Review of Compounded Topical Creams for Pain Relief

PainRelief.com Interview with:


Debra A. Schwinn, M.D. (Committee Chair) – President-Elect of Palm Beach Atlantic University; former professor of anesthesiology, pharmacology, and biochemistry at the University of Iowa

Edmund J. Elder, Ph.D., R.Ph. – Director of the Zeeh Pharmaceutical Experiment Station, School of Pharmacy at the University of Wisconsin–Madison

·John T. Farrar, M.D., Ph.D. -Associate Professor of epidemiology and neurology, University of Pennsylvania School of Medicine 

PainRelief.com:  What is the background for this study?

Response: Compounding is the process of altering or combining ingredients to create medications that are tailored for an individual. Typically, compounded topical pain creams – which are applied to the skin in the form of gels, lotions, or ointments – are used by patients who cannot tolerate oral pain medications.

However, compounded topical preparations are not subject to the same level of extensive testing and stringent regulatory oversight as FDA-approved products. There are a number of safety concerns associated with their use, ranging from minor skin irritations to drug toxicity.

In response, FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to make recommendations for how the available scientific data on safety and effectiveness should inform future prescribing decisions.

PainRelief.com: What are the main findings?

Response: The report found there is limited scientific evidence to support the safety and effectiveness of compounded topical pain creams in adults. The committee assessed 20 Active Pharmaceutical Ingredients (APIs) that are commonly used in compounded topical pain creams. Out of the 20 APIs reviewed, 3 individual APIs and 1 two-drug combination demonstrate potential clinical effectiveness in compounded topical pain creams.

When possible, providers should prescribe FDA-approved products. Pharmacists and providers who prescribe compounded topical pain creams should also educate their patients about how much to use, which conditions to use it for, and the potential risks.

Among the report’s other findings about safety and effectiveness:

·         The rate and extent of the drug’s absorption into the skin and beyond is often unknown

·         There is no clear clinical rationale for specific combinations of APIs and dosages used

·         Labeling requirements for compounded preparations are often inadequate

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Acupuncture for Migraine Pain Relief

PainRelief.com Interview with:

Prof. Wei Wang
Department of Neurology,
Tongji Hospital, Tongji Medical College,
Huazhong University of Science and Technology,
Wuhan, Hubei, P.R. China

acupuncture

PainRelief.com:  What is the background for this study?

Response: The burden of migraine is substantial, resulting in considerable economic and social losses. The latest Global Burden of Disease Study showed that 1.25 billion people had migraine in 2017. A significant number of patients are still not responding well to drug therapy, or cannot tolerate the adverse effects of drugs, or have contraindications, which can lead to low medication compliance, headache chronification and acute medication overuse. Prophylactic drugs should be recommended for migraineurs who have at least four headache days per month, but only 13% of patients reported current use of preventive drugs. Besides, ineffectiveness of and/or contraindications to migraine medication affect 10-15% of people with migraine. Hence, a need exists to investigate non-drug interventions.

Previous studies suggest that acupuncture works particularly well on a range of pain disorders. However, clinical evidence for the benefit of manual acupuncture for migraine prophylaxis remains scarce. Appropriate placebo control settings and successful blinding are two critical elements in addressing this challenge. Sham acupuncture involving penetrating needles should be avoided in clinical trials. Previous acupuncture research has often used penetrating sham acupuncture, involving needling non-acupuncture points, needling irrelevant acupuncture points, or superficial needling. However, whether the needle is inserted into an acupuncture point or a non-acupuncture point, it could produce a physiological effect. Comparisons between true acupuncture and sham acupuncture might also be biased by unsuccessful blinding. To ensure an inert placebo control and successful blinding, we recruited acupuncture-naive patients, using non-penetrating sham acupuncture at heterosegmental non-acupuncture points as the control, and designed the same procedures to perform the same rituals as much as possible in the manual and sham acupuncture groups.

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Knee Osteoarthritis: Physical Therapy vs Steroid Injection for Pain Relief

MedicalResearch.com Interview with:
Dr. Gail Deyle, PT, DSc, DPT, OCS, FAAOMPT
Professor with Baylor University Graduate School 

Dr. Gail Deyle, PT, DSc, DPT, OCS, FAAOMPT
Professor with Baylor University Graduate School

Study authors in addition to Gail Deyle are Chris Allen, Stephen Allison, Norman Gill, Benjamin
Hando, Evan Petersen, Douglas Dusenberry, and Daniel Rhon

Summary:

Physical therapy is superior to glucocorticoid (steroid) injections for stiff and aching knees says Dr Gail Deyle, a physical therapist specializing in orthopaedics and manual physical therapy. A study recently published in the New England Journal of Medicine directly compared physical therapy with glucocorticoid injections to determine which was better primarily at one year but also in the short term.

The research was a collaborative effort of providers from physical therapy, orthopaedics, and
rheumatology at two Army Medical Centers. Dr Deyle, who is a professor with Baylor University Graduate School, and the senior author of the study, states, our results leave no doubt that physical therapy should be strongly considered for patients with knee osteoarthritis. They will clearly benefit from a physical therapist’s hands-on treatment and decision making for exercise and activity selection.

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Targeting Specific Inflammatory Cells May Offer Enhanced Pain Relief

PainRelief.com Interview with:
Prof. Dr. Halina Machelska
Department of Experimental Anesthesiology
Charité-Universitätsmedizin Berlin
Berlin, Germany

Prof. Dr. Halina Machelska
Department of Experimental Anesthesiology
Charité-Universitätsmedizin Berlin
Berlin, Germany

PainRelief.com:  What is the background for this study?

Response: Pathological pain such as pain resulting from nerve injury is often accompanied by inflammation. This is manifested by accumulation of immune cells, including macrophages, in the damaged tissue. Current research mostly emphasizes the role of these cells in the enhancement of pain. One of the suggested strategies in the basic research is to deplete immune cells from the affected tissue. However, several previous preclinical studies, including our own, have shown that this approach did not sufficiently decrease pain. We think that one of the reasons is that not all immune cells invading damaged tissue are detrimental and in fact, some are needed there to counteract pain.

Macrophages are very heterogeneous and they comprise at least two subpopulations, pro-inflammatory M1 and anti-inflammatory M2 macrophages. Our idea in this study was to promote the analgesic properties of macrophages. We took advantage of the cytokine interleukin-4 (IL-4) to switch macrophages from the M1 to the M2 state.

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Chiropractic Care Linked to Lower Use of Opioids for Spinal Pain Relief

PainRelief.com Interview with:
Jim Whedon DC, MS
Director of Health Services Research
SCU Health System
Southern California University of Health Sciences
Whittier, CA 

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: Utilization of nonpharmacological pain management may prevent unnecessary use of opioids.

Our objective was to evaluate the impact of chiropractic utilization upon use of prescription opioids among patients with spinal pain. Overall, in the states of CT, MA and NH, at any particular time in the study period of 2012-2017, between 1.55 and 2.03 times more nonrecipients of chiropractic care.filled an opioid prescription, as compared with recipients.

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Animal Study Finds Ibuprofen for Pain Relief Can Cause Liver Damage

PainRelief.com Interview with:
Aldrin V. Gomes, Ph.D., FAHA
Professor and Vice-Chair for Teaching,
Department of Neurobiology, Physiology, and Behavior
University of California, Davis
Davis, CA 95616

Dr. Gomes

PainRelief.com:  What is the background for this study?

Response: While many over the counter non-steroidal anti-inflammatory drugs (NSAIDs) now include a warning about potential cardiovascular disease, warnings about liver injury are hardly mentioned. This is because most NSAIDs including ibuprofen is considered to have very little potential to cause liver toxicity.

However, a 2018 publication (doi: https://doi.org/10.1016/j.cgh.2017.07.037) showed a relatively high prevalence of ibuprofen -induced liver injury in Spanish and Latin-American DILI (Drug induced liver injury) registries. As such, we were interested in determining what effects, if any, ibuprofen had on mice liver.

Low Back Pain: AI Can Expedite Pain Relief Recommendations Through Electronic Record

PainRelief.com Interview with:

Ismail Nabeel MD, MPH
Associate Professor
Public Health and General Preventive Medicine
Mount Sinai Medical Center

Dr. Nabeel

PainRelief.com:  What is the background for this study?

Response: Acute and chronic low back pain (LBP) are different conditions with different treatments. However, they are coded in electronic health records with the same International Classification of Diseases, 10th revision (ICD-10) code (M54.5) and can be differentiated only by retrospective chart reviews. This prevents an efficient definition of data-driven guidelines for billing and therapy recommendations, such as return-to-work options, etc.

In this feasibility study, we evaluated if Artificial intelligence can automatically distinguish the quality of Low Back Pain (LBP) episodes by analyzing free-text clinical notes from the treating providers. 

These clinical notes were collected during a previous pilot study evaluating an RTW tool based on EHR data that included nearly 40,000 encounters for 15,715 patients spanning from 2016 to 2018 and clinical notes written by 81 different providers. We used a dataset of 17,409 clinical notes from different primary care practices; of these, 891 documents were manually annotated as “acute low back pain” and 2,973 were generally associated with LBP via the recorded ICD-10 code. 

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Gene Responsible for Sensing Mechanical Pain Identified

PainRelief.com Interview with:
Reza Sharif Naeini, Ph.D.
Associate Professor
Department of Physiology & Cell Information Systems Group
McGill University
Life Sciences Complex (Bellini),
Montréal, Québec

PainRelief.com:  What is the background for this study?

Response: My lab is interested in understanding how our bodies detect signals from the environment, like our sense of touch and pain. This process is done by specialized sensors we have that detect mechanical stimuli, ranging from a hair deflecting under the wind, a gentle stroke, or a pinch. These sensors are called mechanosensitive ion channels and they convert mechanical forces into electrical signals that our nervous system can understand.

Their existence was first proposed in 1950 (to my knowledge) by Bernard Katz, and in 1999, researchers at the University of California in San Francisco, led by Dr. Jon Levine, demonstrated that pain-sensing neurons (termed nociceptors) express these channels. But their molecular identity remained elusive.

In 2010, the group of Dr. Ardem Patapoutian discovered the genes Piezo1 and Piezo2, with the latter being essential for our sense of touch and proprioception. While these findings were transformative to the field of somatosensation, mice lacking these genes were still able to respond to painful mechanical stimuli.

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Nebulized Ketamine May Offer Pain Relief to Emergency Room Patients

PainRelief.com Interview with:

Jefferson Drapkin BS
Research Associate
Maimonides Medical Center
Department of Emergency Medicine
Brooklyn, New York

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: Nebulized administration of ketamine has been studied in the areas of palliative care, therapy for asthma, and acute postoperative management of sore throat. To our knowledge, there is no literature regarding analgesic efficacy and safety of nebulized ketamine’s role in managing acute painful conditions in the emergency department (ED).

As all five patients had a decrease in pain from baseline to 120 min, this case series demonstrates that the inhalation route of ketamine delivery via breath-actuated nebulizer may have utility for managing pain in the ED.

Safety And Efficacy Of The Unique Opioid Buprenorphine For Chronic Pain Relief

PainRelief.com Interview with:
Joseph V. Pergolizzi, Jr., M.D.

Co-Founder and Chief Operating OfficerNEMA Research Inc.

Joseph V. Pergolizzi, Jr., M.D.
 Co-Founder and Chief Operating OfficerNEMA Research Inc.

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: Chronic low back pain (CLBP) is a leading cause of disability.

  • Acetaminophen and nonsteroidal anti-inflammatory drugs are first-line analgesic options or mild CLBP; however, when certain patients with moderate to severe CLBP do not achieve adequate pain relief, opioids are considered as an add-on therapy. Unfortunately, most opioid analgesics have the potential for adverse effects, abuse, and diversion.
  • Buprenorphine buccal film (Belbuca®) is an opioid analgesic classified as a Schedule III controlled substance in the United States and is a partial μ-opioid receptor agonist.
  • Buprenorphine buccal film is a unique analgesic that is approved by the US Food and Drug Administration for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment for whom alternative treatment options are inadequate.
  • Two pivotal phase 3 clinical trials (Study 307, Clinical Trial ID NCT01675167, and Study 308, Clinical Trial ID NCT01633944) established the efficacy and safety profiles of buprenorphine buccal film.
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