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Roelofs PD

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Systematic review

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A comprehensive review of clinical trials on the efficacy and safety of drugs for the treatment of low back pain.

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Journal Journal of pain and symptom management
Year 2004
Links Pubmed DOI

This article is included in 2 Broad syntheses 50 Broad syntheses (2 references)

This article includes 50 Primary studies 50 Primary studies (50 references)

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A systematic review involving 50 randomized controlled trials (4,863 patients) published since 1980 was undertaken with the objective of assessing efficacy and safety of low back pain (LBP) medications. The methodological quality of each trial was evaluated based on a standardized system. Quality scores ranged from 26 to 82 points on a 100-point scale (from 0 to 100), indicating an overall moderate quality of the trials reviewed. Limited evidence was found regarding the effectiveness of drug treatments for LBP and current studies focused on short-term usage of the therapies. Available evidence supported the effectiveness of non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) in acute and chronic LBP, of muscle relaxants in acute LBP, and of antidepressants in chronic LBP; safety results were heterogeneous. More rigorously designed trials should be implemented to establish comparative efficacy and safety of drugs used to treat chronic and acute LBP.

Systematic review

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Muscle relaxants for non‐specific low‐back pain

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Journal Cochrane database of systematic reviews (Online)
Year 2003
Links Pubmed DOI PubMed Central

This article is included in 2 Broad syntheses 18 Broad syntheses (2 references)

This article includes 18 Primary studies 18 Primary studies (18 references)

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BACKGROUND: The use of muscle relaxants in the management of non-specific low back pain is controversial. It is not clear if they are effective, and concerns have been raised about the potential adverse effects involved. OBJECTIVES: The aim of this review was to determine if muscle relaxants are effective in the treatment of non-specific low back pain. SEARCH STRATEGY: A computer-assisted search of the Cochrane Library (Issue 3, 2002), MEDLINE (1966 up to October 2002) and EMBASE (1988 up to October 2002) was carried out. These databases were searched using the algorithm recommended by the Cochrane Back Review Group. References cited in the identified articles and other relevant literature were screened. SELECTION CRITERIA: Randomised and/or double-blinded controlled trials, involving patients diagnosed with non-specific low back pain, treated with muscle relaxants as monotherapy or in combination with other therapeutic modalities, were included for review. DATA COLLECTION AND ANALYSIS: Two authors independently carried out the methodological quality assessment and data extraction of the trials. The analysis comprised not only a quantitative analysis (statistical pooling) but also a qualitative analysis ("best evidence synthesis"). This involved the appraisal of the strength of evidence for various conclusions using a rating system based on the quality and outcomes of the studies included. Evidence was classified as "strong", "moderate", "limited", "conflicting" or "no" evidence. MAIN RESULTS: Thirty trials met the inclusion criteria. Twenty-three trials (77%) were of high quality, 24 trials (80%) were on acute low back pain. Four trials studied benzodiazepines, 11 non-benzodiazepines and two antispasticity muscle relaxants in comparison with placebo. Results showed that there is strong evidence that any of these muscle relaxants are more effective than placebo for patients with acute LBP on short-term pain relief. The pooled RR for non-benzodiazepines versus placebo after two to four days was 0.80 [95% CI; 0.71 to 0.89] for pain relief and 0.49 [95% CI; 0.25 to 0.95] for global efficacy. Adverse events, however, with a relative risk of 1.50 [95% CI; 1.14 to 1.98] were significantly more prevalent in patients receiving muscle relaxants and especially the central nervous system adverse effects (RR 2.04; 95% CI; 1.23 to 3.37). The various muscle relaxants were found to be similar in performance. AUTHORS' CONCLUSIONS: Muscle relaxants are effective in the management of non-specific low back pain, but the adverse effects require that they be used with caution. Trials are needed that evaluate if muscle relaxants are more effective than analgesics or non-steroidal anti-inflammatory drugs.

Systematic review

Unclassified

Systematic review of antidepressants in the treatment of chronic low back pain.

Journal Spine
Year 2003
Links Pubmed DOI

This article is included in 2 Structured summaries of systematic reviews 22 Structured summaries of systematic reviews (2 references) 2 Broad syntheses 22 Broad syntheses (2 references)

This article includes 22 Primary studies 22 Primary studies (22 references)

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BACKGROUND: Three previous reviews have reached conflicting conclusions regarding the efficacy of antidepressants for patients with back pain. OBJECTIVES: To systematically review the efficacy of antidepressants for the treatment of patients with back pain and to determine whether there is evidence that outcomes vary between classes of antidepressants. MATERIALS AND METHODS: Best evidence synthesis of randomized, placebo-controlled trials of oral antidepressive agents in patients with back pain. Studies were identified by searching MEDLINE, PsycINFO, and the Cochrane Controlled Trials Registry. Two independent reviewers performed data extraction and assessed included studies with a 22-point methodologic quality assessment scale. Effect sizes were calculated if sufficient data were available. RESULTS: Twenty-two trials of antidepressants for the treatment of back pain were identified, of which seven studies of chronic low back pain met inclusion criteria. Among studies using antidepressants that inhibit norepinephrine reuptake (tricyclic or tetracyclic antidepressants), four of five found significant improvement in at least one relevant outcome measure. Assessment of these agents' impact on functional measures produced mixed results. No benefit in pain relief or functional status was found in three studies of antidepressants that do not inhibit norepinephrine reuptake. CONCLUSIONS: Based on a small number of studies, tricyclic and tetracyclic antidepressants appear to produce moderate symptom reductions for patients with chronic low back pain. This benefit appears to be independent of depression status. SSRIs do not appear to be beneficial for patients with chronic low back pain. There is conflicting evidence whether antidepressants improve functional status of patients with chronic low back pain.

Systematic review

Unclassified

Muscle relaxants for nonspecific low back pain: a systematic review within the framework of the Cochrane Collaboration.

Journal Spine
Year 2003
Links Pubmed DOI

Without references

This article is included in 2 Broad syntheses 0 Broad syntheses (2 references)

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STUDY DESIGN: A systematic review of randomized and/or double-blinded controlled trials. SUMMARY OF BACKGROUND DATA: The use of muscle relaxants in the management of nonspecific low back pain is controversial. It is not clear if they are effective, and concerns have been raised about the potential adverse effects involved. OBJECTIVES: The aim of this review was to determine if muscle relaxants are effective in the treatment of nonspecific low back pain. METHODS: A computer-assisted search of the Cochrane Library (Issue 2, 2002), MEDLINE (1966 up to October 2001), and EMBASE (1988 up to October 2001) was carried out. These databases were searched using the algorithm recommended by the Cochrane Back Review Group. References cited in the identified articles and other relevant literature were screened. Randomized and/or double-blinded controlled trials, involving patients diagnosed with nonspecific low back pain, treated with muscle relaxants as monotherapy or in combination with other therapeutic methods, were included for review. Two reviewers independently carried out the methodologic quality assessment and data extraction of the trials. The analysis comprised not only a quantitative analysis (statistical pooling) but also a qualitative analysis ("best evidence synthesis"). This involved the appraisal of the strength of evidence for various conclusions using a rating system based on the quality and outcomes of the studies included. Evidence was classified as "strong," "moderate," "limited," "conflicting," or "no" evidence. RESULTS: Thirty trials met the inclusion criteria. Twenty-three trials (77%) were of high quality; 24 trials (80%) were on acute low back pain. Four trials studied benzodiazepines, 11 nonbenzodiazepines, and 2 antispasticity muscle relaxants in comparison with placebo. Results showed that there is strong evidence that any of these muscle relaxants are more effective than placebo for patients with acute low back pain on short-term pain relief. The pooled relative risk for nonbenzodiazepines versus placebo after 2 to 4 days was 0.80 (95% confidence interval: 0.71 to 0.89) for pain relief and 0.49 (95% confidence interval: 0.25 to 0.95) for global efficacy. Adverse events, however, with a relative risk of 1.50 (95% confidence interval: 1.14 to 1.98) were significantly more prevalent in patients receiving muscle relaxants and especially the central nervous system adverse effects (relative risk 2.04; 95% confidence interval: 1.23 to 3.37). The various muscle relaxants were found to be similar in performance. CONCLUSIONS: Muscle relaxants are effective in the management of nonspecific low back pain, but the adverse effects require that they be used with caution. Trials are needed that evaluate if muscle relaxants are more effective than analgesics or nonsteroidal anti-inflammatory drugs.

Systematic review

Unclassified

The effect of antidepressant treatment on chronic back pain: a meta-analysis.

Journal Archives of internal medicine
Year 2002
Links Pubmed DOI

This article is included in 1 Structured summary of systematic reviews 9 Structured summaries of systematic reviews (1 reference) 1 Broad synthesis 9 Broad syntheses (1 reference)

This article includes 9 Primary studies 9 Primary studies (9 references)

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BACKGROUND: Back pain is one of the most common problems in primary care. Antidepressant medication is often prescribed, especially for chronic back discomfort, to alleviate pain and restore the patient's ability to conduct activities of daily living. OBJECTIVE: To assess the efficacy of antidepressants in treating back pain in adults. METHODS: We searched the MEDLINE (1966-2000), PsycLit, Cinhal, EMBASE, AIDSLINE, HealthSTAR, CANCERLIT, the Cochrane Library (clinical trials registry and the Database of Systematic Reviews), Micromedex, and Federal Research in Progress databases and references of reviewed articles. Included articles were written in English and dealt with randomized placebo-controlled trials of antidepressant medication use among adults with chronic back pain. Two reviewers abstracted data independently. Two continuous outcomes, change in back pain severity and ability to perform activities of daily living, were measured. Study quality was assessed with the methods used by Jadad and colleagues, and data were synthesized using a random-effects model. RESULTS: Nine randomized controlled trials with 10 treatment arms and 504 patients were included. Seven treatment arms included patients with major depression. Patients had chronic back pain, averaging 10.4 years. Patients treated with antidepressants were more likely to improve in pain severity than those taking placebo (standardized mean difference, 0.41; 95% confidence interval, 0.22-0.61) but not in activities of daily living (standardized mean difference, 0.24; 95% confidence interval, -0.21-0.69). Patients treated with antidepressants experienced more adverse effects (22% vs 14%, P =.01) than those receiving placebo. CONCLUSION: Antidepressants are more effective than placebo in reducing pain severity but not functional status in chronic back pain.

Systematic review

Unclassified

Cyclobenzaprine and back pain: a meta-analysis.

Journal Archives of internal medicine
Year 2001
Links Pubmed DOI

This article is included in 1 Structured summary of systematic reviews 9 Structured summaries of systematic reviews (1 reference) 1 Broad synthesis 9 Broad syntheses (1 reference)

This article includes 9 Primary studies 9 Primary studies (9 references)

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BACKGROUND: Back pain is a common problem for which cyclobenzaprine hydrochloride is frequently prescribed. OBJECTIVE: To perform a systematic review of cyclobenzaprine's effectiveness in the treatment of back pain. METHODS: We searched MEDLINE, PsycLIT, CINAHL, EMBASE, AIDSLINE, HEALTHSTAR, CANCERLIT, the Cochrane Library, Micromedex, Federal Research in Progress, and the references of reviewed articles, and contacted Merck, Sharpe and Dohme for English-language, randomized, placebo-controlled trials of cyclobenzaprine in adults with back pain. Outcomes included global improvement and 5 specific domains of back pain (local pain, muscle spasm, range of motion, tenderness to palpation, and activities of daily living). Study quality was assessed using the methods of Jadad. Summary outcomes were obtained using a random-effects model. RESULTS: Patients treated with cyclobenzaprine were nearly 5 times (odds ratio, 4.7; 95% confidence interval, 2.7-8.1) as likely to report symptom improvement by day 14 as were those treated with placebo. Slightly fewer than 3 individuals (2.7; 95% confidence interval, 2.0-4.2) needed treatment for 1 to improve. The magnitude of this improvement was modest, with an effect size of 0.38 to 0.58 in all 5 outcomes (local pain, muscle spasm, tenderness to palpation, range of motion, and activities of daily living). Treatment efficacy for these 5 outcomes was greatest early, in the first few days of treatment, declining after the first week. Patients receiving cyclobenzaprine also experienced more adverse effects, the most common being drowsiness. CONCLUSIONS: Cyclobenzaprine is more effective than placebo in the management of back pain; the effect is modest and comes at the price of greater adverse effects. The effect is greatest in the first 4 days of treatment, suggesting that shorter courses may be better. Studies comparing the relative value of acetaminophen, nonsteroidal anti-inflammatory drugs, and cyclobenzaprine individually and in combination in the treatment of back pain are needed.

Systematic review

Unclassified

Nonsteroidal anti-inflammatory drugs for low back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group.

Journal Spine
Year 2000
Links Pubmed DOI

Without references

This article is included in 1 Structured summary of systematic reviews 0 Structured summaries of systematic reviews (1 reference) 2 Broad syntheses 0 Broad syntheses (2 references)

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STUDY DESIGN: A systematic review of randomized and double-blind controlled trials was performed. SUMMARY OF BACKGROUND DATA: Nonsteroidal anti-inflammatory drugs are the most frequently prescribed medications worldwide and are widely used for patients with low back pain. OBJECTIVES: To assess the effects of nonsteroidal anti-inflammatory drugs in the treatment of nonspecific low back pain with or without radiation, and to assess which type of nonsteroidal anti-inflammatory drug is most effective. METHODS: For this study, the Cochrane Controlled Trials Register, Medline and Embase, and reference lists of articles were searched. Two reviewers blinded with respect to authors, institution, and journal independently extracted data and assessed the methodologic quality of the studies. If data were considered clinically homogeneous, a meta-analysis was performed. If data were considered clinically heterogeneous, a qualitative analysis was performed using a rating system with four levels of evidence: strong, moderate, limited, and no evidence. RESULTS: This review involved 51 trials and 6057 patients. Of these trials, 16 (31%) were of high quality. The pooled relative risk for global improvement after 1 week was 1.24 (95% confidence interval [CI] = 1.10-1.41), and for additional analgesic use was 1.29 (95% CI = 1.05-1.57), indicating a statistically significant but small effect in favor of nonsteroidal anti-inflammatory drugs as compared with a placebo. The results of the qualitative analysis showed that there is conflicting evidence (Level 3) that nonsteroidal anti-inflammatory drugs are more effective than paracetamol for acute low back pain, and that there is moderate evidence (Level 2) that nonsteroidal anti-inflammatory drugs are not more effective than other drugs for acute low back pain. There is strong evidence (Level 1) that various types of nonsteroidal anti-inflammatory drugs are equally effective for acute low back pain. CONCLUSIONS: The evidence from the 51 trials included in this review suggests that nonsteroidal anti-inflammatory drugs are effective for short-term symptomatic relief in patients with acute low back pain. Furthermore, there does not seem to be a specific type of nonsteroidal anti-inflammatory drug that is clearly more effective than others. Sufficient evidence on chronic low back pain still is lacking.

Systematic review

Unclassified

Conservative treatment of sciatica: a systematic review.

Journal Journal of spinal disorders
Year 2000
Links Pubmed DOI

Without references

This article is included in 1 Structured summary of systematic reviews 0 Structured summaries of systematic reviews (1 reference) 2 Broad syntheses 0 Broad syntheses (2 references)

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Most patients with sciatica (often caused by disc herniations) are managed conservatively at first. The natural course seems to be favorable. The additional value of many conservative therapies remains controversial. Because a systematic review of the conservative treatment of sciatica is lacking, such a review was carried out. After a standardized literature search and selection procedure, methodology and outcome of randomized controlled trials (RCTs) were assessed by three observers. If possible, trial results were statistically pooled (= metaanalysis). The 19 RCTs that were selected showed greatly varying methodologic quality. Pooled odds ratios were calculated for several treatment types. Neither traction, exercise therapy, nor drug therapy was unequivocally effective. Epidural steroids may be beneficial for subgroups of nerve root compression. The literature suggests possible effectiveness of epidural steroids for sciatica. The authors recommend trials to investigate this treatment option further, especially with regard to patient subgroups (e.g., acute sciatica). The effects of clinical heterogeneity and methodology on review results are illustrated.