UMEM Educational Pearls

Category: Pharmacology & Therapeutics

Title: Naproxen plus adjunct diazepam or placebo for low back pain

Keywords: NSAID, diazepam, back pain (PubMed Search)

Posted: 3/4/2017 by Michelle Hines, PharmD (Updated: 4/25/2024)
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Question

The addition of diazepam to naproxen for patients with acute, nontraumatic, nonradicular lower back pain did not improve pain or functional outcomes at 1 week or 3 months after ED discharge compared to placebo.

Answer

Study design: single-center, prospective, randomized, double-blind, placebo-controlled trial

Patients:

Adults age 21 to 69 years who preseted to the ED for management of nontraumatic, nonradicular low back pain <2 weeks in duration with score >5 on Roland-Morris Disability Questionnaire (RMDQ) who were discharged home from the ED
Exclusion criteria: radicular back pain, nonmusculoskeletal etiology of pain, direct back trauma within past 1 month, pregnant/breast feeding, chronic pain syndrome

Treatment groups:

Control: naproxen 500 mg PO twice daily + placebo 1-2 tablets PO every 12 hours PRN pain
Intervention: naproxen 500 mg PO twice daily + diazepam 5 to 10 mg PO every 12 hours PRN pain

Outcomes:

Primary: RMDQ score 1 week after ED discharge
Secondary: pain intensity 1 week and 3 months after ED discharge

Results:

Of 545 patients assessed for enrollment, data from 57 in the diazepam group and 55 in the placebo group were included in the primary outcome analysis
No difference in mean improvement in RMDQ score between the naproxen + placebo (11; 95% CI 8 to 13) and naproxen + diazepam (11; 95% CI 9 to 13) groups at 1 week
No difference in incidence of moderate or severe low back pain between the naproxen + placebo (22%; 95% CI 13% to 35%) or naproxen + diazepam (32%; 95% CI 21% to 45%) groups at 1 week or 3 months (naproxen + placebo, 9%; 95% CI 4% to 21%) (naproxen + diazepam, 12%; 95% CI 5% to 24%)
No difference in the incidence of adverse effects between groups

Conclusions:

The addition of diazepam to naproxen for patients with acute, nontraumatic, nonradicular lower back pain did not improve pain or functional outcomes at 1 week or 3 months after ED discharge compared to placebo.
This study does not support adding diazepam to an NSAID to outpatient therapy for acute, nontraumatic, nonradicular low back pain.

References

Citation: Friedman BW, Irizarry E, Solorzano C, et al. Diazepam is no better than placebo when added to naproxen for acute low back pain. Ann Emerg Med 2017. PMID 28187918

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