The U.S. National Institutes of Health, National Library of Medicine, Pub Med Website includes many clinical studies and articles about how opioids and the opioid antagonist, which is what Low Dose Naltrexone LDN is, impact liver conditions such as Hepatitis C and the immune system. These Clinical Studies (whose PUBMed ID number is included below) demonstrate the safety and very beneficial effects of Naltrexone to the liver for dosages below 300mg a day in a variety of ways, including:
1. Reducing Liver Enzymes Levels (ALT & AST), including Hepatitis
(PMID: 16839858 & PMID: 9411543)
2. Reducing Liver Damage in Hepatitis
(PMID: 19023176 & 15389866)
3. Reducing Liver Injury in Cholestasis
4. Reducing Liver Enzymes in Cholestasis
5. Reducing Liver Fibrosis
6. Anti-inflammatory effects & improving hepatic dysfunction
(PMID: 19023176 & 15917999)
7. Benefits in Cholestatic Pruritus
(PMID: 9322521 & PMID: 15517116)
While the above are not specific to Low Dose Naltrexone (LDN), these studies demonstrate the beneficial affect that Naltrexone may have on liver disease such as Hepatitis C. In smaller doses, LDN appears to both enhance the immune system (by increasing endorphin levels), as well as being an anti-inflammatory; this has been demonstrated in prior clinical studies with LDN and other immune diseases.
I would like to thank Joyce and her Hepatitis_Children_and_CAM_Alternatives Yahoo Group
(http://health.groups.yahoo.com/group/Hepatitis_Children_and_CAM_Alternatives/) for helping me discover LDN and locate these studies. These studies can be looked at in more depth at http://www.ncbi.nlm.nih.gov by their PMID #.
LDN- What is it, how does it work, how to get it, and side effects:
"LDN may well be the most important therapeutic breakthrough in over fifty years. It provides a new method of medical treatment by mobilizing the natural defenses of one's own immune system." — David Gluck, MD
What is low-dose naltrexone(LDN)?
Naltrexone is an opioid receptor antagonist and was approved by the FDA in 1984. By blocking opioid receptors, naltrexone also blocks the reception of the opioid hormones that our brain and adrenal glands produce: beta-endorphin and metenkephalin. Virtually every cell of the body's immune system has receptors for these endorphins and enkephalins.
In 1985, Bernard Bihari, MD, discovered the effects of a much smaller dose of naltrexone on the body's immune system. He found that this low dose of naltrexone, taken at bedtime, was able to enhance a patient's response to infection by HIV. Since then, various studies have been performed with LDN.
How does LDN work?
In short, LDN boosts the immune system thus activating the body's own natural defenses.
The longer version:
Over the past two decades, research has pointed repeatedly to one's own endorphin secretions (our internal opioids) as playing the central role in the beneficial orchestration of the immune system. LDN, taken at bedtime, results in the brief blockade of opioid receptors between 2 a.m. and 4 a.m. during which it is believed to produce a prolonged up-regulation of vital elements of the immune system by causing an increase in endorphin and enkephalin production. LDN animal research by I. Zagon, PhD, and his colleagues has shown a marked increase in metenkephalin levels as well.
Clinical studies suggest that Low-dose naltrexone LDN could be promising for those with autoimmune diseases or central nervous system disorders or who face a deadly cancer (including liver cancer). LDN could also provide the first low-cost, easy to administer, and side-effect-free therapy for HIV/AIDS.
How can I obtain LDN and what will it cost?
Naltrexone is a prescription drug, so your physician would have to give you a prescription after deciding that LDN appears appropriate for you.
LDN prescriptions are now being filled by hundreds of local pharmacies, as well as by some mail-order pharmacies, around the US. Your doctor may call one of the below recommended Pharmacies and provide your prescription over the phone, along with the patient’s name and phone number. The Pharmacy will then call the patient for billing and mailing information. Many Pharmacies will fill a few months worth of the prescription (such as five, 5 months) at a time – but the patient must ask the Pharmacy to do this. This reduces mailing costs and avoids running out of LDN at the end of every month.
Some pharmacists have been grinding up the 50mg tablets of naltrexone to prepare the 4.5mg capsules of LDN; others use naltrexone, purchased as a pure powder, from a primary manufacturer. One of the first pharmacies to do so was Irmat Pharmacy in Manhattan. Their recent price for a one-month's supply of 4.5mg LDN (30 capsules) was $38. Irmat does monthly quality control testing on its LDN, accepts prescriptions from any licensed physician, checks for insurance coverage, and includes shipment anywhere in the US or to other countries. In contrast, Gideon’s Drugs charges $15 for a one month’s supply of 4.5mg LDN but it does not accept insurance and it will charge for shipment.
IMPORTANT: Make sure to specify that you do NOT want LDN in a slow-release form.
IMPORTANT: Make sure to fill your Rx at a compounding pharmacy that has a reputation for consistent reliability in the quality of the LDN it delivers as the FDA has found a significant error rate in compounded prescriptions produced at randomly selected pharmacies.
Pharmacies that are known to be reliable compounders of LDN
(according to http://www.ldninfo.org/#How_can_I_obtain_LDN):
Irmat Pharmacy, New York, NY
(212) 685-0500, (800) 975-2809, FAX(212) 532-6596
Gideon's Drugs, New York, NY
(212) 575-6868, FAX(212) 575-6334
The Compounder Pharmacy, Aurora, IL
(630) 859-0333, (800) 679-4667, FAX(630) 859-0114
The Pharmacy Shop and Compounding Center, Canandaigua, NY
(585) 396-9970, (800) 396-9970 FAX(585) 396-7264
McGuff Compounding Pharmacy,Santa Ana, CA
(714) 438-0536, (877) 444-1133 FAX(877) 444-1155
Skip's Pharmacy, Boca Raton, FL
(561) 218-0111, (800) 553-7429 FAX(561) 218-8873
Smith's Pharmacy, Toronto, Canada
(416) 488-2600, (800) 361-6624 FAX(416) 484-8855
Dickson Chemist, Glasgow, Scotland
+44-141-647-8032, +44-800-027-0673 FAX+44-141-647-8032
What dosage and frequency should my physician prescribe?
The usual adult dosage is 4.5mg taken once daily at night. For children, the normal dose is 1.5 to 3.0 mg at night. LDN is best taken between 9pm and 3am. Most patients take it at bedtime.
Are there any side effects or cautionary warnings?
LDN has virtually no side effects. Occasionally, during the first week's use of LDN, patients may complain of some difficulty sleeping. This rarely persists after the first week. But it can in some and it took my mother quite some time to get used to it.
To avoid this common side effect, the Hepatitis / CAM Yahoo Group Moderator suggests the following: "Patients start at a lower dose (1.5 mg for one week), and possibly add sleeping aids when first taking LDN. If you experience sleep disturbance at 1.5 mg, then it can be further reduced when first beginning LDN. Once adjusted to 1.5 (approximately 1 week), then the LDN may be increased to 3.0 mg at night for the next week, and eventually to 4.5 in the third week. For most normal sized adults the optimal dose is 4.5 mg / night. For children, the beginning dose is smaller, approximately 1.0 or 1.5 / night, going up to 3.0 mg/night."
There are cautionary warnings and notable exceptions which can further researched at:
When will the low-dose use of naltrexone become FDA approved?
Although naltrexone itself is an FDA-approved drug, the varied uses of LDN still await application to the FDA after related scientific clinical trials which need to be funded at the cost of many millions of dollars.
All physicians understand that appropriate off-label use of an already FDA-approved medication such as naltrexone is perfectly ethical and legal. Because naltrexone itself has already passed animal toxicity studies, one could expect that once testing is able to begin, LDN could complete its clinical trials in humans and receive FDA approval for one or more uses within two to four years.
LDN, Hepatitis C Case Studies, and Your Doctor
Do not be afraid to approach your doctors — physicians today are increasingly open to learning about new therapies in development. Integrative and Functional practitioners have been some of the first medical professionals to see the benefits of LDN in the Hepatitis patients. There is a Medical Hypothesis Article which may be very helpful to you and your doctor in concisely explaining LDN and how/why it has helped many immune related diseases. It can be located in pdf format: Low-dose naltrexone for disease prevention and quality of life at http://www.ldn4cancer.com
While LDN may not help every person who uses it, it has helped many who have used it (at very low cost and no negative side effects except transitory sleep disturbance when first beginning LDN).
The Hepatitis_Children_and_CAM_Alternatives Yahoo Group
(http://health.groups.yahoo.com/group/Hepatitis_Children_and_CAM_Alternatives/) has a growing number of Members who are successfully using LDN as part of their multi-pronged approach in helping their livers and Hepatitis. The Group welcomes both ADULTS & those with CHILDREN affected by Hepatitis. The Hepatitis Children and CAM Alternative Yahoo Group provides clinical research on a variety of Complementary & Alternative Medicine (CAM) protocols that help all forms for Hepatitis (B, C, AutoImmune, etc.) to assist patients in discussions with their doctor on CAM Hepatitis treatments. Please feel free to join the Group and read about other people’s successful use of LDN.
Additionally, you may read a case study on a child with Hepatitis B and her inclusion of LDN in her protocol in detail (including all liver lab results, etc.) in the free book "Those Who Suffer Much, Know Much" (her Hepatitis B Case Study is found on pages 91-97). This book is published by the non-profit patient advocacy group, Case Health (of Australia). It is a collection of Case Studies written by patients, as well as doctor's commentaries. You can locate it on either: http://casehealth.com.au or http://www.ldn-database.carnebeach.com/ldn.pdf
CLICK HERE to get more free information on Hepatitis C complimentary and alternative treatments.