MS Strength

For the past several years there has been a bit of a cult following with a drug called LDN (low-dose naltrexone) . While writing at Suite101’s health site, I encountered several readers with MS who promoted the drug in comments sections, as well as a fellow health writer (with hyperthyroidism) who valued and wrote about its merits. There wasn’t much known about the drug then except that it wasn’t FDA-approved for multiple sclerosis patients and it wasn’t clear whether the drug could actually slow MS disease progress. Just recently I read an article from the National Multiple Sclerosis Society’s Momentum magazine with a current view about LDN. Here is what Dr. Allen C. Bowling, a neurologist and professor at the University of Colorado-Denver and Health Sciences Center, reports:

What is Low-Dose Naltrexone?

Dr. Bowling addresses the fact that LDN is getting a great deal of coverage on the internet, including various websites that are run by low-dose naltrexone organizations. Although LDN is reported to help patients with multiple sclerosis, it is considered a CAM or complementary and alternative medicine because it has not been extensively tested for effectiveness in patients with MS. Currently naltrexone is approved for opiate and alcohol addiction, with patients being treated with doses of roughly 50 milligrams/day. Patients who take LDN for MS use about 1.5 to 4.5 milligrams/daily, hence the name.

Naltrexone, which may increase endorphin productivity and increase the body’s sensitivity to it, could very well reduce pain and inflammation, as well as stabilize overall mood. It also may decrease the formation of free radicals (considered harmful) and thus protect nerve cells from injury.

LDN Studies, to Date

Not a great deal of low-dose naltrexone research has been done. Here are some recent studies and their results:

• Two small, preliminary studies of LDN for EAE (experimental autoimmune encephalomyelitis which is an animal model of MS) found that LDN decreased nervous system inflammation, immune cell activation, and possible disease severity. These studies were presented at the annual meeting of the European Congress for Treatment and Research in MS (2008.)
• A small clinical trial on humans with MS (reported at the same meeting this past year) was conducted at the University of California-San Francisco. 80 people were treated for 8 weeks with either LDN or a placebo. The LDN showed no effect on physical functioning, but it showed an improvement in some patients’ mental health and pain symptoms.
• 40 primary-progressive MS patients in Italy were studied in 2008. LDN was administered for 6 months, although there was no placebo-treated control group for comparison. Patients noted an improvement in spasticity, but no effects on depression, fatigue, or overall quality of life. Some patients reported a worsening of pain. Only one patient showed a neurological worsening during the treatment.

What Does this Mean to MS Patients?

Dr. Bowling stresses that the preliminary studies still don’t show enough evidence that LDN effectively reduces multiple sclerosis inflammation/nerve attacks in humans and thereby slows MS’s progression in patients. The studies are a good start in the discovery of what low-dose naltrexone is capable of, although the studies on EAE were done on animals and not true MS patients, and the other studies were brief and the results were conflicting.

Questions Dr. Bowling—as well as other neurologists– still have:

• Does LDN truly and consistently decrease the severity of MS symptoms?
• Does LDN slow the progression of relapsing and/or progressive MS?
• Is LDN safe to use on a long-term basis?
• Does LDN interact with conventional MS medications?

In the meantime, low-dose naltrexone continues to be considered a complimentary and alternative medicine and is being further studied to determine its ability to slow disease progression (like other disease-modifying meds), its long-term safety, and its ability to effectively treat symptoms. At this point, many MS patients have been able to acquire it for “non-MS” use.

For further reference:

Bowling, Allen C, MD. “Low-Dose Naltrexone (LDN): The ‘411′ on LDN.” Momentum, the Magazine of the National Multiple Sclerosis Society. Spring 2009, pp 44 – 46.

Tysabri, a disease-modifying medication indicated for the use of treating numerous autoimmune diseases including multiple sclerosis, is a lab-produced monoclonal antibody. This basically means the drug works to prevent an autoimmune attack where immune cells (for reasons unknown) fight their own body tissues. In the case of multiple sclerosis, this involves the immune system attacking the coverings of the nerves located in the brain and the spinal cord (the central nervous system.)

Tysabri, or its chemical name “natalizumab”, is indicated for use in MS patients who have not tolerated or had favorable results with the disease-modifying injectable drugs– Avonex, Betaseron, Copaxone, or Rebif— or for serious initial multiple sclerosis attacks where a stronger medication is desirable. Tysabri is believed to be about 70 – 75% effective in slowing multiple sclerosis attacks and resulting disability (the injectable drugs have a varying effectiveness of up to roughly 40%.)

Tysabri patients may develop side-effects from use of the drug, including body aches, fatigue, stomach pains, headaches, lowered immunity to certain infections, an allergic reaction upon administration, and other complications. A more serious side effect is the possible development of PML, or progressive multifocal leukoencephalopathy, a neurological virus that can be fatal. Because of this very serious risk, Tysabri has a structured system for intravenous administration throughout the United States, called the “Touch” prescribing program. It is given by infusion about once a month.

There have been three reported deaths from PML after the use of Tysabri. Two were reported during Phase III clinical trials (2005) where the two patients were taking other immunomodulating medications with the Tysabri. A recent death has been reported in the United States, after several cases of PML were acknowledged this year. Because of these deaths, Tysabri is considered a controversial medication, although thousands of patients worldwide have stabilized and even improved from its use.

****For more information about Tysabri (and its administration), see The National Multiple Sclerosis Society (US), Multiple Sclerosis Trust (UK), The Boston Business Journal (a financial perspective), and The Irish Examiner (Elan, the pharmaceutical company who co-owns the Tysabri patent with American company Biogen, is based in Ireland.)

Rebif, or interferon beta 1- a, is a manufactured  medication used for the treatment of multiple sclerosis. Interferons are naturally-occurring proteins produced by the immune system and they help to ward off infections, although it is not fully understood how interferon medications aid against multiple sclerosis attacks.

Rebif, which has the same composition as the disease-modifying medication Avonex, was introduced in Europe in 1998 and approved by the U.S. FDA in 2002. With regular use, Rebif has been proven to be 30 to 40% effective in reducing multiple sclerosis relapses in some patients. Just like the other disease-modifying medications, *Rebif is not a cure for multiple sclerosis, and it is not effective in every patient.

Rebif Advantages

• Rebif is administered three times a week, making it one of the least-administered disease-modifying medications

• Rebif has a higher dose and administration frequency of interferon beta – 1a, so its effectiveness is considered higher than that of Avonex’s, which is the same interferon

• Rebif comes in easy-to-administer syringes

• This medication has a proven track record (in Europe) dating back to 1998

Rebif Drawbacks

• Being one of the interferon medications, Rebif can cause flu-like side-effects: fever, chills, nausea, and body aches

• Rebif can cause any of the following other side-effects: depression, anemia, seizures (rare), heart abnormalities (rare), abnormal liver function readings, thyroid abnormalities, and reduced immunity to infections and illnesses

• This medication needs to be refrigerated during certain circumstances

*any decision to take medication should be thoroughly discussed with your doctor

References: The U.S. Food and Drug Administration, The National MS Society, All About MS- Rebif