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
Thursday, January 21, 2010
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.
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
Abstract
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.
Introduction
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®).
http://www.medscape.com/viewarticle/580229_6
Pamela Ellsworth, MD, FAAP, FACS; Anthony Caldamone, MD, FAAP, FAC
Abstract
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.
Introduction
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®).
http://www.medscape.com/viewarticle/580229_6
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.
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.
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.
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.
[
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.
[
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