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Compounded Pain Creams Shown Ineffective in New Trial

Results bring into question the high cost of the products

A PPM Brief

Compounded pain creams have been shown to be no more effective for treating localized pain than placebo, results of a new study say.1 A double-blind, randomized controlled trial showed no differences in the mean reduction in average pain scores between treatment and control groups for patients with neuropathic pain, nociceptive pain, or mixed localized chronic pain. Compounded pain creams include drugs such as ketamine, baclofen, cyclobenzaprine, and lidocaine, and are not FDA-approved.

Investigators conducted a double-blind, randomized parallel study of 399 patients with localized pain classified as neuropathic (n = 133), nociceptive (n = 133), or mixed (n = 133). Study participants were treated between 2015 and 2018 and consisted of those aged from 47 to 57 years old. Inclusion criteria included patients that had localized pain in the face, back, buttocks, neck, abdomen, chest, groin, or up to two extremities. Participants were also required to have an average pain score of 4 or greater on a 10-point numerical rating scale during the preceding week, and have symptoms lasting more than 6 weeks.

Patients were randomly assigned to receive either a compounded pain cream or a placebo cream. Pain cream formulations were selected by systemic indications for neuropathic and nociceptive pain. Following treatment, participants recorded their average and worst pain scores twice each day in a pain diary.

Results bring into question the high cost of the products and use over FDA-approved variations. (Source: 123RF)

The results showed no difference in worst pain score or medication reduction for any type of pain classification for all patients at 1 and 3 months between the drug and placebo groups. At 3 months, no difference was observed for any participant's average pain score between the drug and placebo groups for the entire cohort or any pain classification.

Two significant limitations existed in the study: First, some of the participants had failed with conventional treatments before enrolling in the study, which increased the likelihood that further therapy would also be ineffective. Second, investigators did not include capsaicin, which is FDA-approved for both neuropathic and nociceptive pain, or amitriptyline, which is not FDA-approved for chronic pain and has not been shown to be effective topically.

Study authors note that due to the results of the study, compounded pain creams should be put into question due to their higher costs and should be curtailed in favor of FDA-approved variations.

Last updated on: February 19, 2019
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