Alternative Treatments For Neuropathy Dismiss Or Embrace

Today's post from nytimes.com (see link below) is not directly related to neuropathy but has definite relevance for people living with neuropathic problems. Because of a lack of definitive and universally effective treatments for neuropathy, many people are forced to seek relief in the alternative medicinal circuit. Referring to it as that, immediately implies that it's something less than the standard range of treatments but that's not universally true. This article looks at alternative medicine and asks the question, how much of what we think about alternative therapies is based on preconceptions and labels? The fact is, alternative medicine just isn't going away and that suggests that enough people gain considerable benefit from it to make it a valid option, especially for desperate people as neuropathy patients frequently are.

Labels Like ‘Alternative Medicine’ Don’t Matter. The Science Does.
Aaron E. Carroll AUG. 10, 2015

The University of Toronto recently stirred up a bit of controversy by offering an uncritical class on “Alternative Medicine.” A variety of bloggers and journalists brought up many valid concerns about the curriculum, but there is a much larger problem: No one is sure how best to teach that subject.

The dichotomy, however, between alternative and traditional medicine, or between Eastern and Western medicine, is a false one. We would be much better off if we could reframe the issue.

People often think of Eastern or alternative medicine as more “natural.” Many feel that Western medicine is built around technology and products produced in a lab. They’re not entirely wrong. Many of the gains that have been made in traditional medicine have been the result of innovation in laboratories.
 But that doesn’t mean that everything doctors are taught in medical school involves a drug or device. I talk to patients all the time about diet and exercise. I don’t do this because there’s a company making money off it. I do it because both of these things have proved to be important for health.

Nor do all medications get cooked up in a lab. We recommend folic acid, which is a B Vitamin, for pregnant women because research has shown that it reduces the risk of major birth defects in newborns. We all know that adequate intake of vitamin C prevents scurvy and that vitamin D prevents rickets.

None of these things are controversial to physicians. We recommend them all the time. That’s not because they were developed in the Western Hemisphere. It’s because they have been subjected to the rigor of scientific investigation — and found to have merit.

There are many other forms of nontechnological medicine that have the weight of scrutiny behind them. In a meta-analysis published just a few years ago, researchers looked at all the accumulated randomized controlled trials examining how acupuncture fared in treating people with chronic pain. They found that not only did acupuncture work better than no-acupuncture control groups, but there were also significant differences between acupuncture and sham acupuncture. This suggests that not all of the benefits are placebo effects.

People have been treating many mental health problems with therapy for years. Full disclosure: I’m one who has been treated. I’ve never taken any of the long-term psychotropic drugs, and many patients prefer not to if possible. Austin Frakt, my Upshot co-contributor, wrote recently about the evidence supporting cognitive behavioral therapy for insomnia, as well as for a host of other health problems. Even mindfulness, or meditation, has been studied extensively, and found to be pretty effective in treating anxiety and mood problems. I’ve been convinced enough by this evidence to try meditation myself.

I would argue that all the therapies I mention here aren’t considered complementary therapies — they’re often just considered therapies. That’s because they’ve been studied, and they’ve proved to work. Too often, though, those who consider themselves supporters of alternative medicine disdain the idea that any of their treatments need to be studied. They make an appeal to the fact that their medicine is more natural; has been used for long periods of time; or has the support of many people in other cultures.

Of course, not long ago, all therapies could be described in this way. The application of modern science allowed us to devise and conduct trials that could prove or disprove a treatment’s efficacy or harm. Many of the drugs we use today had natural origins. Digitalis comes from foxglove, quinine from cinchona bark, penicillin from bread mold and aspirin from willow tree bark. Conventional medicine may have improved our ability to purify these substances, but it acknowledges that many natural therapies hold value.

Yet science rejects many forms of complementary medicine as ineffective. Just a few months ago, the National Health and Medical Research Council of Australia released a report in which it fully reviewed 225 studies of homeopathy, the practice of treating sick people with small amounts of substances that cause similar symptoms in healthy people. They found no well-designed studies that found it to outperform a placebo or function as well as any conventionally approved therapies. Their conclusions echoed a previous report from Britain, and those found in many Cochrane systematic reviews. 

My friends who believe in homeopathy don’t really care.

Those who favor conventional medicine, though, can be just as blinded. Too often, when confronted with evidence that advanced technology might not be providing benefits, the medical community refuses to change its behavior. My Upshot articles are littered with examples of this, including potentially too-widespread mammography screening, advanced life support and many surgical procedures. Supporters of Western medicine are often blind to their own prejudices.

Butterbur, a plant extract, has been found in medical studies to be as effective as antihistamines in treating allergic rhinitis, without the sedating side effects conventional drugs often have. Horse chestnut seed extract appears to be safe and effective in the short-term treatment of chronic venous insufficiency. Peppermint oil can be used to relieve the symptoms of irritable bowel syndrome. I know of few physicians who promote these therapies as often as they do prescription or over-the-counter drugs. Granted, that could be because it’s potentially hard to be sure of supplements you’re buying, but there are ways to overcome those problems.

In 1998, The Journal of the American Medical Association published a theme issue on alternative medicine for common chronic medical conditions. The randomized controlled trials within it offered evidence that spinal manipulation did not improve tension-type headaches, that acupuncture and acupressure didn’t reduce pain caused by H.I.V.-related peripheral neuropathy and that the supplement Garcinia cambogia did not help with weight loss. However, the same issue contained studies that showed that yoga-based interventions improved carpal tunnel syndrome more than wrist splinting, that the Chinese practice of moxibustion significantly increased fetal activity and fixed breech presentations before delivery, and that Chinese herbal medicine appeared to improve symptoms in some patients with irritable bowel syndrome. Although some of this research has been continued, to my knowledge neither side of medicine has changed practices or beliefs much based on this work.

In an accompanying editorial, Phil Fontanarosa and George Lundberg, two of JAMA’s editors, wrote: “There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking.”

I’d change this only by adding, “There is no conventional medicine.”

Correction: August 10, 2015
An earlier version of this article misstated the surname of an editor at JAMA. He is George Lundberg, not Lungberg.
 
Aaron E. Carroll is a professor of pediatrics at Indiana University School of Medicine. He blogs on health research and policy at The Incidental Economist, and you can follow him on Twitter at @aaronecarroll.

http://www.nytimes.com/2015/08/11/upshot/labels-like-alternative-medicine-dont-matter-the-science-does.html?_r=0&abt=0002&abg=0

Tapentadol A New Alternative For Neuropathic Pain

Today's post comes from marketwatch.com (see link below) and is a press release for Tapentadol, a new centrally-acting opioid made by Janssen Pharmceuticals to control neuropathic pain. Far be it from me to promote either a company or an opioid but we're always looking for alternatives to the treatments that either don't work, or have unpleasant side effects. This is another opium derivative, so there will undoubtedly be issues regarding side effects and addiction for some people but the tests look promising. The post is long because Janssen have provided a complete description of how the drug works and what the potential side effects may be and that's worth reading. One assumes that this information will all appear on the leaflet inside the box when the drug achieves general release. Tapentadol will not be for everybody, as is the case for all similar treatments but it may be a breakthrough for some. Time will tell.
More information about Tapentadol can be found here (and is easier to digest),

Phase 3 Data Show NUCYNTA® ER (tapentadol) Extended-Release Tablets Provide Pain Management for Patients with Diabetic Peripheral Neuropathy (DPN)

Study results presented at the 31st Annual Scientific Meeting of the American Pain Society

press release May 17, 2012,

RARITAN, N.J., May 17, 2012 /PRNewswire via COMTEX/ -- Janssen Pharmaceuticals, Inc. today announced the results of an investigational Phase 3 study suggesting NUCYNTA® ER (tapentadol) extended-release tablets were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neuropathy (DPN). Results of the study were presented at the 31st Annual Scientific Meeting of the American Pain Society being held May 16-19 in Honolulu, Hawaii.

Diabetes affects nearly 26 million people in the United States(1)- and its prevalence is expected to grow significantly during the coming decades(2). Over time, people with diabetes can develop a type of nerve damage called neuropathy. Approximately 60 to 70 percent of people with diabetes have some form of neuropathy(3). The most common type is diabetic peripheral neuropathy, which causes pain or loss of feeling in the toes, feet, legs, hands, and arms.

The study found, among patients who had at least a one-point reduction in pain intensity during three weeks of treatment with tapentadol ER, those who continued on an optimized dose of tapentadol ER (100-250 mg twice daily) for an additional 12 weeks experienced significantly better pain control compared to those who switched to placebo(4). Treatment-emergent adverse events reported in 10 percent or more of tapentadol ER-treated patients during the double-blind maintenance period included nausea (21.1 percent) and vomiting (12.7 percent)(4).

"Painful DPN is a common and burdensome complication of diabetes, and controlling pain in people with DPN can be challenging," said Aaron I. Vinik, M.D., Ph.D., FCP, MACP, Director of Research and Neuroendocrine Unit at Strelitz Diabetes Center for Endocrine and Metabolic Disorders at Eastern Virginia Medical School, and lead investigator of the study. "These data suggest tapentadol ER provides a significant reduction in chronic pain in adult patients with DPN."

The findings of this study are consistent with those of another Janssen-sponsored study published early last year, which found tapentadol ER to be effective versus placebo for relieving moderate to severe chronic pain associated with diabetic peripheral neuropathy.

"We are pleased the Phase 3 data presented today showed tapentadol ER was effective at providing pain management for patients with chronic, moderate to severe pain associated with DPN," said Christine Rauschkolb, M.D., Ph.D., Vice President and Head of Integrated Operations, Janssen Research & Development, LLC and one of the study's authors. "Janssen has a long history of helping physicians provide responsible treatment for patients to relieve their acute and chronic pain. We are committed to developing new pain management options for the millions of Americans who have painful DPN."

About the Study

This Phase 3 clinical trial was a randomized-withdrawal, placebo-controlled study. It enrolled adult patients who had moderate to severe, chronic painful DPN for six months or more and a history of analgesic use for painful DPN for three months or more. This trial had three phases: an open-label phase, which included a 3-week titration period during which the individually optimized tapentadol ER dose (100-250 mg two times per day) was determined for each patient; a 12-week, double-blind maintenance phase, during which patients with a one-point or greater reduction in pain intensity from beginning to end of titration were randomized either to continue taking tapentadol ER (at their optimal dose) or to receive placebo; and a follow-up period with a clinic visit at four days and a telephone interview at 10 to 14 days after discontinuation of study drug.

The primary efficacy endpoint of the study was the mean change in average pain intensity from baseline (point of randomization) to the last week of the 12-week, double-blind maintenance phase, as determined by an 11-point pain rating scale or numerical rating scale (NRS; 0='no pain,' 10='pain as bad as you can imagine'). Safety assessments were performed on the open-label and double-blind safety populations (all patients who received greater than or equal to 1 dose of open-label and double-blind treatment, respectively). Treatment-emergent adverse events (TEAEs), defined as any AEs (new or worse in intensity) that occurred after the first intake of study drug during the open-label or double-blind phase, were monitored throughout the study.

In the open-label titration period, 459 patients received one or more doses of tapentadol ER and were included in the open-label safety population. At the start of the 3-week, open-label phase, the majority of patients (87.1 percent) reported severe pain (6 or more on the 11-point NRS) with a mean pain intensity of 7.3. By the end of the open-label phase, the mean pain intensity was reduced to 3.6. Treatment-emergent adverse events (TEAEs) experienced by 10 percent or more of patients during the open-label phase were nausea (24.4 percent), dizziness (17), constipation (11.8) and somnolence (10.7).

A total of 358 patients completed the open-label titration period; 318 were randomized and received one or more dose of study medication (n=152 for placebo, 166 for tapentadol ER).

Following randomization, during the double-blind treatment phase to week 12, pain increased in the placebo group (as demonstrated by the mean change in pain intensity of 1.3), while in the tapentadol ER group, efficacy was maintained, as indicated by the mean change in pain intensity of 0.28. The least-squares mean difference between the tapentadol ER and placebo groups in the change in average pain intensity was -0.95 on the 11-point NRS favoring tapentadol ER (95 percent CI, -1.42 to -0.49; p<0.001, tapentadol ER vs. placebo)(4).

For more details about the study design, please visit www.clinicaltrials.gov (NCT01041859).

Janssen Research & Development, LLC and Grunenthal GmbH, conducted this study, which Janssen Research & Development, LLC has included as part of its Supplemental New Drug Application (sNDA) submitted on October 28, 2011 to the U.S. Food and Drug Administration (FDA) for tapentadol ER tablets for the management of neuropathic pain associated with DPN in patients 18 years of age or older. The FDA currently is reviewing this supplemental application.

About Tapentadol and NUCYNTA® ER

Tapentadol is a centrally-acting synthetic analgesic. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act.

NUCYNTA® ER (tapentadol) extended-release tablets are an oral analgesic available by prescription only and indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. NUCYNTA® ER is taken twice daily and available in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths.

Outside the United States, tapentadol is marketed by Janssen Inc. in Canada; Grünenthal GmbH discovered tapentadol and markets immediate- and extended-release formulations of tapentadol (PALEXIA®) in various countries in Europe.

IMPORTANT SAFETY INFORMATION FOR NUCYNTA® ER (tapentadol) extended-release tablets

WARNING: POTENTIAL FOR ABUSE, PROPER PATIENT SELECTION, AND LIMITATIONS OF USE

Potential for Abuse

NUCYNTA® ER contains tapentadol, a mu-opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics.

NUCYNTA® ER can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when prescribing or dispensing NUCYNTA® ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Schedule II opioid substances, which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone, and methadone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

Proper Patient Selection

NUCYNTA® ER is an extended-release formulation of tapentadol indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

NUCYNTA® ER is not intended for use as an as-needed analgesic.

NUCYNTA® ER is not intended for the management of acute or postoperative pain.

NUCYNTA® ER tablets are to be swallowed whole and are not to be split, broken, chewed, dissolved, or crushed. Taking split, broken, chewed, dissolved, or crushed NUCYNTA® ER tablets could lead to rapid release and absorption of a potentially fatal dose of tapentadol.

Patients must not consume alcoholic beverages, or prescription or nonprescription medications containing alcohol. Co-ingestion of alcohol with NUCYNTA® ER may result in a potentially fatal overdose of tapentadol.

CONTRADICTIONS

NUCYNTA® ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment.

NUCYNTA® ER is contraindicated in any patient who has or is suspected of having a paralytic ileus.

NUCYNTA® ER is contraindicated in patients who are receiving monoamine oxidase inhibitors (MAOIs) or who have taken them within the last 14 days due to potential additive effects on norepinephrine levels, which may result in adverse cardiovascular events.

NUCYNTA® ER is contraindicated in patients with a known hypersensitivity to the active substance, tapentadol, or any component of the product. Angioedema has been reported in association with use of tapentadol.

WARNINGS & PRECAUTIONS

NUCYNTA® ER tablets are to be swallowed whole and are not to be split, broken, chewed, dissolved, or crushed. Taking split, broken, chewed, crushed, or dissolved NUCYNTA® ER tablets leads to the rapid release and absorption of a potentially fatal dose of tapentadol.

NUCYNTA® ER tablets must be kept in a secure place out of the reach of children. Accidental consumption of NUCYNTA® ER, especially in children, can result in a fatal overdose of tapentadol.

Respiratory depression is the primary risk of mu-opioid agonists. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation.

Use NUCYNTA® ER with caution in patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve, such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression, or coma. In such patients, even usual therapeutic doses of NUCYNTA® ER may increase airway resistance and decrease respiratory drive to the point of apnea. Alternative non-mu-opioid agonist analgesics should be considered, and NUCYNTA® ER should be employed only under careful medical supervision at the lowest effective dose in such patients. If respiratory depression occurs, it should be treated as any mu-opioid agonist-induced respiratory depression.

Patients receiving other opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, centrally acting muscle relaxants, or other CNS depressants (including alcohol) concomitantly with NUCYNTA® ER may exhibit additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, coma, or death may result if these drugs are taken in combination with NUCYNTA® ER. When such combined therapy is contemplated, a dose reduction of one or both agents should be considered.

Opioid analgesics can raise cerebrospinal fluid pressure as a result of respiratory depression with carbon dioxide retention. Therefore, NUCYNTA® ER should not be used in patients who may be susceptible to the effects of raised cerebrospinal fluid pressure, such as those with evidence of head injury and increased intracranial pressure. Opioid analgesics may obscure the clinical course of patients with head injury due to effects on pupillary response and consciousness. NUCYNTA® ER should be used with caution in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure.

Tapentadol is a mu-opioid agonist and is a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is an act subject to criminal penalty.

Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids.

NUCYNTA® ER can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing NUCYNTA® ER in situations where the physician or pharmacist is concerned about an increased risk of misuse and abuse. Concerns about abuse and addiction should not prevent the proper management of pain. However, all patients treated with mu-opioid agonists require careful monitoring for signs of abuse and addiction, since use of mu-opioid agonist analgesic products carries the risk of addiction even under appropriate medical use.

Drug abusers may attempt to abuse NUCYNTA® ER by crushing, chewing, snorting, or injecting the product. These practices may result in the uncontrolled delivery of NUCYNTA® ER and pose a significant risk to the abuser that could result in overdose and death.

NUCYNTA® ER may cause severe hypotension. Patients at higher risk of hypotension include those with hypovolemia or those taking concurrent products that compromise vasomotor tone (eg, phenothiazines, general anesthetics).

Patients should be cautioned that NUCYNTA® ER may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. This is to be expected, especially at the beginning of treatment, at any change of dosage, as well as in combination with alcohol or tranquilizers.

NUCYNTA® ER may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause CNS depression, because respiratory depression, hypotension, hypertension, and profound sedation, coma, or death may result.

NUCYNTA® ER has not been evaluated in patients with a predisposition to a seizure disorder, and such patients were excluded from clinical studies. As with other opioids, NUCYNTA® ER should be prescribed with care in patients with a history of a seizure disorder or any condition that would put the patient at risk of seizures.

Cases of life-threatening serotonin syndrome have been reported with the concurrent use of tapentadol and serotonergic drugs. Serotonergic drugs comprise selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, drugs that affect the serotonergic neurotransmitter system (eg, mirtazapine, trazodone, and tramadol), and drugs that impair metabolism of serotonin (including MAOIs). This may occur within the recommended dose. Serotonin syndrome may include mental-status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (eg, hyperreflexia, incoordination) and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea), and can be fatal.

Withdrawal symptoms may occur if NUCYNTA® ER is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely, hallucinations. Withdrawal symptoms may be reduced by tapering NUCYNTA® ER.

A study with the immediate-release formulation of tapentadol in subjects with hepatic impairment showed higher serum concentrations of tapentadol than in those with normal hepatic function. Tapentadol should be used with caution in patients with moderate hepatic impairment.

NUCYNTA® ER has not been studied in patients with severe hepatic impairment, and use in this population is not recommended.

Like other drugs with mu-opioid agonist activity, NUCYNTA® ER may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.

NUCYNTA® ER should be used with caution in the following conditions: adrenocortical insufficiency (eg, Addison's disease); delirium tremens; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis.

Pregnancy Category C. There are no adequate and well-controlled studies of NUCYNTA® ER in pregnant women. NUCYNTA® ER should be used during pregnancy ONLY if the potential benefit justifies the potential risk to the fetus.

ADVERSE REACTIONS

The most common (greater than equal to 10%) adverse reactions were nausea, constipation, headache, dizziness, and somnolence.

About Janssen Pharmaceuticals, Inc. and Janssen Research and Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop and bring innovative products, services and solutions to people throughout the world.

Janssen Pharmaceuticals, Inc., and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies.

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas. Innovative therapies Janssen Pharmaceuticals, Inc. offers currently include ACIPHEX® (rabeprazole sodium), DORIBAX® (doripenem for injection), ELMIRON® (pentosan polysulfate sodium), NUCYNTA® (tapentadol), NUCYNTA® ER (tapentadol) extended-release tablets and XARELTO® (rivaroxaban) tablets. The full prescribing information for NUCYNTA® ER, including boxed warnings, is available here; the full prescribing information for XARELTO®, including boxed warnings, is available here.

For more information on Janssen Pharmaceuticals, Inc., visit us at www.janssenpharmaceuticalsinc.com or follow us on Twitter at www.twitter.com/JanssenUS .

For more information on Janssen Research & Development, LLC, visit us at http://www.janssenrnd.com/ .

http://www.marketwatch.com/story/phase-3-data-show-nucynta-er-tapentadol-extended-release-tablets-provide-pain-management-for-patients-with-diabetic-peripheral-neuropathy-dpn-2012-05-17

A New Alternative To Opiates For Nerve Pain

Today's post from consultqd.clevelandclinic.org (see link below) talks about a new advance in stem cell therapy concerning mesenchymal stem cells (MSC). These have been shown to reduce nerve pain and if they are injected directly into the vein, they have also been shown to reduce the side effects and addictiveness of opioids. Of course it's not as simple as this but these wonder cells apparently also can travel to the site of nerve injury and repair nerve cells on the spot. It may all seem a bit sci-fi and magical but it is true and reveals the huge potential of stem-cell therapy for all sorts of medical issues in the future. The fact that mesenchymal stem cells (MSC) directly apply to neuropathy problems makes it an exciting development for nerve pain patients across the world. Now we have to find the money in state budgets to develop the science and insurance companies who will pay for the treatment - don't hold your breath.

 Stem Cell Therapy for Neuropathic Pain: New Findings Show Promise
Animal studies demonstrate effectiveness

Aug. 10, 2016 / Pain Management / Research

Stem cell research at Cleveland Clinic could pave the way for an entirely new approach to chronic pain treatment that reduces medicine’s current reliance on opioid therapy for intractable pain. The modality also shows promise as a tool to reverse opioid tolerance (OT) and opioid-induced hyperalgesia (OIH), particularly problematic side effects of opioid therapy. Jianguo Cheng, MD, PhD, and his colleagues at Cleveland Clinic have developed patented methods of attenuating opioid tolerance.

Animal studies by Dr. Cheng and his colleagues have demonstrated the effectiveness of mesenchymal stem cell (MSC) transplantation in reducing hyperalgesia due to nerve injury. The group’s work has shown MSC transplantation’s effectiveness in reducing pain induced by sciatic nerve injury in rats and mice. MSC transplantation significantly reduced pain sensitivity evaluated by foot withdrawal thresholds in animals in response to thermal or mechanical stimulation. These cells produced immune modulatory and anti-inflammatory effects, promoted sensory nerve repair, and showed strong analgesic properties that could provide a safer and more effective alternative to current treatment modalities, in the management of neuropathic pain, says Dr. Cheng, Professor of Anesthesiology and Director of the Cleveland Clinic Multidisciplinary Pain Medicine Fellowship Program.

Pain medicine researchers are searching for an alternative to opioid therapy because neuropathic pain often does not respond to morphine and other opioids. Opioid analgesics can also lead to a variety of complications, ranging from itching and constipation to dependence, addiction, respiratory depression and death.

About 30 percent of neuropathy cases are caused by nerve damage associated with diabetes. However, hundreds of diseases are linked to neuropathic pain. Sources of neuropathic pain include alcoholism, amputation (which can result in phantom pain), some chemotherapy drugs (for example, Cisplatin®, Paclitaxel®, Vincristine®), radiation therapy, complex regional pain syndrome type II, trigeminal neuralgia, shingles, spinal stenosis, and central nervous system disorders, such as Parkinson disease and multiple sclerosis.

Recent research by Dr. Cheng and his group has yielded new discoveries that bode well for MSC transplantation as a potential future treatment modality. One investigation compared the analgesic effects of MSC derived from bone marrow with MSC derived from adipose tissue. Adipose-derived cells were found to be as efficacious as bone marrow-derived cells in reducing neuropathic pain in rats. The finding suggests that stem cell therapy could offer a practical option because stem cells from adipose tissue are relatively easy to obtain.

Recent investigations by Dr. Cheng and his colleagues comparing the analgesic effectiveness of intrathecal versus intravenous methods of MSC transplantation show both methods to be equally effective. The finding has important implications because intravenous transplantation of MSC could offer a safer and more expeditious route of delivery than intrathecal transplantation.

“We originally thought that stem cells would have to be introduced intrathecally in order to reduce pain, and that stem cells introduced intravenously would pass through the lungs and fail to produce analgesia,” says Dr. Cheng. “The finding that intravenous transplantation is as effective as intrathecal transplantation is encouraging.”

Dr. Cheng’s group has also discovered that MSCs can be found in the area surrounding the injured nerve following MSC transplantation. “For reasons we do not yet fully understand, these cells have the ability to migrate to the injury site to promote repair of the injured nerve fibers,” Dr. Cheng says. “The cells can sense the injury’s location and travel to it.”

Although many questions must be answered before it can be known whether stem cell therapy is safe and effective for humans, some small patient studies show potential, Dr. Cheng says. According to one observational study in Australia, MSC transplantation reduced pain in patients suffering from trigeminal neuralgia, a particularly difficult condition to treat. “Though the findings are preliminary, the study provides some evidence that what we have learned in the laboratory can be translated to clinical use,” Dr. Cheng says.

Dr. Cheng’s team has achieved analgesia with MSC transplantation from rats to mice, providing early evidence that stem cells’ anti-inflammatory and immuno-modulatory properties can be transferred between species. An important pre-clinical study will be to see whether the transplantation of human stem cells to animals also can produce analgesic and anti-tolerance effects, Dr. Cheng says.

Dr. Cheng’s team presented research at the 2016 annual meeting of the American Academy of Pain Medicine showing MSC’s potential to reverse opioid tolerance and opioid-induced hyperalgesia, problems that can compromise the safety and efficacy of opioid therapy. Intravenous transplantation of bone marrow-derived MSC significantly attenuated OT and OIH in animals whether the transplantation was performed seven days before or 14 days after the initiation of daily morphine injections. These data demonstrate that MSC transplantation can not only prevent the development of OT and OIH but can also reverse it.

https://consultqd.clevelandclinic.org/2016/08/stem-cell-therapy-neuropathic-pain-new-findings-show-promise/

Sensus An Alternative Electrotherapy For Neuropathic Symptoms

Today's post from sensusrx.com (see link below) announces a new portable, wearable electro-sensory unit comparable to the better known TENS units. From reading the promotion, it certainly sounds easier, more convenient and more sophisticated but you should always be aware that these electrotherapy devices don't work for everybody at the same levels and may disappoint the buyer. That said, many people swear by them so it's best to discuss it thoroughly with your doctor or specialist and do your own research before taking the plunge.
 

How is SENSUS Optimized for Painful Diabetic Neuropathy?  SENSUS Blog Tuesday, February 3rd, 2015

SENSUS was designed to meet the unique needs of those suffering from neuropathic pain conditions such as painful diabetic neuropathy (PDN). People with diabetes and PDN often have physiology that responds differently to electrotherapy than that of someone without diabetes. For instance, nerve degeneration and elevated skin resistance to electrical stimulation are typical in those with diabetes. Effective pain relief may therefore require a more powerful device with higher stimulation output. Most conventional TENS devices do not have the capability of delivering the stimulation characteristics that are needed for those with diabetic peripheral neuropathy and therefore may have limited efficacy and utility for treating PDN.

SENSUS is a wearable pain relief device designed to provide the user the freedom to be active while they are receiving therapy. Conventional TENS units include multiple individual electrodes connected to lead wires, which may be awkward to place for pain in the lower legs and feet and it would inhibit the user’s mobility. The SENSUS and integrated electrode are placed on the upper calf. The device is slim enough to be worn discreetly under clothing so the user can go about their daily activities while therapy is being provided.

Since PDN often disrupts sleep, traditional TENS devices are not an option for night time pain relief because they cannot be used during sleep. SENSUS is the only nerve stimulator approved by the FDA for use during sleep so it is an option for around the clock pain relief.

Finally, most people with diabetes have complicated treatment programs involving multiple medications and devices such as blood glucose meters. Consequently, many of them will want to avoid an addition to their therapeutic regime that is unnecessarily complicated. Unlike conventional TENS devices, SENSUS is highly automated and can be setup by at home in just a few minutes. Therapy is initiated and stopped by pressing the sole button on the device and will automatically run throughout the day without any management on the part of the user.

The SENSUS Pain Management System has been optimized for people with diabetes, and includes advanced technology to enhance convenience while maximizing pain relief.

Posted by NeuroMetrix in Painful Diabetic Neuropathy

http://www.sensusrx.com/blog/index.html?blogid=42

Alternative treatment for sciatic nerve pain

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