<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_448"
                     title="Inflammatory Bowel Disease Linked to Dangerous VT (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/Gastroenterology/InflammatoryBowelDisease/tb/18362?impressionId=1265746135647"
                     
      &lt;p&gt;Patients with active inflammatory bowel disease (IBD) could be at far greater risk for potentially deadly blood clots than doctors previously thought, a new British study found.&lt;/p&gt;
&lt;p&gt;Nonhospitalized patients with active IBD are 16 times more likely to suffer venous thromboembolism than the general population, with an occurrence rate of 6.4 per 1,000 person-years (HR 15.8, 95% CI 9.8 to 25.5, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001), according to an online report in the Feb. 9 issue of &lt;em&gt;The Lancet&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The authors concluded that such patients could benefit from preventative treatment to prevent blood clotting.&lt;/p&gt;
&lt;p&gt;&quot;Despite the low absolute risks during nonhospitalised periods, these results suggest that active inflammatory bowel disease in ambulatory patients might be a far greater risk factor for venous thromboembolism than previously recognised,&quot; Matthew J. Grainge, MD, of the University of Nottingham, and colleagues wrote.&lt;/p&gt;
&lt;p&gt;Patients with venous thromboembolism in the leg have a short term-mortality rate of about 6%, increasing as high as 20% when the clot has circulated to the lung.&lt;/p&gt;
&lt;p&gt;Researchers believe that infection and inflammation, such as occur in IBD, predispose patients to this life-threatening condition, and those with inflammatory bowel disease seem to be at particular risk.&lt;/p&gt;
&lt;p&gt;Grainge and colleagues used records from the U.K. General Practice Research Database from November 1987 through July 2001, to match 13,756 patients with IBD against 71,672 controls without the disease.&lt;/p&gt;
&lt;p&gt;Of the subjects, 139 patients and 165 controls developed a blood clot during the study period.&lt;/p&gt;
&lt;p&gt;Their results agreed with previous studies indicating that patients hospitalized for IBD are at high risk for venous thromboembolism. However, the new study also found the danger extends to nonhospitalized IBD patients, particularly during a flare-up.&lt;/p&gt;
&lt;p&gt;Overall, the researchers reported, patients with IBD had three times as much risk of an embolism as controls (HR 3.4, 95% CI 2.7 to 4.3; &lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001) with an occurrence rate of 2.6 per 1,000 per person-years.&lt;/p&gt;
&lt;p&gt;During a flare-up, IBD patients were at dramatically greater risk.&lt;/p&gt;
&lt;p&gt;The researchers cautioned that the study excluded patients likely to have received corticosteroids for chronic respiratory disease and rheumatoid arthritis, so the results may not reflect blood clotting rates in these populations.&lt;/p&gt;
&lt;p&gt;They also noted that they relied on anonymous patient records and were dependent on family doctors&apos; diagnoses of inflammatory bowel disease, flare-ups and venous thromboembolism.&lt;/p&gt;
&lt;p&gt;Despite the limitations of the study, they argued that research into ways to prevent embolism in IBD outpatients is warranted.&lt;/p&gt;
&lt;p&gt;&quot;We believe that the medical profession needs to recognise the increased risk in people with inflammatory bowel disease when assessing the likelihood of venous thromboembolism and to address the difficulty of reducing this risk in patients with a flare who are not admitted to hospital,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;They suggested that strategies used to prevent blood clots in hospitalized patients  --  courses of low molecular weight heparin or other newly available anticoagulants  --  might be also be used to prevent clots in nonhospitalized IBD patients experiencing a flare-up.&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, Geoffrey C. Nguyen, MD, and Erik L. Yeo, MD, of the University of Toronto, noted that &quot;the use of steroid prescriptions as a surrogate indicator of acute disease flare restricts the applicability of Grainge and colleagues&apos; findings to flares that are moderate to severe. Whether patients with mild flares are also at increased risk is not clear.&quot;&lt;/p&gt;
&lt;p&gt;&quot;Recognition of venous thromboembolism might be increased during periods of frequent contact with doctors, such as during flares compared with during remission of inflammatory bowel disease, thus potentially introducing a bias in ascertainment of venous thromboembolism,&quot; they added.&lt;/p&gt;
&lt;p&gt;Nguyen and Yeo also argued that the clinical efficacy and cost-effectiveness of pharmacological prevention in patients with inflammatory bowel disease should be proven before it is routinely recommended during acute flares.&lt;/p&gt;
&lt;p&gt;However, they acknowledged that such evidence could be difficult to acquire, given the low numbers of nonhospitalized IBD patients who suffer venous thromboembolism.&lt;/p&gt;
&lt;p&gt;&quot;A pragmatic initial approach to reduction of the rates of morbidity and mortality resulting from venous thromboembolism in ambulatory patients with inflammatory bowel disease would be nonpharmacological thromboprophylaxis, including patients&apos; education and awareness of risk and signs and symptoms of venous thromboembolism, and use of support stockings,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;&quot;Physicians should clinically assess for signs and symptoms of this embolism during visits for acute flare of inflammatory bowel disease.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was funded by the National Association for Colitis and Crohn&apos;s Disease.&lt;/p&gt;&lt;p&gt;The authors reported no financial conflicts of interest.&lt;/p&gt;&lt;p&gt;Nguyen reported serving on advisory boards for Schering-Plough, Canada, and Abbott Pharmaceuticals.&lt;/p&gt;&lt;p&gt;Yeo reported receiving an honorarium from sanofi-aventis.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_371"
                     title="Single Ultrasound for DVT May Suffice (CME/CE)"
                     score="0.011"
                     href="http://www.medpagetoday.com/Cardiology/VenousThrombosis/tb/18257?impressionId=1265746135647"
                     
      &lt;p&gt;For patients with suspected deep vein thrombosis, the risk of symptomatic venous thromboembolism after a single, negative whole-leg compression ultrasound examination is low, a meta-analysis showed.&lt;/p&gt;
&lt;p&gt;Pooled results from seven studies showed the risk to be just 0.57% (95% CI 0.25% to 0.89%) through three months of follow-up in patients who were not given anticoagulants, Scott Stevens, MD, of Intermountain Medical Center in Murray, Utah, and colleagues reported in the Feb. 3 issue of the &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The researchers suggested that a repeated compression ultrasound evaluation to detect distal thrombi moving upward  --  recommended in clinical practice guidelines five to seven days after a negative finding  --  may not be necessary.&lt;/p&gt;
&lt;p&gt;&quot;The efficiency and convenience of whole-leg compression ultrasound as a single study is superior to that of repeated ... evaluations,&quot; the researchers concluded.&lt;/p&gt;
&lt;p&gt;However, an accompanying editorial by Robert McNutt, MD, PhD, of Rush University Medical Center in Chicago, and Edward Livingston, MD, of the University of Texas Southwestern Medical Center in Dallas, cautioned against basing clinical decisions on a meta-analysis.&lt;/p&gt;
&lt;p&gt;They pointed to the variation in event rates among the seven included studies, ranging from 0.24% to 1.95%. The highest rate was found in hospitalized patients, although most of the studies included ambulatory patients.&lt;/p&gt;
&lt;p&gt;&quot;So using this average probability [0.57%] for clinical decision making in some clinical contexts may do more harm than good,&quot; they wrote. &quot;Greater detail about individual patient scenarios is necessary to facilitate better application of the study results to individual patients.&quot;&lt;/p&gt;
&lt;p&gt;Although whole-leg compression ultrasound reliably identifies the presence or absence of deep vein thrombosis above the knee, its accuracy for thrombi below the knee is less certain, according to Stevens and colleagues.&lt;/p&gt;
&lt;p&gt;So guidelines have recommended repeating the examination after a negative finding to rule out the upward propagation of a distal thrombus.&lt;/p&gt;
&lt;p&gt;But only 1% to 2% of those repeat exams actually detect thrombus propagation.&lt;/p&gt;
&lt;p&gt;Thus, a single whole-leg compression ultrasound may reliably exclude both proximal and distal deep vein thrombosis, the authors said.&lt;/p&gt;
&lt;p&gt;They reviewed the literature to assess the risk of venous thromboembolism in patients with suspected lower extremity deep vein thrombosis who had a single, negative whole-leg compression ultrasound and who had not received anticoagulation treatments for 90 days.&lt;/p&gt;
&lt;p&gt;Seven studies were included  --  one randomized controlled trial and six prospective cohort studies  --  comprising 4,731 patients, mostly from the ambulatory setting.&lt;/p&gt;
&lt;p&gt;Through three months of follow-up, 0.7% of patients had either confirmed venous thromboembolism or suspected venous thromboembolism-related death. All nine who died were either acutely ill, hospitalized patients, or patients with advanced cancer.&lt;/p&gt;
&lt;p&gt;The risk of having an event during follow-up increased with greater pretest probability of having deep vein thrombosis  --  0.29% for low risk, 0.82% for moderate risk, and 2.49% for high risk.&lt;/p&gt;
&lt;p&gt;However, because of low patient numbers, the researchers wrote, &quot;using a single negative whole-leg compression ultrasound result as the sole diagnostic modality in patients with high pretest probability of deep vein thrombosis requires further study.&quot;&lt;/p&gt;
&lt;p&gt;The authors listed several limitations of the analysis: &lt;ul&gt; &lt;li&gt;The variability in ultrasound techniques between the included studies may limit the validity and generalizability of the findings.&lt;/li&gt; &lt;li&gt;The pretest probability of deep vein thrombosis was not assessed using a standardized clinical prediction rule by most studies.&lt;/li&gt; &lt;li&gt;The findings might have limited generalizability to pregnant women, patients with cancer, and inpatients, who were underrepresented in the studies.&lt;/li&gt; &lt;li&gt;Longer-term outcomes were not assessed.&lt;/li&gt; &lt;li&gt;The findings might have been affected by verification bias, because only patients with symptoms were evaluated for venous thromboembolism during follow-up.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;Steven did not report any conflicts of interest. One of his co-authors reported receiving consulting fees from AGEN Biomedical, Janssen-Ortho, Boehringer-Ingelheim, sanofi-aventis, and AstraZeneca, and receiving speaker&apos;s fees from Pfizer, Leo Pharma, and sanofi-aventis.&lt;/p&gt;&lt;p&gt;The editorialists did not make any financial disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_400"
                     title="Fractured Evidence: Spine Repair Debate Heats Up"
                     score="0.009"
                     href="http://www.medpagetoday.com/Surgery/Orthopedics/tb/18303?impressionId=1265746135647"
                     
      &lt;p&gt;Hundreds of thousands have benefited from vertebroplasty, advocates insist. They say the minimally-invasive procedure has freed them from hospital beds and dependence on intravenous narcotics.&lt;/p&gt;
&lt;p&gt;Spine physicians swear that inserting a large-gauge needle into fractured vertebrae and injecting a cement compound to stabilize the bone hastens healing and helps relieve the often-crippling pain of compression fractures brought on by osteoporosis or metastatic disease.&lt;/p&gt;
&lt;p&gt;But two recently-published, randomized controlled trials  --  the gold standard of evidence-based medicine  --  say otherwise. As far as disability and pain relief were concerned, they found that vertebroplasty for osteoporotic vertebral compression fractures was no better than a sham procedure.&lt;/p&gt;
&lt;p&gt;Publication of the results triggered an outraged backlash from radiologists, for whom vertebroplasty is a bread-and-butter operation. The entire specialist community lambasted the studies  --  statistically and methodologically.&lt;/p&gt;
&lt;p&gt;But experts in evidence-based medicine argue that when profits are on the line, it&apos;s easy to be persuaded that studies are flawed.&lt;/p&gt;
&lt;p&gt;So the debate rages, with radiologists citing case after case of success, arguing that patients with the worst fractures will have no treatment alternatives if the nation&apos;s third-party payers  --  Medicare and the insurance companies&lt;strong&gt; -&lt;/strong&gt;- refuse to pay for the procedure anymore.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;The Studies&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Both randomized, controlled studies were published last August in the &lt;em&gt;New England Journal of Medicine&lt;/em&gt;. They involved a combined total of about 200 patients. Each found that vertebroplasty did not yield significantly better results in terms of disability or short-term pain relief than sham procedures for patients with this type of vertebral fracture.&lt;/p&gt;
&lt;p&gt;In an e-mail to &lt;em&gt;MedPage Today&lt;/em&gt;, the author of one study, Rachelle Buchbinder, PhD, of Monash University in Australia, suggested that the research showed the procedure was ineffective.&lt;/p&gt;
&lt;p&gt;&quot;Based upon the results of both trials I don&apos;t think that this treatment should be offered in routine care,&quot; she declared.&lt;/p&gt;
&lt;p&gt;But the leader of the other trial, David Kallmes, MD, of the Mayo Clinic in Rochester, Minn., offered a different interpretation. He said the studies have been largely misunderstood by the trials&apos; critics&lt;strong&gt;.&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;&quot;I&apos;ve been practicing for 15 years and had strong confidence that the procedure was effective, and that&apos;s exactly what we showed,&quot; he said in a telephone interview.&lt;/p&gt;
&lt;p&gt;Mean baseline pain intensity on a 10-point scale was 6.9 in the vertebroplasty group and 7.2 in the sham-operated group in his trial, which had 131 patients. One month later, these scores had declined to 3.9 and 4.6, respectively.&lt;/p&gt;
&lt;p&gt;Kallmes said this degree of pain reduction with vertebroplasty &quot;exactly reproduces our prior experience.&quot; He vehemently denied that the findings were &quot;discordant&quot; with prior experience, as two statements from the Society of Interventional Radiology (SIR) put it.&lt;/p&gt;
&lt;p&gt;&quot;I don&apos;t know what they&apos;re talking about,&quot; Kallmes said. &quot;It is concordant.&quot;&lt;/p&gt;
&lt;p&gt;He said the real surprise was the effectiveness of the sham procedure, which should be the focus of follow-up investigations.&lt;/p&gt;
&lt;p&gt;It involved inserting needles into the spinal column and injecting short-acting painkillers such as lidocaine, as was also done with vertebroplasty prior to inserting needles into the fractured vertebrae and injecting the cement.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;The Flaws&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Critics of the two studies cite a laundry list of complaints: too few patients, failure to meet enrollment, inclusion of patients with milder degrees of pain and disability than those usually treated.&lt;/p&gt;
&lt;p&gt;In a November commentary from SIR, issued in conjunction with &lt;em&gt;NEJM&apos;s &lt;/em&gt;publication of letters critical of the studies, J. Kevin McGraw, MD, of Riverside Radiology and Interventional Associates in Columbus, Ohio, highlighted the fact that Kallmes&apos; study originally called for 250 patients.&lt;/p&gt;
&lt;p&gt;Only 131 enrolled, and the vast majority  --  1,682 of 1,813 screened  --  were excluded, &quot;introducing significant selection bias into the study,&quot; he complained.&lt;/p&gt;
&lt;p&gt;McGraw also pointed out that Kallmes&apos; group didn&apos;t use screening MRI to ensure that a fracture was the cause of the patient&apos;s pain.&lt;/p&gt;
&lt;p&gt;In addition, he did some additional statistical noodling and found that if one additional patient had reported a favorable response in the vertebroplasty group, the &lt;em&gt;P&lt;/em&gt;-value would be 0.04, rather than a nonsignificant 0.06. Likewise, if one more patient had an unfavorable response in control group, the association&apos;s&lt;em&gt; P&lt;/em&gt;-value would become significant.&lt;/p&gt;
&lt;p&gt;Finally, in the crossover part of the trial, McGraw highlighted that 12% of patients in the vertebroplasty arm elected the sham procedure, while 43% of those who got the sham went for the real thing.&lt;/p&gt;
&lt;p&gt;&quot;The tremendous crossover rate speaks for some obvious benefit of vertebroplasty over sham and is worthy of a future adequately powered analysis to evaluate,&quot; McGraw wrote.&lt;/p&gt;
&lt;p&gt;As for the Buchbinder trial, McGraw said it was convoluted by selection bias, since two-thirds of patients came from a single center and their procedures were performed by a single radiologist. The commentary also criticizes the volume of cement injected into vertebrae as lower than normal.&lt;/p&gt;
&lt;p&gt;Similarly, the North American Spine Society issued a critique of patient selection criteria and outcome measures, and questioned whether the sham treatment was actually an active therapy. The statement suggested that dry needling might be a more appropriate control.&lt;/p&gt;
&lt;p&gt;One of the letters published in &lt;em&gt;NEJM&lt;/em&gt; also criticized the protocol requirement that patients undergo four weeks of medical therapy prior to enrollment in the trial. During that time, some fractures would have already healed, &quot;resulting in a study on healed fractures,&quot; a group of Australian physicians wrote.&lt;/p&gt;
&lt;p&gt;SIR president Brian F. Stainken, MD, took issue with the fact that patients with the most pain  --  typically older, osteoporotic women  --  weren&apos;t represented.&lt;/p&gt;
&lt;p&gt;McGraw said these patients would be the least likely to agree to be in a randomized trial with a 50% chance of receiving the sham treatment.&lt;/p&gt;
&lt;p&gt;&quot;Most people in severe pain won&apos;t enroll,&quot; Stainken said. &quot;At some level, research design has to take reality into consideration.&quot;&lt;/p&gt;
&lt;p&gt;&quot;The population with low-grade pain, that&apos;s the population these papers focused on,&quot; he continued. &quot;It&apos;s not clear what the right solution is for this group. But I think the contribution of these [two &lt;em&gt;NEJM&lt;/em&gt; studies] may be toward that.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;On the Defense&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Kallmes, however, responded that there was no difference in baseline pain scores between patients entering the study and those considered eligible but refusing to participate.&lt;/p&gt;
&lt;p&gt;He also told &lt;em&gt;MedPage Today&lt;/em&gt; that he and colleagues &quot;enrolled patients that are very similar to those treated around the world.&quot;&lt;/p&gt;
&lt;p&gt;&quot;These studies were by far, by far, the best studies ever done,&quot; Kallmes declared.&lt;/p&gt;
&lt;p&gt;&quot;I have full confidence that if we had shown something different, that is, if we had found the procedure was more effective than placebo, people would have embraced it and said they were great studies,&quot; he continued.&lt;/p&gt;
&lt;p&gt;&quot;They would have said, &apos;Look at it, they were prospective, randomized, blinded, near 100% follow-up.&apos; They would have been held up as the paragon for how to do studies in the future  --  if we had reinforced people&apos;s preconceived notions.&quot;&lt;/p&gt;
&lt;p&gt;Richard Deyo, MD, MPH, professor of evidence-based medicine at Oregon Health &amp;amp; Science University in Portland and deputy editor of &lt;em&gt;Spine,&lt;/em&gt; told &lt;em&gt;MedPage Today&lt;/em&gt; that the studies are the best evidence to date regarding the effectiveness of vertebroplasty in these patients.&lt;/p&gt;
&lt;p&gt;&quot;No study is perfect, and these are not perfect, but I do think they&apos;re the best we have,&quot; Deyo said.&lt;/p&gt;
&lt;p&gt;Deyo said there was some validity to complaints that the studies enrolled too few patients, although both trials were adequately powered to detect a difference in pain reduction.&lt;/p&gt;
&lt;p&gt;&quot;If the benefit of this treatment were as enormous as many of the advocates argue,&quot; he said, &quot;then it would take a much smaller study to demonstrate a huge benefit.&quot;&lt;/p&gt;
&lt;p&gt;On the other hand, the studies were too small to evaluate the effects among various patient subgroups.&lt;/p&gt;
&lt;p&gt;Kallmes also criticized the societies&apos; press releases, charging they were written by some &quot;who haven&apos;t read the studies carefully.&quot;&lt;/p&gt;
&lt;p&gt;&quot;The societies are in a great position,&quot; he said. &quot;They have thought leaders that they can partner with to move the science forward. Moving the science forward is not done by sending out press releases.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Radiologists&apos; Concerns&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;SIR&apos;s reaction may not be surprising, given that radiologists are so vested in vertebroplasty. Medicare will pay physicians from $522 to $554 for a procedure on one vertebra performed in a hospital or outpatient surgery clinic  --  or more than $2,000 if it&apos;s conducted in the physician&apos;s office.&lt;/p&gt;
&lt;p&gt;The number of annual procedures varies from office to office, and radiologists provide varying estimates. McGraw said he performs about 150 vertebroplasties annually, and Stainken said the procedure accounts for about 20% of radiologists&apos; procedures, although that estimate &quot;may be a little high.&quot;&lt;/p&gt;

&lt;p&gt;One of the radiologists&apos; main concerns is that insurance companies will use the trials to justify ending coverage of vertebroplasty for osteoporotic spinal fractures.&lt;/p&gt;
&lt;p&gt;But insurers started playing that card long before the &lt;em&gt;NEJM&lt;/em&gt; trials were published.&lt;/p&gt;
&lt;p&gt;In a 2008 report, the Technology Evaluation Center of the Blue Cross and Blue Shield Association (BCBSA) concluded that neither vertebroplasty nor the related kyphoplasty  --  which restores compression-fractured vertebrae to their normal size with a balloon before the cement injection  --  had been demonstrated to be any better at improving net health outcomes than medical treatments.&lt;/p&gt;
&lt;p&gt;That same year, Wellpoint, the insurance giant with 35 million members, announced plans to classify both procedures &quot;investigational.&quot; That prompted a letter from SIR imploring the company to reconsider.&lt;/p&gt;
&lt;p&gt;Another spine physician, Christopher Bono, MD, of Brigham &amp;amp; Women&apos;s Hospital in Boston, told &lt;em&gt;MedPage Today &lt;/em&gt;that Aetna was also reconsidering coverage for vertebroplasty following the &lt;em&gt;NEJM&lt;/em&gt; publications.&lt;/p&gt;

&lt;p&gt;He said that he believed the firms would not end coverage entirely, but policies would be more restrictive.&lt;/p&gt;
&lt;p&gt;&quot;My gut sense is that payers are going to be much more selective in who they will pay for [regarding vertebroplasty],&quot; Bono said. &quot;They will ask for certain documentation and many more criteria than they did in the past.&quot;&lt;/p&gt;
&lt;p&gt;McGraw worries that seniors will be &quot;denied coverage when they are in the twilight of their lives and could possibly have long-standing suffering&quot; that &quot;could lead to their demise.&quot;&lt;/p&gt;
&lt;p&gt;Stainken said there&apos;s &quot;clear, unambiguous data that prolonged bed rest is the beginning of the cycle of decline for these patients. The key is to be able to do everything we can to ... keep these patients ambulatory and avoid that whole scenario.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Change is Hard&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Deyo said money may partly explain the reluctance of physicians who perform vertebroplasties to scale back their use of the procedure.&lt;/p&gt;
&lt;p&gt;&quot;There are people who are making a living doing this, and you don&apos;t easily change what you do for a living,&quot; Deyo said.&lt;/p&gt;
&lt;p&gt;The man credited with coining the term &quot;evidence-based medicine&quot; agreed.&lt;/p&gt;
&lt;p&gt;&quot;If you are making money from a procedure, it is very easy to persuade yourself that new evidence that the procedure is ineffective is in some way flawed or limited to allow you to continue to make money on the procedure,&quot; Gordon Guyatt, MD, of McMaster University in Hamilton, Ontario, told &lt;em&gt;MedPage Today.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;&quot;When we have opinions and beliefs, we are very resistant to new evidence.&quot;&lt;/p&gt;
&lt;p&gt;Kallmes, too, said there are psychological reasons for not accepting the results: &quot;People just don&apos;t want to be convinced. They don&apos;t want to change their preconceived notions.&quot;&lt;/p&gt;
&lt;p&gt;&quot;They have this anecdotal experience,&quot; he added, &quot;but I can tell them anecdotes of miraculous results with the placebo. So if they do this same study themselves, they may find the same thing I found.&quot;&lt;/p&gt;
&lt;p&gt;Still, McGraw and Bono insisted the studies were too flawed to serve as the evidence base for clinical practice.&lt;/p&gt;
&lt;p&gt;&quot;Before we make these two studies the Holy Grail of evidentiary medicine with regard to vertebroplasty, we need to have larger trials,&quot; McGraw said.&lt;/p&gt;
&lt;p&gt;Bono said evidence-based medicine, properly implemented, has three components: reviewing and applying the best data, &quot;but also incorporating surgeon experience and patient preference.&quot;&lt;/p&gt;
&lt;p&gt;&quot;If you are just using the first, and I&apos;m a strong advocate for using data and literature and references, I think you&apos;re doing a disservice,&quot; he said. &quot;And then if you are misinterpreting the data or twisting the data or slanting the data, and eliminating the other two, you are really abusing the word evidence-based medicine.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Outcomes&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;So, will vertebroplasty go the way of other procedures that seemed to work clinically, but bombed in trials, such as knee arthroscopy for osteoarthritis?&lt;/p&gt;
&lt;p&gt;SIR is awaiting the results of VERTOS II, a 200-patient Dutch trial comparing vertebroplasty with conservative therapy in patients with painful, osteoporotic vertebral compression fractures. And Stainken called for large trials that will address several of the methodology issues raised with the &lt;em&gt;NEJM &lt;/em&gt;reports.&lt;/p&gt;
&lt;p&gt;With regard to the potential placebo effect, Kallmes said he has nearly completed a 20-patient, open-label study of a procedure like that used as the sham in the randomized trial  --  a spinal injection of short-acting painkillers.&lt;/p&gt;
&lt;p&gt;Also in the works is a comparative trial of vertebroplasty and balloon kyphoplasty, he said.&lt;/p&gt;
&lt;p&gt;Stainken said he has heard from colleagues who said they had slowed down or stopped doing the procedures after the studies were published, &quot;which is not unreasonable  --  to think it through and understand the situation.&quot;&lt;/p&gt;
&lt;p&gt;However, most have resumed performing the procedure, and demand for it continues, he added.&lt;/p&gt;
&lt;p&gt;Aman Patel, MD, an associate professor of radiology and neurosurgery at Mount Sinai School of Medicine in New York City, said he and his colleagues have not changed their practice since learning of the studies&apos; findings.&lt;/p&gt;
&lt;p&gt;However, he has started telling patients about the findings from the &lt;em&gt;NEJM&lt;/em&gt; studies so they can be fully informed of the existing evidence about the risks and benefits of vertebroplasty.&lt;/p&gt;
&lt;p&gt;&quot;I firmly believe this procedure benefits some, if not many, patients,&quot; Patel said.&lt;/p&gt;
&lt;p&gt;McGraw said he tells patients about the trials, but he also tells patients who he thinks would benefit from vertebroplasty that he doesn&apos;t believe the findings apply to them.&lt;/p&gt;
&lt;p&gt;He said one patient had initially declined the procedure after talking it over. &quot;That patient called me up a week later to proceed with vertebroplasty,&quot; he said.&lt;/p&gt;
&lt;p&gt;Even if the findings don&apos;t change the way spine doctors use vertebroplasty in the short term, Deyo suspects the results will lead to fewer procedures in the long run.&lt;/p&gt;
&lt;p&gt;Guyatt and Deyo predicted that eventually, a critical mass of evidence would be assembled  --  assuming future randomized studies replicate these results  --  that would convince even the most steadfast adherents.&lt;/p&gt;
&lt;p&gt;Also, the &lt;em&gt;NEJM&lt;/em&gt; studies could have an immediate effect in promoting more research by increasing the level of doubt about the procedure, Deyo said: &quot;I don&apos;t think we have the final word here.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;Deyo, Guyatt, Patel, and Stainken reported having no relevant conflicts of interest.&lt;/p&gt;&lt;p&gt;Bono reported financial relationships other than research funding with Life Spine, Depuy, Medtronic, and Stryker, and research funding from Archus Orthopedics and Synthes Spine. He was lead author of the North American Spine Society&apos;s critique of the two randomized trials published in the &lt;em&gt;New England Journal of Medicine&lt;/em&gt;.&lt;/p&gt;&lt;p&gt;McGraw has had relationships with Cardinal Spine, Arthrocare Spine, and Hatch Medical.&lt;/p&gt;&lt;p&gt;Kallmes reported relationships with ArthroCare, Stryker, Cardinal, and Cook.&lt;/p&gt;&lt;p&gt;Buchbinder reported receiving research funding from Cook.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_361"
                     title="Hidden Dangers of Herbal Meds Reviewed"
                     score="0.007"
                     href="http://www.medpagetoday.com/PrimaryCare/AlternativeMedicine/tb/18244?impressionId=1265746135647"
                     
      Herbal medicines are not always the harmless nostrums that many patients and even some physicians think, but may actually contribute to cardiovascular morbidity and mortality, researchers warned in a review covering 44 years of research into the subject.&lt;br&gt;
&lt;br&gt;Many such products, including aloe vera, ginkgo biloba, ginseng, and green tea, can interact with conventional cardiovascular drugs and lead to serious adverse reactions, according to Arshad Jahangir, MD, of the Mayo Clinic in Scottsdale, Ariz., and two other Mayo physicians.&lt;br&gt;
&lt;br&gt;&quot;There is a clear need for better public and physician understanding of herbal products through health education, early detection and management of herbal toxicities, scientific scrutiny of their use, and research on their safety and effectiveness,&quot; they wrote in the Feb. 9 &lt;em&gt;Journal of the American College of Cardiology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Jahangir and colleagues also called for increased regulation of such products, at least requiring manufacturers of herbal medicines to register with the FDA and provide evidence of good manufacturing practices.&lt;/p&gt;
&lt;p&gt;&quot;Some of these adverse drug reactions are preventable,&quot; Jahangir told &lt;em&gt;MedPage Today&lt;/em&gt; in a telephone interview. &quot;Simple things like taking a good history or giving that history and discussing these issues, probably we can avoid [such reactions].&quot;&lt;/p&gt;
&lt;p&gt;Other physicians contacted by &lt;em&gt;MedPage Today&lt;/em&gt; and ABC News agreed that the growth in popularity of herbal medicines poses problems for physicians and patients.&lt;/p&gt;
&lt;p&gt;&quot;Because these remedies are &apos;natural,&apos; their potential dangers are not considered the same way they would be if they were medication,&quot; commented Suzanne Steinbaum, MD, a cardiologist at Lenox Hill Hospital in New York City, in an e-mail.&lt;/p&gt;
&lt;p&gt;&quot;For many reasons, patients tend not to disclose to their doctors if they are taking herbal remedies, including fear that their doctors won&apos;t approve or they will be told to stop them,&quot; Steinbaum added. &quot;This lack of knowledge and full-disclosure, for some, might be a fatal omission.&quot;&lt;/p&gt;
&lt;p&gt;Jahangir and colleagues reviewed nearly 90 publications that have addressed herbal or complementary therapies and cardiovascular effects since 1966.&lt;/p&gt;
&lt;p&gt;Their &lt;em&gt;JACC&lt;/em&gt; article listed 15 common herbal medicines known to interact adversely with conventional cardiovascular drugs.&lt;/p&gt;
&lt;p&gt;In many cases, the herbal products compete with the regular medicines for the same drug-metabolizing cytochrome P450 enzymes, potentiating the latter&apos;s effects. In other cases, the herbal products have their own cardiovascular effects.&lt;/p&gt;
&lt;p&gt;Many physicians already know that grapefruit juice occupies the CYP3A4 enzyme, leading to slower-than-expected metabolism and, therefore, higher blood levels of a host of pharmaceuticals.&lt;/p&gt;
&lt;p&gt;These include the statins, calcium channel antagonists, several common anti-arrhythmic drugs, and the angiotensin receptor blocker irbesartan (Avapro), Jahangir and colleagues noted.&lt;/p&gt;
&lt;p&gt;Garlic is one of several common herbal remedies with specific cardiovascular effects in its own right (others include ginkgo biloba, ginseng, and saw palmetto). Garlic inhibits platelet aggregation and thus can lead to increased bleeding risks when combined with aspirin, clopidogrel (Plavix), or warfarin (Coumadin), the researchers noted.&lt;/p&gt;
&lt;p&gt;The Mayo group identified 10 herbal products that increase bleeding risks with anticoagulant and antiplatelet drugs, as well as 14 that can induce arrhythmias.&lt;/p&gt;
&lt;p&gt;In all, Jahangir and colleagues listed 27 herbal products that patients with cardiovascular diseases would do well to avoid. These include such common and harmless-seeming products as green tea, capsicum pepper, licorice, and kelp, as well as grapefruit juice and garlic.&lt;/p&gt;
&lt;p&gt;&quot;We need to check with our patients what type of products they are using, to identify these potential interactions,&quot; Jahangir told &lt;em&gt;MedPage Today&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;He cited the previously reported figure of 100,000 deaths annually from drug interactions, adding, &quot;We don&apos;t even know how many of these are due to use of compounds that we are not aware that our patients are taking.&quot;&lt;/p&gt;
&lt;p&gt;Jahangir said he was surprised, in preparing the review, at the scale of hebal medicine use in the U.S.&lt;/p&gt;
&lt;p&gt;He and his colleagues found data from the 1990s suggesting that more patients consult complementary and alternative medicine providers than regular physicians.&lt;/p&gt;
&lt;p&gt;The total annual out-of-pocket expenditure on complementary and alternative medicine services and products also was greater than for conventional physician services.&lt;/p&gt;
&lt;p&gt;&quot;The surprise for me was . . . how much people are willing to spend on a type of therapy which has not shown, in any scientific way, to be effective or safe,&quot; Jahangir said.&lt;/p&gt;
&lt;p&gt;He added that the trend may reflect shortcomings of the conventional medical system.&lt;/p&gt;
&lt;p&gt;&quot;What is the reason people are going there? Is it because there is some unmet type of need that we are not recognizing as practitioners of conventional medicine?&quot;&lt;/p&gt;
&lt;p&gt;Jahangir said it may be that physicians aren&apos;t spending enough time with patients to understand their true needs. He said it appears that, &quot;despite the advancement in our technology and new medicines, there is a demand for alternative therapies that is increasing.&quot;&lt;/p&gt;
&lt;p&gt;He recommended that, in addition to asking patients in detail about herbal and other alternative therapies they may be using, physicians should educate themselves on what these therapies purport to do and what is known about their real biological effects.&lt;/p&gt;
&lt;p&gt;The &lt;a href=&quot;http://nccam.nih.gov&quot; mce_href=&quot;http://nccam.nih.gov&quot; target=&quot;_blank&quot;&gt;National Center for Complementary and Alternative Medicine&lt;/a&gt; at the National Institutes of Health is a good starting point for such information, both for physicians and for patients, Jahangir said.&lt;/p&gt;
&lt;p&gt;Lenox Hill&apos;s Steinbaum said it was important that conventional physicians &quot;become more open-minded and accepting&quot; of alternative medicine, if only because so many of their patients are already practicing it.&lt;/p&gt;
&lt;p&gt;David Meyerson, MD, JD, a Johns Hopkins University cardiologist, told &lt;em&gt;MedPage Today&lt;/em&gt; and ABC News in an e-mail that he advises patients to limit their use of &quot;unstudied and unproven and FDA-unregulated herbal medications.&quot;&lt;/p&gt;
&lt;p&gt;&quot;It&apos;s unfortunately very big business, and potential drug interactions and potential harmful effects abound,&quot; he wrote.&lt;/p&gt;
&lt;p&gt;But another physician criticized the Mayo physicians&apos; emphasis on adverse effects in their review.&lt;/p&gt;
&lt;p&gt;&quot;For many of products listed, evidence for side effects seems to be minimal,&quot; Scott Grundy, MD, of the University of Texas Southwestern Medical Center in Dallas, argued in an e-mail.&lt;/p&gt;
&lt;p&gt;He agreed that the efficacy and safety of such drugs remains largely unproven, but added, &quot;It is mainly for these reasons that they cannot be recommended for use.&quot;&lt;/p&gt;
&lt;p&gt;Creating alarm about side effects &quot;may not be the appropriate way to discourage their use,&quot; Grundy said.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;This article was developed in collaboration with ABC News. &lt;/em&gt;&lt;img src=&quot;http://www.medpagetoday.com/upload/2009/10/1/14357_1.jpg&quot; mce_src=&quot;http://www.medpagetoday.com/upload/2009/10/1/14357_1.jpg&quot; alt=&quot;&quot;&gt;&lt;/p&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_348"
                     title="No Rebound Seen After Antiplatelet Withdrawal (CME/CE)"
                     score="0.006"
                     href="http://www.medpagetoday.com/Cardiology/PCI/tb/18226?impressionId=1265746135647"
                     
      &lt;p&gt;No evidence of a platelet aggregation rebound occurs with abrupt discontinuation of clopidogrel (Plavix) in patients undergoing percutaneous coronary intervention (PCI), investigators in a randomized clinical trial concluded.&lt;/p&gt;
&lt;p&gt;Values for adenosine diphosphate (ADP)-induced platelet aggregation did not differ significantly between patients whose clopidogrel therapy was withdrawn abruptly and those in whom clopidogrel was tapered before discontinuation, they wrote in an article in the Feb. 9 issue of the &lt;em&gt;Journal of the American College of Cardiology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The findings also showed that tapering of clopidogrel does not lead to lower platelet aggregation values after clopidogrel withdrawal, according to Dirk Sibbing, MD, of Technical University Munich in Germany, and colleagues&lt;em&gt;&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;&quot;The time course of platelet aggregation values  --  regardless of the device, the agonist, or the agonist concentration used  --  after clopidogrel cessation provides no evidence for the existence of a rebound phenomenon of platelets after discontinuing clopidogrel,&quot; they wrote in conclusion.&lt;/p&gt;
&lt;p&gt;For patients undergoing PCI, dual antiplatelet therapy with aspirin and clopidogrel has become the mainstay for prevention of thrombotic events. Lifelong aspirin therapy is recommended for patients after PCI, but clinical guidelines recommend discontinuation of clopidogrel after six or 12 months. The standard practice is to withdraw clopidogrel abruptly, the authors noted.&lt;/p&gt;
&lt;p&gt;Recent studies have shown a clustering of thrombotic events in the first few weeks after discontinuation of long-term clopidogrel therapy. The observations have led to the hypothesis of a rebound phenomenon of platelet aggregation. However, the hypothesis had not been examined specifically within the context of clopidogrel withdrawal.&lt;/p&gt;
&lt;p&gt;&quot;Because different studies have demonstrated that insufficient suppression of platelet reactivity to ADP is associated with an increased risk of thrombotic events after coronary stent placement, the observed clustering of adverse events reported in clinical studies might be related to an intermittent status of platelet hyperreactivity or so-called platelet rebound with very high ADP-induced platelet aggregation levels,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;A tapering of clopidogrel treatment over a certain period of time before stopping the intake of the drug completely might provide a beneficial treatment strategy to attenuate this supposed rebound phenomenon of platelets.&quot;&lt;/p&gt;
&lt;p&gt;Sibbing and colleagues designed a randomized clinical trial to determine whether a rebound phenomenon exists after discontinuation of clopidogrel and whether the rebound can be attenuated by a clopidogrel-tapering regimen.&lt;/p&gt;
&lt;p&gt;The investigators enrolled 69 patients receiving clopidogrel in association with PCI procedures. In all cases, discontinuation of clopidogrel was planned.&lt;/p&gt;
&lt;p&gt;The patients were randomized to two strategies of discontinuation: tapering of the clopidogrel dose over four weeks, followed by discontinuation; or treatment for four weeks, as planned, followed by abrupt discontinuation.&lt;/p&gt;
&lt;p&gt;Investigators assessed platelet aggregation at enrollment and during weeks two through eight after randomization. Aggregation was assessed simultaneously by light transmission aggregometry (LTA) and multiple electrode aggregometry (MEA).&lt;/p&gt;
&lt;p&gt;The primary endpoint was the highest rate of ADP-induced platelet aggregation by LTA in weeks five through eight after clopidogrel withdrawal.&lt;/p&gt;
&lt;p&gt;Platelet aggregation by LTA peaked at 73% in the group that had clopidogrel abruptly withdrawn and at 69.3% in the tapering group, resulting in a nonsignificant difference (&lt;em&gt;P&lt;/em&gt;=0.21). The between-group values did not differ across the range of ADP concentrations used (1.25 to 20 &amp;#181;mol/L).&lt;/p&gt;
&lt;p&gt;Results by MEA were similar: The peak aggregation value associated with abrupt withdrawal was 925 AU x min compared with 890 AU x min with clopidogrel tapering (&lt;em&gt;P&lt;/em&gt;=0.55).&lt;/p&gt;
&lt;p&gt;Studies with different agonists of platelet aggregation also yielded similar results in the two patient groups.&lt;/p&gt;
&lt;p&gt;Despite finding no difference between the two strategies for clopidogrel withdrawal, the authors did not rule out the possibility of a beneficial effect of tapering clopidogrel.&lt;/p&gt;
&lt;p&gt;&quot;It could be hypothesized that, apart from the maximal values of platelet aggregation observed, a more gradual increase of platelet aggregation values achieved by a clopidogrel-tapering regimen is beneficial for the reduction of thrombotic events,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;In fact, we observed a relatively rapid increase of platelet aggregation values in the [abrupt withdrawal] group of patients in our study. Whether this rapid increase might be disadvantageous in case of stopping clopidogrel treatment remains uncertain.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by Cordis, Medtronic, and Dynabyte.&lt;/p&gt;&lt;p&gt;Sibbing disclosed relationships with Dynabyte and Eli Lilly.&lt;/p&gt;&lt;p&gt;Co-author Adnan Kastrati disclosed relationships with Eli Lilly, sanofi-aventis, and Bristol-Myers Squibb.&lt;/p&gt;&lt;p&gt;Co-author Nicolas von Beckerath disclosed relationships with Eli Lilly and sanofi-aventis.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
</recommendedContent>