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Diazepam no better than placebo for low back pain

Naproxen plus diazepam did not improve functional outcomes or pain compared with naproxen plus placebo among patients with acute low back pain measured at 1 week and 3 months after discharge, according to findings published in Annals of Emergency Medicine.

“Low back pain is responsible for 2.4% of visits to U.S. EDs, resulting in 2.7 million visits annually. Pain outcomes for these patients are generally poor,” Benjamin W. Friedman, MD, MS, from the department of emergency medicine at Albert Einstein College of Medicine and Montefiore Medical Center, and colleagues wrote. “It is not clear whether the addition of other classes of therapeutic agents to nonsteroidal anti-inflammatory drugs can further improve low back pain outcomes.”

Although doctors commonly treat patients with low back pain with NSAIDs and benzodiazepines, the efficacy of benzodiazepines remains uncertain. Researchers conducted a double-blind study to compare pain and functional outcomes 1 week and 3 months after ED discharge among patients with low back pain randomly assigned to a 1-week course of naproxen plus diazepam or naproxen plus placebo in an urban health care setting.

Using the Roland-Morris Disability Questionnaire, (which, according to the questionnaire’s website, is a widely-used health status measure for low back pain) they determined level of functional impairment caused by low back pain to assess potential improvement in the score between ED discharge and 1 week later. All patients randomly received either 28 tablets of diazepam 5 mg or identical placebo. Patients took one or two tablets every 12 hours as needed for pain.

Of the 114 patients who had a score greater than 5 on the Roland-Morris Disability Questionnaire, 112 provided 1-week outcome data. The results showed the mean score improved by 11 for both the naproxen plus diazepam (95% CI, 9-13) and naproxen plus placebo (95% CI, 8-13). The investigators found that 18 of 57 patients assigned to diazepam reported moderate or severe back pain (32%; 95% CI, 21-45) compared with 12 of 55 placebo patients (22%; 95% CI, 13-35) at 1-week follow-up. At 3-month follow-up, six of 50 (12%) diazepam patients experienced moderate or severe back pain (95% CI, 5-24) compared with five of 53 (9%) placebo patients (CI, 95% CI, 4-21). They also found that 21% of diazepam patients (95% CI, 12-33) and 15% of placebo patients (95% CI, 7-26) reported adverse events.

“Diazepam does not appear to confer any benefit beyond that of placebo when added to naproxen for the treatment of nonradicular, nontramatic, acute low back pain,” Friedman and colleagues wrote. “Our data contribute to an increasing body of literature suggesting that, in general, most medications do not improve acute low back pain.”

This research dovetails with a recent recommendation from the ACP advocating drug-free treatment for low back pain, citing a systematic review that evaluated noninvasive pharmacological and non-pharmacological treatments of acute or chronic nonradicular or radicular low back pain of clinical trials conducted through April 2015. Another systematic review that evaluated the effectiveness of nonsteroidal anti-inflammatory drugs vs. placebo in managing spinal pain suggested only one in six patients treated with NSAIDs received any significant benefit, and that these drugs may also increase the risk for gastrointestinal infections. – by Savannah Demko

Disclosure: Friedman reports no relevant financial disclosures.

Further reading: http://www.rmdq.org/