Low-Dose Naltrexone: A Potential ‘Wonder Drug’ Held Back by Costly Trials

Low-dose naltrexone (LDN) is generating buzz as a potential treatment for a range of conditions, from chronic pain to autoimmune disorders, offering new hope for patients with difficult-to-manage symptoms.

While hailed for its symptom relief, some health experts warn that LDN may not tackle the underlying causes of disease. The question remains: Is this affordable, underutilized drug a breakthrough or merely a temporary fix?

A Lifeline

Linda Elsgood felt unstoppable. A mother of two and full-time bank manager, she balanced work and family with ease. “I was Wonder Woman. I could do anything,” she told The Epoch Times. But when both her parents fell ill, the stress of caregiving began to take its toll.

Soon after, Elsgood began experiencing troubling symptoms: numbness in her leg and face, extreme fatigue, and vision issues. In 2000, she was diagnosed with relapsing-remitting multiple sclerosis (MS). By 2003, the disease had progressed to secondary progressive MS, and her doctors informed her that no further treatment options were available. “I was devastated,” she recalled.

Facing limited options, Elsgood discovered LDN on an online forum, a drug commonly prescribed for addiction but now being explored for other conditions like MS.

For three weeks, Elsgood saw no improvement. “I thought it wasn’t going to work for me,” she admitted. “I honestly didn’t have another plan.”

Then, things changed.  “Amazingly, after three weeks, I could think again. I wasn’t talking rubbish anymore. I was coherent.”

That renewed clarity, she said, felt like a gift. “I was starting to feel like myself again.”

Today, Elsgood leads the LDN Research Trust, a charity she founded to raise awareness and fund research into LDN’s potential benefits. “I was deteriorating so quickly. Without it, I don’t think I would’ve lived much longer,” she said. “LDN gave me my life back.”

Now 68, Elsgood remains steadfast in her commitment to the treatment. “There’s no way I’m ever going to stop taking it,” she says. “Today, I feel in a good place.”

Expanding Uses

Naltrexone, initially developed to treat opioid and alcohol addiction, is now drawing attention for its potential to manage a wide range of chronic conditions.

Approved by the U.S. Food and Drug Administration (FDA) at higher doses—typically 50 to 100 milligrams per day—to block opioid receptors, naltrexone functions differently in smaller doses, usually ranging from 0.1 to 6 milligrams. These lower amounts are believed to reduce inflammation and regulate the immune system.

Low-dose naltrexone is being studied for conditions like multiple sclerosis, the illness Elsgood was diagnosed with in 2000. While large-scale studies are still lacking, smaller trials and patient testimonials indicate that LDN may help reduce symptoms and improve quality of life.

A 2023 study in Biomedicines looked at LDN’s use in chronic pain conditions like fibromyalgia, with 65 percent of patients reporting pain relief. Side effects were minimal, with only 11 percent experiencing issues such as nausea, vomiting, anxiety, or headaches—these patients discontinued use of the drug.

LDN is also being studied for its potential to aid those struggling with long COVID, or post-acute sequelae of SARS-CoV-2 infection. A recent study in International Immunopharmacology found that patients treated with LDN experienced improvements in fatigue, brain fog, and sleep disturbances. The study suggests LDN’s anti-inflammatory properties may help relieve lingering COVID-19 symptoms.

Board-certified gastroenterologist Dr. Leonard Weinstock refers to low-dose naltrexone as a “wonder drug” for its potential to treat irritable bowel syndrome (IBS) and other digestive disorders. “LDN works. There’s no denying its effectiveness,” he said.

Weinstock told The Epoch Times in an email that LDN increases the body’s endorphin levels, which helps calm the immune system and reduce inflammation. By blocking toll-like receptors, LDN decreases the production of inflammatory substances, which can relieve symptoms in conditions like IBS.

LDN is now being used to treat a growing list of conditions, including restless leg syndrome, mast cell activation syndrome (MCAS), and postural orthostatic tachycardia syndrome (POTS). In MCAS, the body overreacts to allergens. With POTS, the heart rate increases, and blood pressure can drop when standing, which can lead to lightheadedness, dizziness, and fainting.

According to Weinstock, low-dose naltrexone is remarkably safe and well-tolerated. He notes that side effects occur in around 15 percent of people but are usually mild and reversible. Common side effects include headaches, vivid dreams, and gastrointestinal issues like diarrhea. Reducing the dose or gradually increasing it can help minimize headaches, while taking the medication in the morning may ease vivid dreams.

Overlooked Option

Despite its potential to address various conditions, low-dose naltrexone remains under-prescribed, according to Elsgood. One significant reason, she explains, is that LDN is off-patent.

When a drug loses patent protection, its exclusive manufacturing rights expire, allowing generic versions to enter the market. While this lowers costs for patients, it also reduces the financial incentive for pharmaceutical companies to invest in costly large-scale clinical trials. Because they no longer monopolize production, it’s challenging to recoup their costs.

“Getting FDA approval for a specific indication takes a lot of money. Naltrexone, which was FDA-approved at high doses for prevention of narcotic and alcohol abuse in 1984, has a high bar to jump over,” said Weinstock. “It is hard to do expensive studies on a generic drug.”

Without the large-scale trials required for widespread FDA approval, LDN remains mostly overlooked by mainstream medicine. Its low cost—typically around $1 a day at U.S. compounding pharmacies—further reduces the motivation to pursue it, making it challenging to fund the research needed to secure its place in the medical community.

Low-dose naltrexone must be prescribed and monitored by a physician. While naltrexone is FDA-approved for addiction treatment, its use in low doses for other conditions like autoimmune disorders is considered “off-label.”

Only compounding pharmacies can dispense LDN, typically in the form of tablets, sublingual tablets, capsules, or transdermal creams. This adds another layer of complexity, as many doctors may be hesitant to prescribe a treatment that hasn’t gone through rigorous regulatory approval for these off-label uses.

“Doctors are not taught about low-dose naltrexone in medical school or residency, and there is no drug rep that comes around to teach them either,” said Weinstock. “The open-minded integrative physicians and naturopaths know best.”

To bridge the gap in research and awareness, Elsgood founded the LDN Research Trust in 2004. The nonprofit organization aims to fund clinical trials on low-dose naltrexone, particularly for autoimmune diseases and cancer. The Trust has helped more than 100,000 people worldwide access LDN through private prescriptions and health care providers.

Right Dose

Determining the correct dosage of LDN is challenging. The drug’s effectiveness varies widely depending on the individual, and no single dose works for every patient.

Patients often respond to LDN in between three to four weeks, said Weinstock, noting that the fastest improvements tend to occur in patients with conditions such as mast cell activation syndrome, psoriasis, restless leg syndrome, and Crohn’s disease. However, he emphasized the need for personalized dosing, advising, “For sensitive people, it is best to go low and slow.”

The dosing range for LDN is wide, and finding the “sweet spot” often requires careful monitoring and adjustment. Many patients find relief between 3 and 4.5 milligrams per day.

“If they do have side effects,” Weinstock adds, “it is always worth scaling back the dose quite a bit.”

A recent study in the Journal of Pain Research underscores the individualized nature of LDN dosing. The observational study, which examined 41 patients with chronic musculoskeletal pain, found that the maximally effective dose of LDN varied significantly among participants.

The study found that patients experienced pain relief with doses ranging from 0.1 mg to 6 mg per day, with some showing reduced effectiveness or worsened symptoms at higher doses due to a phenomenon called hormesis. Hormesis occurs when a drug that provides benefits at low doses can have the opposite effect at higher doses, leading to diminished results or negative side effects.

In an interview with The Epoch Times, study author Dr. Norman Marcus highlighted the limited research on optimal LDN dosing, noting that many current regimens, such as the standard 4.5-milligram nightly dose, are based on little scientific data.

“What works for one patient may not work for another,” Marcus explained, highlighting the idiosyncratic nature of the drug’s dosing.

While LDN holds promise for treating various conditions, the study emphasizes that its dosing must be carefully tailored to each individual, with adjustments made according to the patient’s response and any side effects.

A Helpful Tool

Although LDN has attracted attention for its ability to alleviate symptoms of chronic conditions, it is not a cure-all. Experts warn that while it may reduce inflammation, LDN by itself does not address the underlying causes of autoimmune disorders or other chronic health issues.

“LDN can downregulate some of the inflammatory activity in the body, but it doesn’t fix the systems driving the immune-inflammatory process,” Ben Galyardt, a chiropractor and functional medicine expert, told The Epoch Times.

According to Galyardt, factors such as blood sugar imbalances, adrenal dysfunction, leaky gut, and liver issues are key contributors to autoimmune conditions—issues that LDN cannot resolve.

“Relying solely on LDN without addressing the root causes risks continued damage to the body, even if symptoms improve slightly,” he said.

LDN is most effective when integrated into a broader, holistic treatment plan.

“It’s a tool in the toolbox, but it’s not a miracle,” says Elsgood. “You still need to reduce stress, prioritize quality sleep, spend time outdoors, and eat nourishing foods.”

Galyardt agrees, noting that while LDN can aid in symptom relief, it should be paired with other anti-inflammatory supplements such as turmeric, resveratrol, and vitamin D to support the body’s overall healing.

“LDN can be useful for symptom relief, but it’s important that patients understand how it works and ensure they’re also tackling the root causes of their health issues,” said Galyardt.

Path to Hope

For many, low-dose naltrexone provides a renewed sense of possibility, especially for those battling chronic conditions who feel like they’ve exhausted all options.

“LDN offers hope,” said Elsgood, who credits the drug with turning her life around after her MS diagnosis. Now, through the LDN Research Trust, Elsgood is committed to raising awareness about the drug’s potential benefits.

“So many severely ill people have been stripped of hope,” she said. “For me, LDN was life-changing.”

Elsgood’s larger mission is to advocate for more comprehensive research on LDN, which she believes is essential to unlocking its full potential. The LDN Research Trust funds studies to promote greater recognition and acceptance of LDN in mainstream medicine.

For Elsgood and many others who have found relief, LDN represents more than just managing symptoms—it provides a way forward for those who feel let down by conventional treatments.

Reposted from: https://www.theepochtimes.com/health/low-dose-naltrexone-a-potential-wonder-drug-held-back-by-costly-trials-5729547

Benefits of Low Dose Naltrexone (LDN) - Dr. Sajad Zalzala

AgelessRx Co-founder and Chief Medical Officer, Dr. Sajad Zalzala shares his knowledge on the benefits of LDN:

What you should know about LDN:

• Low Dose Naltrexone (LDN) works with endorphin and immune systems to reduce overall oxidative stress
• LDN relates to doses of 10mg per day or less
• LDN is shown to reduce chronic inflammation, autoimmunity, obesity, fatigue, and chronic pain
• LDN is a safe and effective treatment for over 40 years

My Experience with LDN

I first learned about Low Dose Naltrexone (LDN) when I attended an integrative medicine conference as a medical student. I was naturally intrigued when I heard about the effects LDN has on autoimmunity and chronic inflammation and its benefits. Individuals diagnosed with a disease falling under these two broad conditions often do not receive much relief from conventional therapies. When they do, the conventional therapies typically come with detrimental side effects.

After much research, I decided that LDN would benefit many individuals who were seeking answers to their health issues. During my residency training, I was able to convince one of my supervising physicians to allow me to try LDN on a patient—and there began my obsession with it.

As time went on, I began prescribing LDN in my very own brick-and-mortar clinic. There was still more I felt I could do to help patients. So, I decided to create a nationwide service to provide access to patients wanting to experience the benefits of LDN. In 2016, I launched LDN Direct. Since then, I have prescribed LDN to over 1,000 patients. The vast majority of these patients experience symptom relief to some degree. Many of these patients have claimed life-changing benefits from LDN.

LDN & Lyme Disease

As the service became widespread and consultations quickly increased, I began to notice patterns in how individuals reacted to LDN. For example, individuals dealing with Lyme or related infections tended to need to start at a much lower dose—sometimes even a micro-dose of Naltrexone—to avoid uncomfortable side effects. I hypothesize that these patients’ immune systems have been devastated by these infections and need to be brought back in balance very gently and slowly.

Others in this category include those with chronic migraines and patients sensitive to multiple medications or foods. More recently, I have seen an uptick in MCAS (Mast Cell Activation Syndrome) consultations; these patients also tend to require a lower initial dose and slower titration schedule.

LDN & Thyroid Diseases

While there is some school of thought that individuals with a Hashimoto’s diagnosis need to start at a lower than normal dose of 0.5 mg, I have actually found that these particular patients tend to require a higher maintenance dose than others in order to keep symptoms at bay and regulate the immune response. If they begin at a low dose, it takes some time to find relief. Some may throw in the towel before they get the relief they seek. I prefer to start these individuals at a “regular” starting dose of 1.5mg daily. I will educate them on the potential to titrate back if they experience long-lasting side effects. Hashimoto’s—and thyroid disorders in general—seem to be particularly susceptible to the effects of Low Dose Naltrexone.

We ask any patients taking thyroid medication to have a full thyroid panel checked by their physician every 6-8 weeks while titrating up to their maintenance dose or sooner if they experience symptoms of hyperthyroid. I have seen many thyroid patients need to reduce their dose after starting LDN, and I even find that it lowers auto-antibodies.

LDN & Elher’s Danlos Syndrome (EDS)

A formerly uncommon diagnosis that I have started to see is Elher’s Danlos syndrome (EDS). This is a condition that conventional therapies have almost no treatment for—yet the increase in diagnosis is quite staggering. Over the last year, we have seen close to 50 patients with this diagnosis. LDN seems to be one of the few treatments that yields results for them. Several have actually emailed in excitement about the difference they feel after only a few weeks of taking LDN. The majority of these patients seem to have an “acquired” form of EDS, rather than the classic purely genetic variety we learn about in medical school. I suspect the acquired form of EDS has an immune dysfunction component that LDN is helping to resolve.

LDN & Fibromyalgia/Chronic Fatigue Syndrome

There are many benefits of LDN. The most common success stories with LDN are Fibromyalgia (FMS) and Chronic Fatigue Syndrome (CFS). Again, these patients often fall through the cracks with conventional therapy, and many do not respond well to common medications. Fatigue and phantom pain are the most commonly reported symptoms in patients with FMS and CFS diagnoses, and, in fact, these two diagnoses commonly go hand-in-hand. While neither is technically considered an autoimmune disease, they have many commonalities with other autoimmune diagnoses. Even for those patients who do not have an actual diagnosis, but have similar symptoms that are clearly based on a dysfunctional immune system and chronic inflammation, LDN has shown to be successful to some degree, time and again—with some patients experiencing near-complete resolution of symptoms.

LDN & Longevity

Considering how LDN works in the body to balance the immune system and reduce inflammation, it poses the question: Does it also help to increase longevity?

My answer is Yes! The mechanism by which Low Dose Naltrexone works is by boosting the body’s natural production of endorphins (read more about that process here). Considering that endorphins are a key constituent in the production of SuperOxide Dismutase, and SuperOxide Dismutase is the body’s most prominent way of decreasing oxidative stress—the most common cause of aging—it bears considering that utilizing Naltrexone at a low dose could be a wonderful long-term preventative to early aging.

Find healthcare providers: www.ifm.org/find-a-practitioner (Functional Medicine)