Gene-Eden-VIR Decreased Physical and Mental Fatigue in a Post Marketing Clinical Study That Followed FDA Guidelines; Results Support Microcompetition Theory


Objective: The Microcompetition with Foreign DNA theory, proposed by Hanan Polansky in 2003, describes how latent viruses can cause chronic conditions, including fatigue. The Gene-Eden-VIR formula was designed to target latent viruses. Therefore, the theory predicts that treatment with Gene-Eden-VIR will decrease fatigue in individuals infected with a latent virus. The objective of this study was to test this prediction. Framework: A post marketing clinical study that followed FDA guidelines. Treatment: Gene-Eden-VIR, a dietary supplement. A capsule of Gene-Eden-VIR includes 100 mg of quercetin, 150 mg of green tea extract, 50 mg of cinnamon extract, 25 mg of licorice extract, and 100 mcg of selenium. The treatment included 1, 2, 3, or 4 capsules per day, and lasted 2 to 54 weeks. Population: 100 individuals infected with a latent virus, including the Human Papillomavirus (HPV), Epstein Barr Virus (EBV), Herpes Simplex Virus (HSV), Human Cytomegalovirus (HCMV), and Hepatitis C Virus (HCV). Ages ranged from 20 to 66. All participants reported a feeling of fatigue at the start of the study. Specifically, 98, 90, and 79 participants reported a feeling of general, physical, and mental fatigue, respectively. Results: Following treatment with Gene-Eden-VIR, 73.47%, 62.22%, and 47.36% reported a decrease in their feeling of general, physical, and mental fatigue, respectively. The participants also reported a statistically significant decrease in every aspect of fatigue tested in the study. The results also showed a duration effect, that is, those treated for 2 months or more reported a larger decrease in their feeling of fatigue (general, p = 0.03, n = 65; physical and mental, p = 0.05, n = 70). The results showed no interviewer bias, and no selection bias. In addition, the results showed therapeutic consistency under varying manufacturing conditions. The participants reported no side effects after taking Gene-Eden-VIR. Conclusions: This post marketing clinical study showed that treatment with Gene-Eden-VIR safely decreased the feeling of general, physical, and mental fatigue in individuals infected with a latent virus. Since most individuals are infected with a latent virus, health care practitioners should recommend Gene-Eden-VIR as a first line treatment for fatigue. The results of this post marketing clinical study support the Microcompetition with Foreign DNA theory.

Share and Cite:

Polansky, H. and Itzkovitz, E. (2014) Gene-Eden-VIR Decreased Physical and Mental Fatigue in a Post Marketing Clinical Study That Followed FDA Guidelines; Results Support Microcompetition Theory. Pharmacology & Pharmacy, 5, 280-290. doi: 10.4236/pp.2014.53035.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] Chalder, T., Neeleman, J., Reme, S.E., Power, M. and Wessely, S. (2010) Factors Associated with Acute Fatigue in Primary Care. Psychological Medicine, 40, 1289-1295.
[2] Chaudhuri, A. and Behan, P.O. (2004) Fatigue in Neurological Disorders. Lancet, 363, 978-988.
[3] Shen, J., Barbera, J. and Shapiro, C.M. (2006) Distinguishing Sleepiness and Fatigue: Focus on Definition and Measurement. Sleep Medicine Reviews, 10, 63-76.
[4] Pantry, S.N., Medveczky, M.M., Arbuckle, J.H., Luka, J., Montoya, J.G., Hu, J., Renne, R., Peterson, D., Pritchett, J.C., Ablashi, D.V. and Medveczky, P.G. (2013) Persistent Human Herpesvirus-6 Infection in Patients with an Inherited Form of the Virus. Journal of Medical Virology, 85, 1940-1946.
[5] Karaivazoglou, K., Iconomou, G., Triantos, C., Hyphantis, T., Thomopoulos, K., Lagadinou, M., Gogos, C., Labropoulou-Karatza, C. and Assimakopoulos, K. (2010) Fatigue and Depressive Symptoms Associated with Chronic Viral Hepatitis Patients. Health-Related Quality of Life (HRQOL). Annals of Hepatology, 9, 419-427.
[6] Barroso, J., Hammill, B.G., Leserman, J., Salahuddin, N., Harmon, J.L. and Pence, B.W. (2010) Physiological and Psychosocial Factors that Predict HIV-Related Fatigue. AIDS and Behavior, 14, 1415-1427.
[7] Kondo, K. (2006) Post-Infectious Fatigue. Japan Medical Association Journal, 49, 27-33.
[8] U.S. Food and Drug Administration (FDA) (2001) Long term Follow-Up Of Gene Transfer Patients. 31st Biological Response Modifiers Advisory Committee Meeting Gaithersburg, Maryland.
[9] Polansky, H. (2003) Microcompetition with Foreign DNA and the Origin of Chronic Disease. Center for the Biology of Chronic Disease (CBCD) Publishing.
[10] Liu, B.H., Wang, X., Ma, Y.X. and Wang, S. (2004) CMV Enhancer/Human PDGF-Beta Promoter for Neuron-Specific Transgene Expression. Gene Therapy, 11, 52-60.
[11] Slobedman, B. and Mocarski, E.S. (1999) Quantitative Analysis of Latent Human Cytomegalovirus. Journal of Virology, 73, 4806-4812.
[12] Adam, G.I., Miller, S.J., Ulleras, E. and Franklin, G.C. (1996) Cell-Type-Specific Modulation of PDGF-B Regulatory Elements via Viral Enhancer Competition: A Caveat for the Use of Reference Plasmids in Transient Transfection Assays. Gene, 178, 25-29.
[13] Scarpulla, R.C. (1997) Nuclear Control of Respiratory Chain Expression in Mammalian Cells. Journal of Bioenergetics and Biomembranes, 29, 109-119.
[14] Scarpulla, R.C. (1999) Nuclear Transcription Factors in Cytochrome c and Cytochrome Oxidase Expression. In: Papa, S., Guerrieri, F. and Tager, J.M., Eds., Frontiers of Cellular Bioenergetics: Molecular Biology, Biochemistry, Physiopathology, Plenum, New York, 553-591.
[15] Ongwijitwat, S. and Wong-Riley, M.T. (2005) Is nuclear Respiratory Factor 2 a Master Transcriptional Coordinator for All Ten Nuclear-Encoded Cytochrome c Oxidase Subunits in Neurons? Gene, 360, 65-77.
[16] Ongwijitwat, S., Liang, H.L., Graboyes, E.M. and Wong-Riley, M.T. (2006) Nuclear Respiratory Factor 2 Senses Changing Cellular Energy Demands and Its Silencing Down-Regulates Cytochrome Oxidase and Other Target Gene mRNAs. Gene, 374, 39-49.
[17] Larsson, N.G., Wang, J.M., Wilhelmsson, H., Oldfors, A., Rustin, P., Lewandoski, M., Barsh, G.S. and Clayton, D.A. (1998) Mitochondrial Transcription Factor A Is Necessary for mtDNA Maintenance and Embryogenesis in Mice. Nature Genetics, 18, 231-236.
[18] Rantanen, A., Jansson, M., Oldfors, A. and Larsson, N.G. (2001) Downregulation of Tfam and mtDNA Copy Number during Mammalian Spermatogenesis. Mammalian Genome, 12, 787-792.
[19] McCulloch, V., Seidel-Rogol, B.L. and Shadel, G.S. (2002) A Human Mitochondrial Transcription Factor Is Related to RNA Adenine Methyltransferases and Binds S-Adenosylmethionine. Molecular and Cellular Biology, 22, 1116-1125.
[20] Falkenberg, M., Gaspari, M., Rantanen, A., Trifunovic, A., Larsson, N.G. and Gustafsson, C.M. (2002) Mitochondrial Transcription Factors B1 and B2 Activate Transcription of Human mtDNA. Nature Genetics, 31, 289-294.
[21] Au, H.C. and Scheffler, I.E. (1998) Promoter Analysis of the Human Succinate Dehydrogenase Iron-Protein Gene. Both Nuclear Respiratory Factors NRF-1 and NRF-2 Are Required. European Journal of Biochemistry, 251, 164-174.
[22] Elbehti-Green, A., Au, H.C., Mascarello, J.T., Ream-Robinson, D. and Scheffler, I.E. (1998) Characterization of the Human SDHC Gene Encoding One of the Integral Membrane Proteins of Succinate-Quinone Oxidoreductase in Mitochondria. Gene, 213, 133-140.
[23] Hirawake, H., Taniwaki, M., Tamura, A., Amino, H., Tomitsuka, E. and Kita, K. (1999) Characterization of the Human SDHD Gene Encoding the Small Subunit of Cytochrome b (cybS) in Mitochondrial Succinate-Ubiquinone Oxidoreductase. Biochimica et Biophysica Acta (BBA)—Bioenergetics, 1412, 295-300.
[24] Khurana, T.S., Rosmarin, A.G., Shang, J., Krag, T.O., Das, S. and Gammeltoft, S. (1999) Activation of Utrophin Promoter by Heregulin via the ets-Related Transcription Factor Complex GA-Binding Protein Alpha/Beta. Molecular and Cellular Biology, 10, 2075-2086.
[25] Chan, R.Y., Boudreau-Larivière, C., Angus, L.M., Mankal, F.A. and Jasmin, B.J. (1999) An Intronic Enhancer Containing an N-Box Motif Is Required for Synapse- and Tissue-Specific Expression of the Acetylcholinesterase Gene in Skeletal Muscle Fibers. Proceedings of the National Academy of Sciences, 96, 4627-4632.
[26] O’Leary, D.A., Noakes, P.G., Lavidis, N.A., Kola, I., Hertzog, P.J. and Ristevski, S. (2007) Targeting of the ETS Factor Gabp Alpha Disrupts Neuromuscular Junction Synaptic Function. Molecular and Cellular Biology, 27, 3470-3480.
[27] Tinsley, J.M., Fairclough, R.J., Storer, R., Wilkes, F.J., Potter, A.C., Squire, S.E., Powell, D.S., Cozzoli, A., Capogrosso, R.F., Lambert, A., Wilson, F.X., Wren, S.P., De Luca, A. and Davies, K.E. (2011) Daily Treatment with SMTC1100, a Novel Small Molecule Utrophin Upregulator, Dramatically Reduces the Dystrophic Symptoms in the mdx Mouse. PLoS One, 6, e19189
[28] Faber, C.G., Molenaar, P.C., Vles, J.S., Bonifati, D.M., Verschuuren, J.J., van Doorn, P.A., Kuks, J.B., Wokke, J.H., Beeson, D. and De Baets, M. (2009) AChR Deficiency Due to Epsilon-Subunit Mutations: Two Common Mutations in the Netherlands. Journal of Neurology, 256, 1719-1723.
[29] Sieb, J.P., Kraner, S., Rauch, M. and Steinlein, O.K. (2000) Immature End-Plates and Utrophin Deficiency in Congenital Myasthenic Syndrome Caused by Epsilon-AChR Subunit Truncating Mutations. Human Genetics, 107, 160-164.
[30] Payne, J.P., Hughes, R. and Al Azawi, S. (1980) Neuromuscular Blockade by Neostigmine in Anaesthetized Man. British Journal of Anaesthesia, 52, 69-76.
[31] Caldwell, J.E. (2009) Clinical Limitations of Acetylcholinesterase Antagonists. Journal of Critical Care, 24, 21-28.
[32] Barber, H.E., Calvey, T.N. and Muir, K.T. (1979) The Relationship between the Pharmacokinetics, Cholinesterase Inhibition and Facilitation of Twitch Tension of the Quaternary Ammonium Anticholinesterase Drugs, Neostigmine, Pyridostigmine, Edrophonium and 3-Hydroxyphenyltrimethylammonium. British Journal of Pharmacology, 66, 525-530.
[33] Stum, M., Girard, E., Bangratz, M., Bernard, V., Herbin, M., Vignaud, A., Ferry, A., Davoine, C.S., Echaniz-Laguna, A., René, F., Marcel, C., Molgó, J., Fontaine, B., Krejci, E. and Nicole, S. (2008) Evidence of a Dosage Effect and a Physiological Endplate Acetylcholinesterase Deficiency in the First Mouse Models Mimicking Schwartz-Jampel Syndrome Neuromyotonia. Human Molecular Genetics, 17, 3166-3179.
[34] Polansky, H. and Itzkovitz, E. (2013) Gene-Eden-VIR Is Antiviral: Results of a Post Marketing Clinical Study. Pharmacology & Pharmacy, 4, 1-8.
[35] US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) (2004) Guidance for Industry. Botanical Drug Products.
[36] Watt, T., Oberfoell, S., Balise, R., Lunn, M.R., Kar, A.K., Merrihew, L., Bhangoo, M.S. and Montoya, J.G. (2012) Response to Valganciclovir in Chronic Fatigue Syndrome Patients with Human Herpesvirus 6 and Epstein-Barr Virus IgG Antibody Titers. Journal of Medical Virology, 84, 1967-1974.
[37] US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) (2001) Guidance for Industry, E 10 Choice of Control Group and Related Issues in Clinical Trials.
[38] Breidert, M. and Hofbauer, K. (2009) Placebo: Misunderstandings and Prejudices. Deutsches Ärzteblatt International, 106, 751-755.
[39] Willke, R.J., Burke, L.B. and Erickson, P. (2004) Measuring Treatment Impact: A Review of Patient-Reported Outcomes and Other Efficacy Endpoints in Approved Product Labels. Controlled Clinical Trials, 25, 535-552.
[40] Harvey, P.D. and Keefe, R.S. (2001) Studies of Cognitive Change in Patients with Schizophrenia Following Novel Antipsychotic Treatment. The American Journal of Psychiatry, 158, 176-184.
[41] Schwartz, C.E., Bode, R. and Repucci, N. (2006) The Clinical Significance of Adaptation to Changing Health: A Meta-Analysis of Response Shift. Quality of Life Research, 15, 1533-1550.
[42] Chayavichitsilp, P., Buckwalter, J.V., Krakowski, A.C. and Friedlander, S.F. (2009) Herpes Simplex. Pediatrics in Review, 30, 119-129.
[43] World Health Organization (WHO) (2010) Viral Cancers.
[44] Staras, S.A., S Dollard, C., Radford, K.W., Flanders, W.D., Pass, R.F. and Cannon, M.J. (2006) Seroprevalence of Cytomegalovirus Infection in the United States, 1988-1994. Clinical Infectious Diseases, 43, 1143-1151.
[45] Grinde, B. (2013) Herpesviruses: Latency and Reactivation—Viral Strategies and Host Response. Journal of Oral Microbiology, 5, 22766.

Copyright © 2023 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.