A Skeptical Look at the AcuGraph and Stimplus Pro

Stephen Barrett, M.D.

The AcuGraph system, which has been marketed since 2003, is claimed to determine health problems and make therapeutic recommendations based on measurements of skin resistance at so-called "acupuncture points." The Stimplus Pro is claimed to "harness the power of electro-acupuncture." Both are marketed by Miridia Technology, which is located in Meridian, Idaho. Miridia's president, Adrian P. Larsen, D.C., F.A.S.A., C.Ac., is licensed as a chiropractor and certified as an acupuncturist in Idaho.

Larsen traces the theory behind the use of his devices to observations made by a Japanese physician named Yoshio Nakatani:

In 1950, Yoshio Nakatani M.D., Ph.D. was measuring electrical resistance of the skin in an edematous patient with nephritis, when he found a line, similar to the kidney meridian of acupuncture, that had a series of points at which increased electrical conductance was measured on the surface of the skin. . . . Because this line offered increased electrical conductance, and seemed to follow the traditional kidney meridian, he named this line, the kidney "ryodoraku" (ryo=good, 'do=(electro) conductive, 'raku=line.) (5). A better English translation might be, "good electrical pathway."

Upon further research, Dr. Nakatani found other ryodoraku lines, corresponding to organ disorders, and following the classical Chinese meridian pathways. . . .

Dr. Nakatani refined his procedures to encompass both diagnosis and treatment. Diagnosis was performed with an electrical instrument that measured electrical conductivity of the skin. By measuring the conductivity of each meridian, energetic excesses and deficiencies could be located and charted. Treatment consisted of stimulating specific acupuncture points to either "tonify" a deficient meridian, or "sedate" an excessive meridian. An additional set of acupuncture points was used to balance meridians that showed significant energetic differences between the right and left sides of the body [1].

Practitioner Web sites describe AcuGraph's current usage this way:

The AcuGraph Digital Meridian Imaging system is a computerized tool used to analyze and document the energetic status of the acupuncture meridians. . . .Acupuncture meridians are energy pathways in your body that have been used therapeutically for over 5000 years. These meridians conduct life-force energy, or Qi . . . in and around all the parts of your body. Blockage or interference in these meridian pathways can result in energetic imbalances that may contribute to negative health conditions. The primary goal of acupuncture treatment is to restore energetic balance and proper energy flow to these meridians, thus allowing your body to function normally and return to health naturally. The AcuGraph system allows us to measure and analyze the energy level of each acupuncture meridian. Armed with this information, we can make better-informed decisions about your condition, and provide the best treatment possible [2].

AcuGraph Claims

The AcuGraph system consists of software plus a box and cables that provide for three electrical connections, One cable connects from the box to the USB port of the practitioner's computer. A second cable runs from the box to a handle that the patient holds in one hand. The third cable connects to a probe that the practitioner touches to the patient's hand or foot, setting up a circuit. As the probe is touched, the software generates charts and recommends foods and products. The system, which does not include the computer, sells from $2,195 to $2,595. After the first year, there is also an annual service fee that ranges from $295 to $695. Click here for a sample report.  

The "introduction to AcuGraph 5" video on Miridia Technology's Web site states:

A booklet sent to prospective buyers states that "each new patient easily turns into an income flow of $2,200 per year." [4]

The legal requirements for marketing devices depend on the extent to which use of the device involves matters of life and death or serious injury and whether the device is entirely new or is similar to a previously approved device [5]. Major diagnostic devices generally require FDA approval based on clinical trial evidence. Less critical devices may receive 510(k) clearance based on substantial similarity. The AcuGraph device is neither approved nor cleared, but Larsen claims it is an "acupuncture point locator" (product code BWJ) that is exempt from the clearance requirement. "Acupuncture point locators" are indeed exempt [6], but product code BWJ is for acupuncture needles that are intended to pierce the skin [7,8]. Moreover, devices are classified according to their intended use. Even if the AcuGraph probes could be considered the equivalent of a needle, the system as marketed is intended to make assessments and recommend treatment, which means that it (or its software) would require premarket approval.

Stimplus Pro Claims

The Stimplus Pro is a hand-held device that is claimed to locate and measure skin resistance at acupuncture points and deliver corrective microcurrents at those points. Larsen says it is particularly useful for auriculotherapy, which he describes as "a technique of using points on the skin of the auricle (external ear) to diagnose and treat pain and medical conditions of the body. To operate the device, the practitioner moves it along the skin of the ear until it beeps—which supposedly indicates it has located an acupuncture point—and then delivers a tiny electric current for up to 15 seconds.

Auriculotherapy—also called auriculoacupuncture—is based on the notion that body structures and functions are somehow "mapped" on the outer surface of the ear and can be helped by stimulating corresponding "acupuncture points" on the ear [8].

The Auriculo 3D Web site states that "Auriculotherapy can treat nearly any condition—if you know the right points to use." The picture to the right is from a poster available from Miridia that shows the location of the supposed points. Miridia also sells Auriculo 3D, a software program that tells what points are related to hundreds of problems and provides protocols for treating them.

The Stimplus Pro has FDA 510(k) clearance as a transcutaneous electrical nerve stimulator (TENS) device for the"symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain." [9]

 

Miridia charges $249 for the Stimplus Pro, $149 for the Auriculo 3D software, $389 for the combination, and higher prices for packages that include training and marketing materials.

As with the AcuGraph, I believe that the intended use of the Stimplus Pro exceeds what is cleared by the FDA. TENS devices are used to deliver currents steadily, not just for a few seconds. In addition, it is not cleared to locate "acupuncture points" or treat "almost any condition." I do not believe that the FDA would knowingly clear any device for treating diseases of internal organs by applying small currents to the skin.

Herbal Products

Meridia's Web site offers 22 herbal products priced at $8 per 20-30 day supply (60 tablets). The product details include: "TCM therapeutic actions," "TCM indications," "modern indications," "contraindications," "TCM contraindications," "pharmaceutical interactions," "recommended usage" [dosage], and "comments." The "modern indications" lists, which total more than 100 different problems, include acne, AIDS, amnesia, arteriosclerosis, asthma, chronic bleeding, coronary heart disease, deafness, diabetes, floating kidney, gallstones, hepatitis, herpes zoster, high blood pressure, impotence, low blood pressure, neurosis, "resisting viruses," senile dementia, tuberculosis, and violent vomiting. A typical product description looks like this:

TCM Therapeutic Actions: Harmonizes the two meridians of Shaoyang—the Triple Warmer and Gallbladder. Supplements Qi, transforms phlegm, spreads Liver Qi, and clears Heat TCM Indications: Alternating chills and fever, distention in the chest or rib area, bitter mouth, dry throat, retching, dizziness, severe loss of appetite. Modern Indications: Infection of biliary tract, gallstones, gallbladder infection, hepatitis, pleuritis, chronic gastritis, indigestion, intercostal neuralgia, neurosis, breast disease, underarm lymph node edema, and AIDS. Contraindications: Contraindicated in pregnancy and for patients taking Interferon. May cause headache, bleeding gums and dizziness due to energy rising in long-term use. Patients with chronic fatigue or post viral patterns may have a temporary recurrence when starting this formula until pathogen is eliminated from the body. Chronic usage or large dosages are not recommended in cases of edema, hypokalemia, kidney disorders, hypertension and congestive heart failure. TCM Contraindications: Prolonged use or overdose may consume Yin. Use cautiously in patients with Yin deficiency, Blood deficiency, Yin-deficient Fire, Liver Yang rising, or Liver Wind rising. Not suitable for patients with upper excess and lower deficiency. Pharmaceutical Interactions: This formula may INCREASE the effects of Monoamine Oxidase Inhibitors (MAOI's), anticoagulants and antiplatelets; may increase potassium loss with diuretics and laxatives, which may interfere with antiarrhythmics. This formula may DECREASE plasma glucose levels, and may decrease the effects of antihypertensive agents and antidiabetic medications. This formula may cause hypertension and fluid retention when used with oral contraceptives. May decrease endogenous testosterone levels in men and women with polycystic ovary disease. May increase the half-life of systemic corticosteroids. May lessen overall availability of tolbutamide. Comments: If it is difficult to pinpoint the specific meridians or organ functions causing a particular problem, or if the patient has taken many Western medications, this herbal formula can help clarify the underlying condition. In severe cases or in early stages, may increase dose 50% for a few weeks, then decrease as symptoms improve. Recommended Usage: 2-3 tablets twice daily with warm water.

Products marketed in interstate commerce for the prevention or treatment of disease are subject to federal regulation. Marketing a drug product without FDA approval is illegal. Section 321(g)(1) of the Federal Food, Drug, and Cosmetic Act defines "drug" as any article (except devices) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or function of the body." Regulation 201.5 require labeling to contain adequate directions for all intended uses. Labeling includes any written, printed or graphic material that accompanies a product. Intended use is determined by the facts at hand. Drugs not generally recognized as safe and effective by experts are "new" drugs. Marketing an unapproved (by FDA) new drug in interstate commerce is a federal crime. Marketing a drug without adequate directions for use is a federal crime (misbranding). It is also illegal to import drug products that lack FDA approval. I can find no record that the FDA has approved any of the Meridia's herbal products as drugs. For this reason, I believe it is illegal to market them in interstate commerce or import them into the United States for use as drugs.

My Opinions

References

  1. Larsen AP. Ryodoraku history and research. Document created by Cameron Larsen, General Manager of Miridia Technology, Dec 1, 2006. Downloaded from Miridia Web site, Nov 28, 2017.
  2. AcuGraph 5. Body Talk Web site, accessed Jan 19, 2018.
  3. Introduction to AcuGraph (video). Accessed Jan 19, 2018.
  4. Thompson K. How to create a steady stream of profitable wellness patients. Miridia Technology, Sept 2017.
  5. Yellen AK. What are 510(K) clearance and premarket approval? Device Watch, Jan 9, 2009.
  6. Product classification: Locator, acupuncture point. FDA Medical Device Database, accessed Jan 18, 2018.
  7. Medical devices; exemptions from premarket notification: Class II devices. Federal Register 82:31976-32002, July 11, 2017.
  8. Barrett S. Auriculotherapy: A skeptical look. Acupuncture Watch, Feb 2, 2008.
  9. Acupuncture needle. 21CFR880.5580, revised April 1, 2017.
  10. 510(k) Summary #K041359. Body Clock Health Care Ltd., Aug 20, 2004.
  11. Barrett S. Be Wary of acupuncture, Qigong, and "Chinese Medicine." Jan 12, 2011.

This article was revised on February 3, 2018.

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