For patients with acute low back pain, the combination of diazepam, a benzodiazepine + naproxen, a nonsteroidal anti-inflammatory drug (NSAID) did not improve functional outcomes or pain compared to naproxen use alone.

In the U.S., diazepam is prescribed in approximately 300,000 visits for low back pain annually, however the evidence regarding its efficacy is surprisingly lacking. Researchers from Albert Einstein College of Medicine and the Department of Pharmacy at Montefiore Medical Center sought to investigate whether the addition of oral diazepam to naproxen could improve outcomes in patients presenting to the emergency department (ED) with acute nontraumatic and nonradicular low back pain.

A total of 114 patients were included in this randomized, double-blind, comparative trial. Each patient scored ≥5 on the Roland-Morris Disability Questionnaire. All patients were given 20 tablets of naproxen 500mg, to be taken twice daily. They were also randomized to either 28 tablets of diazepam 5mg or placebo, to be taken as 1 or 2 tablets every 12 hours as needed for low back pain.

The primary endpoint was improvement in score between ED discharge and 1 week later. Secondary outcomes included pain intensity 1 week and 3 months after ED discharge.

Ninety-eight percent (n=112) of patients provided 1 week outcome data. Results showed that both groups, those randomized to naproxen and diazepam and those randomized to naproxen and placebo, had the same improvement of 11 for the mean Roland-Morris Disability Questionnaire score (95% CI; 9 to 13).

Eighteen of 57 (32%; 95% CI 21% to 45%) patients in the diazepam group reported moderate or severe low back pain versus. 12 of 55 in the placebo group (22%; 95% CI 13% to 35%) at 1-week follow-up. 

Related Articles

At 3-month follow-up, six of 50 patients on diazepam (12%; 95% CI 5% to 24%) reported moderate or severe low back pain versus five of 53 placebo patients (9%; 95% CI 4% to 21%). Twelve of 57 diazepam patients (21%; 95% CI 12% to 33%) and 8 of 55 placebo patients (15%; 95% CI 7% to 26%) reported adverse events.

The authors concluded that “diazepam should not be routinely added to nonsteroidal analgesics for these patients.”

For more information visit