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THE NUMBER ONE COMPOUNDING PHARMACY IN THE EGYPT
Low-Dose Naltrexone (LDN)

About LDN

Naltrexone is an opioid antagonist used primarily in the management of alcohol and opioid dependence; the FDA approved Naltrexone in 1984 at 50mg. However, there is “Accumulating evidence suggests LDN can promote health supporting immune- modulation, which reduces various oncogenic inflammatory autoimmune processes.”

The value of Naltrexone as an immune modulator was recognized by Dr. Ian Zagon at the University of Pennsylvania. The late Dr. Bernard Bihari, a Neurophysician from New York, USA (who passed away on May 16th, 2010) began treating his patients in the late 1980s. Since that time, many doctors throughout the United States prescribe LDN for a number of indications including Multiple Sclerosis (MS), Parkinson’s disease, Crohn’s disease, HIV/AIDS, cancer and other autoimmune and inflammatory diseases.

A number of research and clinical trials have been completed and undergone in regards to LDN immunotherapies, with phase I and phase II clinical trials successfully run at a number of universities in the United States and Europe, including Pennsylvania State University Medical School at Hershey; University of Chicago; State University of New York; SUNY Upstate Medical University; London Health Sciences Centre – University Hospital, USA; Alpert Medical School of Brown University; Department of Neurology, San Raffaele Scientific Institute; Division of Rheumatology, St. Louis College of Pharmacy; Department of Internal Medicine, University of Utah; Jondi-Shapoor University of Medical Sciences; Department of Psychiatry & Behavioral Sciences, Duke University Medical Center; and Multiple Sclerosis Center at UCSF6. These efforts were pioneered by leading immunologists Dr. Nicholas Plotnikoff, Dr. Ronald Herberman, Dr. Bernard Bihari, Dr. Angus Dalgleish, Dr. Ian S. Zagon, Dr. Jill Smith, Dr. McLaughlin, Dr. Jacqueline McCandless, and Moshe Rogosnitzky, among others.

How LDN Works

The mechanism of action of naltrexone, in autoimmune diseases and cancer, is still being researched, but there are theories as to the mechanism of action that both explain why LDN works on both autoimmune diseases and cancers, as well as inflammatory disease.

According to Mark J. Donahue’s paper on LDN that uses interviews from Dr. David, Gluck, Dr. Jacquelyn McCandless, Dr. Jarred Younger, and Dr. Ian Zagon:

“LDN is an opioid antagonist that not only blocks the reception of opiates, but also the body’s own endogenous opioids – endorphins. However, because LDN is administered in such a ‘low dose’ it is believed that LDN only briefly (for 3-4 hours) obstructs the effects of endorphins. Sensing an endorphin deficit, the hypothalamus signals for increased production of endorphins in what is called ‘the rebound effect.’ The rebound effect results in three things happening:

  • Opioid receptor production increases in order to try and capture more endorphins.
  • Opioid receptor sensitivity increases, also in order to try and capture more endorphins.
  • Production of endorphins is increased in order to compensate for the perceived shortage.

Once LDN is metabolized by the liver and eliminated from the body (after 3-4 hours), the elevated levels of endorphins produced, as a result of the rebound effect, can now interact and bind with the more sensitive and more plentiful opioid receptors. These opioid receptors, are found throughout the body, including virtually every cell of the body’s immune system.

The elevated levels of endorphins will usually last around 18-20 hours. During this time the elevated endorphins act by up-regulating vital elements of the body’s immune cells. By doing so clinical trials has been shown that elevated levels of

  • Down regulating inflammatory cytokines
  • Reducing inflammation and oxidative stress
  • Facilitating tissue repair and wound healing
  • Restoring T-helper/CD4 levels
  • Restoring the balance between Th1 & Th2 lymphocytes
  • Increasing cytotoxic T cells and natural killer (NK) cells
  • Regulating cell growth & inhibiting tumor growth
  •  Reducing excitotoxicity and microglial activation
  • Reducing apoptosis of the myelin-producing oligodendrocytes
  • Stimulating mucosal healing (lining of bowel)”

According to Dr. Nancy Sajben in an article she wrote about LDN, she explains it’s mechanism as follows:

“In 2008 in the US and UK have shown that naltrexone in addition to binding to the opiate receptor’s binds to naltrexone in addition to binding to the opiate receptor’s binds to Toll Like Receptors (TLR),. There are 13 TLRs, and so far they have studied naltrexone only in two of them TRL4 and TRL9. That is important because the TLR receptors are part of the innate immune system and effect the inflammatory markers.

The Toll Like Receptors are not like other receptors. They are not these snug little pockets where naltrexone binds. Instead the Toll Like Receptors are like an entire football field, with enormous nooks and crannies where it has many interactions with many molecules. Now, in 2010, scientists are asking if naloxone or naltrexone is acting at TLR4 or even higher up in the cascade. The study of immune cell glial interactions is in its infancy. Glial cells are the immune cells in your central nervous system (brain, spinal cord). They are very involved in dysregulation of pain systems, neuroinflammation, and some neurological diseases such as Multiple Sclerosis, Alzheimer’s, Parkinson ’s disease, Autism, ALS, infections of the brain, etc.”

What is being treated with LDN

There are a number of conditions where LDN could benefit based on clinical studies and patient data.
There are several published studies that LDN shows promising beneficial result.

  • Fibromyalgia
  • Melanoma,
  •  Cervical Cancer
  •  Ulcerative Colitis
  •  Chemo Resistant Advanced Carcinoma
  •  Glioma Patients
  •  Complex Regional Pain Syndrome
  •  Gastrointestinal Disorders
  • Low-dose naltrexone for disease prevention and quality of life 
  • Crohn’s Diseases
  • Multiple Sclerosis HIV/AIDS
  • Prostate Cancer Autism
  • Hepatoblastoma Metastatic Breast
  • Gulf War Syndrome
  • Pruritus in Systemic Sclerosis
  • Irritable Bowel Syndrome
  • Low Dose Naltrexone (LDN) Immune Monitoring (LDNIM)

For a list of current ongoing LDN studies, please go to the following website:
https://clinicaltrials.gov/ct2/results?term=low+dose+naltrexone&Search=Search

Below are the list of disorder and illnesses that patient reported LDN is beneficial.

  • Malaria
  • Hepatitis C
  •  Rheumatoid Arthritis
  •  Systemic Lupus Erythematosus
  •  Parkinson’s Disease
  •  Wound Healing
  •  Malignant Melanoma
  •  Glioblastoma
  •  Liver Cancer
  •  Multiple Myeloma
  •  Ovarian Cancer
  • Epstein-Barr Syndrome Lung Cancer
  • Bladder Cancer
  • Breast Cancer
  • Lymphoma (Hodgkin’s and NonHodgkin’s)
  • Colon & Rectal Cancer Uterine Cancer
  • Throat Cancer
  • Neuroblastoma
  • Renal Cell Carcinoma

Suggested Method of Therapy
According to Dr. Zagon’s studies, the optimal daily dose of LDN is between 2.5 and 10mg.
According to LDNScience.org, a public information project of the MedInsight® Research Institute, co-founded by Moshe Rogosnitzky:
“There is no single dose that will work for every person. Some people find that a daily dose as low as 2mg is effective, and others have found that they achieve greatest benefit using two doses of 4.5mg each day (12 hours apart). The clinical trials so far have used a single daily dose of 4.5mg and for most users this dose seems to be effective.”
Please see individual studies for any indication-specific recommendations.

 

Revitalife Compounding Pharmacy offers low dose naltrexone therapy to the patients based on the discretion and suggestion of medical doctor of the patient. Revitalife Compounding Pharmacy has available LDN tablets at the following dosages: .5mg; 1mg; 1.5mg; 3mg and 4.5mg.

References:

  • Brown N, Panksepp J. Low-dose naltrexone for disease prevention and quality of life. Med Hypotheses. 2009;72:333-337. doi:10.1016/j.mehy.2008.06.048.
  • Zagon IS, McLaughlin PJ. Naltrexone modulates tumor response in mice with neuroblastoma. Science. 1983;221:671-673. doi:10.1126/science.6867737.
  • Zagon IS, McLaughlin PJ. Naltrexone modulates body and brain development in rats: a role for endogenous opioid systems in growth. Life Sci. 1984;35:2057-2064. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citatio n&list_uids=6092812.
  • Bihari B, Ottomanelli GA, Drury F, Ragone VP. T-cell subsets and treatment response in AIDS. AIDS Res. 1986;2(4):263-266.
  • Bihari B, Finvola DM, Ragone VP, Ottomanelli GA, Buimovici-klein E. Low Dose Naltrexone in the Treatment of Acquired Immune Deficiency Syndrome. 1988;(June).
  • ClinicalTrials.gov. https://clinicaltrials.gov/ct2/results?term=low+dose+naltrexone&Search=Search.
  • Donahue MJ. Low-Dose Naltrexone (LDN). 1995;(4).
  • LDN World Database – Low Dose Naltrexone | Pain Management Specialist in San Diego & La Jolla on WordPress.com. http://painsandiego.com/2011/01/19/ldn-world-database/. Accessed February 23, 2015.
  • Watkins LR, Hutchinson MR, Rice KC, Maier SF. The “toll” of opioid-induced glial activation: improving the clinical efficacy of opioids by targeting glia. Trends Pharmacol Sci. 2009;30(11):581-591. doi:10.1016/j.tips.2009.08.002.
  • LDNScience – What is LDN Used For? http://www.ldnscience.org/low-dose- naltrexone/what-is-ldn-used-for. Accessed February 23, 2015.
  • Zagon IS. Cancer Therapy – Opioid growth factors. 1975:1-10.
  • Zagon IS, McLaughlin PJ. Opioid growth factor and the treatment of human pancreatic cancer: a review. World J Gastroenterol. 2014;20:2218-2223. doi:10.3748/wjg.v20.i9.2218.
  • Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS. Low-dose naltrexone therapy improves active Crohn’s disease. Am J Gastroenterol. 2007;102:820-828. doi:10.1111/j.1572-0241.2007.01045.x.
  • Smith JP, Bingaman SI, Ruggiero F, et al. Therapy with the opioid antagonist naltrexone promotes mucosal healing in active Crohn’s disease: A randomized placebo-controlled trial. Dig Dis Sci. 2011;56:2088-2097. doi:10.1007/s10620-011-1653-7.
  • Zagon IS, Rahn KA, Turel AP, McLaughlin PJ. Endogenous opioids regulate expression of experimental autoimmune encephalomyelitis: a new paradigm for the treatment of multiple sclerosis. Exp Biol Med (Maywood). 2009;234:1383-1392. doi:10.3181/0906-RM- 189.
  • Zagon IS, McLaughlin PJ. Naltrexone modulates growth in infant rats. Life Sci. 1983;33:2449-2454. doi:10.1016/0024-3205(83)90639-2.
  • The Low Dose Naltrexone Homepage. http://www.lowdosenaltrexone.org/#Are_there_any_side_effects. Accessed February 25, 2015.
  • Trust LR. Low-dose Naltrexone ( LDN ) Fact Sheet 2015. 2015:1-17. doi:10.1111/j.1526- 4637.2009.00613.x/abstract.

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