Is pregabalin an effective treatment for the pain of acute or chronic sciatica?
Pregabalin does not relieve pain in patients with sciatica. (LOE = 1b)(www.essentialevidenceplus.com)
Mathieson S, Maher CG, McLachlan A, et al. Trial of pregabalin for acute and chronic sciatica. N Engl J Med 2017;376(12):1111-1120.
Study design: Randomized controlled trial (double-blinded)
Funding source: Government
Setting: Outpatient (any)
The closely related drugs gabapentin and pregabalin are widely used for the treatment of neuropathic pain, including sciatica. This Australian trial recruited patients with moderate to severe sciatica, defined as pain radiating below the knee and accompanied by evidence of nerve root or spinal nerve involvement such as sensory deficits, diminished reflexes, or weakness. The pain had to have been present for between 1 week and 1 year. The average age of the 207 participants was 54 years, 85% had dermatomal pain, 37% had a neurologic deficit, and 30% had a motor deficit. The patients were randomly assigned to receive either pregabalin in a dose of 75 mg twice daily, increasing to a final target dose of 300 mg twice daily at 8 weeks, or matching placebo. The primary outcome was pain on a 10-point scale, with a difference of 1.5 points considered to be the minimal clinically important difference. Patients were followed up for up to 1 year, and a variety of secondary outcomes were measured, as well. Groups were balanced at the start of the study, and analysis was by intention to treat. At both 8 weeks and 52 weeks, there was no significant difference in the primary outcome, and no difference in secondary outcomes including disability, back pain intensity, global perception of the effect, and quality of life.
Mark H. Ebell, MD, MS
University of Georgia
Are gabapentinoids safe and effective in treating patients with chronic low back pain?
The existing data on gabapentinoids for chronic low back pain are limited in number and quality. The amount of pain reduction is low to moderate, while the rate of adverse effects is high. The few studies that assessed function found no improvement. (LOE = 2a-)(www.essentialevidenceplus.com)
Shanthanna H, Gilron I, Rajarathinam M, et al. Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials. PLoS Med 2017;14(8):e1002369.
Study design: Meta-analysis (randomized controlled trials)
Setting: Various (meta-analysis)
These authors searched 2 databases and the Cochrane clinical trials register to identify randomized trials of gabapentinoids (gabapentin, pregabalin) for treating adults with back pain lasting at least 3 months. Two authors independently assessed the inclusion of articles and they resolved disagreements by consensus or through third-party adjudication. Ultimately they included 8 small studies with 3 different comparison treatments. Most of the studies had methodologic quality issues, including selection bias and inadequate concealment of randomization. Three studies with 185 patients compared gabapentin with placebo, finding minimal improvement in pain. Three studies with 332 patients compared pregabalin with other analgesics, finding pregabalin was more effective in average pain response. The remaining studies, which assessed pregabalin as an adjunct to pain management, were heterogeneous and the authors chose not to pool the data. The largest of these studies, however, found that adding pregabalin didn't improve pain. We have commented frequently on the inconsistent reporting of treatment harms in clinical trials and these studies are no exception. However, the authors were able to pool data and estimate the number needed to treat to harm (NNTH) for several adverse effects: dizziness (NNTH = 7; 95% CI 4 - 30), fatigue (NNTH = 8; 4 - 44), altered mentation (NNTH = 6; 4 - 15), and vision disturbance (NNTH = 6; 4 - 13). The studies generally did not report on functional outcomes.
Henry C. Barry, MD, MS
Michigan State University
East Lansing, MI
In patients with mild to moderate ankle sprain, does physical therapy (physiotherapy) hasten or improve recovery?
Physical therapy (up to 7 sessions) does not hasten resolution of symptoms or improve function in adults with ankle sprain: Approximately 60% of patients who receive usual care or physical therapy do not achieve "excellent" resolution. Send patients home with the usual RICES protocol: rest, ice, compression, elevation, and splinting. (LOE = 1b)(www.essentialevidenceplus.com)
Brison RJ, Day AG, Pelland L, et al. Effect of early supervised physiotherapy on recovery from acute ankle sprain: randomised controlled trial. BMJ 2016;355:i5650.
Study design: Randomized controlled trial (nonblinded)
Setting: Emergency department
These authors studied the effect of longitudinal, supervised, stepwise physical therapy in addition to usual acute management of mild to moderate ankle sprain (grade 1 or 2) in 503 patients, 16 years or older, who presented to an emergency department in Canada. It's interesting that 84% of patients received an x-ray although approximately 30% of patients had mild (grade 1) sprain and any patients who required immobilization were excluded. One week after evaluation and basic management with RICES (rest, ice, compression, elevation, splinting), patients were randomized, using concealed allocation, to continue with usual care or to add stepwise physical therapy of up to seven 30-minute visits combined with home exercise. The main outcome was a score of "excellent" (at least 450) at 3 months on a 500-point patient questionnaire of symptoms, stiffness, pain, function, recreational activity, and quality of life. At 3 months approximately 40% of patients scored at least 450, with no difference between groups (42% vs 40%). After 6 months, the percentage of patients experiencing excellent recovery was slightly higher in the usual care group than in the intervention group, but the difference was not statistically significant between groups (65% vs 56%; P = .09). In addition to patient reports of symptoms and function, the researchers also conducted clinical and biomechanical evaluation, again not finding any difference between the groups. The study had the power of at least 80% to find an increase in excellent recovery from 60% to 75%, if one existed.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Do intra-articular corticosteroids improve pain and function and decrease cartilage loss in adults with osteoarthritis of the knee?
This well-done study found that regular three-month intra-articular injections of triamcinolone for two years resulted in no significant difference in pain and function assessments compared to saline. However, a significant increase in cartilage loss and damage did occur in patients receiving steroids compared to saline. This study confirms the findings of the only other published study with a low risk of bias (see Synopsis). (LOE = 1b)(www.essentialevidenceplus.com)
McAlindon TE, LaValley MP, Harvey WF, et al. Effect of intra-articular triamcinolone vs saline on knee cartilage volume and pain in patients with knee osteoarthritis: a randomized clinical trial. JAMA 2017;317(19):1967-1975.
Although intra-articular corticosteroids are commonly used for the treatment of knee osteoarthritis, data are limited in terms of benefits and safety. The most recent Cochrane Review on this topic evaluated 27 randomized controlled trials (26 with a high risk of bias) and found minimal improvement in pain and function in the short-term with steroids compared with placebo. The only study with low risk of bias found no benefit from steroids (Jüni P, et al. Cochrane Database Syst Rev 2015;(10):CD005328). These investigators recruited 140 adults, 45 years or older, with knee osteoarthritis diagnosed using standard national criteria. Eligible patients randomly received (concealed allocation assignment) either ultrasound-guided intra-articular triamcinolone (40 mg) or saline injections every 3 months for 2 years. Patients, clinicians administering the injections, and outcome assessors remained masked to treatment group assignment. Pain and function assessments based on validated questionnaires and physical examination occurred regularly throughout the study. Periodic magnetic resonance imaging occurred at 0, 12, and 24 months to evaluate changes in knee cartilage volume over the 2-year period. Complete follow-up occurred for 95% of patients at 2 years. Using intention-to-treat analysis, pain and function scores did not significantly differ between the 2 groups. However, the rate of cartilage loss and damage was significantly greater in the triamcinolone treatment group. There were no significant group differences in serious adverse events. The authorship of this POEM is attributed to Emma J. Pace, MD, Fellow and Instructor, Department of Family Medicine, University of Virginia, Charlottesville, VA.
David Slawson, MD
Professor and Vice Chair for Education and Scholarship
University of North Carolina Chapel Hill, Carolinas HealthCare System
POEMs are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, please see http://www.essentialevidenceplus.com(www.essentialevidenceplus.com).
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Top 20 POEMs of 2017