GIRISH: This following article may not be new, but it is interesting for a few believers on this list. Although Grace [Holloran] has been discredited in the past, I believe that there is some truth in microcurrent therapy. Because improved vision was observed when computer chips were introduced into the eyes of retinitis pigmentosa (RP) patients. [Editor's note: see "Microchip Implantation."] These chips were generating microcurrent and stimulating the retina. How different is this from the microcurrent therapy? From the outside, it looks quite similar, but skeptics and pharmaceutical companies have no interest in promoting this idea, so we will not see any research in this area for a long time.

Quoted from wnbc.com:

Electricity Slows Macular Degeneration, Blindness
About 12 Million Americans Suffer From Condition
New York, November 26, 2002

Macular Degeneration Treatment

Macular degeneration is one of the most common forms of vision loss in this country. About 12 million Americans have it, and that number is expected to escalate to 30 million within the next few years. Lasers are the usual treatment for macular degeneration, but some experts say electricity is a better, non-invasive, alternative.

Grace Halloran was declared legally blind 30 years ago. She has macular degeneration, and she's tried everything to restore her vision.

"I was on nutrition, color therapy, exercises for the eye and upper body, acupressure and stress management ..." she said.

Patients with macular degeneration don't see the world like most people do. Their view's obscured by a large black spot that usually gets worse over time.

But Halloran came up with an idea during her son's rehabilitation from an elbow fracture.

"[The doctors] were using microcurrent technology to improve, speed up the process in sprains or back injuries and I found it to be useful in sports medicine, so I said, 'Why not the eyes?'" she said. "So I started using it."

The procedure Halloran used is called microcurrent stimulation. It involves applying an electrical current to acupuncture spots around your eyes, twice a day, three to four days a week.

"I've seen fields improve, color vision improve, and acuity -- coming down more than two lines on the eye charts," she said.

Dr. Damon Miller says microcurrent stimulation can help most patients with macular degeneration.

"I've had people who are legally blind who are driving again," Miller said. "I've had people who couldn't see the face on their grandchildren who can do that again. People who couldn't read do that again."

So why would the electric current help people see? No one is sure, but Miller believes it allows the eye to heal itself. But the problem is, there's no scientific proof.

Miller says that's the fault of the medical establishment.

"Medical studies in this country have been funded by drug companies -- and this is not a drug," he said.

The eye doctors NewsChannel 4 spoke to said they didn't know enough about microcurrent stimulation to comment about it. They did say they doubt it's a cure for macular degeneration. Miller also believes that microcurrent stimulation isn't a cure, but he says it can slow down the disease in most patients.

(End of article)

GISLIN DAGNELIE, Ph.D.: Grace Halloran has advocated a number of unconventional therapies for retinal degenerations over the years, and received some criticism for her wholesale embrace of most of those. But that doesn't mean there isn't some truth in there somewhere.

In particular, the idea that the same principles may underlie the reports that: 1. Dr. Chow's multiphotodiode array may give improved sight, even in retinal areas away from the device, and 2. patients receiving extraocular microcurrent stimulation have (temporarily) improved vision, suggests that small electrical currents may be good for sick rods and cones.

I wouldn't be surprised at all if some labs are going to pick up on this idea in the near future, even if there isn't big money in it, and even if the chances are slim that there will be a long-term benefit. As long as not much else is available, it seems worthwhile to explore any avenue that may bring even modest slowing of the degeneration process. The National Center for Complementary and Alternative Medicine (or even the National Eye Institute or the Foundation Fighting Blindness) might fund a small study, if the information gets a little less anecdotal than it has been thus far.

GIRISH: The following article surprised me to find that FDA has approved this form of therapy for retina. I thought it was still experimental. I don't think anyone should rush and get treated, but I would like to see more research funding in this area. I believe it has promise.

Microcurrent Stimulation (MicroStim or MCS)

MCS is novel, non-invasive and inexpensive treatment adapted from a FDA approved therapy used to treat other disorders. Preliminary studies have shown the MCS can be effective in treating retinal diseases ranging from Macular Degeneration (both wet and dry), Retinitis Pigmentosa, Stargardt's Disease, retinal vein occlusion and swelling, and other retinopathies.

The following 3 studies were summarized from the October, 2002 issue of the Townsend Newsletter:

The first study on MCS was a 2-year study done from 1983-1985 on 114 patients by Grace Halloran, Ph.D. The results of the study were as follows:

18 patients had Macular Degeneration, 16 improved.
78 had Retinitis Pigmentosa, 62 showed improvement.
18 patients had other various retinopathies, 16 improved.

Of the ones that did not demonstrate any improvement, 14 stayed the same (although they otherwise would have been expected to lose vision), 2 continued to lose vision, although only slightly.

A ten-year clinical study was done by Drs. Jarding and Michael on the use of MCS to treat Macular Degeneration. Of the 400 eyes studied, the results were as follows:

78% of the eyes showed from 1-9 lines of improvement in reading of the visual acuity chart.
Over 50% improved from 2-9 lines.

In the study, 2 patients suffered from retinal vein occlusion and swelling of the macula. Both had dramatic improvement in vision.

Damon Miller, MD, reviewed the results of using Microcurrent Stimulation in the treatment of Stargardt's Disease, Retinitis Pigmentosa and other degenerative retinal diseases. His results indicated that, of the 120 patients treated, 83% showed improvement of greater than or equal to 2 lines of visual acuity in one or both eyes.

There are several metabolic processes that are enhanced through the use of Microcurrent Stimulation. The first to boost the cells' ability to rid themselves of waste products. A cell with "stuck" waste products becomes a dead cell and interferes with cellular communication throughout the area where it is located. Cells need to take in nutrients and eliminate waste like all other living organisms. The energy supplied by Microcurrent Stimulation slows cells to become vital and less sluggish.

The second way Microcurrent Stimulation works is by increasing blood supply to the area stimulated. By increasing blood flow to the area cells and tissu es are nourished, refreshed and oxygenation is increased.

In general, the electrical current gently wakes up the cells from sleep and stimulates the healing process.

Individuals reporting a significant improvement in visual acuity after this therapy include legendary golfing great Sam Snead. [Editor's note: This claim was later denied privately by Mr. Snead.]

As its premier research project, the Macular Degeneration Foundation plans to conduct a nationwide controlled clinical trial to define the vision-enhancing value of administering what it terms Microcurrent Stimulation (MCS).

The Foundation's two-year preliminary MCS trial involving 120 patients resulted in an average of:

68 percent improvement over pre-treatment vision for patients with the dry macular degeneration.
58 percent improvement over pre-treatment vision for those with the wet form of macular degeneration.

Among certain subsets of patients with dry disease the results were even more dramatic, with a third gaining 100 percent or more improvement and a sixth gaining 150 percent or more improvement.

Patients were able to sustain these vision improvements over time by periodic self-administration of booster treatments and many report that this therapy has made a remarkable difference to their lives.

Is Microcurrent Stimulation Safe?

No side effects or adverse outcomes related to this treatment have been seen so far. No increase in the conversion to the wet form of ARMD has been seen to those who have been treated.

In a consensus statement by the NIH reports that, "One of the advantages...is that the incidence of adverse affects is substantially lower than that of many drugs or other accepted medical procedures used for the same conditions."

(End quote)

DR. DAGNELIE: Well, I guess there were more studies than I had realized. Unfortunately, they have not been published in peer-reviewed journals, or at least not in any that are listed on Medline. So I think we should look at these reports with some healthy skepticism.

By the way, the fact that the equipment has been approved by the FDA just means that it is safe for human use if used as directed. The normal use is for the treatment of motor nerve and muscle problems, and even for that application it is not widely used. There are only about a dozen Medline publications over the last 10 years, less than half of which present solid data. The equipment was never tested for FDA approval for sensory nerve stimulation, nor for applications with the electrodes on the eyelids. It is, therefore, not at all clear whether this is a safe procedure in untrained hands, or whether it can cause long-term damage.

For now, I would not go out and spend $800 on something for which the safety and efficacy have not been demonstrated. But I still think more and better research is justified.

EARL: I've read about microcurrent therapy, and I think that it is worth further research in the field. From my knowledge, correct me if I'm wrong, that the ganglion cells talk to each other via tiny electric currents but how to control the message sending through those cells is still up to this point unknown is it not?? So isn't this equipment kind of risky? It might not do anything, but also wouldn't it make things worse?

DR. DAGNELIE: Ganglion cells use electrical impulses to send signals to the brain. Cells in the retina do not really talk to each other through electrical impulses (they use chemical messengers instead), though in the outer retina voltage levels probably play some role in cell to cell communication between horizontal cells. The microcurrent stimulation takes place through the eyelids, pretty far from the retina. You are correct, however, that safety is a concern. If the currents are too large, they would damage, rather than help, the remaining retinal cells.

GARY: I read with interest the articles regarding the use of electrical stimulation to assist with retinal disorders. My viewpoint is that if there is no side effect, it may be worth giving it a try. Psychologically, it is amazing what happens when a given area is concentrated on. I feel that in the cold light of day, things would very soon return to the original status when the "buzz" has worn off.

My way of dealing with RP is getting on with life being positive. Look back over the years, and find out how many people have been greatly helped by "miracle cures" for RP. It is far better to deal with reality.

Any medical research into retinal disorders is important, and I can well understand a doctor wanting to stake a claim for treatments that can help. But when they then follow by marketing devices, it spells out commercial and material gain for them. They would probably argue that it is a way of bringing attention to their cause. I understand the use of electrical stimulus on muscle tissue producing contraction and regenerating tissue, but I cannot find any truth in how it can trigger dead or diseased cells to function when a disease like RP is in your DNA blue print. You have what you have, and no amount of treatment can effect it, unless you can influence the original blue print at the source (i.e. the genes).

I think I'll carry on as I am with my RP, since I've gotten used to it now for 44 years. I don't accept it, don't like it, but have learned to cope with it.

PHILIP: Five or six years ago when people were talking about going to Cuba to have eye surgeries for RP, I suggested on this list that we be patient, not damage our eyes any further, and wait for breakthroughs that have more of a potential for success. I hoped we wouldn't have to be this patient. There still is no accepted cure, but we do seem to be closer, with several potential avenues for success.

So, let's be patient. Maybe some of the loss we experience everyday can be reversed. Let's not muck up the what capacities we may still have left and save our money for procedures that we have some assurance will work.

JOHN: Gary brought and interesting point out when he alluded to the idea that a cure or product that is marketed is a clue to finincial gain rather than an actual cure.

I believe that, just like counterfeiters try to get close to the real thing in order to gain. So, shysters market products and services to get gain. However, the marketing itself is not the issue, nor is the money that is being counterfeited. What matters is when the shyster who knows what he is peddling is worthless.

I have experienced some things in my life, both with my RP and other things that I was told were just a placebo affect. That is great as far as I am concerned. I welcome the placebo affect for any area in my life it improves. Especially, those parts of my life where I received improvments that doctors could not do a thing with.

Dr. Dagnelie, can you prove, or has it ever been proven, that "Cells in the retina do not really talk to each other through electrical impulses (they use chemical messengers instead)?" I would like to read scientic proof that they do not speak electronically. I am curious how science can actually prove that, as they can't actually prove how electricity works.

DR. DAGNELIE: I can't possibly summarize the literature on the physiology of the retina, which has accumulated over at least 40 years and is growing by leaps and bounds daily. There are excellent books on the subject (such as John Dowling's "The Retina: An Approachable Part of the Brain") that will give you a good overview. One of the things you will learn there is that cells in the retina communicate via synapses, small contact areas where information is exchanged in the form of neurotransmitters (special molecules).

Within cells, electrical currents are very important, and charged ions flow in and out through cell membranes continuously to allow the signal transmission at synapses to occur.

Only in the last few years has there been solid evidence that some ce ll-to-cell communications in the retina are purely electrical, and only for a very limited class of cells and limited types of information.

Dr. Frank Werblin at UC Berkeley has a series of wonderful animation videos to show how information is processed in the retina. You can reach those through his lab web page at http://mcb.berkeley.edu/labs/werblin.

BARBARA: I always copy and print information about treatments to show my eye specialist. If he feels suspect about it, then he will warn me not to go ahead. I haven't presented anything to him about this treatment, but I will show it to him and find out.

WENDY STROUSE WATT, O.D. (Member, Professional Advisory Board, Macular Degeneration Support): I agree with Dr. Dagnelie's thoughts about microcurrent stimulation. I am bothered by the misquote in the article about the NIH consensus statement on Acupuncture. As to the safety of the instrument, they purposely misquote the Acupuncture NIH consensus Statement 1997 Nov 3-5; 15(5):1-34, by substituting MCS Therapy for Acupuncture.

They quote,"In a consensus statement by the National Institutes of Health, they report that, "One of the advantages of MCS Therapy is that the incidence of adverse affects is substantially lower than that of many drugs or other accepted medical procedures used for the same conditions."

They also state, "The procedure is safe, noninvasive and painless and no side effects or adverse reactions have been observed. The deliberate misquoting and representing an instrument as safe to use because it is an off label use of an instrument approved by the FDA. The instrument is approved by the FDA for pain and not for use around the eyes or the head and neck and the FDA has not established that the instrument is safe and effective for the new use."

People with macular degeneration are desperate to improve their vision. When a treatment is presented as safe and with no side effects, they are willing to pay anything, are easily mislead, and are put at risk. ScyFIX and Dr. Edward Paul are promoting, distributing, and selling Micro 400 for a new use, the treatment of macular degeneration and other ocular diseases. Grace Halloran, Damon Miller, George Khouri, and Edward Kondrot are all promoting, distributing, and selling the Microstim in the same manner.

The claims they all have made for the treatment of macular degeneration are anecdotal, and they rely on testimonials and not controlled clinical trials. The clinical studies that they list on their sites quote the statistics of others and were not controlled studies, and the instruments used were entirely different instruments. (The first two articles used the ElectroAcuscope and the third the Microstim). They are all in the business to make money and have no interest in going through the proper steps to get the instrument approved and to do the scientific research needed to gain credibility. In fact, Dr. Kondrot says he is doing a NIH study, and this claim is false according to the NIH.

The following information is from the FDA warning letter sent to Damon Miller on November 5, 2001:

"Both the MicroStim 100-2C and the MicroStim 100i were cleared through the 510(k) premarket notification process as Transcutaneous Electrical Nerve Stimulation (TENS) devices. The MicroStim 100-2C and the MicroStim 100i are intended for the symptomatic relief of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical traumatic pain problems. The beginning of your web site (http://www.acupunctureworks.com/micro.htm) includes a broad discussion of Microcurrent Stimulation. There you discuss how Microcurrent Stimulation is used for treating problems in the muscles, joints, tendons, and bones; the reduction of scar formation following plastic surgery; treating acute sports injuries, non-healing bone fractures, retinal disease, and other eye diseases such as the wet and dry forms of macular degeneration and the treatment of Stargardt's disease.

"Other sections of your web site specifically mention the use of the MicroStim 100-2C and the MicroStim 100i, manufactured by Microcurrent Technology, for the treatment of age-related macular degeneration. In these sections, you discuss your use of the Microstim devices in the treatment of age-related macular degeneration. You state that your patient's vision improved by becoming clearer and brighter. Additionally, you indicate that of 120 patients treated in your office, 101 (83%) of those patients showed improvement greater than or equal to two lines of visual acuity in one or both eyes. You further state that if you were to include those patients who had at least one line of improvement in visual acuity, your success rate jumps to 93%.

"We advise you that claims for the treatment of age-related macular degeneration or any other disease conditions (not specifically cleared) represent a major modification in the intended use of these devices as described at 21 CFR 807.81 (a)(3)(ii) and require the submission of a new 510(k).

"Promoting the MicroStim 100-2C and/or the MicroStim 100i for claims of age-related macular degeneration is a violation of the law..."

The following information is from the FDA warning letter sent to George Khouri on January 3, 2002:

"During an inspection of your firm located in West Palm Beach, Florida August 30, 2001, FDA Investigator Michelle S. Dunaway collected information revealing serious regulatory problems involving MicroStim Model 100 TENS units. The inspection revealed that you promote, distribute and sell Model 100 TENS units, manufactured by MicroStim Technology, Tamarac, Florida, for therapeutic treatment of age related macular degeneration (AMD). AMD is a new use for these device(s), for which neither premarket approval or premarket clearance has been obtained.

"Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act, these products are devices, because they are used in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. During the inspection the investigator documented violations of the Act resulting in the devices being adulterated within the meaning of section 501 (f)(l )(B) and misbranded within the meaning of section 502(0) of the Act."

On the surface, these people seem to be out for the patient's best interest, but it appears that money is their main motivation. I don't doubt that they are helping some patients, but without instrumentation that is specific for the eye, works consistently, and proven to be safe, patients could be misled and could receive little to no benefit. Those who are treating patients should be trained to look into the eye and be able to see if there are any adverse reactions. Several of those treating patients are not eye care specialists. To have the patients best interest in mind and to improve their vision must be the ultimate goal. Those treating seem to not want to take the time and to make the commitment to gain proper approval of the treatment and instrumentation.

EDWARD L. PAUL, JR., O.D., Ph.D.: [Here is] a study [which I] presented to the Swedish Academy of Ophthalmology regarding microcurrent stimulation therapy: The Treatment of Retinal Diseases With Micro Current Stimulation and Nutritional Supplementation. [Editor's note: This file is in PDF format, requiring Acrobat Reader to open.]

DAMON P. MILLER II, M.D., N.D.: As to the costs, we do our best to keep the costs as low as possible. The cost of the unit may seem high, but included in that cost is all of the contact time with us. These are all therapies that people learn to do for themselves, for they must be done on an almost daily basis to work. The cost of our entire program is less than one some people are paying as their out-of-pocket portion for a single treatment with photodynamic laser therapy. Why are you not writing about the most recent papers presented at the ophthalmology co nferences showing the dismal results from PDT (NO improvement of vision, still at high risk of bleeding). Why have you never mentioned on your discussion board that the centers (Johns Hopkins, UCLA, etc.) that were doing the long term follow-up of patients treated with conventional coagulating laser have stopped the studies because people treated with conventional laser were MORE prone to bleed than those who were never treated -- yet many eye doctors continue to treat people with coagulating laser. I see and talk with them everyday.

Retinal tissue is capable of healing, even regeneration, but the conditions for this to occur need to be optimal. We are working to define and provide those optimal conditions. If you want a better understanding of Microcurrent Stimulation, I suggest you read the book by Robert Becker, MD called "The Body Electric".

DAN ROBERTS, Director, MD Support: I would like very much to communicate with anyone who can provide proof that microcurrent stimulation has either significantly improved or even stabilized their retinal condition. For years, I have requested that patients write to me, either with such proof or at least a positive report following treatment, but I have yet to hear from anyone. Their comments would be well-received and published in our Treatment Archives for others to read.

You may remember that your reply to me of a few years ago was published in the MD Support Library. I also moderated a discussion a while back with Dr. Edward Kondrot, in which he was invited to present his views about both chelation therapy and microcurrent stimulation. That transcript may be read in our Clinic section.

In other words, I am doing all that I can to present both sides of this issue. If my personal opinion seems biased, it is because, in addition to not having heard from patients themselves, I have not seen any results from a peer-reviewed double-blind study published in a major journal after carefully-controlled trials. If I am to speak positively of any treatment, this is my standard. Until such convincing evidence is forthcoming, the best I can do is to present opportunities for people to learn as much as possible about the issue so that they can make their own educated decisions. The open discussion now taking place is part of that approach, and I appreciate your taking part in it.

In response to your other comments:

I don't have an argument with the costs of the treatment or the equipment. My concern (which is also the principal concern of most doctors with whom I have spoken) is that money is being charged for a yet-unproven therapy.

You wrote: "Why are you not writing about the most recent papers presented at the ophthalmology conferences showing the dismal results from PDT (NO improvement of vision, still at high risk of bleeding)." PDT (photodynamic therapy) is intended to neither improve vision nor stop future neovascularization. I read the reports, but I have seen nothing that would cause me to stop recommending PDT as an option. If there were such misrepresentation going on, you know the FDA would rescind its approval as fast as they did recently when Novartis could not provide enough evidence to satisfy them that the therapy would be effective in cases of occult choroidal neovascularization.