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CES being used in pain clinics

CES units were becoming more widely used in pain clinics at the dawning of the 21st century. The clinics typically do not wait for pain studies to be completed, but simply try CES with their patients to see what effect they can observe, then compare it with their historical experience with those same types of patients. A typical such clinic is one just outside Dallas, Texas. A nursing assistant puts CES electrodes on patients as they enter the waiting room to await their turn with physicians or other therapists. The wait can vary from a few minutes to a half hour, depending on the patient load at a given time. The patients complete a 10 point self rated pain score prior to receiving CES. When they are called into treatment by the treatment staff, the CES is removed, the amount of time they were on the device is recorded, as a post CES self rated pain score if obtained.

The clinic has become so enthusiastic about the results, that this protocol has become a permanent part of their core treatment program. They now enthusiastically prescribe CES home units for their large number of patients who now request them, and the staff reports their clinic is much more effectively treating chronic pain than they were previously.

Pain clinic treatment results have been published, however. An interesting CES study was completed in a pain clinic near Bombay, India, in 2001. It was an open clinical trial of CES, used alone as a treatment of pain patients who had been refractory to all other previous efforts of treatment of their pain at the clinic. They were given CES treatments one hour per day, 5 days a week, for three weeks. They were asked to rate their pain level on a VAS scale of 0 to 10, with 10 being the most intense pain. Following treatment their mean self reported pain level had been reduced by 62%. Analyzing the data for individual patients it was found that 15% of the patients did not respond to the treatment, 30% gained total relief, while the remainder of the patients claimed significant relief ranging from 33% to 94%.

A View from the Trenches: Why Psychiatry needs CES – Part 1

Why Psychiatry needs CES
by Jason Worchel, M.D.

Jason Worchel, M.D. is a noted psychiatrist and Director of the Hilo Mental Health Center in Hilo, HI. The following posts are taken from a paper written by Dr. Worchel in his testimony before the F.D.A. concerning the effectiveness and safety of CES from the perspective of a practicing psychiatrist.

The Challenge of Psycho-Pharmacology

As a practicing psychiatrist, I am constantly struggling with balancing purported efficacy with known risks of somatic interventions. While currently approved interventions have demonstrated efficacy relative to placebo, the rate of improvement with placebo remains consistently above 30%.

With the increasing prevalence of polypharmacy, there is an increasing risk of adverse side effects for the statistical hope for improved outcomes as demonstrated in clinical trials conducted with select populations in controlled environments. In addition to evaluating the risk/benefits of various treatments, I know from multiple studies most patients are not adherent to the prescribed medication regimens and discontinue medications altogether within a relatively short period of time.

Though my goal is to treat the presenting illness or alleviate its symptoms, my primary duty to my patients is to “do no harm.” This typically results in an approach that follows a spectrum of interventions with initial treatments being those with the least risk of adverse side effects.

There is no risk conventional interventions that currently constitute the standard of care will be bypassed by using CES.

Experience

I have worked with primary care physicians in our federally qualified health clinics on the Big Island. They, like others across the country, are stymied and frustrated by the challenge of treating chronic pain.

In particular, they face patients with bona fide pain but who also have depression, anxiety, insomnia and substance abuse. With regards to treatment interventions, they are damned if the do and damned if the don’t treatment with various classes of analgesic medications, including narcotic medications.

They are particularly afraid of the increasing fatalities occurring with the use of narcotic analgesic medications in combination with benzodiazepines and antidepressant medications. They welcome alternatives to medications for those patients whose emotional distress intensifies their suffering and pain sensation. CES could provide a safe alternative for them that do not currently exist.

In summary, CES represents as safe intervention for conditions for which existing treatments, especially pharmacologic and invasive interventions pose significant risk for adverse side effects. It is especially beneficial in defined populations. These include those who refuse medications and psychotherapy, dual diagnosed patients, geriatric patients, females of child bearing age and during pregnancy.

Advantages of CES

I would like to highlight various advantages of CES relative to other existing treatments, especially medications that may not be well appreciated. Take for example, the difficulty faced by primary care physicians and mental health professionals in treating female patients of child bearing age. All available medications have teratogenic risk and are not recommended during pregnancy and breast feeding. Patients desiring to become pregnant have justified concerns about taking psychotropic medication

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Current treatment algorithms encourage polypharmacy when initial treatments with a single drug are not effective. While there is some increased response, polypharmacy only increases the side effects burden and can result in untoward drug/drug interactions. These types of problems do not occur with CES.

Many psychotropic medications for the treatments of depression, anxiety and insomnia have discontinuation syndromes. Given the high rate of discontinuation of these medications by patients due to side effects and lack of efficacy, many patients unfortunately suffer when the take a medication prescribed to alleviate their suffering. This does not occur with CES. There are circumstances, for example prior to surgery, when certain psychotropic medications are required to be discontinued. CES does not have to be discontinued prior to surgery.

One my greatest concerns in treating patients with depression, anxiety and insomnia involves suicide. We know increased risk of suicide in depressed patients but it is often global insomnia is a significant risk factor for suicide as well as anxiety/agitation. Although safer than the older tricyclic and tetracylcic antidepressants, the current medications carry a significant risk of death in overdose, especially when combined with other analgesic medications. Too often, the medications we prescribed to prevent suicide become a means through which the patient attempts suicide. In fact, there are black box warnings that these medications may increase suicidal impulses, especially in adolescents. CES does not pose this risk.

As in many developed countries, we are an aging population. The treatment of depression, anxiety and insomnia in the geriatric patients with medications present unique challenges due to the increased risk of adverse side effects. These side effects include the risk of falls and motor vehicle accidents. Again, the number of medications taken in our geriatric patients continues to increase. Thus risk of adding psychotropic medications to their other medications poses additional drug/drug interactions and side effect burden.

CES avoids this disadvantage and provides a safe alternative to patients, their families and care givers. Furthermore, missing a CES treatment does not carry the risks of missing doses of psychotropic medications in this population.

More CES Research – https://www.cesultra.com/research-resources.php

A View from the Trenches: Why Psychiatry needs CES – Part 2

Anxiety

There are many non-pharmacologic interventions for reducing anxiety. Some of these include dietary supplements, acupuncture, meditation, yoga, and exercise. These interventions, however, are not employed by a large segment of society which suffers from anxiety. These persons instead seek medications from their physician to alleviate their suffering.

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Typical classes of medications for anxiety include the SSRI’s, benzodiazepines as well as the off label use of antihistamines and atypical antipsychotic medications and antiepileptic medications. In addition to the inherent problems with SSRI’s, there are also problems with the other classes of medications.

A serious potential side effect of benzodiazepines is their potential for inducing physical and psychological dependence. In addition, withdrawal symptoms can prove life threatening, especially with the shorter acting benzodiazepines like alprazolam. When taken as directed, which is often not the case; this class of medications can result in compromised coordination, slowed reaction time, falls, disinhibition, delirium, and anterograde amnesia.

It is not uncommon to see suicide attempts involving a combination of a benzodiazepines together with alcohol and/or another sedative hypnotic. While buspirone is relatively well tolerated, it has poor efficacy and a 3 to 4 week lag time to have an effect. Medications such as gabapentin are used off label but there is no research to support its efficacy for anxiety disorders.

Unfortunately, physicians have begun using the atypical antipsychotic medications to treat anxiety. This class of medications has a large and increasing number of very serious side effects. Recent attention has been focused on their causing metabolic syndrome. They frequently cause extra pyramidal side effects, sedation, elevated prolactin levels and drug/drug interactions. All of these medications should be avoided during pregnancy and used with caution in the elderly.

In short, the side effect profile of current pharmacologic treatments for anxiety limits their safe use. CES is a safe, initial alternative to such medications.

By Jason Worchel, M.D., a noted psychiatrist and Director of the Hilo Mental Health Center in Hilo, HI. This post is from a paper written by Dr. Worchel in his testimony before the F.D.A. concerning the effectiveness and safety of CES from the perspective of a practicing psychiatrist.

Why Psychiatry needs CES

The prime directive – Do No Harm

The primary duty to patients should be to “do no harm”. Avoiding harm typically results in an approach that follows a spectrum of interventions beginning with treatments that pose the least risk of adverse side effects.

The harm reduction approach increases the likelihood patients will benefit without being exposed to unnecessary risks of harm. CES should be included in the spectrum of available treatments as it poses very low risk of harm to patients.

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CES as a safe and effective alternative

People worried about the use of pharmaceutical drugs should consider CES as a safe and effective alternative

The FDA has expressed concern as to utilization of CES without first employing more “conventional” treatments. Unfortunately, the more conventional treatments at times are not only ineffective but also in many circumstances contribute to a worsening of the condition or result in deleterious side effects.

This can result in necessary therapeutic alliance adversely impacted. Frequently, patients will mention the advertisements they see on television by various attorneys soliciting patients who have been harmed by approved medications, ECT or other treatments. They are worried about being harmed by prescribed treatments and become suspicious of their health care professionals.

There is excellent data and clinical experience however to support the safety and lack of adverse side effects from CES and it should be included in the spectrum of available treatments as it poses very low risk of harm to patients.

Excerpts from “A View from the Trenches” written by Jason Worchel, M.D.

More CES Research – https://www.cesultra.com/research-resources.php

CES and the aging brain

There is a growing body of evidence suggesting that the aging brain undergoes neuroplastic changes to respond to functional declines and keep performance on the best level. During these changes, additional brain areas are recruited, such as the ipsilateral motor cortex. First proof of principle has been provided that CES might modulate cortical functions even in old subjects. Nevertheless, this exciting and progressing field is still at a starting point and more studies are needed to further substantiate the hypothesis that CES can be used to enhance functions that have declined with age. In comparison to pharmacological interventions, CES is applied focally and does not have systemic side effects, a crucial point to consider in this population. Moreover, these techniques are easy to apply and can be coupled with training protocols or rehabilitative programs, such as physio-, occupational, speech therapy, or gait training to enhance impaired functions with a consecutive improvement of quality of life.

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