Medical Foods for Chronic Pain Patients

Medical Foods Hold Promise In Chronic Pain Patients – Practical Pain Management – By Michael J. Brennan, MDSteve H. Yoon, MD and Todd Lininger, MD – Sept 2016

Despite the inherent differences in patient populations and their pathologies, there are common approaches to the medical management of chronic pain

The clinician’s goal is to maximize the patient’s functionality by enhancing the analgesic response, and to minimize treatment-related side effects or toxicities.

For the right patients, incorporating an inherently safe option with documented efficacy—like medical foods—into a regimen that includes active exercises, nonopioid and minimal opioid analgesic therapies, and cognitive and behavioral approaches can offer the most effective approach to pain of numerous etiologies.  

Adding medical foods into the pain management mix may enhance the ability to maintain or promote analgesia, reduce analgesic doses, and likely lessen actual and potential toxicities of analgesic and coanalgesic agents.

Limitations of Current Analgesic Therapies

NSAIDs are commonly prescribed, but their analgesic efficacy is often modest and comes with a number of serious adverse effects.

The most frequent NSAID-related adverse effects are within the gastrointestinal (GI) tract, including ulceration, gastritis, and gastroesophageal reflux.

It has been estimated that
NSAID-related GI bleeding is responsible for
100,000 hospitalizations and
16,500 deaths per year.

NSAID-induced adverse events are dose-related, and elderly patients are at highest risk for these outcomes. As a result of these risks, the American Geriatrics Society recommends that NSAIDs be restricted, or even eliminated, in individuals older than 65 years.

Yet, older people will also have more pain and the CDC recommends that NSAIDs be used instead of opioids.

The CDC is behind the curve when it comes to biological research and medical progress.

Acetaminophen is another medication commonly relied on to manage chronic pain, but its efficacy is questionable, and it is associated with significant risk of adverse events.

there was high-quality evidence of no benefit for acetaminophen (4 g per day) over placebo for reducing pain intensity at any time over 12 weeks of treatment.

Yes, you read this correctly: high-quality evidence for no benefityet this drug is pushed on us repeatedly in most over the counter medications plus our prescription pain medications, like Vicodin or Norco.

The review also found that acetaminophen had no beneficial effect on quality of life, function, global impression of recovery, or sleep quality, at any time point

The poor efficacy of acetaminophen, combined with the risk of severe liver toxicity, presents sufficient doubt about the near-universal reliance on this class of medications for the treatment of chronic low back pain.  

Medical foods fall into a distinct FDA regulatory category that differs from both pharmaceutical agents and dietary supplements.

Medical food is defined by the FDA as

“a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”

The FDA identifies that medical foods are intended for specific dietary requirements of a condition, and

“are specifically formulated and processed (as opposed to naturally occurring foodstuff) for a patient who requires use of the product as a major component of a disease or condition’s specific dietary management.”

With regard to pain, medical foods are intended to meet the potential needs of unique nutritional requirements, resulting from a specific disease or condition as determined by medical evaluation.

Medical foods must be prescribed by a physician after a diagnosis has been made, yet they are not regulated as drugs, and are not subject to any regulatory requirements that specifically apply to drugs.

They are also exempt from food labeling requirements pertaining to health claims under the Nutritional Labeling Act.

Because of their positive safety profile, medical foods may help minimize the number of the concerns typically associated with conventional analgesics.

The rationale for using medical foods in the treatment of chronic pain syndromes arises from an understanding that the metabolic process is disrupted, leading to a depletion of neurotransmitters and an associated synaptic fatigue that results from an increase in precursor turnover and dietary deficiency of the precursors.

A number of neurotransmitters are involved in the modulation and sensation of pain, particularly in conditions such as sleep dysfunction, mood disorders, and fatigue (Table 2). 

Abnormalities in neurotransmitter levels also have been documented in fibromyalgia.

Two randomized double-blind studies have evaluated an amino acid formulation (AAF) that contains the neurotransmitter precursors

  • choline,
  • L-histidine,
  • 5-hydroxytryptophan,
  • serine, and
  • arginine  (Theramine, Targeted Medical Pharma LLC).

This AAF formulation has been developed as a medical food for the dietary modulation of the metabolic processes associated with pain and inflammation.

These studies demonstrated that the AAF is both safe and more effective than low-dose NSAIDs for the treatment of low back pain.

In 1 study, 129 adult patients with back pain lasting more than 6 weeks were randomized to 1 of 3 groups for 28 days:

  1. naproxen only (250 mg/day),
  2. AAF only (2 capsules twice daily), or
  3. an AAF/naproxen combination.

The goal of medical foods is to restore the homeostasis of these neurotransmitter levels.4,19 Thus, medical foods that correct nutritional deficiencies may be an appropriate target for patients who experience poorly managed pain.

The primary efficacy endpoint of these studies was the change in participants’ awakening stiffness and pain scores

Those receiving AAF alone achieved a statistically significant reduction from baseline in the Oswestry Disability Index (−33%) and Roland-Morris Lower Back Pain Scale (−44%) compared to no change for those receiving naproxen only.

Those in the AAF/naproxen combination group achieved even greater reductions in these pain indices (−60% and −65%, respectively).

All treatments were well tolerated with no adverse events reported; however,

  • those in the naproxen-only group experienced significant increases in hepatic transaminases (ALT, AST), indicative of hepatocellular inflammation,
  • while those in the AAF or AAF/naproxen groups had no significant increase.

This seems to show that these medical foods can also mitigate the damage from NSAIDs or other pain-relievers.

This incidental finding could be the most important of all. If any neurotransmitter deficiencies (which could lead to hyperalgesia) resulting from opioids can be corrected by these supplements, then it would make sense to add these to opioid therapy.

Comparable results were seen in a similarly designed study, involving 122 patients with chronic back pain who were randomized to 1 of 3 groups:

  • ibuprofen alone (400 mg/day),
  • AAF alone, or
  • a combination of the 2 for 28 days

Patients receiving AAF or AAF/ibuprofen achieved significantly greater reductions from baseline to day 28.

Notably, this study also documented that amino acid precursor levels were more than 2 standard deviations (SDs) below the mean for normal subjects at baseline.

Here we see how long running chronic pain depletes the precursors needed for the body’s own pain relieving mechanisms.

Measurements over the 4-week study showed that treatment with AAF was associated with a significant increase in these precursors.

Overall, these results suggest that AAF, alone or in combination with low-dose NSAIDs, restores plasma amino acid levels and produces measurable improvements in pain as well as demonstrated decreases in inflammation.

A double-blind, placebo-controlled trial in 111 adult patients with a history of sleep disturbance evaluated the effect of another AAF-containing acetylcholine and serotonin precursors (Sentra PM, Physician Therapeutics) on sleep parameters.

those receiving AAF and AAF/trazodone experienced a 3.86- and 6.48-point improvement, respectively, in sleep quality (10-point scale) and a 41- and 56-minute reduction in sleep latency compared to no improvement for either parameter in the trazodone and placebo groups (P<0.001 for both).

Medical Foods in Perspective

Medical foods provide a new alternative to traditional medication therapies.

The GRAS ingredients of medical foods present no concerns for drug interactions and no risk of long-term complications

This seems to be a completely unfounded statement since there are no studies of how these supplements might also disturb the body’s balance of materials.

No inputs to the body have zero effects or results. There are always some side-effects, and some of them can be deleterious, especially in the long run.

I’m surprised anyone with a medical degree would presume to know that this particular addition to the diet will have absolutely no undesired effects, even in the long run.

In addition, because medical foods have a unique mechanism of action (ie, replacement of amino acids that are essential for the synthesis of neurotransmitters responsible for transmitting pain signals and mediating their perception), medical foods may also be used in combination with traditional pharmaceuticals, producing enhanced efficacy and the potential to reduce the dose of the concomitant medication.

Relying on medical foods for pain management will maintain efficacy safely, while reducing the risk of adverse events.

This was evidenced in the AAF/NSAID combination trials where the low doses of NSAIDs used in combination with AAF were associated with a low rate of adverse events.

Indeed, while NSAIDs alone were associated with a slight increase in liver transaminases, the AAF/NSAID combination was not

In summary, medical foods have been an underutilized option for the treatment of chronic pain.

Medical foods provide clinicians with a unique therapeutic modality that has the potential to improve patient outcomes by alleviating pain, and at the same time maximize tolerability and safety.

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4 thoughts on “Medical Foods for Chronic Pain Patients

  1. Emily Raven

    Wow anything and everything that isn’t an opioid eh? I don’t think I like the “exempt” from labeling status. Look at what they push on sick people and our elders in hospital/hospice…. Ensure which is the worst of the worst quality as far as those meal replacements go (I had the “pleasure” of looking in to them and finding what one didn’t violently come out of one of two ends when I tried to eat it during the time the doctors were knowingly starving me out due to taking my pain meds away)

    I agree with the “no future repercussions.” That’s an arrogant statement since studies upon studies and untold number of anecdotes have reported that processed foods lead to worse outcomes. Also do we have a profile for those additives? No? Well then….

    Liked by 1 person

    1. Zyp Czyk Post author

      I was shocked to learn that they think Ensure is a meal replacement. Looking at the ingredients, it’s an awful junk food that we’d never consider part of a “healthy diet”.

      Our medical system is so terribly broken…

      Liked by 1 person

      1. Emily Raven

        Oh it’s absolutely horrid. Here they even use it for people with the direct to stomach feeding lines. So people who need the best possible because they can’t handle very much of anything. It’s absolutely disgusting. It’s possible other places are different; my zany adventures seem to be somewhat regional due to Midwest area/most specialists and hospitals not operating 10 years behind the science are closer to the coast; but still. It’s a person’s nutrition. That’s the LAST thing to cheap out on when someone’s sick, hospital in the middle of The City Of Ghettofabulous or not.

        Liked by 1 person

  2. Kathy C

    More Pseudo Science. It really amazes me that they would even print this in a legitimate appearing Medical Publication. The entire piece was not only deceptive, but mean to misinform, and peddle another Snake Oil product.. Nutrition is a basic necessity of life, and here they try to monetize it, a profitable venture for the unscrupulous. They slipped Trazedone into the mix on the “Sleep Study.” A diet of Ding Dongs and Diet Coke with Trazedone would have the same outcome.
    They are pushing Trazedone an Anti Psychotic, because when people are in a drugged stupor they are less capable of reporting any symptoms, They are peddling this along with Anti Psychotics for all kinds of ailments, including depression. It does not “Cure” anything, or provide any benefit, but it will make it difficult;t to articulate or think, thus appearing to be a “treatment.” Since many of the Drugs they are currently marketing for sleep, depression, pain or even PTSD don’t work, they threw Trazedone in the mix. Trazedone is now the drug of choice at the V.A.and Low Income Clinics. Desperate people who have trouble sleeping due to pain or psychological distress, have no other options. It is very unlikely any Physicians will speak up, they have been silenced. Trazedone is popular because it is nto very toxic, it does nto improve quality of life or any of the disorders it is prescribed for, but that is not a consideration anymore. As we can see, when combined with “Super-foods” or Twinkies it improves sleep. This is a dreamless, drugged and non restorative “Sleep.” This drug has been handy for the drug them and send the away “Treatment”, that keeps a Clinic Financially afloat. It is all about the Bottom Line. If a patient takes enough of it, they won’t be bothered anymore. It is not as if they have to participate in life, keep a job, or be a Human being anymore. Trazedone will keep them in a drugged stupor, it is the best the Medical Industry has come up with for troublesome patients.



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