Andrea D. Furlan

Updated method guidelines for systematic reviews in the cochrane collaboration back review group.

Study Design. Descriptive method guidelines. Objectives. To help reviewers design, conduct, and report reviews of trials in the field of back and neck pain. Summary of Background Data. In 1997, the Cochrane Collaboration Back Review Group published method guidelines for systematic reviews. Since its publication, new methodologic evidence emerged and more experience was acquired in conducting reviews. Methods. All reviews and protocols of the Back Review Group were assessed for compliance with the 1997 method guidelines. Also, the most recent version of the Cochrane Handbook (4.1) was checked for new recommendations. In addition, some important topics that were not addressed in the 1997 method guidelines were included (e.g., methods for qualitative analysis, reporting of conclusions, and discussion of clinical relevance of the results). In May 2002, preliminary results were presented and discussed in a workshop. In two rounds, a list of all possible recommendations and the final draft were circulated for comments among the editors of the Back Review Group. Results. The recommendations are divided in five categories: literature search, inclusion criteria, methodologic quality assessment, data extraction, and data analysis. Each recommendation is classified in minimum criteria and further guidance. Additional recommendations are included regarding assessment of clinical relevance, and reporting of results and conclusions. Conclusions. Systematic reviews need to be conducted as carefully as the trials they report and, to achieve full impact, systematic reviews need to meet high methodologic standards.

2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group.

Study Design. Method guidelines for systematic reviews of trials of treatments for neck and back pain. Objective. To help review authors design, conduct and report systematic reviews of trials in this field. Summary of Background Data. In 1997, the Cochrane Back Review Group published Method Guidelines for Systematic Reviews, which was updated in 2003. Since then, new methodologic evidence has emerged and standards have changed. Coupled with the upcoming revisions to the software and methods required by The Cochrane Collaboration, it was clear that revisions were needed to the existing guidelines. Methods. The Cochrane Back Review Group editorial and advisory boards met in June 2006 to review the relevant new methodologic evidence and determine how it should be incorporated. Based on the discussion, the guidelines were revised and circulated for comment. As sections of the new Cochrane Handbook for Systematic Reviews of Interventions were made available, the guidelines were checked for consistency. A working draft was made available to review authors in The Cochrane Library 2008, issue 3. Results. The final recommendations are divided into 7 categories: objectives, literature search, inclusion criteria, risk of bias assessment, data extraction, data analysis, and updating your review. Each recommendation is classified into minimum criteria (mandatory) and further guidance (optional). Instead of recommending Levels of Evidence, this update adopts the GRADE approach to determine the overall quality of the evidence for important patient-centered outcomes across studies and includes a new section on updating reviews. Conclusion. Citations of previous versions of the method guidelines in published scientific articles (1997: 254 citations; 2003: 209 citations, searched February 10, 2009) suggest that others may find these guidelines useful to plan, conduct, or evaluate systematic reviews in the field of spinal disorders.

Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects

Background: Chronic noncancer pain (CNCP) is a major health problem, for which opioids provide one treatment option. However, evidence is needed about side effects, efficacy, and risk of misuse or addiction. Methods: This meta-analysis was carried out with these objectives: to compare the efficacy of opioids for CNCP with other drugs and placebo; to identify types of CNCP that respond better to opioids; and to determine the most common side effects of opioids. We searched MEDLINE, EMBASE, CENTRAL (up to May 2005) and reference lists for randomized controlled trials of any opioid administered by oral or transdermal routes or rectal suppositories for CNCP (defined as pain for longer than 6 mo). Extracted outcomes included pain, function or side effects. Methodological quality was assessed with the Jadad instrument; analyses were conducted with Revman 4.2.7. Results: Included were 41 randomized trials involving 6019 patients: 80% of the patients had nociceptive pain (osteoarthritis, rheumatoid arthritis or back pain); 12%, neuropathic pain (postherpetic neuralgia, diabetic neuropathy or phantom limb pain); 7%, fibromyalgia; and 1%, mixed pain. The methodological quality of 87% of the studies was high. The opioids studied were classified as weak (tramadol, propoxyphene, codeine) or strong (morphine, oxycodone). Average duration of treatment was 5 (range 1–16) weeks. Dropout rates averaged 33% in the opioid groups and 38% in the placebo groups. Opioids were more effective than placebo for both pain and functional outcomes in patients with nociceptive or neuropathic pain or fibromyalgia. Strong, but not weak, opioids were significantly superior to naproxen and nortriptyline, and only for pain relief. Among the side effects of opioids, only constipation and nausea were clinically and statistically significant. Interpretation: Weak and strong opioids outperformed placebo for pain and function in all types of CNCP. Other drugs produced better functional outcomes than opioids, whereas for pain relief they were outperformed only by strong opioids. Despite the relative shortness of the trials, more than one-third of the participants abandoned treatment.

Massage for low-back pain.

BACKGROUNDnLow-back pain (LBP) is one of the most common and costly musculoskeletal problems in modern society. It is experienced by 70% to 80% of adults at some time in their lives. Massage therapy has the potential to minimize pain and speed return to normal function.nnnOBJECTIVESnTo assess the effects of massage therapy for people with non-specific LBP.nnnSEARCH METHODSnWe searched PubMed to August 2014, and the following databases to July 2014: MEDLINE, EMBASE, CENTRAL, CINAHL, LILACS, Index to Chiropractic Literature, and Proquest Dissertation Abstracts. We also checked reference lists. There were no language restrictions used.nnnSELECTION CRITERIAnWe included only randomized controlled trials of adults with non-specific LBP classified as acute, sub-acute or chronic. Massage was defined as soft-tissue manipulation using the hands or a mechanical device. We grouped the comparison groups into two types: inactive controls (sham therapy, waiting list, or no treatment), and active controls (manipulation, mobilization, TENS, acupuncture, traction, relaxation, physical therapy, exercises or self-care education).nnnDATA COLLECTION AND ANALYSISnWe used standard Cochrane methodological procedures and followed CBN guidelines. Two independent authors performed article selection, data extraction and critical appraisal.nnnMAIN RESULTSnIn total we included 25 trials (3096 participants) in this review update. The majority was funded by not-for-profit organizations. One trial included participants with acute LBP, and the remaining trials included people with sub-acute or chronic LBP (CLBP). In three trials massage was done with a mechanical device, and the remaining trials used only the hands. The most common type of bias in these studies was performance and measurement bias because it is difficult to blind participants, massage therapists and the measuring outcomes. We judged the quality of the evidence to be low to very low, and the main reasons for downgrading the evidence were risk of bias and imprecision. There was no suggestion of publication bias. For acute LBP, massage was found to be better than inactive controls for pain ((SMD -1.24, 95% CI -1.85 to -0.64; participants = 51; studies = 1)) in the short-term, but not for function ((SMD -0.50, 95% CI -1.06 to 0.06; participants = 51; studies = 1)). For sub-acute and chronic LBP, massage was better than inactive controls for pain ((SMD -0.75, 95% CI -0.90 to -0.60; participants = 761; studies = 7)) and function (SMD -0.72, 95% CI -1.05 to -0.39; 725 participants; 6 studies; ) in the short-term, but not in the long-term; however, when compared to active controls, massage was better for pain, both in the short ((SMD -0.37, 95% CI -0.62 to -0.13; participants = 964; studies = 12)) and long-term follow-up ((SMD -0.40, 95% CI -0.80 to -0.01; participants = 757; studies = 5)), but no differences were found for function (both in the short and long-term). There were no reports of serious adverse events in any of these trials. Increased pain intensity was the most common adverse event reported in 1.5% to 25% of the participants.nnnAUTHORS CONCLUSIONSnWe have very little confidence that massage is an effective treatment for LBP. Acute, sub-acute and chronic LBP had improvements in pain outcomes with massage only in the short-term follow-up. Functional improvement was observed in participants with sub-acute and chronic LBP when compared with inactive controls, but only for the short-term follow-up. There were only minor adverse effects with massage.

Massage for low-back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group.

Background. Low back pain (LBP) is one of the most common and costly musculoskeletal problems in modern society. Proponents of massage therapy claim it can minimize pain and disability and speed return-to-normal function. Objectives. To assess the effects of massage therapy for nonspecific LBP. Search Strategy. We searched MEDLINE, Embase, Cochrane Controlled Trials Register, HealthSTAR, CINAHL, and dissertation abstracts through May 2001 with no language restrictions. References in the included studies and in reviews of the literature were screened. Contact with content experts and massage associations was also made. Selection Criteria. The studies had to be randomized or quasirandomized trials investigating the use of any type of massage (using the hands or a mechanical device) as a treatment for nonspecific LBP. Data Collection and Analysis. Two reviewers blinded to authors, journals, and institutions selected the studies, assessed the methodologic quality using the criteria recommended by the Cochrane Collaboration Back Review Group, and extracted the data using standardized forms. The studies were analyzed in a qualitative way because of heterogeneity of population, massage technique, comparison groups, timing, and type of outcome measured. Results. Nine publications reporting on eight randomized trials were included. Three had low and five had high methodologic quality scores. One study was published in German, and the rest, in English. Massage was compared with an inert treatment (sham laser) in one study that showed that massage was superior, especially if given in combination with exercises and education. In the other seven studies, massage was compared with different active treatments. They showed that massage was inferior to manipulation and transcutaneous electrical nerve stimulation; massage was equal to corsets and exercises; and massage was superior to relaxation therapy, acupuncture, and self-care education. The beneficial effects of massage in patients with chronic LBP lasted at least 1 year after the end of the treatment. One study comparing two different techniques of massage concluded in favor of acupuncture massage over classic (Swedish) massage. Conclusions. Massage might be beneficial for patients with subacute and chronic nonspecific LBP, especially when combined with exercises and education. The evidence suggests that acupuncture massage is more effective than classic massage, but this needs confirmation. More studies are needed to confirm these conclusions, to assess the effect of massage on return-to-work, and to measure longer term effects to determine cost-effectiveness of massage as an intervention for LBP.

Spinal cord stimulation for chronic pain

Background nSpinal cord stimulation (SCS) is a form of therapy used to treat certain types of chronic pain. It involves an electrical generator that delivers pulses to a targeted spinal cord area. The leads can be implanted by laminectomy or percutaneously and the source of power is supplied by an implanted battery or by an external radio-frequency transmitter. The exact mechanism of action of SCS is poorly understood. n nObjectives nTo assess the efficacy and effectiveness of spinal cord stimulation in relieving certain kinds of pain, as well as the complications and adverse effects of this procedure. n nSearch methods nWe searched MEDLINE and EMBASE to September 2003; the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 3, 2003); textbooks and reference lists in retrieved articles. We also contacted experts in the field of pain and the main manufacturer of the stimulators. n nSelection criteria nWe included trials with a control group, either randomized controlled trials (RCTs) or non-randomized controlled clinical trials (CCTs), that assessed spinal cord stimulation for chronic pain. n nData collection and analysis nTwo independent reviewers selected the studies, assessed study quality and extracted the data. One of the assessors of methodological quality was blinded to authors, dates and journals. The data were analysed using qualitative methods (best evidence synthesis). n nMain results nTwo RCTs (81 patients in total) met our inclusion criteria. One was judged as being of high quality (score of 3 on Jadad scale) and the other of low quality (score of 1 on Jadad scale). One trial included patients with Complex Regional Pain Syndrome Type I (reflex sympathetic dystrophy) and the other patients with Failed Back Surgery Syndrome. The follow-up periods varied from 6 to 12 months. Both studies reported that SCS was effective, however, meta-analysis was not undertaken because of the small number of patients and the heterogeneity of the study population. n nAuthors conclusions nAlthough there is limited evidence in favour of SCS for Failed Back Surgery Syndrome and Complex Regional Pain Syndrome Type I, more trials are needed to confirm whether SCS is an effective treatment for certain types of chronic pain. In addition, there needs to be a debate about trial designs that will provide the best evidence for assessing this type of intervention.

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

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 showedthat 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.

Gabapentin for neuropathic pain: systematic review of controlled and uncontrolled literature.

ObjectiveTo assess the efficacy/effectiveness and side effects of gabapentin for the treatment of neuropathic pain. DesignSystematic review of the literature. MethodsExtensive search of several electronic databases located both controlled and uncontrolled studies. Efficacy was assessed through meta-analysis of randomized controlled trials (RCTs), whereas the effectiveness of gabapentin in uncontrolled studies was assessed via a novel system of dichotomous classification of “bad” versus “good” results. FindingsThirty-five papers involving 727 patients with multiple neuropathic pain conditions met the inclusion criteria. The meta-analysis of the 2 high-quality, placebo-controlled RCTs showed positive effect of gabapentin in diabetic neuropathy and post-herpetic neuralgia. The addition of 2 low-quality, placebo-controlled RCTs did not alter the magnitude or direction of observed effect. The uncontrolled studies demonstrated positive effect on pain in different neuropathic syndromes, as well as benefit on different types of neuropathic pain; highest dose administered and rate-of-dose escalation showed wide variability between prescribers. Fewer and less severe side effects were reported in the uncontrolled studies. ConclusionsGabapentin seems to be effective in multiple painful neuropathic conditions. The variable prescribing patterns of the uncontrolled studies raise the suspicion that effectiveness may be reduced if one limits administration of the drug to very low doses, whereas rapid dose escalation may be associated with increased central nervous system side effects. Well-designed controlled trials may provide insight into differential symptom sensitivity to the drug.

Muscle relaxants for non‐specific low‐back pain

BACKGROUNDnThe 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.nnnOBJECTIVESnThe aim of this review was to determine if muscle relaxants are effective in the treatment of non-specific low back pain.nnnSEARCH STRATEGYnA 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.nnnSELECTION CRITERIAnRandomised 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.nnnDATA COLLECTION AND ANALYSISnTwo reviewers 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.nnnMAIN RESULTSnThirty 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.nnnREVIEWERS CONCLUSIONSnMuscle 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.

Opioids for chronic noncancer pain: a new Canadian practice guideline

See related commentary by Chou, page [881][1]nnUndertreated chronic noncancer pain and growing misuse of opioids are two challenges presented by opioid therapy. A new Canadian guideline addresses these challenges with recommendations and tools for safe and responsible selection, prescription,