On February 5, the Annals of Internal Medicine published results from a study that aimed to determine the efficacy of compounded creams utilized for chronic pain. Researchers from Walter Reed National Military Medical Center separated 399 patients into groups of those experiencing neuropathic pain, nociceptive (non-neuropathic) pain or mixed pain. The treatments were composed of commonly compounded drug ingredients and compared against placebo for effectiveness.
- The neuropathic pain group used a cream composed of ketamine 10%, gabapentin 6%, clonidine 0.2% and lidocaine 2%.
- The nociceptive pain group used a cream with ketoprofen 10%, baclofen 2%, cyclobenzaprine 2%, and lidocaine 2%.
- The mixed pain group used a cream containing ketamine 10%, gabapentin 6%, diclofenac 3%, baclofen 2%, cyclobenzaprine 2%, and lidocaine 2%.
Patients self-administered the pain cream or placebo cream three times daily to the affected area.
Of these ingredients utilized in topical pain creams, only clonidine, lidocaine and diclofenac have attained FDA approval for topical use. It may be noted, however, that topical clonidine is only approved as a transdermal patch for the treatment of hypertension, not pain. Yet custom creams continue to make use of these other ingredients, and despite increasing prices for compounds, there is little evidence that they lead to meaningful improvement.
The primary outcome measure in this study was average pain score following one month of treatment. For this outcome, there was no significant difference found between the treatment groups and the control groups. Additionally, there were no significant differences observed in functional improvement or patient satisfaction. In essence, the compounded pain creams were no better than placebo creams. The authors further concluded that their higher costs compared to FDA-approved products should curtail their routine use.
What does this mean to you?
The FDA does not review custom compound medications for safety and efficacy, so they carry no approved indications. Therefore, myMatrixx treats all compounds as non-formulary medications. Should you have any questions concerning compounds or any other drugs, myMatrixx pharmacists are available for assistance. Please email Clinical@myMatrixx.com.