Clinical question
How effective is cyclobenzaprine for acute back pain?
Bottom line
Cyclobenzaprine reduces pain and leads to global improvement compared with placebo for 1 in every 3 to 9 patients in the first week. Cyclobenzaprine generally adds little to naproxen. Taken 3 times daily, 5 mg is as effective as 10 mg, with less somnolence.
Evidence
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In 3 systematic reviews (9 to 46 RCTs, 820 to 5401 patients) of non-benzodiazepine muscle relaxants versus placebo, differences were statistically significant1–3:
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Cyclobenzaprine versus placebo:
–One systematic review (14 RCTs, 3023 patients) showed global improvement (NNT = 3) at about 10 days.4
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–We pooled data from 2 publications with 2 RCTs each.
—Pain relief (1389 patients) was achieved at 7 days in 50% of those taking 5 mg of cyclobenzaprine 3 times daily versus 38% taking placebo (NNT = 9; P < .001).5 No difference was noted in 5 mg versus 10 mg or 2.5 mg versus placebo.
—No difference was noted between 30 mg extended release once daily and 10 mg immediate release 3 times daily (504 patients).6
An RCT of cyclobenzaprine plus ibuprofen (867 patients) showed no benefit to adding ibuprofen.7
An RCT of naproxen plus cyclobenzaprine (323 patients) showed no benefit to adding cyclobenzaprine at day 7, but only about 30% had frequent or continual back pain then.8
Context
Most trials were industry sponsored; had small samples, short durations, and poorly defined targets; and were unclear about whether cutoffs were clinically meaningful.4
No differences in efficacy were seen among the muscle relaxants, although cyclobenzaprine was more consistently evaluated.3 Cyclobenzaprine is equal or superior to diazepam.3 Other direct comparisons are lacking.
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Adverse events include dose-related somnolence and dry mouth. Somnolence occurred in 10% of those taking placebo, 29% taking 5 mg 3 times daily, and 38% taking 10 mg 3 times daily.5
–Taken 3 times daily, 10 mg caused more somnolence than 5 mg (number needed to harm of 12).
–Rates of discontinuation owing to somnolence were 0.8% for placebo, 2.5% for 5 mg 3 times daily, and 5.2% for 10 mg 3 times daily.5
Guidelines recommend cyclobenzaprine for the treatment of acute low back pain.9
Implementation
About 50% to 90% of people will have back pain; about 90% of those cases will be nonspecific.9 X-ray scans are discouraged for acute nonspecific back pain.10 For acute back pain, acetaminophen is no better than placebo11; NSAIDs provide global improvement for 1 in every 11 patients compared with placebo.12 Cyclobenzaprine is structurally similar to tricyclic antidepressants and has similar adverse events. It should be avoided in the elderly13 and be given as 5 mg. While muscle relaxants have abuse potential,14 we did not find studies describing abuse of cyclobenzaprine.
Footnotes
The opinions expressed in Tools for Practice articles are those of the authors and do not necessarily mirror the perspective and policy of the Alberta College of Family Physicians.
References
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