To the Editor: The Institute of Medicine's To Err is Human"To Err is Human: Building a Safer Health System" is a groundbreaking report issued in 2000 by the U.S. Institute of Medicine which resulted in an increased awareness of U.S. medical errors. The push for patient safety that followed its release currently continues.
..... Click the link for more information. made headlines by estimating that medical errors account for between 44,000 and 98,000 deaths annually in the United States. Together with the subsequent quality dimension report, Crossing the Quality Chasm, the Institute of Medicine has brought patient safety into the spotlight. (1) The greatest variance of adverse events in medicine probably is due to medication errors. Today's primary care physician has a multitude of electronic devices such as personal digital assistants, software, and newsletters designed to help minimize medication error and promote safe medication practices. (2) Electronic therapeutic devices can actively reduce the number of medication errors by reducing the amount of medication needed to treat anxiety, depression, insomnia, and pain. Among the electromedical devices available to the ordinary office practice of general medicine is the cranial electrotherapy stimulation cranial electrotherapy stimulation NET, neuroelectric therapy, TCET, transcranial electrotherapy Psychiatry A maneuver in which electrodes are placed on or near the ears to pass low level–less than that used in electroshock therapy–electricity (CES) device. CES is the noninvasive application of low levels of microcurrent (less than 1 milliamperemil·li·am·pere n.
Abbr. mA A unit of current that is equal to one thousandth (10-3) of an ampere.

CES is a treatment modality that has been neglected by mainstream medicine for the treatment of anxiety, depression, or insomnia. Selective serotonin reuptake inhibitorsSelective Serotonin Reuptake Inhibitors Definition

Selective serotonin reuptake inhibitors are medicines that relieve symptoms of depression.
Purpose
..... Click the link for more information. (SSRIs) are known as the gold standard for the treatment of depression. However, CES is now more relevant because of recent government warnings on SSRIs [here and here]. Thus far, CES has not demonstrated any of these adverse effects. There is no shortage of antidepressantantidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy.
..... Click the link for more information. research, but today's peer-reviewed literature has a relative dearth of CES reports. The companies that produce these devices are small and as yet unable to support high-budget standards of double-blinded, randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. , institutional review board--controlled studies. A surprising number of CES studies in the peer-reviewed literature have been done without funding.

CES in the United States has received Food and Drug Administration marketing clearance for the treatment of anxiety, depression, and insomnia. CES devices are sold over the counter in Europe and other parts of the world. Mooddisordered alcoholics have shown increased activity of the enzyme MAO-B in the spinal fluid after 20 CES treatments. (3) Patients with treatment-resistant depression have shown significant (P < 0.0089) elevations in plasma serotonin. (4) Increases in cerebrospinal fluid levels of [beta]-endorphins up to 219%, plasma endorphins endorphins (endôr`finz), neurotransmitters found in the brain that have pain-relieving properties similar to morphine. There are three major types of endorphins: beta endorpins, found primarily in the pituitary gland; and enkephalins and up to 98%, and cerebrospinal fluid serotonin up to 200% have been demonstrated in normal volunteers receiving 20 minutes of CES. (5) A recent annotated bibliography of CES by Kirsch (6) details 126 human and 29 experimental animal studies of CES conducted over the past 40 years. More than half the studies cited are from the peer-reviewed literature. The majority of the studies were double-blinded and conducted at major American universities. In aggregate, there were 6,007 patients treated under varying research conditions, with 4,541 actually receiving CES treatment. One hundred twelve (89%) of the studies reported positive outcomes. Seventeen studies followed up the patients to assess any continued results after 1 week to 2 years, and all the patients showed at least some residual effect after one or a series of treatments.

CES is both noninvasive and considerably less expensive. Neurosurgical implantation techniques of deep brain--stimulating electrodes and vagal vagal /va·gal/ (va´gal) pertaining to the vagus nerve.
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va·gal
adj.
Of or relating to the vagus nerve.

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vagal

pertaining to the vagus nerve. nerve stimulators that are currently used and studied for the treatment of affective disorders are more expensive. However, CES requires continuing medical assessment and supervision. The same caveat is true of all antidepressants Antidepressants
Medications prescribed to relieve major depression. Classes of antidepressants include selective serotonin reuptake inhibitors (fluoxetine/Prozac, sertraline/Zoloft), tricyclics (amitriptyline/ Elavil), MAOIs (phenelzine/Nardil), and heterocyclics and other medications in today's Physician's Desk Reference Physician's Desk Reference (PDR),
n an informational, scientifically validated resource that provides information relating to indications, chemical formulations, actions and potential hazards associated with most medicinal remedies currently being used. for the treatment of anxiety, depression, and insomnia. The patient safety movement and burgeoning Internet resources are working to increase the number of patients more actively involved in their own care. CES deserves to be a modality in the armamentarium ar·ma·men·tar·i·um
n. pl. ar·ma·men·tar·i·ums or ar·ma·men·tar·i·a
The complete equipment of a physician or medical institution, including drugs, books, supplies, and instruments. not only for chronic pain but for reducing or occasionally replacing the amount of medication necessary in the treatment of anxiety and depression. CES is not a miraculous modality, but it's definitely worth a try.

Safe Effective Nondrug Treatment of Chronic Depression: A Review of Research on Low-Voltage Cranial Electrical Stimulation and Other Adjunctive Therapies
C. Norman Shealy, MD, PhD
Holos Institutes of Health, Inc, Fair Grove, Missouri, norm@normshealy.com

Paul Thomlinson, PhD

Burrell Center, Springfield, Missouri

Although clinical practice guidelines tend to emphasize pharmacological treatments for chronic depression, safe and effective nondrug treatments are available. This article reviews three decades of research at the Shealy Institute on nonpharmacological treatments for chronic depression in chronic pain patients via low-voltage electrical stimulation and other adjunctive therapies. More than 30,000 chronically depressed patients have been treated with cranial electrical stimulation at 1 to 2 mA at 15,000 Hz, modulated at 500 and 15 Hz. Approximately half of patients treated with this approach experienced marked clinical improvement. When combined with photostimulation at 1 to 7 Hz, 85% of patients improved adequately without use of antidepressant drugs and without complications. Magnesium replacement and nutrition education are useful adjuncts. This program is cost effective and can be carried out by a nurse practitioner and an assistant. Further controlled clinical research and research on mechanisms of action would strengthen the validity of these findings and increase the application of these therapeutic approaches.

References

1. Institute of Medicine. In Kohn LT, Corrigan JM, Donaldson MS (eds). To Err Is Human: Building a Safer Health System. Washington, DC, National Academy Press, 2000.

2. Institute for Safe Medication Practices [http://www.ismp.org/]. 1800 Byberry Road, Suite 810, Huntingdon Valley, PA 19006 Voice: 215.947.7797 Fax: 215.914.1492. Email ismpinfo@ismp.org.

3. Krupisky EM, Burakov AM, Karandashova GF, et al. The administration of transcranial electric treatment for affective disturbances therapy and alcoholic patients. Drug Alcohol Depend 1991;27:1-6.

4. Shealy CN, Cady RK, Wilkie RG, et al. Depression: a diagnostic, neurochemical neu·ro·chem·is·try
n.
The study of the chemical composition and processes of the nervous system and the effects of chemicals on it.

neu profile and therapy with cranial electrotherapyelectrotherapy /elec·tro·ther·a·py/ (-ther´ah-pe) treatment of disease by means of electricity.

e·lec·tro·ther·a·py
n.
Medical therapy using electric currents.
..... Click the link for more information. simulation (CES). J Neurol Orthop Med Surg 1989;10:319-321.

5. Shealy CN, Cady RK, Wilkie RG, et al. Cerebral Spinal Fluid and Plasma Neurochemicals: Response to Cranial Electrotherapy Stimulation. J Neurol Orthop Med Surg 1998;18:94-97.

6. Kirsch DL. The Science Behind Cranial Electrotherapy Stimulation. Edmonton, Alberta, Canada. Medical Scope Publishing Corporation, 2002.

Marshall F. Gilula, MD

Paul R. Barach, MD, MPH

Department of Anesthesiology

Center for Patient Safety

Jackson Memorial Hospital Jackson Memorial Hospital (also known as "Jackson" or abbreviated "JMH") is a non-profit, tertiary care teaching hospital and the major teaching hospital of the University of Miami Leonard M. Miller School of Medicine in Miami, Florida.

University of Miami This article is about the university in Coral Gables, Florida. For the university in Oxford, Ohio, see Miami University.

The University of Miami (also known as Miami of Florida,[2] UM,[3] or just The U School of Medicine

Miami, FL

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