Several marketers state that the Xrroid was first used in 1985 as the Electro-Physio-Feedback-Xrroid (EPFX) System. In 1989, the Eclosion Corporation of Commerce City, Colorado, received FDA permission (510K clearance) to market the EPFX as a biofeedback device. However, the claim that it was a biofeedback device was simply a ploy to mislead the FDA.

Biofeedback is a relaxation technique that can help people learn to control various autonomic functions. The patient is connected to a device that continuously signals the heart rate, degree of muscle contraction, or other indicator. The patient is instructed to relax so that the signals decrease to a desirable level. The patient may ultimately learn to control the body function subconsciously without the machine.

Legitimate biofeedback devices are not used for diagnosis or claimed to influence any disease process. When the agency learned that the EPFX was being used for diagnosing and treating medical conditions, it informed Eclosion that this was illegal and, in 1992, the company issued a recall notice for the software for 139 devices that had been distributed at that time [7,8]. A 1992 FDA report states that the device was being used primarily by chiropractors, dentists, and physicians interested in homeopathic diagnosis and treatments and that company had made unapproved changes to the software program that deviated significantly from the original 510(k) application [7].

幾つかの販売業者はXrroidは1985年にEPFXシステムとして使われたと主張している。1989年にコロラド州Commerce CityのEclosion Corporationが、バイオフィードバック装置としてEPFXを販売する許可をFDAから得た(510K clearance)。しかし、バイオフィードバック装置であるという主張は、FDAを欺くための策略にすぎなかった。



For several years, the QXCI was described an improved version of the EPFX. During the past few years, however, the device has been marketed mainly under the name EPFX or SCIO. The manufacturer is QX Ltd, of Budapest, Hungary. The device is not legally marketable in the United States as a diagnostic or treatment device, but distributors and importers get around the law by pretending that it is legitimately used as a biofeedback device for stress reduction. QX Ltd. has stated that more than 3,000 Xrroid devices have been sold worldwide. The 2002 price for the interface device, software, user manual, and basic training was $13,000. Used devices reportedly sold for $8,000.

Additional training has been available from several sources, the most notable of which was the International Medical University Natural Education (IMUNE, which was headquartered in Geneva, Switzerland but appeared to operate primarily in the United States. IMUNE provided "educational programs leading to certification in biofeedback for . . . individuals who have demonstrated not only an understanding of the QXCI but who have firm roots in an approved health care practice." Its offerings included a professional seminar series ($400) and a 6-day "certification" course ($2,000) [9]. The IMUNE Web site suggested that practitioners have their clients sign an "informed consent" which states (in part):

I . . . understand that the QXCI is a device used to identify and balance sources of bio-energetic stress that may impact on the mind-body system. No information should be construed as a claim or representation that this device is used in the diagnosis, cure, mitigation, treatment or prevention of disease or any other medical condition [10].

ここ数年、QXCIはEPFXの機能向上バージョンだとされてきた。しかし、過去数年、この装置は主としてEPFXあるいはSCIOという名称で販売されてきた。製造業者はハンガリーのブダペストのQX Ltdである。この装置は、診断あるいは治療装置として米国で合法的に販売できない。しかし、販売業者や輸入業者は、ストレス緩和のためのバイオフィードバック装置として正統に使われていると装って、法規制を回避している。QX Ltdは3000台以上のXrroid装置を全世界に販売したと主張している。2002年時点のインタフェース装置・ソフトウェア・ユーザーマニュアル・基本トレーニングの価格は13,000ドルである。中古価格は8000ドルだと言われている。

幾つかの業者から追加トレーニングサービスが提供されており、その中でも最も有名なのがInternational Medical University Natural Education (IMUNE)である。IMUNE社は本拠地をスイスのジュネーヴに置いているが、主として米国で活動している。IMUNEは「QCXIを理解し、認証されたヘルスケアを開業している者に対して、バイオフィードバックの認定資格を得られる教育」を提供している。IMUNE社は、プロフェッショナルセミナー(400ドル)と6日間認定資格コース(2000ドル)を提供している[9]。IMUNE社のウェブサイトは、治療者に対して、クライアントに以下のようなインフォームドコンセントにサインさせるように提案している。

[7] Gill LJ. Warning letter to Michelle Vandepas, president, Phazx Systems, Inc., May 19, 2000.
[8] FDA Enforcement Report, Dec 9, 1992.
[9] IMUNE home page May 25, 2002
[10] Informed consent. IMUNE Web site, accessed May 25, 2002

[Stephen Barrett, M.D.: "Some Notes on the Quantum Xrroid (QXCI) and William C. Nelson" (2009/07/12)]
法規制回避のために販売に際して「バイオフィードバック装置」だと称するのは、日本でも同様。詐欺師William Nelsonのいんちきな経歴を掲げたホメオパシージャパンの販売ページも、病気の診断・治療と解釈できる表現を避けている。

[ホメジャ (魚拓)]

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