) assessment of homeopathy, 2010- 2015
向聯邦申訴專員控訴有關國家衛生與醫學研究評議會 (NHMRC) 對順勢療法的評估(2010-2015)
- Complementary MedicinesAustralia (CMA)
- 澳洲補充醫學學
- Australian HomœopathicAssociation (AHA)
- 澳洲順勢療法醫學
- Australian Traditional MedicineSociety (ATMS)
- 澳洲傳統醫學學

Executive Summary

Between October 2010 and March 2015 the National Health and Medical Research Council(NHMRC) conducted an investigation into homeopathy, to inform the Australiancommunity on the “effectiveness of homeopathy.” This investigation was anexample of NHMRC’s function to ‘advise the community’ under section 71〕〔aof the NHMRC Act 1992. It was instigated under the NHMRC Strategic Plan2010-2012 “to examine the evidenceunderlying the alternative medicines most highly used” and culminated in aformal review of the evidence for effectiveness of homeopathy (the HomeopathyReview).
  在 2010 10 月至2015 3 月之間,國家衛生與醫學研究評議會 (NHMRC) 對順勢療法執行了一項調查,目的是要告訴澳洲民眾關於「順勢療法的有效性」。這項調查是NHMRC 行使忠告公眾(Advisethe community)此功能的一個示範(制定在NHMRCAct 1992 71〕〔a之下),調查的誕生是以NHMRC2010-2012 審視最高使用率的替代療法之證據的戰略計劃作為出發點,並最終以一份關於順勢療法有效性證明的正式評審作為結束(順勢療法評審)。

NHMRC’s findings were that, for the 61 health conditions covered by the Review, “…no good-quality, well-designed studieswith enough participants for a meaningful result reported either thathomeopathy caused greater health improvements than placebo, or caused healthimprovements equal to those of another treatment”.
      NHMRC的發現如下——對於包含在評審內容中的 61 個健康狀況,「沒有高質素、設計良好的研究,也沒有足夠參與者來構成有意義結果,以證明順勢療法比安慰劑更能對健康造成改善,也不能證明順勢療法引起的健康改善,等同於另一種治療方法。」

Their overall conclusion, based on this assessment of the evidence was that, “…there are no health conditions for whichthere is reliable evidence that homeopathy is effective.”

NHMRC’s media release announcing publication of the Review claimed that, “The conclusion is based on the findings ofa rigorous assessment of more than 1800 papers” and was accompanied by astatement presenting their interpretation of the results as, “Homeopathy should not be used to treathealth conditions that are chronic, serious, or could become serious.”
    NHMRC透過媒體發佈的評審出版物內聲稱:「所得結論是根據對超過1,800 份實驗之嚴格評估後的結論,同時,亦把所有調查結果表成以下的陳述:不應使用順勢療法來治療慢性、嚴重、或有可能變得嚴重的健康狀況。

The potential impact of an evidence review by a respected institution such as NHMRCcannot be overstated – the general public, health practitioners,decision-makers and other researchers all rely on their findings. It istherefore essential that NHMRC reviews are free from bias, providing a fair andobjective assessment of a given topic. Risk of bias is normally minimised bythree key safeguards:
  由 NHMRC 那樣備受尊崇的機構所執行之實證評審,說它潛在影響深遠一點也不為過——一般公眾、健康從業人員、決策者和其他研究員都會信賴他們的研究結果。因此,NHMRC進行的所有評審,都必須是不帶任何偏見,目的是對選定的議題,提供一個公正和客觀的評估。構成偏見的風險,可以透過以下三個重點預防措施來減至最低:

1.  Use of standardisedand accepted scientific methods

2.  Internal policies andprocedures e.g.adherence to NHMRC legislation, standards, guidelines and conflict of interestpolicy
2.內部政策和程序——例如:嚴守NHMRC 法規、標準、指導方針,以及利益衝突申報之政策;

3. Transparency andaccountabilitye.g. public disclosure of processes followed, meaningful public consultationand accurate communications to the public.

It is our contention that in the case of the NHMRC Homeopathy Review all three safeguards were breached,exposing the process to unacceptable levels of anti-homeopathy bias – evidentin both its administrative and methodological aspects – which led directly todistortion of the Review results. Key examples of this bias are outlined below:
  我們認為是次NHMRC 的順勢療法評審完全違反這三項預防措施,讓評審過程陷於反對順勢療法的偏見,達至令人不可接受的程度,在行政及方法這兩個層面顯然出現的偏見,直接扭曲評審的結果,此等偏見的關鍵例子列舉如下:

In December 2010 the NHMRC agreed a draft position statement, describinghomeopathy as ‘unethical’,‘inefficacious’, ‘implausible’ and even ‘deceptive’.This statement was prepared without any scientific evaluation of homeopathy byNHMRC, being based solely on the findings of a single non-academic reportprepared by a committee of Members of Parliament in the UK. This anti-homeopathyposition on the part of NHMRC was echoed in an article published around thesame time by its CEO Professor Anderson who described homeopathy as “a retreat from reason” and “an alleged therapy”. In the wake ofcriticism relating to bias and lack of procedural and scientific rigourfollowing leak of this draft statement into the public domain, NHMRC initiateda formal investigation into homeopathy, instigated by Professor Anderson.
     在2010 年12 月,NHMRC議定了一份立場聲明草稿,內容描述順勢療法是不道德沒有效力難以置信,甚至是騙人的。這份聲明是 NHMRC 在沒有任何科學評估的情況下起草,只是單憑一份由英國下議院委員會 (Committee of Members of Parliament) 提出的非學術報告,運用當中的結果來發表。由NHMRC 所作出的反順勢療法立場,與當時差不多同期出版的文章產生回響,那是一篇由 NHMRC 執行長安德森教授(Professor Anderson) 撰寫的文章,他把順勢療法形容為理性的倒退、以及聲稱的療法。這份聲明草稿被泄漏至公眾之後,NHMRC被批評帶有偏見、缺乏程序和科學精確性,於是在安德森教授的推波助瀾下,NHMRC 對順勢療法展開了一項正式的調查。

Professor Anderson appointed an expert overviewcommittee for the Review that was compromisedby conflicts of interest and bias from the outset. This Homeopathy WorkingCommittee (HWC), which was directly involved in deciding how the evidence wasanalysed and interpreted, was initially chairedby Professor Peter Brooks who signed a Declaration of Interest (DOI) form,declaring he was not “affiliatedor associated with any organisation whose interests are either aligned with oropposed to homeopathy,” despite being a member of the anti-homeopathymedico-political lobby group Friends of Science in Medicine (FSM). The CEOappointed Professor Brooks as Chair after being notified by letter of FSM’sattempt to influence NHMRC reviewers. After the conflict was exposed, althoughProfessor Brooks stood down as Chair, the CEO/NHMRC supported his continuingpresence as an active member of the HWC for the duration of the Review.
     安德森教授委派的那個專家綜述委員會來進行是次評審從一開始已經出現利益衝突與偏見的問題。這個順勢療法工作委員會 (Homeopathy Working Committee, HWC)直接參與決定要如何分析和詮釋證據,最初是彼得布魯克教授(Professor Peter Brooks) 擔任主席,他簽署了一份利益聲明表 (DOI form),聲明他不是隸屬於任何機、或與任何機構掛鉤,他的利益也不會與助長或打壓順勢療法有關,不過他事實上是「醫學科學之友」 (Friends of Sciencein Medicine, FSM) 的一名成員,「醫學科學之友」是一個反順勢療法政治-醫學的院外遊說團。執行長安德森教授以書面知悉FSM 試圖影響NHMRC 評審員之後,仍然委任布魯克教授擔任主席。當此利益衝突被揭發之後,布魯克教授雖然下台,但NHMRC 執行長安德森教授依然支持他繼續出席,在整過評審期間於 HWC 擔當活躍成員。

The HWC also failed to contain a singleexpert in either homeopathy or homeopathic research; exclusion of a topicexpert is unprecedented in NHMRCprocesses of this kind and is in breach of NHMRC guidelines and policiesinforming appointments to its expert committees.
     同時,HWC連一名順勢療法或順勢療法研究專家也沒有;NHMRC 在進行這種程序中,將議題專家排斥在外是史無前例的做法,這樣任命其專家委員會職位已違背 NHMRC 的指引和政策。

The HWC carried out the formal review of the evidence for effectiveness ofhomeopathy twice, under two different external contractors. NHMRC’s claim thatthe first review, which appears to have found positive evidence for theeffectiveness of homeopathy, was rejected on grounds of poor quality, not itsresults; this is despite the review being conducted by a highly experienced andreputable reviewer who is co-author of NHMRC’s own Additional Levels of Evidence and Grades for Recommendations forDevelopers of Guidelines guidance document. The existence of this first review (final draft completed in August2012) was hidden from the public andNHMRC continues to refuse to disclose details of this review and why it wasterminated.
     HWC 曾經兩度完成關於順勢療法效用證據的正式評審,分別是在兩個不同的外部承辨專家管理下進行,第一份評審似乎發現到順勢療法效用的正面證據,但是遭到否決,NHMRC 聲稱是由於它的品質惡劣,而不是因為它的結果;然而這第一份評審是由一位富有經驗、聲譽良好的評審員進行,他曾與 NHMRC 合著其機構的指引文件《建議的附加證據水平及等級,給指引訂製者的指引文件》(AdditionalLevels of Evidence and Grades for Recommendations for Developers of Guidelinesguidance document),這是NHMRC 自己本身的出版物。NHMRC 曾向公眾隱了第一份評審報告(最終草案於2012 年8 月完成),而NHMRC 至今仍舊拒絕透露這份評審的內容細節,以及它何以會被終止。

The method used for assessing the evidence the second time (resulting in the finalpublished Homeopathy Review), was not a ‘standardised accepted method’; it wascreated specifically for this Review by NHMRC. The approach hinged on theirunique definition of ‘reliable’ evidencei.e. for a trial to be ‘reliable’ it had to have more than 150 participants andmeet an unusually high standard of trial quality (scoring 5 out of 5 on the‘Jadad’ quality rating scale or equivalent on other scales). All trials whichfell below either of these thresholds were disregarded as being of ‘insufficient size and/or quality to warrantfurther consideration of their findings’ (Overview Report, p.38). NHMRC’squality threshold for a ‘reliable’ trial is highly unusual, but their decision to set a minimum ‘samplesize’ of 150 participants for trial reliability was completely arbitrary,unprecedented and cannot be justified scientifically.
     第二次用來評估證據的方法(結果出版成為順勢療法評審的最終版本),並不是一種「被公認的標準化方法」;而是 NHMRC 專門為了這份評審而創造的。該方法的重點是他們對可信賴證據的獨特定義,即是:一項試驗要被評為「可靠」,就必須要擁有多於 150 名的參與者,而且要達到異常高的實驗品質(在「Jaded」評分量表中要得到5 分滿分,又或是在其他評分量表中得到同等成績)。所有無法到達這些門檻的實驗都會被棄之不理,它們的「規模和/或質量不足以讓他們的結果受到任進一步的考量(概述報告,p.38)。NHMRC對於「可靠」試驗所訂之品質門檻十分不尋常,然而,他們把可靠試驗的樣本人數設定為最少 150 名參與者,完全是隨心所欲、史無前例的,而且也沒有科學方法可以證明這是正確的。

When explaining their decision to classify trials with less than N=150 as being‘small’ or ‘very small’, NHMRC refer to an article in the highly respectedjournal BMJ1. NHMRC said: “HWC considered the following study in thedevelopment of these thresholds: Influence of trial sample size on treatmenteffect estimates: meta-epidemiological study.” (Overview Report Appendices,p.274). This implies that their decision to dismiss trials smaller than N=150as ‘unreliable’ is scientifically justified by this paper. It is not. NHMRCcorrectly describe most of the homeopathic trials they assessed as using‘continuous outcomes’, yet the BMJpaper states categorically that its findings cannot be applied to trials ofthis kind.
      至於何以會將少於N=150 的試驗分類為「小」或「非常小」,NHMRC在解釋他們的決定時,引用了一份受到高度尊崇的期刊《英國醫學期刊》(BMJ) 1。NHMRC 說:HWC在製定這些門檻中時參考了以下研究:試驗中樣本人數對於治療效果的影響:薈萃流行病學研究。(概述報告附錄,p. 274)。這意味著,可以從這份參考文獻中證明他們將少於N=150 的試驗視為「不可靠」之決定是合乎科學的,但其實並不然。NHMRC正確地描述出大部份他們評估過的順勢療法試驗都運用了「連續性的成果衡量指標」,然而BMJ 的文章卻直截了當的指出,他們的結果不適用於這類實驗。

NHMRC use this citation of the BMJ study against the N=150 threshold multiple timesacross the final report documents released to the public, who would notquestion that an expert body such as NHMRC would make such a fundamental errorand/or intentionally publish misleading information.
  NHMRC在最終出版的報告文件中,多次引用BMJ 的這篇研究來支持N=150 這個門檻,誰又會去懷疑,如NHMRC 這類的專家團體,竟然會犯如此基本的錯誤,和/或故意向公眾出版誤導性質的資訊。

 樓主| admin 發表於 2017-7-7 23:09:04 | 顯示全部樓層
In NHMRC’s 2015 media release they further misled the public by stating that “more than 1800” papers underwent “rigorous assessment”, implying that their conclusions were based on a thorough examination of this exhaustive body of evidence. In fact, although 1863 papers on homeopathy were identified by NHMRC reviewers or submitted by external parties, NHMRC’s choice of inclusion criteria meant that only 2671 studies were assessed in any detail, being considered to be possibly relevant to the Review; of those, only 176 trials were finally assessed as suitable to be entered into the Review.

1267 studies were reviewed in full text, comprising 183 studies identified by Optum (a mixture of systematic reviews and individual trials), 25 trials submitted to NHMRC by stakeholders and 59 trials submitted through public consultation.

Applying NHMRC’s combined ‘reliability’ filter of 150 participants plus very high quality, then led to 171 out of 176 trials being dismissed as ‘unreliable’ and of “insufficient size and/or quality to warrant further investigation of their findings”. Having reduced the evidence base to only 5 ‘reliable’ trials, none of which NHMRC considered to show homeopathy to be effective, the HWC found (unsurprisingly) that there is ‘no reliable evidence’ that homeopathy is effective.
     應用 NHMRC 那結合了150 位參與者及非常高質素的「可靠性」濾網之後,那 176 項試驗中,就有 171 項被定為「不可靠」而不予考慮,以及是「規模和/或質量不足以讓他們的結果受到任何進一步的考量」。將實證基礎減少到只有 5 個「可靠」的試驗,當中沒有一個讓 NHMRC 認為能夠顯示順勢療法的有效性,(不驚訝地)HWC發現「沒有可靠的證據」表明順勢療法是有效的。

The direct impact of this approach was to exclude good quality, positive trials showing homeopathy to be effective, thus distorting the results. This issue was identified in 2013 by NHMRC’s own expert independent reviewer with no connection to the homeopathy sector, who expressed concern about NHMRC’s concluding statements, saying, “If the intent is to provide general statements about the effectiveness of homeopathy, then ‘no reliable evidence’ may not adequately reflect the research. For example, when a substantial proportion of small (but good quality) studies show significant differences, […] 'no reliable evidence' does not seem an accurate reflection of the body of evidence."2

NHMRC’s chosen scientific method for the Homeopathy Review was an ‘overview’ i.e. a ‘review of reviews’. This meant that instead of analysing the 176 individual studies themselves, they relied only on secondary data provided about those trials in other ‘systematic reviews’ (SRs) that summarise evidence. As much of the necessary information was inaccurate or missing, this inherent flaw reduces the credibility of the Review.
      NHMRC為順勢療法評審所選擇的科學方式是「概述」(overview),即是:「以多個評審作的評審」。這意味著他們並不是親自去分析那176項個別的研究,而只是依賴二次數據,即是只依賴其他「系統評審(Systematic Reviews)」中提供有關那些試驗的概括證據。由於許多必要的資料並不準確或有遺漏,這種固有缺陷降低了評審的可信度。

A further ‘limitation’ listed by NHMRC in using this approach is that they may have missed relevant single trials that were not described in the SRs, but misleadingly suggest that this ‘risk’ was ‘offset’ by inviting submissions from homeopathy interest groups and a via a formal public consultation. They inaccurately state that this externally submitted evidence was, “…assessed using a similar method to that applied in the overview” (Information Paper, p.8) but ‘… did not alter the overall findings of the assessment of the evidence (Information Paper, p.25).

In fact, external submissions were assessed entirely differently and separately from the rest of the evidence base, in a way which meant that it was never possible for any externally submitted evidence to alter the results of the Review: of 49 submitted trials that NHMRC considered suitable for their Review, 0 entered the Overview Report. This makes a sham of NHMRC’s apparent attempt at external co-operation and transparency.

NHMRC also failed to disclose that the external contractor who assessed submissions from the public consultation (40 studies, representing almost a quarter of the total evidence considered for the Review) has direct links to the anti-homeopathy lobby group FSM: the Australian Research Centre for Health of Women and Babies (ARCH), Robinson Research Institute (RRI), University of Adelaide employed supporters of FSM with direct links to FSM’s co-founder, Professor Alastair MacLennan. Prof MacLennan had already directly lobbied NHMRC (8 April 2014) on behalf of FSM to support NHMRC’s negative findings on homeopathy, urging that Australians not be “sold snake oil” - a phrase reiterated by the NHMRC CEO in his public orations on the subject3. Over 50 RRI staff, including its Director, are official FSM Supporters yet NHMRC did not report any conflicts of interest.
        NHMRC亦沒有透露那負責評估公眾諮詢呈交之證據(40項研究,佔被考慮評審的總證據四分之一)的外部承辨專家,與反順勢療法組織FSM有直接聯繫:澳洲婦女與嬰兒健康研究中心(ARCH)、魯賓遜研究機構(RRI),阿德萊德大學聘請了與FSM共同創立人阿拉斯泰爾·麥克倫南教授 (Professor Alastair MacLennan) 有直接聯繫的FSM支持者。麥克倫南教授曾代表FSM直接游說NHMRC(2014年4月8日),支持NHMRC對順勢療法的負面結論,促請澳洲人不要「賣蛇油」——NHMRC的執行長在他的公開演講中反復地說的一句話3。超過50名RRI的員工,包括其總監,都是FSM官方的支持者,而NHMRC卻沒有報告任何利益衝突。

Anti-homeopathy conflicts of interest within NHMRC were not limited to the HWC and ARCH: during the Review, members of the NHMRC Health Care Committee (HCC) that the HWC directly reported to, as well as NHMRC Council itself, contained FSM supporters. These significant conflicts were also not reported. This reveals a culture where anti-homeopathy vested interests were present at the highest levels of the organisation. This is exemplified by the Chair of Council’s statement in July 2012 that he was “no supporter of homeopathy” and that “as Chairman of NHMRC I can also assure you that NHMRC does not support homeopathy.”

NHMRC’s own documentation shows that significant modifications were made to the research protocol (the precise method used to assess and interpret the evidence), months into the review process. Furthermore NHMRC did not report that these changes included such key factors as introducing the N=150 threshold which underpinned their findings and overall conclusion. Agreeing a protocol before a review process starts is a recognised safeguard against scientific bias, so making such significant post-hoc changes fundamentally undermines the credibility of the Review results.

In summary, NHMRC have misled the public by giving the impression that ‘no stone has been left unturned’ in the Homeopathy Review process – that the most rigorous, open and transparent methods were used to evaluate all available evidence concerning the effectiveness of homeopathy for any health condition – and they failed to find a single piece of valid scientific evidence that homeopathy works.
     總結,NHMRC誤導了公眾,令人以為他為順勢療法作了一個「巨細無遺」的評審 ----運用了最嚴謹、公開及透明的方法來評估所有現存證據,檢視順勢療法對所有疾病的有效性 ----而且,他們未能找到任何一份有效的科學證據來支持順勢療法的有效性。

It is no wonder that the national and international media, having picked up NHMRC’s press release announcing the findings of the Review ran with such damning headlines as, “Homeopathy Doesn't Work”4, “1800 studies later scientists conclude homeopathy doesn’t work”5 and “There is no scientific case for homeopathy: the debate is over”6.

Yet our investigation has revealed that multiple customary safeguards against bias were removed, facilitating a flawed process that appeared to be engineered to reach predetermined conclusions, sympathetic to the views of anti-homeopathy vested interests. The Submission shows how these interests were allowed undue influence in the Review, directly influencing the outcome, and how key NHMRC personnel – from the CEO down – publically endorsed (even iterated) the same anti-homeopathy views throughout NHMRC’s focus on homeopathy between 2010 and 2015.

Detailed analysis of the NHMRC Overview Report has identified at least 5 clinical conditions (diarrhoea in children, sinusitis, allergic rhinitis, URTIs and lower back pain) for which there is reliable evidence for the effectiveness of homeopathy; it is possible that there are more which we cannot identify due to the lack of accuracy and clarity of NHMRC’s data throughout the Review.

Thus NHMRC’s conclusion that “…there are no health conditions for which there is reliable evidence that homeopathy is effective” is inaccurate, highly misleading to the public and unjustly damaging to the credibility of the homeopathy sector. It is therefore essential that all published documents relating to the Homeopathy Review are rescinded in their entirety.

1.        Dechartres, A., Trinquart, L., Boutron, I. & Ravaud, P. (2013) Influence of trial sample size on treatment effect estimates: meta-epidemiological study, BMJ, 346:f2304
2.        2013-07-09 - Australasian Cochrane Centre Methodological Review - FOI 2015-16 008-13-Doc 13
3.        2014-04-08 - FSM congratulatory open letter to NHMRC re. NHMRC draft Information Paper
4.        Lupkin, S. (2015) Homeopathy Doesn't Work, Major Australian Study Concludes - ABC News http://abcnews.go.com/Health/hom ... s/story?id=29595411
5.        Blakemore, E. (2015) 1,800 Studies Later, Scientists Conclude Homeopathy Doesn’t Work Smithsonian http://www.smithsonianmag.com/sm ... snt-work-180954534/
6.        Ernst, E. (2015) There is no scientific case for homeopathy: the debate is over The Guardian https://www.theguardian.com/comm ... harmacists-placebos
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