==>嗅覚喪失という副作用のあるホメオパシーレメディに対してFDAが警告・消費者に使用停止と破棄を勧告 (2009/06/18)

[Zinc Nasal Sprays Culprit in Loss of Smell (2010/07/19) on MedPage Today]

Zinc nasal sprays used to relieve symptoms of the common cold can cause anosmia.

That was the conclusion of Terence M. Davidson, MD, and Wendy M. Smith, MD, of the University of California San Diego, when they applied the nine Bradford Hill criteria to the relationship.

"It is clear that more stringent FDA regulation is needed to monitor the safety of these popular remedies," they wrote in the July issue of Archives of Otolaryngology -- Head & Neck Surgery

通常の風邪の症状を和らげるために使われる亜鉛鼻スプレイは嗅覚喪失を起こす可能性がある。これが、Bradford Hill criteriaを適用した場合の、UCSDのTerence M. Davidson et alの結論である。

彼らはArchives of Otolaryngologyで、「これらのポピュラーなレメディの安全性についてモニタする、厳格なFDA規制が必要なことは明らか」と述べている。
当該研究は以下のように、UCSDのNasal Dysfunction Clinicに嗅覚喪失の症状があると診察に訪れた25名に対するもの。
[Terence M. Davidson, MD; Wendy M. Smith, MD : "The Bradford Hill Criteria and Zinc-Induced Anosmia -- A Causality Analysis]

Objective To apply the Bradford Hill criteria, which are widely used to establish causality between an environmental agent and disease, to evaluate the relationship between over-the-counter intranasal zinc gluconate therapy and anosmia.

Design Patient and literature review applying the Bradford Hill criteria on causation.

Setting University of California, San Diego, Nasal Dysfunction Clinic.

Patients The study included 25 patients who presented to the University of California, San Diego, Nasal Dysfunction Clinic complaining of acute-onset anosmia after intranasal application of homeopathic zinc gluconate gel.

Main Outcome Measures Each of the 9 Bradford Hill criteria―strength of association, consistency, specificity, temporality, biological gradient (dose-response), biological plausibility, biological coherence, experimental evidence, and analogy―was applied to intranasal zinc gluconate therapy and olfactory dysfunction using published, peer-reviewed medical literature and reported clinical experiences.

Results Clinical, biological, and experimental data support the Bradford Hill criteria to demonstrate that intranasal zinc gluconate therapy causes hyposmia and anosmia.

Conclusions The Bradford Hill criteria represent an important tool for scientifically determining cause between environmental exposure and disease. Increased
研究は、9つのBrandford Hill criteriaおよび、過去の査読論文に基づいて、関連性を結論している。

なお、Zicamに対するFDAの警告が出た昨年(2009年)6月に、非営利法人National Center for Homeopathyは「Zicamはホメオパシーではない」という声明を出している。
[Zicam is NOT Homeopathy! (2009/06)

Zicam is also not prepared like a true homeopathic remedy. Zicam’s labeling is misleading, claiming to be a “homeopathic preparation” of “1x potency” but in reality it is simply a 10% solution of zinc gluconate. Typical homeopathic remedies are much, much more dilute, often so dilute there are no molecules of the original substance left. The manufacturers of Zicam have simply adopted homeopathic nomenclature as a deceptive way to market a 10% solution of zinc gluconate without FDA oversight.

Zicamは本来のホメオパシーレメディのようには作られていない。Zicamのラベルはミスリーディングで、「1x ポテンシー」のホメオパシーレメディだと書かれていたが、実際は10%のグルコン酸亜鉛化合物溶液である。典型的なホメオパシーレメディはもっともっと希釈されており、もとの分子は1個も残っていない。Zicam製造業者は、FDAの規制を受けずにグルコン酸亜鉛化合物10%溶液を市販するために、ホメオパシーをごまかしの手段として利用したものである。

posted by Kumicit at 2010/07/22 03:48 | 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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