“How to Talk to Your Doctor about LDN” – http://gazorpa.com/PatientGuide.html

Dear Friend,

 

Please find enclosed an information pack about Low Dose Naltrexone (LDN).

 

As always, we urge you to gather information and decide on your own judgment whether or not you want to try LDN.  The websites listed in the enclosed pack provide a wealth of information. Personal experiences and views on LDN can be found by visiting this website www.crystalangel.org also the LDN website www.lowdosenaltrexone.org plus http://thecompounder.com/diseasenaltrexone.html and searching under ‘LDN’ or Low Dose Naltrexone.

 

Unfortunately, thus far, many GP’s and Neurologists seem unwilling to prescribe LDN as they have little experience or knowledge of Naltrexone being used in this way ie: such a low dosage and for the treatment of MS symptoms.  Nevertheless, with the enclosed information and an increase in patients demanding LDN, gradually more doctors are prescribing.

 

Please do let us know if you receive replies from the Department of Health or if you are able to obtain a GP or Neurologist’s prescription – this information may help other people with MS to obtain LDN on prescription.

 

 P.S. Please find at the end of this pack, a example letter for you to complete to give to your GP or Neurologist, if you wish to.
Low-dose Naltrexone in the Treatment of Multiple Sclerosis

 

These notes are important.  It is essential that you read and thoroughly understand them before starting the low-dose naltrexone (LDN) treatment.

 

LDN is a treatment method that has been in use in the USA since 1985 but is relatively new in the United Kingdom.  Despite its claimed successful use in America, until fully proved here, it must be considered as experimental and that no beneficial response can be guaranteed.

 

In addition, despite the fact that the drug is at a very low dose, the presence of significant introductory or prolonged side-effects cannot be excluded.  The treatment can only be provided if these conditions are accepted.

 

When starting the treatment please report any adverse side-effects immediately so that the treatment process may be re-assessed and, if necessary, modified.

 

Its effectiveness in stabilizing further progress of this disease is, although anecdotal, well documented and established, and has been shown to be almost absolutely effective in preventing further deterioration or increasing disability.

 

At a dose of either 3 mg or 4.5 mg, the dose is well within the approved range of 50 mg when used to treat opiate drug addiction.  The starting dose of LDN is invariably 3 mg.

 

GPs are often unfamiliar with LDN so please take whatever information you have with you in order to familiarize your doctor with this method of treatment.

 

It may be suggested that LDN is not licensed for the purpose of treating MS but your doctor will also be aware that many other drugs, such as Amantadine, Gabapentin, or Modafinil, already frequently used in MS, are also not licensed for treating this disease.

 

There is therefore no valid reason why LDN should not be used.

 

It may be pointed out that LDN, in the doses used for this purpose, is virtually non-toxic and once the method is established, with absolutely no side-effects.  It is simple to administer (just one capsule each day) and, compared with such as beta interferon, very inexpensive.

 

 Neurologists and General Practitioner information for those offering Prescriptions for Low-dose Naltrexone in the Treatment of Multiple Sclerosis (MS) or other Diseases

 

Naltrexone is a drug, referred to as an opiate antagonist.  Its normal use is to treat opiate drug addicts addicted to such as heroin or morphine.  Doses used for this purpose are usually 50 to 150 mg each day.

 

This treatment method was devised by Dr Bernard Bihari, a practicing neuro-physician in New York, USA.  Dr Bihari is qualified in Internal Medicine, Psychiatry and Neurology.  His address is 29w 15th Street, New York, New York; telephone number: 212 929 4190. 

His internet website is: www.lowdosenaltrexone.org

 

Full and updated information on the use of LDN can be found on this website.

 

The method was first put to use, in the treatment of MS, in 1985.

 

It has since been reported that those receiving this drug, initially at a dose of just 3 mg per day, have experienced a range of improvements, including such as: increased vitality and reduced fatigue, plus improvements in bladder control, heat tolerance, mobility, sleep, muscle spasm, pain, tremor etc.  At this dose, the drug remains in the body for only three to four hours.

 

Some patients are found to gain greater benefit from the slightly higher dose of 4.5 mg/ day.  This increased dose has often been found to be more effective than the initial, lower dose of 3 mg.

 

The benefits of the drug appear to depend upon the temporary inhibition of brain endorphins (a natural pain-killer, produced in the brain).  This results in the increased production of endorphins, which would expectedly result in a reduction in painful symptoms and an increase in the sense of wellbeing.

 

In addition, increased levels of endorphins stimulate the immune system, promoting an overall increase in the numbers of T lymphocytes.  This effect has been observed in Dr Bihari’s research.  This increase in T-cell numbers apparently restores a more normal balance of the T-cells such that the effects of auto-immune diseases, such as MS, are reduced.

 

It must be emphasized that a positive beneficial response to this treatment cannot be assured or guaranteed but extensive anecdotal experience has already demonstrated the method to be almost absolutely effective in halting further progress of the disease.

 

It is known that some toxic side-effects have been detected with the more usual doses of 50 to 150 mg each day.  These effects can include nausea, vomiting, abdominal pain, anxiety, insomnia, headache, lethargy, joint and muscle pain, diarrhea, constipation, increased thirst, chest pain, increased sweating and lacrimation, depression, dizziness, chills, decreased potency, rash, or reversible thrombocytopenia (low blood platelet count).  

 

 

Although the dose used in the treatment of MS is very much smaller, the remote possibility of similar adverse side-effects, or exceptional sensitivity responses, at these lower doses, cannot be entirely excluded. 

 

The likelihood of damaging side-effects however, is believed to be minimal as the drug is used at such a low dose.  The average 3 mg dose used in treating MS is just 2% of the maximum daily dose when used to treat opiate drug addiction.

 

Due to the stimulant effects on the immune system, similar doses of naltrexone have also been successfully used to treat HIV/ AIDS, various cancers, and other autoimmune diseases.

 

Low-dose naltrexone holds great promise for the millions of people worldwide facing a possible death sentence from virtually incurable cancers and other diseases.  In the developing world, LDN could provide the first low-cost, easy to administer, and side-effect-free therapy for HIV/AIDS.

 

Naltrexone itself was approved by the FDA and, within the UK, the MCA, in 1984 in a 50mg dose for the purpose of helping heroin or opium addicts, by blocking the effect of such drugs. By blocking opioid receptors, naltrexone also blocks the reception of the opioid hormones that our brain and adrenal glands produce: beta-endorphin and metenkephalin. Many body tissues have receptors for endorphins and enkephalins, including virtually every cell of the body's immune system.

 

In 1985, Bernard Bihari, MD, a physician with a clinical practice in New York City, discovered the effects of a much smaller dose of naltrexone (approximately 3mg once a day) on the body's immune system. He found that this low dose, taken at bedtime, was able to enhance a patient's response to infection by HIV, the virus that causes AIDS.

 

In the mid-1990’s, Dr. Bihari found that patients in his practice with cancer (such as lymphoma or pancreatic cancer) could benefit, in some cases dramatically, from LDN.  In addition, people who had autoimmune disease (such as lupus) often showed prompt control of disease activity while taking LDN.

 

As of March 2001, Dr. Bihari has been treating 175 AIDS patients using LDN in conjunction with accepted AIDS therapies. Over the past 4 years over 85% of these patients showed no detectable levels of the HIV virus - a much higher success rate than most current AIDS treatments, and with no significant side effects.  It is also worth noting that many HIV/AIDS patients under Dr. Bihari’s care have been living symptom-free for years taking only LDN with no other medications.

 

Additional information derived from the website, www.lowdosenaltrexone.org

 

How does LDN work?

 

LDN boosts the immune system, activating the body’s own natural defenses.  The brief blockade of opioid receptors that is caused by taking LDN at bedtime each night is believed to produce a prolonged up-regulation of vital elements of the immune system by causing an increase in endorphin and encephalin production. Normal volunteers who have taken LDN in this fashion have been found to have much higher levels of beta-endorphins circulating in their blood in the following days. Animal research by I.Zagon, Ph.D., and his colleagues has shown a marked increase in metenkephalin levels as well.

 

Dr Bihari says that his patients with HIV/AIDS who regularly took LDN before the availability of HAART were generally spared any deterioration of their important helper T cells (CD4+).

 

In human cancer, research by Zagon over many years has demonstrated inhibition of number of different human tumors in laboratory studies by using endorphins and low dose by LDN work directly on the tumors' opioid receptors -- and, perhaps, induce cancer cell death (apoptosis). In addition, it is believed that they act to increase natural killer cells and other healthy immune defenses against cancer.

 

In general, in people with diseases that are partially or largely triggered by a deficiency of endorphins (including cancer and autoimmune diseases), restoration of the body's normal production of endorphins is the major therapeutic action of LDN.

 

What diseases has it been useful for?

 

Bernard Bihari, MD has described beneficial effects of LDN on a variety of diseases:

 

Cancers: Breast Cancer; Carcinoid; Colorectal Cancer; Hodgkin's Disease; Lymphocytic Leukemia; Malignant Melanoma; Multiple Myeloma; Neuroblastoma; Non-Hodgkin's Lymphomas; Ovarian Cancer; Pancreatic Carcinoma; Prostate Cancer (untreated); Glioblastoma.

 

Other Diseases: Behcet's Disease; Chronic Fatigue Syndrome; HIV/AIDS; Multiple Sclerosis (MS); Psoriasis; Rheumatoid Arthritis; Systemic Lupus (SLE); Crohn's Disease.

 

How is it possible that one medication can impact such a wide range of disorders? The disorders listed above all share a particular feature: in all of them, the immune system plays a central role -- and low blood levels of endorphins are generally present, playing a role in the disease-associated immune deficiencies.

 

Research by others -- on neuropeptide receptors expressed by various human tumors has found opioid receptors in many types of cancer:

 

Brain tumors (both astrocytoma and glioblastoma)

Breast cancer

Endometrial cancer

Head and neck squamous cell carcinoma

Myeloid leukemia

Lung cancer (both small cell and non-small cell)

Neuroblastoma

 

These findings suggest the possibility for a beneficial LDN effect in a wide variety of common cancers. Dr. Bihari reports that LDN is also highly effective with patients suffering from fibromyalgia.

 

 

How can I obtain LDN and what will it cost?

 LDN can be prescribed by your doctor, and should be prepared by a reliable compounding pharmacy.

Naltrexone is a prescription drug, so your physician would have to give you a prescription after deciding that LDN appears appropriate for you.

> Pharmacies that are known to be reliable compounders of LDN:

 

> IMPORTANT: Make sure to specify that you do NOT want LDN in a slow-release form. SLOW RELEASE (or LONG ACTING) LDN IS NOT TO BE USED.

Reports have been received from patients that their pharmacies have been supplying a slow-release form of naltrexone. Pharmacies should be instructed NOT to provide LDN in an "SR" or slow-release or timed-release form. Unless the low dose of naltrexone is in an unaltered form, which permits it to reach a prompt "spike" in the blood stream, its therapeutic effects may be inhibited.

> 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.

The FDA has found a significant error rate in compounded prescriptions produced at randomly selected pharmacies. Dr. Bihari has reported seeing adverse effects from this problem. Please see our report, Reliability Problem With Compounding Pharmacies. Please see the above list of recommended pharmacies for some suggested sources.

 

What dosage and frequency should my physician prescribe?

 

The usual adult dosage is 3mg or 4.5mg taken once daily at night.  Because of the rhythms of the body's production of master hormones, LDN is best taken between 9pm and 3am. Most patients take it at bedtime.

 

A number of patients who do not appear to respond to 3mg do respond when the dose is increased to 4.5mg.

 

The therapeutic dosage range for LDN is from 1.75mg to 4.5mg every night. Dosages below this range are likely to have no effect at all, and dosages above this range are likely to block endorphins for too long a period of time and interfere with its effectiveness.

 

Are there any side effects or cautionary warnings?

 

Side effects: 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.  There may also be temporary increase in specific symptoms of the MS, such as muscle spasm, pain, tiredness or fatigue.  Should this be so, dosage can be reduced from 3mg to 2mg, or from 4.5mg to 3mg nightly.

 

Cautionary warnings: Because LDN blocks opioid receptors throughout the body for three or four hours, people using medicine that is an opioid agonist, i.e. narcotic medication, such as Codeine, Dihydrocodeine, Ultram, morphine, Tramadol, Percocet, Duragesic patch, diamorph, etc, should not take LDN until such medicine is completely out of one's system. In addition, it is advised that LDN should not be taken during pregnancy.

 

Full-dose naltrexone (50mg) carries a cautionary warning against its use in those with liver disease.  This warning was placed because of adverse liver effects that were found in experiments involving 300mg daily. The 50mg dose does not apparently produce impairment of liver function nor, of course, do the much smaller 3mg and 4.5mg doses.

 

When will the low-dose use of naltrexone become FDA approved? 

 

Although naltrexone itself is an FDA-approved drug, LDN still awaits clinical trials.

 

The FDA approved naltrexone at the 50mg dosage in 1984. LDN (in the 3mg or 4.5mg dosage) has not yet been submitted for approval because the prospective clinical trials that are required for FDA approval 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.

 

Low-dose naltrexone has the potential to reduce the terrible human loss now taking place throughout the globe.  It is a drug that could prevent millions of children from becoming AIDS orphans.  It is a drug that could be a powerful ally in the war against cancer.

 

Please send questions or comments about the website to: email@lowdosenaltrexone.org

 

Additional Information:

 

Bernard Bihari, MD, 29 W. 15th Street, New York, NY 10011; (212) 929-4196.

Ian S. Zagon, Ph.D., Department of Neuroscience and Anatomy, H-109, The Pennsylvania State University, The M.S. Hershey Medical Center, Hershey, PA 17033

 

Summary note by Dr M R Lawrence, Dietary Research Ltd;

 

As an MS sufferer, and managing director of the private company, Dietary Research Ltd, I have been both using, in myself, and providing to others, LDN to up to three hundred MS patients, including some doctors, over the last two years.  The drug is also being tested (with informed consent) in non-Hodgkin’s lymphoma and advanced ovarian cancer.

 

Many of those with MS have shown remarkable improvement in specific symptoms and, within the limits suggested by Dr Bihari, a level of disease stability not even approached by far more toxic and expensive drugs, such as beta interferon, Copaxone, or the immune suppressants.

 

In many cases of early MS (with diagnosis within the last two years) symptoms have been completely resolved with absolutely no residual disability and no persisting side-effects.

 

My findings have convinced me that it is time we detached ourselves from the powerful influences of the major drug companies and started using methods that are safer, more effective and, as in this case, considerably cheaper and less toxic than the exclusive alternatives offered by the established drug industry.

 

Dietary Research Ltd was established in 1991.  Following my enforced retirement in 1986, due to MS, my extensive research into the use of diet and nutritional supplements in MS and other diseases, I have been providing advice and therapy to many hundreds of patients, in the treatment of a variety of disease conditions, since that time.

 

 

The biggest thing to realize is that everyone's body is different and reactions vary.  It would appear that over 85% of people taking LDN have a good response, with some type of symptom relief or lack of progression. Some people have miraculous recoveries and some only mild help. And there is a small percentage of people that it does not seem to help.  A few things are for certain: there are far fewer side effects (and they usually go away within the first few weeks), it is much easier to take and it is much cheaper than the standard Crab medications. 

 

Within the chat site we have noticed that overall men seem to do best with 3.0mg of LDN, and women do best on 4.5mg.  But it is best to try and play around with the dosage to see what works best for your body.  Other ideas are to start by taking a smaller dosage of LDN (maybe 1.5mg) and increasing it slowly to the amount that you react well to.  The theory is that you might have less beginning side effects.  Another thought is to try taking your dosage and pouring it into a small amount of liquid.  Some have reported that this gives them more energy and more symptom relief.  It has also been stated that some people have needed to reduce their dosage slightly as taking it in liquid form seems to be more potent for them.  

Please see the links listed below:

 

My Website and Support Groups for MS and TM

Support Multiple Sclerosis & Transverse Myelitis
Crystal’s MS & TM Website
www.crystalangel.org

If you would like to be put on my Multiple Sclerosis and Transverse Myelitis Mailing List for my Newsletter just go to my Website and at the bottom of most of my pages is a place to sign up. Just put your name and email address and subscribe.

My Multiple Sclerosis and Transverse Myelitis Support Groups
http://www.freewebs.com/crystalangel6267/mstmquestionscomments.htm

http://www.hi5.com/friend/displayInviteGroup.do?groupId=641438

With this group you have to join then go to the Community Tab then "Groups" tab, In the search for a group box put in "Multiple Sclerosis and Transverse Myelitis" and then it will bring up my group, click on it then join to be a member or just go to my profile to my Groups and click on Multiple Sclerosis and Transverse Myelitis Group and join.

 First there is Remedyfind.com where people have been rating LDN.  

http://www.Remedyfind.com

 

Then there is the web site from Dr. Bihari’s office that describes what it is all about. http://www.lowdosenaltrexone.org/

 

Sammie Joe’s web site and her time line

http://www.ldners.org/mission.htm

http://www.ldners.org/SJW_LDN.pdf#search='LDN%20MS'

 

Go to these sites to find out how to get LDN from Mexico without a prescription and how to prepare it.

www.medsmex.com

www.goodshape.net

 

Other sites that have info regarding LDN:

 

The Compounded site that has stories from others that have taken LDN.

http://www.thecompounder.com/ldntestimonials.html

 

The LDN Research Trust site from England that is trying to get testing done, has additional information.

http://www.ldnresearchtrust.org

 

I belong to the following chat site for LDN

http://health.groups.yahoo.com/group/lowdosenaltrexone/

 

Another site for LDN people to talk together

http://ldners.org/

 

Articles about LDN

http://www.mwt.net/~drbrewer/lownaltrex.htm

http://www.gazorpa.com/

 

One common cause that LDN does not work for MS is a miss diagnosis and someone ends up having Lymes Disease. Rife seems to work well for Lymes.

www.lymebook.com

 

 

Here are 2 documents that help to explain LDN and how to talk to your doctor about LDN. 

The Doctor's Folder, the folder of information to show your doctor:

The other is a Patient's Guide to Explaining LDN to your Doctor, which will help you present the Folder to your doctor without your doctor's head exploding:

  http://gazorpa.com/DoctorFolder.html

 

 

 

 Your Name

Your address

Your Telephone Number

 

 

 

 

Date

 

Dear Dr,

 

I am a (your details, eg, 51 yr old female, with primary progressive multiple sclerosis, diagnosed in 1995). I am already aware that many of the drugs used to treat MS are either toxic or ineffective in suitably stabilizing the disease. 

 

I have now discovered that in the USA there is a New York Neurologist, Dr Bernard Bihari, who discovered in 1985, that a very low dose of a drug called Naltrexone, was effective in slowing down or stopping the progression of MS.  The dose of the drug, used for this purpose, is usually either 3 or 4.5 mg per day.  At this dose there is no significant toxicity and, once the method is established, absolutely no side-effects.

 

Both FDA approval in the USA, and MCA approval within the UK, had been given to Naltrexone for treating addictions to substances like heroin, using 50 to 150mg per day, but low-dose naltrexone (LDN) for treating MS or other conditions, has not yet been granted approval in either country. 

 

The low-dose drug method has however been prescribed widely in the US by many doctors in the treatment of MS, and has been shown to be very effective at stabilizing the disease process.

 

Within the USA and the  UK, relatively few GPs or Neurologists seem even aware of the method and, although the drug can be legally prescribed under its present license, and on the basis of clinical freedom, the adoption of the method within the USA and the UK has been slow and not widespread.

 

A common excuse for its refusal is that the drug is not licensed for treating MS.

 

There are however, many other drugs that are already being prescribed for MS without an appropriate product license.  Several drugs, such as Gabapentin, Amantadine or Modafinil, are frequently prescribed for MS, despite the fact that these too are unlicensed for this purpose, and are only minimally effective in this disease.  It must logically be suggested therefore, that a far more effective method, such as LDN, might similarly be made available.

 

For those doctors in the USA and the UK that are willing to prescribe it, the drug is already available, and is presently being prescribed in a suitable formulation.

 

Information describing the use and benefits of this method may be obtained from Dr Bihari’s website, www.lowdosenaltrexone.org , or other similar websites, such as www.ldnresearchtrust.org and www.remedyfind.com.   For your convenience, copies of such information are also enclosed.

 

Without a doubt, this method is obviously in need of full clinical trials to prove its validity but, because the drug is used at such a low dose and is therefore cheap to produce, there appears to be little opportunity for profit for the company producing it.  Certainly Dupont, the company that developed naltrexone, has no plans to market or test the drug for the purpose of treating MS, or anything else.

 

There is one doctor, Dr M R Lawrence MRCS; LRCP, in Wales, who has MS himself, who is distributing LDN privately and is achieving great success for his patients.  In my opinion, it should not be necessary to rely on private practice to provide such a simple, safe, and very effective method.

 

A fully established trial of this method could readily confirm its benefits, when it could replace other more toxic and hazardous methods, such as beta interferon, copaxone or the immune suppressants, thus saving many millions of dollars.

  

I hope that I have given some insight into this method with an indication of the problems faced by so many MS sufferers.

 

As Minister for Health, you are in a position of ultimate power in being able to promote clinical trials and instigate further investigation of this unique and very effective method.  I trust that you will use this power to benefit the many thousands of people presently faced with ever increasing disability and the eventual destruction of their personal and working lives.

 

I look forward to your supportive and positive reply.

 

Yours sincerely,

 

“Information to Show Your Doctor about LDN”  -- http://gazorpa.com/DoctorFolder.html