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Probiotics help reduce severity of atopic dermatitis
tomography for the diagnosis of acute appendicitis. Surg Infect 2003;4: 231-9. 3. McGinn TG, Guyatt GH, Wyer PC, Naylor CD, Stiell IG, Richardson WS. Users’ guides to the medical literature XXII: how to use articles about clinical decision rules. JAMA 2000;284:79-84. 4. Wagner LM, McKinney WP, Carpenter JL. Does this patient have appendicitis? JAMA 1996;276:1589-94. 5. Andersson REB. Meta-analysis of the clinical and laboratory diagnosis of appendicitis. Br J Surg 2004;91:28-37.
Buccal midazolam is effective for acute treatment of seizures McIntyre J, Robertson S, Norris E, Appleton R, Whitehouse WP, Phillips B, et al. Lancet 2005;366:205-10 Context Seizures requiring drug treatment are a common pediatric problem. Although benzodiazepines are often used as initial therapy, there is mixed evidence regarding their effectiveness. Objectives To compare the safety and efficacy of rectal diazepam and buccal midazolam for emergency treatment of acute febrile and afebrile (epileptic) seizures in children. Design
been limited to the use of rectal diazepam; however, because some perceive rectal administration as technically difficult or socially embarrassing, acute outpatient therapy may be underused. McIntyre et al’s study of the effectiveness of buccal midazolam for emergency treatment of acute seizures adds to the publications about transmucosal benzodiazepine use. This article reports the more rapid and greater effectiveness of buccal midazolam compared with rectal diazepam in controlling seizures, although there were nonresponders who required intravenous medication. The risk of respiratory depression was not significant. This study has several clinical implications. In the hospital and emergency room settings, transmucosal benzodiazepines should be an initial choice for seizure management, because they can be rapidly administered and do not require intravenous access. For acute outpatient management of prolonged seizures, buccal midazolam is clearly a treatment option. Once issues of dosing (range, 0.2 to 0.5 mg/kg), portability, and technical aspects of drug delivery are addressed, this may become the treatment of choice for many individuals because of its safety, efficacy, ease of administration, and social acceptability.
Max Wiznitzer, MD
Multicenter, randomized controlled trial.
Division of Pediatric Neurology Rainbow Babies & Children’s Hospital Cleveland, OH 44106
Setting Emergency departments at four hospitals in the United Kingdom. Participants 177 children (219 seizure episodes) age 6 months and older (median age, 3 years), presenting to the hospital with active seizures and without intravenous access. Interventions Children were given either buccal midazolam or rectal diazepam in an age-stratified dose that provided about 0.5 mg/kg of medication. Attending staff were not blinded to treatment allocation. Main outcome measures Cessation of seizures within 10 minutes and for at least 1 hour, without respiratory depression requiring intervention. Results Therapeutic success was 56% (61 of 109) for buccal midazolam and 27% (30 of 110) for rectal diazepam (absolute risk reduction = 29%; 95% confidence interval = 16% to 41%; number needed to treat = 4). Analyzing only initial episodes revealed a similar result. The rate of respiratory depression did not differ between the two groups. When center, age, known diagnosis of epilepsy, use of antiepileptic drugs, prior treatment, and length of seizure before treatment were adjusted for using logistic regression, buccal midazolam was more effective than rectal diazepam. Conclusions Buccal midazolam was more effective than rectal diazepam for children presenting to hospital with acute seizures and was not associated with an increased incidence of respiratory depression. Comment There are several options for the acute management of status epilepticus in the United States. Well-defined emergency room and inpatient protocols use intravenous anticonvulsant medications. Outpatient management has typically
Clinical Research Abstracts For Pediatricians
Probiotics help reduce severity of atopic dermatitis Weston S, Halbert A, Richmond P, Prescott SL. Arch Dis Child 2005;90:892-7 Context Atopic dermatitis (AD) is a common problem in pediatrics. Preliminary studies have explored the use of probiotics in selected groups of young infants with mild AD. Objectives To investigate the effects of probiotics on moderate or severe AD in young children. Design
Randomized, double-blind, placebo-controlled trial.
Setting
Perth, Western Australia.
Participants 56 children age 6 to 18 months with moderate or severe AD were recruited; 53 children completed the study. Interventions The children were given a probiotic (16109 Lactobacillus fermentum VRI-033 PCC; Probiomics) or an equivalent volume of placebo, twice daily for 8 weeks. A final assessment was performed after 16 weeks. Main outcome measures Severity and extent of AD at the end of the study, as measured by the Severity Scoring of Atopic Dermatitis (SCORAD) index. Results The reduction in the SCORAD index over time was significant in the probiotic group (P = .03), but not in the placebo group. Significantly more children receiving probiotics had a SCORAD index better than baseline at week 16 compared with the placebo group (92% vs 63%; P = .01; number needed to treat [NNT] = 4). At the completion of the study, 54% of the children in
143
the probiotic group had mild AD, compared with 30% in the placebo group (P = .066, NNT = 5). Conclusion Supplementation with the probiotic L. fermentum VRI-003 PCC is beneficial in improving the extent and severity of AD in young children with moderate or severe disease. Comment This study by Weston et al is an interesting one. The authors hypothesize that the use of probiotics can improve AD in children. The premise of the study fits with the ‘‘hygiene hypothesis,’’ which posits that normal human immunologic development may be affected by changes in colonic flora and progressively cleaner environments.1 This is a valid and well-executed study. Although the number of participants was small, the two groups were similar at baseline, with most (88%) already using topical corticosteroids. The authors did find an improvement in their main outcome measure; the probiotics reduced the severity of AD over a 16-week treatment period. Interestingly, the effect was sustained for 8 weeks after the treatment was stopped. The small study group may have limited the power to detect differences in some of the secondary outcomes. Specifically, there were no differences in quality of life scores (both groups showed improvement over time) or parental perceptions about disease severity. There were also no differences in the numbers of children using corticosteroids or needing supplemental antibiotics. If the initial results found in this study can be replicated in larger numbers, in more centers, and with older children, then probiotics may become an inexpensive, effective adjunct to other treatments for AD.
Kelly McClean, MD Department of Dermatology University of Michigan Ann Arbor, MI 48109
REFERENCE 1. Murch SH. Probiotics as mainstream allergy therapy? Arch Dis Child 2005;90:881-2.
Tympanostomy tubes do not improve developmental outcomes Paradise JL, Campbell TF, Dollaghan CA, Feldman HM, Bernard BS, Colborn DK, et al. N Engl J Med 2005;35:576-86 Context To prevent later developmental impairments, myringotomy with the insertion of tympanostomy tubes has often been undertaken in young children who have persistent otitis media with effusion. These authors previously reported that prompt versus delayed insertion of tympanostomy tubes in children under age 3 years with persistent effusion did not result in improved developmental outcomes at age 3 or 4 years. Objectives To examine the effect of prompt versus delayed insertion of tympanostomy tubes in children under age 3 years on outcomes at school age. Design
Randomized controlled trial.
Setting Eight sites around Pittsburgh, PA, including hospital and private (both suburban and rural) practices.
144
Clinical Research Abstracts For Pediatricians
Participants Of 6350 healthy infants younger than 62 days of age who were evaluated regularly for middle-ear effusion, 429 children with persistent middle-ear effusion were randomly assigned to have tympanostomy tubes inserted either promptly or up to 9 months later if effusion persisted. The present study includes 395 of these children evaluated at age 6 years. Main outcome measures Cognitive, language, speech, and psychosocial development were assessed using formal tests, conversational samples, and parental questionnaires. Results At age 6 years, 85% of children in the early-treatment group and 41% of those in the delayed-treatment group had received tympanostomy tubes. There were no significant differences in mean ( ± standard deviation) scores favoring early versus delayed treatment on any of 30 measures, including the Wechsler Full-Scale Intelligence Quotient (98 ± 13 vs 98 ± 14); Number of Different Words test, a measure of word diversity (183 ± 36 vs 175 ± 36); Percentage of Consonants Correct– Revised test, a measure of speech sound production (96 ± 2 vs 96 ± 3); the SCAN test, a measure of central auditory processing (95 ± 15 vs 96 ± 14); and several measures of behavior and emotion. Conclusions In otherwise healthy children under age 3 years who have persistent middle-ear effusion within the duration of effusion studied, prompt insertion of tympanostomy tubes does not improve developmental outcomes at age 6 years. Comment This study reports the 6-year follow-up of children from a previously published randomized controlled trial. A total of 429 children with persistent ear effusions were randomized to receive immediate tympanostomy tube placement or to have this procedure delayed for 6 to 9 months. The outcomes studied were hearing and a battery of language and intelligence tests, all performed by personnel blinded to the patients’ group assignment with good interobserver reliability (94%). Power was good, intention to treat was followed, baseline characteristics were equal, and follow-up was 92% at 6 years. No differences in any of the outcomes were found. Unfortunately, only 28% of those in the immediate tube placement group received tubes within 30 days of randomization, and 10% of those in the delayed tube placement group received tubes within 6 months of randomization, leading to significant crossover and possible dilution of any treatment effect. So should tubes be placed at all? The authors attempted to answer this question by following a second cohort of children who had persistent ear effusions but did not meet eligibility criteria. No association was found between the degree and duration of the middle ear effusion and any of the hearing or language outcomes. The results of this study provide support to counsel parents that placement of tympanostomy tubes can be delayed for at least 9 to 12 months, in the absence of significant hearing loss or structural eardrum abnormalities.
Brett Robbins, MD Departments of Pediatrics and Internal Medicine University of Rochester Rochester, NY 14642
The Journal of Pediatrics January 2006
Buccal midazolam is effective for acute treatment of seizures McIntyre J, Robertson S, Norris E, Appleton R, Whitehouse WP, Phillips B, et al. Lancet 2005;366:205-10 Context Seizures requiring drug treatment are a common pediatric problem. Although benzodiazepines are often used as initial therapy, there is mixed evidence regarding their effectiveness. Objectives To compare the safety and efficacy of rectal diazepam and buccal midazolam for emergency treatment of acute febrile and afebrile (epileptic) seizures in children. Design
been limited to the use of rectal diazepam; however, because some perceive rectal administration as technically difficult or socially embarrassing, acute outpatient therapy may be underused. McIntyre et al’s study of the effectiveness of buccal midazolam for emergency treatment of acute seizures adds to the publications about transmucosal benzodiazepine use. This article reports the more rapid and greater effectiveness of buccal midazolam compared with rectal diazepam in controlling seizures, although there were nonresponders who required intravenous medication. The risk of respiratory depression was not significant. This study has several clinical implications. In the hospital and emergency room settings, transmucosal benzodiazepines should be an initial choice for seizure management, because they can be rapidly administered and do not require intravenous access. For acute outpatient management of prolonged seizures, buccal midazolam is clearly a treatment option. Once issues of dosing (range, 0.2 to 0.5 mg/kg), portability, and technical aspects of drug delivery are addressed, this may become the treatment of choice for many individuals because of its safety, efficacy, ease of administration, and social acceptability.
Max Wiznitzer, MD
Multicenter, randomized controlled trial.
Division of Pediatric Neurology Rainbow Babies & Children’s Hospital Cleveland, OH 44106
Setting Emergency departments at four hospitals in the United Kingdom. Participants 177 children (219 seizure episodes) age 6 months and older (median age, 3 years), presenting to the hospital with active seizures and without intravenous access. Interventions Children were given either buccal midazolam or rectal diazepam in an age-stratified dose that provided about 0.5 mg/kg of medication. Attending staff were not blinded to treatment allocation. Main outcome measures Cessation of seizures within 10 minutes and for at least 1 hour, without respiratory depression requiring intervention. Results Therapeutic success was 56% (61 of 109) for buccal midazolam and 27% (30 of 110) for rectal diazepam (absolute risk reduction = 29%; 95% confidence interval = 16% to 41%; number needed to treat = 4). Analyzing only initial episodes revealed a similar result. The rate of respiratory depression did not differ between the two groups. When center, age, known diagnosis of epilepsy, use of antiepileptic drugs, prior treatment, and length of seizure before treatment were adjusted for using logistic regression, buccal midazolam was more effective than rectal diazepam. Conclusions Buccal midazolam was more effective than rectal diazepam for children presenting to hospital with acute seizures and was not associated with an increased incidence of respiratory depression. Comment There are several options for the acute management of status epilepticus in the United States. Well-defined emergency room and inpatient protocols use intravenous anticonvulsant medications. Outpatient management has typically
Clinical Research Abstracts For Pediatricians
Probiotics help reduce severity of atopic dermatitis Weston S, Halbert A, Richmond P, Prescott SL. Arch Dis Child 2005;90:892-7 Context Atopic dermatitis (AD) is a common problem in pediatrics. Preliminary studies have explored the use of probiotics in selected groups of young infants with mild AD. Objectives To investigate the effects of probiotics on moderate or severe AD in young children. Design
Randomized, double-blind, placebo-controlled trial.
Setting
Perth, Western Australia.
Participants 56 children age 6 to 18 months with moderate or severe AD were recruited; 53 children completed the study. Interventions The children were given a probiotic (16109 Lactobacillus fermentum VRI-033 PCC; Probiomics) or an equivalent volume of placebo, twice daily for 8 weeks. A final assessment was performed after 16 weeks. Main outcome measures Severity and extent of AD at the end of the study, as measured by the Severity Scoring of Atopic Dermatitis (SCORAD) index. Results The reduction in the SCORAD index over time was significant in the probiotic group (P = .03), but not in the placebo group. Significantly more children receiving probiotics had a SCORAD index better than baseline at week 16 compared with the placebo group (92% vs 63%; P = .01; number needed to treat [NNT] = 4). At the completion of the study, 54% of the children in
143
the probiotic group had mild AD, compared with 30% in the placebo group (P = .066, NNT = 5). Conclusion Supplementation with the probiotic L. fermentum VRI-003 PCC is beneficial in improving the extent and severity of AD in young children with moderate or severe disease. Comment This study by Weston et al is an interesting one. The authors hypothesize that the use of probiotics can improve AD in children. The premise of the study fits with the ‘‘hygiene hypothesis,’’ which posits that normal human immunologic development may be affected by changes in colonic flora and progressively cleaner environments.1 This is a valid and well-executed study. Although the number of participants was small, the two groups were similar at baseline, with most (88%) already using topical corticosteroids. The authors did find an improvement in their main outcome measure; the probiotics reduced the severity of AD over a 16-week treatment period. Interestingly, the effect was sustained for 8 weeks after the treatment was stopped. The small study group may have limited the power to detect differences in some of the secondary outcomes. Specifically, there were no differences in quality of life scores (both groups showed improvement over time) or parental perceptions about disease severity. There were also no differences in the numbers of children using corticosteroids or needing supplemental antibiotics. If the initial results found in this study can be replicated in larger numbers, in more centers, and with older children, then probiotics may become an inexpensive, effective adjunct to other treatments for AD.
Kelly McClean, MD Department of Dermatology University of Michigan Ann Arbor, MI 48109
REFERENCE 1. Murch SH. Probiotics as mainstream allergy therapy? Arch Dis Child 2005;90:881-2.
Tympanostomy tubes do not improve developmental outcomes Paradise JL, Campbell TF, Dollaghan CA, Feldman HM, Bernard BS, Colborn DK, et al. N Engl J Med 2005;35:576-86 Context To prevent later developmental impairments, myringotomy with the insertion of tympanostomy tubes has often been undertaken in young children who have persistent otitis media with effusion. These authors previously reported that prompt versus delayed insertion of tympanostomy tubes in children under age 3 years with persistent effusion did not result in improved developmental outcomes at age 3 or 4 years. Objectives To examine the effect of prompt versus delayed insertion of tympanostomy tubes in children under age 3 years on outcomes at school age. Design
Randomized controlled trial.
Setting Eight sites around Pittsburgh, PA, including hospital and private (both suburban and rural) practices.
144
Clinical Research Abstracts For Pediatricians
Participants Of 6350 healthy infants younger than 62 days of age who were evaluated regularly for middle-ear effusion, 429 children with persistent middle-ear effusion were randomly assigned to have tympanostomy tubes inserted either promptly or up to 9 months later if effusion persisted. The present study includes 395 of these children evaluated at age 6 years. Main outcome measures Cognitive, language, speech, and psychosocial development were assessed using formal tests, conversational samples, and parental questionnaires. Results At age 6 years, 85% of children in the early-treatment group and 41% of those in the delayed-treatment group had received tympanostomy tubes. There were no significant differences in mean ( ± standard deviation) scores favoring early versus delayed treatment on any of 30 measures, including the Wechsler Full-Scale Intelligence Quotient (98 ± 13 vs 98 ± 14); Number of Different Words test, a measure of word diversity (183 ± 36 vs 175 ± 36); Percentage of Consonants Correct– Revised test, a measure of speech sound production (96 ± 2 vs 96 ± 3); the SCAN test, a measure of central auditory processing (95 ± 15 vs 96 ± 14); and several measures of behavior and emotion. Conclusions In otherwise healthy children under age 3 years who have persistent middle-ear effusion within the duration of effusion studied, prompt insertion of tympanostomy tubes does not improve developmental outcomes at age 6 years. Comment This study reports the 6-year follow-up of children from a previously published randomized controlled trial. A total of 429 children with persistent ear effusions were randomized to receive immediate tympanostomy tube placement or to have this procedure delayed for 6 to 9 months. The outcomes studied were hearing and a battery of language and intelligence tests, all performed by personnel blinded to the patients’ group assignment with good interobserver reliability (94%). Power was good, intention to treat was followed, baseline characteristics were equal, and follow-up was 92% at 6 years. No differences in any of the outcomes were found. Unfortunately, only 28% of those in the immediate tube placement group received tubes within 30 days of randomization, and 10% of those in the delayed tube placement group received tubes within 6 months of randomization, leading to significant crossover and possible dilution of any treatment effect. So should tubes be placed at all? The authors attempted to answer this question by following a second cohort of children who had persistent ear effusions but did not meet eligibility criteria. No association was found between the degree and duration of the middle ear effusion and any of the hearing or language outcomes. The results of this study provide support to counsel parents that placement of tympanostomy tubes can be delayed for at least 9 to 12 months, in the absence of significant hearing loss or structural eardrum abnormalities.
Brett Robbins, MD Departments of Pediatrics and Internal Medicine University of Rochester Rochester, NY 14642
The Journal of Pediatrics January 2006