Diazepam Doesn’t Help Back Pain
March 22, 2017
Short Attention Span Summary
It was a Valium effort…
NSAIDs are an evidence-based treatment for low back pain but not benzos, yet they are often prescribed as a muscle relaxer. This was a randomized, double-blind trial of naproxen + diazepam vs. naproxen + placebo in patients with moderate functional impairment due to pain. They found the same improvement in functional impairment in both groups and worsening pain in those who received diazepam at one week.
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Diazepam doesn’t help low back pain. Here is RCT data that proves it. REBEL EM covered this article in depth.
Abstract
Ann Emerg Med. 2017 Jan 19. pii: S0196-0644(16)31214-8. doi: 10.1016/j.annemergmed.2016.10.002. [Epub ahead of print]
Diazepam Is No Better Than Placebo When Added to Naproxen for Acute Low Back Pain.
Friedman BW1, Irizarry E2, Solorzano C3, Khankel N2, Zapata J2, Zias E3, Gallagher EJ2.
Author information:
1Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY. Electronic address: bwfriedmanmd@gmail.com.
2Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.
3the Department of Pharmacy, Montefiore Medical Center, Bronx, NY.
Abstract
STUDY OBJECTIVE:
Low back pain causes more than 2.5 million visits to US emergency departments (EDs) annually. Low back pain patients are often treated with nonsteroidal anti-inflammatory drugs and benzodiazepines. The former is an evidence-based intervention, whereas the efficacy of the latter has not been established. We compare pain and functional outcomes 1 week and 3 months after ED discharge among patients randomized to a 1-week course of naproxen+diazepam versus naproxen+placebo.
METHODS:
This was a randomized, double-blind, comparative efficacy clinical trial conducted in an urban health care system. Patients presenting with acute, nontraumatic, nonradicular low back pain of no more than a duration of 2 weeks were eligible for enrollment immediately before discharge from an ED if they had a score greater than 5 on the Roland-Morris Disability Questionnaire, a validated 24-item inventory of functional impairment caused by low back pain. Higher scores on the questionnaire indicate greater functional disability. The primary outcome in the trial was improvement in the score between ED discharge and 1 week later. Secondary outcomes included pain intensity 1 week and 3 months after ED discharge, as measured on a 4-point descriptive scale (severe, moderate, mild, and none). All patients were given 20 tablets of naproxen 500 mg, to be taken twice a day as needed for low back pain. Additionally, patients were randomized to receive either 28 tablets of diazepam 5 mg or identical placebo, to be received as 1 or 2 tablets every 12 hours as needed for low back pain. All patients received a standardized 10-minute low back pain educational session before discharge. Using a between-group mean difference of 5 Roland-Morris Disability Questionnaire points, a previously validated threshold for clinical significance, we calculated the need for at least 100 patients with primary outcome data.
RESULTS:
Enrollment began in June 2015 and continued for 9 months. Five hundred forty-five patients were screened for eligibility. One hundred fourteen patients met selection criteria and were randomized. Baseline demographic characteristics were not substantially different between the 2 groups. One hundred twelve patients (98%) provided 1-week outcome data. The mean Roland-Morris Disability Questionnaire score of patients randomized to naproxen+diazepam improved by 11 (95% confidence interval [CI] 9 to 13), as did the mean score of patients randomized to naproxen+placebo (11; 95% CI 8 to 13). At 1-week follow-up, 18 of 57 diazepam patients (32%; 95% CI 21% to 45%) reported moderate or severe low back pain versus 12 of 55 placebo patients (22%; 95% CI 13% to 35%). At 3-month follow-up, 6 of 50 diazepam patients (12%; 95% CI 5% to 24%) reported moderate or severe low back pain versus 5 of 53 placebo patients (9%; 95% CI 4% to 21%). Adverse events were reported by 12 of 57 diazepam patients (21%; 95% CI 12% to 33%) and 8 of 55 placebo patients (15%; 95% CI 7% to 26%).
CONCLUSION:
Among ED patients with acute, nontraumatic, nonradicular low back pain, naproxen+diazepam did not improve functional outcomes or pain compared with naproxen+placebo 1 week and 3 months after ED discharge.
Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
PMID: 28187918 [PubMed – as supplied by publisher]