Wednesday, January 1, 2014

Another Book About Pain; Only Much Better

A Nation in PainOf nearly 240 million adults in the United States, more than 4 in 10, or about 100 million, live with chronic pain of some sort. Yet, the professional and popular news media focus more on abuses of pain medications than the dreaded conditions the drugs are intended to treat. Meanwhile, the suffering of untreated or mistreated patients with pain is largely overlooked.

In her new book — A Nation in Pain: Healing Our Biggest Health Problem — author Judy Foreman provides a deeply researched account of today’s chronic pain crisis and reasons behind it, and she discusses some solutions that could be within reach. Far more than just a symptom, Foreman explains, chronic pain can be a disease in its own right, and the failure to manage pain better in the U.S. and other countries worldwide may be tantamount to torture.

A great many (perhaps, too many) books have been written on the subject of pain; all are well-intentioned and often they are self-published. While some of the books are of interest, most appear to be riddled with personal opinion, biased perspectives, and/or misinformation rather than being guided by facts and solid evidence. As a journalist and investigative health reporter, Foreman has done a noteworthy job of crafting easy-to-read text that also is excellently documented with enough citations of her evidentiary sources to satisfy even the most skeptical readers — which is quite rare for a book intended for both lay and professional audiences, as is A Nation in Pain.

Friday, December 27, 2013

More Evidence That Naltrexone Aids Fibromyalgia

Opioid AntagonistsThe difficult-to-treat chronic pain disorder fibromyalgia syndrome (FMS) is characterized by diffuse musculoskeletal pain, fatigue, sleep disturbance, and cognitive impairments. Significant numbers of patients with FMS do not respond adequately to drugs currently approved for the disorder by the U.S. FDA: pregabalin (Lyrica®), milnacipran (Savella®), and duloxetine (Cymbalta®). Naltrexone — an orally administered opioid-receptor antagonist sometimes used to treat alcohol or opioid dependence — is hypothesized to aid FMS by enhancing endogenous endorphin function and suppressing centrally-acting proinflammatory cytokines, thereby helping to attenuate pain and other symptoms.

At the 2013 Annual meeting of the American College of Rheumatology (ACR), Samy Metyas, MD and colleagues presented a prospective, open-label, single-center, uncontrolled pilot study involving 25 patients (24 female) diagnosed with FMS by ACR criteria [Metyas et al. 2013]. Subjects were started on low-dose oral naltrexone, 3 mg, at night, with titration up to a maximum 4.5 mg nightly. Primary outcome was measured on the Revised Fibromyalgia Impact Questionnaire (FIQR) at month 3, and adverse reactions were also recorded.

Friday, December 20, 2013

Is 5,000 IU/Day of Vitamin D Enough for Pain?

Super DIn a recent article, John Cannell, MD — Executive Director of the nonprofit Vitamin D Council — explains how the organization arrived at its recommendation that all adults should take at least 5,000 IU/day of vitamin D for the rest of their lives [see blogpost here]. Previously, we had described research surrounding the potential benefits of oral vitamin D3 supplementation for various pain conditions; however, some may believe that 5,000 IU/day is too much, while it could actually be inadequate for many patients with chronic pain.

As Cannell acknowledges, the U.S. Institute of Medicine’s Food and Nutrition Board claims that merely 600 IU/day of vitamin D is enough for most adults, while the Endocrine Society says 2,000 IU/day is sufficient. However, he notes, “We think the safest thing to do while all the research is going on is to maintain natural vitamin D levels.”

Saturday, December 14, 2013

The 6 Worst Words in Evidence-Based Medicine

Language MattersWriting in the November 2013 edition of the Journal of the American Medical Association, R. Scott Braithwaite, MD, MS, from New York University School of Medicine, comments on a deceptive 6-word phrase often used in evidence-based medicine (EBM) that frequently leads to dangerously false inferences for clinical decision making [Braithwaite 2013]. We further contend that, applied to the interpretation and application of pain research — such as relating to the use of opioids analgesics for chronic pain — those 6 words also can encourage poor quality pain management and inexcusable patient suffering.

What are the offending 6 words? They are quite simply, There is no evidence to suggest…. Braithwaite proposes that this phrase should be banished from the lexicon of EBM and, while this could be important, we also recognize that it could foster uncertainty and doubt that could be discomforting to many professionals and patients in the pain field.

Saturday, November 16, 2013

Confusion Over Why Youths Misuse Rx Opioids

Teenage Drug AbuseThe misuse of prescription opioid analgesics by young persons has garnered significant news-media coverage and created much concern, but there has been inadequate attention focused on the underlying motives for such behaviors. A new study among adolescent students revealed that most of the alleged medication misuse was for treating legitimate pain; however, there are some confusing aspects of this investigation that muddle the interpretation and usefulness of outcomes.

Researchers at the University of Michigan surveyed 2,964 students in Detroit, Michigan (grades 7-12; 51% female) during 2011 to 2012 to assess motives for medical misuse of prescription opioids, as well as substance abuse and diversion behaviors [McCabe et al. 2013]. “Medical misuse” of Rx opioids was defined as “the use of prescribed opioids by a patient with a prescription for an opioid analgesic who uses the prescription in a manner not intended by the prescriber (eg, higher or more frequent doses, using intentionally to get high, or coingesting with alcohol or other drugs).” Whereas, “nonmedical use” of the drugs was defined as any use of someone else's prescription opioids, whether for pain relief, to get high, or in conjunction with other drugs.

Tuesday, November 5, 2013

Nov 2013 – Pain Product Announcements & Warnings

Pain Product AnnouncementsFeatured Items: hydrocodone (Zohydro ER) approved as a single-entity product; FDA announces plan for hydrocodone combination products reclassification; diclofenac capsules (Zorvolex) approved as new NSAID formulation; tocilizumab (Actemra) subcutaneous formulation approved for RA; certolizumab pegol (Cimzia) approved for active psoriatic arthritis; methotrexate (Otrexup) self-injection device approval;. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Hydrocodone Extended-Release Capsules (Zohydro ER®) – FDA Approved
The FDA announced an October 2013 approval of the single-entity, extended-release, oral hydrocodone bitartrate product Zohydro ER for pain management. The agent is a Schedule II controlled substance manufactured by Zogenix, Inc. and is indicated for the management of severe pain when continuous long-term treatment is needed and other treatment options have been ineffective. Six Zohydro ER strengths — 10-, 15-, 20-, 30-, 40-, and 50-mg — will offer healthcare practitioners a wide range of titration options.

Friday, October 25, 2013

Dubious Study Disclaims Vitamin D for Back Pain

Vitamin DThere is bad news and good news from the research literature on vitamin D. Nonspecific chronic low-back pain (CLBP) is a common condition burdening large numbers of patients worldwide, and prior research suggests that CLBP often may be associated with vitamin D3 deficiency. A newly reported study examined that hypothesis in a randomized controlled trial. Results refute the benefits of vitamin D supplementation in relieving CLBP; however, the quality and strength of evidence were very weak. In a separate study, researchers found that serum levels of vitamin D, over a wide range of values, were not associated with development of kidney stones.

In the study of vitamin D3 for chronic low-back pain (CLBP), a team of Iranian researchers conducted a double-blind, randomized, placebo-controlled clinical trial among 53 patients aged between 18–40 years (≈75% female) [Sandoughi et al. 2013]. Patients with nonspecific CLBP were randomly assigned to receive once every week for 8 weeks either oral vitamin D3 (50,000 IU; N=26) or oral placebo (N=27). Serum 25(OH)D was assessed using an enzyme-linked immunosorbent assay kit, and pain was measured using a visual analogue scale (VAS; apparently a 0–7 point scale, but this was unclear in the report).

Wednesday, October 23, 2013

Yoga for Neck Pain? Maybe.

Yoga for PainChronic neck pain is a significant health problem affecting from 30% to 50% of the population annually. While there are relatively few evidence-based treatments for this condition, research studies have suggested that yoga may be a clinically effective option. A recently reported study helps to confirm that Iyengar yoga can be more efficacious than a home exercise program for relieving neck pain and improving quality of life; however, evidence for this is relatively sparse and the quality is weak.

As reported in the Clinical Journal of Pain, Holger Cramer PhD — at the University of Duisburg-Essen, Germany — and colleagues randomly assigned 51 patients with chronic neck pain (mean age ≈48 yrs; 82% female) to either weekly 90-minute Iyengar yoga classes during a 9-week period (n=25) or to home-based exercises for neck-pain relief (n=26) using a self-care manual [Cramer et al. 2013A]. The main outcome measure was current neck pain intensity on a 100mm visual analog scale (VAS). Secondary outcome measures included functional disability (Neck Disability Index), pain at motion (VAS), health-related quality of life (Short Form-36 questionnaire), cervical range of motion, proprioceptive acuity, and pressure-pain threshold.

Friday, October 4, 2013

Oct 2013 – Pain Product Announcements & Warnings

Featured Items: ustekinumab (Stelara) approved for active psoriatic arthritis; fentanyl pain patch color change; new safety measures for ER/LA opioid analgesics; new 15-mcg/hour dose for buprenorphine patch (Butrans); fluoroquinolone warning of peripheral neuropathy risk; MOTRIN drops product recall; Ortiga safety warning regarding hidden drug ingredient; new warnings for Arzerra and Rituxan; bupivacaine single-dose vial recall.— All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Ustekinumab (Stelara®) – FDA Approved for Active Psoriatic Arthritis
Janssen Biotech announced a September 2013 U.S. Food and Drug Administration (FDA) approval of Stelara for adult treatment of moderate to severe active psoriatic arthritis in patients who are appropriate candidates for phototherapy or systemic therapy. It is the first human interleukin antagonist (IL-12 and IL-23) therapy approved for psoriatic arthritis — a chronic autoimmune disease that can cause pain, joint inflammation, and skin lesions. . . .

Saturday, September 21, 2013

Calculating Benefits & Harms in Pain Research

Making Sense of Pain ResearchPart 15 – NNT, NNH, and Harm-to-Benefit Ratios

Pain research reports typically convey an array of statistical analyses, but among the more useful, and at the same time least frequently presented, is the Number-Needed-to-Treat (NNT) for benefit or harm from a therapy or intervention. In simplest terms, NNT helps healthcare providers, and their patients, to assess the extent to which a pain treatment is likely to be helpful or harmful in specific ways. This article in the series “Making Sense of Pain Research” explains why and how to calculate and use NNT statistics, which are simple in concept yet can be challenging to properly interpret.

Friday, September 20, 2013

Pain Control & Patient Satisfaction Differ

Pain SurveyTo date, few studies have investigated the direct association between pain-intensity scores and patient satisfaction with the control of their pain. A newly reported study found, surprisingly, that there is no statistical association between pain relief and patient satisfaction with their pain management; however, there were some important limitations and deficiencies of this important investigation to consider.

Shay Phillips — of the University of North Carolina at Chapel Hill, School of Medicine — and colleagues observe that the primary assessment tool used by most healthcare providers to measure the outcomes of pain management programs is the standard 0–10 numerical rating scale (NRS) of pain intensity [Phillips et al. 2013]. However, it is unclear if this clinical tool should be used as the sole indicator of positive outcomes of pain therapy and interventions. Furthermore, while it might be assumed that pain-intensity scores — however, measured — would be correlated with patient satisfaction, few studies have adequately evaluated the association.

Tuesday, September 10, 2013

FDA Issues ER/LA-Opioid Prescribing Changes

FDAIn accordance with new actions by the U.S. Food and Drug Administration (FDA), healthcare professionals and consumers will soon find updated class-wide labeling for extended-release and long-acting (ER/LA) opioid analgesics to help ensure safe and appropriate use. Besides emphasizing prescribing of these agents only for severe pain, the FDA will stress avoidance of opioids during pregnancy and is requiring manufacturers to study risks when these drugs are used long-term.

Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research stated in an announcement [here], “The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications. They also are meant to reduce problems associated with their use,” and “to make opioids as safe as possible for those who need them.”