Healing can often occur naturally if the body receives the proper nutritional support. Supplementation with certain natural compounds from plant sources is a convenient way to balance and support the beneficial processes within our own bodies. Such is the case with Herp-Eezeâ„¢ Next Generation.

The Herpes Simplex Virus, Type 1 and 2
Herpes Simplex infection occurs after exposure to the virus through a break in the skin or through mucus membranes. There is strong evidence that the virus may be transmitted even when symptoms are not present. The virus spreads to nerve cells within the body and then to other mucosal skin surfaces. The Herpes Simplex Virus (HSV) can cause blister-

like sores on the skin. There are two types of HSV: Type 1, in and around the mouth and Type 2, in the genital area. Some people seldom experience symptoms, while for others it can be an embarrassing, painful infection, which returns with annoying regularity. The virus remains dormant in the body after an active infection and recurrences of the symptoms can take place at a later time. Overexposure to sunlight, fever, stress, or certain foods and drugs may precipitate recurrences.

What is a virus and how does it affect homeostasis of the body?
A virus is an infectious agent that has either viral RNA or DNA as its genetic material. Viruses ‘hijack’ the body’s cellular machinery in order to live, grow and replicate. As viruses replicate, the cells in which they are growing are destroyed releasing millions of new virus particles and an array of cellular toxins. The damaging effects of viral replication continue to disrupt homeostasis in the body, often for long periods of time.

Herp-Eezeâ„¢ Next Generation contains a unique blend of natural ingredients and synergistic antioxidants which have numerous, documented biological activities. Together, this unique chemistry functions to promote homeostasis in the body. Homeostasis is a state of stability and balance in the body’s internal environment. This balance is achieved by cellular systems, i.e. the immune system, nervous system, endocrine system, etc. and chemical mechanisms, i.e. inflammatory cascade, immune reaction, hormonal release, etc. that act in synchrony to control and regulate the body’s state of being. When homeostasis is disrupted by environmental or physical stresses, the proper functioning of the body’s systems may be compromised. The immune system is instrumental in maintaining homeostasis in the body. It includes the cellular and molecular components of the body that function as a defense against invasion of the body by foreign organisms and infectious agents. Some of the major components of this intricate system include white blood cells, antibodies and chemical factors such as interleukins and leukotrienes. Herp-Eezeâ„¢ Next Generation is a unique and proprietary combination of selected ingredients that work together with your immune system to assist the body to achieve cellular homeostasis.

A study, which included the active ingredients in Herp-Eezeâ„¢ Next Generation, was done on a number of Chinese medicinal plants and their effects on the herpes virus. The results found that these actives were among the most effective against the virus that causes herpes. Researchers believe that these ingredients work in two ways: by stopping the herpes virus from multiplying within the infected cell and by preventing it from binding to healthy cells.

In 1992, French biologists found that all of the herpes viruses were inhibited or killed by extracts from one of the active ingredients in Herp-Eezeâ„¢ Next Generation. The researchers included twenty-eight references to the anti-viral action of this ingredient in their report. This ingredient seems to show itself as an immune system builder by directly stimulating phagocytosis, an immune system response in which cells ingest harmful microorganisms and foreign matter. It also contains natural flavonoids and esters that create a structural complex that infectious microorganisms may not readily develop a resistance to.

Research done by a virologist named Dr. Harold Renis, while at the well-known pharmaceutical company UpJohn and published by the American Society for Microbiology, found that an active component of Herp-Eezeâ„¢ Next Generation inhibited the growth of the herpes virus. The researchers credit a number of unique properties possessed by this active compound for its broad killing power which include: an ability to interfere with critical amino acid production essential for viruses; an ability to contain viral infection and/or spread by inactivating viruses or by preventing virus shedding, budding or assembly at the cell membrane; the ability to directly penetrate infected cells and stop viral replication and its ability to stimulate phagocytosis. The research suggests that this may be a true anti-viral compound because it appears to selectively block an entire virus-specific system in the infected host. Therefore, it appears to offer healing effects not addressed by pharmaceutical antibiotics.

Herp-Eezeâ„¢ Next Generation also contains L-lysine. L-lysine is an amino acid with a pharmacological use much more specific than that of most other amino acids. Supplementation of L-lysine is one of the best options available for the relief of herpes simplex virus infections, especially oral forms. L-lysine competes with L-arginine for intestinal absorption and transport so when you supplement with L-lysine, this tilts the balance between L-lysine and L-arginine heavily in favor of L-lysine. This ameliorates herpes outbreaks because the herpes virus depends on the presence of L-arginine for its replication.

Herpes viruses are especially prevalent in humans. In fact, over 100 million people in the U.S. alone are afflicted with conditions such as cold sores, shingles and genital herpes. In vitro and clinical studies of the ingredients found in Herp-Eezeâ„¢ Next Generation have shown tremendous efficacy in preventing herpes virus replication and guarding against cell death caused by viral invasion.

Supplement Facts Servings Size: Four (4) Capsules Servings Per Container: 30 Amount Per Serving: Vitamin C (Ascorbic Acid) Zinc (AAC) Proprietary Blend    Self Heal (Prunella vulgaris), Lysine,    Olive Leaf Extract, Clove Flower    Powdered Extract (Syzygium    aromaticum), Bitter Melon (Momordica    charantia), Rosmarinic Acid, and Acerola    Extract (Malpighia glabra). 60 mg 15 mg 3212 mg 100% 100% † †Daily Value not established.

Other Ingredients: Microcrystalline Cellulose (Plant Fiber), Rice Flour, Magnesium Stearate, and Silica.

 

CONFIDENTIAL Herpes Treatment Clinical Trial Project

Effects of six months of dietary supplementation with a proprietary herbal and nutritional supplement on herpes simplex virus infections

ABSTRACT

Herp-Eeze Next Generation is a commercially available dietary supplement intended for use by people who experience herpes simplex virus-induced skin lesions. Anecdotal evidence suggests that Herp-Eeze use can result in reduced frequency and/or severity of herpetic lesions. A clinical trial was begun to test the efficacy and safety of Herp-Eeze. Six study participants were enrolled. Five of the six study participants reported favorable results. One study participant reported nausea in association with use of Herp-Eeze. The study was terminated before the full complement of study participants could be enrolled.

INTRODUCTION

The purpose of the research was to test Herp-Eeze Next Generation for its ability to limit the frequency and severity of recurrence of HSV-induced skin lesions. The primary endpoints were quantifiable reductions in the number of observed skin lesions, reduction in the time required for healing of lesions and reduction in lesion-associated pain. A secondary endpoint was quantifiable reduction in blood levels of herpes simplex virus following the six month treatment period. Since there were no previous clinical studies of Herp-Eeze, an additional concern for the study was careful monitoring of any side-effects that may occur while taking Herp-Eeze. It was anticipated that a clinical setting will allow for the collection of information on the efficacy of Herp-Eeze from a significant number of study participants with genital lesions. Herpes Simplex viruses (HSV types 1 and 2) infect many cell types including epithelial cells [1] and neurons [2]. Infected neurons provide a persistent source of virus production that can cause repeated cycles of painful sore formation in skin close to the axonal endings of infected neurons [2]. The frequency and severity of recurrent herpes is variable and appears to be influenced by exposure to environmental insults and nutritional status [3]. It has been hypothesized that stress can inhibit immune system function and allow recurrence of HSV-induced skin lesions [4]. An important class of environmental insults results in oxidative damage to tissues.

There has been considerable interest in the use of antioxidants for the treatment of herpes [5]. Antioxidants do not directly target HSV, but can assist natural homeostatic and repair processes resulting in limitations on the tissue damage caused by viruses.

The components of Herp-Eeze (described below) may have antiviral, antioxidant, wound healing and immune system modulating properties.

Anecdotal results suggest that about one month of use of Herp-Eeze Next Generation may be required before its maximal anti-HSV effect is noticed by users. The components of Herp-Eeze may provide a synergistic combination that benefits those who are infected with herpes simplex viruses. A controlled clinical trial was needed to more carefully evaluate the effectiveness of Herp-Eeze Next Generation. It was expected that a clinical setting would allow collection of efficacy data for participants with both facial and genital lesions.

METHODS

The study was designed to test the hypothesis that use of the Herp-Eeze supplement would reduce the rate of recurrence of HSV-induced skin lesions and result in demonstrable improvements in the rate of lesion healing and/or reduction in lesion-associated pain. Collection of data relied on record keeping by study participants as in previous published literature [6]. A Daily Log was used to make a record of skin lesions and any use of pain medication associated with skin lesions. Phone calls to study participants were used to monitor and assure compliance with the daily dosage and maintaining the Daily Log.

One possible mechanism for Herp-Eeze is reduction in virus levels. The study was designed to allow for PCR-based quantification of blood virus levels during periods of time when study participants were in the clinic with active skin lesions. A blood sample for viral PCR assay was collected from study participants who had skin lesions at the time of clinic visits. Serum from the blood samples was collected and stored for eventual PCR testing. Virus levels in samples collected at study entry and for treated and control groups at study exit were to be compared. These data would have provided a test of the possibility that Herp-Eeze use could result in lower virus levels.

Dosage protocol: 8 capsules each day during weeks 1-2 and 6 capsules each day during weeks 3-24 in two divided doses.

Criteria required participants to have at least 4 outbreaks per year. Study participation was not allowed if there was any ongoing treatment for Herpes Simplex Viral Infection, not including use of OTC pain medication. Other criteria for exclusion from the study were chronic disease that might interfere with the study such as liver or kidney disease or immunodeficiency, a history of abnormal blood pressure regulation resulting in hypotension, diabetes or any past indication of hypoglycemia, pregnancy or lactation and any past allergic reaction to components of Herp-Eeze Next Generation.

Three clinic visits were required by study participants. The first visit was for blood sample collection. Basic blood chemistry tests (electrolyte, blood cell and enzyme levels) were performed to confirm that no indications of major health problems were detected before enrolling potential study participants. Health-related quality-of-life was assessed at the start and end of the study using an SF-36 form (second and third visits). Height, body weight, blood pressure and heart rate values were recorded at the start and end of the study. Blood chemistry tests from the end of the study were performed to check for possible adverse effects on liver or kidney function.

RESULTS

Demographics

The results of the six patients completing the study are discussed below. See Table 1 for demographics.

Table 1. Patient Characteristics at Enrollment

No. (%)
Sex
Male	3 (50%)
Female	3 (50%)
Ethnicity
White/Non-Hispanic	4 (67%)
Black	1 (17%)
Hispanic	1 (17%)
Age (yr) (Range)	30 to 56
Age (yr) (Mean+SD)	40.3+11.0
Wt (kg) (Mean+SD)	73.6+16.7
Ht (m) (Mean+SD)	1.68+0.10
BMI (kg/m2) (Mean+SD)	24.8+4.8
Blood pressure (mm Hg) (Mean+SD)	125.8/78.8+22.5/17.0
History of herpetic outbreaks in each patient	4 or more per year
Type of herpetic lesion
Genital lesions	All 6 patients
Facial lesions	0

 

Compliance

Compliance with the product use was good in majority (5 of 6) of the study participants. The daily interventions were well tolerated without major self-reported difficulties.

Adverse Reaction

One study participant reported nausea within 2 weeks of taking the treatment intervention but continued with the study. This female study participant had a lower than average BMI (21.3 kg/m²) compared to the other five volunteers. The patient was small in stature and weight, and also reported a significant amount of stress in her life due to moving and returning to school. When the patient attempted to continue using Herp-Eeze, she experienced outbreak of herpetic lesions. Direct correlation of the adverse reaction to the intervention could not be determined or substantiated in the participant.

The lab results of the patients completing the blood tests did not indicate any significant changes in basic blood chemistry compared to the baseline values including whole blood counts, hepatic and renal functions. No abnormal lab changes were found.

Efficacy Outcomes

Most of the study participants reported favorable results while using Herp-Eeze. Five of the six study participants had no lesions while using Herp-Eeze. One patient reported having a rebound lesion within days of discontinuing the treatment intervention.

CONCLUSION

The initial results indicate a favorable response to Herp-Eeze from 5 of 6 study participants. All of these study participants had genital lesions, suggesting that it would be possible to obtain the desired information on genital herpes sufferers in a clinical setting. The intervention was well tolerated as indicated by the high compliance. There were no reported adverse events except for the one patient who reported nausea and side effects from taking the full dosage of the capsules.

REFERENCES

1. Syrjanen, S., Mikola, H., Nykanen, M., and Hukkanen, V. In vitro establishment of lytic and nonproductive infection by herpes simplex virus type 1 in three-dimensional keratinocyte culture. (1996) J Virol 70(9), 6524-8.

2. Steiner, I. Human herpes viruses latent infection in the nervous system. (1996) Immunol Rev 152, 157-73.

3. Brady, R. C., and Bernstein, D. I. Treatment of herpes simplex virus infections. (2004) Antiviral Res 61(2), 73-81.

4. Sheridan, J. F., Dobbs, C., Jung, J., Chu, X., Konstantinos, A., Padgett, D., and Glaser, R. Stress-induced neuroendocrine modulation of viral pathogenesis and immunity. (1998) Ann N Y Acad Sci 840, 803-8.

5. Farag, R. S., Shalaby, A. S., El-Baroty, G. A., Ibrahim, N. A., Ali, M. A., and Hassan, E. M. Chemical and biological evaluation of the essential oils of different Melaleuca species. (2004) Phytother Res 18(1), 30-5.

6. Levy, S. E., Souders, M. C., Wray, J., Jawad, A. F., Gallagher, P. R., Coplan, J., Belchic, J. K., Gerdes, M., Mitchell, R., and Mulberg, A. E. (2003). Children with autistic spectrum disorders. I: comparison of placebo and single dose of human synthetic secretin. Arch Dis Child 88, 731-736.