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In an effort to reduce chronic pain, many people are looking for hope by paying between $ 20 and several thousand dollars for a tube of prescription topical cream or gel. Now, the results of a rigorous study funded by the federal government mandated by Congress show no statistically significant statistical difference between the relief offered by these creams and placebos, according to researchers at Johns Hopkins Medicine and the Military Medical Center national Walter Reed. A report of the study is published in the February 5 issue of Annals of Internal Medicine.
"Our study of nearly 400 patients with pain suggests that people who use these creams and gels are being used appropriately because the scientific evidence available to support a benefit does not exist," says Steven P. Cohen, MD, professor of anesthesiology and criticism. medical care, neurology, physical medicine and rehabilitation at the Johns Hopkins University School of Medicine. He is also Director of Pain Research at Walter Reed.
Tricare, a government-run health insurance plan for serving and retired members of the military and their families, announced $ 259 million in topical pain painkillers in fiscal 2013 and amounted to $ 746 million in 2014. in the month of 2015, the Department of Defense spent about $ 6 million a day on drugs. Similarly, the Medicare Part D program has disbursed more than half a billion dollars for creams in 2015. Significant data on spending and limited efficiency have triggered news and requests for money. surveys, the researchers said. Finally, Congress asked for evidence of the effectiveness of creams.
Cohen argues that the conceptual value of creams is that they appear to be a safer way of relieving pain without the risks or side effects of potentially addictive or dangerous drugs usually given orally or by injection.
Compound creams and gels typically contain one or more prescription drugs or other anesthetics, badgesics, sedatives, antidepressants, anti-epileptics or muscle relaxants used to treat pain.
To explore the effectiveness of these creams, the researchers conducted a double-blind, randomized, placebo-controlled study at Walter Reed from August 2015 to February 2018. The research was conducted on 399 participants aged 18 to 18 years. at 90 years old. Nearly 43% were active duty military; the remaining participants were retirees or dependents, such as spouses. More than half (51%) were women. All participants were patients in military treatment centers and could use TRICARE outside military treatment centers.
First, the participants were randomly divided into two groups – one for the topical cream and the other for the placebo cream (the actual and placebo creams had the same consistency and feel). The participants were then divided into three groups of the same number based on their history of localized chronic pain: neuropathic pain caused by disease or nerve damage, such as shingles or diabetes; nociceptive (non-neuropathic) pain caused by tissue injury, such as a burn or sprain; and so-called mixed pain caused by nerve and tissue damage, such as some back pain.
All participants had pains localized to specific areas: the face, the back, the bad, the neck, the abdomen, the chest, the groin and / or up to two ends.
During the week preceding the study, the participants' average pain score was equal to or greater than 4 on the 0-10 pain scale. The average duration of their symptoms was 6.7 years. Some patients had previously been opioid, but the percentage of these patients was not registered.
Participants were asked to apply the cream three times a day and to record the mean and worst scores twice daily in a pain diary. Newspapers were used to determine the results.
Cohen stated that after the end of the treatment, the investigators found no statistically significant difference between the mean reduction in mean self-reported pain scores by all treatment and placebo patients.
For the neuropathic pain group, there was a 0.1 point difference between the drug group (-1.4) and the placebo group (-1.3).
For the mixed pain group, there was a -1.3 point reduction for the placebo group and a -1.6 reduction for the treatment group, for a difference of 0.3 point.
Cohen says that all participants improved slightly throughout the study, confirming the long-established placebo effect, which is generally more powerful for pain management than for other treatments for medical conditions.
"With the number of research participants studied as long as they were studied, we could have seen a statistically significant difference in pain reduction if these creams actually worked," says Cohen, lead author of the # 39; section. "But we did not see that in our data, and the pain reduction we saw in pain control patients was almost the same reduction we had seen with placebo – it was not There was simply not enough difference for the reduction to be possible – scientifically significant. "
Researchers believe that there is a tiny difference in favor of pain creams because they contain two substances – lidocaine and nonsteroidal anti-inflammatory drugs, especially ketoprofen and diclofenac – whose efficacy in the context of randomized previous trials has been demonstrated.
Without outside help, Walter Reed's pharmacy research team, which included the lead investigator, Lieutenant-Colonel Robert Brutcher, prepared pain creams containing a combination of several of the same drugs than those used in commercially available topical creams.
The neuropathic pain group used a cream containing ketamine, gabapentin, clonidine and lidocaine. The cream used by the nociceptive pain group contained ketoprofen, baclofen, cyclobenzaprine, and lidocaine. In the mixed pain group, participants used a cream containing ketamine, gabapentin, diclofenac, baclofen, cyclobenzaprine, and lidocaine.
Cohen cautioned that the new study was somewhat limited in terms of applicability for specific conditions, in part because of the wide variety of medical conditions and pain disorders among participants. In addition, capsaicin, a derivative of pepper commonly used in lotions and creams for muscle pain, can not be used in study compounds because the recognizable odor and the demands of the body. The application would have compromised the double-blind process that prevented caregivers and subjects from knowing if they were getting active creams or placebos.
However, says Cohen, given the high cost and relatively minor benefits of creams, the prescription and the consistent use of these compound creams are not a good idea and do not advance the efforts in favor of health care valuable.
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Other researchers who participated in the study are Parvaneh Moussavian-Yousefi, Pharm.D .; Lieutenant-Colonel Robert E. Brutcher, Pharm.D., Ph.D., US Army; Connie Kurihara, R.N .; Major David E. Reece, M.D., US Army; Petty Officer 1st Clbad Lisa M. Solomon, B.S., US Navy; Colonel Scott R. Griffith, M.D., US Army; and David E. Jamison, MD, and Mark C. Bicket, MD, of Johns Hopkins.
The main funding for the research came from the Rehabilitation Science Research Center, the Defense Health Agency, and the United States Department of Defense.
None of the authors has reported any conflict of interest.
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