LDN for Sjögren's Syndrome

Dr. Scott Zashin is a board-certified internist and rheumatologist in Dallas, Texas, who is a respected expert in arthritis and specializes in diagnosis and treatment of rheumatologic conditions in adults. He is a clinical professor at the University of Texas- Southwestern Medical School at Dallas and practices rheumatology at Presbyterian Hospitals of Dallas. He served as President of the Lupus Foundation’s North Texas chapter, and is currently a board member of both the Lupus Foundation and the Arthritis Foundation of North Texas. Dr. Zashin’s website is: http://www.scottzashinmd.com/low-dose-naltrexone/

I first used LDN to treat a patient of mine with fibromyalgia a number of years ago, at their request. Over the last few years I gained more experience [with it]. When this patient came to see me with a diagnosis of both Sjӧgren's and fibromyalgia, she had seen a number of rheumatologists and was still having significant pain and fatigue and was looking for some relief. At that time I offered a trial of low dose naltrexone. Fortunately, she got tremendous benefit within a few weeks of starting therapy.

I continue to see positive results in patients with Sjӧgren's treated with LDN. I'm also very pleased with the safety profile

I've put about 20 of my patients with Sjӧgren's on LDN with varying success. Some continue to take it at this time. I hope to publish my data on these additional patients with Sjӧgren's to see how many of them got benefit or are still taking the medication. But I continue to see positive results in patients with Sjӧgren's treated with LDN. I'm also very pleased with the safety profile. While there are potential side effects with any treatments, including LDN, I haven't had any side effects, when they have occurred, that were not resolved when stopping the medication.

I've had a number of my patients report that LDN actually helps them sleep better, and, as rheumatologists, we know that if we can improve the quality of sleep, the fatigue also improves

The mostly likely benefit I see is the relief of pain, and this is typically the flu-like symptoms that many patients with Sjӧgren's experience. They feel achiness in their joints and muscles. So that's the primary area that I get positive results. It may also help patients with fatigue. And while some patients complain of vivid dreams at night, thereby interrupting their sleep, I've had a number of my patients report that LDN actually helps them sleep better, and, as rheumatologists, we know that if we can improve the quality of sleep, the fatigue also improves. I haven't seen dramatic benefit looking in the dryness of the eyes and mouth, so the predominant benefits I see is more in the constitutional symptoms: the musculoskeletal pain and fatigue.

LDN not only helped symptoms, but also helped improve the inflammatory process

In the first case I published, I was quite amazed and pleased that when this patient improved clinically, her measures of inflammation that we monitor in people with Sjӧgren's syndrome, such as the sedimentation rate, also improved. So, basically, what this showed was that LDN not only helped symptoms, but also helped improve the inflammatory process. In other words, it had a disease modifying benefit in patients with Sjӧgren's syndrome.

Because LDN is not FDA-approved to treat autoimmune and other conditions, we don't have the long-term studies that you might see with other FDA approved drugs. So, basically, looking at a limited number of patients, and this is anecdotal, I would say that the safety of LDN compares favorably to other treatments that we use to help (what we describe as) constitutional symptoms. That includes NSAIDs, such as high dose ibuprofen or naproxen, or a disease modifying drugs such as hydroxychloroquine (also called Plaquenil®) or methotrexate, which is another one that has been reported as being possibly helpful in patients with Sjӧgren's.

I think patients with Sjӧgren's syndrome may also find that the drug [LDN] works quicker than the “standard” treatment remedies, so they may get a quicker response and may not require taking other immunosuppressants such as prednisone and corticosteroids

I would say with any medication that I prescribe, I want to make sure that, in my mind, the benefits of prescribing the drug outweigh the potential side effects. I think LDN, based on its limited use, has a very good benefit/risk ratio. And so, for patients with Sjӧgren's syndrome whose options for treatment are so limited, and with a safety profile that appears quite benign, I think the benefits outweigh the risks. Again, long term safety studies are needed to really answer that fully, and long-term clinical trials. I think patients with Sjӧgren's syndrome may also find that the drug [LDN] works quicker than the “standard” treatment remedies, so they may get a quicker response and may not require taking other immunosuppressants such as prednisone and corticosteroids.

In some patients, I "go low and slow" starting with 0.5mg and increasing weekly up to the target dose of 4.5mg. For some patients who need more immediate benefit and may not be on concomitant thyroid, I may start with a dose of 1.5mg and get up to the target dose over 3 weeks.

I have patients who may get clinical improvement within a few weeks, but typically I tend to see improvement within 3 months.

I have patients who may get clinical improvement within a few weeks, but typically I tend to see improvement within 3 months.

LDN certainly can be considered, in my experience, a first-line drug

Definitely. LDN certainly can be considered, in my experience, a first-line drug. Some patients prefer the side effect profile of LDN as opposed to the potential side effects of corticosteroids, methotrexate, or Plaquenil®. So, I think because there are no FDA-approved treatments for the musculoskeletal manifestations, or constitutional symptoms, of Sjӧgren's syndrome, and that includes the achiness- what we call arthralgias, myalgias, and fatigue, I think it's not unreasonable to consider it as a first line treatment. Again I would caution that the studies are limited. My published article was the first peer-reviewed article for a patient with Sjӧgren's syndrome treated with LDN. So, really, to validate that, we need larger studies. We also need to have prospective controlled trials, which I hope to be able to be involved with going forward in the future, to document that this treatment needs to be considered one of the standard therapies for patients with Sjӧgren's syndrome.

I think the ideal patient with Sjӧgren's syndrome who I would choose to recruit are definitely those that have high measures of inflammation, specifically the sedimentation rate. Because not only can we follow them symptomatically (or clinically, based on their symptoms) but we'd also have a marker of inflammation that would help verify and solidify whether or not LDN is effective in both treating the symptoms but also the underlying inflammatory component.

My suspicion is that LDN will also help patients with lupus for their musculoskeletal symptoms as well as fatigue, which is common in both autoimmune conditions

I think if a clinical trial will be done, it is likely to be done through benevolent patients who are willing to fund it, through larger organizations where myself or other investigators apply for funds, and possibly even the National Institutes of Health here in the United States. Sjӧgren's syndrome is a common condition and has relevance to other autoimmune conditions. I've put a few patients on LDN who have Lupus or similar connective tissue diseases. My suspicion is that LDN will also help patients with lupus for their musculoskeletal symptoms as well as fatigue, which is common in both autoimmune conditions.

I do have a case that I could submit for publication on what would probably be the first case report of lupus being treated with LDN. I have some free time coming up in the next few months, so hopefully I'll use that free time to submit another article: either the larger study of Sjӧgren's or the initial case report for lupus.

In those patients where it works, LDN can really change their life

I'm just very pleased to have the opportunity to use this product [LDN] to help patients. It is very gratifying to see. It doesn't help everybody, but it's certainly worth a try to help people who have been to a number of doctors...who have been around and haven't really found answers. In those patients where it works, LDN can really change their life.

We at LDNscience thank you very much, Dr. Zashin, for sharing your time and expertise to help increase understanding about low dose naltrexone.