PAIN RELIEF MEDICATIONS BLOG

Ask Dr. Weil: Achy Joints

April 30, 2007

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QUESTION: I have achy joints. My doctor wants to prescribe anti-inflammatory medication, but I’d rather try something natural. What remedies do you suggest?

DR. WEIL: A lot of people ask me this, especially since the popular arthritis drugs valdecoxib and rofecoxib were pulled from the market in 2004 and 2005. The FDA has since strengthened warnings on related nonsteroidal anti-inflammatory drugs (NSAIDs), noting that long-term use may increase your risk of stroke, heart attack, and gastrointestinal bleeding. There are several natural supplements that, in my experience, can ease joint pain as well as these drugs, without their risks.

I think it’s reasonable to try natural remedies first, or take them along with your NSAIDs to improve pain relief, which may help keep your NSAID dose as low as possible, cutting the risk of side effects. Ask your doctor about adding one or more of these to your pain-relief regimen. Keep in mind that natural remedies are slower than drugs — give them at least 8 weeks to work.

Zyflamend: Lab tests on cancer cells show that this herbal mix inhibits the COX-2 enzyme that triggers joint inflammation. Some NSAIDs, such as celecoxib, also target this enzyme.

Dose: Follow the package instructions. If you already take NSAIDs for your pain, I recommend this regimen: Take Zyflamend at half the recommended dose along with your prescribed medication; after 1 month, cut your NSAID dose in half and increase Zyflamend to full dosage; a month later, drop your NSAID and see if your symptoms are controlled. If your pain returns, you may need to resume taking your NSAID again.

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Glucosamine and chondroitin sulfate: Derived from cartilage, this supplement combination brought relief to about 350 arthritis patients who suffered moderate to severe knee pain, according to a landmark study of nearly 1,600 people published in the New England Journal of Medicine. However, the duo didn’t benefit mild arthritis sufferers any more than a placebo.

Dose: I recommend taking a total of 1,500 milligrams of glucosamine with 1,200 milligrams of chondroitin in divided doses two or three times a day. Take it with your prescription; after 8 weeks, forgo your prescription and see if you’re still pain free.

SAM-e (S-adenosylmethionine): This compound, found in different tissues throughout the body, relieved knee pain as well as the arthritis drug celecoxib in a 16-week study of 56 adults at the University of California, Irvine — though SAM-e took longer than the drug to become effective.

Dose: I suggest starting with 400 milligrams twice a day; after 2 weeks, decrease to 200 milligrams twice a day. Caution: SAM-e could trigger manic episodes, particularly in those with bipolar disease, which may be undiagnosed.

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Neuromed licenses chronic pain product from ALZA Corporation

April 26, 2007

Neuromed Pharmaceuticals has announced that it has licensed from ALZA Corporation the exclusive U.S. rights to develop and commercialize OROS(R) Hydromorphone, an extended release formulation of a potent opioid analgesic in Phase 3 clinical development.

Under the terms of the agreement Neuromed will make an upfront payment of $30 million, additional regulatory milestone payments, and will pay royalties based on commercial sales of the product. Neuromed will develop and market the product in the U.S., while ALZA will retain the rights to develop and market the product in other countries. ALZA will manufacture the product for Neuromed as well as for other markets in which the product is sold.

OROS(R) Hydromorphone was developed by ALZA and uses the OROS(R) PUSH-PULL(TM) delivery system to release the opioid at a controlled rate. OROS(R) Hydromorphone has been approved in Germany and other European countries and is marketed by Janssen-Cilag under the name JURNISTA(TM). The product received an Approvable Letter from the U.S. Food and Drug Administration (FDA) in October, 2000. Neuromed anticipates that one successful adequate and well-controlled clinical trial will be needed to support approval of OROS(R) Hydromorphone in the U.S.

“Our licensing of the U.S. rights to OROS(R) Hydromorphone from ALZA is an excellent fit with Neuromed’s strategy to address the significant need for alternative chronic pain treatments,” said Dr. Christopher Gallen, President & CEO of Neuromed. “Hydromorphone is an effective and well-known pain reliever and we believe a once-daily version can provide a significant benefit for the large number of patients with moderate to severe pain that require pain relief around the clock.”

“OROS(R) Hydromorphone is a perfect fit with our existing programs, including our partnered N-type calcium channel program and our own T-type calcium channel blocker program,” Dr. Gallen added. “Neuromed will develop a specialized sales force to market OROS(R) Hydromorphone in the U.S. upon FDA approval. The addition of a commercial presence in the U.S. will allow Neuromed to market niche products while continuing its dedication to the research and discovery of novel, breakthrough analgesics.”

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Hydromorphone is a Schedule II opioid that has been widely used for many years under the brand name DILAUDID(R) and is also available from various generic manufacturers. Current formulations of hydromorphone marketed in the U.S. are immediate release, requiring dosing several times per day.

OROS(R) Hydromorphone employs the OROS(R) osmotic drug delivery technology.

The OROS(R) osmotic drug delivery technology provides controlled drug release over an extended period and has been employed as a sustained release formulation for many successful products, including CONCERTA(R), DITROPAN XL(R), COVERA-HS(R), and PROCARDIA XL(R). Four dosage strengths of OROS(R) Hydromorphone (8 mg, 16 mg, 32 mg and 64 mg) are currently marketed in Europe, with an additional lower strength (4 mg) in development.

OROS(R) Hydromorphone is an investigational product and is not approved by the FDA for use in the U.S. OROS(R) Hydromorphone has been studied in more then 1000 pain patients. The most common adverse events seen in clinical trials to date were opioid-related events of constipation, nausea, somnolence, headache, vomiting and dizziness. Respiratory depression is the most important hazard of opioid preparations including OROS(R) Hydromorphone.

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Healing the hurt

April 24, 2007

ST. PETERSBURG - A platoon of nurses has prepared 12-year-old Alyssa Marie Bodurka for pain. They’ve been at it an hour. She has leukemia, they have three awful procedures to do and they’re shooting for a score of 4 on the pain scale. That’s between “hurts a little bit” and “hurts even more.” Alyssa has done all this before, but she is quietly playful in nightgown and bandanna. She shows no fear.

Pain relief for an adult going through Alyssa’s type of treatment might constitute a shot in the butt and a pat on the back. But the science of pediatric pain is more complex, includes more players, and sets a higher, if not always achievable, bar. Pediatric hospitals have Pain Teams and Pain Initiatives.

Pain in kids is viewed not as a single sharp sting or chronic ache, but as waves of physical and emotional sensations. Children experience pain through “an emotional lens,” says Dr. Linda Rice, director of pain management at All Children’s Hospital in St. Petersburg. Pain is visual. Pain is visceral. Pain is felt before it happens. There’s no good pain, like the prick of a needle delivering medicine.

“To a child, a needle is the epitome of evil.” Ask a child like Alyssa which form of pain relief she would prefer: a needle full of narcotics or a hug from mom. Bet $1-million. On m-o-m.

- - -

The new thing in pediatric pain management is mostly the old things, only integrated into a holistic orchestration. All Children’s and St. Joseph’s in Tampa have both launched hospitalwide Pain Initiatives to make sure everyone does all the old things the same way.

It has been a quiet revolution. A generation ago, a child’s pediatrician was the pain manager. If he didn’t prescribe pain relief, the child didn’t get it. There was some debate over whether newborns even felt pain.

Every department at St. Joseph’s now has what looks like a lunch box. It’s labeled “Pain Free Tool Kit.” One ingredient is a baby pacifier. Both hospitals have standing orders to apply a numbing cream before any needle puncture. St. Joseph’s has standing orders for morphine for any child showing up in the ER with a limb bent by a fracture. Both hospitals have “life care specialists” - therapists who meet every child coming into the ER - to guide them through their pain.

“A new magic bullet?” asks Rice at All Children’s. “No. We’re not reinventing the wheel; we’re using all the parts of it.” Pain managers have even reaffirmed that the 19th century “grandma’s sugar tit,” a spoonful of sugar tied up in a patch of cloth, remains an incredible pain antidote.

Along with the pacifier, the Pain Free Tool Kit at St. Joseph’s includes a tiny packet of concentrated sugar. It has been found in clinical studies to be as effective for pain relief in infants under 3 months as the most powerful analgesics. “Parents beg us to let them take it home,” says RN Lorri Hunt, who leads St. Joseph’s Pain-Free Task Force.

Other rediscoveries: A dinosaur bandage provides better pain relief than a plain one. And, says Rice, “Mommy’s kiss is more effective than Daddy’s.

“The most modern advance may be the appreciation that kids, newborns, preemies, all have pain,” she says, as well as an understanding that children don’t give second chances. “If you blow it the first time, that’s it.”

There’s some excitement over the potential of hypnosis. One pain conference last year included testimony from a man who endured prostate surgery just through hypnosis.

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In pediatrics, another word for hypnosis is distraction. Even video games at bedside can be hypnotic. And teddy bears, of course, have nearly supernatural powers. Nurse specialist Susan Senecal, a member of All Children’s Pain Team, explains the mantra of high-tech pediatric pain management:

“Never take a snuggly from a 2-year-old.”

- - -

Alyssa Bodurka’s snuggly is her mom, Dawn Kraemer. Technically, Kraemer is Alyssa’s aunt, but Kraemer has raised her since age 7 and to Alyssa she is indisputably, in all situations, mom. They live together in Port Richey. They’ve stood side by side since the roof fell in on their lives three months ago. Alyssa was found to have a fast-growing type of leukemia called AML.

She’s on her third round of chemo at All Children’s. She won’t take chemo without Kraemer holding her. Kraemer had 15 inches of her own hair shorn off to make a wig for Alyssa when the chemo is over.

“I used to be able to handle pain,” Alyssa says. She often sounds like an adult. At All Children’s she’s described as 12 going on 25. “I could cut my leg wide open while playing and keep going,” she says. “But now I get a needle and I cry like a baby.”

- - -

At this session, Alyssa has three things to get through: the extraction of bone marrow from her hip (an ordeal one nurse likened to “sucking a milk shake through a coffee straw”); the extraction of fluid from her spinal column, a drop at a time; and the infusion of chemo into her spinal column. The first two are to ensure that her cancer is in remission. The third is to deliver chemo to the brain. (At another time, chemo is delivered to the rest of her body through a port in her chest.)

A numbing cream has been rubbed on her hip, so she won’t feel the needle pricks. She is injected with Versed, an “antianxiety hypnotic” that actually causes amnesia. She is also injected with Fentanyl, a narcotic. Last, she gets a shot into the bone of her hip of a local anesthetic called Lidocaine.

Alyssa has snuggled into Kraemer’s arms. She is lying on her hip. She is already woozy from the Versed. She’s telling about a novel she just read, Crank, about a girl with a drug addiction.

She whispers, “I read it in two days.”

On one side of her is Cindy Guerra, a hemo/oncology nurse practitioner, and Senecal from the Pain Team. Guerra is doing the spinal tap and delivering the chemo. Senecal is massaging the patient’s shoulder.

“You okay, baby?” she asks.

On Alyssa’s other side is Brittany Nelson, a life care specialist. Her basic mission is like Senecal’s - more TLC.

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Intrathecal Baclofen for spasticity-related pain in amyotrophic lateral sclerosis

April 18, 2007

An estimated 5,600 people in the United States are diagnosed every year with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease, and as many as 30,000 Americans have the disease at any given time.

Unfortunately, there is no cure for ALS, and it leads to death most typically two to five years after diagnosis. One of the side effects of ALS is spasticity, a condition resulting from excess motor neuron excitation due to lesions in the upper motor neuron pathway that lead to the absence of inhibition of alpha and/or gamma motor neurons. Spasticity can cause uncontrollable and often painful muscle contractions. Although the pain associated with spasticity can usually be controlled with medication and physical therapy, some patients are unresponsive to this treatment.

Researchers at the University of Minnesota Medical School and the Cleveland Clinic explored the efficacy of treating ALS patients with intractable spasm-related pain with an intrathecal baclofen (ITB) pump. Eight patients were implanted with the ITB pump between January 2003 and December 2005 at the Cleveland Clinic.

The results of this study, Intrathecal Baclofen for Spasticity-Related Pain in Amyotrophic Lateral Sclerosis: Efficacy and Factors Associated with Pain Relief, will be presented by Shearwood McClelland III, MD, 3:57 to 4:09 p.m. on Tuesday, April 17, 2007, during the 75th Annual Meeting of the American Association of Neurological Surgeons in Washington, D.C. Co-authors are Francois A. Bethoux MD, Matthew H. Sutliff, PT, Darlene K. Stough RN, Kathleen M. Schwetz, RN, Danuta M. Gogol, RN, Michelle Harrison, PT, Erik P. Pioro, MD, PhD, and Nicholas M. Boulis, MD.

Patients were selected by the operating surgeon and neurologists specializing in the treatment of ALS on the basis of a history of longstanding ALS-associated spasticity, despite optimal medication management. Following successful test injection, patients were referred to the Cleveland Clinic Center for Neurological Restoration for programmable ITB implantation.

* The eight patients ranged in age from 33 to 77, with a mean age of 43.8 at surgery.
* The duration of the patients’ ALS symptoms ranged from 14 to 108 months, with an average of 47.4 months at surgery.
* Both pre- and postoperative pain was quantified using a 0-10 scale, with 0 representing no pain and 10 representing maximum pain.
* The mean modified preoperative pain score was 7.69, ranging from 6 to 10.

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Following surgery, patients were transferred to an inpatient rehabilitation unit before eventually returning home with continuing outpatient or in-home rehabilitation. Patients were subsequently followed by the ALS and related disorders team at the Cleveland Clinic for ITB pump adjustments and refills. Mean follow-up was 9.8 months.

The following outcomes were noted:

* Following ITB pump placement, the average pain score was 3.56 (range = 0 to , a reduction of 54 percent from preoperative scores.
* No patients experienced neurological morbidity or mortality.
* Six patients (75 percent) experienced pain relief, of which three received complete pain relief (postoperative pain score of 0).

“The degree of pain relief following preoperative ITB test injection correlated with the degree of postoperative pain relief following ITB implantation,” stated Dr. McClelland. The two patients who did not experience pain relief from implantation were the same patients who failed to experience pain relief from preoperative ITB test injection. The three patients who experienced complete pain relief also experienced complete pain relief following preoperative ITB.

“These results support ITB as a treatment modality for pain associated with refractory spastic ALS, and underscore the importance of pain documentation following preoperative ITB test injection. In appropriately selected ALS patients with spasticity, ITB implantation can offer a significant quality of life improvement for an incurable and often painful condition,” concluded Dr. McClelland.

Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons (AANS) is a scientific and educational association with more than 6,800 members worldwide. The AANS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. All active members of the AANS are certified by the American Board of Neurological Surgery, the Royal College of Physicians and Surgeons (Neurosurgery) of Canada or the Mexican Council of Neurological Surgery, AC. Neurological surgery is the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affect the entire nervous system, including the spinal column, spinal cord, brain and peripheral nerves.

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Chondroitin brings no more relief than a placebo against arthritis pain: Study

April 17, 2007

In spite of the popular belief held by osteoarthritis patients all over the world, a new report suggests that the popular dietary supplement chondroitin does not bring any more relief than a placebo from hip or knee pain during arthritis.

In a report published in the April 17 issue of the Annals of Internal Medicine, researchers say that chondroitin does not have any effect on the pain that osteoarthritis patients suffer. Chondroitin is a cartilage extract and is assumed to be a “magic pill” for those who suffer from hip and knee pain in arthritis.

It is widely sold in health food stores, pharmacies and online in the US, with analysts saying that the sales of the drug have reached $1 billion last year. Chondroitin is often combined with glucosamine.

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Health experts say that over 21 million people in the US are suffering from osteoarthritis. They believe that the number will increase with increasing obesity in young people. The study was carried out by researchers at the University of Bern in Switzerland, who studied data from 20 clinical trials involving a total of 3,846 patients.

Dr. David Felson, a professor of medicine and epidemiology at Boston University and author of the study, says that any effect experienced by the supplement is just a placebo effect. “Chondroitin is not efficacious for pain in osteoarthritis. I don’t recommend that patients start taking glucosamine and chondroitin, because glucosamine also doesn’t work. I am happy to support their using it, because there may be some groups where it is helpful. But a lot of it is a placebo effect.

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Polymer delivery system enhances pain relief

April 12, 2007

The product has been developed by the DRJ Group, one of the leading providers of pain relief products in the US - a market that is currently valued at $250m.

Stopgain is an over-the-counter pain relief brand that has now been extended with the launch of the new cream formulation, incorporating the delivery system.

According to Skinvisible, the addition of its delivery system means that the product now offers pain relief for extended periods of time for individuals suffering from muscle stiffness, arthritis, or muscle strains.

Indeed, the company claims that the incorporation of its delivery system has helped to provide four hours of pain relief for users, a feat that has been achieved thanks to the added efficiencies it provides for the delivery and sustained release of the analgesic.

“By including Invisicare, we are offering our customers a product that is different from anything else currently on the market. We expect this advantage to be well received by both the trade and the customer,” said Robert Miller, CEO of DRJ.

The licensing agreement will mean that Invisicare will attain a nationwide exposure as the product is expected to be distributed in around 25,000 pharmacies in the course of the next few months.

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The two companies also said that they were considering further opportunities to combine resources by including the delivery system in future product launches for the pain relief category.

The company received a patenting license for the Invisicare technology at the beginning of 2006, which concentrated on protection of the polymer composition for the technology’s delivery system.

The patent has enabled the company to protect the mechanisms used by the formulation that enable the skin to cling on to skin care formulations for long periods of time.

This means that the formulation benefits from longer duration of action, reduced irritation and lower dosage of active agent required.

These functions aim at creating better skin care products as well as enabling producers to save money on lower doses of more expensive active ingredients.

Skinvisible has focused its business on providing proprietary formulations for a wide range of pharmaceutical and cosmeceutical products, as well as providing a number of solutions for providers of a range of skin care products.

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Off-Label Use: Pain Medication and Antipsychotics May Stop Brain Tumor Growth

April 10, 2007

After screening nearly 1,300 chemical compounds, scientists have identified a number of drugs in use today that may in stop the growth of neural stem cells, including cancerous populations. The finding, reported in this week’s issue of Nature Chemical Biology, opens up the possibility of using drugs already available to battle brain tumors, which kill an estimated 13,000 people in the U.S. yearly.

“A lot of the receptors for those drugs were thought to be exclusively expressed in mature cells in the central nervous system,” says study co-author Peter Dirks, a neurosurgeon and researcher at The Hospital for Sick Children’s Brain Tumor Research Center in Toronto, “They may have the same function on stem cells as they do on the mature cells,” which makes them candidates for treating brain cancer. Dirks and his team found 160 compounds that interfered with the development and proliferation of neurospheres—clusters of cells in different stages of differentiation, ranging from stem cells to cells well on their way to becoming neurons or glia (cells that support and insulate neurons). The researchers then tested the drugs both in vitro, with cells derived from an embryonic mouse brain, human brain tumor cells and with cancer cells from knockout mice, which were genetically predisposed to develop brain tumors.
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Several of the prescreened drugs seemed to inhibit tumor growth in the human and mouse cancer cells as well as in the knockout mice. “Some of the drugs were quite selective for the human cancer cells versus the normal human cells,” Dirks says, “suggesting there may be some window of therapeutic opportunity.” The drugs are already being used to treat other disorders.

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Among them: butaclamol is used to inhibit receptors for dopamine (a neurotransmitter active in the brain’s reward and pleasure systems) and as an antipsychotic for schizophrenics. Ifenprodil acts on the amino acid NMDA, the receptors of which play a role in long-term memory. It is often prescribed to relax cerebral blood vessels after a stroke. Carbetapentane is a cough suppressant that heightens the activity of opioid receptors, which are active in pain relief. The myriad actions of the drugs tested, Dirks notes, “suggests the incredible diversity of pathways that might be regulating neural stem cells.”

According to Dirks, now that the preliminary screen for candidate therapies has been performed, his group will take the most promising and determine whether they can inhibit the proliferation and growth of human tumor cells engrafted into the brains of mice. “We’ve cured cancer in the dish many times over, but we need to show this in vivo,” says Dirks, who hopes to have the results of the new research by the end of the year.

If those tests are successful, he believes he can move somewhat swiftly to human trials, especially since terminal brain cancer patients are often more willing to engage in new, unproved treatment options. “Because we know that all the conventional therapies eventually fail,” Dirks explains, “many patients do go on investigational therapy.”

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Stormont in need of pain relief

April 5, 2007

I was most pleased to hear that one of the first joint actions by Dr Paisley and Mr McGuinness was to ask the Secretary of State - ‘Hain the Pain’ or ‘Hine the Pine’ as he was known in England during his dissident days - to leave his offices at Stormont.

History is indeed benignly cyclical.

The imposition of Direct Rule by the late Edward Heath in 1972 was both undemocratic and disastrous and that became indubitably clear when Peter Hain was given the (part-time) post he now holds.

His blustering style and arrogance were first seen on the playing fields of England in the late sixties and early ’70s and, more recently, in the hallowed halls of Stormont.

The present Labour Party - in deep pain itself - deserves him.

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Will he soon be asked to vacate Hillsborough Castle as well so that it reverts back exclusively to its original purpose as Her Majesty’s residence in Northern Ireland?

Perhaps he could find new offices at Spooks’ Corner in Holywood? (How I miss the Belfast banter in Athens!)

Whatever happens from now on, Stormont and you, the people of Northern Ireland, have just witnessed one of the most historic weeks in your history.

Your relief is deserved and tangible.

That certainly was the week that was (in the words of Sir David Frost’s popular television programme of the ’70s)!

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Scientists target relief for back pain and osteoporosis sufferers

April 3, 2007

Two very common medical problems are dorsopathy, or what the average person calls back pain, and osteoporosis. While most episodes of dorsopathy can be resolved within a few weeks, it is a complex and frustrating problem for doctors and patients alike. As for osteoporosis, more women suffer from this disease of the bone than men. Scientists have been working with interventional radiology to treat these two ailments. Changes have impacted radiology more in the last two decades than almost any other medical discipline, giving radiology the backbone it needs to advance the human condition.

There is relief for back pain sufferers.

For Professor Dr Afshin Gangi, Head of the Radiological Department at the University Hospital of Strasbourg, France, scientists now have access to the technology to help them remedy damage that was once considered virtually or completely inoperable. “This can be done quite quickly and without undesirable side effects,” Prof Gangi explained at the 2007 European Congress of Radiology conference in Vienna on 9-13 March.

Scientists are now using computer and magnetic resonance tomography to give them a clearer perception of what is going on with the structures of the human body. This technology, which is superior to conventional x-ray imaging, allows experts to conduct minimally invasive surgery.

The experts are now focusing on osteoporosis (special cement for new support); accident-induced spinal fractures (cement instead of bones); and burning bone lesions or bone metastases with radio frequency ablation (RFA).

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Patients affected with osteoporosis usually contend with the partial fracture of the body of a vertebra. Conventional treatment involved bed rest of three to six weeks, which resulted in muscular atrophy and longer convalescence for patients. In percataneous vertebroplasty, special cement is injected into the patient through an insertion hole only 1mm in size. The procedure, which was discussed at the forum, is MR-guided right to the spot where support is needed. The patient can leave after 48 hours since the pain is quick to disappear. Dutch, Belgian and Italian scientists were instrumental behind the success of this procedure.

Young people with accident-related vertebral fractures minus nerve damage are treated with balloon cyphoplasty, where a specially shaped balloon is inserted into a tiny hole at the spot where the vertebra has collapsed. The balloon inflates the area, which is then injected with special calcium-phosphate base cement. The cement is reabsorbed by the body over time and replaced by real bone.

RFA, meanwhile, helps patients with osteiod osteomas (benign bone lesions) or bone metastases. While there was little one could do to treat the problem in the past, key-hole procedures are the treatments du jour. Prof Gangi explained at the forum that a probe with an electrode on the end is inserted into the skin and the metastases and lesions are then burned out of the bone. Twelve hours post-op and the patient is no longer in pain.

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