Thursday, January 28, 2010

Management of Acute Otitis Media Without Antibiotics Has Not Increased

From Medscape Medical News

Laurie Barclay, MD

January 25, 2010 — The management of acute otitis media (AOM) without antibiotics has not increased after publication of the 2004 American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) clinical practice guideline on AOM allowing "watchful waiting," according to the results of a study reported Online First January 25 and to be published in the February issue of Pediatrics.

"Observation without initial antibiotic therapy was accepted as an option for ...AOM management in the 2004 American Academy of Pediatrics and American Academy of Family Physicians clinical practice guideline," write Andrew Coco, MD, MS, from Lancaster General Research Institute in Lancaster, Pennsylvania, and colleagues. "The guideline also recommended amoxicillin as the first-line treatment for most children, and analgesic treatment to reduce pain if it was present. Our objective was to compare the management of AOM after publication of the 2004 guideline."

Using the National Ambulatory Medical Care Survey from 2002 to 2006, the investigators analyzed data from 1114 children aged 6 months to 12 years who were diagnosed with AOM in US physicians' offices. They also made comparisons for the 30-month periods before and after the guideline was released in 2004. The main endpoint of the study was the rate of encounters with no reported antibiotic-prescribing, and secondary endpoints were predictors of encounters at which no antibiotic-prescribing was reported and rates of antibiotic- and analgesic-prescribing.

After guideline publication, the rate of AOM encounters at which no antibiotic prescribing was reported did not change significantly (11% - 16%; P = .103).
Absence of ear pain, absence of reported fever, and receipt of an analgesic prescription independently predicted encounters at which no antibiotic-prescribing was reported.

Changes after guideline publication were increased rate of amoxicillin-prescribing (40% - 49%; P = .039), decreased rate of amoxicillin/clavulanate-prescribing (23% - 16%; P = .043), increased rate of cefdinir-prescribing (7% - 14%; P = .004), decreased rate of prescribing other cephalosporins (12% - 6%; P = .025), and increased rate of analgesic-prescribing (14% - 24%; P = .038).

"Although management of AOM without antibiotics has not increased after the publication of the 2004 American Academy of Pediatrics and American Academy of Family Physicians clinical practice guideline, children who did not receive antibiotics were more likely to have mild infections," the study authors write. "In accordance with the guideline, the prescribing of amoxicillin and analgesics has increased. Contrary to the guideline, the prescribing of amoxicillin/clavulanate has decreased, whereas the prescribing of cefdinir has increased."

Limitations of this study include retrospective nature of the data, inclusion of data immediately after the release of the guideline (which may not have allowed sufficient time for adopting the guideline recommendations), exclusion of telephone and email contact information, and inability to distinguish between the prescribing of high-dose vs standard-dose amoxicillin.

"It is encouraging that after the publication of the guideline, amoxicillin-prescribing has increased and the pain associated with AOM is more frequently being treated," the study authors conclude.

In an accompanying editorial, Robert M. Siegel, MD, from Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio, notes that educating patients and families regarding antibiotic use and ensuring that the child's ear pain is adequately managed will lead to decreased antibiotic use and better patient satisfaction.

"Today's patients and families are more medically sophisticated than the last generation, because they have greater access to information through the Internet and its educational resources such as wikis and blogs," Dr. Siegel writes. "Health care providers should embrace and encourage this empowerment and involve patients in shared decision-making regarding whether to use antibiotics for otitis media. With the assurance of a pediatrician that prescribed analgesics will probably remove their child's pain, patients will appreciate being asked to participate in the decision as to when to fill an antibiotic prescription for AOM."

The study authors have disclosed no relevant financial relationships. Dr. Siegel is a member of the Scientific Advisory Board of Atkins Nutritionals, Inc.

Pediatrics. Published online January 25, 2010.

Toilet Seat Dermatitis Making a Comeback

From WebMD Health News

Jennifer Warner

January 25, 2010 — Exotic wooden toilet seats and harsh chemical cleaners may be behind a new resurgence of toilet seat dermatitis, a skin condition once thought to be wiped out in the U.S.

A new study documents five recent cases of toilet seat dermatitis in children, some of whom suffered for years before getting a proper diagnosis.

“Toilet seat dermatitis is one of those legendary conditions described in medical textbooks and seen in underdeveloped countries, but one that younger pediatricians have not come across in their daily practice,” researcher Bernard Cohen, MD, director of pediatric dermatology at Johns Hopkins Children’s Center, says in a news release. “If our small analysis is any indication of what’s happening, we need to make sure the condition is on every pediatrician’s radar.”

Toilet Seat Trouble

Toilet seat dermatitis causes skin irritation around the buttocks and upper thighs. If it isn’t treated properly, researchers say discomfort can persist and lead to painful and itchy skin eruptions.

The condition was first described in 1927. At that time, exposure to wooden toilet seats and the associated varnish, lacquers, and paints were to blame for the skin irritation.

In the 1980s and 1990s, most public facilities and homeowners switched from wooden to plastic toilet seats and sanitary seat covers became readily available, which researchers say prompted a dramatic decline in the condition.

But recently, some homeowners have opted for toilet seats made from exotic woods, and there has been an increased use of harsh toilet seat detergents.

In two of the cases described in the study, the children's toilet seat dermatitis had been caused by their school’s use of harsh chemical cleaners, containing ingredients such as didecyl dimethyl ammonium chloride and alkyl dimethyl benzyl ammonium chloride, which have previously been documented to cause severe skin irritation.

To prevent toilet seat dermatitis, researchers recommend the following steps:

Use toilet seat covers in public restrooms, including hospital and school bathrooms. Such covers are widely available in major retail stores. The researchers add that allergy to toilet seat covers has not been reported in the medical literature.
Replace wooden toilet seats with plastic ones.
Avoid harsh cleaners.

Litvinov, I. Pediatrics, February 2010; vol 125: pp e419-e422.

Sunday, January 24, 2010

Battery Ingestion

In recent years, our electronic toys and gadgets have become increasingly miniaturized. Their power requirements are being met by a new generation of compact, high-performance batteries. These disk batteries are small, pill- or coin-shaped devices that contain heavy metals such as zinc, mercury, silver, nickel, cadmium, and lithium. They also contain concentrated solutions of caustic electrolytes, usually potassium or sodium hydroxide. Their compact size and harmless appearance hide their true danger.

The danger comes when children (and sometimes adults) knowingly or mistakenly put these tiny batteries in their mouths and swallow them.

Most swallowed batteries cause no problem (89.9% of the time).

Batteries lodged in the esophagus (the food pipe between mouth and stomach) must be removed immediately. They cause damage by their pressure against the wall of the esophagus, from leakage of caustic alkali, and the electrical current they generate. Injury can occur in as short a time as 1 hour. Full-thickness burns can occur in 4 hours.
Batteries passing through the esophagus usually pass uneventfully through the entire digestive tract.

Blood Stored More Than 14 Days Increases Risk for Organ Failure in Transfused Children

Medscape Medical News from the:
Society of Critical Care Medicine (SCCM) 39th Critical Care Congress

Deborah Brauser

January 19, 2010 (Miami Beach, Florida) — Critically ill children transfused with red blood cell (RBC) units stored longer than 14 days have an increased incidence of multiple organ failure and a longer stay in pediatric intensive care units (PICU) than those receiving fresher blood, according to an analysis from a large observational study presented here at the Society of Critical Care Medicine (SCCM) 39th Critical Care Congress.

The results of this study, which was a Critical Care Congress Research Citation Finalist, were presented by lead author Oliver Karam, MD, PICU physician from CHU Sainte-Justine in Montreal, Quebec, during a poster presentation.

"Transfusion is a common treatment in pediatric intensive care. In fact, nearly 1 out of 2 children admitted for more than 48 hours in a PICU will be transfused," said Dr. Karam. "While past studies conducted with adults have suggested that prolonged length of RBC unit storage is associated with worse clinical outcomes, no such studies have been prospectively conducted in children."

Older Blood May Lead to MODS

In this secondary analysis of an observational study, the investigators evaluated 447 children younger than 18 years of age who stayed 48 hours or more in a PICU at 1 of 29 North American centers. Of these patients, 176 were transfused once and 271 were transfused multiple times.

An increase in multiple organ dysfunction syndrome (MODS) after transfusion was the primary outcome measure; 28-day mortality and PICU length of stay were secondary end points. The median length of RBC storage was 14 days.

The results showed an adjusted odds ratio [OR] of 1.87 (95% confidence interval [CI], 1.06 - 3.31; P = .03) for increased incidence of multiple organ failure for the group receiving blood stored for 14 days or more.

"At least 30% of the patients who received old blood, defined as over 14 days, had new or progressive MODS. They came in with respiratory failure and dynamic instability and then they experienced liver or kidney dysfunction, platelet problems, and other things," reported Dr. Karam.

These patients also had a significantly longer total PICU stay (adjusted median difference, +3.7 days; P < .001) and a trend toward developing new or progressive MODS faster (hazard ratio, 1.43; P = .08) than those who received fresher blood.

There was no significant difference in mortality between the 2 groups.

"In other words, transfusion of units stored for more than 2 weeks seems to be independently associated with an increased occurrence of multiple organ failure in critically ill children," said Dr. Karam during an interview with Medscape Critical Care.

"Patients who come into the [PICU] sicker have a higher probability of having more need of transfusions, and then have a higher probability of getting at least 1 old RBC unit," he noted. "So the sicker you are, the higher the probability of getting old blood and of having these outcomes. But independent of the severity of illness and the number of transfusions, the age of blood appears important for all patients."

Second Study, Similar Results

In a second study, also receiving a Research Citation, the same investigational team performed a secondary observational analysis of the Transfusion Requirements in Pediatric Intensive Care Units (TRIPICU) trial, which was conducted in 19 sites in Canada, the United States, the United Kingdom, and Belgium.

"The maximum recommended duration of RBC storage is presently 42 days," said Marisa Tucci, MD, also from the PICU at CHU Sainte-Justine, while presenting the results during a poster session. "We wanted to look at the association between RBC length of storage and the development of MODS."

In this study, the investigators examined data from 455 stable critically ill children enrolled in the TRIPICU trial who were randomized to either a restrictive (n = 145) or liberal (n = 310) RBC transfusion strategy. In addition to measuring increased MODS, they examined increased pediatric logistic organ dysfunction (PELOD) scores and 28-day mortality.

Cut-off storage thresholds of 7, 14, and 21 days were evaluated. For patients transfused multiple times (n = 135), storage time was defined as the oldest RBC unit used.

At the end of the analysis, the investigators found that new or progressive MODS was associated with an RBC storage time of more than 21 days (adjusted OR, 3.29; 95% CI, 1.21 - 9.04) in the restrictive group.

"That same association was found in the liberal group when the storage time was over 14 days [adjusted OR, 2.50; 95%, CI, 1.12 - 5.58]," reported Dr. Tucci.

In a meta-analysis that combined data from all transfused patients, increased MODS was associated with a storage time of more than 14 days (adjusted OR, 2.23; 95% CI, 1.20 - 4.15); increased daily PELOD scores (adjusted mean difference, 4.26; 95% CI, 1.99 - 6.53) and higher mortality (9.2% vs 3.8%) were associated with a storage time of more than 21 days.

"As with the other study, our findings from this analysis showed that stable critically ill children receiving RBC units with increased storage time may be at greater risk of developing new or progressive MODS," said Dr. Tucci. "However, definitive conclusions about a cause-and-effect relationship cannot be drawn from this secondary analysis. Rather, these data justify undertaking a randomized controlled trial to address this issue."

Dr. Karam agreed. "These 2 studies give the same signal — that older blood is probably less good for our patients. But as long as we don't do a pediatric [randomized controlled trial], there are always going to be biases."

When asked if clinicians should consider throwing out or just not using old blood right now, he gave an emphatic "no."

"Getting only blood that is less than 14 days old could have huge implications because blood banks would have to throw away a lot of old blood. And it's going to cost much more," said Dr. Karam. "These studies suggest that the length of storage is something important and something worth testing in a [randomized controlled trial]. But I wouldn't conclude anything yet and wouldn't change my practice based on just these studies."

More Studies Needed

"I think these findings are parallel to the adult situation in the sense that we believe that there are downsides to delivering any blood, but particularly blood that has had a long storage," said session comoderator Pamela Lipsett, MD, FCCM, codirector of the surgical intensive care units and professor of surgery, anesthesiology, and critical care medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland, and the new president-elect of the SCCM. She was not involved with either study.

"To say simplistically that we should stop using old blood may have serious unintended consequences, including not having enough needed blood available," said Dr. Lipsett. "It's really a systems issue. Can we make it a safer, better, but still-adequate system by having a shorter duration of time from donation to administration? We just don't know."

She added that the age of blood is information that is not generally available to the clinician. "It's an interesting concept to note whether or not that would influence decision making. The parallel to that is that many institutions, including our own, are now looking at whether having cost information available for certain radiologic tests or even medications influence ordering behavior. This is similar, although slightly different. I'm still worried, though, that this possible influence will lead to an overall lack of blood availability."

Dr. Lipsett said that she'd be interested in knowing whether the effects from older blood are different for certain types of patients. "We saw that sicker patients have more of a chance of receiving older blood through their multiple transfusions, but does receiving that older blood itself cause a bigger effect if it's a sicker patient? What about age? Do the effects go down as a patient's age increases?"

She added that further studies are needed. "A large follow-up looking at these questions is the type of study we should invest our funding in because it could have a tremendous impact. Plus, anything that affects kids is a big deal. I personally think this should have a moderately high priority in where our dollars go. But, of course, that's a simplistic answer to a very complex problem."

Dr. Karam reported that his group has already started enrolling adult patients into the prospective randomized Age of Blood Evaluation (ABLE) trial. "We hope to include 2500 patients. The threshold for RBC storage in ABLE will be 7 days. We hope to have those results in a few years."

The same team has started the pediatric version of this trial, called Age of Blood in Children (ABC), which is currently in the pilot phase.

The original study for the first analysis was supported by Johnson & Johnson and Fonds de la Recherche en Santé du Québec (FRSQ). The second study was supported by FRSQ and the Canadian Institutes of Health Research. Dr. Karam, Dr. Tucci, and Dr. Lipsett have disclosed no relevant financial relationships.

Society of Critical Care Medicine (SCCM) 39th Critical Care Congress: Abstracts 100 and 106. Presented January 10, 2010.

Steeply Sloped Bed Reduces Regurgitation in Infants

From Reuters Health Information

NEW YORK (Reuters Health) Jan 15 An infant bed with a 40-degree slope helps minimize gastroesophageal reflux and associated problems, according to the findings of a pilot study from Belgium.

"The Multicare AR-Bed decreases infant regurgitation and improves quality of life of infants and parents," lead investigator Dr. Yvan Vandenplas told Reuters Health by email. "The bed significantly reduces the number of infants on medication for gastroesophageal reflux and thus decreases the side effects of medication."

In the January issue of the Archives of Disease in Childhood, Dr. Vandenplas of Universitair Ziekenhuis Kinderen, Brussels, and colleagues report on their study of 30 infants ages 3 weeks to 3 months. All had frequent regurgitation and reflux-associated symptoms, mainly during feeding, and 20 had been treated with proton pump inhibitors or other drugs.

Parents were instructed to place the baby in the bed, in a supine position, after feeding and to leave the baby there as long as he or she was comfortable.

Eight of the infants did not tolerate the bed positioning and were withdrawn from the study within 2 days. Also, by the end of the 1-week study, 3 of the 22 remaining babies had not responded. Considering these 3, plus the 8 who dropped out, the researchers observe that the bed "did not improve symptoms" in 11 patients (37%).

In an intent-to-treat analysis of the entire 30-baby cohort, however, there were significant reductions in daily incidence of regurgitation (p<0.001) and in measures of gastroesophageal reflux (p<0.001).

In the 15 infants with 24-hour pH monitoring data, the authors saw a significant drop in reflux index from 5.2 at baseline to 2.47 after 1 week (p < 0.001).

The babies used the beds for an average of 3.2 months, until they outgrew them.

Although medication discontinuation "was not an endpoint of this pilot study," the researchers point out, "all medication could be successfully stopped in more than half of the patients."

"Considering this experience," the team concludes, "the MC AR-Bed needs to be evaluated in a larger series of infants prior to pharmacological treatment in infants presenting with frequent regurgitation and reflux-associated symptoms."

The authors developed the bed in collaboration with Peos (Ninove, Belgium), which now sells the product. Although the estimated purchase cost is 1000 euros, the researchers suggest the bed could be rented from pharmacies for only 1.75 euros per day.

Arch Dis Child 2010;95:26-30.

Thursday, January 21, 2010

Report New Cases of Guillain-Barré After H1N1 Flu Vaccine

From Medscape Medical News
Allison Gandey

September 1, 2009 — Neurologists should be vigilant in tracking any new cases of Guillain-Barré syndrome after patients have received the H1N1 flu vaccine, say officials. The American Academy of Neurology (AAN) is teaming up with the Centers for Disease Control and Prevention (CDC) to make sure doctors remain alert.

Guillain-Barré has been linked to several vaccines, including the preparation for the 1976 swine flu. In a statement issued by the AAN, experts said that although they do not expect the 2009 H1N1 vaccine to increase the risk for the autoimmune disease, this is a concern with any pandemic vaccine. "The active participation of neurologists is going to be critical for monitoring for any possible increase in Guillain-Barré following 2009 H1N1 influenza vaccination," AAN spokesperson Orly Avitzur, MD, said in a news release.

The H1N1 vaccine is currently in production. High-risk groups will be encouraged to receive the vaccine this fall. Infants, children, young adults, pregnant women, adults 25 years and older with underlying health conditions, and healthcare workers are considered good candidates for the vaccine.

Doctors are being asked to report adverse events using the standard CDC and US Food and Drug Administration Vaccine Adverse Event Reporting System.

Guillain-Barré affects 1 to 4 people per 100,000 annually around the world.
It causes respiratory failure requiring ventilation in an estimated 25% of people, and between 4% and 15% die.

The AAN guidelines on the treatment of Guillain-Barré are available online

Death After Cervarix Propels HPV Vaccination Into Headlines Again

From Medscape Medical News
Zosia Chustecka

September 30, 2009 (updated October 1, 2009) — The sudden death of a 14-year-old British girl shortly after she received Cervarix, a vaccine against human papillomavirus (HPV) to prevent cervical cancer, hit headlines worldwide yesterday. Today, however, the death is being reported as unlikely to have been related to the vaccine. The next day, a postmortem revealed that the girl had a large tumor in her chest cavity.

This is not the first time that a death has been reported after HPV vaccination; many of the other cases have been reported after inoculation with Gardasil in the United States, although there has been no proof of causality.
Some of these deaths have also received wide media attention, and last month a mother who lost her daughter after HPV vaccination testified before a US Food and Drug Administration (FDA) advisory committee meeting.

In the latest incident, Natalie Morton, of Coventry in the United Kingdom, died on the same day that she received the vaccine at school as part of a national HPV vaccination program. She collapsed less than 2 hours after the injection, which was the first dose of a planned 3-dose course.

A preliminary postmortem revealed that she had "a serious underlying medical condition which was likely to have caused death," according to Caron Grainger, MD, joint director of public health in Coventry.

"We are awaiting further test results. However, indications are that it is most unlikely that the vaccination was the cause of death," Dr. Grainger said in a statement.

In response to the news of the death, several health authorities in the United Kingdom announced that they were temporarily suspending their HPV vaccination programs.

The Department of Health said all vaccines from the same batch (HPV1 Cervarix AHP VA04 3BB) would be quarantined as a precaution.

"No link can be made between the death and the vaccine until all the facts are known and a postmortem takes place," the Department wrote in a letter to health professionals. "As a purely precautionary measure, it is important that all stocks of Cervarix vaccine from the above batch are quarantined until the above incident has been fully investigated."

Further details were revealed the following day at a hearing at Coventry Magistrates' Court. Deputy coroner Louise Hunt said the postmortem revealed a large tumor that had "heavily infiltrated" the heart and had extended into the left lung. A pathologist told the inquest that the condition was "so severe that death could have arisen at any point," according to a report on BBC News.

Cervarix in UK, But Gardasil Elsewhere

The UK national program of HPV vaccination began last year, offering the vaccine through schools to all girls in the 12- to 13-year-old age range. A catch-up program for older girls, up to 18 years, was launched just recently, with the aim of covering all girls under 18 years by 2011. An estimated 1.4 million girls in the United Kingdom have already received the vaccine.

The United Kingdom chose to use Cervarix, manufactured by GlaxoSmithKline, for its national program, whereas many other countries — including the United States and Australia — chose to use Gardasil from Merck & Co.
In fact, Cervarix is not available in the United States, and may not be for some time yet, it now appears.

Yesterday, the FDA announced that it was postponing its decision on approval of Cervarix, saying that it needed more time to consider the data, even though an FDA advisory committee meeting recently voted overwhelmingly for approval, as previously reported by Medscape Oncology.

The UK decision to choose Cervarix and not Gardasil has been questioned in the British press, with newspapers pointing out that the reasons behind the choice were never revealed, but is widely speculated to have been based on cost, with Cervarix being cheaper.

But the 2 vaccines also differ from each other in a key aspect.

Cervarix protects against 2 types of HPV virus (types 16 and 18), which together account for about 70% of all cervical cancer.
Gardasil also protects against these, but in addition offers protection against HPV types 6 and 11, which cause genital warts.
This extra activity means that Gardasil is also indicated for the prevention of genital warts in girls and women, and could be used for this indication in boys and men (it was recommended for approval for this use at the recent FDA advisory committee meeting).

However, the main purpose behind the development of these vaccines was to prevent cervical cancer, and for this indication, Cervarix is the better of the 2 vaccines, according to expert Diane Harper, MD, from the University of Missouri–Kansas City School of Medicine.

Dr. Harper has been involved in clinical trials with both vaccines, and was approached by Medscape Oncology for comment.
As previously reported, Dr. Harper said that Cervarix was longer lasting, resulted in higher antibody titers, and offered wider cross protection against other HPV types than Gardasil.

But Dr. Harper has also been very vocal in emphasizing that these vaccines are not the only way to protect against cervical cancer, and she has repeatedly stressed that even when they are used, it remains vital to screen for cervical cancer with regular Pap tests.

She has joined in with questions over the benefit–risk analysis of HPV vaccination that have been raised, most recently in an editorial in the Journal of the American Medical Association (JAMA), as reported by Medscape Oncology.

That August 19 issue of JAMA also published details of adverse events that have been reported with Gardasil during its 2.5 years on the market (JAMA. 2009;302:750-757). These reports were made to the US Vaccine Adverse Event Reporting System, which is operated jointly by the FDA and the Centers for Disease Control and Prevention (CDC).
The authors emphasized that a report of an adverse event does not necessarily mean there is a causal link.
The paper noted that 12,424 reports of adverse events had been received, of which 772 (6.2%) were for serious adverse events, including 32 deaths.

This is a sobering reality.
In the United States, the death rate from cervical cancer (3 of 100,000 women, according to statistics from the CDC) is currently similar to the rate of reported serious adverse events from Gardasil (3.4 of 100,000 doses distributed), Dr. Harper pointed out.
"This is a sobering reality," she said. "Would a parent accept such a rate of serious adverse events if the same cancer prevention can occur with continued Pap screening? Is there any acceptable level of risk of serious adverse events, including death, to prevent genital warts?"

A debate about the HPV vaccine is running on Medscape's Green Mountain Doc blog, written by Katharine Hikel, MD, who specializes in writing about women's health issues.
Her post, entitled "'One Less Sucker' — Gardasil," criticized the marketing of this product, questioned whether it was medically necessary, and highlighted its adverse event rate.

"The rush-to-market approach for this questionable product, with billions spent on promotion, has completely [over-ridden] good judgment, critical analysis, and clear thinking on the part of providers," Dr. Hikel writes. She asserts that this has put millions of women "needlessly at risk."

In contrast, many cervical cancer specialists have spoken up in favor of HPV vaccination, as previously reported by Medscape Oncology.
Maurie Markman, MD, professor of gynecologic medical oncology at the University of Texas MD Anderson Cancer Center in Houston, and an editorial advisor to Medscape Oncology, has repeatedly emphasized the benefits of the vaccine and the unique opportunity that it offers for protection from cervical cancer. He has spoken reassuringly about the safety of the vaccine, most recently in his videoblog "How Safe Is the HPV Vaccine?"

This view was echoed recently by the Society of Gynecologic Oncologists (SOG), which said that HPV vaccination represented a "paradigm-shifting prevention strategy for cervical cancer."
In a statement released to the recent FDA advisory committee meeting, the SOG said: "The public-health value of the protection afforded by HPV vaccination overwhelmingly outweighs the self-limiting local side effects and even the rare but more serious effects that may or may not be vaccine-related."

Dr. Harper reports having received honoraria from Merck & Co and GlaxoSmithKline, and institutions at which she has worked have received funding from both companies to support clinical trials on HPV vaccines. Dr. Markman reports having received grants for educational activities from Eli Lilly and serving as an advisor or consultant for Genentech, Celgene Corporation, Tibotec, and Boehringer Ingelheim.

Thursday, January 14, 2010

Pediatric Voiding Dysfunction: Current Evaluation and Management

From Urologic Nursing

Pamela Ellsworth, MD, FAAP, FACS; Anthony Caldamone, MD, FAAP, FAC

Voiding dysfunction and urinary incontinence in children is common. Both are associated with significant effects on quality of life and co-morbidities, including urinary tract infections (UTIs) and constipation. A thorough history, physical examination, and non-invasive evaluation are essential in determining the etiology. Interventions, such as behavioral therapy/biofeedback and pharmacologic therapies, are primary treatments. Prevalence rates, current evaluation, and management techniques are discussed in this article.


The prevalence of pediatric voiding dysfunction and daytime incontinence is difficult to determine due to varying definitions of urinary incontinence (UI) and different study designs. Furthermore, few studies have evaluated the prevalence of the different types of voiding dysfunction in children.
The prevalence of daytime wetting varies with age and gender. Overall rates vary from 1% to 10%. In 6 to 7-year-old children, the rate is between 2% to 4%, with a rapid decrease in subsequent years (Bloom, Seeley, Ritchey, & McGuire, 1993; Bower, Moore, Shepherd, & Adams, 1996).

Management Of Bowel Symptoms
Critical to the management of pediatric voiding dysfunction is the management of any underlying bowel dysfunction. It is important to identify those children with bowel dysfunction during the initial evaluation by asking questions regarding bowel habits (see Table 2 ). As with voiding dysfunction, a behavioral approach to the management of bowel dysfunction is important. Bowel regimens consisting of timed attempts at having a bowel movement are important. Children are encouraged to try to have a bowel movement after meals, taking advantage of the gastrocolic reflex. It is important that the child has enough fiber in his or her diet and is drinking enough fluids. Those children who fail to improve with simple dietary and behavioral measures will benefit from the addition of laxatives, such as polyethylene glycol 3350 (Miralax®).

Depression, Suicidal Ideation More Likely in Adolescents With Late vs Earlier Set Bedtimes

From Medscape Medical News

January 1, 2010 — Adolescents whose parents mandate bedtimes of midnight or later are 24% more likely to be depressed and 20% more likely to express suicidal ideation than adolescents whose parents set bedtimes of 10 pm or earlier, according to a study in the January 1 issue of Sleep.

These findings suggest that earlier parentally set bedtimes may help protect adolescents from depression by ensuring they get enough sleep. James Gangwisch, PhD, Columbia University Medical Center, New York City, and multicenter colleagues found that the average amount of sleep reported by 15,659 adolescents involved in the National Longitudinal Study of Adolescent Health (Add Health) was 7 hours and 53 minutes — considerably less than the 9 or more hours recommended for adolescents by the American Academy of Sleep Medicine.

However, adolescents whose parents had set a bedtime of 10 pm or earlier slept 33 minutes more, on average, than those with a bedtime of 11 pm, and 40 minutes more on average than adolescents with a parental bedtime of midnight or later. Adolescents who reported getting on average 5 or fewer hours of sleep per night were also 71% more likely to be depressed and 48% more likely to think about committing suicide than adolescents who reported getting 8 hours of sleep a night.

"Short sleep duration could be either a symptom of depression or it could be causative of depression, so we tried to get at this question by looking at parentally mandated bedtimes because if you leave it up to a child as to when they go to bed, an argument could be made that [lack of] sleep is simply a symptom of depression," Dr. Gangwisch told Medscape Neurology. "And our study lends support to the idea that lack of sleep could be causative for depression."

Add Health

Add Health involved a nationally representative sample of adolescents in the United States who were in grades 7 to 12 between 1994 and 1996. An 18-item version of the Centers for Epidemiologic Study–Depression Scale was administered to assess individuals for the presence of depressive symptoms, and the presence of suicidal ideation was determined by responses to the question: "During the past 12 months, did you ever seriously think about committing suicide?"

As investigators note, more than two thirds of Add Health participants reported going to bed at a time that complied with their parents' reported set bedtime. In unadjusted analyses, adolescents with late parentally mandated bedtimes of midnight and later were 42% more likely to be depressed, and those with set bedtimes of 11 pm were 15% more like to be depressed, than adolescents with set bedtimes of 10 pm.

Again in unadjusted analyses, adolescents with parentally set bedtimes of midnight or later and 11 pm were 30% and 15% more likely to suffer from suicidal ideation, respectively, in comparison with adolescents with parental set bedtimes of 10 pm. Risks were attenuated depending on the model used.

"Adolescents want to go to bed later now because there are so many different distractions, plus they have to get up really early for school, so it's easy for them not to get enough sleep," Dr. Gangwisch noted.

"But what we are saying is that getting adequate sleep is very important for mental health, and compromising on the amount of sleep by doing other activities can have negative consequences, including a increased risk of depression."Substantiated Empirical Belief

Commenting on the study, William Kohler, MD, from the Florida Sleep Institute, Springhill, told Medscape Neurology that the study "substantiated the empirical belief that lack of sleep leads to difficulties with cognition." Even though inherent inaccuracies do occur with a questionnaire-based study such as this one, "the sample size was large, and it was a very good study." There was, as he indicated, no information on the quality of sleep reported by the adolescents, so that participants might have been in bed 8 hours but had gotten little sleep.

Still, Dr. Kohler feels that the study underscored how important it is for physicians to ask adolescent patients about their sleep habits — what time they go to bed, how much sleep they have or perceive they get — to make sure poor sleeping habits are not contributing to underlying depression.

He also feels that schools need to look at start times for students because "no matter how much money we throw at public education, if children are getting up at 5 in the morning to get to school, they are not going to learn properly because they are sleep-deprived."

Financial support for this study was provided by a grant from the Robert Wood Johnson Health and Society Scholars Program at Columbia University, but it was not an industry-supported study. Dr. Gangwisch and Dr. Kohler have disclosed no relevant financial relationships.

Sleep. 2010;33(1):97-106.

Wednesday, January 13, 2010

New Data Support Long-Term Health Benefits of Male Circumcision

From Medscape Medical News
Fran Lowry

Review data January 4, 2010 — The American Academy of Pediatrics (AAP) policy on newborn male circumcision, initiated in 1999 and reaffirmed in 2005, states that data are insufficient to recommend routine neonatal circumcision. However, recent results from 3 randomized trials showing that it prevents sexually transmitted infections suggest that it is time to revise this policy to fully reflect these benefits, according to a review published in the January 2010 issue of the Archives of Pediatric and Adolescent Medicine.

“During the past 4 years, substantial new data have been published on the health benefits of circumcision,” write Aaron A. R. Tobian, MD, from Johns Hopkins University School of Medicine, Baltimore, Maryland, and colleagues. “While the historical evidence strongly suggests that male circumcision reduces urinary tract infections and penile inflammatory disorders in infants, we reviewed the more recent evidence with regard to effects on sexually transmitted infections (STIs) in adulthood.”

To evaluate the effect of circumcision on HIV prevention, the researchers analyzed 3 randomized controlled trials of more than 10,000 men from South Africa, Kenya, and Uganda.

The trials enrolled HIV-negative men to circumcision on enrollment or after 21 to 24 months, and all 3 trials demonstrated that male circumcision significantly decreased male heterosexual HIV acquisition by 53% to 60%, despite differences in age eligibility criteria, urban or rural settings, and surgical procedure.

Results Prompted New WHO/UNAIDS Recommendations

Because of this new evidence, the World Health Organization (WHO), together with the Joint United Nations Program on HIV/AIDS (UNAIDS), recommended that male circumcision be provided as an important intervention to reduce heterosexually acquired HIV in men, the study authors report.

The trials also found that male circumcision decreased herpes simplex virus type 2 (HSV-2) acquisition by 28% to 34% and the prevalence of human papillomavirus (HPV) by 32% to 35% in men.

Among female partners of circumcised men, bacterial vaginosis was reduced by 40% and Trichomonas vaginalis infection was reduced by 48%, the study authors write.

The study authors note that the rates of neonatal circumcision complications are between 0.2% and 0.6% of operations performed. The most common complications are bleeding and local infection, which are controlled with pressure and wound care or antibiotics. Other complications, such as phimosis and concealed penis, adhesions, fistula, meatitis, meatal stenosis, and injury to the glans, are extremely rare.

They add that there was no evidence of change in sexual behavior after circumcision in the African randomized controlled trials. “Thus, there are risks to neonatal circumcision, but serious long-term complications are extremely rare,” the study authors write.

“The rare short-term risks of neonatal circumcision need to be weighed against the potential benefits accrued in infancy and childhood (eg, reduction of urinary tract infections), the longer-term benefits that may accrue in adolescence and adulthood (eg, reduced risks of HIV, HSV-2, and HPV), as well as possible benefits to female sexual partners of circumcised men (eg, reduced bacterial vaginosis and trichomonas),” Dr. Tobian and colleagues write.

Medicaid does not cover the cost of male circumcision in 16 states, and the lack of coverage particularly affects disadvantaged minorities, who have the highest risk for HIV and sexually transmitted diseases. “These socioeconomically disadvantaged groups could benefit most if Medicaid covered the costs of neonatal circumcision. Thus, the AAP’s policy has important implications for the health of disadvantaged minorities,” they write.

They conclude that it is time for the AAP policy to fully reflect current data.

Coverage for Circumcision

In an accompanying editorial, Michael T. Brady, MD, from Nationwide Children’s Hospital in Columbus, Ohio, writes that the study authors have provided a very objective review of the available data. Although the 3 randomized trials were performed in Africa, “it is clear that circumcision does offer health benefits, even in the United States,” he notes.

The current evidence on the health benefits of circumcision is adequate enough to include circumcision in medical coverage provided by Medicaid or commercial insurance providers, Dr. Brady points out. “This is particularly relevant since over the past decade many state Medicaid programs have discontinued payment for circumcision.”

He concludes that recommendations for routine newborn circumcision will need to wait for well-designed studies that verify its cost-effectiveness for the individual and/or society. “With available data, we are not there yet, but we may be getting closer.”

Dr. Tobian and Dr. Brady have disclosed no relevant financial relationships.

Arch Pediatr Adolesc Med. 2010;164:78-84, 94-96.

Tuesday, January 12, 2010

Childhood and Adolescent Immunization Schedules Approved for 2010

From Medscape Medical News
Laurie Barclay, MD

January 4, 2010 — The 2010 recommended childhood and adolescent immunization schedules have been approved by the American Academy of Pediatrics (AAP), the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention, and the American Academy of Family Physicians, according to a report posted online January 4 and to be published in the January 2010 issue of Pediatrics.

There are 3 revised schedules describing current guidelines for use of US Food and Drug Administration (FDA)–licensed vaccines: one for children from birth through age 6 years, one for children and adolescents aged 7 through 18 years, and a catch-up immunization schedule for children and adolescents who start late or fall behind with scheduled vaccinations.

Noteworthy changes in the 2010 schedule are a new recommendation for influenza A (H1N1) 2009 monovalent vaccine, a recommendation to revaccinate children who remain at increased risk for meningococcal disease with meningococcal conjugate vaccine (MCV4), recommendations on combination vaccines, and recommendations for the recently licensed bivalent human papillomavirus (HPV) vaccine in girls and the quadrivalent HPV vaccine in boys.

Specific changes from last year's recommendations for vaccination with FDA-approved vaccines include the following:

A footnote refers to ACIP recommendations regarding use of influenza A (H1N1) 2009 monovalent vaccine.
Only children 6 months or older should receive trivalent inactivated influenza vaccine (TIV), and only those 2 years or older should receive the live attenuated influenza vaccine (LAIV).
Healthy children aged 2 to 6 years may receive either TIV or LAIV.
However, children aged 2 to 4 years who have a history of wheezing in the preceding 12 months should not receive LAIV.
The dose of TIV is 0.25 mL for children aged 6 to 35 months and 0.5 mL for those at least 3 years old. For children younger than 9 years given the influenza vaccine for the first time, 2 doses should be given 4 weeks apart. Children who received a single dose of influenza vaccine the previous season should be given 2 doses, separated by 4 weeks or more.

Children who remain at increased risk for meningococcal disease because of persistent complement deficiency, asplenia, or other conditions should be revaccinated with MCV4.
Children who received the initial MCV4 dose at ages 2 through 6 years should receive a dose of MCV4 after 3 years.
If the first dose was given at age 7 years or older, children should be revaccinated after 5 years. These children should then be revaccinated with MCV4 every 5 years.

Children not previously vaccinated with MCV4 should be given this vaccine at age 11 or 12 years or between ages 13 and 18 years.
College freshmen living in a dormitory who have not previously received MCV4 should be given this vaccine.

Combination vaccines are usually preferred to separate injections of the equivalent component vaccines. Updated recommendations regarding the inactivated poliovirus vaccine series are that the final dose should be given on or after the fourth birthday and at least 6 months after the previous dose.
Children receiving 4 doses before age 4 years should receive an additional (fifth) dose at ages 4 through 6 years.

Updated recommendations describe use of the recently licensed bivalent HPV vaccine in girls and the quadrivalent HPV vaccine in boys. Girls not previously vaccinated against HPV should receive the bivalent HPV series at ages 13 through 18 years.
For catch-up, the second and third HPV dose should be given at 1 to 2 months and at 6 months after the first dose. The minimal interval for vaccination is 4 weeks between the first and second doses, 12 weeks between the second and third doses, and 24 weeks or more between the first dose and third dose.

Revisions to most of the footnotes for the individual vaccines offer additional information and explain recommendations provided in the schedules.

The guidelines note that clinically significant adverse events after vaccination should be reported to the Vaccine Adverse Event Reporting System or at 1-800-822-7967. Details of ACIP recommendations for individual vaccines, including recommendations for children with high-risk conditions, are available on the Centers for Disease Control and Prevention Web site.

All of the guidelines authors filed conflict-of-interest statements with the AAP, and any conflicts were resolved through a process approved by the Board of Directors. The AAP neither solicited nor accepted any commercial involvement in the development of the content of this publication.

Pediatrics. Published online January 4, 2010.

Bifocals Slow Myopic Progression in Children

From Medscape Medical News

Fran Lowry

January 11, 2010 — Bifocal lenses can moderately slow myopic progression in children with high rates of myopic progression after 24 months, according to new research published in the January issue of the Archives of Ophthalmology.

"Myopia is a common refractive problem, particularly in East Asia, where reported prevalence values in children can be as high as 50% to 60% by the age of 12 years. Prevalence of myopia is also high among Asian children living in Western countries," write Desmond Cheng, OD, MSc, PhD, formerly from Queensland University of Technology, Brisbane, Australia, and currently from Hong Kong Polytechnic University, Hong Kong, and colleagues.

"A number of well-designed prospective studies have investigated the effect of positive lenses, in bifocal or multifocal form, on myopic progression in children. However, bifocals and multifocals have proven to be relatively ineffective myopia-control treatments in children," the authors write.

Myopic progression rate appears to be an important factor in determining the effectiveness of multifocal lens treatment, the authors point out.

The aim of this study was to determine whether bifocal and prismatic bifocal spectacles could control myopia in children with high rates of myopic progression, defined as 0.5 diopters or more in the preceding year.

The study randomly assigned 135 Chinese Canadian children (73 girls and 62 boys) with myopia of at least 1.00 diopter to receive single-vision lenses (n = 41), +1.50-diopter executive bifocals (n = 48), or +1.50-diopter executive bifocals with a 3-prism diopter base-in prism in the near segment of each lens (n = 46).

The authors explain that their randomization was done by putting subjects' file numbers on slips of paper and drawing them from a container at random. In addition, subjects and the investigator were aware of the treatment assignments, as blinding was difficult to achieve because the lens treatments were visually very different.

The mean age of the children was 10.3 years (standard error [SE], 0.15 years), and their mean visual acuity was −3.08 diopter (SE, 0.10 diopter).

Myopic progression was measured by an automated refractor under cycloplegia, and increase in axial length was measured by A-scan ultrasonography at 6-month intervals for 24 months.

Of the original 135 children, 131 (97%) completed the trial at 24 months.

The results showed that myopic progression averaged −1.55 diopter (SE, 0.12 diopter) for children who wore single-vision lenses, −0.96 diopter (SE, 0.09 diopter) for those who wore bifocals, and −0.70 diopter (SE, 0.10 diopter) for those who wore prismatic bifocals.

Significant Effect of Lens Design

There was a significant effect of lens design on the degree of myopic progression (P < .001), the authors report. Compared with the single-vision lens group, the magnitude of mean myopic progression was −0.59 diopter (P < .001) in the bifocal lens group and −0.85 diopter (P < .001) less in the prismatic bifocal lens group.

The study also found that axial length increased an average of 0.62 mm (SE, 0.04 mm), 0.41 mm (SE, 0.04 mm), and 0.41 mm (SE, 0.05 mm) in the single-vision lens, bifocal lens, and prismatic bifocal lens groups, respectively.

The treatment effect of bifocals (0.59 diopter) and prismatic bifocals (0.85 diopter) was significant, with a P value less than .001, and both bifocal groups had less axial elongation than the single-vision lens group (0.21 mm; P < .001), the authors report.

The findings of this study could be generalized to children with rapidly progressing myopia, irrespective of ethnicity, although this clearly needs to be tested, the authors state.

Limitations of the study include the use of an atypical randomization scheme to assign subjects to treatment groups and potential bias because the investigator was not masked.

The authors concede that the treatment effect of bifocal and prismatic bifocal lenses of 38% and 55%, respectively, that they found in their study — although greater than those in other studies — is still modest.

"Whether or not the effect tapers off will decide clinical significance," they write. "If the treatment effects continued over time, then the treatment could have a significant role in preventing the development of very high pathologic myopia."

For now, they conclude, bifocals should be offered to myopic children "with caution" in clinical practice.

Dr. Cheng has reported no relevant financial relationships.

Arch Ophthalmol. 2010;128:12-19.


Anitbiotics in H1N1 pneumonia

When to Consider the Use of Antibiotics in the Treatment of 2009 H1N1 Influenza-Associated Pneumonia

A difficulty arises when a patient has influenza or influenza with a bacterial superinfection that requires antibiotics.[3]
A recent report showed that bacterial pathogens, including Staphylococcus aureus, were present in 17/53 (32%) of fatal cases of novel H1N1 infection, including 8 in children.[4]
Table 3 summarizes the clinical features of influenza vs influenza with a bacterial superinfection.

Table 3. Detection of Agents of Pneumonia: Influenza vs Influenza + Bacterial Pathogen

Indicator Influenza Influenza + Bacterial Pathogen
Influenza identified Usually found Often found less because later in disease course
Fever Usually found Usually found after a period of defervescence
Respiratory specimen culture Normal flora Pathogen: usually S pneumoniae, S aureus or Group A strep
X-ray Diffuse Lobar consolidation
Onset of respiratory compromise Early: 1-2 days Later: 4-7 days

In regard to antimicrobial selection, these experts recommend coverage for methicillin-resistant Staphylococcus aureus (MRSA) and Streptococcus pneumoniae using a second- or third-generation cephalosporin with the addition of MRSA coverage if there is evidence of necrotizing pneumonia or if a Gram stain or culture of respiratory secretions suggests this pathogen. For outpatients, they suggest amoxicillin-clavulanate or a second- or third-generation cephalosporin.

Commentary. The clinical features suggesting bacterial superinfection are reminders of the well-known report of the 1957-1958 pandemic from NY Hospital-Cornell,[5] when the classic biphasic pattern with typical flu symptoms -- improvement and then rapid deterioration with lobar pneumonia -- was described. The main pathogens then and now are S pneumoniae, S aureus, and group A streptococci. The antibiotics preferred for hospitalized patients with suspected S pneumoniae would be cefotaxime or ceftriaxone. For S aureus (either MRSA or untested), the preference would be for vancomycin dosed to trough levels of 15-20 µg/mL or linezolid (which appears to have better lung penetration).

Firecracker Injury to Eye

From Medscape Ophthalmology > Interactive Case Series
A 5-Year-Old With Firecracker Injury to the Eye
Caroline L. Belanger, MD; Kimberly G. Yen, MD; Evelyn A. Paysse, MD

Posted: 12/17/2009

Firecracker damage to the eye can result in mechanical, thermal, and chemical injury. Most firecrackers are made of flash-powder, a mixture of oxidizer and metallic fuel that burns quickly and, if confined, produces a loud noise.[1] Metallic particles, such as aluminum, may be found in firecrackers, and they can appear radio-opaque on CT scans.

The treatment for chemical injury to the eye from a firecracker includes copious irrigation of the eye as soon as the injury is detected.
Any remaining particles in the fornices should be removed because they can cause tissue necrosis.
A shield is recommended to protect the eye and a regimen of cycloplegics and steroid drops or ointments should be started as soon as possible to decrease inflammation. Amniotic membranes are thought to deliver anti-inflammatory factors to the ocular surface, thus reducing scarring and providing a protective structure where the epithelial cells could replicate.
Steroids must be decreased after 1 week of treatment because they can inhibit wound healing and promote infection.

Treatment for the 4 grades of corneal burns must be adjusted according to the severity of injury.
In a grade 1 corneal burn, only corneal epithelial loss is present and no conjunctival ischemia is found. The prognosis is very good.
Grade 2 is associated with some corneal edema and corneal haze; conjunctival ischemia affects less than one third of the limbus and some permanent scarring may occur.
Grade 3 is associated with significant haziness of the cornea, and limbal ischemia is less than one half of the limbus. Prognosis is variable and vision is usually impaired. Finally, a corneal burn is grade 4. The cornea is opaque, and limbal ischemia affects greater than one half of the limbus.
Grade 4 burns may be associated with globe perforation, and the prognosis is poor.

Fireworks-related Injuries
Fireworks are thought to have originated in China[5] and are commonly used throughout the world to celebrate the New Year, Independence Day (United States), Halloween, and many smaller festivals.

In 2006, 9200 people were treated in emergency departments for fireworks-related injuries in the United States.[1] One of every 3 people injured were children younger than 15 years, with boys being affected 3 times more frequently than girls.[1] Some reports state that people actively participating in fireworks-related activities are more frequently and severely injured than bystanders.[1] The body parts most often injured were hands, eyes, and the head, face, and ear.[6] Common injures that occur are blindness, third-degree burns, and permanent scarring.[1]

Burns were the most common injury to all body parts, except the eyes and head, where contusions, lacerations, and foreign bodies in the eye occurred more frequently.[1] Although fewer injuries were associated with items such as sparklers and rockets,[1] one third of the injuries to children younger than 5 years were due to sparklers.[1] Injuries resulting from public fireworks displays are extremely rare. Risk factors for injuries include proximity to the device; lack of physical coordination necessary to safely handle fireworks, such as in the case of younger children; and curiosity, a common factor in children.[1] Alcohol consumption is also admitted in a high percentage of patients with fireworks injuries.[6]

Preventive safety measures when working with firecrackers, such as wearing safety glasses, have been shown to be effective in reducing the number of injuries.[6]
The World Health Organization (1984) has recommended a worldwide ban on the manufacture of all fireworks.

My note: Wear Eye protection when playing with firecrackers - they can blind u!!


Treatment of Severe Scalp Psoriasis: From the Medical Board of the National Psoriasis Foundation
Chan CS, Van Voorhees AS, Lebwohl MG, et al
J Am Acad Dermatol. 2009;60:962-971

A task force of the National Psoriasis Foundation Medical Board has written a consensus statement on therapy for scalp psoriasis. A MEDLINE search for "scalp psoriasis" was performed and the results were graded on the basis of levels of evidence developed by Shekelle and colleagues.[1] Treatment recommendations within the consensus statement are divided into first- and second-line options, and first-line treatment options are further divided into those that are appropriate for short-term vs long-term use.

The recommended first-line, short-term therapy for scalp psoriasis is topical corticosteroids, which have been the mainstay in the treatment of scalp psoriasis for years. The lowest-strength agent that is efficacious is preferred, although in general high-potency agents can be used safely. A limited number of head-to-head studies have demonstrated the superior efficacy of topical corticosteroids in scalp psoriasis compared with other topical agents. However, the major limitation of these agents is that superpotent topical corticosteroids are approved by the US Food and Drug Administration (FDA) for a maximum of 4 weeks of consecutive use due to the risk for skin atrophy, striae, and telangiectasias. No studies exist supporting the safety of these agents for use on the scalp beyond this time period. Because steroid-sparing medications are associated with fewer long-term risks, agents such as calcipotriene/calcipotriol, salicylic acid, dithranol/anthralin, coal tar, and topical retinoids (ie, tazarotene) are recommended as first-line, long-term therapy for scalp psoriasis. Combination therapy with the aforementioned topical agents has advantages over monotherapy because of enhanced efficacy with minimized toxicity and side effects.

All other treatment options for scalp psoriasis were based on anecdotal evidence. Alternative first-line treatment options include intralesional corticosteroids, which should be used only for localized scalp disease due to the increased risk for side effects associated with this method of administration. Alternative second-line treatment options include phototherapy and systemic medications. Although phototherapy is an effective treatment for nonscalp psoriasis, this modality is difficult to use on the scalp due to the presence of hair, which blocks the adequate penetration of ultraviolet light. To date, no studies exist that have specifically evaluated systemic treatments for scalp psoriasis. However, on the basis of the known efficacy of systemic agents in plaque psoriasis, a therapeutic trial of these agents can be considered when scalp psoriasis has not responded adequately to the aforementioned topical therapies.

The scalp is the most common area of psoriasis involvement and one of the most difficult to treat. Scalp involvement occurs in approximately 79% of psoriasis patients[2] and historically has been treated with low-potency topical steroids. FDA safety labeling limits the consecutive use of superpotent topical corticosteroids to 4 weeks. However, despite the lack of clinical trial data supporting the use of these agents for more than 4weeks, most -- if not all -- clinicians use long-term dosing of topical corticosteroids in the treatment of scalp psoriasis, especially corticosteroids of less than super potency. Underused options are coal tar, anthralin, and salicylic acid. Coal tar and anthralin are safe and effective for long-term use but often stain hair and may have a distinct, pungent smell. Salicylic acid is effective for the removal of thick scale, which allows for better penetration of other topical agents, rendering them more efficacious. Combination treatment regimens using topical steroids and topical nonsteroidal treatments can minimize or avoid the risk for steroid side effects. Because scalp skin is quite thick, some of the common side effects of topical steroids, such as atrophy, striae, and telangiectasias, are virtually never seen on the scalp. Consequently, the main safety concern with the use of topical steroids on the scalp is adrenal suppression, especially during long-term use of superpotent topical steroids. To minimize such risk, we recommend intermittent use of regimens with potent agents, such as the one we use with clobetasol propionate spray: 2-4 weeks on, followed by 2-4 weeks off, then back to 2-4 weeks on, if necessary, and so on. Used in this way, it is unlikely that the adrenal suppression encountered will be anything more than transient physiologic adrenal suppression rather than pathologic adrenal suppression leading to clinically relevant adrenal insufficiency.

Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines: developing guidelines. BMJ. 1999;318:593-596.
Van de Kerkhof PC, Steegers-Theunissen RP, Kuipers MV. Evaluation of topical drug treatment in psoriasis. Dermatology. 1998;197:31-36. Abstract

Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis. Section 3. Guidelines of Care for the Management and Treatment of Psoriasis With Topical Therapies
Menter A, Korman NJ, Elmets CA, et al
J Am Acad Dermatol. 2009;60:643-659

A work group of experts in psoriasis is formulating consensus guidelines for the management of psoriasis and psoriatic arthritis. The individual sections of these guidelines focus on different aspects of psoriasis management. Section 3 pertains to the management of psoriasis with topical therapies. It discusses the efficacy and safety of corticosteroids, vitamin D analogs, tazarotene, tacrolimus, pimecrolimus, emollients, salicylic acid, anthralin, and coal tar. Combination therapies are also evaluated.

Data were obtained using an evidence-based model via search of the MEDLINE database from 1960 to 2008. The evaluation of evidence was based on the 3-point numeric grading scale of the Strength of Recommendation Taxonomy used in primary care journals: I = good-quality patient-oriented evidence; II = limited-quality patient-oriented evidence; and III = other evidence, including consensus guidelines, opinion, or case studies.[1] Clinical recommendations were then formulated using the following scale: A = recommendation based on consistent and good-quality evidence; B = recommendation based on inconsistent or limited-quality patient-oriented evidence; C = recommendation based on consensus, opinion, or case studies.

Ultimately, the work group formulated recommendations for the practical clinical use of each of the topical agents and commented on the following aspects: indications, dosing, efficacy, contraindications/adverse reactions, pregnancy/nursing use, and pediatric use. The document is too complex to summarize in this review, but the reader is referred to the especially helpful tables in the article that summarize treatments, strength of recommendation, level of evidence, and supporting references.

Psoriasis affects approximately 2% of the population, and clinicians need to become familiar with the treatment of this cutaneous disease. The expanding arsenal of agents used to treat this often complex condition is growing constantly. This set of guidelines, presented in an evidence-based approach by top psoriasis experts, is crucial to the care of people with psoriasis. In our opinion, every clinician who treats psoriasis should use this document. Although not every patient presents a straightforward case, these guidelines should be used as a starting point for the creation of treatment regimens based on each patient's unique disease parameters. In our clinical practice, these guidelines are not only an extremely useful reference for patient care but also an essential "textbook" for the education of medical students, residents, and fellows who are attempting to become familiar with the management of psoriasis patients.

Ebell MH, Siwek J, Weiss BD, et al. Simplifying the language of evidence to improve patient care: strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in medical literature. J Fam Pract. 2004;53:111-120. Abstract

Cochrane Review: Topical Treatments for Chronic Plaque Psoriasis
Mason AR, Mason J, Cork M, Dooley G, Edwards G
Cochrane Database Syst Rev. 2009;(2):CD005028. DOI: 10.1002/14651858.CD005028.pub2.

The Cochrane Collaboration is an independent organization that produces quarterly systematic reviews of healthcare interventions called Cochrane Reviews. These reviews seek to address the effectiveness and appropriateness of disease-related treatment regimens in a comprehensive, unbiased, and scientifically validated manner. The purpose is to facilitate the choices made by healthcare providers and policy makers regarding the care of patients. This recent Cochrane Review focuses on topical treatments for plaque psoriasis with 2 goals in mind: (1) to compare the effectiveness, tolerability, and safety of topical treatments for chronic plaque psoriasis with placebo; and (2) to compare vitamin D analogs with other topical treatments.

Results of 13 randomized controlled trials with a total of 21,448 study participants revealed the following regarding the topical treatments for plaque psoriasis:

Vitamin D agents, corticosteroids, anthralin, and tazarotene were each more effective than placebo;
Head-to-head comparisons of vitamin D agents vs potent/very potent corticosteroids showed no statistically significant efficacy differences;
The combination of a vitamin D agent and a steroid was more efficacious than either agent alone;
Vitamin D agents were superior to coal tar;
Vitamin D agents were more effective with occlusion and/or twice-daily application;
Potent corticosteroids were less likely than vitamin D agents to cause local adverse events such as skin irritation; and
There was no difference in frequency of systemic adverse events between placebo and all other topical agents (although the Cochrane authors pointed out that this may be due to absence of evidence rather than evidence of absence).
The authors recommend that practicing dermatologists become acquainted with the Cochrane Library as a source of sound scientific information for treatment decisions. The discerning reader has the opportunity to appraise the actual data used by the authors to draw conclusions on treatment regimens by reviewing the full document version, while the more time-constrained reader can quickly peruse the summary section for a brief overview.

A quick search for Cochrane Reviews on psoriasis revealed 6 related articles. With the advent of biologic agents, it is impressive that the Cochrane reviewers chose to focus on the use of topical agents in the treatment of psoriasis. Because the majority of psoriasis patients have localized involvement, topical agents are and should remain the first-line agents of choice in most psoriasis cases and will continue to be a mainstay of treatment, except for those with generalized disease.

The obvious limitation of this document is that the information cannot be generalized to long-term maintenance therapy because the studies of these topical agents were, on average, only 6 weeks in duration. One-year safety and efficacy data are available only for vitamin D analogs (calcipotriene cream, calcipotriene plus betamethasone dipropionate ointment, and calcitriol ointment). The results showed that these agents are safe and effective for up to 1 year, and clinical practice suggests that they are safe and effective for even longer use. More long-term studies are needed, especially for agents that are not vitamin D analogs.


This activity is supported by an independent educational grant from Galderma.