2013/02/03

Boironのホメオパシー製品COCCULINEに効果がないというDavid Pérol et al. 2012

ホメオパシー製品最大手のBoironの商品に吐気に効くと称するものがある:
[COCCULINE

Nausea, including motion sickness

Does the thought of travelling make your stomach turn? Cocculineレジスタードマーク alleviates the symptoms of motion sickness including nausea.

The non-drowsy, quick-dissolving tablets can be taken by adults and children 2 years of age and older to relieve the queasiness, vomiting, dizziness and cold sweats associated with car, plane, train and boat travel. So make your next trip worry-free with Cocculineレジスタードマーク!
COCCULINE.png
このCOCCULINEを使って、ホメオパシーの効果を二重盲検ランダム化対照実験で調べた研究が発表された[via Edzard Ernst]。その方法は、化学療法を受ける非転位乳癌患者に標準的な抗嘔吐治療とともに、Cocculineもしくはプラセボを与えて、吐気・嘔吐の頻度を評価するというもの:
Chemotherapy-naive patients with non-metastatic breast cancer scheduled to receive 6 cycles of chemotherapy including at least three initial cycles of FAC 50, FEC 100 or TAC were randomized to receive standard anti-emetic treatment plus either a complex homeopathic remedy (Cocculine, registered in France for treatment of nausea and travel sickness) or the matching placebo (NCT00409071 clinicaltrials.gov). The primary endpoint was nausea score measured after the 1st chemotherapy course using the FLIE questionnaire (Functional Living Index for Emesis) with 5-day recall. Secondary endpoints were: vomiting measured by the FLIE score, nausea and vomiting measured by patient self-evaluation (EVA) and investigator recording (NCI-CTC AE V3.0) and treatment compliance.

[David Pérol et al. 2012]
よく考えられた、倫理的な問題をクリアした実験デザインである。で、結果は...
From September 2005 to January 2008, 431 patients were randomized: 214 to Cocculine (C) and 217 to placebo (P). Patient characteristics were well-balanced between the 2 arms. Overall, compliance to study treatments was excellent and similar between the 2 arms. A total of 205 patients (50.9%; 103 patients in the placebo and 102 in the homeopathy arms) had nausea FLIE scores > 6 indicative of no impact of nausea on quality of life during the 1st chemotherapy course. There was no difference between the 2 arms when primary endpoint analysis was performed by chemotherapy stratum; or in the subgroup of patients with susceptibility to nausea and vomiting before inclusion. In addition, nausea, vomiting and global emesis FLIE scores were not statistically different at any time between the two study arms. The frequencies of severe (Grade >= 2) nausea and vomiting were low in our study (nausea: P: 17.6% vs C: 15.7%, p=0.62; vomiting: P: 10.8% vs C: 12.0%, p=0.72 during the first course).

[David Pérol et al. 2012]
COCCULINEとプラセボに有意差はなく、明瞭な結論となっている:
This double-blinded, placebo-controlled, randomised Phase III study showed that adding a complex homeopathic medicine (Cocculine) to standard anti-emetic prophylaxis does not improve the control of CINV in early breast cancer patients.

二重盲検・プラセボコントロール・ランダム化フェーズIII研究は、標準的な抗嘔吐治療に、追加的に実施した複合ホメオパシー薬品(Cocculine)が初期癌患者の化学療法による吐気・嘔吐のコントロールを改善しないことを示した。

[David Pérol et al. 2012]
これについて、Edzard Ernstは...
Homeopaths might argue that this trail did not follow the rules of classical homeopathy where treatments need to be individualised. This may be true but, in this case, they should campaign for all OTC homeopathy to be banned.
ホメオパスたちは、この実験がクラシカルホメオパシーのルールである治療の個別化に反していると主張するかもしれない。これは本当かもしれないが、この場合、彼らはOTCホメオパシーの禁止運動をすべきだろう。

[A new and refreshingly rigorous trial of homeopathy (2013/02/02) on EdzradErnst,com]
と評している。


posted by Kumicit at 2013/02/03 11:52 | 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
この記事へのコメント
コメントを書く
お名前:

メールアドレス:

ホームページアドレス:

コメント: [必須入力]


この記事へのトラックバック
×

この広告は180日以上新しい記事の投稿がないブログに表示されております。