Do People Really Understand Their Neuropathic Pain

Today's post from healthskills.wordpress.com (see link below) asks the question as to whether people really understand the nature of their neuropathic pain. It's a very interesting study which concludes that people do much better with their problem if they receive a cogent explanation of what's happening to them. Unfortunately, with neuropathy that's rarely the case, as doctors assume that the medical science is often too complex for their patients to understand. It is pretty much a given that patients can cope much better with symptoms if they know why they are happening and what's going on inside their bodies. After that, an explanation of any treatment is also useful.

How well do people understand their neuropathic pain? 
 Martin, S., Daniel, C. Williams,  (2014)

When coming to terms with a chronic pain problem, one of the important steps involves obtaining a diagnosis that fits with both the individual’s personal experience of their pain, and also their knowledge (drawn from what is available in the general population). If the label doesn’t square with their experience, people continue searching until they find something that does.

There has been an enormous wave of excitement about giving people good “pain education”. I’ve always been a bit anxious about the term “education”, because it can so often mean giving an information dump, leaving the person being “educated” with little or no relevant knowledge about their personal concerns – and it’s the individual and unique concerns that influence how a person interprets what is happening, and how they respond. As a result, I prefer “helping people to develop a personal pain formulation” or “reconceptualising” their pain. Putting the pedantics aside, it seems really important for health professionals to not only understand what people with pain already know about their health condition, but also to understand how people interpret what they’re told – if they’re told anything.

In this study, 75 people with neuropathic pain were asked to sort a series of statements about neuropathic pain according to their level of agreement with them. This is known as Q-methodology. The sorted statements are then analysed to identify common features amongst them.

 Four factors were identified:
Neuropathic pain is a nervous system problem, psychology influences the pain experience and acceptance, and being open to psychological interventions – this group of respondents had tried psychological treatments, their pain was on average about 6 – 7 years.

Neuropathic pain is nerve damage, psychology is irrelevant in pain experience, neutral about psychological treatments – this group of people had not tried psychological treatments, but had tried surgery and medications.

Neuropathic pain is irreparable nerve damage, symptom management is needed, psychological factors play a part in pain perception but psychological treatment is not OK – this group of individuals had pain for an average of 10 years, and they had used breathing, positive thoughts, medications and physical treatments.

Neuropathic pain cause should be identified, psychological influences may play a part, and treatment can include both medical and psychological – this group had pain for an average of 1 -2 years, and they had tried a range of medications, physical methods, yoga, meditation and complementary therapies.

The authors point out several limitations of this study – people were not recruited on the basis of an particular characteristics, there could be a number of recruitment biases, and they were all identified via online recruitment processes, therefore it’s hard to generalise. What it does indicate is that there is no coherent biopsychosocial explanation put forward by participants, they appeared to have received very little explanation about their problem, and this affected their readiness for psychological or self management interventions.

Another interesting point is how many of these participants, across all the four factor groups, described experiencing being given psychosomatic explanations of their pain. The authors write :”Across all accounts, participants’ comments indicated that they had received psychosomatic explanations of their pain and had been distressed and offended, consistent with other studies which use open-ended methods to sample patients’ experiences. (p. 353).” The influence of psychological factors was found to be associated more with adjusting to chronic pain, rather than to developing an integrated model of pain. Factor 1 were the only group to endorse the notion of acceptance, or learning to live with pain – and the groups in Factors 3 and 4 were strongly against the idea that pain could be lived with.

I find this study interesting, not so much in what it has discovered, but rather more in terms of the discussion about psychological factors and medical factors – but nothing on social factors. I find myself wondering again whether we have a biopsychological model of pain, rather than a more complex biopsychosocial model.

That being said, I agree with a point made in the conclusion: people with chronic pain value a coherent explanation for their pain, it helps resolve their worry and enables them to approach their pain differently. The problem facing people with chronic pain is how to access evidence-based and accessible information about neuropathic (or indeed any type of) pain. Often people find out about neuropathic via biomedical models, and they rarely get exposed to the complexity of a biopsychological model, let alone a biopsychosocial one.

We desperately need to understand the best ways to personalise an explanation for an individual with chronic pain. I think a case formulation approach is the most useful, but I’ve found that many clinicians think this takes “too long” and is “too complex”. I wonder about this. A formulation might take a couple of sessions, but it’s a lot less expensive and has lower risk than surgery.

In light of the very limited range of interventions for people with neuropathic pain, perhaps taking the time to respond to the person’s unique questions about their pain would be time and money well spent.

People who have chronic pain are often very reluctant to consider the influence of psychological factors on their pain, reflecting their fear that by accepting this, their pain is being dismissed as “not real”, or not legitimate. This means people may not accept (or indeed be referred for) psychological interventions. Treatment approaches based on a cognitive behavioural approach have good evidence to support them, but they don’t do much good if people are not ready for them, or even referred for them.

Martin, S., Daniel, C., & Williams, A. (2014). How do people understand their neuropathic pain? A Q-study PAIN®, 155 (2), 349-355 DOI: 10.1016/j.pain.2013.10.021

http://healthskills.wordpress.com/2014/03/11/how-well-do-people-understand-their-neuropathic-pain/

For Which Neuropathies Is Lyrica Really Suitable

Today's post is a Pfizer Press release (see link below) concerning Lyrica being prescribed for a specific form of neuropathy. The American FDA has approved its use for neuropathy associated with spinal cord injuries (for which there was no approved treatment before). It's a Pfizer press release, so it positively glows with pride at the achievement, yet they have withdrawn the drug for treatment of HIV-related and other neuropathies. It doesn't make sense. The pain receptors that Lyrica targets are much the same for most forms of neuropathy, yet some are considered suitable for Lyrica treatment and others not. It is still widely prescribed for HIV-related neuropathy across the world, as different medical authorities try to decide what to do about it and what the truth is. Considering the court cases Pfizer have had to face concerning the side effects of Lyrica, it would be advisable to talk carefully with your doctor before starting a course of this drug - the possible side effects shouldn't be underestimated (more articles about this subject in the list on the right of the blog). Maybe Pfizer should consider explaining the situation in simple terms to the patients themselves?

FDA Approves Lyrica For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review

June 21, 2012

First and Only Treatment Option Approved in the U.S. for Pain Condition Affecting 40 Percent of Spinal Cord Injury Patients

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) approved the use of Lyrica^® (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury. Lyrica received a priority review designation for this new indication from the FDA. More than 100,000 patients – approximately 40 percent of the 270,000 patients with spinal cord injury in the United States - suffer from this chronic, complex pain condition. Neuropathic pain associated with spinal cord injury can be severely debilitating and may significantly hinder rehabilitation and the ability to regain function.
  
“This milestone represents an important opportunity for physicians to more effectively manage the debilitating neuropathic pain that often accompanies spinal cord injury,” said clinical study investigator Diana Cardenas, MD, MHA, professor and chair, department of rehabilitation medicine, University of Miami Miller School of Medicine and chief of service for rehabilitation medicine and medical director of Jackson Rehabilitation Hospital, Miami, Florida. “Given the clinical challenges of investigating neuropathic pain in this patient population, any advancements in treatment are welcome by physicians and patients alike.”
  
An estimated 12,000 new spinal cord injury patients are diagnosed in the U.S. each year. There are a wide variety of causes for spinal cord injury, including traumatic and non-traumatic causes. Traumatic causes may include motor vehicle accidents, violence, falls and sports injuries. In these instances, a spinal cord injury typically begins with a sudden, traumatic blow to the spine that fractures or dislocates vertebrae. The damage begins at the moment of injury when displaced bone fragments, disc material, or ligaments bruise or tear into spinal cord tissue. Non-traumatic causes may involve congenital and developmental abnormalities, genetics and metabolism, infections and inflammation, removal of a benign spinal tumor and spinal cord ischemic stroke.
  
Neuropathic pain can be experienced above, at or below the level of the spinal cord injury, and is typically not confined to one area in the body. Approximately one-third of spinal cord injury patients report below-level neuropathic pain that is severe or excruciating. Patients may experience neuropathic pain associated with spinal cord injury as early as two weeks after injury and it may persist for up to 25 years.
  
“Until now, no FDA approved treatment options were available in the U.S. for people with neuropathic pain associated with spinal cord injury, a condition which can be extremely disabling,” said Steven J. Romano, MD, senior vice president and head, medicines development group, Global Primary Care Business Unit, Pfizer. “The approval of Lyrica for this indication is a significant milestone, exemplifying Pfizer’s commitment to pursue scientific advancements that address unmet medical needs.”
  
About Lyrica Phase 3 Clinical Studies
The FDA approval is based on two randomized, double-blind, flexibly dosed (150–600 mg/day), placebo-controlled Phase 3 trials, which enrolled 357 patients. Among other medications, patients were allowed to continue taking other pain medications, including NSAIDs, opioids and non-opioids. The population of one study consisted of traumatic spinal cord injury patients. The population of the other study consisted of traumatic spinal cord injury patients and patients who had injury to the spinal cord from non-traumatic causes: e.g., removal of a benign spinal tumor or spinal cord ischemic stroke (five percent of patients).
  
The primary finding in these studies was that Lyrica significantly reduced neuropathic pain associated with spinal cord injury from baseline throughout the duration of the studies (12 weeks and 16 weeks, respectively), compared to placebo. In addition, more patients receiving Lyrica showed a 30 percent and 50 percent reduction in pain than did patients receiving placebo. In some patients, the reduction in pain with Lyrica was significant as early as week one and continued throughout the duration of the trials.
  
The most common adverse events in these trials in patients receiving Lyrica were somnolence, dizziness, dry mouth, fatigue and peripheral edema.
  
About Lyrica
Lyrica is currently approved for various indications in 120 countries and regions globally. In the United States, Lyrica is indicated for diabetic nerve pain, post herpetic neuralgia (pain after shingles), fibromyalgia, neuropathic pain associated with spinal cord injury and partial onset seizures in adults with epilepsy who take one or more drugs for seizures. Antiepileptic drugs (AEDs) including Lyrica increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication.
There have been post-marketing reports of angioedema and hypersensitivity with Lyrica. Treatment with Lyrica may cause dizziness, somnolence, dry mouth, edema and blurred vision. Other most common adverse reactions include weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormal (primarily difficulty with concentration/attention).
For Lyrica prescribing information, please visit www.lyrica.com.
  
Pfizer Inc.: Working together for a healthier world^®
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.

http://www.pfizer.com/news/press_releases/pfizer_press_release.jsp?guid=20120621005572en

Are Neurontin And Lyrica Really The Best Options For Neuropathic Pain

Today's post from wellnessresources.com (see link below) is an out and out attack on Lyrica (pregabalin) and neurontin as drugs for neuropathic symptoms. However, it has to be said, it's now wildly out of date. Nevertheless, the prophetic warnings in the article have been borne out. It was written in 2009 and since then the FDA has issued strong warnings about Lyrica...and Pfizer (the manufacturers) have themselves withdrawn positive advice for its use in tackling diabetic and HIV-related neuropathy. Yet, these drugs are still universally popular and widely prescribed by doctors. Is this a case of heavy promotion by the drug company, or a refusal to face the facts on the part of health professionals? Unfortunately, Lyrica is one of those drugs that seems to have a multi-function and is prescribed for all sorts of nerve problems. It is so deeply entrenched in the lexicon of nerve problem treatments that subsequent warnings, law suits and withdrawals of support from its own maker, have had little effect on its popularity. If your doctor or neurologist wants to prescribe Lyrica for you, it may be time to pose some serious questions, especially if your neuropathy stems from diabetes or HIV-related causes. There are alternatives which may be safer for you in the long run. More articles on this subject can be found by typing in 'Lyrica' in the search box to the right of this blog.

Neurontin and Lyrica are a Death Sentence for New Brain Synapses
Byron J. Richards, Board Certified Clinical Nutritionist Wednesday, October 14, 2009

Neurontin and its newer more potent version, Lyrica, are widely used for off-label indications that are an outright flagrant danger to the public. These blockbuster drugs were approved for use even though the FDA had no idea what they actually did in the brain. A shocking new study shows that they block the formation of new brain synapses1, drastically reducing the potential for rejuvenating brain plasticity – meaning that these drugs will cause brain decline faster than any substance known to mankind.

The problem of these drugs is compounded by their flagrant illegal marketing. Neurontin was approved by the FDA for epilepsy back in 1994. The drug underwent massive illegal off-label promotion that cost Warner-Lambert 430 million dollars (the very first big fine for off-label promotion). The drug is now owned by Pfizer. Pfizer also owns Lyrica, a super-potent version of Neurontin. It has been approved by the FDA for various types of pain and fibromyalgia. Lyrica is one of four drugs which a subsidiary of Pfizer illegally marketed, resulting in a $2.3 billion settlement against Pfizer.

Even though the marketing of these drugs has been heavily fined, they continue to rack up billions in sales from the off-label uses. Doctors use them for all manner of nerve issues because they are good at suppressing symptoms. However, such uses can no longer be justified because the actual mechanism of the drugs is finally understood and they are creating a significant long-term reduction in nerve health.

The researchers in the above study try to downplay the serious nature of the drugs by saying “adult neurons don’t form many new synapses.” That is simply not true. The new science is showing that brain health during aging relies on the formation of new synapses. Even these researchers managed to question the common use of these medications in pregnant women. How is a fetus supposed to make new nerve cells when the mother is taking a drug that blocks them?

These are the kind of situations the FDA should be all over. As usual, the FDA is sitting around pondering a suicide warning for Lyrica while its off-label uses include bi-polar disorder and migraine headaches. The FDA is likely to twiddle its thumbs for the next decade on the brain damage issue. Consumer beware.

http://www.wellnessresources.com/freedom/articles/neurontin_and_lyrica_are_a_death_sentence_for_new_brain_synapses/

Does Pregabalin Lyrica Really Help with Neuropathic Pain

Pregabalin or Lyrica, is one of the most frequently prescribed drugs to help with neuropathic pain. It's an epilepsy/seizure drug that has found a new lease of life in the treatment of neuropathic disorders but there are strong arguments both for and against its usefulness. Many people can't live with the side effects and many people find that it just doesn't work for them. That, set against the people for whom there is a marked improvement, makes it a difficult medication to evaluate. The fact that they're still studying it and that the first American Academy of Neurology guidelines will not emerge until April, 2012, makes you wonder why it is so widely issued by doctors and neurologists. It forms part of what is now accepted as a standard pathway through the possible options for neuropathy patients: somewhere between anti-depressants and morphine! Pregabalin/Lyrica definitely remains a viable option but it's advisable to ask every question that worries you and research as much as you can because at best, you will be suppressing symptoms and not curing them, by using a drug with known side effects. However, for many people if that takes away the pain, then it's worth it. The article comes from emaxhealth.com (see link below).

Pregabalin May Benefit Diabetic Nerve Pain
By Denise Reynolds RD on April 14, 2011

The American Academy of Neurology has issued new guidelines on the most effective treatments for diabetic nerve pain and has found that a seizure drug can treat the neuropathy and improve quality of life for patients with diabetes. The guideline was presented at the American Academy of Neurology’s Annual Meeting in Honolulu.

Diabetic Neuropathy Is Undertreated in the United States
Pregabalin, brand name Lyrica, is an oral medication used for treating pain caused by neurologic diseases as well as seizures. It is also used for treating fibromyalgia. It is believed to work by binding to calcium channels on nerves and possibly modifying the release of neurotransmitters. The US Food and Drug Administration approved pregabalin in December 2004.

Diabetic nerve pain, tingling or burning pain in the hands and feet caused by nerve damage from hyperglycemia, is estimated to affect 16% of the more than 25 million people in the United States living with diabetes. It is believed that about two out of five cases go unreported and untreated.

The recommended initial dose of pregabalin for neuropathic pain is 50 milligrams, three times a day. The dose may be increased to a maximum of 100 mg three times daily after one week. The most common side effects are dizziness, drowsiness, dry mouth, edema, blurred vision, weight gain and difficulty concentrating.

While the evidence is strong that pregabalin is effective in treating diabetic neuropathy, doctors should determine if it is appropriate for their patients on a case-by-case basis. Certain medications can interact with Lyrica, requiring careful monitoring by a physician

The American Academy of Neurology guidelines note that other seizure treatments such as gabapentin and valproate, antidepressants such as venlafaxine or duloxetine, and painkillers are probably also effective. Transcutaneous electric nerve stimulation (TENS) should also be considered as an option for treating diabetic nerve pain.

“We were pleased to see that so many of these pain treatments had high-quality studies that support their use,” said lead guideline author Vera Bril MD FRCP of the University of Toronto. “Still, it is important that more research be done to show how well these treatments can be tolerated over time since diabetic nerve pain is a chronic condition that affects a person’s quality of life and ability to function.”

The AAN guidelines will be released in 2012 and will appear in the April issue of the journal Muscle and Nerve from the American Association of Neuromuscular and Electrodiagnostic Medicine as well as the April issue of PM&R, the journal of the American Academy of Physical Medicine and Rehabilitation.

http://www.emaxhealth.com/1506/pregabalin-may-benefit-diabetic-nerve-pain