Systematic reviews including this primary study

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Systematic review

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Journal Annals of internal medicine
Year 2017
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BACKGROUND: A 2007 American College of Physicians guideline addressed pharmacologic options for low back pain. New evidence and medications have now become available. PURPOSE: To review the current evidence on systemic pharmacologic therapies for acute or chronic nonradicular or radicular low back pain. DATA SOURCES: Ovid MEDLINE (January 2008 through November 2016), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and reference lists. STUDY SELECTION: Randomized trials that reported pain, function, or harms of systemic medications versus placebo or another intervention. DATA EXTRACTION: One investigator abstracted data, and a second verified accuracy; 2 investigators independently assessed study quality. DATA SYNTHESIS: The number of trials ranged from 9 (benzodiazepines) to 70 (nonsteroidal anti-inflammatory drugs). New evidence found that acetaminophen was ineffective for acute low back pain, nonsteroidal anti-inflammatory drugs had smaller benefits for chronic low back pain than previously observed, duloxetine was effective for chronic low back pain, and benzodiazepines were ineffective for radiculopathy. For opioids, evidence remains limited to short-term trials showing modest effects for chronic low back pain; trials were not designed to assess serious harms. Skeletal muscle relaxants are effective for short-term pain relief in acute low back pain but caused sedation. Systemic corticosteroids do not seem to be effective. For effective interventions, pain relief was small to moderate and generally short-term; improvements in function were generally smaller. Evidence is insufficient to determine the effects of antiseizure medications. LIMITATIONS: Qualitatively synthesized new trials with prior meta-analyses. Only English-language studies were included, many of which had methodological shortcomings. Medications injected for local effects were not addressed. CONCLUSION: Several systemic medications for low back pain are associated with small to moderate, primarily short-term effects on pain. New evidence suggests that acetaminophen is ineffective for acute low back pain, and duloxetine is associated with modest effects for chronic low back pain. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality. (PROSPERO: CRD42014014735).

Systematic review

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Journal Cochrane Database of Systematic Reviews
Year 2016
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BACKGROUND: Analgesic medication is the most frequently prescribed treatment for low back pain (LBP), of which paracetamol (acetaminophen) is recommended as the first choice medication. However, there is uncertainty about the efficacy of paracetamol for LBP. OBJECTIVES: To investigate the efficacy and safety of paracetamol for non-specific LBP. SEARCH METHODS: We conducted searches on the Cochrane Central Register of Controlled Trials (CENTRAL, which includes the Back and Neck Review Group trials register), MEDLINE, EMBASE, CINAHL, AMED, Web of Science, LILACS, and IPA from their inception to 7 August 2015. We also searched the reference lists of eligible papers and trial registry websites (WHO ICTRP and ClinicalTrials.gov). SELECTION CRITERIA: We only considered randomised trials comparing the efficacy of paracetamol with placebo for non-specific LBP. The primary outcomes were pain and disability. We also investigated quality of life, function, adverse effects, global impression of recovery, sleep quality, patient adherence, and use of rescue medication as secondary outcomes. DATA COLLECTION AND ANALYSIS: Two review authors independently performed the data extraction and assessed risk of bias in the included studies. We also evaluated the quality of evidence using the GRADE approach. We converted scales for pain intensity to a common 0 to 100 scale. We quantified treatment effects using mean difference for continuous outcomes and risk ratios for dichotomous outcomes. We used effect sizes and 95% confidence intervals as a measure of treatment effect for the primary outcomes. When the treatment effects were smaller than 9 points on a 0 to 100 scale, we considered the effect as small and not clinically important. MAIN RESULTS: Our searches retrieved 4449 records, of which three trials were included in the review (n = 1825 participants), and two trials were included in the meta-analysis. For acute LBP, there is high-quality evidence for no difference between paracetamol (4 g per day) and placebo at 1 week (immediate term), 2 weeks, 4 weeks, and 12 weeks (short term) for the primary outcomes. There is high-quality evidence that paracetamol has no effect on quality of life, function, global impression of recovery, and sleep quality for all included time periods. There were also no significant differences between paracetamol and placebo for adverse events, patient adherence, or use of rescue medication. For chronic LBP, there is very low-quality evidence (based on a trial that has been retracted) for no effect of paracetamol (1 g single intravenous dose) on immediate pain reduction. Finally, no trials were identified evaluating patients with subacute LBP. AUTHORS' CONCLUSIONS: We found that paracetamol does not produce better outcomes than placebo for people with acute LBP, and it is uncertain if it has any effect on chronic LBP.

Systematic review

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Journal BMJ (Clinical research ed.)
Year 2015
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OBJECTIVE: To investigate the efficacy and safety of paracetamol (acetaminophen) in the management of spinal pain and osteoarthritis of the hip or knee. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, Embase, AMED, CINAHL, Web of Science, LILACS, International Pharmaceutical Abstracts, and Cochrane Central Register of Controlled Trials from inception to December 2014. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials comparing the efficacy and safety of paracetamol with placebo for spinal pain (neck or low back pain) and osteoarthritis of the hip or knee. DATA EXTRACTION: Two independent reviewers extracted data on pain, disability, and quality of life. Secondary outcomes were adverse effects, patient adherence, and use of rescue medication. Pain and disability scores were converted to a scale of 0 (no pain or disability) to 100 (worst possible pain or disability). We calculated weighted mean differences or risk ratios and 95% confidence intervals using a random effects model. The Cochrane Collaboration's tool was used for assessing risk of bias, and the GRADE approach was used to evaluate the quality of evidence and summarise conclusions. RESULTS: 12 reports (13 randomised trials) were included. There was "high quality" evidence that paracetamol is ineffective for reducing pain intensity (weighted mean difference -0.5, 95% confidence interval -2.9 to 1.9) and disability (0.4, -1.7 to 2.5) or improving quality of life (0.4, -0.9 to 1.7) in the short term in people with low back pain. For hip or knee osteoarthritis there was "high quality" evidence that paracetamol provides a significant, although not clinically important, effect on pain (-3.7, -5.5 to -1.9) and disability (-2.9, -4.9 to -0.9) in the short term. The number of patients reporting any adverse event (risk ratio 1.0, 95% confidence interval 0.9 to 1.1), any serious adverse event (1.2, 0.7 to 2.1), or withdrawn from the study because of adverse events (1.2, 0.9 to 1.5) was similar in the paracetamol and placebo groups. Patient adherence to treatment (1.0, 0.9 to 1.1) and use of rescue medication (0.7, 0.4 to 1.3) was also similar between groups. "High quality" evidence showed that patients taking paracetamol are nearly four times more likely to have abnormal results on liver function tests (3.8, 1.9 to 7.4), but the clinical importance of this effect is uncertain. CONCLUSIONS: Paracetamol is ineffective in the treatment of low back pain and provides minimal short term benefit for people with osteoarthritis. These results support the reconsideration of recommendations to use paracetamol for patients with low back pain and osteoarthritis of the hip or knee in clinical practice guidelines. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42013006367.

Systematic review

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Journal Spine
Year 2008
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Study Design. A systematic review of randomized controlled trials. ObjectiveS. To assess the effects of nonsteroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors in the treatment of nonspecific low back pain and to assess which type of NSAID is most effective. Summart of Background Data. NSAIDs are the most frequently prescribed medications worldwide and are widely used for patients with low back pain. Selective COX-2 inhibitors are currently available and used for patients with low back pain. Methods. We searched the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Trials up to and including June 2007 if reported in English, Dutch, or German. We also screened references given in relevant reviews and identified trials. Randomized trials and double-blind controlled trials of NSAIDs in nonspecific low back pain with or without sciatica were included. Results. In total, 65 trials (total number of patients = 11,237) were included in this review. Twenty-eight trials (42%) were considered high quality. Statistically significant effects were found in favor of NSAIDs compared with placebo, but at the cost of statistically significant more side effects. There is moderate evidence that NSAIDs are not more effective than paracetamol for acute low back pain, but paracetamol had fewer side effects. There is moderate evidence that NSAIDs are not more effective than other drugs for acute low back pain. There is strong evidence that various types of NSAIDs, including COX-2 NSAIDs, are equally effective for acute low back pain. COX-2 NSAIDs had statistically significantly fewer side effects than traditional NSAIDs. Conclusion. The evidence from the 65 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute and chronic low back pain without sciatica. However, effect sizes are small. Furthermore, there does not seem to be a specific type of NSAID, which is clearly more effective than others. The selective COX-2 inhibitors showed fewer side effects compared with traditional NSAIDs in the randomized controlled trials included in this review. However, recent studies have shown that COX-2 inhibitors are associated with increased cardiovascular risks in specific patient populations. © 2008 Lippincott Williams & Wilkins.

Systematic review

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Authors Davies RA , Maher CG , Hancock MJ
Journal European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
Year 2008
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The objective of this study was to assess the efficacy of paracetamol (acetaminophen) in the treatment of pain and disability in patients with non-specific low back pain. We conducted a systematic review of randomized controlled trials to assess the efficacy of paracetamol in the treatment of pain and disability in patients with non-specific low back pain. A search for randomized controlled trials was conducted using the Medline, Embase and CINAHL databases. Trials were eligible if they were randomized controlled trials comparing paracetamol to no treatment, placebo or another treatment in patients with non-specific low back pain. Two of the authors independently assessed trials for methodological quality on the PEDro Scale and extracted data. Continuous pain and disability data were converted to a common 0-10 scale; ordinal data were dichotomized (e.g., no pain, pain). The data was analyzed using the MIX version 1.61 meta-analysis software. Out of 205 unique articles found in the searches, 7 eligible trials were identified. The trials enrolled a total of 676 participants with 5 investigating acute low back pain, 1 investigating chronic low back pain and 1 investigating both. No trial provided data comparing paracetamol to placebo and only one trial compared paracetamol to no treatment. In general the trials were small (only 1 trial had >25 subjects per group) and of low methodological quality (only 2 had a score above 6 on the quality scale). All but one of the trials provided imprecise estimates of the effects of treatment with confidence intervals spanning clinically important beneficial and also harmful effects of paracetamol. No trial reported a statistically significant difference in favor of paracetamol. There is insufficient evidence to assess the efficacy of paracetamol in patients with low back pain. There is a clear need for large, high quality randomized controlled trials evaluating paracetamol, to provide reliable evidence of paracetamol's effectiveness in patients with low back pain and to establish the validity of the recommendations in clinical guidelines.

Systematic review

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Journal Cochrane database of systematic reviews (Online)
Year 2008
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BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) are the most frequently prescribed medications worldwide and are widely used for patients with low-back pain. Selective COX-2 inhibitors are currently available and used for patients with low-back pain. OBJECTIVES: The objective was to assess the effects of NSAIDs and COX-2 inhibitors in the treatment of non-specific low-back pain and to assess which type of NSAID is most effective. SEARCH STRATEGY: We searched the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Trials up to and including June 2007 if reported in English, Dutch or German. We also screened references given in relevant reviews and identified trials. SELECTION CRITERIA: Randomised trials and double-blind controlled trials of NSAIDs in non-specific low-back pain with or without sciatica were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed methodological quality. All studies were also assessed on clinical relevance, from which no further interpretations or conclusions were drawn. If data were considered clinically homogeneous, a meta-analysis was performed. If data were lacking for clinically homogeneous trials, a qualitative analysis was performed using a rating system with four levels of evidence (strong, moderate, limited, no evidence). MAIN RESULTS: In total, 65 trials (total number of patients = 11,237) were included in this review. Twenty-eight trials (42%) were considered high quality. Statistically significant effects were found in favour of NSAIDs compared to placebo, but at the cost of statistically significant more side effects. There is moderate evidence that NSAIDs are not more effective than paracetamol for acute low-back pain, but paracetamol had fewer side effects. There is moderate evidence that NSAIDs are not more effective than other drugs for acute low-back pain. There is strong evidence that various types of NSAIDs, including COX-2 NSAIDs, are equally effective for acute low-back pain. COX-2 NSAIDs had statistically significantly fewer side-effects than traditional NSAIDs. AUTHORS' CONCLUSIONS: The evidence from the 65 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute and chronic low-back pain without sciatica. However, effect sizes are small. Furthermore, there does not seem to be a specific type of NSAID which is clearly more effective than others. The selective COX-2 inhibitors showed fewer side effects compared to traditional NSAIDs in the RCTs included in this review. However, recent studies have shown that COX-2 inhibitors are associated with increased cardiovascular risks in specific patient populations.

Systematic review

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Journal Cochrane Database of Systematic Reviews
Year 2006
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Background: Heat and cold are commonly utilised in the treatment of low-back pain by both health care professionals and people with low-back pain. Objectives: To assess the effects of superficial heat and cold therapy for low-back pain in adults. Search methods: We searched the Cochrane Back Review Group Specialised register, the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to October 2005), EMBASE (1980 to October 2005) and other relevant databases. Selection criteria: We included randomised controlled trials and non-randomised controlled trials that examined superficial heat or cold therapies in people with low-back pain. Data collection and analysis: Two authors independently assessed methodological quality and extracted data, using the criteria recommended by the Cochrane Back Review Group. Main results: Nine trials involving 1117 participants were included. In two trials of 258 participants with a mix of acute and sub-acute low-back pain, heat wrap therapy significantly reduced pain after five days (weighted mean difference (WMD) 1.06, 95% confidence interval (CI) 0.68 to 1.45, scale range 0 to 5) compared to oral placebo. One trial of 90 participants with acute low-back pain found that a heated blanket significantly decreased acute low-back pain immediately after application (WMD -32.20, 95%CI -38.69 to -25.71, scale range 0 to 100). One trial of 100 participants with a mix of acute and sub-acute low-back pain examined the additional effects of adding exercise to heat wrap, and found that it reduced pain after seven days. There is insufficient evidence to evaluate the effects of cold for low-back pain, and conflicting evidence for any differences between heat and cold for low-back pain. Authors' conclusions: The evidence base to support the common practice of superficial heat and cold for low back pain is limited and there is a need for future higher-quality randomised controlled trials. There is moderate evidence in a small number of trials that heat wrap therapy provides a small short-term reduction in pain and disability in a population with a mix of acute and sub-acute low-back pain, and that the addition of exercise further reduces pain and improves function. The evidence for the application of cold treatment to low-back pain is even more limited, with only three poor quality studies located. No conclusions can be drawn about the use of cold for low-back pain. There is conflicting evidence to determine the differences between heat and cold for low-back pain. Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.