<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_463"
                     title="AAPM: Online Program Helps Manage Pain (CME/CE)"
                     score="0.013"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18393?impressionId=1265790914194"
                     
      &lt;p&gt;SAN ANTONIO  --  A personalized, online self-management program helped patients with pain syndromes improve coping skills and reduce stress and depression in two studies reported here.&lt;/p&gt;
&lt;p&gt;Patients randomized to the self-management program demonstrated significant improvement in multiple social, emotional, and behavioral outcomes after six months (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01). Improvement in some parameters occurred within one month. A control group that was not exposed to the program showed no significant improvement.&lt;/p&gt;
&lt;p&gt;&quot;Our goal is to help people communicate better with providers, understand better how they can use social support, understand the comorbid conditions, like anxiety and depression, and develop cognitive skills to help get them through their pain episodes,&quot; said Emil Chiauzzi, PhD, of Inflexxion, the Newton, Mass. company that developed the program.&lt;/p&gt;
&lt;p&gt;Although the studies involved patients with migraine or low-back pain, programs are being developed for other types of pain condition, including several forms of neuropathic pain.&lt;/p&gt;
&lt;p&gt;The online program, demonstrated at &lt;a href=&quot;http://www.painACTION.com&quot; mce_href=&quot;http://www.painACTION.com&quot; target=&quot;_blank&quot;&gt;www.painACTION.com&lt;/a&gt;, employs patient-specific information to generate individualized self-management strategies.&lt;/p&gt;
&lt;p&gt;Patient responses to assessments are analyzed by a &quot;recommendation engine,&quot; which produces content recommendations designed to address each patient&apos;s informational and self-management needs.&lt;/p&gt;
&lt;p&gt;Elements on the Web site include multimedia education units, a pain inventory, interactive tools that provide information based on patient-provider communication, and medication risk management.&lt;/p&gt;
&lt;p&gt;&quot;The content on the Web site is focused on teaching people practical skills to manage the behavioral side of pain,&quot; Jonas Bromberg, PsyD, also of Inflexxion, said in an interview.&lt;/p&gt;
&lt;p&gt;Bromberg presented results of a randomized study involving 210 patients, all of whom met International Headache Society diagnostic criteria for migraine, with or without aura.&lt;/p&gt;
&lt;p&gt;Patients assigned to the online program completed at least eight 30-minute session during the first month of the study and at least five more 30-minute sessions during the five-month follow-up period. Patients in the control group continued to receive usual care without exposure to the Web site.&lt;/p&gt;
&lt;p&gt;Participants assigned to the online program had a minimum set of requirements for each session, which were provided at log-in. Follow-up assessments occurred at one, three, and six months.&lt;/p&gt;
&lt;p&gt;The two groups were balanced with respect to sex and headache frequency and severity, the researchers said.&lt;/p&gt;
&lt;p&gt;Bromberg reported that patients assigned to the self-management program demonstrated significant improvement in: &lt;ul&gt; &lt;li&gt;Headache self-efficacy (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01 compared with baseline)&lt;/li&gt; &lt;li&gt;Use of relaxation (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Use of social support (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Pain catastrophizing (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Depression (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Stress (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Chiauzzi presented results from a randomized study of 209 patients with low-back pain. The design was similar to that of the migraine study, except results were analyzed for between-group differences.&lt;/p&gt;
&lt;p&gt;The results showed significant improvement in the study group versus control group with respect to: &lt;ul&gt; &lt;li&gt;Stress (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Coping (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Social supports (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The data showed significant effects of both treatment (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01) and time (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01) favoring the Web site versus control. Chiauzzi said patients assigned to the Web site had greater mean improvement at posttest, three months, and six months.&lt;/p&gt;
&lt;p&gt;Qualitative analysis suggested that Web site participants had clinically meaningful improvement in depression, anxiety, and stress.&lt;/p&gt;
&lt;p&gt;Additionally, patients in the self-management program reported a 12.3% decrease in pain from baseline, versus 7% in the control group.&lt;/p&gt;
&lt;p&gt;Access to the Web site did not improve physical functioning.&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 studies were funded by the National Institutes of Health.&lt;/p&gt;&lt;p&gt;Chiauzzi and Bromberg are employees of Inflexxion, developer of the online program.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_434"
                     title="AAPM: Capsaicin Patch Unaffected by Anesthestics (CME/CE)"
                     score="0.013"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18351?impressionId=1265790914194"
                     
      &lt;p&gt;SAN ANTONIO  --  The analgesic properties of a capsaicin patch (NGX-4010, Qutenza) remained intact when used in combination with three different topical anesthetics to reduce initial skin discomfort, researchers reported here.&lt;/p&gt;
&lt;p&gt;Pain reduction among patients with neuropathic pain conditions averaged about 30% during weeks two through 12 compared with baseline levels and did not differ by the the type of lidocaine-based pretreatment.&lt;/p&gt;
&lt;p&gt;Between 45% and 50% of patients in each group had at least a 30% decrease in pain.&lt;/p&gt;
&lt;p&gt;&quot;No significant differences in tolerability were noted among the three topical anesthetics evaluated,&quot; Lynn R. Webster, MD, of Lifetree Clinical Research in Salt Lake City, and colleagues concluded in a poster presentation at the American Academy of Pain Medicine meeting.&lt;/p&gt;
&lt;p&gt;&quot;Preliminary efficacy of NGX-4010 was similar, irrespective of the topical anesthetic and comparable to results in previous phase III studies using NGX-4010 in patients with postherpetic neuralgia.&quot;&lt;/p&gt;
&lt;p&gt;The 8% capsaicin patch has FDA approval for management of postherpetic neuralgia. Prior to applying the patch, the skin is treated with a topical anesthetic to reduce discomfort. In previous studies of NGX-4010, a 4% lidocaine cream (LMX4) had been applied prior to the patch.&lt;/p&gt;
&lt;p&gt;Whether the type of anesthetic pretreatment affected the safety and efficacy of NGX-4010 was unclear. To address the issue, investigators conducted a randomized, multicenter, open-label clinical study involving 117 patients with moderate-to-severe postherpetic neuralgia, HIV-distal sensor polyneuropathy, or peripheral diabetic neuropathy.&lt;/p&gt;
&lt;p&gt;The patients were randomized to a 60-minute pretreatment period with one of three 4% lidocaine-based topical anesthetics (LMX4, Topicaine, or Betacaine). Within each anesthetic group, patients were further randomized to a 60- or 90-minute application of NGX-4010.&lt;/p&gt;
&lt;p&gt;Safety and tolerability assessments included adverse events, skin assessments by a 7-point scoring system, pain score on the day of treatment, and use of medication for treatment-related discomfort.&lt;/p&gt;
&lt;p&gt;The principal efficacy outcome was the percentage change in mean pain scores (reflecting average pain for the past 24 hours) from baseline to weeks two through 12.&lt;/p&gt;
&lt;p&gt;Men accounted for about 60% of the study population, and three-fourths of the patients had peripheral diabetic neuropathy. Duration of pain averaged four to five years. The baseline pain level averaged 5 to 6 (moderate) on the 0-10 pain scale.&lt;/p&gt;
&lt;p&gt;In all three groups, the pain level increased slightly or not at all, following application of the capsaicin patch. In general, patients treated for 90 minutes reported more pain than those treated for 60 minutes, but the difference was not statistically significant.&lt;/p&gt;
&lt;p&gt;Within the first 48 hours, 70% to 75% of patients in each group reported &amp;#8805;33% increase in pain.&lt;/p&gt;
&lt;p&gt;More than half the patients in each group required oral analgesics for treatment-related pain, and patients treated for 90 minutes with transdermal capsaicin were more likely to require oral analgesics than were the patients who were treated for 60 minutes.&lt;/p&gt;
&lt;p&gt;The most common adverse event in all three groups was mild to moderate burning or pain at the application site.&lt;/p&gt;
&lt;p&gt;From weeks two through 12, the average pain reduction compared with baseline ranged from 27.2% to 34.3% and did not differ significantly among the groups. About half the patients had at least a 30% reduction in pain compared with baseline.&lt;/p&gt;
&lt;p&gt;At week 12, 35% to 42% of patients in each group reported that their pain was &quot;much improved,&quot; and about 60% to 70% said their pain was &quot;improved.&quot;&lt;/p&gt;
&lt;p&gt;None of the between-group differences was statistically significant.&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 NeurogesX.&lt;/p&gt;&lt;p&gt;Webster&apos;s disclosures include Ameritox, Cephalon, King Pharmaceuticals, Medtronic, Arcion Therapeutics, Advanced Bionics, CoMentis, F. Hoffman-La Roche, Forest Laboratories, Hisamitsu Pharmaceuticals, Merck, Myriad Pharmaceuticals, Nektar Therapeutics, NeurogesX, Pfizer, Wyeth, XenoPort, Nervo, Neuromed Pharmaceuticals, and Purdue Pharma.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_426"
                     title="AAPM: Spine Stimulation Leads to Durable Pain Relief (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18344?impressionId=1265790914194"
                     
      &lt;p&gt;SAN ANTONIO  --  Spinal cord stimulation provided durable pain relief for patients with complex regional pain syndrome (CRPS) but did not halt progression, a retrospective analysis of a small clinical series showed.&lt;/p&gt;
&lt;p&gt;During follow-up for as long as 20 years, patients continued to rate their pain as significantly below baseline levels. Improvements in depression, medication use, and quality of life also proved durable.&lt;/p&gt;
&lt;p&gt;However, the pain syndrome progressed to other areas in all patients.&lt;/p&gt;
&lt;p&gt;&quot;All patients in this series experienced a gradual enlargement in the area affected over time,&quot; Krishna Kumar, MB, BS, of Regina Qu&apos;appelle Health Region in Regina, Saskatchewan, said at the American Academy of Pain Medicine meeting. &quot;Stimulation does not appear to retard disease spread.&quot;&lt;/p&gt;
&lt;p&gt;Nonetheless, 22 of the 25 patients in the series said they were satisfied with their pain relief and would have the procedure again.&lt;/p&gt;
&lt;p&gt;In a separate presentation at the meeting, Kumar reported that spinal cord stimulation led to significantly better outcomes than medical management in patients with failed back surgery syndrome.&lt;/p&gt;
&lt;p&gt;CRPS has an undetermined etiology, and there&apos;s no cure. The condition responds poorly to conventional medical therapy and to interventions such as transcutaneous electrical nerve stimulation, chemical blocks, sympathectomy, and physical therapy, said Kumar.&lt;/p&gt;
&lt;p&gt;Several studies and meta-analyses have shown that spinal cord stimulation relieves pain and other symptoms of CRPS during short- and mid-term follow-up. Whether the benefits persisted over the long term was unclear, Kumar continued.&lt;/p&gt;
&lt;p&gt;To assess long-term outcomes after spinal cord stimulation, Kumar and colleagues examined records of 196 patients who underwent spinal cord stimulation procedures. They identified 25 patients who met International Association for the Study of Pain criteria for CRPS and who agreed to participate.&lt;/p&gt;
&lt;p&gt;The cohort had a median follow-up of 63 months, a mean of 88 months, and a range of 18 to 235 months. The group comprised 13 men and 12 women whose mean age was 51 and whose ages ranged from 32 to 91. Ten of the 25 had upper-extremity pain and 15 had lower-extremity pain. In all cases the pain had not responded to conventional medical therapy.&lt;/p&gt;
&lt;p&gt;Assessment of each patient included pain rating by a visual analog scale (VAS), an index of physical functioning, a depression scale, a general health status survey, and a quality-of-life survey. Patients were assessed at implantation, three months and one year after implantation, and at last follow-up.&lt;/p&gt;
&lt;p&gt;All categories of medication use remained below baseline levels at last follow-up, including antidepressants, anticonvulsants, anti-inflammatory drugs, and narcotic drugs.&lt;/p&gt;
&lt;p&gt;Average scores on all of the survey instruments improved significantly from implantation to three months (&lt;em&gt;P&lt;/em&gt;=0.002 to &lt;em&gt;P&lt;/em&gt;=0.000). One-year results showed some reversal of the improvement, but scores for all outcomes remained below baseline levels.&lt;/p&gt;
&lt;p&gt;At last follow-up, mean scores remained significantly improved over baseline values (&lt;em&gt;P&lt;/em&gt;=0.003 to &lt;em&gt;P&lt;/em&gt;=0.001).&lt;/p&gt;
&lt;p&gt;The greatest improvement in health status and pain scores occurred in patients who were 40 or younger, who had stage I CRPS, and who underwent spinal cord stimulation within a year of diagnosis, said Kumar.&lt;/p&gt;
&lt;p&gt;&quot;Spinal cord stimulation is equally effective for men and women and for upper- and lower-limb CRPS,&quot; he said. &quot;Early institution is necessary to secure optimal patient outcomes, as delay exceeding one year appears to limit the effectiveness of the intervention.&quot;&lt;/p&gt;
&lt;p&gt;&quot;On the basis of these results, we conclude that spinal cord stimulation is an effective long-term management modality for CRPS and should be considered earlier in the treatment continuum, preferably within the first year of symptom onset,&quot; Kumar added.&lt;/p&gt;
&lt;p&gt;In a separate poster presentation, Kumar reported findings from a study of 100 patients with failed back surgery syndrome who were treated at 12 centers worldwide. Half the patients received conventional medical management and half had medical management plus spinal cord stimulation. The primary outcome was pain at six and 24 months after treatment.&lt;/p&gt;
&lt;p&gt;At six months, 48% of patients with spinal cord stimulation had at least 50% improvement in leg pain, compared with 9% of patients who received only medical treatment. Additionally, 38% of the spinal stimulation-group reported at least 30% improvement in back pain at six months versus 14% of the medically managed patients.&lt;/p&gt;
&lt;p&gt;Patients who were dissatisfied with their assigned treatment after six months were allowed to switch to the opposite therapy. Kumar reported that 30 of 50 patients in the medical group opted for spinal cord stimulation, compared with four of 50 in the spinal stimulation group who opted for continued treatment with medication alone.&lt;/p&gt;
&lt;p&gt;At 24 months, 42 of the original 50 patients remained in the spinal stimulation group, compared with 11 of 50 in the medical group. Differences observed at six months were maintained, including leg pain (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001), physical functioning (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0002), and quality of life (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001).&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;Kumar disclosed relationships with Medtronic and Boston Scientific.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_425"
                     title="AAN: Industrial Cleaner Again Tied to Parkinson Risk (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAN/tb/18338?impressionId=1265790914194"
                     
      TORONTO  --  The degreasing agent trichloroethylene (TCE) has been linked to increased rates of Parkinson&apos;s disease among industrial workers in yet another study, this time involving a large, well-studied group of World War II veterans.&lt;br&gt;
&lt;br&gt;Parkinson&apos;s disease developed in individuals with occupational exposure to TCE at more than five times the rate seen in those without such exposure (odds ratio 5.5, 95% CI 1.02 to 30), reported Samuel Goldman, MD, of the Parkinson&apos;s Institute in Sunnyvale, Calif.&lt;br&gt;
&lt;br&gt;Goldman described the research in a phone interview with &lt;em&gt;MedPage Today&lt;/em&gt;. It&apos;s scheduled for presentation here in April at the American Academy of Neurology&apos;s annual meeting.&lt;br&gt;
&lt;br&gt;A previous study in 2008 had fingered TCE as the most likely culprit behind a cluster of Parkinson&apos;s disease cases afflicting workers at a single industrial plant. (See &lt;a href=&quot;http://www.medpagetoday.com/Geriatrics/ParkinsonsDisease/7894&quot; mce_href=&quot;http://www.medpagetoday.com/Geriatrics/ParkinsonsDisease/7894&quot; target=&quot;_blank&quot;&gt;Trichloroethylene Implicated as Risk for Parkinsonism&lt;/a&gt;)&lt;p&gt;&lt;/p&gt;
&lt;p&gt;Also, Goldman said, animal studies have found that TCE is selectively toxic to nigral dopaminergic neurons, the same type of nerve cell that progressively dies off in Parkinson&apos;s disease. He said the chemical&apos;s activity in rodent brains is very similar to that of MPTP (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine), a dopaminergic neurotoxin commonly used to simulate Parkinson&apos;s disease in preclinical research.&lt;/p&gt;
&lt;p&gt;Goldman said the new study was the first population-based analysis to link TCE to the disease.&lt;/p&gt;
&lt;p&gt;It focused on 198 twin pairs in the National Academy of Sciences-National Research Council&apos;s World War II Twins Cohort, which comprises some 16,000 twin pairs overall.&lt;/p&gt;
&lt;p&gt;Members of the all-male cohort, who were born from 1917 to 1927 and served in the war, have been followed since the 1960s. Occupational histories for participants are available along with medical records from the VA healthcare system.&lt;/p&gt;
&lt;p&gt;In those pairs chosen for the current study, records showed that one twin had developed Parkinson&apos;s disease and the other had not. This design largely eliminates genetics as a confounding factor in the analysis.&lt;/p&gt;
&lt;p&gt;Goldman explained that occupational histories for each participant were reviewed by a blinded industrial hygienist and a preventive medicine physician to identify likely exposures to TCE and four other industrial chemicals: xylene, toluene, carbon tetrachloride, and tetrachloroethylene.&lt;/p&gt;
&lt;p&gt;As a single source of exposure, only TCE was significantly associated with development of Parkinson&apos;s disease, Goldman said.&lt;/p&gt;
&lt;p&gt;People working as aircraft mechanics, machinists, plumbers, and electricians likely had regular exposure to TCE, Goldman said. The chemical was commonly used as a &quot;spot&quot; cleaner to remove grease and oils from metal surfaces. It was also used for a time as a dry cleaning solvent, although tetrachloroethylene was more common for that purpose.&lt;/p&gt;
&lt;p&gt;Goldman said no increased risk was seen with xylene or toluene, but there were near-significant trends toward increased Parkinson&apos;s disease risk from carbon tetrachloride and tetrachloroethylene: &lt;ul&gt; &lt;li&gt;Carbon tetrachloride: OR 2.8 (95% CI 0.97 to 7.8)&lt;/li&gt; &lt;li&gt;Tetrachloroethylene: OR 9.0 (95% CI 0.78 to 103)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Twins exposed to either TCE or tetrachloroethylene were at significantly increased risk, with an odds ratio of 8.1 (95% CI 1.43 to 43) relative to individuals with no exposure to either chemical.&lt;/p&gt;
&lt;p&gt;Goldman said the analysis also examined whether duration of exposure was associated with increased risk. He said the results were in the same pattern as for the yes-no exposure analysis, but the findings were very uncertain because of the relatively small sample size.&lt;/p&gt;
&lt;p&gt;Occupational histories were available for only 99 of the 198 discordant twin pairs and some of the information was obtained by proxy rather than from the participant himself.&lt;/p&gt;
&lt;p&gt;Because of the wide confidence intervals even for the yes-no exposure analysis, the findings need confirmation in a larger study, he said, noting that the best approach would be a cohort study involving people with known, long-term exposure to TCE, compared with well-chosen controls.&lt;/p&gt;
&lt;p&gt;&quot;The study wouldn&apos;t have to be large,&quot; Goldman said. He estimated that 1,000 to 2,000 participants would be adequate to determine if the connection to Parkinson&apos;s disease is real.&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 Institute of Neurological Disorders and Stroke, the Valley Foundation, and the James and Sharron Clark Family Fund.&lt;/p&gt;&lt;p&gt;No potential conflicts of interest were reported.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_358"
                     title="Poststroke Antidepressant Boosts Mental Agility (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/Cardiology/Strokes/tb/18240?impressionId=1265790914194"
                     
      &lt;p&gt;Antidepressants in the first months after a stroke may aid cognitive recovery for patients without depression, according to a randomized trial analysis.&lt;/p&gt;
&lt;p&gt;Global cognitive function scores improved significantly more with escitalopram (Lexapro) than with problem-solving therapy or placebo (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01), according to Ricardo E. Jorge, MD, of the University of Iowa in Iowa City, and colleagues.&lt;/p&gt;
&lt;p&gt;Memory scores rose significantly higher with the antidepressant as well (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01), with both effects independent of those on depression, they reported in the February &lt;em&gt;Archives of General Psychiatry&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;&quot;Adjunctive restorative therapies administered during the first few months after stroke, the period with the greatest degree of spontaneous recovery, reduce the number of stroke patients with significant disability,&quot; the researchers concluded.&lt;/p&gt;
&lt;p&gt;The &lt;a href=&quot;http://www.medpagetoday.com/Cardiology/Strokes/9621&quot; mce_href=&quot;http://www.medpagetoday.com/Cardiology/Strokes/9621&quot; target=&quot;_blank&quot;&gt;primary analysis&lt;/a&gt; of the trial, reported in the &lt;em&gt;Journal of the American Medical Association on&lt;/em&gt; May 28, 2008, showed that prophylactic escitalopram treatment would prevent poststroke depression in one patient for every 7.2 treated &lt;em&gt;(P&lt;/em&gt;&amp;lt;0.001 compared with placebo). That article ultimately raised a controversy over an undisclosed conflict of interest.&lt;/p&gt;
&lt;p&gt;Escitalopram is a selective serotonin reuptake inhibitor (SSRI). Since serotonin plays a role in neuroplastic changes in the developing brain as well as in depression, Jorge&apos;s group analyzed whether there might be such an effect after a stroke.&lt;/p&gt;
&lt;p&gt;The study randomized patients to double-blind treatment with escitalopram (10 mg/d under age 65 or 5 mg/day age 65 and older) or placebo or unblinded problem-solving therapy (12 sessions of going through steps to arrive at a course of action for a patient-selected problem).&lt;/p&gt;
&lt;p&gt;The intent-to-treat analysis included 129 patients treated starting within the first three months after their mild to moderate severity stroke and who did not meet criteria for major or minor depression.&lt;/p&gt;
&lt;p&gt;Overall, global cognitive functioning was significantly changed between groups as measured on the Repeatable Battery for the Assessment of Neuropsychological Status (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01).&lt;/p&gt;
&lt;p&gt;After controlling for change in depression score and type of stroke, escitalopram was associated with the best cognitive recovery, an adjusted mean change of 9.9 points compared with 1.9 for problem-solving therapy (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01) and 4.0 for placebo (&lt;em&gt;P&lt;/em&gt;=0.02).&lt;/p&gt;
&lt;p&gt;Similarly, for delayed memory scores on the same test battery, escitalopram came out on top (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01).&lt;/p&gt;
&lt;p&gt;After adjustment for depression score change and stroke mechanism, the antidepressant was associated with an 11.2 point improvement in delayed memory, compared with a change of -0.7 with problem-solving therapy (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001) and 3.9 with placebo (&lt;em&gt;P&lt;/em&gt;=0.02).&lt;/p&gt;
&lt;p&gt;On test of immediate memory, escitalopram again yielded the best recovery.&lt;/p&gt;
&lt;p&gt;The researchers found mean improvement of 13.4 points with the antidepressant compared with 2.0 with problem-solving therapy (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001) and 7.2 with placebo (&lt;em&gt;P&lt;/em&gt;=0.04), after adjustment for time between stroke and treatment, depression score change, and stroke type.&lt;/p&gt;
&lt;p&gt;These mental benefits appeared to have an impact on functional status as well.&lt;/p&gt;
&lt;p&gt;Cognitive domain scores on the Functional Independence Measure were better for escitalopram-treated patients than those who didn&apos;t get the drug (&lt;em&gt;P&lt;/em&gt;=0.05), as were memory domain scores on the same measure (&lt;em&gt;P&lt;/em&gt;=0.03).&lt;/p&gt;
&lt;p&gt;At baseline, the global cognitive functioning and delayed and immediate memory scores were nonsignificantly lower in the antidepressant group than in the other two groups, which could have biased the results.&lt;/p&gt;
&lt;p&gt;However, the treatment effects appeared to be real, Jorge explained in an interview.&lt;/p&gt;
&lt;p&gt;In an unpublished regression analysis, the baseline scores were not a significant covariate. &quot;If [the results were] related only to the difference in baseline, this would be significant but it wasn&apos;t,&quot; he told &lt;em&gt;MedPage Today&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Moreover, with an initially lower score it might have been expected that the escitalopram-treated group would have had a lower score at the end of the study than the other groups, added co-author Robert G. Robinson, MD, also of the University of Iowa.&lt;/p&gt;
&lt;p&gt;But that wasn&apos;t the case, he said in an interview. With regard to delayed memory, for example, &quot;the escitalopram-treated group went from the most impaired to the best performing.&quot;&lt;/p&gt;
&lt;p&gt;The researchers didn&apos;t compare end scores for the escitalopram, problem solving therapy, and placebo groups, but they were: &lt;ul&gt; &lt;li&gt;For global cognitive functioning 89.8, 89.1, and 91.0 points, respectively&lt;/li&gt; &lt;li&gt;For delayed memory, 96.6, 89.1, and 94.2, respectively&lt;/li&gt; &lt;li&gt;For immediate memory, 95.1, 94.9, and 98.5, respectively&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The treatment showed no effect on other individual cognitive measurements, including those for attention, language, and IQ. Nor were there significant differences in changes in occupational or living conditions.&lt;/p&gt;
&lt;p&gt;Although SSRIs such as escitalopram have been associated with hospitalization for GI bleeding and falls in prior studies, these complications did not occur in Jorge&apos;s study.&lt;/p&gt;
&lt;p&gt;&quot;Long-term administration of SSRIs appears to be an effective and safe treatment option to improve cognitive outcomes among patients with cerebrovascular disease,&quot; they concluded in the &lt;em&gt;Archives&lt;/em&gt; paper.&lt;/p&gt;
&lt;p&gt;The researchers cautioned that the study was limited by lack of CT or MRI scans and the younger age of escitalopram-treated patients, compared with other groups. That may have been a source of bias, although age did not appear to be a significant factor in the trial results.&lt;/p&gt;
&lt;p&gt;In this analysis, the researchers emphasized that the trial was not financially supported in any way by any drug company  --  a declaration hinting at the controversy that brewed last year over failure of one of the authors of the original &lt;em&gt;JAMA&lt;/em&gt; article to &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/13391&quot; mce_href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/13391&quot; target=&quot;_blank&quot;&gt;properly disclose ties&lt;/a&gt; to Forest Pharmaceuticals, which makes escitalopram.&lt;/p&gt;
&lt;p&gt;Another scientist who discovered that omission published the information in a competing journal, inducing &lt;em&gt;JAMA&lt;/em&gt; to issue a gag rule on reporting of undisclosed conflicts of interest. That policy encourages those who discover such conflicts to report them to &lt;em&gt;JAMA&apos;s&lt;/em&gt; editors but prohibits them from disclosing the conflicts publicly pending an investigation by the journal.&lt;/p&gt;
&lt;p&gt;In the current analysis, the disclosure statement indicated that co-author Robertson, had received honoraria and speakers&apos; bureau fees from Forest, with the caveat that &quot;none of the design, analysis, or expenses (including the cost of medications) of this study were supported by monies, materials, or any intellectual input from Forest Laboratories.&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 solely by a grant from the National Institute of Mental Health.&lt;/p&gt;&lt;p&gt;Jorge reported having received travel awards to participate in national meetings from the former Hamilton Pharmaceutical Company and Avanir Pharmaceutical Company.&lt;/p&gt;&lt;p&gt;Co-authors reported financial conflicts of interest with Merck, NMT Medical, Eli Lilly, Centocor, Sanofi-Bristol-Meyers-Squibb, Boerhringer-Ingelheim, Schering-Plough, AstraZeneca, and GlaxoSmithKline, the former Hamilton Pharmaceutical Company, Avanir Pharmaceutical Company, Lubeck, Forest Laboratories, and Pfizer.&lt;/p&gt;&lt;p&gt;No pharmaceutical company donated medications for or had any financial interest in the study.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
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