Research pushes back on benefits of compounded topical pain creams
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"Our study of nearly 400 pain patients suggests that people who use these compounded creams and gels are being taken advantage of, because the scientific evidence to support a benefit is not there," says
Tricare, a government-managed health insurance plan covering some active duty and retired military personnel and their family members, reported it spent
Cohen says the conceptual appeal of the creams is that they appear to be a safer way to get pain relief without the risks or side effects of potentially addictive or dangerous drugs that are usually given orally or by injection.
The compounded creams and gels generally contain one or more prescription or other anesthetic, analgesic, sedative, antidepressant, anti-seizure or muscle relaxant drugs that are used to treat pain.
To explore the effectiveness of these creams, the researchers conducted a double-blind, randomized and placebo-controlled study at Walter Reed from
First, participants were randomly divided into two groups--one for the compounded topical cream and the other a placebo cream (both the real and placebo creams had the same consistency and feel). Then the participants were divided into three equally numbered groups according to their history of chronic localized pain: neuropathic pain caused by disease or damage to the nerves, such as shingles or diabetes; nociceptive pain (non-neuropathic) caused by injury to tissue, such as burns or sprains; and so-called mixed pain caused by damage to the nerves and tissues, such as certain types of back pain.
All the participants had pain localized to specific areas: the face, back, buttocks, neck, abdomen, chest, groin and/or up to two extremities.
During the week before the study, the average pain score for participants was 4 or greater on the 0-10 pain scale. The average duration for their symptoms was 6.7 years. Some of the patients had been treated with opiates in the past, but the percentage of those patients was not recorded.
Participants were instructed to apply the cream three times per day, and to make entries in a pain diary twice per day, which contained average and worst pain scores. The diaries were used to determine the outcomes.
Cohen says that after the treatment period ended, the investigators found no statistically significant difference between the mean reduction in average self-reported pain scores for all patients in the treatment and placebo groups.
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 points.
Cohen says that all participants improved slightly throughout the study, affirming the long-recognized placebo effect, which is generally stronger for pain treatment than for other medical disorder therapies.
"With the number of research participants studied as long as they were studied, we should have been able to see a statistically significant difference in pain reduction if these creams were actually working," says Cohen, senior author of the paper. "But we didn't see this in our data. The pain reduction we saw in patients being treated with the pain cream was nearly the same pain reduction we saw in placebo--there was just not a large enough difference for the reduction to be scientifically meaningful."
The researchers think there was a tiny difference favoring the pain creams because they contained two substances--lidocaine and prescription non-steroidal anti-inflammatory drugs, particularly ketoprofen and diclofenac--that were shown in earlier randomized trials to be effective topically.
Without outside assistance, the Walter Reed research pharmacy team, which included principal investigator Lt. Col.
The neuropathic pain group used 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 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 the participants. In addition, capsaicin, a pepper derivative commonly used in lotions and creams for muscle pain, could not be used in the study compounds because the recognizable smell and application requirements would have undermined the double-blinding process that kept both caregivers and subjects unaware if they were getting active creams or placebos.
However, Cohen says, considering the high cost and relatively minor benefits from the creams, routine prescription and use of these compounded creams is not a good idea and does not move forward efforts being made toward high value health care.
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