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The Journal of Orthomolecular Medicine Vol. 16, 3rd Quarter 2001

Article

Oralmat and HIV Disease: A Report ofFive Cases

Daniel Rubin, N.D.;1 Stephen Levine, Ph.D.

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Introduction

The clinical utility of Oralmat Drops Solution has become increasingly clear. Controlled clinical trials have been completed regarding its effectiveness for the treatment of mild to moderate adult asthma. Although no formal trial has been conducted regarding its role for people with Acquired Immunodeficiency Syndrome (AIDS), the value of Oralmat for such disease has become apparent. This represents clinical observations gathered both from a physician’s standpoint as well as from the patient’s perspective. The cases reported here (unless otherwise noted) are from the Being Alive Wellness Center (Wellness Center), the medical program of AIDS Project Arizona, a free-of-charge, not-for-profit, state and federally-funded program for people infected with and affected by HIV. I have been working with this population for the last two years using a multi-modality approach including nutrition and diet therapy, homeopathy, botanical medicine, hydrotherapy, physical medicine, and Oriental medicine with an emphasis on acupuncture. I feel comfortable saying that we have had good success in treating our patients by ameliorating symptoms from both the virus as well as the antiviral medications, and by increasing their resistance to opportunistic infections. We have also been successful in teaching our patients healthy lifestyle strategies so they can function better on a daily basis and hope to live longer, healthier lives. As the Wellness Center is only open for medical visits two nights a week, our mission is not to provide primary care, rather adjunct care to anyone in the HIV community. The cases that follow are a summary of the experiences I and other physicians have had using Oralmat for the treatment of people with HIV disease. There is also an excerpt from a patient testimonial to provide the reader with a sense of the power of Oralmat in helping those who have chronic or debilitating disease. My personal experience with Oralmat as a physician has been compelling and I feel it is my duty to share this clinical data which I believe represents an important marker for the well-being and longevity of people with HIV and AIDS. I believe that Oralmat finds its strengths in the areas where traditional combination anti-retroviral therapy (i.e. highly active anti-retroviral therapy, HAART) fall short, mainly in promoting quality of life and well-being while effectively augmenting the immune system wherein it quite possibly may control the disease.

What initially piqued my interest in the use of Oralmat Drops Solution for people with HIV disease was two-fold: A testimonial letter from a physician on the East Coast and a review article of the product found in the December 1, 1995, issue of Positive Health News, a Keep Hope Alive Publication. I found the following excerpt on the internet: “Oralmat, the immune modulator from Australia, was tested by 7 PWAs (People With AIDS) in the past 30 days. All persons with fatigue reported feeling a natural burst of energy and a better sense of well-being. Two persons said it got rid of a cold overnight and the flu in 24 hours.” This was one of many reports by Mark Konlee, the author and publisher over the past several years.

The report from the physician on the East Coast reads as follows: “I am writing to inform you of the results I have had using…Oralmat Drops…in treating…HIV positive individuals…for eight months. Out of 47 HIV [positive] patients, I have not had a single patient on Oralmat Drops whose CD4+, CD8+ and WBC (white blood cell) counts declined. In most cases, these afore-mentioned blood values increased or remained the same. I have only to think that in some way, the Oralmat Drops stabilized the immune system since that was the only new addition to their protocol.”

Formulation

Oralmat solution is a patented extract of the young rye plant, Secale cereale, which is harvested at the peak of its nutrient-rich life—while the rye grass is still green. The Secale plant is rich in certain chemicals such as phytoestrogens, genistein, matairesinol, coenzyme Q10, squalene, and beta 1,3 D-glucan. The clinical effect of Oralmat appears to depend on a delicate balance of these nutrients which together act synergistically. Also, Oralmat may contain unknown factors that may contribute to its clinical effect. Interestingly, none of the nutrients listed above have individually been shown to induce the potent effects described in the body of this paper hence the notion of a synergistic phenomenon between the constituents.

Case 1: JB, 43 year-old male, HIV+ and asthma

JB first presented to the Wellness Center on March 30, 2000, with a chief complaint of asthma. He was being managed with fair success using Flovent, Serevent, and prednisone. His prednisone dosage had varied with the range of 20-60 mg daily. JB had unsuccessfully tried to wean off the steroids many times over the previous 1.5 years. Several years before the onset of his asthma, JB suffered from chronic sinusitis which eventually developed into asthma after being diagnosed with fungal sinusitis which was aggressively treated with anti-fungal agents for 4 months. Upon initial presentation, JB, was attempting to wean from 60 mg to 20 mg prednisone. During the initial history taking, it became apparent that JB was considered a long-term non-progressor, as he had been diagnosed with HIV disease over 10 years prior, although he was naïve to HAART—he was able to withstand the onset of AIDS which usually comes within 8 years after seroconversion. JB was placed on N-acetyl cysteine (2000 mg 2 x daily), flax seed oil (2 tbsp daily) and Oralmat (5 drops under the tongue 3 x daily). JB returned to the Wellness Center on April 6, 2000. He was completely off the prednisone and, subjectively, was markedly improved. Acupuncture was started, the NAC was lowered to 2 grams daily, the flax and Oralmat continued as originally prescribed. It should be noted that neither NAC nor flax seed oil have been shown to produce such dramatic results as described here. During the next 3 months JB fell ill with a respiratory virus and was eventually admitted into the hospital and treated for influenza with a high fever. He continued on NAC and Oralmat as well as low-dose metered inhalers. By July 13, 2000, the date of his last office visit, JB still continued to be free of asthmatic symptoms without steroids.

Case 2: SJ, Diagnosed HIV+ 10 years ago

When SJ first presented to the Wellness Center in September, 2000, he had recently switched his HAART. During the period January 2000 (onset of taking new HAART) to September, 2000, his T cell count had been variable. In December, 1999, his absolute CD4+ (T cell) count was 21/mm3 and his HIV-1 RNA (viral load) was approximately 19,000 copies/mL. He was switched onto new medications because he was stable but not remissive with the medications he was taking at the time. The variability of his T cells ranged as follows: 45; 112; 75; 108; 135/mm3. He then began taking Oralmat (5 drops 3x daily under the tongue) and 300 mg of alphalipoic acid daily. Prior to taking these supplements his viral load had only been undetectable once, in June 2000. After starting the supplements, his viral load dropped to <50 copies/mL and his T cells rose to 168/mm3. Along with the supplements, SJ gradually made several important lifestyle modifications. He quit smoking and observed a regular exercise program. Overtime he settled into this program and began chiropractic care. Upon the last interview with SJ, I asked him his subjective response to the Oralmat. He said that the Oralmat had a significant impact on his life in terms of his mental and physical well-being. He was able to control nicotine cravings with the assistance of the Oralmat and gained clarity of thought and increased energy. This aided his strong will to stop smoking which also had a significant impact on his life. When asked if he had any recent opportunistic infections, SJ replied that he had not suffered from any upon the start of the supplements. He recently had a common cold wherein he never became as ill as in the past and he was able to overcome the illness much more quickly. He is very positive about the effects of Oralmat and is continuing with it as part of his daily regimen. He considers the Oralmat as important as the rest of his medications for his overall survival. At the time of this writing SJ’s T cell count was 234 mm3.

Case 3: JH: Personal Testimonial

A letter came to my attention from one of the original nurses who was stuck by a needle in 1981 while treating a patient in San Francisco. The following is an excerpt from that letter:

“This communiqué is to inform you of the benefits received from using Oralmat drops…I cannot praise [this] product enough for all [it has] done for my condition. I am HIV+ and have been for 17 years. In 1981 we nursed the first AIDS (full blown) patients in San Francisco. During this time three nurses contracted HIV (two females and myself) the two females have since died. I am now 70 years old. I believed there was some formula that someone had discovered that could contain the HIV and delay its transmission to AIDS. That was my mission. I contacted several sources where I bought herbal formulas that would strengthen the immune system and other that would promise all kinds of relief from the infections, mouth ulcers, skin disorders, thrush, itching, soreness and skin peeling between the toes. I have been feeling ill most of the past six months and experience increased bouts of thrush, infections, and mouth ulcers. I went on the AIDS Clinic three-drug formula four weeks ago and I started taking the Oralmat drops under my tongue three times as day. I am feeling well, motivated, gaining my energy level back, keep busy from 5 a.m. to 2 p.m., and then take a nap for two hours and work again in my home office until midnight.”

Commentary on letter: The importance of this letter is evident in that the gentleman writing the letter is not only 70 years old, but is functioning well above the level which would be expected from a man of this age. At the time the letter was written, the writer had recently started on HAART. This triple-cocktail regimen is often debilitating and induces clients to become non-compliant about taking their medications. I have many patients who come to the Wellness Center complaining of neuropathy and diarrhea that began after starting HAART. It is well known that HAART induces a sick-syndrome in people who are taking the drugs; the only problem is that they need to stay on the drugs to control the virus. Until the advent of Oralmat Drops Solution, amelioration of the side effects was cumbersome, time-consuming and expensive. Oralmat appears to have a multitiered functionality because it not only seems to have positive effects on the immune systems via augmentation of the natural defenses which most likely includes mobilization of the latent CD4+ leukocyte population, but interacts at the neurohormonal level by improving quality of life. Improvement in quality of life can be assessed either by subjective or objective means. The writer’s situation is clear: he has had dramatic improvement in his well being which has allowed him to take back control of his lifestyle. He has control over his disease rather than his disease having control over him.

Case 4: MT

MT’s experience with Oralmat is short but significant. He was diagnosed with HIV disease in 1996 and promptly began traditional pharmaceutical HAART. However, he was unable to tolerate most of the regimens and ultimately needed to discontinue treatment as his side effect profile was so extensive. During the last five years of treatment with those agents his CD4+ T cell count never rose above 16 cells/mm3 and the lowest viral load reading he received was approximately 4000 copies/mL. For the last five months prior to the writing of this article, MT was off his medications entirely. During this time his viral load rose to 1,000,000 copies/mL and his CD 4+ T cell count fell to 9 cells/mm3. Because of the grim nature of these lab values, it became imperative for MT to restart a triple agent treatment plan. However, this time he started taking Oralmat Drops Solution (12 drops 2 x daily) with the medications. His tolerance for the regimen became excellent. After one month of this treatment his T cells rose to 50 cells/mm3 and his viral load dropped remarkably to 453 copies/mL. Currently, MT continues to feel well and is excited about his future.

Case 5: JC

The case of JC represents one of the most profound recoveries I have witnessed in my medical career. This story is truly monumental and I am fortunate to have played a role in the healing process of JC. Briefly, his story is as follows: JC was in motor vehicle accident in April 1999 and received a spinal injury. By June he was having such severe pain that he visited the local emergency department several times and eventually had intrathecal anesthesia (epidural). He was scheduled to have surgery for a series of ruptured discs, however this was delayed secondary to a ruptured appendix. In March 2000 he underwent a Vax-D procedure in attempt to ameliorate the back pain, which was ultimately unsuccessful. JC’s status began to decline rapidly. One month later JC lost his ability to walk, had total urinary incontinence, diffuse skin rash, oral thrush, neuropathy, pleural effusion causing dyspnea, and eventually acute respiratory distress syndrome. He was admitted into the hospital where he was diagnosed with renal failure secondary to chronic overuse of NSAIDs and anemia secondary to the renal insufficiency. He went into a coma and was later diagnosed HIV+ with progression to AIDS and a T cell count of 30 cells/mm3. He spent three months recovering in the hospital and was later released on HAART and oral morphine for his AIDS symptom complex and unrelenting back pain.

His first office visit to the Wellness Center was on September 7, 2000. At that point his viral load was less than 50 copies/mL and his T cell count was 250 cells/ mm3. Despite his HIV-related laboratory values, his health was failing rapidly and he claimed that his other physicians had given him a month-to-month prognosis. He complained of back pain, neuropathy, insomnia, weight loss, fatigue and decreased appetite. On physical exam I found he had a jejunostomy with a feeding tube and he was unable to phonate due to vocal cord injury. Oralmat Drops Solution (5 drops 3x daily) was prescribed and acupuncture was performed.

Three weeks later he returned to the clinic for a follow-up appointment. His energy was increased dramatically from a 5/10 (10 is the highest rating) to an 8/10 and he was taking less pain medications. Oralmat was continued, alphalipoic acid was added and acupuncture was performed again. One week later he returned again and JC reported that his energy level again increased as did his overall sense of well-being. He had been pain-free for an entire week following the previous acupuncture treatment. By December his feeding tube had been removed, his voice returned, his appetite increased and weight stabilized, his pain reduced overall, and his ability to walk normally was slowly returning. At the time of this writing, JC was almost pain free and living a normal life. His current T cell count is 368 cells/mm3 and his viral load remains undetectable. JC continues taking Oralmat and visits the Wellness Center twice weekly for acupuncture treatments. He claims that the addition of Oralmat to his daily regimen is responsible for his rapid return to health. Looking at JC today, it is difficult to believe that he had been so ill.

Conclusion

These cases clinically illustrate the therapeutic effect of Oralmat Drops Solution when administered to people with HIV Disease. It should be noted by the reader that most people on HAART experience one or more debilitating symptoms such as gastrointestinal upset, neuropathy and mental cloudiness. Presence of such symptoms often induces non-compliance with their medication schedules which becomes medically problematic. Amelioration of these symptoms is an important step for patients in that not only do they continue to take their medicine at regular intervals but they begin to feel better. The regular taking of HAART by people with HIV Disease is important to societies as a whole since undetectable viral loads in such people creates less of an overall risk of transmission of HIV+. Improvement of the immunological status of a person with HIV disease is a landmark event in their individual health, as well as the health of all people. Based on the cases presented here along with my continued clinical experience similar to the above, I believe that Oralmat Drops Solution should be recommended for all people and any stage of HIV Disease.


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