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Placebo Works as Well as Diazepam as Naproxen Add-on for Lower Back Pain

BRONX, NY – Emergency physicians who routinely write a prescription for naproxen and diazepam for acute lower back pain might want to reconsider the practice.

A study in Annals of Emergency Medicine reports that acute back pain patients treated with naproxen and placebo had outcomes as good as or better than patients treated with naproxen and diazepam.

“Our study contributes to the growing body of literature indicating that, in general, most medications do not improve acute lower back pain,” explained lead author Benjamin Friedman, MD, MS, of the Albert Einstein College of Medicine/Montefiore Health System in Bronx, New York. “One week after being discharged from the emergency department, lower back pain patients had improved equally, regardless of whether they were treated with naproxen and diazepam or naproxen and placebo. By three months after visiting the emergency department, most patients had recovered completely, regardless of what treatment they received.”

For the double-blind, randomized clinical trial, researchers focused on 114 patients who presented to the ED with new-onset lower back pain, randomizing them to two groups: one given 20 tablets of naproxen 500 mg, to be taken twice a day as needed for low back pain, and 28 tablets of diazepam 5 mg, to be received as one or two tablets every 12 hours as needed for low back pain; and the other receiving the same amount of naproxen with placebo. All patients also were provided a standardized 10-minute low back pain educational session before discharge.

Results indicate that, a week after visiting the ED, both the diazepam group and the placebo group improved by 11 points on the Roland Morris Disability Questionnaire. At that point, 31.5% of the diazepam patients reported moderate or severe lower back pain, compared to 21.8% of the placebo patients.

After three months, according to the report, 12% of diazepam patients reported moderate or severe lower back pain vs. 9% of placebo patients – a difference without clinical significance.

“Millions of patients come to the ER every year seeking relief for back pain, which can be debilitating,” Friedman explained. “Unfortunately, we have yet to come up with the silver bullet in pill form that helps them. If anything, we may be overmedicating these patients.”