Dubious Claims Made for NutriPax
and Cranial Electrotherapy Stimulation

Stephen Barrett, M.D.

For several years, the NutriPax program was promoted by Biotics Research Northwest, BioEnergetic Nutrition, the Nutritional Therapy Association, Inc®, and NutriPax, all of which were located in or near Seattle, Washington. The program included a low-voltage electrical device, an alleged "nutritional analysis," and a large array of questionable dietary supplements that are prescribed by a network of practitioners, many of whom were chiropractors or naturopaths. BioEnergetic Nutrition described the program this way:

NutriPax Cranial Electrotherapy Stimulation device, combined with a personalized nutritional program, is the up-and-coming modality of choice for persons suffering from anxiety, depression, insomnia or stress.

The NutriPax CES unit is a device small enough to fit it a shirt or pants pocket. It has a small wire that divides into two, ending in padded clips that go on the ears, and delivers a special, brain-friendly frequency of electrical current. Most people enjoy the sensation. If preferred, the current can be adjusted so that it cannot be felt, and the treatment will still be effective.

NutriPax is a pleasant and powerful treatment modality on its own. Combined with supplements, NutriPax activates the potential of available nutrients, significantly enhancing the effectiveness of both CES and nutritional therapy. This combination is safe, gentle, and effective, promoting stability and harmony [1].

According to the Alternative Medical Clinic of Everett, Washington:

Most individuals suffering from disease have digestive and nutritional imbalances. Your emotional balance and well being requires the proper metabolism of amino acids, fatty acids, vitamins, and minerals found in our food.
 
The NutriPax program enhances your capacity to utilize these nutrients and more rapidly correct nutritional deficiencies. You should experience less depression, anxiety, and/or insomnia as your physical health improves [2].

The Elixa Ltd., of Albuquerque, New Mexico claimed that the CES device could produce "neurotransmitter balancing, mood control, IQ gains, sleep, exploration of altered states, peak performance, and much more." [3] This article reports what I found in 2004. In January 2008, I found that NutriPax's Web site had been removed, the sites I had visited no longer mentioned it, and Elixa Ltd. was offering a similar CES Ultra device without any nutrition-related claims. The Internet Archive indicates that the NutriPax site became inactive during 2007.

CES Devices

The NutriPax was a private-label version of the HealthPax HP-1, a class III medical device designed for in-home use. The FDA classifies it as a cranial electrotherapy stimulator and describes it as "a device that applies electrical current to a patient`s head to treat insomnia, depression, or anxiety." It was said to "generate an electric current with an amplitude similar to the human body, and sends the mild electrical impulses through ear clips or electrodes behind your ears." [4] The manufacturer, Health Directions, Inc., of Levittown, Pennsylvania, received FDA marketing clearance in 1988 based on substantial similarity to previously cleared devices [5]. Most prescribers of its devices were medical and osteopathic physicians.  

In 1995, the Journal of Nervous and Mental Disease published a comprehensive review of the history and scientific status of CES devices. The report concluded:

To clarify the diverse published results of cranial electrostimulation (CES) efficacy, we conducted an extensive literature review that identified 18 of the most carefully conducted randomized controlled trials of CES versus sham treatment. For the 14 trials that had sufficient data, we used the techniques of meta-analysis to pool the published results of treating each of four conditions: anxiety (eight trials), brain dysfunction (two trials), headache (two trials), and insomnia (two trials). . . . . The meta-analysis of anxiety showed CES to be significantly more effective than sham treatment (p < .05). Pooling did not affect results that were individually positive (headache and pain under anesthesia) or negative (brain dysfunction and insomnia). Most studies failed to report all data necessary for meta-analysis. Moreover, in all but two trials, the therapist was not blinded and knew which patients were receiving CES or sham treatment. We strongly recommend that future trials of CES report complete data and incorporate therapist blinding to avoid possible bias [6].

In other words, the review team concluded that CES devices have been proven more effective than sham treatment for anxiety and possibly a few other uses. However, that does not indicate how practical it is to use them. Insomnia, anxiety and depression have many possible causes and many possible treatments. I believe that the best approach to these problems is to understand and deal with the cause rather than merely trying to reduce the symptoms. As far as I know, no studies have determined that CES is the best available treatment for any condition. Aetna's Clinical Policy Bulletin states:

Aetna considers transcranial magnetic stimulation experimental and investigational for the diagnosis and treatment of major depression, other neuropsychiatric disorders (e.g., schizophrenia, anxiety disorders, panic disorder, and obsessive-compulsive disorder) or any other indications (e.g., chronic pain, migraine headaches, Tourette syndrome, tinnitus, and levodopa-induced dyskinesia) because its value and effectiveness in these roles has not been established [7].

People considering whether to use such a device should also consider whether or not the prescriber is qualified to diagnose and treat the problems for which it is prescribed. Most chiropractors and naturopaths are not.

In 2004, The FDA ordered Health Directions, Inc., to stop claiming in its literature that the HealthPax device can modify brain wave patterns and is effective against epilepsy, stress-related disorders, and several other conditions. The agency's warning letter stated that the device had been approved for treat insomnia, depression, or anxiety but was being marketed for unapproved purposes [8]. Company president Harold Stecker, Ph.D., quickly replied that the marketing materials would be modified to remove the challenged claims. His letter also indicated that all companies using CES devices produced by Health Directions would be notified and required to similarly modify their marketing materials [9]. The FDA agreed that this was an acceptable plan [10]. In 2004, however, some claims mentioned in the FDA letter still appeared on sites promoting the NutriPax program.

The NutriPax Program

Biotics Research N.W. distributed "NutriPax" program products as one of its innovative and cutting-edge technologies. The program used a "Nutritional Assessment Questionnaire" that asked about health concerns and contained 17 questions about diet, 7 about lifestyle factors, 25 about medications, and 272 about symptoms and medical history. The diet section asks whether various items are consumed daily, weekly, 2-3 times a month, or not at all. The questionnaire was completely inappropriate for assessing people's nutritional needs or nutritional status. BioEnergetic Nutrition, which sold software for interpreting the answers, stated that the software would help the practitioner identify and prioritize areas of the patient's concern, identify "potential weaknesses," and "enhance preventive intervention." The company also sold a "Clinician's Reference Guide," which I presume advised which Biotics Research Products to prescribe for which condition. The manual itself was not displayed, but the BioEnergetic Nutrition site had a "Product Guide" and a "Reverse Reference Guide" that stated:

Biotics Product List by Symptom

Please Note: This information is not intended to imply treatment or cure of disease, but to support normal function, whether or not disease conditions or tendencies are present.

Click on the symptoms below to view the Biotic product associated with that ailment.

Absorption
Addiction
Adrenal
Aging
Antibiotic
Antibodies
Antihistamine
Antioxidant
Antiseptic
Arthritis
Bacterial
Bladder
Blood
Body building
Body odor
Bone
Brain
Bruising
Cancer
Cartilage
Cells
Chemo - after
Cholesterol
Congestion
Cough
Croup
Cyst
Deficiency
Degeneration
Depression
Detox
Digestive
Disease
Drugs
Ear
Endocrine
Endurance
Energy
Exposure
Extremities
Eyes
Fatigue
Fever
Fibroids
Free radical
Fungal
Gallbladder
GI
Gland
Hair
Headaches
Heart
Heavy metals
Illness
Immune
Infection
Inflammation
Joints
Kidney
Libido
Ligament
Liver
Lung
Lymph
Misc
Mood
Morning Sick
Mouth
Mucus
Muscle
MVP
Nausea
Neck
Nerves
NOBP
Nose
Obesity
Organ
Pain
Pancreas
Parasite
Parasympathetic/
Sympathetic
Pathogens
Pesticide
PH balance
Pituitary
Pregnancy
Resistance
Sensitivity
Sexual Function or    Dysfunction
Sinus
Skin
Sleep
Soft Tissue
Soreness
Source
Spine
Spleen
Sports
Stamina
Strength
Stress
Support
Surgery
Sweats
Swelling
Tendons
Thiamine
Throat
Thyroid
Tissue
Toxicity
Urination
Vertigo
Viral
Vitamins
Yeast

Claims made for most of the products and use of the questionnaire made it clear that most of the products were intended to prevent or treat disease; and inspection of the ingredients made it clear that most of the claims made for the products could not be scientifically substantiated. The NutriPax.com Web site invited licensed practitioners to join the NutriPax Network, receive "in-office training" for the NutriPax questionnaire and software, and attend "Foundations of Functional Nutrition" seminars that taught how to identify and correct alleged "metabolic imbalances and nutritional deficiencies."

The Nutritional Therapy Association (NTA), founded in 1997, offered a ""Nutritional Therapist™ Training Program." that was developed by Biotics Research NW's president Gray L. Graham [11]. Those who passed the course could use the designation of Certified Nutritional Therapist® credential. Neither the organization nor the "certification" have any recognized scientific standing, but the association's Web site stated that no license was needed to practice nutritional therapy in the state of Washington. However, I have seen no evidence online that unlicensed NTA members were prescribing NutriPax devices.

The Bottom Line

Cranial electrotherapy stimulation may help relieve certain stress-related symptoms but has not been studied sufficiently to determine whether its use is practical and cost-effective. NutriPax combined its use with dubious dietary supplements selected with the help of a dubious questionnaire. The FDA is made an effort to curb excessive claims for the device, but, as far as I know, the associated nutrition quackery was not addressed by a regulatory agency. I don't know whether the NutriPax program is still used, but I recommend avoiding any practitioner who uses a questionnaire or any device as a basis for recommending dietary supplements.

References

  1. NutriPax. BioEnergetic Nutrition Web site, accessed June 6, 2004.
  2. NutriPax —A drug free treatment for depression, anxiety, and insomnia. Alternative Medicine Clinic Web site, accessed June 6, 2004.
  3. Cranial Electrical Stimulation (CES) for neurotransmitter balancing, mood control, IQ gains, sleep, exploration of altered states, peak performance, and much more. Elixa Ltd. Web site, accessed June 6, 2004.
  4. NutriPax FAQs. Nutripax.com Web site, accessed June 6, 2004.
  5. FDA 510(k) number K883812, Nov 28, 1988.
  6. Klawansky S and others. Meta-analysis of randomized controlled trials of cranial electrostimulation. Efficacy in treating selected psychological and physiological conditions. Journal of Nervous and Mental Disease 183:478-484, 1995.
  7. Transcranial magnetic stimulation and cranial electrical stimulation. Aetna Clinical Policy Bulletin Number 0469, Sept 7 , 2007.
  8. Gardine TD. Warning letter to Harold G. Stecker, Ph.D., March 4, 2004.
  9. Stecker H. Letter to Thomas Gardine, March 16, 2004.
  10. Bonner LS. Letter to Harold D. Stecker, Ph.D., April 6, 2004.
  11. About us. Biotics Research NW Web site, accessed June 7, 2004.

This page was revised onJanuary 28, 2008.

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