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Compound pain creams are no more effective at treating localized pain than placebo, which calls into question the high cost of these products, according to a new study.
The results of a randomized, double-blind controlled trial showed that there was no difference in the average reduction in mean pain scores between the treatment and under-control groups in patients with neuropathic pain, nociceptive pain or mixed localized chronic pain.
"Compound pain creams are no better than placebo creams, and their higher costs compared to approved compounds should limit their use," said researchers, led by Steven P. Cohen, MD, director of pain research at Walter Reed Military Medical Center and professor of anesthesiology. and critical care medicine at the Johns Hopkins School of Medicine, write.
The results were published online on February 4th. Annals of Internal Medicine.
High cost a problem
"Previous research has clearly shown that certain agents such as lidocaine for non-neuropathic nerve pain and nonsteroidal anti-inflammatory drugs such as diclofenac are effective for non-neuropathic pain." The evidence for the other drugs was either anecdotal, either negative or lacking an effective basis, "said Cohen Medscape Medical News.
Many pain relief creams include drugs such as ketamine, baclofen, cyclobenzaprine and lidocaine. However, so far, little work has been done to evaluate their effectiveness in providing significant relief from neuropathic pain, he added.
Cohen noted that Congress mandated this study because of the high cost of composite pain creams and uncertainty about their effectiveness.
To determine the effectiveness of compound creams for the treatment of chronic pain, the researchers conducted a randomized, double-blind, parallel study involving 399 patients with localized pain, clbadified by their treating physician as neuropathic (n = 133). , nociceptives (n = 133) or mixed. (n = 133). The pain was categorized by a certified treating physician in badgesia.
Participants in the study were treated between August 2015 and February 2018, and age in all study groups ranged between 47 and 57 years.
To be included, participants had to have localized pain, including in the face, back, bad, neck, abdomen, chest, groin or both ends.
They also had to have an average pain score of four or more on a 10-point numerical scale over the previous week and had symptoms of more than 6 weeks.
No impact on the CNS
Patients were randomized to receive either a combined pain cream or a placebo cream in a 1: 1 ratio calculated by a computer-generated randomization table.
Pain cream formulations were selected based on accepted systemic indications for neuropathic and nociceptive pain. After treatment, participants recorded their average and extreme pain scores 2 times daily in a pain log, which the researchers then used to calculate the results.
The results showed no difference between the worst pain score or the reduction in medication use for all types of pain or for all patients at 1 and 3 months between the drug group and the placebo group.
At 3 months, no difference was observed for the participants' mean pain score between the drug and placebo groups for the entire cohort or for any pain clbadification.
These results were not surprising, said Cohen.
"Supposedly, these compound painkillers are excellent because they contain opioids, but they have no side effects, but the reason they have no side effects is that they do not penetrate the central nervous system at therapeutic levels.In other words, you can not have your cake and eat it too.
Investigators note that the study had two important limitations.
First, some of the study participants had failed with conventional treatments before enrolling in the study. This increased the likelihood that other treatments would also be ineffective.
Second, although the investigators included some topically effective topical badgesics, they did not include capsaicin, FDA approved for neuropathic and nociceptive pain, or amitriptyline, which was not approved by the FDA for chronic pain and whose effectiveness has not been demonstrated. effective topically.
Unjustified use
Commenting on the results for Medscape Medical NewsKaliq Chang, MD, an interventional pain management specialist at the Atlantic Spine Center, who did not participate in the study, said compound creams "are becoming more and more common in the practice of managing pain. pain and are widely marketed in pharmacies as they are very cost-effective drugs to produce. "
"However, there are not many well-designed studies on the effectiveness of these treatments. [study] the results show that there was no statistically significant improvement in pain with the use of three different compound creams at one or three months of follow-up.
"There was also no statistically significant difference between each compound pain cream and the placebo cream." I agree with the authors' findings that, perhaps, the high costs of these creams compounds do not justify the use of these treatments, "he said.
Study co-author Mark C. Bicket reports funding from the Foundation for Anesthesia Education and Research during the conduct of the study and Axial Healthcare's personal expenses outside of the submitted work . Cohen declares personal expenses of Semnur; grants from SPR Therapeutics; Avanos' grants and personal fees; and members of the Semnur, Boston Scientific and Medtronic Advisory Boards, outside of the submitted work. Chang and the non-appointed studies consultants here have revealed no relevant financial relationship.
Ann Intern Med. Posted online 4 February 2019. Full text
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