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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_466"
                     title="Surgery Trumps Lifestyle Change for Teen Weight Loss (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/Pediatrics/Obesity/tb/18397?impressionId=1265797296210"
                     
      &lt;p&gt;Gastric banding resulted in significantly greater weight loss in obese teens than an intensive lifestyle modification program, a randomized trial showed.&lt;/p&gt;
&lt;p&gt;In the two-year study, 84% of patients in the surgery group lost at least half of their excess weight, compared with 12% who underwent the lifestyle intervention (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001), according to Paul O&apos;Brien, MD, of Monash University in Melbourne, Australia, and colleagues.&lt;/p&gt;
&lt;p&gt;None of the teens who had surgery had metabolic syndrome at the end of follow-up, compared with 22% in the control group (&lt;em&gt;P&lt;/em&gt;=0.025), the researchers reported in the Feb. 10 issue of the &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Although the improvements were substantial, O&apos;Brien and his colleagues stressed that &quot;the gastric banding approach to weight loss is not a quick fix.&quot;&lt;/p&gt;
&lt;p&gt;&quot;For optimal effectiveness,&quot; they wrote, &quot;it requires long-term supportive follow-up by trained health professionals.&quot;&lt;/p&gt;
&lt;p&gt;They also noted that the study demonstrates that lifestyle interventions can be effective for some teens and should remain the first option.&lt;/p&gt;
&lt;p&gt;Surgeons contacted for comment on the study unanimously touted the results as evidence that bariatric surgery can be a safe and effective means of weight loss for obese adolescents, a topic that remains controversial.&lt;/p&gt;
&lt;p&gt;J. Christopher Eagon, MD, a bariatric surgeon at Washington University in St. Louis, noted in an e-mail that the significance of the study lies in the fact that participants were randomized between surgery and medical management of weight.&lt;/p&gt;
&lt;p&gt;&quot;This helps to eliminate biases that may have been present in other studies of the effectiveness of bariatric surgery and should make the case for the benefits of surgery more compelling,&quot; Eagon wrote.&lt;/p&gt;
&lt;p&gt;There are more than five million obese adolescents in the U.S., according to O&apos;Brien and his colleagues, and obesity-related complications, once rare in pediatric populations, are becoming more common.&lt;/p&gt;
&lt;p&gt;Because of the generally disappointing results of lifestyle programs aimed at improving diet, increasing exercise, and modifying unhealthy behaviors, bariatric surgery, widely used in adults, has been explored as a strategy for reducing weight in these patients.&lt;/p&gt;
&lt;p&gt;But no randomized trials of bariatric surgery had been conducted in adolescents.&lt;/p&gt;
&lt;p&gt;So O&apos;Brien&apos;s group randomized 50 obese teens ages 14 to 18 (mean 16.5) to laparoscopic adjustable gastric banding or an intensive, supervised lifestyle modification program.&lt;/p&gt;
&lt;p&gt;The participants all had a body mass index of at least 35 kg/m&lt;sup&gt;2&lt;/sup&gt; and had obesity-related complications, such as hypertension, metabolic syndrome, asthma, back pain, physical limitations, and psychosocial difficulties.&lt;/p&gt;
&lt;p&gt;All had previously failed to lose weight through lifestyle changes.&lt;/p&gt;
&lt;p&gt;Before the study began, prospective participants attended a two-month program teaching them about healthy eating and the importance of physical activity.&lt;/p&gt;
&lt;p&gt;Those randomized to the lifestyle intervention were on a diet of 800 to 2,000 calories a day, and were instructed to increase activity and decrease sedentary behavior at regular visits with a physician, dietitian, exercise coordinator, nurse, and sports medicine physician. The program included six weeks with a personal trainer.&lt;/p&gt;
&lt;p&gt;Teens in the surgery group were given instructions on correct eating and exercising at regular visits.&lt;/p&gt;
&lt;p&gt;Through two years, all but one of the teens in the surgery group completed the study; 18 of 25 in the lifestyle group completed.&lt;/p&gt;
&lt;p&gt;The mean weight loss was significantly greater in the surgery group (76.3 pounds versus 6.6), which equated to a significantly greater percentage of excess weight lost (78.8% versus 13.2%).&lt;/p&gt;
&lt;p&gt;The mean decrease in BMI was 12.7 kg/m&lt;sup&gt;2&lt;/sup&gt; in the surgery group and 1.3 kg/m&lt;sup&gt;2&lt;/sup&gt; in the lifestyle modification group.&lt;/p&gt;
&lt;p&gt;All differences were significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001.&lt;/p&gt;
&lt;p&gt;Insulin sensitivity improved in both groups, but to a larger extent in the surgery group (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;Quality of life was also improved in the surgery group.&lt;/p&gt;
&lt;p&gt;Overall, adverse events occurred at similar rates in the surgery (48%) and lifestyle modification (44%) groups.&lt;/p&gt;
&lt;p&gt;There were no perioperative adverse events in the surgery group, but seven patients required revisional procedures during follow-up, for proximal pouch dilatation or tubing injury.&lt;/p&gt;
&lt;p&gt;The researchers said eating small meals slowly is an important way to avoid these problems.&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, Edward Livingston, MD, a surgeon at the University of Texas Southwestern Medical Center in Dallas, said the high rate of revisional procedures is significant because the study authors &quot;are among the most experienced group in the world with these operations, suggesting that these complication rates will probably be higher in actual community practice.&quot;&lt;/p&gt;
&lt;p&gt;Added Jonathan Schoen, MD, a bariatric surgeon at the University of Colorado Hospital in Denver, in an e-mail: &quot;One thing to keep in mind is that the results they get in Australia with the band are the best in the world and are not uniformly reproducible.&quot;&lt;/p&gt;
&lt;p&gt;In addition to the uncertain generalizability to other settings, the researchers said the study may be limited by its length, which may not be long enough to assess outcomes from the surgery over time.&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 a grant from the National Health and Medical Research Council. The laparoscopic adjustable gastric bands used in the study were provided by the manufacturer, Allergan. The Center for Obesity Research and Education receives an unrestricted research support grant from Allergan.&lt;/p&gt;&lt;p&gt;O&apos;Brien did not make any financial disclosures. One of his co-authors reported having relationships with Allergan, Bariatric Advantage, Scientific Intake, SP Health Co., Optifast, Abbott Australasia, Eli Lilly Australia, Merck Sharp &amp;amp; Dohme Australia, Nestle Australia, and Roche Products Australia.&lt;/p&gt;&lt;p&gt;Livingston did not make any financial disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&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_432"
                     title="Short Needle May Short HBV Protection for Obese (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/Pediatrics/Vaccines/tb/18348?impressionId=1265797296210"
                     
      &lt;p&gt;Obese adolescents and young adults may not generate an adequate immune response to hepatitis B (HBV) vaccine because the needles used to vaccinate them are too short, a randomized study suggests.&lt;/p&gt;
&lt;p&gt;Immunization with a 1.5-inch needle was associated with 80% higher anti-HBV titers than a 1.0-inch needle, researchers reported online in &lt;em&gt;Pediatrics.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;The difference persisted in analyses performed to correct for imbalances in the study population.&lt;/p&gt;
&lt;p&gt;&quot;This supports the hypothesis that inadequate muscle penetration is responsible, at least in part, for lower immune response to HBV vaccine among obese adolescent and adult vaccine recipients,&quot; Amy Middleman, MD, of Baylor College of Medicine in Houston, and colleagues concluded.&lt;/p&gt;
&lt;p&gt;Several studies have shown that adolescents and adults with a higher body mass index (BMI) have lower antibody titers after HBV vaccination. The observations have taken on new significance, given that an increasing number of vaccines target a population that has a rising BMI, the authors wrote.&lt;/p&gt;
&lt;p&gt;Researchers hypothesize that standard-length needles do not penetrate through the deltoid fat and into the muscle of obese adolescents and adults. Because of its less abundant blood supply, adipose tissue may delay antigen presentation to B and T cells responsible for immune response, the authors continued.&lt;/p&gt;
&lt;p&gt;To test the hypothesis, Middleman and colleagues conducted a randomized, clinical trial involving adolescents and adults ages 14 to 24 with no prior exposure to HBV vaccine. Eligibility criteria included weight &amp;gt;90 kg for female patients and &amp;gt;120 kg for male patients.&lt;/p&gt;
&lt;p&gt;Patients were randomized to receive the HBV vaccine series with a standard one-inch needle or a 1.5-inch needle. Patients younger than 19 received 0.5-mL injections, and older patients received 1.0-mL injections.&lt;/p&gt;
&lt;p&gt;Investigators used a standardized injection procedure: insertion of the needle at a 90&amp;#176; angle to the deltoid muscle, leaving 2 to 3 mm of needle visible between the skin and the hub.&lt;/p&gt;
&lt;p&gt;Patients received three doses of vaccine at baseline, one month, and four months. Blood samples were obtained at baseline and two months after the final injection.&lt;/p&gt;
&lt;p&gt;The two groups did not differ significantly with respect to median age (21), BMI (~40), deltoid skinfold (41 mm), triceps skinfold (~40 mm), days between vaccine doses one and three (~135), and days from third vaccine dose to titer assessment (65).&lt;/p&gt;
&lt;p&gt;At the end of the study, 24 patients had completed the immunization protocol, 10 in the one-inch group and 14 in the 1.5-inch group.&lt;/p&gt;
&lt;p&gt;Patients vaccinated with a one-inch needle had a median antibody titer of 189.8 mIU/mL compared with 345.4 mIU/mL for patients vaccinated with the 1.5-inch needle (&lt;em&gt;P&lt;/em&gt;=0.03).&lt;/p&gt;
&lt;p&gt;The between-group difference remained significant in analyses that excluded an outlier from the 1.5-inch group (&lt;em&gt;P&lt;/em&gt;=0.047) and that excluded the only two male patients in the study (&lt;em&gt;P&lt;/em&gt;=0.035).&lt;/p&gt;
&lt;p&gt;&quot;As we continue to experience high rates of obesity in the U.S. and throughout the world, additional evidence-based research on optimizing the effective delivery of immunizations to adolescents and young adults will be critical,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;Following updated needle length recommendations will be a first step toward improving the health of our youth and young adults by preventing vaccine-preventable diseases.&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 federal grants and awards. GlaxoSmithKline provided the vaccine.&lt;/p&gt;&lt;p&gt;The authors had no disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_413"
                     title="ICAO: In Obesity, Fat Legs Better than Fat Middles (CME/CE)"
                     score="0.011"
                     href="http://www.medpagetoday.com/PrimaryCare/Obesity/tb/18322?impressionId=1265797296210"
                     
      Having less abdominal fat but more leg fat may play a role in maintaining metabolic health in obese women, but not in heavy men, researchers found.&lt;br&gt;
&lt;br&gt;Metabolically healthy obese women had significantly more leg fat compared with metabolically unfit women, and smaller waist circumference (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05), Sarah Appleton, a postgraduate student at the University of Adelaide in Australia, and colleagues reported at the International Congress on Abdominal Obesity in Hong Kong.&lt;br&gt;
&lt;br&gt;When there&apos;s no significant differences in total body fat, the high levels of leg fat but low levels of central fat &quot;makes you think this is a protective factor against developing metabolic complications of their obesity, including diabetes,&quot; Appleton told &lt;em&gt;MedPage Today&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Smaller studies have shown that metabolically healthy obese patients have less visceral fat compared with insulin-resistant obese patients, suggesting these may be protective factors that limit the development of metabolic disease.&lt;/p&gt;
&lt;p&gt;On the other hand, normal-weight patients with cardiometabolic risk factors, who are labeled as &quot;metabolically obese,&quot; have higher abdominal adiposity compared with metabolically healthy normal-weight patients. They&apos;re also at increased risk for diabetes and heart disease.&lt;/p&gt;
&lt;p&gt;To examine the relationship, the researchers conducted dual energy X-ray absorptiometry (DEXA) scans of body composition in 1,604 patients who were over age 50 and participated in the North West Adelaide Health Study. They were stratified in four categories: metabolically obese normal-weight, metabolically healthy normal weight, metabolically healthy obese, and metabolically unfit obese.&lt;/p&gt;
&lt;p&gt;Metabolic obesity was defined by having two or more metabolic risk factors including high triglycerides, low HDL cholesterol, high blood pressure, high fasting plasma glucose, or diabetes.&lt;/p&gt;
&lt;p&gt;The researchers also measured waist circumference.&lt;/p&gt;
&lt;p&gt;They found that among normal-weight women, the metabolically obese had significantly more total fat and more trunk fat compared with those who were metabolically healthy (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05). There were no differences in waist circumference or lean mass.&lt;/p&gt;
&lt;p&gt;Among obese women, the metabolically healthy had no significant differences in total body fat, compared with the metabolically unfit. But they had significantly more leg fat, a smaller waist circumference, and the same amounts of lean mass.&lt;/p&gt;
&lt;p&gt;&quot;We would have expected to see that metabolically healthy obese ladies would have more leg fat, but also more lean mass and less central fat, since this combination is protective against developing diabetes,&quot; Appleton said, &quot;but we didn&apos;t see that related to lean mass, which was surprising.&quot;&lt;/p&gt;
&lt;p&gt;Normal-weight men who had metabolic problems had significantly more total fat and trunk (chest and abdominal) fat than metabolically healthy ones, but no differences in lean mass.&lt;/p&gt;
&lt;p&gt;And for obese men, there were no significant differences between the metabolically fit and unfit, which &quot;was a surprise,&quot; Appleton said.&lt;/p&gt;
&lt;p&gt;&quot;Men generally have much less fat and more lean mass,&quot; she added. &quot;Women are the other way around, so maybe it&apos;s not so surprising to see these effects specifically in women.&quot;&lt;/p&gt;
&lt;p&gt;The researchers did find that among all overweight patients, both male and female, metabolic health was associated with significantly lower waist circumference.&lt;/p&gt;
&lt;p&gt;&quot;We know specifically that fat around the abdomen is dangerous because it can drain into your blood very easily and have direct effects on organs including the liver and pancreas,&quot; Appleton said. &quot;The theory is that distribution of fat and maybe an alternative inflammatory profile protects obese ladies from developing the metabolic consequences you&apos;d expect to see in people who are obese.&quot;&lt;/p&gt;
&lt;p&gt;Appleton said the study may have implications for clinical practice, adding that physicians should assess both BMI and waist circumference to determine disease risk. Moreover, physicians &quot;need to focus on healthy weight loss in a way that protects lean mass but also reduces dangerous fat deposits including central adiposity.&quot;&lt;/p&gt;
&lt;p&gt;It also goes to show that &quot;just because somebody looks thin,&quot; Appleton added, &quot;doesn&apos;t mean they&apos;re healthy.&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 researchers reported no conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_397"
                     title="AAPM: Nerve Growth Factor Antibody  May Reduce Pain (CME/CE)"
                     score="0.011"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18300?impressionId=1265797296210"
                     
      &lt;p&gt;SAN ANTONIO  --  A humanized monoclonal antibody against nerve growth factor provided relief in three chronic pain syndromes, according to a summary of small studies reported as an abstract here.&lt;/p&gt;
&lt;p&gt;Treatment with tanezumab led to statistically or clinically significant reductions in pain for patients with osteoarthritis, chronic lower back pain, and interstitial cystitis. The most common adverse events were transient abnormal peripheral sensations, which generally occurred only after the first infusion.&lt;/p&gt;
&lt;p&gt;&quot;Patients with these three different pain syndromes all had significant improvement when treated with tanezumab,&quot; Leslie Tive, PhD, of Pfizer, said in an interview at the American Academy of Pain Medicine meeting. &quot;The pain relief was sustained over time, and patient acceptance was good.&quot;&lt;/p&gt;
&lt;p&gt;&quot;Nerve growth factor is increased in many types of chronic pain and therefore represents an attractive target for therapy,&quot; she added. &quot;Tanezumab is being evaluated in some of these other conditions in ongoing studies.&quot;&lt;/p&gt;
&lt;p&gt;A small phase I study showed that the humanized monoclonal antibody resulted in significant pain improvement in patients with osteoarthritis (&lt;em&gt;Arthritis Rheum&lt;/em&gt; 2005; 52: S461). Tive presented data from a phase II trial involving 400 patients with osteoarthritis of the knee. They were randomized to placebo or to one of five tanezumab doses, administered on day one and day 56.&lt;/p&gt;
&lt;p&gt;All five doses of tanezumab resulted in significant reductions (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05) versus placebo after one week and were sustained through 16 weeks. As assessed by a visual analog scale, the mean change in pain on walking from baseline to week 16 ranged from 30 to 45 points (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001), a two- to threefold difference compared with placebo.&lt;/p&gt;
&lt;p&gt;The trial in chronic low back pain involved 217 adults with Quebec Task Force on Spinal Disorders category 1 or 2 pain for at least three months. The primary location of the pain was between the 12th thoracic vertebra and the lower gluteal folds.&lt;/p&gt;
&lt;p&gt;Eligibility criteria included a score of at least 4 on an 11-point pain scale on at least four occasions in the five days before randomization, as indicated by entries in an electronic pain diary.&lt;/p&gt;
&lt;p&gt;Patients were randomized 2:2:1 to a single infusion of tanezumab, to oral naproxen, or to placebo. The primary endpoint was the change in mean Lower Back Pain Index score from baseline to six weeks, averaged over the last seven days.&lt;/p&gt;
&lt;p&gt;Beginning at week one and continuing through week six, patients who were randomized to either dose of tanezumab had significantly greater improvement in pain than those who took the placebo (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001), and compared with the naproxen group beginning at week two (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01).&lt;/p&gt;
&lt;p&gt;The interstitial cystitis study included 64 men and women who had a score &amp;#8805;13 on Pelvic Pain Symptom/Frequency questionnaire, &amp;#8805;7 score on the O&apos;Leary-Sant Interstitial Cystitis index, and micturition frequency &amp;#8805;8 times a day, as recorded in an electronic diary for at least five consecutive days prior to randomization.&lt;/p&gt;
&lt;p&gt;Patients were randomized to intravenous tanezumab or matching placebo. The primary efficacy endpoint was change from baseline to six weeks in the 11-point pain scale. A difference of at least one point from placebo was considered clinically significant. Statistical significance was not evaluated.&lt;/p&gt;
&lt;p&gt;The mean difference between tanezumab and placebo was -0.7 at week two, increasing to -1.1 at week four and -1.4 at week six. The advantage versus placebo was maintained at week 10 (-0.9) and week 16 (-0.5).&lt;/p&gt;
&lt;p&gt;Adverse events were evaluated for all patients combined in the three studies. Adverse events were reported by 66.3% of tanezumab patients, 61.4% of naproxen patients, and 59.3% of placebo patients. Serious and severe adverse events occurred in 1.6% to 3.4% of patients and 4.8% to 5.7%, respectively.&lt;/p&gt;
&lt;p&gt;Tive said 14.4% of tanezumab patients reported abnormal peripheral sensations, the most common being paresthesia (7.1%), hyperesthesia (4.1%), and hypoesthesia (3.9%).&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 included in the summary were funded by Pfizer.&lt;/p&gt;&lt;p&gt;Investigators included several Pfizer employees.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_310"
                     title="Rotavirus Vaccine Effective in Third World Nations (CME/CE)"
                     score="0.004"
                     href="http://www.medpagetoday.com/Pediatrics/Vaccines/tb/18174?impressionId=1265797296210"
                     
      &lt;p&gt;Vaccination against rotavirus appears to be highly effective in reducing death and serious gastrointestinal disease among young children in developing countries, according to two&lt;strong&gt; &lt;/strong&gt;publications in the Jan. 28 &lt;em&gt;New England Journal of Medicine.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;In Malawi and South Africa, a vaccination program significantly reduced infantile gastroenteritis associated with the pathogen, researchers said.&lt;/p&gt;
&lt;p&gt;In a companion paper, investigators reported that a rotavirus vaccination program in Mexico appears to have been the cause of a marked reduction in deaths from diarrhea among young children.&lt;/p&gt;
&lt;p&gt;Taken together, the two studies suggest that physicians have &quot;another powerful weapon&quot; to help prevent death from diarrhea among young children, according to Mathuram Santosham, MD, of the Johns Hopkins Bloomberg School of Public Health, who was not involved in the research.&lt;/p&gt;
&lt;p&gt;&quot;It is time to act to combat the 1.8 million unnecessary deaths from diarrhea that continue to occur each year,&quot; Santosham wrote in an accompanying editorial.&lt;/p&gt;
&lt;p&gt;Two oral, live attenuated vaccines against rotavirus have been shown to prevent the associated gastroenteritis  --  GlaxoSmithKline&apos;s Rotarix and Merck&apos;s RotaTeq, according to Nigel Cunliffe, MBChB, PhD, of the University of Liverpool in England, and colleagues.&lt;/p&gt;
&lt;p&gt;But trials of those drugs mainly occurred in more developed countries, the researchers noted, so the World Health Organization  --  fearing they might not work as well among the very poor  --  suggested additional trials in the Third World.&lt;/p&gt;
&lt;p&gt;To fill the knowledge gap, Cunliffe and colleagues conducted a randomized, placebo-controlled trial in Malawi and South Africa, enrolling 4,939 healthy infants.&lt;/p&gt;
&lt;p&gt;They were assigned to get either three doses of placebo (at six, 10, and 14 weeks of age), two doses of the Rotarix vaccine and one of placebo to maintain blinding, or three doses of the vaccine.&lt;/p&gt;
&lt;p&gt;The researchers found: &lt;ul&gt; &lt;li&gt;Severe gastroenteritis caused by rotavirus occurred in 4.9% of the placebo group and in 1.9% of the pooled vaccine group, yielding a vaccine efficacy of 61.2%, which was significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001. &lt;/li&gt; &lt;li&gt;Vaccine efficacy was lower in Malawi than in South Africa  --  49.4% versus 76.9%. But the vaccine prevented more cases of severe rotavirus gastroenteritis in Malawi  --  6.7 cases prevented per 100 infants vaccinated yearly versus 4.2.&lt;/li&gt; &lt;li&gt;Efficacy against all-cause severe gastroenteritis was 30.2%.&lt;/li&gt; &lt;li&gt;At least one serious adverse event was reported in 9.7% of the vaccinated infants and 11.5% of the placebo group, but only three were judged to be related to the vaccine.&lt;/li&gt; &lt;li&gt;There was a single case of intussusception -- a 6-month-old child in the three-dose vaccine group, who recovered after bowel resection.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The findings have led WHO to recommend that rotavirus vaccination be included in all national immunization programs, Cunliffe and colleagues noted.&lt;/p&gt;
&lt;p&gt;Mexico phased in rotavirus vaccination over slightly more than a year, from February 2006 through May 2007, according to Manish Patel, MD, of the CDC, and colleagues.&lt;/p&gt;
&lt;p&gt;To estimate the effect of the program, Patel and colleagues compared annual deaths from diarrhea before and after the immunization program began.&lt;/p&gt;
&lt;p&gt;Over the four years before the program started, the median annual number of diarrhea-related deaths among children younger than five was 1,793, the researchers found, for a mortality rate of 18.1 deaths per 100,000.&lt;/p&gt;
&lt;p&gt;In 2008, by contrast, there were 1,118 deaths, a reduction of 765, which yielded a mortality rate of 11.8 per 100,000 children, they reported in the journal.&lt;/p&gt;
&lt;p&gt;The rate reduction of 35% was significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001, Patel and colleagues said.&lt;/p&gt;
&lt;p&gt;The findings come with some caveats, the researchers said. Among them: &lt;ul&gt; &lt;li&gt;It was not possible to pin down the reduction in deaths attributable to vaccination because precise vaccine coverage information is lacking. &lt;/li&gt; &lt;li&gt;Other changes, such as hygiene improvements, might also have affected the trend.&lt;/li&gt; &lt;li&gt;Because of difficulty obtaining fecal specimens, it wasn&apos;t possible to study trends in rotavirus deaths specifically.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;While the studies suggests that rotavirus vaccination would prevent much disease and many deaths, there are obstacles to introducing the vaccine to poorer countries, Santosham noted in the editorial.&lt;/p&gt;
&lt;p&gt;A key obstacle, he said, is that the vaccine requires more refrigeration  --  so-called &quot;cold-chain&quot; storage  --  than typical childhood vaccines.&lt;/p&gt;
&lt;p&gt;Also problematic, he said, is the current recommendation that the vaccines be given early in life to avoid age-dependent occurrence of intussusception, which led to an earlier vaccine being taken off the market.&lt;/p&gt;
&lt;p&gt;In many of the poorest countries, on-time vaccination is rare, which may impede the use of a rotavirus vaccine unless the time window for administration can be opened wider, he said.&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 African study was supported by GlaxoSmithKline and the PATH Rotavirus Vaccine Program, a collaboration with the World Health Organization and the CDC with support from the Global Alliance for Vaccines and Immunization (GAVI). Cunliffe reported financial links with Sanofi Pasteur and GlaxoSmithKline.&lt;/p&gt;&lt;p&gt;For the Mexican study, the researchers did not report any external support or any conflicts.&lt;/p&gt;&lt;p&gt;Santosham reported financial links with GlaxoSmithKline and Merck, both of which make rotavirus vaccines.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
</recommendedContent>