Edzard Ersnst on ホモトキシコロジー

Trick or Treatmentでおなじみの代替医療教授Edzard Ernstは、2004年に、ホモトキシコロジー(同種毒物学)の有効性を検証したという研究論文群のレビューを行っている。
Eur J Clin Pharmacol. 2004 Jul;60(5):299-306. Epub 2004 Jun 9.
Homotoxicology--a review of randomised clinical trials.
Ernst E, Schmidt K.

Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, 25 Victoria Park Road, Exeter EX2 4NT, UK. Edzard.Ernst@pms.ac.uk


AIM: Homotoxicology is a form of therapy that uses homoeopathically diluted remedies with a view of eliminating toxins from the body. It is not a therapeutic method based on accepted scientific principles or biological plausibility. Yet numerous clinical studies have claimed efficacy. The aim of this systematic review is to summarise and critically evaluate the evidence from rigorous clinical trials of this form of therapy.


METHODS: Seven electronic databases were searched for all studies of homotoxicological medicines for any human condition. To be included, trials had to be randomised and placebo-controlled. Data from such studies were validated and extracted according to pre-defined criteria. Their methodological quality was formally assessed using the Jadad score. Key data of all included trials were tabulated and summarised in narrative form.

人間の症状に対するホモトキシコロジー医療についての研究を、7つのデータベースで検索した。レビュー対象にしたのは、ランダム化され、プラセボ対照群を持つものである。そのような研究のデータは、予め定めた基準にしたがって評価し、入手した。それらの研究方法の適切さはJadad scoreを用いて形式的に評価した。レビュー対象としたもののキーデータはテーブル化し、ナラティブ形式にまとめた。

RESULTS: Seven trials met our inclusion criteria. Their Jadad scores indicated mostly a high methodological standard. The trials tested the efficacy of seven different medicines for seven different indications. The results were positive in all but one study. Important flaws were found in all trials. These render the results of the primary studies less reliable than their high Jadad scores might suggest.

7つの研究が我々の基準に合致した。それらのJadad scoreはほぼ高い方法基準にあることを示した。これらの研究は7つの異なる指標について、7つの異なる治療法の有効性を検証していた。結果はひつとを除いて、ポジティブだった。重大な問題点がすべての研究に見つかった。これは、対象とした研究群が、高いJadad scoreの示す水準よりも、信頼性が劣ることを示している。

CONCLUSION: Despite mostly positive findings and high ratings on the Jadad score, the placebo-controlled, randomised clinical trials of homotoxicology fail to demonstrate the efficacy of this therapeutic approach.

大半がポジティブだという結果を出しているが、Jadad scoreも高く、プラセボ対照群がある、ランダム化臨床試験は、このホモトキシコロジー治療法の有効性の証明に失敗している。
これについての紹介記事をEdzard Ernst自身がPulseに寄稿している。
[More than meets the eye (2010/11/08) on PULSE]

I doubt many British GPs will know what homotoxicology is. Put simply, it is a form of homeopathy that currently seems to be gaining popularity.

Homotoxicology was developed by the German physician Hans Reckeweg (1905-1985) and is strongly influenced by homoeopathy; in fact, its remedies are diluted in the homeopathic way. Homotoxicology does not, however, subscribe to the ‘like cures like’ principle, as homeopathy does.

According to the concepts of homotoxicology, human diseases are the result of toxins, which originate either from within the body itself or from its environment. Proponents of homotoxicology believe that each disease process is thought to run through six specific phases and is the expression of the body’s attempt to cope with these toxins.

Diseases are thus viewed as biologically useful and necessary defence mechanisms. Health, on the other hand, is the expression of the absence of toxins in the body. These assumptions are not based on science and bear no relationship to accepted principles of toxicology or therapeutics.

英国の一般医の多くはホモトキシコロジー(同種毒物学)を知らないだろう。簡単に言うと、現在は人気上昇中での、ホメオパシーの一種である。ホモトキシコロジーはドイツの医師Hans Reckeweg(1905-1985)によって開発されたもので、ホメオパシーの影響を強く受けている。事実、ホモトキシコロジーのレメディはホメオパシーな方法で希釈されている。しかし、ホモトキシコロジーはホメオパシーの「似たものが似たものを治癒する」と言う原則を採用しない。


Several years ago, we published a systematic review of all RCTs testing the efficacy homotoxicology [1]. We were able to include seven RCTs; three of which tested the efficacy of Traumeel. This remedy is given after major or minor trauma and is by far the best known homotoxicological remedy in the UK.

All RCTs were of good methodological quality and all suggested that the tested remedies are superior to placebo. But there were a number of caveats that made alarm bells ring for me.

In several RCTs, at least one author was an employee of the manufacturer; yet in most articles no conflicts of interest were declared. Many articles were published in a journal closely linked to, perhaps even owned by the manufacturer.



Our suspicion of sponsor bias was strengthened by correspondence with one manufacturer. They told us that financial support for our research project, i.e. the review [1], would only be given after they had inspected (and, by implication, agreed with) our results. None of the included RCTs reported having an independent monitor which, of course, would have been the normal and adequate measure to minimise this type of bias.

In several trials, de-blinding of the patient was a real possibility. Generally speaking, it is advisable to check blinding rather than to assume it. Other studies could have generated a false-positive result due to their small sample size. In two studies, it was possible that the ‘placebo’ caused a worsening of symptoms thus producing significant inter-group differences in the absence of improvements in the verum groups.



This project has taught me two lessons: 1) Even formally rigorous studies, i.e. those that score highly on validated instruments for assessing bias, can be dodgy; 2) Sometimes one needs to do quite a bit of detective work to notice all the potential weaknesses of apparently rigorous trials.

Commentators to (not just) this blog have often stressed that trials sponsored by big pharma are sometimes less than reliable. I quite agree, we need to be vigilant. But this brief discussion suggests that conflicts of interest and other well-hidden flaws might also play an unfortunate role in some CAM research.

このレビュー研究で2つのことがわかった。1) 形式的には厳格な研究であって、バイアス評価に有効な手段でハイスコアになっていいても、インチキである可能性がある。2) 見かけ上は厳格な試験の、問題の可能性をすべて認識するのは調査活動が必要である。


References :
1. Ernst E, Schmidt K. Homotoxicology - a review of randomised clinical trials. Eur J Clin Pharmacol 2004; 60:299-306

posted by Kumicit at 2010/11/09 07:34 | Comment(0) | TrackBack(0) | Quackery | このブログの読者になる | 更新情報をチェックする



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