Overcoming Barriers to Managing Fibromyalgia

Fibromyalgia Syndrome (FMS) remains a challenge in part because patients expect that their problem will be obvious and modern medicine will have a fix for it. Meanwhile, practitioners feel they should be able to provide a discrete diagnosis and prescribe a specific remedy. Unfortunately, there are still no simple solutions for either patients or healthcare providers, according to an overview article in Managed Care magazine.

In the article, writer Bob Kirsch observes, “It is not for every illness that the FDA recommends massage and emotional support. But fibromyalgia is not like most other illnesses. First, it should be said that there is no longer any question about whether fibromyalgia syndrome is a specific illness — the FDA itself states that these are patients who have gone through a change in the way their brains perceive pain” [Kirsch 2011].

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Why Peppermint Placates IBS Pain

Researchers from the University of Adelaide, Australia, have discovered how peppermint might help to relieve painful symptoms of Irritable Bowel Syndrome (IBS) and other gastrointestinal distress. While peppermint has been known as a remedy for some years, there was no evidence until now to demonstrate why it is effective in relieving such pain.

In a paper just recently appearing online in the international journal Pain, the researchers report that peppermint activates an “anti-pain” (antinociceptive) mechanism in the colon that squelches inflammatory discomfort [Harrington et al. 2011]. A complex series of animal experiments suggest that peppermint acts through a specific antinociceptive channel called TRPM8 to reduce pain-sensing fibers, such as those activated by spicy foods like mustard and chili peppers. “This is potentially the first step in determining a new type of mainstream clinical treatment for Irritable Bowel Syndrome (IBS),” according to one of the investigators, Stuart Brierley, in a news release.

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U.S. FDA Releases Long-Awaited Opioid-REMS

At a press conference on April 19, 2011, the United States government unveiled a multi-agency, multi-pronged master plan aimed at stemming the “nationwide epidemic” of prescription drug abuse. Part of the plan was the long-awaited FDA-backed Risk Evaluation and Mitigation Strategy, or REMS, focusing on reducing the misprescribing, misuse, and abuse of opioid analgesics. However, there are many facets of the Opioid-REMS to be developed during the months ahead.

Gil Kerlikowske, director of the White House Office of National Drug Control Policy (ONDCP), said the new plan — a collaborative effort involving agencies of the departments of Justice (DEA), Health and Human Services (FDA), Veterans Affairs, Defense, and others — provides a national framework for reducing prescription drug abuse and the diversion of prescription drugs for recreational use. Four key elements of the plan include:

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Pain Research: Insignificance of “Significance”

Part 4 – The Problem with P-Values

There is a common misperception that “statistical significance” as denoted by low P-values signifies the strength and importance of research results, and is the hallmark of a “good” study. However, this is far from the truth and, in fact, many allegedly worthwhile research studies with statistically significant findings actually depict small differences or effects that are trivial or have little relevance for pain practice. In short, there are significant problems with P-values.

In preceding articles of this series [here] we noted that some experts have warned of how researchers’ uses of statistics often spawn faulty findings. And, as Albert Einstein pointed out long ago, “Not everything that counts can be counted, and not everything that can be counted counts.” Along those same lines we would add, Not everything that is statistically significant is significant. Understanding this is vital for becoming a more critical consumer of pain research.

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NSAIDs, Opioids, & Fracture Risk in the Elderly

New research concludes that older persons with painful arthritis who initiate analgesic therapy with opioids are more likely to experience a bone fracture than those taking NSAIDs. However, this is yet another study that goes against established evidence-based guidelines regarding analgesia in the elderly, and there are many flaws and methodological biases that are worthy of close inspection.

Writing in the March 2011 edition of the Journal of the American Geriatrics Society (JAGS), researchers conducted a retrospective cohort study to examine the relative risks of fracture associated with starting opioid analgesics compared with nonsteroidal anti-inflammatory drugs (NSAIDs) in elderly patients [Miller et al. 2011]. Searching data spanning 8 years (1/1/99 – 12/31/06) from 2 statewide pharmaceutical benefit programs, 12,436 initiators of opioids and 4,874 initiators of NSAIDs were identified; mean age of all subjects was 81, 85% were female, and all had osteoarthritis. The primary outcome of interest was fracture of the hip, humerus or ulna, or wrist.

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Chorionic Gonadotropin Soothes Intractable Pain?

Human chorionic gonadotropin (hCG), a drug frequently used in fertility therapy, relieved intractable pain for most patients in a small pilot study, according to a recent conference report. However, while hCG might be a viable adjunct to the limited other treatments for intractable pain, more and better research is needed to confirm this.

At the recent annual meeting of the American Academy of Pain Medicine, Forest Tennant, MD, DrPH — of the Veract Intractable Pain Clinic, West Covina, California — described initially administering hCG in challenge dosages of 500 to 1,000 units to 12 patients to determine an effective dosage regimen and possible adverse reactions [Tennant 2011]. All patients were ambulatory adults who had experienced intractable pain for at least 5 years and required opioids for pain management.

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Antiepileptic Drugs for Fibromyalgia Reviewed

Fibromyalgia syndrome (FMS) is a difficult-to-treat chronic pain condition with relatively few specifically approved and effective pharmacotherapies. A recent review examined the relative benefits and harms of pregabalin, the only antiepileptic FDA approved for fibromyalgia, and the antiseizure medication gabapentin in the treatment of FMS. However, the evidence supporting their efficacy was somewhat disappointing.

Writing in the Journal of Pain, researchers from the Oregon Health & Science University, School of Medicine, Portland, Oregon, report conducting an extensive literature search for studies of any antiepileptic drug compared with placebo or another antiepileptic agent in a randomized controlled trial (RCT) or observational study [Siler et al. 2011]. Only 8 studies were discovered matching those inclusion criteria: 7 of pregabalin (Lyrica®) that included 2,964 subjects total, and 1 trial of gabapentin (eg, Neurontin® and generics) that enrolled 150 participants. Populations studied included predominantly women aged 47 to 50 years.

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Do Higher Rx-Opioid Doses Raise Death Risks?

An analysis of opioid analgesic prescription patterns and deaths in a national sample of Veterans Health Administration (VHA) patients found an association of higher prescribed opioid doses with increased risks of overdose death. However, there were many limitations of this research and the risks were so small that one must question what, if anything, this study actually demonstrates.

Reporting in the April 6, 2011 edition of the Journal of the American Medical Association (JAMA), researchers culled a large national database of patients attending VHA facilities from 2004 through 2008 to construct a retrospective case-cohort study [Bohnert et al. 2011]. Cases included all unintentional prescription opioid overdose deaths (n = 750) during that 5-year period compared with a cohort of patients randomly drawn from individuals who used VHA medical services in 2004 or 2005: n = 154,684, 32% of whom had been treated with opioids for pain. Opioids had been prescribed for either cancer pain, chronic bodily pain, headache, neuropathy, or injuries/acute pain.

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Is Buprenorphine Effective for Chronic Pain?

 By guest author, Dmitry M. Arbuck, MD

The transdermal buprenorphine (Butrans®) patch became available in the United States in early 2011 as 5, 10, and 20 mcg/hour doses to be delivered over 7 days [info here]. Since 2001, buprenorphine also has been available in most European countries as Transtec® in 35, 52.5 and 70 mcg/hour transdermal patches that deliver the dose over 96 hours [info here]. Transdermal buprenorphine is approved and indicated for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time.

Sublingual buprenorphine formulations, which are FDA-approved for the treatment of opioid addiction, have been prescribed off-label for the management of chronic pain since they became available in 2002. These come in a pure buprenorphine formulation (Subutex®) and a buprenorphine-plus-naloxone combination (Suboxone®) [info here].

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Validity, Reliability, & Bias in Pain Research

Part 3 – When Bad Things Happen to Good Research

Critics of medical research have proposed that many wrong, or at least unreliable and invalid, therapeutic answers are being generated due to biased studies that are poorly designed and use inappropriate analyses. The pain field is no exception, even though the underlying research may seek answers to important clinical questions that are of value. Understanding potential sources of bias in pain research is vital for assessing reliability and validity of the outcomes.

The first UPDATE article in this series [here] noted some basic principles for understanding limitations of pain research and its interpretation. The second article [here] introduced the importance of evidence-based medicine and presented a hierarchy of research evidence for consideration. Before moving on to the mechanics how to better assess and use data within a study report, there are several other considerations for determining whether a pain research study is worthwhile and potentially meaningful for application in clinical practice.

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Review Raises Doubts About Acupuncture for Pain

Although acupuncture has been used for ages in pain management, a recent review of systematic reviews raises doubts about its effectiveness and safety. However, a close look reveals that the evidence in many cases does suggest benefits of this therapy and acupuncture might still be a viable alternative for select patients with pain.

Writing in the April 2011 edition of the journal Pain investigators from the Universities of Exeter & Plymouth (Exeter, UK) and the Korea Institute of Oriental Medicine (Daejeon, South Korea) collected and critically evaluated systematic reviews of acupuncture as a treatment for pain [Ernst et al. 2011]. After examining 57 qualifying reviews published between 2000 and 2009 that incorporated nearly 700 trials, the authors conclude there is little convincing evidence that acupuncture is effective in reducing many types of pain, and that reports in the literature of 95 serious adverse events associated with acupuncture are of great concern.

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Apr2011 – Pain Product Announcements & Warnings

Featured Items: Shingles vaccine (Zostavax) age indication expanded; topiramate safety alert; Embeda capsules recalled; OTC proton pump inhibitor (PPI) safety warning modified. — Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Zoster (Shingles) Vaccine (Zostavax®) — FDA Lowers Age Approval
The U.S. Food and Drug Administration and Merck announced an expansion of the approved age of 60 years and older for Zostavax administration in the prevention of herpes zoster — commonly referred to as shingles. The added approval for adults 50 to 59 years of age was based on the results of a large clinical trial that showed a 70% reduction in the risk of vaccinated persons developing shingles when compared with those receiving placebo.

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