Alpha Stimpractitionersguide

Practitioner’’sGuide to Using

Alpha-StimHow to Use Alpha-Stim® Technology

to Help Your Patients With Pain, Anxiety, Depression and Insomnia.

Practitioner’’sGuide to Using

Alpha-StimHow to Use Alpha-Stim® Technology

to Help Your Patients With Pain, Anxiety, Depression and Insomnia.

®

Alpha-Stim Practioner's Guide 2/21/06 12:23 PM

Alpha-Stim® is the most researched medical device in its

class with more than 55 completed independent research

studies and published reports and several more underway.

Research shows that 93% of patients reported significant

relief from their pain, anxiety,depression and/or insomnia

after 3 weeks of use.

9 out of 10 tough pain patients, who couldn’t get relief

with anything else, finally had relief with Alpha-Stim®.

The effects of Alpha-Stim®areusually immediate, cumulative,

and long lasting. Because of this, many practitioners

integrate Alpha-Stim® treatment protocols into their

office procedures, as well as prescribe or orderAlpha-Stim®

for their patients to use at home.


occurs in 1 of 506 patients, and skin irritation in 1 of 910 patients. Both of these problems are minor and self-limiting.

With Alpha-Stim® there is no chance of causing tardive dyskinesia,increased suicidal ideation, addiction,death, or hepatic failure, to name justa few of the risks of pharmaceuticalintervention. The worst problem thathas ever been documented with Alpha-Stim® was the rare occurrence of mild disorientation when a cranialelectrotherapy stimulation (CES) session was prematurely interrupted.That problem is easily avoidable bycompleting the full treatment session,which generally takes only 20 minutes.

Proven Efficacy

More than 93% of pain patientsachieve significant relief with Alpha-Stim®, even when conventional intervention has failed. So how can you trust this?

There are only three ways to proveefficacy: research, surveys and testi-monials. Alpha-Stim® has all three inabundance. In fact, with 55 completedstudies and many more underway,there is more research supportingAlpha-Stim® technology than there is formost drugs. An important fact aboutAlpha-Stim® research is that none of it is company-supported. Most of thestudies are double blind placebo controlled and were conducted at majorUS universities. The US governmenthas funded two major Alpha-Stim®

studies. One is a NCI/NIH study forbreast cancer patients undergoingchemotherapy and the other is a VA study for veterans with spinal cord injuries.

So Let’s Look atthe Concrete FactsAbout Using Alpha-Stim®

There are only four reasons why alicensed health care or mental healthprofessional would recommend anyintervention for a particular patient:

1) Safety 2) Efficacy 3) Cost-Effectiveness 4) Reliability and Support

Through this guide we will demonstratehow Alpha-Stim® meets all four criteria.

Alpha-Stim® can easily be incorporatedinto your practice resulting in moresatisfied patients who refer friends and colleagues.

Now let’s look at this in more detail.

Alpha-Stim®

and Your Patients Safety First!

With all the current and on-going publicity about the dangers of drugslike Oxycontin, Vioxx, Celebrex, andthe SSRI’s like Prozac, Zoloft and Paxil,patients are more concerned than everabout the risks they take when theyseek help for their pain or mood disor-ders. Alpha-Stim® technology is not onlysafer than any drug, but it is even saferthan most other devices because itonly uses microamperes (millionths ofan ampere) of electricity. The only sideeffects derived from studies with over6,000 patients are headache, which


In addition to the prospective research,we have survey data from both doctorsand patients. Forty-seven doctorsreported their results on 500 patientsin 22 diagnostic categories resulting ina 50-page analysis of that data pub-lished in the book The Science BehindCranial Electrotherapy Stimulation byDr. Daniel L. Kirsch (2nd Ed. MedicalScope Publishing, Alberta 2002). That data correlates well with a peer-reviewed outcome study of 2,500patients’ self reports published in theAmerican Journal of Pain Management:11(2):62-66, 2001. For most diagnosticcategories, both doctors and patientsreported that 9 out of 10 patients had significant results based on thedrug standard of a minimum of 25%improvement. However, most Alpha-Stim® patients had at least 60%improvement in their symptoms. Furthermore, clinical research tells usthe technology is effective if it achieves

a probability factor of at least P<.05.This means that if the study is repeated20 times, the chances are that a similaroutcome would be reproduced 19times. While that is the benchmark foracceptable science, it is not of greatvalue to a clinician. An advantage ofcomprehensive survey data over otherkinds of research is that it helps us predict more specifically how well apatient in a specific diagnostic categorymight do with this treatment. Forexample, doctors tell us that in 286 painpatients they treated in their offices,27% will achieve a 50 to 74% reductionin their pain. Of 1,947 pain patientswho used Alpha-Stim® for at least 3weeks at home, 38% reported thatsame 50 to 74% level of improvement.We have created convenient charts for clinicians to use this data to assistin prognosis which we call, “Alpha-Stim®

Results at a Glance”.

Finally, there are hundreds of endorsementson our Web site: www.alpha-stim.com

Efficacy of AntidepressantsBeyond the Placebo Response

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Prozac Paxil Zoloft Effexor Serzone Alpha-Stim®CES5 Studies 12 Studies 3 Studies 6 Studies 8 Studies 8 Studies

Kirsch I, Moore TJ, Scorboria A, and Nicholls SS. The Emperor’s New Drugs: an Analysis of Antidepressant Medication Datasubmitted to the FDA. Prevention and Treatment. 2002;5:1-11.

Gilula ME, and Kirsch DL. Cranial Electrotherapy Stimulation Review: A Safer Alternative to Psychopharmaceuticals in theTreatment of Depression. Journal of Neurotherapy. 2005;9(2):7-26.


from physicians and other licensedhealth care professionals, sportsteams and patients. Viewed on thefoundation of our prospectiveresearch, these personal testimonialsto the effectiveness of Alpha-Stim®

technology in adults, children and animals fill in the fine details aboutthe Alpha-Stim® experience that pureresearch reports omit.

Cost-Effectiveness

Forbes Magazine reported annual cost figures for the most populardrugs used to treat various conditionsincluding anxiety and depression,chronic pain and insomnia (“Just SayNo!”, November 29, 2004, pages102-112).

For the customary pharmaceuticaltreatment of depression or anxietyusing the popular drug Zoloft, theannual cost per patient is $850.However, it is well known that Zoloftmay cause insomnia, and Alpha-Stim®

CES is also FDA cleared to treat insomnia. Therefore, patients who useAlpha-Stim® CES to treat anxiety aresimultaneously receiving an effective

treatment for insomnia and depression.Recent studies have acknowledgedwhat has been empirically demonstratedand understood by clinicians for quitesome time – that chronic pain is highlycorrelated with depression, anxiety and insomnia, and vice versa.

According to Forbes, the sum of theannual costs for the drug treatment of anxiety and insomnia is $1,770 per patient. Adding chronic pain to the mix would result in an annual cost per patient of $3,100.

A patient suffering from chronic pain,anxiety and insomnia, spending $3,100annually for Oxycontin, Ambien, andZoloft would begin seeing a cost savings by using Alpha-Stim® CES at1.91 or 3.46 months, depending onthe Alpha-Stim® model. Put another way, against the combined costs ofOxycontin, Ambien, and Zoloft, Alpha-Stim® CES breaks even at about 2 to 31⁄2months, and lasts at least five years.

Over the 5 year warranty that coversevery Alpha-Stim®, the savings canamount to as much as $7,100 for the Alpha-Stim® SCS over Prozac alone. This product-to-product comparisonassumes that drug prices will remain at current levels and the patient willtake their drugs for five years withoutincurring any additional drug or doctorvisit costs. Of course in real life thedrugs and their associated costs would probably be some multiple of these figures. The Alpha-Stim® 100 will take alittle longer to save money over drugsbut it can replace a lot of drugs forboth pain and associated depression so the savings still add up quickly.


Reliability and Support

Electromedical Products International,Inc. (EPI) has been in business since1981. EPI takes care to ensure its operations meet the highest qualitystandards by maintaining a special certification for the medical deviceindustry. This is accomplished by implementing a quality system for business operations in compliance with ISO 13485:2003, an internationallyrecognized quality control standard forthe medical industry. EPI is inspectedannually to insure its quality systemsadhere to the stringent requirements of this ISO standard.

Further, Alpha-Stim® Technology is classified by Underwriters LaboratoriesInc., an independent testing companyin accordance with UL-2601-1 andCA/CSA C22.2 No 601.1.34VF.

Nothing is more important to our management and employees than customer service. We have a variety of resources to assist you and yourpatients including illustrated owner’smanuals, illustrated specialized treatment protocols both in hard copyand on our Web site, and educationalDVDs that explain and demonstrateour pain treatment protocols. We prideourselves on providing the best ongoingsupport of any medical device company.When you buy or prescribe an Alpha-Stim®, you and your patients get accessto the top experts in electromedicine at no additional cost. Our clinical support team fields questions on justabout every topic, from how to do thesimple 2 to 5 minute pain management

protocols, to more complex, difficult to treat cases like reflex sympatheticdystrophy, rheumatoid arthritis andfibromyalgia. We help you through yourlearning curve. No other comparablemedical device company offers thismuch support.

Alpha-Stim®andYour Practice Using Alpha-Stim®

in a Clinical Environment

We have substantiated that Alpha-Stim®

works on 9 out of 10 patients that havetried it. Now that we know it works forpatients, let’s look at how the Alpha-Stim® benefits the health care or mentalhealth professional’s practice. We’ll firstprovide background, suggestions andexamples for the practitioners who seepain patients, followed by the same formental health professionals. Pleasenote that Alpha-Stim® is a medicaldevice regulated in the United Statesby the Food and Drug Administration(FDA). Accordingly, its use in the UnitedStates is by prescription or the order of licensed professionals, although it is available over-the-counter in therest of the world. If you are a licensedpractitioner and can see patients for a specific condition without a referralfrom another practitioner, you canorder Alpha-Stim® for that patient’s condition. Don’t hesitate to call us for more information.


while they are undergoing other procedures, such as dialysis.

Because the results of Alpha-Stim® arecumulative and long lasting, patientsfeel better immediately, with the resultsusually lasting for days before anothertreatment is necessary. Each treatmentadds to the cumulative effect, makingeach treatment last longer than thosepreceding it. For chronic or persistentconditions, the patient can be taught to use the Alpha-Stim® at home betweenvisits to your office, for check-ups andother interventions.

To ensure your best success, we offereverything from a 30 minute DVD ver-sion of the Owner’s Manual (filmed at St. John’s Regional Health Center inSpringfield, Missouri) to an in-depth 61⁄2hour DVD set featuring eight prestigious speakers filmed at theAmerican Academy of PainManagement’s annual meeting in 2003.This can be used for comprehensivestaff training, along with reprints oftextbook chapters on our protocolsand full color posters with examples.Questions beyond that are happilyanswered by our fully trained distribu-tors or our clinical support specialistsusing our toll free 1-800-FOR-PAINnumber. Using these resources you canbe confident in achieving immediateresults with Alpha-Stim®.

Alpha-Stim®forAnxiety, Insomniaand DepressionMental health professionals often haveto deal with drug problems, includingtolerance, side effects, addiction,

Alpha-Stim®forManaging PainThere are as many variations for usingAlpha-Stim® in a practice as there aretypes of practitioners. However, thereis a common model that has emergedthat can be emulated successfully. Most practitioners use Alpha-Stim® forimmediate relief of acute and chronicpain using the probes and our proventreatment protocols right in their office.These procedures can be performedeither by the practitioner, a nurse, orassistant in an examination or treatmentroom. No special tables or otherdevices are required.

Insurance usually pays for treatmentsin a practitioner’s office using estab-lished CPT or DSM codes. It only takesabout 2 to 5 minutes of active probetreatments using our simple provenprotocols to substantially reduce oreliminate pain. You can view the painprotocols on our Web site.

For the best results, probe treatmentsshould be followed by a 20-minute CES session wherein the patient relaxesin a comfortable chair with ear clipelectrodes on. These sessions can beunattended. Accordingly, one assistantcan comfortably treat 3 or 4 patientsper hour. The CES part of the treatmentcan even be done on multiple patientsat one time in a large room limitedonly by the number of chairs. Somepractitioners do this to relax patients


overdosing and polyphar-macy effects. Moreover,given the recent FDAmandated black boxwarnings, more patients

are concerned about every new emo-tion or sensation they experience.

With the side effects and safety issuesof psychotropic drugs, it’s a wonderthat their use has become so prevalentin our society. Here’s a list compiledfrom the safety warning sheets fromseveral of the most popular anti-depressants: gastrointestinal upset,sexual dysfunction, headache, restless-ness, nervousness, insomnia, somno-lence, discontinuation syndrome withsudden withdrawal of certain SSRIs,cardiovascular effects, nausea, drymouth, dizziness, sedation, agitation,constipation, weight loss, weight gain,orthostatic hypotension, anticholinergiceffects, reflex tachycardia, cholinergicrebound upon rapid discontinuation,possibility of severe hepatotoxicity, priapism, risk of elevated supine diastolic blood pressure, cardiac conduction abnormalities, possiblelethality in overdose, routine userequires monitoring of serum drug levels when new meds are started ordiscontinued or in the case of suspectedoverdose or nonadherence or if severeadverse effects develop, and use withcaution in patients with acute angleclosure glaucoma, cardiovascular disease, cognitive impairment, or suicidal tendencies.

The incidence of side effects withAlpha-Stim® are: headache, 0.20%, andskin irritation, 0.11%. These are minorand self-limiting.

Even if your patient is not currentlytaking medication, research demon-

strates that Alpha-Stim® may help theircondition. It simultaneously treats anxiety, depression and insomnia andallows the patient to focus on othertherapies such as relaxation, biofeed-back or cognitive behavioral therapies(CBT). Many mental health professionalsuse Alpha-Stim® during CBT because ithelps the patient focus. Once proveneffective for a particular patient in aclinical setting, Alpha-Stim® can beordered for home use.

The most current review and meta-analyses on CES for anxiety, depression,insomnia, cognitive dysfunction andpain was published as a chapter byKirsch et al. in the 2004 textbook,Bioelectromagnetic Medicine (MarcelDekker, Inc., New York). You can viewthis chapter on our Web site. The reffect sizes from 25 studies of CES fordepression involving 1,075 patients is.57 (which means 57% improvementwhere .10 is considered small, .30medium and .50 high). Surveys of 500anxiety patients detailed in this chapterfound an overall effect size of r = .62,and 21 studies of CES for insomnia in-volving 940 patients also found a meaneffect size of r = .62. (i.e., the meanimprovement in the group was 62%).

Alpha-Stim®

Provides Proof;Others Can’t EvenCome Close Keep in mind that Alpha-Stim’s® provenresults are due to its proprietary technology and protocols that are not transferable. No other device has ourtechnology, nor have any proven they


can achieve these results. Others mayclaim they have a similar technology,but look at it like this: all “five mg whitepills” are not alike. Morphine andaspirin are both analgesics but ofcourse they differ in many ways. Somecompanies would like you to believethat their device can equal Alpha-Stim®

results just because it is in the samecategory. Yet, no other product hasachieved marketing clearance by FDAfor all four primary Alpha-Stim® applica-tions. So another brand of so-calledmicrocurrent stimulator or cranial elec-trotherapy stimulator would have toprovide proof of efficacy for their spe-cific technology. None provide as muchproof of safety and efficacy as Alpha-Stim®. Surprisingly, most devices haveno research at all. We have even seenseveral companies trying to use Alpha-Stim® studies to support their unfound-ed claims for their untested products.Also keep in mind that ElectromedicalProducts International, Inc. offers thebest support and longest warranty forany medical device.

Conclusions Remember, Alpha-Stim® has been aroundsince 1981. It has been proven effectiveby millions of patients and health careprofessionals worldwide, without significant side effects. While we havepainstakingly labored away, accumulatingresearch and endorsements fromdelighted patients and their doctors, we are now witnessing a fundamentalshift in patient and practitioner attitudes.We firmly believe that the health careclimate is changing and that informedpatients are demanding safe and effec-tive treatment from their health care

practitioner. Alpha-Stim® is prepared forthis challenge, and is well positioned tohelp health care practitioners in manydisciplines respond to the changingdynamics of health care delivery. Call us. Give Alpha-Stim® a try, and seeif you and your patients don’t agree.

Try it RISK FREE! As a licensed health care or mentalhealth practitioner, we are pleased tooffer a no-cost, low-risk way to see foryourself how Alpha-Stim® can help yourpatients and your practice. Call our tollfree number, 1-800-FOR-PAIN andchoose Option 4 from our automatedresponse unit. This will put you intouch with one of our experienced andknowledgeable clinical support special-ists who will be happy to answer anyfurther questions you might have.Then, we’ll put you in touch with anauthorized distributor in your area whocan demonstrate Alpha-Stim® in youroffice and show you how to use it onyour patients. Your distributor will beable to provide valuable insights andsuggestions on how to effectivelyintegrate Alpha-Stim into your practiceand introduce it to your patients.

If there is no distributor inyour area, ElectromedicalProducts International, Inc. is your distributor. We willloan you an Alpha-Stim®

to try out absolutely free for 60 days. During andafter your free trial our legendary customer serviceis at your fingertips. Fromclinical and technical support, to insurance


can offer my patients or myself. Mydiastolic blood pressure dropped from82 to 70 within a month as it did formany of my patients. My patientsreport that it has improved theirresponses to the medications that theytake, that it helps them feel better with-out medication and that it improvestheir response to neurofeedback.Several bipolar teenagers have doneconsiderably better with Alpha-Stim®.Adults who are stressed and/or anxioususually respond within about 10 min-utes. One boy with a tic disorder does-n’t tic as long as he uses the Alpha-Stim® in the AM and another, withsevere OCD who was on 300 mg a dayof Zoloft without full benefit, stoppedhis frequent repetitive rituals almostimmediately. So it sounds too good tobe true, and I would not have believedthat something as simple as this couldbe so effective unless I had seen itmyself. I have found the Alpha-Stim®

both good for me, my patients and formy business, as nearly 85% percent ofthe patients who tried it bought one forhome use.”

Henry Mann, MDConnecticut

Alpha-Stim® For Treating Chronicand Acute Pain“As director of the Pain ManagementCenter at Grandview/SouthviewHospitals, I specialize in treatment ofboth acute and chronic pain. The PainManagement Center has been in exis-tence for approximately nine years. I was introduced to the Alpha-Stim® 100early this year and have used it on anumber of the patients that we see in thePain Management Center. I have used iton patients with diagnosis of myofascialpain, fibromyalgia, arthritis, post-surgi-cal incisions, cephalgia, leg pain, kneepain and reflex sympathetic dystrophy.

billing or financing for your patients,we’ll be there for you.

So, call 1-800-FOR-PAIN or email [email protected] today for a free demonstrationor a 60 day free trial.

More Information on Our Website

Visit our website at www.alpha-stim.comwhere a substantial amount of informa-tion about the technology and productsis available.Topics include:

Results at a Glance Research Abstracts and StudiesVideo Clips of Alpha-Stim®in the NewsFrequently Asked Questions

PractitionerComments:Alpha-Stim® for Treating Pain and the Symptoms of Fibromyalgia “There’s been variable acceptanceregarding the safety of using opioidanalgesics to treat non-cancer pain. In fibromyalgia patients, the risk-benefitratio becomes even more complicated.Given that Alpha-Stim® raises serotoninand norepinephrine levels, and has aneutralizing effect on somatic pain generators, I predict this therapy willbecome a mainstream modality forreducing medication reliance andenhancing function in patients with fibromyalgia.”

Stephen E. Plotnick, MD Board-certified rheumatologist. From an articlein Advance For Directors In Rehabilitation(“Finding Hope”, May 2005, page 82)

Alpha-Stim® in Psychiatry; TreatingStress, Anxiety and Depression“I bought an Alpha-Stim® to try on peoplewith ADD and soon found that it is oneof the most calming experiences that I


© Copyright 2006 Electromedical Products International, Inc. ALL RIGHTS RESERVED.Alpha-Stim® is registered in the US Patent and Trademark Office and worldwide.

How to Choose the Alpha-Stim®

That’s Right for You and Your Patients Alpha-Stim®100 Alpha-Stim®SCS Alpha-Stim®PPM

Primary Indications

Pain � �Anxiety � �Depression � �Insomnia � �Treatment Methods

Probes for Pain �Electrodes for Pain � �Ear Clips for CES � �

We have had excellent results with themicrocurrent approach along with thetreatments done at the pain center andpain relief has been excellent. I havealso prescribed for several of mypatients the purchase of the Alpha-Stim®

100 for use in the home.”

B. Harker, DOOhio

Alpha-Stim® for Rehabilitation“I would like to thank you for introducingAlpha-Stim® therapy to my rehabilitationpractice last year. Since that time, wehave been applying it as “attended

electrical stimulation”, as a part of ourpatient’s physical therapy programs.The results have often been very good,and sometimes spectacular. It is espe-cially rewarding to be able to offer thismodality to chronic pain patients whohave been unresponsive to all othertherapies. We have many patients whohave been able to reduce their depend-ence on pain medications and haverealized increased functional capacityas a result of having an Alpha-Stim®

at home.”

Craig H. Lichtblau, MDPennsylvania

For treating multiplepain areas, and theanxiety, insomnia ordepression oftenassociated withchronic pain.

For treating anxiety,insomnia or depres-sion without pain.

For treating simplepain problems onone or two areas of the body withoutattendant anxiety,insomnia or depression.


Electromedical ProductsInternational, Inc. 2201 Garrett Morris Parkway Mineral Wells, TX 76067 USA (800) FOR-PAIN in the USA (940) 328-0788 Fax: (940) 328-0888 Email: [email protected] Web: www.alpha-stim.com

Prescribing InformationCE conformity Statement for Europe: Alpha-Stim®is a class IIa, Type B medical device. It has been independently tested by outside agencies in order to provide assurance of conformityto applicable standards for medical equipment safety and electromagnetic compliance.

Caution Statement for United States: Federal Law (USA only) restricts this device to sale by, or on the order of a licensed health care practitioner. Outside of the USA a prescription is not necessary, but consultation with a qualified health care professional is recommended.

Indications: Alpha-Stim®is an effective treatment with broad applications for a variety of syndromesinvolving pain, and for the management of anxiety, depression, and/or insomnia, or for the shortterm relief of the symptoms of pain, anxiety, depression and/or insomnia. In many cases, it is thesole therapeutic method required. Effective results in pain management have been seen duringand/or subsequent to stimulation over affected body parts, adjacent areas, and areas distant fromthose in pain. As with any therapeutic intervention, not all people will respond to Alpha-Stim®.The degree of efficacy will vary with the nature of the problem being treated, the overall health of the person, and with the method of treatment.

Contraindications: Alpha-Stim®may effect the operation of cardiac pacemakers (particularlydemand type pacemakers). Do not stimulate directly on the eyes, or over the carotid sinus (on the neck beside the larynx).

Precautions: For external use only. Do not allow children to use or handle this device withoutadult supervision. Do not operate potentially dangerous machinery or vehicles during, and in somecases, for several hours after treatment. Caution is advised in cases where other forms of analgesiawould not be used; such as to retain the beneficial aspects of pain for diagnosis or in cases wherepeople may overuse pain-controlled areas. Safety of stimulation has not been established duringpregnancy. There have been isolated reports of blood pressure being lowered by CES so careshould be taken while using Alpha-Stim®with high blood pressure medication.

Adverse Effects: Adverse effects are usually mild and self-limiting. Adverse effects seen inapproximately 4,541 patients in controlled, open, uncontrolled conditions, and by physician surveyand reasonably associated with the use of CES are dizziness (6 cases, 0.13%), skin irritation/electrodeburns (5 cases, 0.11%), and headaches (9 cases, 0.20%). Prolonged CES treatment at higher than necessary currents may cause dizziness or nausea that can last from hours to days. Paradoxical reactionssuch as hyperexcited states, increased anxiety, and sleep disturbances may occur.


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