#LDN as treatment- 4 #Fibromyalgia - Positive Results in Trial

Published in February 2013, study to determine the effectiveness of naltrexone in low doses for fibromyalgia has again displayed positive results as a good treatment option for this condition.  Low Dose Naltrexone showed significant reduction in baseline pain, improvement with general quality of life and also mood improvement.  

Abstract of study is below.

Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels.

Arthritis Rheum. 2013 Feb;65(2):529-38. doi: 10.1002/art.37734.

Younger J, Noor N, McCue R, Mackey S.

Source

Stanford University School of Medicine, Palo Alto, California. jarred.younger@stanford.edu.

Abstract

OBJECTIVE:

To determine whether low dosages (4.5 mg/day) of naltrexone reduce fibromyalgia severity as compared with the nonspecific effects of placebo. In this replication and extension study of a previous clinical trial, we tested the impact of low-dose naltrexone on daily self-reported pain. Secondary outcomes included general satisfaction with life, positive mood, sleep quality, and fatigue.

METHODS:

Thirty-one women with fibromyalgia participated in the randomized, double-blind, placebo-controlled, counterbalanced, crossover study. During the active drug phase, participants received 4.5 mg of oral naltrexone daily. An intensive longitudinal design was used to measure daily levels of pain.

RESULTS:

When contrasting the condition end points, we observed a significantly greater reduction of baseline pain in those taking low-dose naltrexone than in those taking placebo (28.8% reduction versus 18.0% reduction; P = 0.016). Low-dose naltrexone was also associated with improved general satisfaction with life (P = 0.045) and with improved mood (P = 0.039), but not improved fatigue or sleep. Thirty-two percent of participants met the criteria for response (defined as a significant reduction in pain plus a significant reduction in either fatigue or sleep problems) during low-dose naltrexone therapy, as contrasted with an 11% response rate during placebo therapy (P = 0.05). Low-dose naltrexone was rated equally tolerable as placebo, and no serious side effects were reported.

CONCLUSION:

The preliminary evidence continues to show that low-dose naltrexone has a specific and clinically beneficial impact on fibromyalgia pain. The medication is widely available, inexpensive, safe, and well-tolerated. Parallel-group randomized controlled trials are needed to fully determine the efficacy of the medication.

Copyright © 2013 by the American College of Rheumatology.

PMID:

 

23359310

 

[PubMed - in process]

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Low-dose naltrexone for the treatment of fib... [Arthritis Rheum. 2013] - PubMed - NCBI:

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*Videos* - Interview w/ Dr. Bihari about LDN - History of LDN

Want to know about LDN ....or  should I say.. Do you want to know MORE about LDN.?  By now, you should know the basics and then some if you have been reading my blogs that I've posted  about the treatment 

If you haven't watched anything or read anything about LDN, this is the one to watch. The doctor  answers a lot of questions and talks about how the drug works.  You'll understand it.   

Harvard-educated Bernard Bihari, MD is interviewed about his life, and his discovery of Low Dose Naltrexone (LDN) for autoimmune diseases: multiple sclerosis, lupus, rheumatoid arthritis, Crohn's disease; also HIV/AIDS and some cancers. This video was given to me by Dr. Bihari's widow, Jacqueline Young.

The video is below.  The interviewer isn't that great cause you can't hear him to well.  Despite that, the Dr. is easy to understand and follow.   This is a long video  (fyi), not all may be interested if you don't care about knowing how the drug works to treat different diseases .  I watched the whole thing because I like such action packed videos.  lol  Im such a nerd!  

I wanted to hear what the man had to say about his advancements  that he discovered through his lifetime.  He's freaking awesome.  He speaks a lot about the research he was working on before he passed away which was HIV/AIDS and cancer and how LDN really is helpful with regulating the immune system .  But he's talking about the body and how the endorphins in the body effect the immune system/response.  He touches on the following points that you may be interested in watching 

I'm glad I watched this because I have a better understanding of how the medicine works in the body and helps balance/regulate the immune system.  His theory suggests that people with cancer, aids, autoimmune diseases have a lower than normal amt of endorphins in the body.  Its all about increasing the body's endorphins!

11:40 - talks about the improvement in AIDS patients with taking ldn, also talks about cancer patients

16:10 - He speaks about LDN and the endorphins. 

18:45 - cell death (cancer cells)caused by endorphins 

**20:19 - 23:00 ** I would def watch this part.  good explaining about the importance of endorphins more about how ldn works in the body (cancer patients... speaks about low endorphins  and how LDN raises the level of endorphins in the body) 

51:10 - the different endorphin receptors and what they effect in the body. interesting 

 He says around 30K-40K people take LDN.  

& Here it is...LISTEN --->  57:09 - 100:20 Touches on Autoimmune Diseases FINALLY.  My undertsanding of how this works goes like this I think.    -   .our t-helper cells get out of wack and get impaired  some how... (probably by a bacteria,  that throws it off) that therefore effects our killer cells & macrophages which get confused with the self vs the bacteria/fungus.  They get confused and attack own tissue/cells and not the foreign bacteria.  From what he says I think the LDN enhances the functioing of the t-cells by increasing the endorphin levels, the endorphins then regulate immune response

101:13 - the amount it costs to run clinical trials for LDN for each condition.  not sure if  he said 15 or 50 million for the 1st 3 trials.  He says that finding a drug company that would want to run the trials,  work w/ FDA, ability to manufacturer , distribute and then advertise is difficult.  

1:04:40 -  talked about low toxicity rate... it doesn't exist.  That's so bomb!, the cost (super cheap)..  Those aspects are probably the main reason LDN will never get approved to treat any other condition..  There's no money to make with this medicine, what would be the incentive.... to make people better... Yeah ok!! LOL  Guess doctors will just have to continue to write it as "off label use".  

VIDEO- Low Dose Naltrexone (LDN) Pioneer Dr. Bernard Bihari Talks About His Work Through His Life

Background of Low Dose Naltrexone LDN

Naltrexone was licensed in 1984 by the FDA in a 50 mg dose as a treatment for heroin addiction. It is a pure opiate antagonist (blocking agent) and its purpose was to block the opioid receptors that heroin acts on in the brain. When it was licensed, Dr. Bihari, then involved in running programs for treating addiction, tried it in more than 50 heroin addicts who had stopped heroin use. None of the patients would stay on the drug because of side effects experienced at 50 mg such as insomnia, depression, irritability and loss of feelings of pleasure, all due to the effect of the drug at this dose in blocking endorphins. These are the hormones in the body that heroin resembles. Physicians treating heroin addicts therefore, for the most part, stopped prescribing naltrexone. In 1985, a large number of heroin addicts began to get sick with AIDS—studies showed that 50% of heroin addicts were HIV Positive.

Dr. Bihari and his colleagues decided to shift their research focus to AIDS, in particular focusing on ways of strengthening the immune system. Since endorphins are the hormones centrally involved in supporting and regulating the immune system, levels of endorphins were measured in the blood of AIDS patients. They were found to average only 25% of normal.

Naltrexone, when given to mice and people at high doses, raises endorphin levels in the body's effort to overcome the naltrexone blockade. This drug became the focus of Dr. Bihari's research group. When the group discovered that endorphins are almost all produced in the middle of the night, between 2 AM and 4 AM, the studies focused on small doses (1.5-4.5 mg at bedtime) with the hope that a brief period of endorphin blockade before 2 AM might induce an increase in the body's endorphin production. In fact, the drug did so in this dosage range. It had no effect below 1.5 mg and too much endorphin blockade at doses over 5 mg. A placebo-controlled trial in AIDS patients showed a markedly better outcome in patients on the drug as compared with those on placebo.

During the trial, a close friend of Dr. Bihari's daughter had three acute episodes of multiple sclerosis over a nine-month period with complete spontaneous recovery from each. Because of his knowledge of MS as a neurologist and of recent evidence of an autoimmune component in the disease, Dr. Bihari started his daughter's friend on naltrexone at 3 mg every night at bedtime. She took it for five years with no further attacks. At that point, when a particular month's supply ran out, she stopped it because of some denial that she had MS. Three and a half weeks later, she developed an episode of weakness, numbness, stiffness and spasms in her left arm and resumed LDN, which she has stayed on since. This episode cleared and over the 12 years since, she has had no further disease activity.

The apparent mechanism of action of LDN in this disease parallels that in AIDS and other immune-related diseases. A small dose of the drug taken nightly at bedtime doubles or triples the endorphin levels in the body all of the next day restoring levels to normal. Since endorphin levels are low in people with MS, immune function is poorly orchestrated with significant impairment of the normal immune supervisory function of CD4 cells. In the absence of normal orchestration of immune function, some of the immune system cells "forget" their genetically determined ability to distinguish between the body's 100,000 unique chemical structures (called "self") and the chemical structures of bacteria, fungi, parasites and cancer cells (called "non-self"). With this loss of immunologic memory, some cells begin to attack some of the body's unique chemical structures. In the case of people with MS, the tissue attacked by immune cells (particularly macrophages) is primarily the myelin that insulates nerve fibers. These attacks result in scars in the brain and spinal cord called plaques. LDN in such patients works by restoring endorphin levels to normal, thereby allowing the immune system to resume its normal supervision and orchestration.

There exists a common notion that the immune system in a person with an autoimmune disorder is too strong and, in its exuberance, targets a body tissue for attack. Rather, the evidence is more consistent with autoimmunity resulting from immunodeficiency.¹ Kukreja et al have demonstrated that multiple immunoregulatory T cell defects lie behind Type 1 diabetes both in humans and in non-obese diabetic mice.²

Multiple scientific papers from various other research centers have demonstrated that an underlying immunodeficiency is characteristic of any tested autoimmune disease. Examples thus far reported include multiple sclerosis, rheumatoid arthritis, Crohn's disease, and chronic fatigue syndrome.^{3, 4, 5}

Sacerdote et al measured low beta-endorphin levels in two animal examples of autoimmune disease — a mouse strain with a lupus-like syndrome and a strain of chicken with an autoimmune thyroiditis.⁶ They had significantly lower hypothalamic concentrations of the opioid than normal controls. In each case, the low levels of beta-endorphin were found well before the expression of autoimmune disease. This adds to considerable evidence of a key role for endorphins in regulating immune responses and suggests a therapeutic pathway.

Bihari et al found that a low oral dose of the opioid antagonist naltrexone, when taken at bedtime, led to a doubling or tripling of low levels of circulating beta-endorphin.⁷ Bihari has since treated some 100 people with autoimmune disorders. None of them has progressed further while the patient continued taking low dose naltrexone each night at bedtime. Since no side effects are apparently associated with its use, this medication might well be studied as a possible preventive for Type I diabetes in those youngsters with beta-cell autoantibodies.

Footnotes

1. Buckley RH. Primary Immunodeficiency Diseases Due to Defects in Lymphocytes. N Engl J Med. 2000; 343:1313-1324.
2. Kukreja A, Cost G, Marker J, et al. Multiple immuno-regulatory defects in type-1 diabetes. J Clin Invest. 2002;109(1):131-40.
3. Thewissen M, Linsen L, Somers V, Geusens P, Raus J, Stinissen P.Premature immunosenescence in rheumatoid arthritis and multiple sclerosis patients. Ann N Y Acad Sci. Jun 2005;1051: 255-62.
4. Marks DJ, Harbord MW, MacAllister R, Rahman FZ, Young J, Al-Lazikani B, Lees W, Novelli M, Bloom S, Segal AW. Defective acute inflammation in Crohn's disease: a clinical investigation. Lancet. Feb 2006;367 (9511): 668-78.
5. Vernon SD, Reeves WC. The challenge of integrating disparate high-content data: epidemiological, clinical and laboratory data collected during an in-hospital study of chronic fatigue syndrome. Pharmacogenomics. Apr 2006;7 (3): 345-54.
6. Sacerdote P, Lechner O, Sidman C, et al. Hypothalamic beta-endorphin concentrations are decreased in animals models of autoimmune disease. J Neuroimmunol. 1999;97(1-2):129-33.
7. Bihari B, Drury FM, Ragone VP, et al. Low Dose Naltrexone in the Treatment of Acquired Immune Deficiency Syndrome. Oral Presentation at the IV International AIDS Conference, Stockholm, Jun 1988.

Dr. Skip Lenz at the 08 LDN Conference at USC, 

www.skipspharmacy.com - Very good Compounding Pharmacy for LDN

Video talks about taking other drugs with LDN (pain meds)

Dr. Lenz talks about patients' symptoms prior to taking LDN, after taking LDN & side-effects

 (aw poor guy. he said he only makes 32 cents/mo from the sales of LDN (fyi-he owns skips pharmacy..

LDN CONFERENCE (the sound quality is weird)

He says about 4500 doctors write scripts for LDN in the US(these are just #'s at his pharmacy)

He mentions how many people w/ Crohns take LDN from his pharmacy, 200 I believe. and he called Crohnies amazing people.. hahaa Go to 1:33.  He mentions Crystal the chick w/ the list of all doctors that prescribes LDN across the US and many other countries.  She was very helpful to me when i was searching for a prescribing Dr. (If you'd like to know which doctors prescribe in your area, just let me know.  I will give you her contact info)  

LDN CONFERENCE CONT..

Naltrexone is an opiate antagonist drug developed in the 1970s and approved by the FDA in 1984 for opiate and drug abuse treatment. When used at much lower doses in an off-label protocol referred to as low dose naltrexone (LDN), the drug has been shown to halt disease progression in Crohn's disease and certain cancers, to reduce symptoms in multiple sclerosis and autism, and to improve numerous autoimmune and neurodegenerative conditions, including Parkinson's disease and amyotrophic lateral sclerosis (ALS).

Grounded in clinical and scientific research, this book describes the history of naltrexone, its potential therapeutic uses, its effects on the immune system, its pharmacological properties, and how the drug is administered. It also lists fillers and compounding pharmacies, doctors who prescribe LDN, and patient resources, and includes interviews with LDN patients and researchers. *Author: Moore, Elaine A./ Wilkinson, Samantha/ Agrawal, Yash Pal *Binding Type: Paperback *Number of Pages: 213 *Publication Date: 2008/12/04 *Language: English *Dimensions: 8.80 x 5.90 x 0.70 inches

LDN to treat Autoimmune Diseases - Clinical Trials

LDN Clinical Trials:

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Clinical Trials

Am J Gastroenterol. 2007 Apr;102(4):820-8. Epub 2007 Jan 11.

Low-dose naltrexone therapy improves active Crohn's disease.

Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS.

Department of Medicine, Pennsylvania State University College of Medicine, Hershey, Pennsylvania 17033, USA.

OBJECTIVES: Endogenous opioids and opioid antagonists have been shown to play a role in healing and repair of tissues. In an open-labeled pilot prospective trial, the safety and efficacy of low-dose naltrexone (LDN), an opioid antagonist, were tested in patients with active Crohn's disease.

METHODS: Eligible subjects with histologically and endoscopically confirmed active Crohn's disease activity index (CDAI) score of 220-450 were enrolled in a study using 4.5mg naltrexone/day. Infliximab was not allowed for a minimum of 8 wk prior to study initiation. Other therapy for Crohn's disease that was at a stable dose for 4 wk prior to enrollment was continued at the same doses. Patients completed the inflammatory bowel disease questionnaire (IBDQ) and the short-form (SF-36) quality of life surveys and CDAI scores were assessed pretreatment, every 4 wk on therapy and 4 wk after completion of the study drug. Drug was administered by mouth each evening for a 12-wk period.

RESULTS: Seventeen patients with a mean CDAI score of 356 +/- 27 were enrolled. CDAI scores decreased significantly (P=0.01) with LDN, and remained lower than baseline 4 wk after completing therapy. Eighty-nine percent of patients exhibited a response to therapy and 67% achieved a remission (P < 0.001). Improvement was recorded in both quality of life surveys with LDN compared with baseline. No laboratory abnormalities were noted. The most common side effect was sleep disturbances, occurring in seven patients.

CONCLUSIONS: LDN therapy appears effective and safe in subjects with active Crohn's disease. Further studies are needed to explore the use of this compound.

PMID: 17222320

---

Integr Cancer Ther. 2007 Sep;6(3):293-6.

Reversal of signs and symptoms of a B-cell lymphoma in a patient using only low-dose naltrexone.

Berkson BM, Rubin DM, Berkson AJ.

Integrative Medical Center of New Mexico, Las Cruces, USA.

PMID: 17761642

---

Mult Scler. 2008 Sep;14(8):1076-83.

A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis.

Gironi M, Martinelli-Boneschi F, Sacerdote P, Solaro C, Zaffaroni M, Cavarretta R, Moiola L, Bucello S, Radaelli M, Pilato V, Rodegher M, Cursi M, Franchi S, Martinelli V, Nemni R, Comi G, Martino G.

Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy.

A sixth month phase II multicenter-pilot trial with a low dose of the opiate antagonist Naltrexone (LDN) has been carried out in 40 patients with primary progressive multiple sclerosis (PPMS). The primary end points were safety and tolerability. Secondary outcomes were efficacy on spasticity, pain, fatigue, depression, and quality of life. Clinical and biochemical evaluations were serially performed. Protein concentration of beta-endorphins (BE) and mRNA levels and allelic variants of the mu-opiod receptor gene (OPRM1) were analyzed. Five dropouts and two major adverse events occurred. The remaining adverse events did not interfere with daily living. Neurological disability progressed in only one patient. A significant reduction of spasticity was measured at the end of the trial. BE concentration increased during the trial, but no association was found between OPRM1 variants and improvement of spasticity. Our data clearly indicate that LDN is safe and well tolerated in patients with PPMS.

PMID: 18728058

---

Pain Med. 2009 May-Jun;10(4):663-72. Epub 2009 Apr 22.

Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study.

Younger J, Mackey S.

School of Medicine, Department of Anesthesia, Division of Pain Management, Stanford University, 780 Welch Road, Suite 208, Palo Alto, CA 94304-1573, USA.

jarred.younger@stanford.edu

OBJECTIVE: Fibromyalgia is a chronic pain disorder that is characterized by diffuse musculoskeletal pain and sensitivity to mechanical stimulation. In this pilot clinical trial, we tested the effectiveness of low-dose naltrexone in treating the symptoms of fibromyalgia.

DESIGN: Participants completed a single-blind, crossover trial with the following time line: baseline (2 weeks), placebo (2 weeks), drug (8 weeks), and washout (2 weeks).

PATIENTS: Ten women meeting criteria for fibromyalgia and not taking an opioid medication.

INTERVENTIONS: Naltrexone, in addition to antagonizing opioid receptors on neurons, also inhibits microglia activity in the central nervous system. At low doses (4.5 mg), naltrexone may inhibit the activity of microglia and reverse central and peripheral inflammation.

OUTCOME MEASURES: Participants completed reports of symptom severity everyday, using a handheld computer. In addition, participants visited the lab every 2 weeks for tests of mechanical, heat, and cold pain sensitivity.

RESULTS: Low-dose naltrexone reduced fibromyalgia symptoms in the entire cohort, with a greater than 30% reduction of symptoms over placebo. In addition, laboratory visits showed that mechanical and heat pain thresholds were improved by the drug. Side effects (including insomnia and vivid dreams) were rare, and described as minor and transient. Baseline erythrocyte sedimentation rate predicted over 80% of the variance in drug response. Individuals with higher sedimentation rates (indicating general inflammatory processes) had the greatest reduction of symptoms in response to low-dose naltrexone.

CONCLUSIONS: We conclude that low-dose naltrexone may be an effective, highly tolerable, and inexpensive treatment for fibromyalgia.

PMID: 19453963

---

Inflamm Bowel Dis.. [Epub ahead of print]

Low-dose naltrexone for treatment of duodenal Crohn's disease in a pediatric patient.

Shannon A, Alkhouri N, Mayacy S, Kaplan B, Mahajan L.

Department of Pediatric Gastroenterology, Cleveland Clinic Pediatric Institute, Cleveland, Ohio.

PMID: 20014017

---

Annals of Neurology, Volume 9999, Issue 999A, Feb 2010

Pilot trial of low dose naltrexone and quality of life in MS

Bruce A.C. Cree, Elena Kornyeyeva, Douglas S. Goodin

Multiple Sclerosis Center at Univ. of Calif. in San Francisco 350 Parnassus Ave., Suite 908, San Francisco, CA 94117  USA

bruce.cree@ucsf.edu

Objective: To evaluate the efficacy of 4.5 mg nightly naltrexone on the quality of life of multiple sclerosis patients.

Methods: This single center, double-masked, placebo-controlled, crossover studied evaluated the efficacy of eight weeks of treatment with 4.5 mg nightly naltrexone (Low dose naltrexone or LDN) on self reported quality of life of MS patients.

Results: 80 subjects with clinically definite multiple sclerosis were enrolled and 60 subjects completed the trial. 10 withdrew before completing the first trial period: 8 for personal reasons, 1 for a non-MS related adverse event and 1 for perceived benefit. Database management errors occurred in 4 other subjects and quality of life surveys were incomplete in 6 subjects for unknown reasons. The high rate of subject dropout and data management errors substantially reduced the trial's statistical power. LDN was well tolerated and serious adverse events did not occur. LDN was associated with significant improvement on the following mental health quality of life measures: a 3.3 point improvement on the Mental Component Summary score of the SF-36 (P=.04), a 6 point improvement on the Mental Health Inventory (P<.01), a 1.6 point improvement on the Pain Effects Scale (P=.04) and a 2.4 point improvement on the Perceived Deficits Questionnaire (P=.05).

Interpretation: LDN significantly improved mental health quality of life indices. Further studies with LDN in MS are warranted.

_______________________________________________________________________________

Who is LDNscience?  This is what they say......

LDNscience™ is a public information project of theMedInsight^® Research Institute.

The MedInsight^® Research Institute is a U.S.-based 501(c)(3) nonprofit working to bridge the ever-widening gap between medical research and actual medical practice. We are dedicated to bringing relief to those who suffer from cancer or chronic medical conditions by raising awareness of:

• • Commercially unsponsored medications.
• • Off-label or secondary uses for approved medications.
• • Specialized tests that enable treatments to be tailored to the individual.

MedInsight's co-founder, Moshe Rogosnitzky, is an expert in the clinical application of Low Dose Naltrexone (LDN), Opioid Growth Factor (OGF) and related therapies, which have made incredible inroads with Crohn’s disease, cancer and other serious diseases. He collaborates in research with the discoverers of LDN and OGF, Dr. Ian S. Zagon and Dr. Patricia J. McLaughlin of Hershey Medical Center, Penn State University, as well as with Dr. Jill P. Smith of Hershey Medical Center, who conducts clinical research into LDN and OGF.

This site is intended to provide you with general information on the background, use of and evidence forLDN, OGF and related therapies, and to answer any questions on these therapies and our work.  If you cannot find the answer to your particular question, please submit your question and we will respond to you as soon as possible.

To become a much-valued supporter of this site or of our life-changing research into LDN, OGF and related therapies, please visit:  Join Our Supporters.

Thank you,

The LDNscience™ Team

Low Dose Naltrexone Represses Ovarian Cancer Tumor Progression - Promising Findings

The July 2011 issue of Experimental Biology and Medicine published findings of new effective treatment of ovarian cancer with the use of Low Dose Naltrexone (LDN).  

Just Another promising article to keep in mind.

A low dose of naltrexone shows an extraordinary potent antitumor effect on human ovarian cancer in tissue culture and xenografts in nude mice, say researchers at The Pennsylvania State University College of Medicine. When LDN is combined with chemotherapy, there is an additive inhibitory action on tumorigenesis. This discovery, reported in the July 2011 issue of Experimental Biology and Medicine, provides new insights into the pathogenesis and treatment of ovarian neoplasia, the 4th leading cause of cancer-related mortality among women in the United States.

The strategy of LDN therapy in repressing cancer was first reported over 30 years ago by Drs. Zagon and McLaughlin (Science 221:671-673). Naltrexone (NTX) is a general opioid receptor antagonist devoid of intrinsic activity that results in a compensatory elevation in endogenous opioids and opioid receptors. Blockade of opioid peptides from opioid receptors for a short time each day (4 to 6 hr) with LDN provides a sufficient window of time (18-20 hr) for the elevated levels of endogenous opioids and opioid receptors to interact and elicit a response: inhibition of cell proliferation. Thus, LDN acts as a decoy to upregulate native opioids and opioid receptors. When NTX is metabolized and no longer present, an enhanced opioid-receptor effect is permitted to occur. The endogenous opioid peptide, opioid growth factor (OGF) (chemical term = [Met5]-enkephalin) and its receptor (OGFr) is related to LDN action, and constitutes a tonically active inhibitory axis that suppresses cell proliferation through a depression in DNA synthesis by way of cyclin-dependent kinase inhibitory pathways. In the case of human ovarian cancer, this laboratory (Amer. J. Physiol. 296:R1716-1725, 2009) previously found that the OGF-OGFr axis is present and functional in human ovarian cancer.

The present study addressed the question of whether modulation of the OGF-OGFr axis by LDN could alter the progression of established ovarian tumors. Moreover, the authors asked whether LDN can be combined with standard chemotherapy to invoke an even greater effect on ovarian cancer. A model of LDN in tissue culture was established that exposed human ovarian cancer cells to NTX for 6 hr every two days, resulting in reduced DNA synthesis and cell replication from vehicle subjected controls. When a short term exposure to NTX was combined with standard of care chemotherapeutic agents, taxol or cisplatin, an enhanced anticancer action relative to either drug was observed. The effects of LDN, but not taxol or cisplatin, could be reversed, indicating the non-toxic nature of LDN. Although favorable results with LDN alone and in combination with chemotherapeutic drugs were recorded in a tissue culture setting, this begged the question of whether LDN was effective on tumors transplanted into mice. Using nude mice with established xenografts of human ovarian cancer, LDN was found to repress tumor progression, reducing DNA synthesis and angiogenesis but not altering cell survival. LDN's repression of cancer progression was comparable to that of cisplatin or taxol. However, the combination of LDN with cisplatin, but not taxol, had an even greater antitumor effect than LDN or taxol alone. Moreover, cisplatin was toxic to the mice, as detected by weight loss. However, LDN in combination with cisplatin attenuated the toxicity of this chemotherapeutic agent, indicating that LDN was protective of the adverse events elicited by a chemotherapeutic drug. Finally, LDN was discovered to upregulate the expression of both OGF and OGFr, indicating that this endogenous opioid system, which inhibits cell proliferation, was activated by LDN.

The research team was comprised of Dr. Ian S. Zagon, Distinguished University Professor, and Dr. Patricia J. McLaughlin, Professor, along with a doctoral student, Dr. Renee N. Donahue, in the Department of Neural & Behavioral Sciences. Drs. Zagon and McLaughlin have extensive collaborations focused on demonstrating the remarkable properties of LDN and OGF in a variety of preclinical and clinical studies. LDN has proven successful in Phase I and II clinical trials in the treatment of Crohn's disease, and OGF has been found to be safe and efficacious for pancreatic cancer. Co-author Dr. McLaughlin states: "Given the extraordinary biological control of the OGF-OGFr axis with respect to cell proliferation, and the unique modulatory capability of LDN to enhance opioid-receptor response by way of native biological processes, this is particularly attractive as a biological-based treatment in arresting the progression of ovarian cancer." Dr. Zagon adds that "More than 75% of women are diagnosed with ovarian cancer in advanced stages because of a lack of diagnostic biomarkers. Although the initial clinical response to cytoreductive surgery and adjuvant chemotherapy is excellent, nearly 65% of advanced-staged patients relapse within 2 years. All subsequent treatments are pallative. Thus, the clinical implications of our study speak to the urgency for initiating clinical trials using LDN in the treatment of advanced ovarian cancer."

Steven Goodman, Ph.D. Editor-in-Chief of Experimental Biology and Medicine said "Researchers at The Pennsylvania State University College of Medicine have discovered that a low dose of the opioid antagonist naltrexone markedly suppresses progression of human ovarian cancer transplanted into mice. Low dose naltrexone combined with cisplatin, but not taxol, had an additive inhibitory action on tumorigenesis. Therefore low dose naltrexone offers a non-toxic and efficacious biologic pathway-related treatment that may benefit patients with this ovarian cancer."

Source-Eurekalert

List of Doctors that Prescribe LDN

Need list of Doctors who prescribe LDN? 


Please, contact Crystal and tell her where you live and she will generate a list for you.   


contact: angelindisguiseldn@yahoo.com

A Short Article That Says A Lot About LDN

I like this short article because it covers the history of the drug LDN, how it started to get used for autoimmune diseases and why the FDA hasn't approved it for conditions other than drug addiction.  This article is from 2007 however, it's now 2011 and people still haven't heard about low dose naltrexone as an alternative treatment for many diseases.  I began doing research for SAFE and effective treatment for Crohn's Disease because I was on Remicade.  In my opinion, Remicade and other biologic drugs that weaken the immune system are not SAFE options.  Read the side-effect and safety indications for any of the biologics that are being used for many inflammatory diseases.  After reading this for yourself, you will understand why I consider this an unsafe treatment. Next, look up the side-effect and safety warnings for LDN/naltrexone.  

Now which one would you choose ?   

LDN - An Emerging Treatment - Article By Carl Frankel, Care2 Green Living contribution writer

If you’re one of the millions of people with auto-immune disease, there may be help for you. It’s a drug with a mouthful of a name—Low-Dosage Naltrexone, or LDN for short.

LDN is best known for its effect on multiple sclerosis. Thousands of people with MS are persuaded that it has halted the disease’s downward progression, and even reversed their symptoms. People with lupus, fibromyalgia, chronic fatigue syndrome, Crohn’s disease, and psoriasis also report benefits.

The good news doesn’t stop here. LDN is affordable—a bit over a dollar a day. Side effects——and many people don’t have them—are mild and short-term. It’s even FDA-approved, sort of. (It has “off-label” approval, meaning the FDA okayed it for a different purpose.)

The story of LDN is an intriguing saga of one man’s pioneering work, followed by a grass-roots, Internet-driven movement.

Naltrexone, without the “low-dosage” part, was developed by Dupont to treat drug addition, and approved in 1984 by the FDA for that purpose. The standard dosage was 50 milligrams, and it didn’t pan out as a treatment. Naltrexone blocks the opiate receptors in the brain. It works, in other words, by taking the fun out of taking opiates. The problem is, it takes the fun out of just about everything else, too. The result: People wouldn’t stay with the program.

Bernard Bihari, a Harvard-trained neurologist, began researching naltrexone and discovered something remarkable. When people took the drug in very low doses (3.0—4.5 milligrams instead of the standard 50 mg. dosage), it appeared to have a dramatic effect on auto-immune diseases. Bihari hypothesized that this essentially homeopathic dosage caused the body to manufacture more endorphins, which are centrally involved in supporting and regulating the immune system. He also came to believe it helped fight cancer and HIV.

Over the past 15 years or so, many thousands of people have taken LDN, to positive effect. The “anecdotal” evidence, so-called because it’s derived from stories, not studies, is overwhelmingly positive. It is also hugely persuasive, if you’re not the sort of person (your typical doctor, for instance) who requires clinical trials to be persuaded.

Where has the medical establishment been during this explosion of grassroots interest? Until recently, unmotivated and indifferent. Because the patent has expired and the drug is so inexpensive, there’s little money to be made from LDN, and therefore little reason to conduct clinical trials.

This can make it difficult to get a prescription for LDN. Because it hasn’t been clinically proven to be an effective auto-immune disease treatment, many doctors won’t prescribe it.

Recently, the medical establishment has started turning its attention to LDN, for a very simple reason: The anecdotal evidence is that overwhelming. Three national conferences on LDN have been held, and clinical trials have been launched in the United States and elsewhere. The first study to report results came out of Penn State University: “LDN therapy appears effective and safe in subjects with active Crohn’s disease.”

If you’re interested in learning more about LDN, a wealth of information is available at
www.ldninfo.org.

As for whether or not to try LDN, at the end of the day, there’s only one person who knows what’s right for you. And that’s you.

Carl Frankel is a journalist and author who has been writing about green business, green products, and integral living for the past 20 years.

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Read more: http://www.care2.com/greenliving/ldn-an-emerging-treatment.html#ixzz1LfORWCGV

Free E-book about LDN- Those Who Suffer Much, Know Much

This free e-book is approximately 400+ pages with a ton of testimonials by people who are taking LDN from all over the world.  Links are close to the end of the book.  It's worth reading what people experience while taking Low Dose Naltrexone.

The link takes you straight to the e-book.  

Naltrexone - general info & other conditions it could possibly treat

So many people are clueless about this treatment... Thank you FDA, we love you too.
*Naltrexone is only FDA approved for the treatment of opiate/alcohol addiction in the US*  

Low doses of naltrexone can treat Crohn's, Colitis, MS, Cancer, AIDS & an array of other autoimmune diseases (this we know because the clinical trials say so & from personal experience ....  I'm feeling better and I've only been on it for 6 days!!!! YAYYYY)

This is just basic information about naltrexone.   Click on **Other Uses** and see the list of other conditions that Naltrexone can possibly treat.. I can't believe the list.  Autism to sexual dysfunction  Whaaaaaat?

http://en.wikipedia.org/wiki/Naltrexone
http://en.wikipedia.org/wiki/Naltrexone#Other_uses

 

How to Compound Low Dose Naltrexone - Article from E-how

Many people, including myself, have been unsuccessful with getting prescribed LDN from their regular physicians or specialists.  This is mostly due to the lack of knowledge that doctors have about this drug. I send my current doctor that I'm working with for my GI issues, information about the drug so he can learn about LDN.

 I would much prefer to get a "regular" script and fill it the normal way any other drug would get filled.  My options for treatment are limited and i've tried many medications for my Crohn's Disease.  I have done my research on LDN, read reports from the patients who take LDN and I feel confident about the drug and have high hopes that it will work for me.

Anyway, if you have ordered naltrexone independently, and have concerns and questions about compounding/reducing your 50mg tablet, so you are able to take the appropriate dose (between 1mg - 4.5mg), here are the easy instructions.  Very simple to do.

http://www.ehow.com/how_5521192_compound-lowdose-naltrexone.html

LDN Study/Trial for Active Crohn's - *link*

Low Dose Naltrexone study results - show that LDN did help Crohn's Disease sufferers. 


I'm searching to find out why this drug that is said to help people with autoimmune diseases - Crohn's being just one of the diseases, is not approved by the FDA yet for the treatment of autoimmune diseases.

There are so many positives for prescribing this drug vs all the biologics that come with the risk of some very dangerous side effects. Not to mention, naltrexone is super reasonable in price, few side-effects and is effective!

I just wanted to share my findings when searching on the FDA site for clinical trials. Let me know if you find this encouraging or helpful to you.