Archive for August, 2012

More Bad News About Knee Injections

Monday, August 27, 2012 // Uncategorized

Patients with deterioration of the cartilage on the knee are frequently prescribed injections derived from hyaluronic acid derivatives.  These substances are supposed to reduce pain and stiffness when injected in the knees of patients with osteoarthritis.  I have never been impressed by their efficacy when used in my patients and the studies supporting their use show questionable efficacy.  The most recent study adds support to the doubters.

Meta-Analysis: Viscosupplementation for Knee Osteoarthritis Ineffective

Viscosupplementation, the intra-articular injection of hyaluronic acid, offers few benefits for knee osteoarthritis but can lead to serious adverse events, according to an Annals of Internal Medicine analysis.

Examining 89 trials comprising over 12,000 adults, researchers found “a small, clinically irrelevant effect” on pain from viscosupplementation. At the same time, treatment was associated with increased risk for overall serious adverse events (for example, those resulting in significant disability or inpatient hospitalization).

The researchers criticize the methodological and reporting quality of many of the studies, and the fact that safety data were often not reported at all. Nonetheless, they conclude that “the administration of these preparations should be discouraged.”

Here is the abstract from The Annals of Internal Medicines:

Viscosupplementation for Osteoarthritis of the Knee: A Systematic Review and Meta-analysis ONLINE FIRST

Anne W.S. Rutjes, PhD; Peter Jüni, MD; Bruno R. da Costa, MSc; Sven Trelle, MD; Eveline Nüesch, PhD; and Stephan Reichenbach, MD, MSc

Ann Intern Med. 12 June 2012
Text Size: A A A

Background: Viscosupplementation, the intra-articular injection of hyaluronic acid, is widely used for symptomatic knee osteoarthritis.

Purpose: To assess the benefits and risks of viscosupplementation for adults with symptomatic knee osteoarthritis.

Data Sources: MEDLINE (1966 to January 2012), EMBASE (1980 to January 2012), the Cochrane Central Register of Controlled Trials (1970 to January 2012), and other sources.

Study Selection: Randomized trials in any language that compared viscosupplementation with sham or nonintervention control in adults with knee osteoarthritis.

Data Extraction: Primary outcomes were pain intensity and flare-ups. Secondary outcomes included function and serious adverse events. Reviewers used duplicate abstractions, assessed study quality, pooled data using a random-effects model, examined funnel plots, and explored heterogeneity using meta-regression.

Data Synthesis: Eighty-nine trials involving 12 667 adults met inclusion criteria. Sixty-eight had a sham control, 40 had a follow-up duration greater than 3 months, and 22 used cross-linked forms of hyaluronic acid. Overall, 71 trials (9617 patients) showed that viscosupplementation moderately reduced pain (effect size, −0.37 [95% CI, −0.46 to −0.28]). There was important between-trial heterogeneity and an asymmetrical funnel plot: Trial size, blinded outcome assessment, and publication status were associated with effect size. Five unpublished trials (1149 patients) showed an effect size of −0.03 (CI, −0.14 to 0.09). Eighteen large trials with blinded outcome assessment (5094 patients) showed a clinically irrelevant effect size of −0.11 (CI, −0.18 to −0.04). Six trials (811 patients) showed that viscosupplementation increased, although not statistically significantly, the risk for flare-ups (relative risk, 1.51 [CI, 0.84 to 2.72]). Fourteen trials (3667 patients) showed that viscosupplementation increased the risk for serious adverse events (relative risk, 1.41 [CI, 1.02 to 1.97]).

Limitations: Trial quality was generally low. Safety data were often not reported.

Conclusion: In patients with knee osteoarthritis, viscosupplementation is associated with a small and clinically irrelevant benefit and an increased risk for serious adverse events.

Primary Funding Source: Arco Foundation.

Bottom Line:  Don’t waste your time.  You could consider an intra-articular( within the joint) injection of a steroid.

“Intraarticular glucocorticoids slow cartilage catabolism and osteophyte formation in animals [32-35]; they are also effective for short-term pain relief and can increase quadriceps strength after knee injection. A year 2004 meta-analysis of placebo/sham controlled trials found those receiving glucocorticoid injections for OA of the knee to be twice as likely as controls to have short term improvement [36]. A randomized, placebo-controlled trial of fluoroscopically guided glucocorticoid injection for osteoarthritis of the hip demonstrated benefits lasting up to three months in many cases [37].”

TI
Steroid injection for osteoarthritis of the hip: a randomized, double-blind, placebo-controlled trial.
AU
Lambert RG, Hutchings EJ, Grace MG, Jhangri GS, Conner-Spady B, Maksymowych WP
SO
Arthritis Rheum. 2007;56(7):2278.
 
OBJECTIVE: To determine the efficacy of fluoroscopically guided corticosteroid injection for hip osteoarthritis (OA) in a randomized, double-blind, placebo-controlled trial.
METHODS: Fifty-two patients with symptomatic hip OA were randomly allocated to receive placebo (10 mg bipuvicaine, 2 ml saline) (n = 21) or corticosteroid treatment (10 mg bipuvicaine, 40 mg triamcinolone hexacetonide) (n = 31). Patients were followed up for 1, 2, 3, and 6 months. The primary outcome measure was the pain improvement response, defined as a 20% decrease in the Western Ontario and McMaster Universities OA Index (WOMAC) pain score (on 5 100-mm visual analog scales [VAS]) (WOMAC20) from baseline to 2 months postinjection. Secondary outcomes were a 50% decrease in the WOMAC pain score (WOMAC50), changes in other WOMAC subscale scores, patient’s global assessment of health (on a 100-mm VAS), and Short Form 36 (SF-36) quality of life indices. Analyses were based on the intent-to-treat principle.
RESULTS: The mean WOMAC pain score fell 49.2% (decreasing from 310.1 mm to 157.4 mm)at 2 months postinjection in patients receiving corticosteroid, compared with a decrease of 2.5% (from 314.3 mm to 306.5 mm) in the placebo group (P<0.0001). The proportion of WOMAC20 responders at 2 months’ followup was significantly higher in the corticosteroid group (67.7%) compared with the placebo group (23.8%) (P = 0.004); similar proportions of WOMAC50 responders were observed between groups (61.3% in the corticosteroid group versus 14.3% in the placebo group; P = 0.001). Response differences were maintained at 3 months’ followup (58.1% responders in the corticosteroid group versus 9.5% responders in the placebo group; P = 0.004). Significant differences in the WOMAC stiffness and physical function scores (P<0.0001), patient’s global health scores (P = 0.005), and SF-36 physical component scores (P = 0.04) were observed, with patients in the corticosteroid group showing greater improvements. There were no differences in the frequency of adverse events between groups.
CONCLUSION: This placebo-controlled trial confirms that corticosteroid injection can be an effective treatment of pain in hip OA, with benefits lasting up to 3 months in many cases. Future studies should address questions related to the benefits of repeated steroid injection and the effects of this treatment on disease modification.
AD
Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, Alberta, Canada. [email protected]
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Blogger’s Block and Cheesecake Medicine

Wednesday, August 8, 2012 // Uncategorized

I went on vacation with my family.  It was the first time that we had taken two weeks together in a number of years.  I didn’t have to answer my cellphone and wasn’t checking emails hourly.  I got out of my routine which is a good thing, but haven’t been able to get back to blogging.  I’ve read all the same journals and periodicals, but haven’t found much blogworthy even with the Supreme Court ruling on the Affordable care Act.  It was all reminiscent of a letter that I got from my daughter one summer at camp.  “Blah, blah, blah blah,” she wrote for a page.  She didn’t feel she had  anything to say, but felt pressured to write something to us.

  Finally,  popped up from Dr. Atul Gawande, a physician and author, who I find thought provoking even though I don’t always  agree with  his opinions.  He writes about reducing risks in hospitals by standardizing procedures and protocols in medicine.  Here he writes about Cheesecake medicine in The New Yorker.

Annals of Health Care

Big Med

Restaurant chains have managed to combine quality control, cost control, and innovation. Can health care?

by August 13, 2012

Medicine has long resisted the productivity revolutions that transformed other industries. But the new chains aim to change this.

Medicine has long resisted the productivity revolutions that transformed other industries. But the new chains aim to change this.

 

It was Saturday night, and I was at the local Cheesecake Factory with my two teen-age daughters and three of their friends. You may know the chain: a hundred and sixty restaurants with a catalogue-like menu that, when I did a count, listed three hundred and eight dinner items (including the forty-nine on the “Skinnylicious” menu), plus a hundred and twenty-four choices of beverage. It’s a linen-napkin-and-tablecloth sort of place, but with something for everyone. There’s wine and wasabi-crusted ahi tuna, but there’s also buffalo wings and Bud Light. The kids ordered mostly comfort food—pot stickers, mini crab cakes, teriyaki chicken, Hawaiian pizza, pasta carbonara. I got a beet salad with goat cheese, white-bean hummus and warm flatbread, and the miso salmon.

The place is huge, but it’s invariably packed, and you can see why. The typical entrée is under fifteen dollars. The décor is fancy, in an accessible, Disney-cruise-ship sort of way: faux Egyptian columns, earth-tone murals, vaulted ceilings. The waiters are efficient and friendly. They wear all white (crisp white oxford shirt, pants, apron, sneakers) and try to make you feel as if it were a special night out. As for the food—can I say this without losing forever my chance of getting a reservation at Per Se?—it was delicious.

The chain serves more than eighty million people per year. I pictured semi-frozen bags of beet salad shipped from Mexico, buckets of precooked pasta and production-line hummus, fish from a box. And yet nothing smacked of mass production. My beets were crisp and fresh, the hummus creamy, the salmon like butter in my mouth. No doubt everything we ordered was sweeter, fattier, and bigger than it had to be. But the Cheesecake Factory knows its customers. The whole table was happy (with the possible exception of Ethan, aged sixteen, who picked the onions out of his Hawaiian pizza).

I wondered how they pulled it off. I asked one of the Cheesecake Factory line cooks how much of the food was premade. He told me that everything’s pretty much made from scratch—except the cheesecake, which actually is from a cheesecake factory, in Calabasas, California.

I’d come from the hospital that day. In medicine, too, we are trying to deliver a range of services to millions of people at a reasonable cost and with a consistent level of quality. Unlike the Cheesecake Factory, we haven’t figured out how. Our costs are soaring, the service is typically mediocre, and the quality is unreliable. Every clinician has his or her own way of doing things, and the rates of failure and complication (not to mention the costs) for a given service routinely vary by a factor of two or three, even within the same hospital.

It’s easy to mock places like the Cheesecake Factory—restaurants that have brought chain production to complicated sit-down meals. But the “casual dining sector,” as it is known, plays a central role in the ecosystem of eating, providing three-course, fork-and-knife restaurant meals that most people across the country couldn’t previously find or afford. The ideas start out in élite, upscale restaurants in major cities. You could think of them as research restaurants, akin to research hospitals. Some of their enthusiasms—miso salmon, Chianti-braised short ribs, flourless chocolate espresso cake—spread to other high-end restaurants. Then the casual-dining chains reëngineer them for affordable delivery to millions. Does health care need something like this?

Big chains thrive because they provide goods and services of greater variety, better quality, and lower cost than would otherwise be available. Size is the key. It gives them buying power, lets them centralize common functions, and allows them to adopt and diffuse innovations faster than they could if they were a bunch of small, independent operations. Such advantages have made Walmart the most successful retailer on earth. Pizza Hut alone runs one in eight pizza restaurants in the country. The Cheesecake Factory’s major competitor, Darden, owns Olive Garden, LongHorn Steakhouse, Red Lobster, and the Capital Grille; it has more than two thousand restaurants across the country and employs more than a hundred and eighty thousand people. We can bristle at the idea of chains and mass production, with their homogeneity, predictability, and constant genuflection to the value-for-money god. Then you spend a bad night in a “quaint” “one of a kind” bed-and-breakfast that turns out to have a manic, halitoxic innkeeper who can’t keep the hot water running, and it’s right back to the Hyatt.

Medicine, though, had held out against the trend. Physicians were always predominantly self-employed, working alone or in small private-practice groups. American hospitals tended to be community-based. But that’s changing. Hospitals and clinics have been forming into large conglomerates. And physicians—facing escalating demands to lower costs, adopt expensive information technology, and account for performance—have been flocking to join them. According to the Bureau of Labor Statistics, only a quarter of doctors are self-employed—an extraordinary turnabout from a decade ago, when a majority were independent. They’ve decided to become employees, and health systems have become chains.

I’m no exception. I am an employee of an academic, nonprofit health system called Partners HealthCare, which owns the Brigham and Women’s Hospital and the Massachusetts General Hospital, along with seven other hospitals, and is affiliated with dozens of clinics around eastern Massachusetts. Partners has sixty thousand employees, including six thousand doctors. Our competitors include CareGroup, a system of five regional hospitals, and a new for-profit chain called the Steward Health Care System.

ILLUSTRATION: Harry Campbell

Read more http://www.newyorker.com/reporting/2012/08/13/120813fa_fact_gawande#ixzz2314WHAKW

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