Monthly Archives: January 2014

Arthroscopic Partial Meniscectomy Does Not Improve Symptoms of Degenerative Medial Meniscus Tear in Patients Without Knee Osteoarthritis

Reference:N Engl J Med 2013 Dec 26;369(26):2515 (level 1 [likely reliable] evidence)

Arthroscopic surgeries for patients with established knee osteoarthritis are becoming less common due to a lack of clinical evidence supporting their use. A Cochrane review found that arthroscopic surgery is ineffective for unselected patients with knee osteoarthritis (Cochrane Database Syst Rev 2008 Jan 23;(1):CD005118), based partly on the findings of a randomized trial showing no significant improvement in pain or function scores with either arthroscopic debridement or arthroscopic lavage compared to placebo surgery (N Engl J Med 2002 Jul 11;347(2):81 full-text). Another randomized trial subsequently showed that the addition of arthroscopic surgery to physical and medical therapies did not improve function or pain scores in patients with moderate-to-severe knee osteoarthritis (N Engl J Med 2008 Sep 11;359(11):1097 full-text). More recently, a randomized trial in patients with meniscal tear and knee osteoarthritis showed that arthroscopic partial meniscectomy plus physical therapy did not improve symptoms more than physical therapy alone (N Engl J Med 2013 May 2;368(18):1675 full-text, seeDynaMed EBM Focus Volume 8, Issue 13).

However, the implications for patients without clearly established knee osteoarthritis have remained unclear. A recent randomized trial comparing meniscectomy to strengthening exercises in patients presenting with degenerative medial meniscus tear and no clear evidence of osteoarthritis (Kellgren-Lawrence grade 0-1) found no significant between-group differences in function, pain, or patient satisfaction scores (Am J Sports Med 2013 Jul;41(7):1565). Now, a randomized trial compares arthroscopic partial meniscectomy to sham surgery in patients with medial meniscus tear without knee osteoarthritis.

A total of 146 patients aged 35-65 years with symptomatic degenerative medial meniscus tear without knee osteoarthritis were randomized to arthroscopic partial meniscectomy vs. sham surgery and followed for 12 months. Postoperative care, including walking aids and instructions for graduated exercises, was identical for both groups, and all patients were instructed to take over-the-counter analgesics as required. Symptoms were assessed using the Lysholm and Western Ontario Meniscal Evaluation Tool (WOMET) scores, which both range from 0 to 100, with higher scores indicating less severe symptoms. Knee pain was assessed after exercise using a numeric rating scale with a range of 0 to 10, with higher scores indicating greater pain severity.

Both groups had a significant improvement from baseline in symptom and knee pain scores, but there were no significant between-group differences for these outcomes at 12 months. The mean improvement in the Lysholm score was 21.7 points with arthroscopic partial meniscectomy group vs. 23.3 points with sham surgery, with a difference of 11.5 points considered clinically meaningful. Similarly, the mean improvement in the WOMET score was 24.6 points with partial meniscectomy vs. 27.1 points with sham surgery, with a difference of 15.5 points considered clinically meaningful. The mean improvement in knee pain was 3.1 points with partial meniscectomy vs. 3.3 points with sham surgery, with a difference of 2 points considered clinically meaningful. There were also no significant differences in the rate of subsequent knee surgery, patient-reported satisfaction, patient-reported improvement, or serious adverse events.

Recent clinical evidence from randomized trials has consistently shown a lack of efficacy of arthroscopic surgeries for patients with knee osteoarthritis, including patients with meniscus tears. This trial extends those findings to patients with meniscus tears but without established knee osteoarthritis, showing no significant difference in symptom or pain scores between patients receiving arthroscopic partial meniscectomy and those receiving sham surgery. It should be noted that the Lysholm and WOMET scores used in this trial for symptom assessment are primarily focused on basic activities of daily living, and may not adequately describe high-level function as may be required for strenuous work or sports.

For more information, see the Meniscus tears topic in DynaMed.

From DynaMed http://campaign.r20.constantcontact.com/render?llr=ajhjdadab&v=001mlQdTtwnjRDYHy_SNbIFMrpbgcWhxdYqg5ZYQBnzxDnUQzmHCZtKLt6h9wCqE9NYWHZhvLgQ3RRUjUZE4lkP1xLIU0WTpQj5JW7CDghYIQ60oLhwFxFAOnb_v2KmGCGPLM98VM4w3LWe-nq7HhI1F0nrJ5WbZaZo
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Repeat BMD testing: little, if any, value in elderly men and women

Clinical question: 

Is there any clinical benefit to a repeat bone mineral density screening test after an initial baseline screen in elderly men and women?

Bottom line
This study found little, if any, added benefit to repeat bone mineral density (BMD) screening at 4 years beyond baseline BMD testing in elderly men and women. A recent similar study (Gourlay ML, et al. NEJM 2012;366(3):225-33) recommended a baseline examination at age 65 with repeat testing necessary only after 15 years in patients with mild osteopenia and after 5 years in patients with moderate osteopenia. It looks like we should be doing a lot fewer DEXA scans than we’ve been doing. (LOE = 1b)

Reference
Berry SD, Samelson EJ, Pencina MJ, et al. Repeat bone mineral density screening and prediction of hip and major osteoporotic fracture. JAMA 2013;310(12):1256-1262.

Study design: Cohort (prospective)

Funding source: Government

Setting: Population-based

Synopsis
These investigators analyzed data obtained from consenting adult participants of the ongoing Framingham cohort invited to have 3 BMD tests each about 4 years apart starting in 1987. Study participants (310 men and 492 women; mean age = 74.8 years) included those who had at least 2 BMD measures with a mean time between each of 3.7 years. Follow-up occurred for participants until death or through 2009 or 12 years after the second BMD. Individuals assessing medical records confirmed self-reported hip fractures, but no other major osteoporotic fractures, including spine, forearm, or shoulder. During a mean follow-up of 9.6 years, 1 or more major osteoporotic fracture occurred in 113 (14%) patients. Prediction modeling for hip or major osteoporotic fracture based on baseline BMD performed much better than models based on BMD change. Furthermore, adding BMD change as a variable to models using baseline BMD did not significantly improve prediction performance. Overall, the net change in the percentage of patients with a hip fracture reclassified with a second BMD as being at high risk was not significant (3.9%; 95% CI, -2.2% to 9.9%). Likewise, the net change in the percentage of patients without hip fracture reclassified as low risk by a second BMD was also not significant (-2.2%; 95% CI, -4.5% to 0.1%).

David Slawson, MD
Vice Chair, Department of Family Medicine
University of Virginia
Charlottesville, VA

What is the best treatment for actinic keratosis?

Bottom Line

This network meta-analysis found that 5-fluorouracil (5-FU) is the most effective treatment for actinic keratosis, based on the outcome of participant complete clearance. The authors caution that the final choice of therapy should take into account other factors, such as tolerability (which might favor imiquimod) or cost (which would favor cryotherapy). (LOE = 1a-)

Reference

Gupta AK, Paquet M. Network meta-analysis of the outcome ‘participant complete clearance’ in nonimmunosuppressed participants of eight interventions for actinic keratosis: a follow-up on a Cochrane review. Br J Dermatol 2013;169(2):250-259.

Study Design: Meta-analysis (randomized controlled trials)

Funding: Unknown/not stated

Setting: Various (meta-analysis)

Allocation: Unknown

Synopsis

A network meta-analysis is a relatively new approach to synthesizing the medical literature. A traditional meta-analysis combines results from similar trials (for example, 5-FU versus placebo for the treatment of actinic keratosis); a network meta-analysis instead allows us to compare interventions indirectly. For example, if both 5-FU and imiquimod were compared with placebo in several studies, we can determine the relative efficacy of the 2 drugs compared with each other. The authors built on a recent Cochrane review, and identified a total of 32 studies comparing treatments to each other and/or to placebo. The outcome used was “participant complete clearance,” which is a good patient-oriented outcome (although the exact definition varied somewhat between studies). The authors concluded that 5-FU 5% is the best treatment, followed by imiquimod, 5-aminolaevulinic acid-photodynamic therapy, ingenol mebutate, and methyl aminolaevulinate-photodynamic therapy, which were all similarly effective. Cryotherapy was less effective than all of these, diclofenac/hyaluronic acid was even less effective, and placebo was least effective of all (not surprisingly). All studies had a follow-up of one year or less, a limitation.

Mark H. Ebell, MD, MS
Associate Professor
University of Georgia
Athens, GA

Do adults with DM II treated with pioglitazone have increased risk of bladder cancer?

Bottom line

This review of all available data found a much increased risk of bladder cancer among adults with type 2 diabetes treated with pioglitazone. Pioglitazone also significantly increases the risk of heart failure and there is minimal, if any, patient-oriented evidence of benefit from treatment (Richter B, et al. Cochrane Database Syst Rev. 2006 Oct 18;[4]:CD006060). Both the French and German governments have either suspended or strongly curtailed the use of pioglitazone. It lowers glycosylated hemoglobin levels, but I would not want my loved ones taking this stuff. (LOE = 2b)

Reference
Ferwana M, Firwana B, Hasan R, et al. Pioglitazone and risk of bladder cancer: A meta-analysis of controlled studies. Diabet Med 2013;30(9):1026-1032.

Study design: Systematic review

Funding source: Self-funded or unfunded

Setting: Various (meta-analysis)

Synopsis
Because of concern that pioglitazone is associated with an increased risk of bladder cancer, both the French and German medicine agencies have either suspended the use of pioglitazone or strongly advised physicians to stop prescribing it. These investigators thoroughly searched multiple databases (MEDLINE, EMBASE, the Cochrane Register, the FDA website, and Clinical-Trial.gov), reviewed bibliographic references of relevant articles, and contacted known researchers for longitudinal studies of patients with type 2 diabetes with or without exposure to pioglitazone. Two authors independently performed the search and evaluated both the methodologic rigor and the eligibility of individual trials. Disagreements were resolved by consensus discussion with a third reviewer. Both observational and experimental trials were included and sensitivity analyses were performed to assess the effect of study design and quality. Six articles (N = 215,142 pioglitazone users) met inclusion criteria, including one large randomized controlled trial, one prospective cohort study, and 4 retrospective studies. The retrospective studies included reports from large population-based databases, including the French health care system, Kaiser Permanente Northern California, the Taiwanese national health system, and the United Kingdom general practice research database. Follow-up occurred for a median of 44 months. Compared with the nonexposed group, bladder cancer occurred significantly more often among patients exposed to pioglitazone (hazard ratio = 1.23; 95% CI, 1.09-1.39; number needed to treat to harm = 20,903). The risk of bladder cancer was significantly increased with longer duration of pioglitazone use but not with increasing cumulative dosage.

David Slawson, MD
Vice Chair, Department of Family Medicine
University of Virginia
Charlottesville, VA

Copyright © 2013 John Wiley & Sons, Inc.

Natural history of actinic keratosis progression, regression, and recurrence

Clinical Question:  In patients with actinic keratosis, what are the average progression, regression, and recurrence rates of these skin lesions?

Bottom Line

Single actinic keratoses (AKs) progress to squamous cell carcinoma at a rate of 0% to 0.53% per year, whereas regression rates of single AKs ranged from 15% to 63% per year. AK recurrence rates range from 15% to 53%. (LOE = 1b-)

Reference

Werner RN, Sammain A, Erdmann R, Hartmann V, Stockfleth E, Nast A. The natural history of actinic keratosis: a systematic review. Br J Dermatol 2013;169(3):502-518.

Synopsis

In this systematic review of 24 articles, the authors describe the natural history of AKs: progression to squamous cell carcinoma, regression to healthy skin, or recurrence of the lesions. Because the studies were quite different regarding inclusion criteria, design (both observational and randomized controlled trials), definitions, and follow-up, the authors decided that statistically combining studies was inappropriate. Therefore, they only report the ranges for similar studies and do not perform a meta-analysis. For example, the risk of progression ranged from 0% to 0.53% per lesion for patients both with and without a history of nonmelanoma skin cancer. The authors estimate regression rates of 15% to 63% per lesion, and rates of recurrence range from 15% to 53%. Data describing changes in total AK counts over time vary widely, largely due to underlying differences with regard to sunscreen use or sun avoidance among the patients. In studies where patients were explicitly told to use sunscreen or to avoid the sun, a greater trend toward reduction in total AK count was found, ranging from ?53 to +20%. This study has several limitations that affect its clinical estimates. Many of the articles did not fully report sunscreen use or the impact of age upon lesion behavior. High drop-out rates in some studies, as well as highly variable follow-up rates, also affect the quality of estimates. Several studies did not include information with regard to the treatment performed, especially in situations where squamous cell carcinoma was suspected, and most studies only followed patients for up to 12 months. And, finally, relying on clinical assessments of AK changes or total count can be challenging, particularly in patients with sun-damaged skin. Lauren S. Hughes, MD, MPH Robert Wood Johnson Foundation Clinical Scholar Department of Family Medicine University of Michigan Ann Arbor, MI

Mark H. Ebell, MD, MS
Associate Professor
University of Georgia
Athens, GA

Prenatal iron associated with fewer low birth weight deliveries

Bottom Line

Routine iron supplementation during pregnancy decreases the risk of anemia in mothers and decreases the likelihood of a low-birth-weight baby. It does not seem to affect the risk of preterm birth, small-for-gestational-age babies, or birth length. (LOE = 1a)

Reference

Haider BA, Olofin I, Wang M, et al, for the Nutrition Impact Model Study Group (anaemia). Anaemia, prenatal iron use, and risk of adverse pregnancy outcomes: systematic review and meta-analysis. BMJ 2013;346:f3443 doi 10.1136/bmj.f3443.

Study Design: Systematic review Funding: Foundation
Setting: Various (meta-analysis) Allocation: Unknown

Synopsis

These authors identified randomized and observational studies of iron use during pregnancy by searching 2 databases (but not the Cochrane Library), as well as reference lists of identified studies and review articles. They excluded articles that evaluated multiple vitamins unless the use of iron (with or without folic acid) was specifically isolated. They included observational studies that evaluated the association between baseline anemia and birth outcomes. Two reviewers independently screened articles for inclusion and extracted data. They identified 48 trials, including 17,793 women, and 44 cohort studies reporting on almost 2 million women. Overall, the results are conflicting, with much heterogeneity among the studies for many outcomes. Iron use during pregnancy lowers the rate of low birth weight by 19%. It does not, however, decrease the risk of preterm birth, small-for-gestational-age births, or birth length. The effect on maternal or neonatal mortality or birth complications could not be evaluated. Iron supplementation, as might be expected, increases maternal hemoglobin concentration and reduces the risk of anemia. It’s counterintuitive, but the effects on maternal anemia were higher in high-income countries.

Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA

Sure I can multitask: Distracted Driving and Risk of Road Crashes among Novice and Experienced Drivers

Sheila G. Klauer et al, “Distracted Driving and Risk of Road Crashes among Novice and Experienced Drivers,” New England Journal of Medicine 2014; 370:54-59.

BACKGROUND

Distracted driving attributable to the performance of secondary tasks is a major cause of motor vehicle crashes both among teenagers who are novice drivers and among adults who are experienced drivers.

METHODS

We conducted two studies on the relationship between the performance of secondary tasks, including cell-phone use, and the risk of crashes and near-crashes. To facilitate objective assessment, accelerometers, cameras, global positioning systems, and other sensors were installed in the vehicles of 42 newly licensed drivers (16.3 to 17.0 years of age) and 109 adults with more driving experience.

RESULTS

During the study periods, 167 crashes and near-crashes among novice drivers and 518 crashes and near-crashes among experienced drivers were identified.

The risk of a crash or near-crash among novice drivers increased significantly if:

  • they were dialing a cell phone (odds ratio, 8.32; 95% confidence interval [CI], 2.83 to 24.42),
  • reaching for a cell phone (odds ratio, 7.05; 95% CI, 2.64 to 18.83),
  • sending or receiving text messages (odds ratio, 3.87; 95% CI, 1.62 to 9.25),
  • reaching for an object other than a cell phone (odds ratio, 8.00; 95% CI, 3.67 to 17.50),
  • looking at a roadside object (odds ratio, 3.90; 95% CI, 1.72 to 8.81),
  • eating (odds ratio, 2.99; 95% CI, 1.30 to 6.91).

Among experienced drivers:

  • dialing a cell phone was associated with a significantly increased risk of a crash or near-crash (odds ratio, 2.49; 95% CI, 1.38 to 4.54);
  • the risk associated with texting or accessing the Internet was not assessed in this population.

The prevalence of high-risk attention to secondary tasks increased over time among novice drivers but not among experienced drivers.

CONCLUSIONS

The risk of a crash or near-crash among novice drivers increased with the performance of many secondary tasks, including texting and dialing cell phones.

The article be found at http://www.nejm.org/doi/full/10.1056/NEJMsa1204142?query=featured_home