Is arthroscopy better than nonsurgical treatment for patients with meniscal tears?
The existing research base, with biases that typically make interventions look better, is unable to demonstrate that arthroscopy for meniscal injuries is any better than nonoperative approaches. Since this is a costly intervention, and is being used more frequently, perhaps insurance companies should re-evaluate whether to continue paying for it. (LOE = 1a-)(www.essentialevidenceplus.com)
Monk P, Garfjeld Roberts P, Palmer AJ, et al. The urgent need for evidence in arthroscopic meniscal surgery. Am J Sports Med 2017;45(4):965-973.
Study design: Systematic review
Funding source: Government
Setting: Various (meta-analysis)
These authors searched multiple databases, including registries of clinical trials and the reference lists of retrieved studies, to identify randomized trials of systematic reviews published in English. Two authors independently decided which studies to include and determined the risk of bias in the included studies. They resolved disagreements through conversation and, when necessary, through third-party adjudication. Ultimately, they included 9 randomized trials and 8 systematic reviews. The clinical trials included 68 to 351 patients and the systematic reviews included 98 to 1374 patients. All the systematic reviews were published after 2012, so the variation in sample size is rather striking and reflects the inclusion criteria. For example, the largest systematic review evaluated case series, only slightly less biased than expert opinion in determining the effectiveness of an intervention. The main recurring problems with the randomized trials were the lack of adequate masking and the selective outcome reporting. Only 2 of the trials compared arthroscopy with sham surgery. The others used active comparisons (for example, resection, exercise, physical therapy, steroid injections, and bioabsorbable arrows). The follow-up duration for the studies ranged from 6 months to 5 years. The studies also used several different outcome assessments: repeat tear, radiographic findings, pain on a visual analog scale, Western Ontario and McMaster Universities Osteoarthritis Index score, Knee Injury and Osteoarthritis Outcome Score, and so forth. The authors, appropriately, decided not to pool the data and just summarize the findings. Most of the systematic reviews failed to identify clinically meaningful improvements and only one of the randomized trials found "marginal benefit" in patients treated arthroscopically. Since the systematic reviews included cohort and case-control study designs and the randomized trial flaws all tend to be biased in favor of intervention, the existing data strongly suggest that arthroscopy for meniscal injuries is ineffective. I find it remarkable that so many systematic reviews exist with only 9 clinical trials. This seems like overanalyzing the existing data. The authors seem disappointed, and no matter how many times the data demonstrate no advantage to arthroscopy they will likely call for more clinical trials. No, we do not have an urgent need for evidence—the existing evidence is plenty.
Henry C. Barry, MD, MS
Michigan State University
East Lansing, MI
Is extracorporeal shock wave therapy, when added to supervised exercise, effective in treating patients with subacromial shoulder pain (also called impingement syndrome)?
After 24 weeks, adults with subacromial shoulder pain experience an improvement in symptoms regardless of intervention. In this well-conducted study, adding radial extracorporeal shock wave therapy (rESWT) to supervised exercise therapy had no effect on the degree of improvement compared with exercise therapy alone. (LOE = 1b)(www.essentialevidenceplus.com)
Kvalvaag E, Brox JI, Engebretsen KB, et al. Effectiveness of radial extracorporeal shock wave therapy (rESWT) when combined with supervised exercises in patients with subacromial shoulder pain: a double-masked, randomized, sham-controlled trial. Am J Sports Med 2017;45(11):2547-2554.
Study design: Randomized controlled trial (double-blinded)
Funding source: Industry
Setting: Outpatient (specialty)
These authors randomly assigned adults with at least 3 months of subacromial shoulder pain to receive weekly rESWT (n = 69) or sham rESWT (n = 74) for 4 weeks. All patients also received supervised exercise therapy (weekly for the first 4 weeks, then twice a week). The patients underwent active treatment for 12 weeks and the researchers evaluated them for up to 24 weeks. Study personnel and those administering treatment were masked to treatment assignment. To be included, the patients needed to have clinical signs of an impingement syndrome. The researchers used a true intention-to-treat analysis to assess the severity of symptoms, pain, and function (that is, although a few patients stopped treatment, the researchers included all of them in the final analysis). At the end of 24 weeks, patients in each treatment group had clinically meaningful improvements in symptoms, but the degree of improvement was the same. Similarly, patients in each group experienced improvements in pain and function and there was no difference in the degree of improvement. In the subgroup of 23 patients with rotator cuff calcification, those treated with rESWT had slightly greater improvement in symptom severity than the patients treated with sham rESWT. The results from this study are similar to those from the many other studies of rESWT we have reviewed: Other than its use in patients with urolithiasis, the preponderance of data suggests that rESWT has no real usefulness.
Does long-term use of bisphosphonates increase the risk of fractures in older women?
In this cohort study, older women at a high risk of fractures who used oral bisphosphonates for 10 to 13 years had a higher risk of fractures than women who used bisphosphonates for only 2 years. (LOE = 2b)(www.essentialevidenceplus.com)
Drieling RL, LaCroix AZ, Beresford SAA, et al. Long-term oral bisphosphonate therapy and fractures in older women: The Women's Health Initiative. J Am Geriatr Soc 2017;65(9):1924-1931.
Study design: Cohort (prospective)
The Women's Health Initiative had 2 components, a randomized trial that busted a bunch of myths about hormone replacement therapy and an observational study with nearly 100,000 women that serves as the basis for this study. These authors pulled a subset of women who had taken an oral bisphosphonate for at least 2 years, had follow-up data, and who had a FRAX score placing their 5-year fracture risk at 1.5% or higher. Additionally the authors excluded women who took medications that affect bone metabolism (eg, calcitonin, parathyroid hormone, aromatase, inhibitors, and so forth). Ultimately, they included 5120 women. They then compared the rate of clinical fractures in women who had taken oral bisphosphonates for only 2 years with those who had taken them for 3 to 5 years, 6 to 9 years, and 10 to 13 years. It would have been helpful if they had included a group of women with no bisphosphonate exposure. The women were, on average, 80 years old. The women had an average of 4 years of follow-up data and reported 127 hip fractures, 159 wrist or forearm fractures, 235 clinical vertebral fractures, and a total of 1313 clinical fractures (presumably hip plus wrist plus forearm plus clinical vertebral plus all other fractures). After taking into account other factors that might influence the rate of fractures, 10 to 13 years of bisphosphonate use was associated with a higher risk of any clinical fracture (but not at any single specific site) than 2 years of use (hazard ratio = 1.29; 95% CI 1.07 - 1.57). There was no significant association between intermediate-term use of bisphosphonates and fracture risk. When the authors only looked at women with a fracture after age 54, the relationship between long-term bisphosphonate use and subsequent fracture remained.
How effective is glucosamine plus chondroitin sulfate in improving moderate to severe pain and function in patients with symptomatic knee degenerative joint disease?
This is one of many studies showing that, after 6 months of treatment, glucosamine plus chondroitin sulfate is no better than placebo in improving pain and function in patients with symptomatic knee degenerative joint disease (DJD). In fact, this is one of the first studies to suggest that placebo is better. (LOE = 1b-)(www.essentialevidenceplus.com)
Roman-Blas JA, Castaneda S, Sanchez-Pernaute O, Largo R, Herrero-Beaumont G, CS/GS Combined Therapy Study Group. Combined treatment with chondroitin sulfate and glucosamine sulfate shows no superiority over placebo for reduction of joint pain and functional impairment in patients with knee osteoarthritis: a six-month multicenter, randomized, double-blind, placebo-controlled clinical trial. Arthritis Rheumatol 2017;69(1):77-85.
In this industry-sponsored study, researchers evaluated adults with radiographically moderate to severe knee DJD and moderate to severe pain (40 mm to 80 mm on a 100-mm visual analog scale). The authors excluded patients with a body mass index greater than 35, those with concurrent arthritic conditions, and those who they thought would not be able to complete the study. They randomized patients to receive 1200 mg bovine chondroitin sulfate plus 1500 mg crustacean glucosamine (n = 81) or a "conveniently masked placebo" (n = 83). The authors evaluated pain and function using a modified intention-to-treat analysis, as well as a per-protocol approach. A worrisome matter is that by the 6-month assessment more than 20% of enrolled patients dropped out of each group. The types of analyses and the drop-out rate are both more likely to bias the results in favor of intervention. The authors report that by 6 months, regardless of analytic approach, patients treated with placebo experienced larger decreases in pain scores and function scores than patients treated with glucosamine plus chondroitin sulfate, although the differences were not statistically significant (with the exception of pain analyzed by modified intention to treat). Finally, if we estimate the proportion of patients classified as "responders" (based on the Outcome Measures in Rheumatology Osteoarthritis Research Society International 2004 response criteria and the use of rescue medication), 47% of placebo-treated patients were responders for pain or function compared with 28% of actively treated patients (number needed to treat to harm = 5). The potential biases in this study strengthen the conclusion that glucosamine plus chondroitin sulfate is ineffective. Now, do you want to hear something REALLY interesting? The data safety monitoring board, masked to interventions, stopped the study at 6 months because one intervention was clearly better than the other: placebo!
In patients with acute low back pain, does the addition of diazepam to analgesic treatment improve symptoms?
Diazepam (Valium) added to naproxen does not improve disability or pain scores in patients with acute low back pain more than naproxen alone. The dose was standard and most patients had significant relief regardless of whether they took diazepam or placebo in addition to analgesia. (LOE = 1b)(www.essentialevidenceplus.com)
Friedman BW, Irizarry E, Solorzano C, et al. Diazepam is no better than placebo when added to naproxen for acute low back pain. Ann Emerg Med 2017;70(2):169-176.
Funding source: Foundation
Setting: Emergency department
These authors enrolled 114 patients who presented to an emergency department with uncomplicated low back pain that lasted less than 2 weeks and had a score of at least 5 (median = 18) on the Roland-Morris Low Back Pain and Disability Questionnaire. The 24-item disability questionnaire asked patients about daily activities that would be limited by back pain. The patients were randomized, allocation concealment uncertain, to receive naproxen 500 mg twice daily as needed for 1 week with either placebo or diazepam 5 mg, 1 or 2 tablets every 12 hours, as needed. Scores at 1 week by telephone interview had improved by an average 11 points on the disability scale in both groups. Moderate to severe pain was still reported in 32% of patients in the diazepam group and 22% of patients in the placebo group (P = NS) at 7 days. Other outcomes—length of time to return to work, desire to seek additional treatment, or desire to take the prescribed medicine (diazepam or placebo) again—were also not different. The study had 80% power to find a difference in scores of at least 5.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
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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