Immune Modulation with Low Dose Naltrexone

Low Dose Naltrexone and Cancer

Although prospective, controlled clinical trials on LDN in the treatment of cancer are yet to be accomplished, as of March 2004 clinical "off-label" use of this medication in some 450 patients with cancer — almost all of whom had failed to respond to standard treatments — suggests that more than 60% of patients with cancer may significantly benefit from LDN.

Of the 354 patients with who had regular follow-up, 86 have shown objective signs of significant tumor shrinkage, at least a 75% reduction. 125 patients have stabilized and/or are moving toward remission.

These results sharply contrast to prior usual cancer treatment outcomes: either a cancer-induced death or a total cure. LDN therapy presents a viable third alternative, the possible long-term stabilization and/or gradual reduction of tumor mass volume.

Thus, with LDN, cancer can — in some cases — become a manageable chronic disease. Patients have the possibility of living free of symptoms, without, in many cases, the crippling side-effects of chemotherapy and radiation treatment.

How Low Dose Naltrexone May Work Against Cancer

Low dose naltrexone might exert its effects on tumor growth through a mix of three possible mechanisms:

  1. By inducing increases of metenkephalin (an endorphin produced in large amounts in the adrenal medulla) and beta endorphin in the blood stream;
  2. By inducing an increase in the number and density of opiate receptors on the tumor cell membranes, thereby making them more responsive to the growth-inhibiting effects of the already-present levels of endorphins, which induce apoptosis (cell death) in the cancer cells; and
  3. By increasing the natural killer (NK) cell numbers and NK cell activity and lymphocyte activated CD8 numbers, which are quite responsive to increased levels of endorphins.

Low Dose Naltrexone and Crohn's Disease

Dr. Jill Smith’s (Penn State College of Medicine, Hershey, PA) original article, "Low-Dose Naltrexone Therapy Improves Active Crohn’s Disease," was published in the Jan 11, 2007 online edition of the American Journal of Gastroenterology (2007;102:1–9). This was the first clinical study of LDN published by a US medical journal.

Dr. Smith, Professor of Gastroenterology at Pennsylvania State University's College of Medicine, found that two-thirds of the patients in her pilot study went into remission and fully 89% of the group responded to LDN treatment to some degree. She concluded that “LDN therapy appears effective and safe in subjects with active Crohn’s Disease.”  That open-label Penn State trial demonstrated the efficacy of LDN in a small group of patients.

As a result, Dr. Smith received an NIH grant that permitted a more definitive Phase II placebo-controlled clinical trial, which by September 2008 had already studied almost all of the 40 patients it plans to include. With just a few patients yet to be added to the study, Dr. Smith is very optimistic about the usefulness of LDN in inflammatory bowel diseases, such as Crohn’s Disease.

Dr. Smith’s most recent research on the effects of LDN is a double blind placebo controlled Phase ll study of youngsters from ages 6 to 17 with active Crohn’s Disease. It was launched at Penn State in July 2008 and is expected to run until July 2010. Participants “will be treated with either naltrexone or placebo for the first 8 weeks then all subjects will receive active naltrexone drug the last 8 weeks.”

Low Dose Naltrexone and Autoimmune Disease

There is growing recognition in the scientific community that autoimmune diseases result from immunodeficiency, which disturbs the ability of the immune system to distinguish "self" from "non-self". The normalization of the immune system induced by LDN makes it an obvious candidate for a treatment plan in such diseases.

The experience of people who have autoimmune diseases and who have begun LDN treatment has been remarkable. Patients with diagnoses such as systemic lupus, rheumatoid arthritis, Behcet's syndrome, Wegener's granulomatosis, bullous pemphigoid, psoriasis, and Crohn's disease have all benefited.

Because LDN clearly halts progression in multiple sclerosis, its use has been more recently extended to other neurodegenerative diseases, such as Parkinson's disease and amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) whose etiology remains unknown but for which there is suggestive evidence of a possible autoimmune mechanism.