From Medscape Medical News
Laurie Barclay, MD
January 3, 2011 — The prevalence of tonsillectomy, the associated morbidity, and the availability of hundreds of randomized clinical trials evaluating associated interventions create a pressing need for evidence-based guidance to aid clinicians, according to the multidisciplinary Clinical Practice Guideline: Tonsillectomy in Children, published online January 3, 2011, in Otolaryngology–Head and Neck Surgery.
"Over half a million tonsillectomies are done every year in the United States," said guideline coauthor Richard M. Rosenfeld, MD, MPH, from SUNY Downstate Medical Center and Long Island College Hospital in Brooklyn, New York, in a news release. "The tonsillectomy guideline will empower doctors and parents to make the best decisions, resulting in safer surgery and improved quality of life for children who suffer from large or infected tonsils."
The new guideline, which is intended for all clinicians in any setting who care for children 1 to 18 years old in whom tonsillectomy is being considered, offers evidence-based recommendations on identifying children who are the best candidates for tonsillectomy, and on preoperative, intraoperative, and postoperative care and management. Other objectives of this guideline include highlighting the need for evaluation and intervention in special populations, improving counseling and education for families, describing management options for patients with modifying factors, reducing inappropriate or unnecessary variations in care, and discussing the significant public health implications of tonsillectomy.
The definition of tonsillectomy is a surgical procedure in which the peritonsillar space between the tonsil capsule and the muscular wall is dissected to completely remove the tonsil, including its capsule. The term often refers to tonsillectomy with adenoidectomy, especially in relationship to sleep-disordered breathing (SDB) or other contexts where adenoidectomy is appropriate.
SDB refers to a continuum of obstructive disorders ranging in severity from primary snoring to obstructive sleep apnea (OSA). SDB is characterized by abnormalities of respiratory pattern or of the adequacy of ventilation during sleep, as well as by associated daytime symptoms such as excessive sleepiness, inattention, poor concentration, and hyperactivity.
Indications for tonsillectomy include recurrent throat infections and SDB, both of which can significantly impair childhood health and quality of life (QoL). Throat infection, which includes strep throat and acute tonsillitis, pharyngitis, adenotonsillitis, or tonsillopharyngitis, is defined as sore throat caused by viral or bacterial infection of the pharynx, palatine tonsils, or both, which may or may not be culture positive for group A streptococcus.
"The importance of tonsillectomy as an intervention relates to its documented benefit on child QoL," the guidelines authors write. "For example, when compared with healthy children, children with recurrent throat infections have more bodily pain and poorer general health and physical functioning. Tonsillectomy may improve QoL by reducing throat infections, health care provider visits, and the need for antibiotic therapy."
SDB in children is also associated with cognitive and behavioral impairment that usually improves after tonsillectomy, as do QoL, sleep disturbance, and vocal quality. The potential benefits of tonsillectomy must be weighed against possible surgical complications, including throat pain; postoperative nausea and vomiting; delayed feeding; voice changes; hemorrhage; and, rarely, death.
Guideline Recommendations
Specific recommendations included in the clinical practice guideline are as follows:
* Watchful waiting for recurrent throat infection is recommended if there have been fewer than 7 episodes in the previous year, fewer than 5 episodes per year in the previous 2 years, or fewer than 3 episodes per year in the previous 3 years (statement 1).
* Tonsillectomy may be an option for recurrent throat infection with a frequency of at least 7 episodes in the previous year, at least 5 episodes per year for 2 years, or at least 3 episodes per year for 3 years, provided that the medical record documents each episode of sore throat and the presence of at least one of the following: temperature of more than 38.3°C, cervical adenopathy, tonsillar exudate, or positive test result for group A β-hemolytic streptococcus (statement 2).
* Children with recurrent throat infection who do not meet the criteria in statement 2 may have modifying factors favoring tonsillectomy, including but not limited to multiple antibiotic allergy/intolerance, periodic fever, aphthous stomatitis, pharyngitis and adenitis, or a history of peritonsillar abscess (statement 3).
* Clinicians should ask caregivers of children with SDB and tonsillar hypertrophy about comorbid conditions that might improve after tonsillectomy, such as growth retardation, poor school performance, enuresis, and behavioral problems (statement 4).
* Caregivers of children with abnormal polysomnography results who also have tonsillar hypertrophy and SDB should be counseled about tonsillectomy as a means to improve health issues related to SDB (statement 5).
* Caregivers should be informed that SDB may persist or recur after tonsillectomy and may require further management (statement 6).
* A single, intraoperative dose of intravenous dexamethasone should be given to children undergoing tonsillectomy (statement 7; strong recommendation).
* Clinicians should not routinely administer or prescribe perioperative antibiotics to children undergoing tonsillectomy (statement 8; strong recommendation).
* Clinicians should advocate for pain management after tonsillectomy and should educate caregivers about the need to manage and reevaluate pain (statement 9).
* At least annually, clinicians who perform tonsillectomy should determine their rate of primary and secondary posttonsillectomy hemorrhage (statement 10).
Otolaryngol Head Neck Surg. Published online January 3, 2011.
Monday, January 3, 2011
Wednesday, December 29, 2010
Sucrose Analgesia for Infants: State of the Science
From Medscape Pediatrics > Viewpoints
Analgesic Effects of Sweet-Tasting Solutions for Infants: Current State of Equipoise
Harrison D, Bueno M, Yamada J, Adams-Webber T, Stevens B
Pediatrics. 2010;126:894-902
Study Summary
This article describes a meta-analysis of multiple randomized controlled trials that evaluated oral sucrose (or other sugar product) for acute, painful procedures in infants. Harrison and colleagues examined whether a state of equipoise (equilibrium about whether an intervention is likely to be helpful) still exists in regard to the use of oral sucrose for pain amelioration.
They noted that many randomized, placebo-controlled trials have been conducted despite the fact that reviews published throughout the 2000s demonstrated overwhelming evidence of clinical effectiveness. In addition to conducting a meta-analysis of the literature, this study sought to identify research questions or areas upon which future studies could focus.
The investigators reviewed 4 online literature databases and existing evidence-based reviews on the topic. They identified 125 primary research studies on the topic, with 49% using heel lance as the painful procedure, 14% using venipuncture or intramuscular injection, and 6% studying pain relief related to circumcision.
In 103 studies (93%), the use of sucrose or other sweet solution reduced pain response. One of 8 studies evaluating pain control with circumcision had negative results, but the other 7 (87.5%) demonstrated benefit. The solutions used in the trial varied greatly, but the most common was sucrose.
In general, sweeter solutions (higher concentrations) tended to have higher rates of success. The investigators concluded that there is no longer ethical justification for placebo groups in trials investigating the use of sweet solutions to limit short-term procedural pain. They pointed out the following knowledge gaps that could ethically be the focus of future investigation:
* Are sweet solutions effective in mitigating procedural pain for extremely premature infants?
* Are repeated administrations of the solution more effective than single administrations?
* Are sweet solutions effective over extended hospitalizations?
* How do sweet solutions compare with narcotic pain medications for short procedures?
* What is the effectiveness of sweet solutions for longer noxious procedures?
* Are sweet solutions effective in this setting for older children?
Harrison and coworkers suggested that these unanswered questions should be the focus of future research.
Analgesic Effects of Sweet-Tasting Solutions for Infants: Current State of Equipoise
Harrison D, Bueno M, Yamada J, Adams-Webber T, Stevens B
Pediatrics. 2010;126:894-902
Study Summary
This article describes a meta-analysis of multiple randomized controlled trials that evaluated oral sucrose (or other sugar product) for acute, painful procedures in infants. Harrison and colleagues examined whether a state of equipoise (equilibrium about whether an intervention is likely to be helpful) still exists in regard to the use of oral sucrose for pain amelioration.
They noted that many randomized, placebo-controlled trials have been conducted despite the fact that reviews published throughout the 2000s demonstrated overwhelming evidence of clinical effectiveness. In addition to conducting a meta-analysis of the literature, this study sought to identify research questions or areas upon which future studies could focus.
The investigators reviewed 4 online literature databases and existing evidence-based reviews on the topic. They identified 125 primary research studies on the topic, with 49% using heel lance as the painful procedure, 14% using venipuncture or intramuscular injection, and 6% studying pain relief related to circumcision.
In 103 studies (93%), the use of sucrose or other sweet solution reduced pain response. One of 8 studies evaluating pain control with circumcision had negative results, but the other 7 (87.5%) demonstrated benefit. The solutions used in the trial varied greatly, but the most common was sucrose.
In general, sweeter solutions (higher concentrations) tended to have higher rates of success. The investigators concluded that there is no longer ethical justification for placebo groups in trials investigating the use of sweet solutions to limit short-term procedural pain. They pointed out the following knowledge gaps that could ethically be the focus of future investigation:
* Are sweet solutions effective in mitigating procedural pain for extremely premature infants?
* Are repeated administrations of the solution more effective than single administrations?
* Are sweet solutions effective over extended hospitalizations?
* How do sweet solutions compare with narcotic pain medications for short procedures?
* What is the effectiveness of sweet solutions for longer noxious procedures?
* Are sweet solutions effective in this setting for older children?
Harrison and coworkers suggested that these unanswered questions should be the focus of future research.
Tuesday, December 28, 2010
Complementary, Alternative Medicine Linked to Adverse Events in Children
From Medscape Medical News
Laurie Barclay, MD
December 27, 2010 — The use of complementary and alternative medicine (CAM) can be associated with serious, and even fatal, adverse events in children, according to the results of a monthly active surveillance study reported online December 22 in the Archives of Disease in Childhood.
"...CAM is commonly administered to children," write Dr. Alissa Lim, from Royal Children's Hospital in Melbourne, Australia, and colleagues. "As CAM is frequently regarded as natural and therefore safe, adverse events may go unreported."
The goal of the study was to assess the types of adverse events linked to use of CAM that came to the attention of Australian pediatricians. Between January 2001 and December 2003, a total of 39 cases of adverse events associated with CAM use were reported to the Australian Paediatric Surveillance Unit, and a physician completed the questionnaire.
Almost two thirds of the reported cases (64%) were considered to be severe, life threatening, or fatal. Reported adverse events included constipation, bleeding, pain, allergic reactions, mouth ulcers, seizures, vomiting, stunted growth, infections, and malnutrition.
Several areas of concern were apparent that posed significant risks, including those related to failure to use conventional medicine because CAM therapy was substituted, those associated with medication changes made by CAM practitioners, and those caused by dietary restriction in the belief that this would cure symptoms. There were 4 reported deaths associated with a failure to use conventional medicine because a CAM treatment was substituted.
"CAM use has the potential to cause significant morbidity and fatal adverse outcomes," the study authors write. "The diversity of CAM therapies and their associated adverse events demonstrate the difficulty addressing this area and the importance of establishing mechanisms by which adverse effects may be reported or monitored."
Limitations of this study include lack of information about the products used, information collected only from pediatricians, and underreporting by families and also by clinicians because of time pressures and uncertainly about causality and severity of outcome. Although 46 instances of adverse events associated with CAM were reported during the study period, only 40 questionnaires were completed, and one of these was a duplicate, leaving 39 cases for analysis.
"Discussions with families about CAM use may empower them to talk about any medication changes suggested by a CAM practitioner before altering or ceasing the medication," the study authors conclude. "However, many of the adverse events associated with failure to use conventional medicine resulted from the family's belief in CAM and determination to use it despite medical advice."
The study authors have disclosed no relevant financial relationships.
Arch Dis Child. Published online December 22, 2010. Abstract
Laurie Barclay, MD
December 27, 2010 — The use of complementary and alternative medicine (CAM) can be associated with serious, and even fatal, adverse events in children, according to the results of a monthly active surveillance study reported online December 22 in the Archives of Disease in Childhood.
"...CAM is commonly administered to children," write Dr. Alissa Lim, from Royal Children's Hospital in Melbourne, Australia, and colleagues. "As CAM is frequently regarded as natural and therefore safe, adverse events may go unreported."
The goal of the study was to assess the types of adverse events linked to use of CAM that came to the attention of Australian pediatricians. Between January 2001 and December 2003, a total of 39 cases of adverse events associated with CAM use were reported to the Australian Paediatric Surveillance Unit, and a physician completed the questionnaire.
Almost two thirds of the reported cases (64%) were considered to be severe, life threatening, or fatal. Reported adverse events included constipation, bleeding, pain, allergic reactions, mouth ulcers, seizures, vomiting, stunted growth, infections, and malnutrition.
Several areas of concern were apparent that posed significant risks, including those related to failure to use conventional medicine because CAM therapy was substituted, those associated with medication changes made by CAM practitioners, and those caused by dietary restriction in the belief that this would cure symptoms. There were 4 reported deaths associated with a failure to use conventional medicine because a CAM treatment was substituted.
"CAM use has the potential to cause significant morbidity and fatal adverse outcomes," the study authors write. "The diversity of CAM therapies and their associated adverse events demonstrate the difficulty addressing this area and the importance of establishing mechanisms by which adverse effects may be reported or monitored."
Limitations of this study include lack of information about the products used, information collected only from pediatricians, and underreporting by families and also by clinicians because of time pressures and uncertainly about causality and severity of outcome. Although 46 instances of adverse events associated with CAM were reported during the study period, only 40 questionnaires were completed, and one of these was a duplicate, leaving 39 cases for analysis.
"Discussions with families about CAM use may empower them to talk about any medication changes suggested by a CAM practitioner before altering or ceasing the medication," the study authors conclude. "However, many of the adverse events associated with failure to use conventional medicine resulted from the family's belief in CAM and determination to use it despite medical advice."
The study authors have disclosed no relevant financial relationships.
Arch Dis Child. Published online December 22, 2010. Abstract
Monday, December 20, 2010
Moderate vs Low ICS Doses May Not Give Added Benefit in Childhood Asthma
From MedscapeCME Clinical Briefs
News Author: Laurie Barclay, MD
CME Author: Charles P. Vega, MD
December 8, 2010 — Compared with low doses, moderate doses of inhaled corticosteroids (ICSs) may not give an added benefit to children with mild to moderate persistent asthma, according to the results of a systematic review and meta-analysis reported online December 6 in Pediatrics.
"...ICSs are currently considered the first-line treatment for persistent childhood asthma; however, uncertainty remains regarding the optimal dose," write Linjie Zhang, MD, PhD, from the Maternal and Child Health Unit, Faculty of Medicine, Federal University of Rio Grande in Rio Grande, Brazil, and colleagues.
"The most recent asthma guidelines recommend a dose of up to 400 μg/day beclomethasone dipropionate (BDP)-hydrofluoroalkane equivalent for children with mild-to-moderate persistent asthma, but these recommendations are generally based on results from individual randomized trials rather than a body of evidence that has been critically appraised by a systematic review."
The reviewers searched MEDLINE for articles published between 1950 and August 2009 describing randomized controlled trials that compared 2 or more different ICS doses in children aged 3 to 18 years with persistent asthma.
The analyses focused on study endpoints of morning and evening peak expiratory flow, forced expiratory volume in 1 second, asthma symptom score, use of β2-agonists, withdrawal for lack of efficacy, and adverse events.
The investigators used meta-analyses to compare moderate doses of ICSs (300 - 400 μg/day) vs low doses of ICSs (≤ 200 μg/day beclomethasone equivalent).
The 14 included randomized controlled trials enrolled a total of 5768 asthmatic children and evaluated 5 ICSs. Moderate vs low doses were slightly but statistically significantly more effective in improving forced expiratory volume in 1 second among children with mild to moderate asthma, based on the pooled standardized mean difference from 6 trials (standardized mean difference, 0.11; 95% confidence interval, 0.01 - 0.21). However, other efficacy outcomes were not significantly different between the 2 doses, and there was no evidence of a dose-response relationship at low to moderate doses. Local adverse events were uncommon.
"Compared with low doses, moderate doses of ICSs may not provide clinically relevant therapeutic advantage in children with mild-to-moderate persistent asthma," the study authors write. "Additional RCTs [randomized controlled trials] are needed to clarify the dose-response relationship of ICSs in persistent childhood asthma."
Limitations of this study include an unclear risk for bias in the included trials, as well as nonuniform reporting of continuous efficacy outcome results and incomplete reporting of data collection and adverse events. Because of the language limitation, 1 small randomized trial conducted in Germany was not included.
"Although ICSs are generally considered safe treatment for children with asthma, the potential systemic adverse effects such as adrenal suppression, linear growth retardation, and effects on bone mass, are still of concern," the study authors conclude. "A limited number of studies included in this review assessed adverse effects of ICSs given at different doses on linear growth and on hypothalamic-pituitary-adrenal function, and their findings were inconsistent. There are no suitable data for investigating dose-response relationship of systemic adverse effects of ICSs."
Dr. Zhang has received grants from the Brazilian government agency CAPES for postdoctoral training in the Institute for Clinical Research and Health Policy Studies (Tufts Medical Center, Boston, Massachusetts).
Pediatrics. Published online December 6, 2010.
Clinical Context
ICSs are first-line therapy for children with persistent asthma, but the long-term use of these medications among children raises concerns regarding significant long-term adverse effects. This issue was addressed in a review by Allen, which was published in Advances in Pediatrics in 2006. He notes that the use of ICSs alone at small doses does not appear to be associated with any significant systemic adverse events. Although ICSs can retard vertical linear growth when given at high doses, ICS use alone does not appear to affect final adult height. Routine ICS use also should not lead to significant adrenal suppression or bone loss.
Although ICSs at low doses may be safe for children, are they effective enough? The current study examines the dose response to ICSs among children with persistent asthma.
News Author: Laurie Barclay, MD
CME Author: Charles P. Vega, MD
December 8, 2010 — Compared with low doses, moderate doses of inhaled corticosteroids (ICSs) may not give an added benefit to children with mild to moderate persistent asthma, according to the results of a systematic review and meta-analysis reported online December 6 in Pediatrics.
"...ICSs are currently considered the first-line treatment for persistent childhood asthma; however, uncertainty remains regarding the optimal dose," write Linjie Zhang, MD, PhD, from the Maternal and Child Health Unit, Faculty of Medicine, Federal University of Rio Grande in Rio Grande, Brazil, and colleagues.
"The most recent asthma guidelines recommend a dose of up to 400 μg/day beclomethasone dipropionate (BDP)-hydrofluoroalkane equivalent for children with mild-to-moderate persistent asthma, but these recommendations are generally based on results from individual randomized trials rather than a body of evidence that has been critically appraised by a systematic review."
The reviewers searched MEDLINE for articles published between 1950 and August 2009 describing randomized controlled trials that compared 2 or more different ICS doses in children aged 3 to 18 years with persistent asthma.
The analyses focused on study endpoints of morning and evening peak expiratory flow, forced expiratory volume in 1 second, asthma symptom score, use of β2-agonists, withdrawal for lack of efficacy, and adverse events.
The investigators used meta-analyses to compare moderate doses of ICSs (300 - 400 μg/day) vs low doses of ICSs (≤ 200 μg/day beclomethasone equivalent).
The 14 included randomized controlled trials enrolled a total of 5768 asthmatic children and evaluated 5 ICSs. Moderate vs low doses were slightly but statistically significantly more effective in improving forced expiratory volume in 1 second among children with mild to moderate asthma, based on the pooled standardized mean difference from 6 trials (standardized mean difference, 0.11; 95% confidence interval, 0.01 - 0.21). However, other efficacy outcomes were not significantly different between the 2 doses, and there was no evidence of a dose-response relationship at low to moderate doses. Local adverse events were uncommon.
"Compared with low doses, moderate doses of ICSs may not provide clinically relevant therapeutic advantage in children with mild-to-moderate persistent asthma," the study authors write. "Additional RCTs [randomized controlled trials] are needed to clarify the dose-response relationship of ICSs in persistent childhood asthma."
Limitations of this study include an unclear risk for bias in the included trials, as well as nonuniform reporting of continuous efficacy outcome results and incomplete reporting of data collection and adverse events. Because of the language limitation, 1 small randomized trial conducted in Germany was not included.
"Although ICSs are generally considered safe treatment for children with asthma, the potential systemic adverse effects such as adrenal suppression, linear growth retardation, and effects on bone mass, are still of concern," the study authors conclude. "A limited number of studies included in this review assessed adverse effects of ICSs given at different doses on linear growth and on hypothalamic-pituitary-adrenal function, and their findings were inconsistent. There are no suitable data for investigating dose-response relationship of systemic adverse effects of ICSs."
Dr. Zhang has received grants from the Brazilian government agency CAPES for postdoctoral training in the Institute for Clinical Research and Health Policy Studies (Tufts Medical Center, Boston, Massachusetts).
Pediatrics. Published online December 6, 2010.
Clinical Context
ICSs are first-line therapy for children with persistent asthma, but the long-term use of these medications among children raises concerns regarding significant long-term adverse effects. This issue was addressed in a review by Allen, which was published in Advances in Pediatrics in 2006. He notes that the use of ICSs alone at small doses does not appear to be associated with any significant systemic adverse events. Although ICSs can retard vertical linear growth when given at high doses, ICS use alone does not appear to affect final adult height. Routine ICS use also should not lead to significant adrenal suppression or bone loss.
Although ICSs at low doses may be safe for children, are they effective enough? The current study examines the dose response to ICSs among children with persistent asthma.
HPV Immunization for Male and Female Patients: Strategies to Reduce the Disease Burden
Kenneth A. Alexander, MD, PhD, Course Chair; Amanda Frisch Dempsey, MD, PhD, MPH; Maura L. Gillison, MD, PhD; Stephen E. Goldstone, MD
http://www.medscape.org/viewprogram/31840?src=cmemp
Contents of This CME Activity
1. Introduction
Kenneth A. Alexander, MD, PhD, Course Chair
Available As: Slides/Audio | Transcript
2. HPV Epidemiology: Infection to Genital Warts and Cancer
Maura L. Gillison, MD, PhD
Available As: Slides/Audio | Transcript
3. HPV Immunization: Making the Case for Males and Females
Stephen E. Goldstone, MD
Available As: Slides/Audio | Transcript
4. Incorporating HPV Into Adolescent Immunization
Amanda Frisch Dempsey, MD, PhD, MPH
Available As: Slides/Audio | Transcript
5. Talking to Patients and Parents
Faculty
Available As: Slides/Audio | Transcript
Earn CME Credit »
http://www.medscape.org/viewprogram/31840?src=cmemp
Contents of This CME Activity
1. Introduction
Kenneth A. Alexander, MD, PhD, Course Chair
Available As: Slides/Audio | Transcript
2. HPV Epidemiology: Infection to Genital Warts and Cancer
Maura L. Gillison, MD, PhD
Available As: Slides/Audio | Transcript
3. HPV Immunization: Making the Case for Males and Females
Stephen E. Goldstone, MD
Available As: Slides/Audio | Transcript
4. Incorporating HPV Into Adolescent Immunization
Amanda Frisch Dempsey, MD, PhD, MPH
Available As: Slides/Audio | Transcript
5. Talking to Patients and Parents
Faculty
Available As: Slides/Audio | Transcript
Earn CME Credit »
FDA Hearing on Mercury-Based Dental Fillings Pleases Both Sides of Debate
From Medscape Medical News
Robert Lowes
December 18, 2010 — An advisory panel to the US Food and Drug Administration (FDA) concluded this week that there are no huge scientific flaws in the agency's 2009 finding that mercury-based dental fillings, known as dental amalgam, are safe for adults and children aged 6 years and older.
However, at the end of its 2-day hearing, the agency's dental products panel recommended that the FDA look at more data — and the latest data — on the possible health risks that the filling material poses to pregnant women and their fetuses and to young children, particularly nursing infants whose mothers have these fillings. The panel also said the agency should consider adding warnings for these groups to the material's product instructions.
In one sense, the outcome of the hearing temporarily preserves the status quo for dental amalgam — so much so that the American Dental Association immediately issued a press release praising the expert panel's recommendations. The American Dental Association maintains that dental amalgam is safe and warrants no further regulation by the FDA as a medical device.
At the same time, the panel's quest for more scientific data about vulnerable populations acknowledged the concerns of dental amalgam opponents, who link mercury exposure to dozens of diseases ranging from autism to Alzheimer's disease. At high enough levels, mercury exposure can damage the brain and kidneys.
"We have to recognize that some patients should not have amalgam," said panel member Amid Ismail, BDS, DrPH, a professor and dean at the Kornberg School of Dentistry at Temple University in Philadelphia, Pennsylvania.
"There is really no place for mercury in children," added Suresh Kotagal, MD, a pediatric neurologist at the Mayo Clinic in Rochester, Minnesota. "The bottom line is, do no harm."
An attorney for the International Academy of Oral Medicine and Toxicology (IAOMT), which advocates mercury-free dentistry, told Medscape Medical News that he was encouraged by the consensus positions of the panel (no formal votes were taken).
"There was a lot of support that risk assessment needs to be done again," said Jim Love, the attorney for the group. "I thought it was a very constructive dialogue."
The FDA convened the hearing after the IAOMT and other antiamalgam groups and individuals petitioned the agency to reconsider its 2009 decision to reclassify the material from a lower-risk class I device to a moderate-risk class II device. That reclassification entailed revising product instructions to state in part that
* clinical studies have not established a causal link between dental amalgam and health problems for adults and children aged 6 years and older,
* the developing nervous systems of fetuses and young children "may be more sensitive to the neurotoxic effects of mercury vapour," and
* little or no clinical data are available regarding long-term health outcomes for fetuses, children younger than 6 years, and breast-fed infants.
The petitioners urged the agency to either ban dental amalgam, as Norway, Sweden, and Denmark already have done, or else reclassify it as a high-risk class III device with more restrictions on its use.
"Industry Will Go Crazy if That Reference Level Gets Moved"
By weight, dental amalgam is composed of roughly 40% to 50% liquid elemental mercury and a powdered alloy of mostly silver, copper, and tin. Much of the 2-day hearing focused on how much mercury is absorbed by people with these fillings, and what should be the reference exposure level (REL), or safety threshold, for the mercury vapor that the fillings release. Because mercury doses can be calculated from vapor exposure levels, an REL can establish a permissible dose. At the end, the advisory panel recommended that the agency take a second look at its positions on these issues.
The FDA currently holds that an individual with 7 to 10 amalgam fillings absorbs 1 to 5 μg of mercury per day. Amalgam opponents say this dose can be 4 times as high, meaning that tens of millions of people with these fillings are at risk for health problems, based on the current REL in place. The advisory panel's advice to the FDA is to study mercury doses for various population categories.
"We have virtually no data on fetuses," panel chairwoman Marjorie Jeffcoat, DMD, a professor at the University of Pennsylvania School of Dental Medicine, told Medscape Medical News. "It's important to subset out the different populations."
Also in dispute is the REL for mercury vapor. The FDA uses an REL of 0.3 μg/m3, set by the US Environmental Protection Agency (EPA). The EPA refers to this safety threshold as a "reference concentration" (RfC), which is an REL for inhaled, as opposed to swallowed, chemicals. This REL or RfC of 0.3 μg/m3 translates into a permissible dose that lies in the same range as the actual amalgam-derived dose assumed by the FDA.
The IAOMT told the panel that the REL for elemental mercury should be lower than 0.1 μg/m3 and cited a study it commissioned as proof. That study, whose lead author is Canadian biologist G. Mark Richardson, PhD, states that the EPA based its REL in part on studies of industrial workers exposed simultaneously to mercury and chlorine gas, with the gas acting to reduce mercury exposure, thus skewing the numbers. He notes that Health Canada, the Canadian equivalent of the US Department of Health and Human Services (and his former employer), set an REL of 0.06 μg/m3 by relying on studies free of this distortion.
The panel did not fully agree with Dr. Richardson's critique and called his chlorine gas argument a "red herring." Nevertheless, it advised the FDA to reexamine the scientific literature to reassess the REL and develop its own, noting that "the EPA RfC needs to be updated with the latest studies," according to an FDA hearing summary.
In essence, the panel wants the FDA to determine whether the REL really protects vulnerable populations, Dr. Jeffcoat told Medscape Medical News. "Tiny children can't speak for themselves," she said.
However, any lowering of the REL for elemental mercury has enormous consequences that extend far beyond the dentist's office, IAOMT attorney Jim Love told Medscape Medical News. The EPA, he said, uses this REL to regulate how much mercury that heavy industry can put into air and water, as well as to designate waste sites for its Superfund clean-up program. A lower REL means higher environmental protection costs — think billions of dollars — all around.
"Industry will go crazy if that reference level gets moved," said Love.
Need to Acknowledge Amalgam Benefits
The panel also revisited the question — raised in the FDA's 2009 deliberations — of whether clinical studies point to a causal relationship between dental amalgam and adverse health events. The panel reaffirmed that the literature at that time failed to do so, but only in terms of the general population. Again, it recommended that the agency continue to study the issue, particularly in terms of "susceptible subpopulations."
The panel grappled with how to best spell out the possible health risks of dental amalgam in the product instructions that dentists receive. It finally suggested adding warnings for young children, pregnant women, and individuals with metal allergies, and making the reference to limited scientific data about such individuals more explicit.
Panel members also stressed the need for dentists to discuss this information with patients. A number of individuals who spoke at the hearing complained that their dentists never mentioned mercury-associated risks for amalgam fillings, which they blamed for serious illnesses.
A model for warning language, incidentally, lies north of the border. Health Canada states on its Web site that although dental amalgam generally does not pose a health threat, the primary teeth of children should be filled with a nonmercury material when feasible. Pregnant women, individuals allergic to mercury, and those with impaired kidney function should avoid mercury-based fillings, according to Health Canada.
Tempering the panel's recommendations on Wednesday was an acknowledgment that amalgam's risks must be weighed against its benefits — namely, its superiority over tooth-colored composite fillings for restoring multiple surfaces, and its greater durability. In addition, although the use of amalgam has drastically declined during the last few decades as a result of patients choosing more cosmetically attractive alternatives, its lower price has made it the default material for poorer patients, who might not be able to afford more expensive fillings if amalgam were banned.
"It's nice for us to talk about risk and benefit and choice," said panel member Thomas Burbacher, PhD, a professor of environmental and occupational health sciences at the University of Washington in Seattle. "But if you don't have a choice, that discussion is meaningless."
Robert Lowes
December 18, 2010 — An advisory panel to the US Food and Drug Administration (FDA) concluded this week that there are no huge scientific flaws in the agency's 2009 finding that mercury-based dental fillings, known as dental amalgam, are safe for adults and children aged 6 years and older.
However, at the end of its 2-day hearing, the agency's dental products panel recommended that the FDA look at more data — and the latest data — on the possible health risks that the filling material poses to pregnant women and their fetuses and to young children, particularly nursing infants whose mothers have these fillings. The panel also said the agency should consider adding warnings for these groups to the material's product instructions.
In one sense, the outcome of the hearing temporarily preserves the status quo for dental amalgam — so much so that the American Dental Association immediately issued a press release praising the expert panel's recommendations. The American Dental Association maintains that dental amalgam is safe and warrants no further regulation by the FDA as a medical device.
At the same time, the panel's quest for more scientific data about vulnerable populations acknowledged the concerns of dental amalgam opponents, who link mercury exposure to dozens of diseases ranging from autism to Alzheimer's disease. At high enough levels, mercury exposure can damage the brain and kidneys.
"We have to recognize that some patients should not have amalgam," said panel member Amid Ismail, BDS, DrPH, a professor and dean at the Kornberg School of Dentistry at Temple University in Philadelphia, Pennsylvania.
"There is really no place for mercury in children," added Suresh Kotagal, MD, a pediatric neurologist at the Mayo Clinic in Rochester, Minnesota. "The bottom line is, do no harm."
An attorney for the International Academy of Oral Medicine and Toxicology (IAOMT), which advocates mercury-free dentistry, told Medscape Medical News that he was encouraged by the consensus positions of the panel (no formal votes were taken).
"There was a lot of support that risk assessment needs to be done again," said Jim Love, the attorney for the group. "I thought it was a very constructive dialogue."
The FDA convened the hearing after the IAOMT and other antiamalgam groups and individuals petitioned the agency to reconsider its 2009 decision to reclassify the material from a lower-risk class I device to a moderate-risk class II device. That reclassification entailed revising product instructions to state in part that
* clinical studies have not established a causal link between dental amalgam and health problems for adults and children aged 6 years and older,
* the developing nervous systems of fetuses and young children "may be more sensitive to the neurotoxic effects of mercury vapour," and
* little or no clinical data are available regarding long-term health outcomes for fetuses, children younger than 6 years, and breast-fed infants.
The petitioners urged the agency to either ban dental amalgam, as Norway, Sweden, and Denmark already have done, or else reclassify it as a high-risk class III device with more restrictions on its use.
"Industry Will Go Crazy if That Reference Level Gets Moved"
By weight, dental amalgam is composed of roughly 40% to 50% liquid elemental mercury and a powdered alloy of mostly silver, copper, and tin. Much of the 2-day hearing focused on how much mercury is absorbed by people with these fillings, and what should be the reference exposure level (REL), or safety threshold, for the mercury vapor that the fillings release. Because mercury doses can be calculated from vapor exposure levels, an REL can establish a permissible dose. At the end, the advisory panel recommended that the agency take a second look at its positions on these issues.
The FDA currently holds that an individual with 7 to 10 amalgam fillings absorbs 1 to 5 μg of mercury per day. Amalgam opponents say this dose can be 4 times as high, meaning that tens of millions of people with these fillings are at risk for health problems, based on the current REL in place. The advisory panel's advice to the FDA is to study mercury doses for various population categories.
"We have virtually no data on fetuses," panel chairwoman Marjorie Jeffcoat, DMD, a professor at the University of Pennsylvania School of Dental Medicine, told Medscape Medical News. "It's important to subset out the different populations."
Also in dispute is the REL for mercury vapor. The FDA uses an REL of 0.3 μg/m3, set by the US Environmental Protection Agency (EPA). The EPA refers to this safety threshold as a "reference concentration" (RfC), which is an REL for inhaled, as opposed to swallowed, chemicals. This REL or RfC of 0.3 μg/m3 translates into a permissible dose that lies in the same range as the actual amalgam-derived dose assumed by the FDA.
The IAOMT told the panel that the REL for elemental mercury should be lower than 0.1 μg/m3 and cited a study it commissioned as proof. That study, whose lead author is Canadian biologist G. Mark Richardson, PhD, states that the EPA based its REL in part on studies of industrial workers exposed simultaneously to mercury and chlorine gas, with the gas acting to reduce mercury exposure, thus skewing the numbers. He notes that Health Canada, the Canadian equivalent of the US Department of Health and Human Services (and his former employer), set an REL of 0.06 μg/m3 by relying on studies free of this distortion.
The panel did not fully agree with Dr. Richardson's critique and called his chlorine gas argument a "red herring." Nevertheless, it advised the FDA to reexamine the scientific literature to reassess the REL and develop its own, noting that "the EPA RfC needs to be updated with the latest studies," according to an FDA hearing summary.
In essence, the panel wants the FDA to determine whether the REL really protects vulnerable populations, Dr. Jeffcoat told Medscape Medical News. "Tiny children can't speak for themselves," she said.
However, any lowering of the REL for elemental mercury has enormous consequences that extend far beyond the dentist's office, IAOMT attorney Jim Love told Medscape Medical News. The EPA, he said, uses this REL to regulate how much mercury that heavy industry can put into air and water, as well as to designate waste sites for its Superfund clean-up program. A lower REL means higher environmental protection costs — think billions of dollars — all around.
"Industry will go crazy if that reference level gets moved," said Love.
Need to Acknowledge Amalgam Benefits
The panel also revisited the question — raised in the FDA's 2009 deliberations — of whether clinical studies point to a causal relationship between dental amalgam and adverse health events. The panel reaffirmed that the literature at that time failed to do so, but only in terms of the general population. Again, it recommended that the agency continue to study the issue, particularly in terms of "susceptible subpopulations."
The panel grappled with how to best spell out the possible health risks of dental amalgam in the product instructions that dentists receive. It finally suggested adding warnings for young children, pregnant women, and individuals with metal allergies, and making the reference to limited scientific data about such individuals more explicit.
Panel members also stressed the need for dentists to discuss this information with patients. A number of individuals who spoke at the hearing complained that their dentists never mentioned mercury-associated risks for amalgam fillings, which they blamed for serious illnesses.
A model for warning language, incidentally, lies north of the border. Health Canada states on its Web site that although dental amalgam generally does not pose a health threat, the primary teeth of children should be filled with a nonmercury material when feasible. Pregnant women, individuals allergic to mercury, and those with impaired kidney function should avoid mercury-based fillings, according to Health Canada.
Tempering the panel's recommendations on Wednesday was an acknowledgment that amalgam's risks must be weighed against its benefits — namely, its superiority over tooth-colored composite fillings for restoring multiple surfaces, and its greater durability. In addition, although the use of amalgam has drastically declined during the last few decades as a result of patients choosing more cosmetically attractive alternatives, its lower price has made it the default material for poorer patients, who might not be able to afford more expensive fillings if amalgam were banned.
"It's nice for us to talk about risk and benefit and choice," said panel member Thomas Burbacher, PhD, a professor of environmental and occupational health sciences at the University of Washington in Seattle. "But if you don't have a choice, that discussion is meaningless."
Tuesday, October 5, 2010
Probiotics for Gastroenteritis and Allergies -- A Double Benefit?: Commentary
What Are Probiotics?
by Diseree lie MD
Probiotics are defined by the World Health Organization (WHO) as "live microorganisms which, when administered in adequate amounts, confer a health benefit on the host."
Probiotics are found in the gastrointestinal tract or as components of foods and beverages.
They are different from prebiotics, which are complex carbohydrates (nondigestable, fermentable polysaccharides) that stimulate the growth and/or activity of beneficial bacteria already in the colon. Prebiotics may be considered precursors to probiotics, and their role has yet to be defined in larger clinical studies.
Probiotics and prebiotics may be combined in a single product called synbiotics.
Most probiotics are either Lactobacillus or Bifidobacterium and their various species and strains (for example, Lactobacillus acidophilus and Bifidobacterium bifidus).
Other common probiotics are yeasts -- for example, Saccharomyces boulardii.
Probiotics are believed to reinforce the integrity of the intestinal lining as a protective barrier to prevent invasion by pathogenic organisms, and they are purported to prevent harmful bacteria or yeast from breaching the gastrointestinal mucosa.
They have an effect on priming immunophysiologic regulation in the intestinal mucosal barrier and may exert clinical effects beyond the nutritional value of food.
This effect is the rationale for their efficacy in preventing infectious or other forms of diarrhea and for the treatment of allergic conditions.
Formulations of Probiotics
Probiotics are available as tablets, powder, capsules and can also be mixed into beverages such as yogurt, milk, or juice.
Many different forms are offered worldwide.
Bifidobacteria appear to be safe when used orally, including in those under 2 years and ill neonates.
For example, a combination probiotic consisting of Lactobacillus, Bifidobacteria, and Streptococcus salivarius, known as VSL#3, was used in children ages 1 to 16 years for up to a year.
For preventing diarrhea in children, 5-10 billion live Lactobacillus GG have been used twice daily as tablets. Doses of 10-100 billion live organisms are available in tablet form, and capsules of 3 grams are also available.
Clinical Evidence
Diarrhea-associated illness.
There is a body of evidence supporting the benefit of probiotics in diarrhea-associated diseases. Several probiotics (Saccharomyces boulardii and a mixture of L acidophilus and B bifidum) have shown efficacy for preventing traveler's diarrhea with a relative risk (RR) reduction of 15% (RR=0.85, P < .001).[8,9]
Probiotics have also been shown to benefit antibiotic-associated and pediatric infectious diarrhea, especially rotavirus-related diarrhea. Probiotics have been used for a variety of gastrointestinal disorders as well, including these clinically successful applications for conditions related to inflammatory bowel disease:
•Lactobacillus GG to maintain remission in those with ulcerative colitis;
•S boulardii in combination with mesalamine to prevent clinical relapse of Crohn's disease (it should be noted that a Cochrane review concluded that studies to date have been too small to draw conclusions about use of probiotics for Crohn's disease prophylaxis);
•VSL#3 for prophylaxis of pouchitis and improved quality of life following ileal pouch-anal anastomosis; and
•VSL #3 for prevention of recurrent pouchitis after antibiotic-induced remission in patients with a refractory form of this condition.
Probiotics have also been found to be helpful in diarrhea-predominant irritable bowel syndrome. For example, in a meta-analysis, the odds ratio (OR) in favor of active probiotic treatment over placebo in children for diarrhea was 0.39 (P < .001) for yeast and 0.34 (P < .01) for Lactobacilli.
Similarly, probiotics offer a possible way to prevent antibiotic-associated diarrhea. A randomized study using 100g of a drink containing Lactobacillus casei, Lactobacillus bulgaricus, and Streptococcus thermophilus taken twice daily for one week after a course of antibiotics reduced the incidence of antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea.[12]
Allergic diseases. Two Cochrane reviews looking at the prevention of allergic disease and food hypersensitivity in infants found positive evidence from studies using Lactobacillus rhamnosus in favor of eczema prevention but not treatment.
A few reviews found encouraging, but not strong, effects, for several species of Lactobacilli for atopic dermatitis; these reports were based on placebo-controlled, randomized studies, using the SCORing Atopic Dermatitis (SCORAD) index for assessment, with possibly greater effects in children who have cow's milk allergy.
As noted in other reviews, a benefit was more likely to be seen for the prevention of eczema than for improvement of existing eczema. Most of the studies showing benefit were small and limited in scope. Of interest, when mothers consumed probiotics during pregnancy (starting 2 to 4 weeks before delivery), the likelihood of atopic dermatitis in the child was reduced at 2 years by about 50% in one study, and the cumulative effect on prevention was still evident at 4 years.
However, there was no effect on respiratory allergy, immunoglobulin E (IgE) levels, or allergic sensitization in these children. When infants were given probiotics in the first 6 months of life, a similar reduction in incidence of atopic eczema at 2 and 4 years was noted in these 2 studies.
Another randomized controlled trial of infants 5 months and younger, however, showed no effect of probiotic supplementation with L rhamnosus compared with placebo in the form of a hydrolyzed whey-based formula on atopic dermatitis in children when given for 3 months.
Overall, while there is a sound theoretical basis for a benefit of using probiotics for allergic disease, there is currently insufficient data to recommend it for all allergic conditions. With that said, there is more evidence supporting its use in preventing atopic dermatitis in children than for other allergic or immune conditions.
Respiratory illnesses. Studies in teenagers and adults with established respiratory disease have failed to show symptom improvement in asthma or allergic rhinitis although quality of life was improved in 1 study.
Studies on the common cold in adults have shown a reduction in duration and severity but not the incidence of cold episodes with improved cytotoxic T and T- suppressor cell immune function.
When given in winter for at least 3 months, a combination of probiotics and vitamins and minerals reduced both the incidence and severity of common cold infections in adults with concomitant immune function improvement.
In children, a twice-daily dose of L acidophilus alone or in combination with Bifidobacterium compared with a placebo given over 6 months in winter was found to reduce:
•Antibiotic use by 68% (single strain) to 84% (strain combination);
•Absenteeism from day care due to respiratory infection by 32% (single strain) and 28% (strain combination); and
•Symptoms of cough, fever, and rhinorrhea by 28% to 60%.[38]
These observations were confirmed in another study of 571 children attending day care centers that provided cow's milk with or without Lactobacillus GG for 7 months, and found a relative reduction in:
•Incidence of respiratory infection (17% reduction);
•Antibiotic use for infection (19% reduction); and
•Absence from day care due to illness (16% or 1-day difference; P = .03).
http://www.medscape.com/viewarticle/728125_2
by Diseree lie MD
Probiotics are defined by the World Health Organization (WHO) as "live microorganisms which, when administered in adequate amounts, confer a health benefit on the host."
Probiotics are found in the gastrointestinal tract or as components of foods and beverages.
They are different from prebiotics, which are complex carbohydrates (nondigestable, fermentable polysaccharides) that stimulate the growth and/or activity of beneficial bacteria already in the colon. Prebiotics may be considered precursors to probiotics, and their role has yet to be defined in larger clinical studies.
Probiotics and prebiotics may be combined in a single product called synbiotics.
Most probiotics are either Lactobacillus or Bifidobacterium and their various species and strains (for example, Lactobacillus acidophilus and Bifidobacterium bifidus).
Other common probiotics are yeasts -- for example, Saccharomyces boulardii.
Probiotics are believed to reinforce the integrity of the intestinal lining as a protective barrier to prevent invasion by pathogenic organisms, and they are purported to prevent harmful bacteria or yeast from breaching the gastrointestinal mucosa.
They have an effect on priming immunophysiologic regulation in the intestinal mucosal barrier and may exert clinical effects beyond the nutritional value of food.
This effect is the rationale for their efficacy in preventing infectious or other forms of diarrhea and for the treatment of allergic conditions.
Formulations of Probiotics
Probiotics are available as tablets, powder, capsules and can also be mixed into beverages such as yogurt, milk, or juice.
Many different forms are offered worldwide.
Bifidobacteria appear to be safe when used orally, including in those under 2 years and ill neonates.
For example, a combination probiotic consisting of Lactobacillus, Bifidobacteria, and Streptococcus salivarius, known as VSL#3, was used in children ages 1 to 16 years for up to a year.
For preventing diarrhea in children, 5-10 billion live Lactobacillus GG have been used twice daily as tablets. Doses of 10-100 billion live organisms are available in tablet form, and capsules of 3 grams are also available.
Clinical Evidence
Diarrhea-associated illness.
There is a body of evidence supporting the benefit of probiotics in diarrhea-associated diseases. Several probiotics (Saccharomyces boulardii and a mixture of L acidophilus and B bifidum) have shown efficacy for preventing traveler's diarrhea with a relative risk (RR) reduction of 15% (RR=0.85, P < .001).[8,9]
Probiotics have also been shown to benefit antibiotic-associated and pediatric infectious diarrhea, especially rotavirus-related diarrhea. Probiotics have been used for a variety of gastrointestinal disorders as well, including these clinically successful applications for conditions related to inflammatory bowel disease:
•Lactobacillus GG to maintain remission in those with ulcerative colitis;
•S boulardii in combination with mesalamine to prevent clinical relapse of Crohn's disease (it should be noted that a Cochrane review concluded that studies to date have been too small to draw conclusions about use of probiotics for Crohn's disease prophylaxis);
•VSL#3 for prophylaxis of pouchitis and improved quality of life following ileal pouch-anal anastomosis; and
•VSL #3 for prevention of recurrent pouchitis after antibiotic-induced remission in patients with a refractory form of this condition.
Probiotics have also been found to be helpful in diarrhea-predominant irritable bowel syndrome. For example, in a meta-analysis, the odds ratio (OR) in favor of active probiotic treatment over placebo in children for diarrhea was 0.39 (P < .001) for yeast and 0.34 (P < .01) for Lactobacilli.
Similarly, probiotics offer a possible way to prevent antibiotic-associated diarrhea. A randomized study using 100g of a drink containing Lactobacillus casei, Lactobacillus bulgaricus, and Streptococcus thermophilus taken twice daily for one week after a course of antibiotics reduced the incidence of antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea.[12]
Allergic diseases. Two Cochrane reviews looking at the prevention of allergic disease and food hypersensitivity in infants found positive evidence from studies using Lactobacillus rhamnosus in favor of eczema prevention but not treatment.
A few reviews found encouraging, but not strong, effects, for several species of Lactobacilli for atopic dermatitis; these reports were based on placebo-controlled, randomized studies, using the SCORing Atopic Dermatitis (SCORAD) index for assessment, with possibly greater effects in children who have cow's milk allergy.
As noted in other reviews, a benefit was more likely to be seen for the prevention of eczema than for improvement of existing eczema. Most of the studies showing benefit were small and limited in scope. Of interest, when mothers consumed probiotics during pregnancy (starting 2 to 4 weeks before delivery), the likelihood of atopic dermatitis in the child was reduced at 2 years by about 50% in one study, and the cumulative effect on prevention was still evident at 4 years.
However, there was no effect on respiratory allergy, immunoglobulin E (IgE) levels, or allergic sensitization in these children. When infants were given probiotics in the first 6 months of life, a similar reduction in incidence of atopic eczema at 2 and 4 years was noted in these 2 studies.
Another randomized controlled trial of infants 5 months and younger, however, showed no effect of probiotic supplementation with L rhamnosus compared with placebo in the form of a hydrolyzed whey-based formula on atopic dermatitis in children when given for 3 months.
Overall, while there is a sound theoretical basis for a benefit of using probiotics for allergic disease, there is currently insufficient data to recommend it for all allergic conditions. With that said, there is more evidence supporting its use in preventing atopic dermatitis in children than for other allergic or immune conditions.
Respiratory illnesses. Studies in teenagers and adults with established respiratory disease have failed to show symptom improvement in asthma or allergic rhinitis although quality of life was improved in 1 study.
Studies on the common cold in adults have shown a reduction in duration and severity but not the incidence of cold episodes with improved cytotoxic T and T- suppressor cell immune function.
When given in winter for at least 3 months, a combination of probiotics and vitamins and minerals reduced both the incidence and severity of common cold infections in adults with concomitant immune function improvement.
In children, a twice-daily dose of L acidophilus alone or in combination with Bifidobacterium compared with a placebo given over 6 months in winter was found to reduce:
•Antibiotic use by 68% (single strain) to 84% (strain combination);
•Absenteeism from day care due to respiratory infection by 32% (single strain) and 28% (strain combination); and
•Symptoms of cough, fever, and rhinorrhea by 28% to 60%.[38]
These observations were confirmed in another study of 571 children attending day care centers that provided cow's milk with or without Lactobacillus GG for 7 months, and found a relative reduction in:
•Incidence of respiratory infection (17% reduction);
•Antibiotic use for infection (19% reduction); and
•Absence from day care due to illness (16% or 1-day difference; P = .03).
http://www.medscape.com/viewarticle/728125_2
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