OBJECTIVES: Patients with low back pain (LBP) are often treated with nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs are modestly effective for LBP, but many patients with LBP continue to suffer despite treatment with these medications. We compared pain and functional outcomes 1 week after emergency department (ED) discharge among patients randomized to a 1-week course of ibuprofen plus acetaminophen versus ibuprofen plus placebo.
METHODS: This was a randomized, double-blind study conducted in two urban EDs. Patients presenting with acute, nontraumatic, nonradicular LBP of no more than 2 weeks' duration were eligible for enrollment immediately prior to discharge from an ED if they had a score > 5 on the Roland Morris Disability Questionnaire (RMDQ), a 24-item validated instrument, indicating more than minimal functional impairment. All patients were given a standardized 10-minute LBP educational session prior to discharge. The primary outcome was improvement on the RMDQ between ED discharge and 1 week later. One secondary outcome was pain intensity, as measured on a 4-point descriptive scale (severe, moderate, mild, none) at 1 week.
RESULTS: Enrollment began in October 2018. A total of 120 patients met selection criteria and were randomized. Baseline demographic characteristics were comparable between the two groups. By 1 week after the ED visit, patients randomized to ibuprofen plus placebo reported a mean (±SD) improvement in the RMDQ of 11.9 (±9.7), while those randomized to ibuprofen plus acetaminophen reported a mean (±SD) improvement of 11.1 (±10.7). The 95% CI for the between-group difference of 0.8 was -3.0 to 4.7. At 1 week, moderate or severe pain was reported by 15 of 53 (28%) patients in the ibuprofen plus placebo group and 16 of 57 (28%) patients in the ibuprofen plus acetaminophen group (95% CI for between-group difference of 0% = -17% to 17%).
CONCLUSION: Among ED patients with acute, nontraumatic, nonradicular LBP, adding acetaminophen to ibuprofen does not improve outcomes within 1 week.
Poorly written abstract that fails to characterize the study arms or allocation protocol. Apparently, patients with benign back pain were randomized to a single drug or a combination (but without considering an acetaminophen-only arm) and found no average difference. This finding is of very low impact on decision-making, including cost of care decisions. Practitioners may well choose to simply work out a plan with the individual patient based on preference.
While this was one trial, in a specific location, with a specific demographic, etc. etc., it is hard not to become nihilistic these days about the treatment of low back pain. Maybe there will eventually be reduced expectations - like treatments for the common cold - but I suspect it will take a very long time to train physicians and patients to decrease their expectations for some medication to effectively relieve low back pain. It appears that mostly all we can do is be patient, give sympathy, and suggest the use a heating pad for one of life's common discomforts.
This is a well designed randomized control trial looking at 600mg ibuprofen plus 500-1000mg of acetaminophen or placebo for breakthrough pain. The population selected is well representative of a general ED population. Additionally, the main outcome measure was a functional assessment, instead of just pain scores. The study results demonstrate that addition of acetaminophen as a breakthrough analgesic may not have any additional benefit in terms of quality of life or functional outcomes. Pain outcomes, return visits and primary care follow-up was also not affected. What remains unanswered is if regular combined NSAIDs are helpful, instead of a breakthrough regime. As with other studies on this topic, the majority of patients (>80%) got better, regardless of treatment received. Predicting who will have ongoing pain remains difficult, which emphasizes the need for good primary care follow-up.
I was surprised by the small sample size, low back pain has a wide range of improvement and the Roland Morris Disability Questionnaire which are nonparametric data. I would expect a larger sample size to get a good representation of this population. Also, 600 mg of ibuprofen was given regularly. However, acetaminophen was given 500 mg or 1000 mg and if taking only 500 mg the patient had to wait 30 minutes before taking another 500 mg. Results could have been different if patients used 1000 mg regularly. Acetaminophen is safe and has few side effects. This study does not convince me to stop using the ibuprofen acetaminophen combination.