Can ‘Medical Food’ Treat Chronic Pain?

By Pat Anson, PNN Editor

Do you keep a supply of gamma-aminobutyric acid in your medicine cabinet? What about hydroxytryptophan? Or the ominous sounding devil’s claw root?

They’re not exactly household names to the average person, but to Fabio Lanzieri they are essential ingredients in a new “medical food” product called Proleeva, a dietary supplement he developed that contains a blend of a dozen natural herbs, enzymes and amino acids.

“I fervently believe that prescription medications are very beneficial to man, but I also believe that nature does offer us the ability to find solutions to natural diseases. Because of this, I was always interested and read a lot about vitamins, supplements and bioflavonoids,” says Lanzieri, who spent nearly four decades in the pharmaceutical industry. “I believe that supplementing prescription medications with natural substances is the best way of treating chronic pain or any disease state.”

Several years ago, Lanzieri’s wife Maria began experiencing joint pain as a side effect of taking a hormone suppressant to help her recover from breast cancer.     

“I did start feeling the pain in my joints, particularly my fingers. I was having a really hard time sometimes just opening a bottle or doing simple things,” Maria told PNN.

To help his wife, Lanzieri began experimenting with different blends of herbs and other natural substances. Some, like ginseng and curcumin, have been used for centuries as natural remedies for pain and inflammation. Others, like choline bitartrate and L-arginine, have only recently been recognized as essential nutrients that help restore amino acids and neurotransmitters to healthy levels.

You can buy all of these supplements individually, but Lanzieri combined them all into one proprietary formula and gave it to Maria. Her joint pain slowly began to improve.

“After about a month, month and a half, I started having relief of those symptoms.  I didn’t have the joint pain. I felt like I could do a lot of those tasks that I couldn’t do before,” Maria said. “At one point I stopped taking it and it then was all coming back. It was weird. I didn’t think it was the Proleeva. I didn’t associate it with that. But then I went back on it and suddenly I was not feeling it again.”

The Lanzieri’s began sharing Proleeva with family and friends, who also reported positive results.

Only recently have they begun selling Proleeva to the general public on their website and through Amazon, marketing it as “the ultimate comfort food” that “helps bring your nervous system back into balance.”

A Proleeva bottle contains 120 capsules – about a month’s supply – and costs $40.

“I’ve been taking Proleeva for the last seven years and I don’t have any inflammation. I take it because it balances the body with the right ingredients that it needs to fight to heal itself,” says Lanzieri. “Your body needs amino acids and they are not reproduced naturally in the body. And over time, the older we get, the less we have of those amino acids. And therefore, we have to supplement them.”

For now, there is only anecdotal evidence to support these health claims, although a small clinical trial of Proleeva is underway.  Unlike pharmaceuticals, dietary supplements are only loosely regulated by the Food and Drug Administration, allowing supplement makers to introduce new products and make health claims without substantial evidence that they work.

‘One Formulation Makes a Lot of Sense’

Dr. Forest Tennant is intrigued by Proleeva. An expert in treating intractable pain, Tennant recommends that pain patients take gamma-aminobutyric acid (GABA), herbs and other supplements as part of their medical treatment to restore damaged nerve tissue and relieve pain.

“Having a lot of different supplements in one formulation actually makes a lot of sense, because we’re not certain which ones are going to work,” says Tennant. “But I do think there is some urgency or necessity in people with pain taking a variety of these supplements. They can’t hurt themselves and they probably are going to benefit themselves.

“And this particular product is doing something else. It recognizes that it’s got stuff in there like GABA that stimulates the nerve receptors that provide pain relief.”  

Tennant says the supplement industry has become more innovative than the pharmaceutical industry – particularly in an age when opioids and some other medications are harder to get.

“I think the innovation is really great,” Tennant said. “I really think that anyone who has chronic pain, particularly constant pain, really needs to be on a number of supplements right now. We’ll figure out exactly which ones work the best later, but right now I think taking a combination of these things is worthwhile.”

People who try Proleeva or other supplements should not expect instant results. It may take up to a month to feel any benefits.

“The biggest problem is making them stay with this for 30 days. We’re a society of instant gratification. Prescription drugs do that. But unfortunately, natural substances take time,” says Lanzieri.

Natural Herbs for Intractable Pain Syndrome

By Dr. Forest Tennant, PNN Columnist 

Intractable Pain Syndrome (IPS) is defined as constant pain with cardiovascular, metabolic and hormonal complications. IPS is caused by neuroinflammation inside the brain and spinal cord (central nervous system or CNS) that comes from excess electromagnetic energy generated by a painful disease or injury.

Excess electromagnetic energy activates an immune cell in the CNS called “microglia” to produce inflammation that then destroys tissue in the CNS. Unfortunately, tissue destroyed by inflammation impairs or damages the normal CNS mechanisms that shut off or cause pain to cease. A person may, therefore, develop constant (24/7) pain that overstresses the cardiovascular, metabolic and hormonal systems.

Tissue destruction in the CNS is well documented by brain scans. This relatively recent understanding of how neuroinflammation destroys CNS tissues and causes constant pain is arguably the most important discovery for pain treatment in the 21st Century. Why? We now have some ideas on how to treat IPS that can possibly cure or at least permanently reduce pain rather than just provide temporary, symptomatic relief. 

Treating CNS Inflammation 

When someone develops IPS, it is human nature to seek immediate pain relief and ignore its basic cause. If you have constant (24/7) pain, however, one must accept the fact that you have inflammation in the CNS that must be suppressed. Otherwise, you can reasonably assume that the pain will get worse.  

While research has documented that CNS inflammation may spread, it is unknown whether it ever “burns out.” As of yet, there is no blood or x-ray test to know if “burn out” may occur. This means that every person with IPS must take one or more anti-inflammatory agents to stop further tissue destruction and the worsening of pain. 

A problem when suppressing inflammation in the CNS is that only a few of the anti-inflammatory agents which are commercially available cross the blood brain barrier and enter the spinal fluid in sufficient amounts to be effective. This includes the non-specific anti-inflammatory drugs (NSAIDs) and corticosteroids.  

Benefits of Natural Herbal Products

Interestingly, natural products such as botanicals, herbs, enzymes and hormones tend to cross the blood brain barrier and provide anti-inflammatory activity. A well-known common example is aspirin (acetylsalicylic acid), which is derived from willow tree bark.

This has caused a great deal of interest in the use of natural products for suppression of CNS inflammation. Several research studies in both laboratory tests and animals have found that some natural agents do indeed suppress CNS inflammation.

To date, research has identified five herbs that suppress CNS inflammation. There are likely other natural products that suppress CNS inflammation, but this list is a good start:

  1. Ginseng

  2. Curcumin

  3. Resveratrol

  4. Ginger

  5. Fisetin

Currently, there are very few controlled blind studies in humans to demonstrate the effectiveness of these herbal products. Personally, I have often seen considerable effectiveness of natural products in reducing the pain of IPS. Other anecdotal reports from patients and doctors are also starting to accumulate.

Precise dosages are unknown, but the manufacturer of each herbal product will have some starting instructions on the label. Herbal agents appear quite safe and have few reported side effects. Herbs can be taken with corticosteroids, opioids, naltrexone, electrical stimulators, neuropathic agents, and essentially all medication used for treatment of IPS.

At this time, we believe there is enough research and clinical experience to recommend both herbal, non-prescription as well as prescription anti-inflammatory agents to assist treatment of IPS. The time has come to treat IPS with a broader-based approach rather than just the use of symptomatic pain relievers.

Based on our current knowledge, IPS will likely get worse unless a person’s treatment program includes agents that suppress CNS inflammation.

Forest Tennant, MD, DrPH, MPH is retired from clinical practice but continues his research on the treatment of arachnoiditis and intractable pain at the Arachnoiditis Research and Education Project. The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.