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以下是順勢療法研究所HRI對有關Posadzki「順勢療法的副作用...

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admin 發表於 2016-3-22 19:38:57 | 顯示全部樓層 |閱讀模式
以下是順勢療法研究所(Homeopathy Research Institute)對有關Posadzki「順勢療法的副作用」一文的回應:

Tournier A, Roberts ER, Viksveen P.Adverse effects of homeopathy: asystematic review of published case reports and case series - comment byTournier et al. Int J Clin Pract. 2013 Apr;67(4):388-9. doi:10.1111/ijcp.12138.


To the Editor:
致編輯:

We write to express grave concern about therecent article by Posadzki et al. [1] in which the authors claim to haveidentified 1159 patients who have experienced mild-to-severe adverse effects(AE) caused either directly or indirectly by homeopathic treatment, includingfour fatalities.
我們來信對最近一篇由Posadzki等人寫的文章表示重大的關注。 [1],其中,作者聲稱已經確定1159名病人因順勢療法治療而出現直接或間接、輕度至重度的不良反應(AE),包括四死亡。

Our concern about this systematic review is notthat it highlights the potential for AE from homeopathy, as it would be mostpeculiar for any medical intervention to be entirely harm-free. Rather, onscrutiny of the article, we have discovered that the reporting of publishedcases, as well as the methods and analyses applied by the authors are seriouslyflawed, leading to unreliable conclusions about the relative safety ofhomeopathy.

我們關注這份系統評價,並不是因為它强調順勢療法有不良作用的潛在可能性,事實上,如果有任何醫療干預是完全無風險的話,這才是最奇怪的事。我們現在關注的,是那報告的審查,我們發現報告中引用的案例,以及作者應用的方法和分析,都有嚴重徧差,所以隨之得出來,有關順勢療法安全性的結論並不可靠。

Detailed examination of the 37 original articlescited by Posadzki and colleagues has uncovered numerous striking errors. Asthere are too many to mention in this comment, we draw your attention to justsome examples of our key concerns below.

詳細審查了由Posadzki研究團隊所列舉的37篇報告原文,我們發現了許多令人咋舌的錯誤。由於實在有太多,不能在此全部提及和評論,但您特別可注意以下我們引用來說明的一些例子。

Misreporting
誤報

In reporting on four cases of AEs published byIbsen et al., Posadzki and colleagues categorise these as ‘likely’ to have beencaused by homeopathy[23]. However, there is actually no reference made tohomeopathy whatsoever in the Ibsen article. The word ‘homeopathy’ only appearedin the English abstract as an incorrect translation of the term ‘alternativetreatment’.

四個不良事件的案例來自Ibsen等人發表的報告,Posadzki及其同事歸類這些為「可能」是由順勢療法引起的。但是,在Ibsen等人發表的文章中,實際上完全沒有提及有關順勢療法的案例。「順勢療法」這個詞只出現在報告的英文摘要中,其翻譯者錯誤地把「替代治療」(alternativetreatment) 翻譯為「順勢療法」(Homeopathy)

Of even greater concern is the reporting of acase report by Geukens[20] of cure by homeopathy, which has been reported byPosadzki et al. as a case of homeopathy causing ‘heart disease and bladdercancer’. In actual fact, the patient was cured from his initial symptoms ofvertigo and heart disease using homeopathic medicines; he then presented 7years later with cancer of the bladder. It is difficult to see how thecausality of the cancer could be attributed to the successful treatment of theheart-condition. The cancer was subsequently treated using conventional treatment,the side-effects of which were successfully dealt with using homeopathy. Thepatient recovered, with no further complaint. How does one end up withcausality ‘Almost certain’ for homeopathy in a clear case were homeopathy wasinstrumental in providing cure?

更令人關注的,是一個由Geukens發表的案例報告,那是一份有關使用順勢療法治療成功的報告,被Posadzki等人引用,作為順勢療法引起「心臟疾病和膀胱癌」的情況。事實上,病人最初的眩暈症狀和心臟病已被順勢療法治癒;然後,他7年後出現了膀胱癌。這很難想像那次的癌症如何可以歸因於之前成功治療的心臟情況。癌症隨後以主流西醫方式處理,而其中的副作用在使用順勢療法後亦成功地處理了。患者痊癒,沒有進一步申訴。這是一個表明順勢療法對治療有幫助的個案,作者怎能歸類此案例為「幾乎可以肯定」是順勢療法引起的不良作用?

Another striking example is a case of DRESS(Drug Rash with Eosinophilia and Systemic Symptoms) presented by Bernez etal.[10]. In this case, a homeopathic sleeping pill was taken on two occasionswithout any AE (4 months and 3 weeks before DRESS occurred). The originalauthors (a team of dermatologists at the University of Tours, France) statevery clearly in their conclusions that they do not believe homeopathy wascausative in this case. Yet Posadzki et al. report the causality caused by homeopathyas ‘Certain’.

另一個突出的例子是DRESS(藥物皮疹伴嗜酸細胞增多和全身症狀),原文由Bernez等人提出。在這個案例下,患者服了兩次順勢療法的安眠藥,沒有任何不良事件(而這是DRESS出現前的4個月加3週)。原文作者(圖爾大學皮膚科醫生團隊,法國)的結論非常明確,他們不相信,順勢療法在這個案例中致病。然而Posadzki等人則報告,順勢療法「肯定」引起是次DRESS

Such instances of significant divergence betweenthe conclusions of the original authors as published in their case reports andPosadzki et al.'s reporting of them, cast a heavy shadow on the scientificvalidity of the whole review (Data S1).

原作者對他們案件的報告,與Posadzki等人匯報的結論之間有顯著分歧,令整份系統評價(數據S1)的科學有效性蒙上陰影。

Differentiating between ordinary standards of homeopathic careand clinical negligence
標準順勢療法護理與臨床疏忽間的差異

When assessing the safety of a medicalintervention it is usual to differentiate between non-preventable AEs and thosewhich are preventable with ordinary standards of care [2] i.e. cases ofclinical negligence. Posadzki et al. have failed to make any such distinction.The four deaths they report as being caused by homeopathy involve eithermisprescribing of poisonous substances[8,32] or failure to refer the patientfor essential conventional medical treatment[41,26]. As these cases contravenewhat is considered standard homeopathic care, they should be classified ascases of clinical negligence [3] (Data S1).

當評估醫療干預的安全性的時候,經常會混淆不可預防的不良事件,與以可預防的(即臨床疏忽)之間之區別。而Posadzki等人就是未能作出任何區別。他們報告的那四個死亡的個案,涉及錯誤處方有毒物質[8,32],或沒有把患者轉介至必要的常規藥物治療[41,26]。由於這些情況違反了標準的順勢療法護理,他們應該被歸類為臨床疏忽[3](數據S1)的案件。

Inclusion of non-homeopathic cases
包含非順勢療法的案例

Failure to clearly define ‘homeopathy’ or a‘homeopathic medicinal product’ at the outset of this review has led toinclusion of multiple cases of misprescribing of poisons as well as cases whichare simply not homeopathy at all. For example, a case of AEs caused by Rhustoxicodendron tincture[34] belongs in a review of herbal medicine, nothomeopathy, as does the report of a pharmacist who self-administered a tinctureof the poisonous plant Aconite[22].
是次系統評價未能在一開始時明確界定「順勢療法」或「順勢療法藥品」,導致多個錯誤處方毒藥的案例、以及根本就不是使用順勢療法的案件也被包含於此系統評價之內。例如,由毒葛引致的不良事件[34]屬於草藥的評述,並不是順勢療法的,另外,有一報告是一名藥劑師自己為自己處方有毒植物烏頭之原草藥酊劑[22]

Inaccuracies
不準確性

Even at a glance, the Posadzki et al. articledoes not inspire confidence in its reporting standards. In their Abstract theystate 38 reports met their eligibility criteria, whereas on the same page inthe results section they state that 35 reports met their eligibility criteria,yet their results tables actually include 37 reports. Two indirect AEs werealso misclassified as direct AEs (Data S1).

其實即使只是閱讀一下Posadzki等人的文章,就會知道那報告標準是無法取信於人的。在他們的摘要中,他們陳述有38份報告達到他們的標準,可是在相同的頁面上結果那部分,他們指出,35份報告達到他們的標準,而他們的結果中,實際上是包括了37份報告。此外,兩個間接的不良事件也被錯誤歸類為直接的不良事件(數據S1)。

The authors have also shown a lack ofconsistency in their decision-making processes regarding inclusion/exclusion ofdata. For example, 1070 of the 1159 cases identified by Posadzki et al. comefrom a single article reporting calls to a toxicological information centre.These comprised calls for information (e.g. following inadvertent ingestion of ahomeopathic remedy) some of which lead to actual AE cases with a maximumseverity of ‘minor’ or ‘mild’[38]. As the article by Zuzak et al.[40] presented2143 similar cases, it is unclear why these were omitted.

作者就包含/排除數據的決策過程中缺乏一致性。例如,1159個案例中的1070個,是Posadzki等人引用一份紀錄致電到毒理學信息中心之個案報告。當中包含很多致電來查詢的個案(如:剛剛意外吞下了順勢療法療劑應如何處理),而其中真實導致不良事件的案例,最大嚴重程度也只是「輕微」或「輕度」[38]。至於由Zuzak等人[40]的報告中提出了2143個類似的案件,卻沒有清楚說明為什麼這些會被省略。

Whilst it is beyond the scope of this comment topresent a full re-analysis of the data, our examination of the originalliterature has raised many important issues worthy of further investigatione.g. the need to clearly define homeopathic medicinal products. We thereforerecommend that a new review be carried out using rigorous methods to produce a reliablestudy of the safety of homeopathy.
要全面重新此報告中的分析數據已超出此評論的目的,不過,單單是以上對原文的檢閱,已經有太多許多值得進一步探討的重要問題,例如:必須為順勢療法醫藥品下明確的定義。因此,我們建議進行一個新的評論,使用嚴格的方法,以作出順勢療法安全的可靠研究。
As clinicians look to systematic reviews onsafety to inform their clinical decision-making, any claims that anintervention carries the risk of causing serious harm or death must be based onresearch carried out to the highest of standards, both in terms of process andaccuracy.
臨床醫生都會閱讀安全性的系統評價,以決定其臨床決策,任何聲稱某治療方法帶有造成嚴重傷害或死亡的風險,都必須在最高標準的研究基礎上進行,不論是在研究的過程和準確性上也當如此。
Sadly the quality of this review by Posadzki etal. falls short of this standard by such a large margin, that at best theauthors’ results are unreliable, and at worst we must consider whether thedegree of inaccuracy is such that retraction of this article becomes necessaryto preserve the quality of the peer-reviewed literature.

可悲的是,Posadzki等人審查的質量,遠遠達不到此標準,最少的影響是作者的研究結果失去可靠性,最大的影響是,我們必須考慮其誤差程度是否有必要回收,以保留同行評審文獻的質量。



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