Drugs for the acute treatment of migraine in children and adolescents.

BACKGROUND: Numerous medications are available for the acute treatment of migraine in adults, and some have now been approved for use in children and adolescents in the ambulatory setting. A systematic review of acute treatment of migraine medication trials in children and adolescents will help clinicians make evidence-informed management choices. OBJECTIVES: To assess the effects of pharmacological interventions by any route of administration versus placebo for migraine in children and adolescents 17 years of age or less. For the purposes of this review, children were defined as under 12 years of age and adolescents 12 to 17 years of age. SEARCH METHODS: We searched seven bibliographic databases and four clinical trial registers as well as gray literature for studies through February 2016. SELECTION CRITERIA: We included prospective randomized controlled clinical trials of children and adolescents with migraine, comparing acute symptom relieving migraine medications with placebo in the ambulatory setting. DATA COLLECTION AND ANALYSIS: Two reviewers screened titles and abstracts and reviewed the full text of potentially eligible studies. Two independent reviewers extracted data for studies meeting inclusion criteria. We calculated the risk ratios (RRs) and number needed to treat for an additional beneficial outcome (NNTB) for dichotomous data. We calculated the risk difference (RD) and number needed to treat for an additional harmful outcome (NNTH) for proportions of adverse events. The percentage of pain-free patients at two hours was the primary efficacy outcome measure. We used adverse events to evaluate safety and tolerability. Secondary outcome measures included headache relief, use of rescue medication, headache recurrence, presence of nausea, and presence of vomiting. We assessed the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) and created 'Summary of findings' tables. MAIN RESULTS: We identified a total of 27 randomized controlled trials (RCTs) of migraine symptom-relieving medications, in which 9158 children and adolescents were enrolled and 7630 (range of mean age between 8.2 and 14.7 years) received medication. Twenty-four studies focused on drugs in the triptan class, including almotriptan, eletriptan, naratriptan, rizatriptan, sumatriptan, sumatriptan + naproxen sodium, and zolmitriptan. Other medications studied included paracetamol (acetaminophen), ibuprofen, and dihydroergotamine (DHE). More than half of the studies evaluated sumatriptan. All but one study reported adverse event data. Most studies presented a low or unclear risk of bias, and the overall quality of evidence, according to GRADE criteria, was low to moderate, downgraded mostly due to imprecision and inconsistency. Ibuprofen was more effective than placebo for producing pain freedom at two hours in two small studies that included 162 children (RR 1.87, 95% confidence interval (CI) 1.15 to 3.04) with low quality evidence (due to imprecision). Paracetamol was not superior to placebo in one small study of 80 children. Triptans as a class of medication were superior to placebo in producing pain freedom in 3 studies involving 273 children (RR 1.67, 95% CI 1.06 to 2.62, NNTB 13) (moderate quality evidence) and 21 studies involving 7026 adolescents (RR 1.32, 95% CI 1.19 to 1.47, NNTB 6) (moderate quality evidence). There was no significant difference in the effect sizes between studies involving children versus adolescents. Triptans were associated with an increased risk of minor (non-serious) adverse events in adolescents (RD 0.13, 95% CI 0.08 to 0.18, NNTH 8), but studies did not report any serious adverse events. The risk of minor adverse events was not significant in children (RD 0.06, 95% CI - 0.04 to 0.17, NNTH 17). Sumatriptan plus naproxen sodium was superior to placebo in one study involving 490 adolescents (RR 3.25, 95% CI 1.78 to 5.94, NNTB 6) (moderate quality evidence). Oral dihydroergotamine was not superior to placebo in one small study involving 13 children. AUTHORS' CONCLUSIONS: Low quality evidence from two small trials shows that ibuprofen appears to improve pain freedom for the acute treatment of children with migraine. We have only limited information on adverse events associated with ibuprofen in the trials included in this review. Triptans as a class are also effective at providing pain freedom in children and adolescents but are associated with higher rates of minor adverse events. Sumatriptan plus naproxen sodium is also effective in treating adolescents with migraine.

A systematic review of the evidence for pharmacist care of patients with dyslipidemia.

STUDY OBJECTIVE: To evaluate the effect of pharmacist care on patients with dyslipidemia. DESIGN: Systematic review of 21 randomized controlled trials. PATIENTS: A total of 5416 patients who received enhanced pharmacist care or standard care as part of a research study. MEASUREMENTS AND MAIN RESULTS: Nineteen databases and four trial registries were systematically searched from inception through February 21, 2010, with an update in September 2011. In addition, Web sites of relevant professional associations, scientific meetings, and research groups were reviewed, and manual searches of select journals were performed. A total of 8771 articles were identified, and 21 studies included. Data from the studies were analyzed using a random-effects model. The primary outcome measure assessed was the difference between the groups (pharmacist intervention vs standard care) in low-density lipoprotein cholesterol (LDL) level at the end of follow-up. Secondary outcome measures included the difference between the groups at the end of follow-up in total cholesterol, high-density lipoprotein cholesterol, and triglyceride levels; and the proportion of patients who achieved target lipid parameters, underwent lipid panel measurements, adhered to therapy, and/or were instructed to change their lipid-lowering therapy. At the end of follow-up, the mean LDL level was 10.7 mg/dl lower in the enhanced pharmacy care groups compared with the standard care groups (95% confidence interval [CI] -16.9 to -4.6 mg/dl), with moderate heterogeneity. The mean total cholesterol level was significantly lower in the enhanced pharmacy care groups compared with the standard care groups; however, these results were highly heterogeneous. Patients who received enhanced pharmacist care were also more likely than those receiving standard care to achieve target lipid parameters (odds ratio [OR] 2.46, 95% CI 1.43-4.25) and to have a lipid panel ordered or recommended by a pharmacist during the study (OR 2.05, 95% CI 1.30-3.24). Patients in the pharmacist intervention groups were almost twice as likely as patients in the standard care groups to have a change in lipid-lowering therapy (OR 1.82, 95% CI 1.09-3.06). Adherence data could not be analyzed. CONCLUSION: This systematic review showed that enhanced pharmacist care improves lipid parameters, notably LDL levels, in patients with dyslipidemia. These results point to the benefit that pharmacist care can provide across the spectrum of dyslipidemia management, from screening patients to treating them to assisting them in the attainment of clinical targets.

Nebulized epinephrine for croup in children.

BACKGROUND: Croup is a common childhood illness characterized by barky cough, stridor, hoarseness and respiratory distress. Children with severe croup are at risk for intubation. Nebulized epinephrine (NE) may prevent intubation. OBJECTIVES: To evaluate the efficacy and safety of NE in children presenting to emergency department (ED) or admitted to hospital with croup. SEARCH STRATEGY: We searched CENTRAL (The Cochrane Library 2010, Issue 4), containing the Cochrane Acute Respiratory Infections Group's Specialized Register, MEDLINE (1966 to November Week 1, 2010), EMBASE (1980 to November 2010), Web of Science (1974 to November 2010), CINAHL (1982 to November 2010) and Scopus (1996 to November 2010). SELECTION CRITERIA: Randomized controlled trials (RCTs) or quasi-RCTs of children with croup evaluated in an ED or admitted to hospital. Comparisons were: NE versus placebo, racemic NE versus L-epinephrine (an isomer), and NE delivered by intermittent positive pressure breathing (IPPB) versus NE without IPPB. Primary outcome was change in croup score post-treatment. Secondary outcomes were rate and duration of intubation and hospitalization, croup return visit, parental anxiety and side effects. DATA COLLECTION AND ANALYSIS: Two authors independently identified potentially relevant studies by title and abstract (when available) and examined relevant studies using a priori inclusion criteria, followed by methodologic quality assessment. One author extracted data while the second checked accuracy. We performed standard statistical analyses. MAIN RESULTS: Eight studies (225 participants) were included. NE was associated with croup score improvement 30 minutes post-treatment (three RCTs, standardized mean difference (SMD) -0.94; 95% confidence interval (CI) -1.37 to -0.51; I(2) statistic = 0%). This effect was not significant two and six hours post-treatment. NE was associated with significantly shorter hospital stay than placebo (one RCT, mean difference -32.0 hours; 95% CI -59.1 to -4.9). Comparing racemic and L-epinephrine, no difference in croup score was found after 30 minutes (SMD 0.33; 95% CI -0.42 to 1.08). After two hours, L-epinephrine showed significant reduction compared with racemic epinephrine (one RCT, SMD 0.87; 95% CI 0.09 to 1.65). There was no significant difference in croup score between administration of NE via IPPB versus nebulization alone at 30 minutes (one RCT, SMD -0.14; 95% CI -1.24 to 0.95) or two hours (SMD -0.72; 95% CI -1.86 to 0.42). AUTHORS' CONCLUSIONS: NE is associated with clinically and statistically significant transient reduction of symptoms of croup 30 minutes post-treatment. Evidence does not favor racemic epinephrine or LE, or IPPB over simple nebulization. 

North American (Panax quinquefolius) and Asian Ginseng (Panax ginseng) Preparations for Prevention of the Common Cold in Healthy Adults: A Systematic Review.

BACKGROUND: Standardized ginseng extract has become the best-selling cold and flu remedy in Canada, yet much controversy regarding the efficacy of ginseng in preventing common colds remains. OBJECTIVE: To assess the efficacy of ginseng preparations for the prevention of common colds in healthy adults. METHODS: Comprehensive bibliographic database, trial registry and grey literature searches were conducted up to December 2007. Randomized controlled trials or controlled clinical trials comparing North American (Panax quinquefolius) or Asian ginseng (Panax ginseng) root extract to placebo or no treatment in healthy adults were included. Two reviewers independently applied the study selection criteria and assessed methodological quality. RESULTS: Five trials involving 747 participants were included. All five trials examined North American ginseng. The methodological quality of the trials varied widely. Ginseng preparations significantly reduced the total number of common colds by 25% compared to placebo (one trial; 95% CI: 5-45). There was a tendency toward a lower incidence of having at least one common cold or other acute respiratory infection (ARI) in the ginseng group compared to the placebo group (five trials; relative risk: 0.70; 95% CI: 0.48-1.02). Compared to placebo, ginseng significantly shortened the duration of colds or ARIs by 6.2 days (two trials; 95% CI: 3.4-9.0). CONCLUSIONS: There is insufficient evidence to conclude that ginseng reduces the incidence or severity of common colds. North American ginseng appears to be effective in shortening the duration of colds or ARIs in healthy adults when taken preventatively for durations of 8-16 weeks.

A systematic review on the diagnosis of pediatric bacterial pneumonia: when gold is bronze.

BACKGROUND: In developing countries, pneumonia is one of the leading causes of death in children under five years of age and hence timely and accurate diagnosis is critical. In North America, pneumonia is also a common source of childhood morbidity and occasionally mortality. Clinicians traditionally have used the chest radiograph as the gold standard in the diagnosis of pneumonia, but they are becoming increasingly aware that it is not ideal. Numerous studies have shown that chest radiography findings lack precision in defining the etiology of childhood pneumonia. There is no single test that reliably distinguishes bacterial from non-bacterial causes. These factors have resulted in clinicians historically using a combination of physical signs and chest radiographs as a 'gold standard', though this combination of tests has been shown to be imperfect for diagnosis and assigning treatment. The objectives of this systematic review are to: 1) identify and categorize studies that have used single or multiple tests as a gold standard for assessing accuracy of other tests, and 2) given the 'gold standard' used, determine the accuracy of these other tests for diagnosing childhood bacterial pneumonia. METHODS AND FINDINGS: Search strategies were developed using a combination of subject headings and keywords adapted for 18 electronic bibliographic databases from inception to May 2008. Published studies were included if they: 1) included children one month to 18 years of age, 2) provided sufficient data regarding diagnostic accuracy to construct a 2x2 table, and 3) assessed the accuracy of one or more index tests as compared with other test(s) used as a 'gold standard'. The literature search revealed 5,989 references of which 256 were screened for inclusion, resulting in 25 studies that satisfied all inclusion criteria. The studies examined a range of bacterium types and assessed the accuracy of several combinations of diagnostic tests. Eleven different gold standards were studied in the 25 included studies. Criterion validity was calculated for fourteen different index tests using eleven different gold standards. The most common gold standard utilized was blood culture tests used in six studies. Fourteen different tests were measured as index tests. PCT was the most common measured in five studies each with a different gold standard. CONCLUSIONS: We have found that studies assessing the diagnostic accuracy of clinical, radiological, and laboratory tests for bacterial childhood pneumonia have used a heterogeneous group of gold standards, and found, at least in part because of this, that index tests have widely different accuracies. These findings highlight the need for identifying a widely accepted gold standard for diagnosis of bacterial pneumonia in children.

Tissue adhesives for traumatic lacerations in children and adults

Article available on Cochrane Library about lacerations healing using tissue adhesives.

Systematic reviews of pharmacy practice research: methodologic issues in searching, evaluating, interpreting, and disseminating results.

Although there has been a large number of trials on pharmacist care, often demonstrating clinically significant benefits, the trials generally have not changed practice or healthcare policy. What is needed are focused evidence syntheses, such as a systematic review. A systematic review is defined as a summary that addresses a focused clinical question, using methods to reduce the likelihood of bias. These reviews, which are the highest level of evidence, can help to impact policy by bringing together results of various trials. However, systematic reviews of practice research pose some unique methodologic challenges, including issues with searching, interpreting, and evaluating the available research. Well-conducted systematic reviews of pharmacist interventions could go a long way toward changing pharmacy practice and healthcare policy to recognize the important impact that pharmacists could have in the healthcare system.

Risk factors for methamphetamine use in youth: a systematic review.

BACKGROUND: Methamphetamine (MA) is a potent stimulant that is readily available. Its effects are similar to cocaine, but the drug has a profile associated with increased acute and chronic toxicities. The objective of this systematic review was to identify and synthesize literature on risk factors that are associated with MA use among youth.More than 40 electronic databases, websites, and key journals/meeting abstracts were searched. We included studies that compared children and adolescents (< or = 18 years) who used MA to those who did not. One reviewer extracted the data and a second checked for completeness and accuracy. For discrete risk factors, odds ratios (OR) were calculated and when appropriate, a pooled OR with 95% confidence intervals (95% CI) was calculated. For continuous risk factors, mean difference and 95% CI were calculated and when appropriate, a weighted mean difference (WMD) and 95% CI was calculated. Results were presented separately by comparison group: low-risk (no previous drug abuse) and high-risk children (reported previous drug abuse or were recruited from a juvenile detention center). RESULTS: Twelve studies were included. Among low-risk youth, factors associated with MA use were: history of heroin/opiate use (OR = 29.3; 95% CI: 9.8-87.8), family history of drug use (OR = 4.7; 95% CI: 2.8-7.9), risky sexual behavior (OR = 2.79; 95% CI: 2.25, 3.46) and some psychiatric disorders. History of alcohol use and smoking were also significantly associated with MA use. Among high-risk youth, factors associated with MA use were: family history of crime (OR = 2.0; 95% CI: 1.2-3.3), family history of drug use (OR = 4.7; 95% CI: 2.8-7.9), family history of alcohol abuse (OR = 3.2; 95% CI: 1.8-5.6), and psychiatric treatment (OR = 6.8; 95% CI: 3.6-12.9). Female sex was also significantly associated with MA use. CONCLUSION: Among low-risk youth, a history of engaging in a variety of risky behaviors was significantly associated with MA use. A history of a psychiatric disorder was a risk factor for MA for both low- and high-risk youth. Family environment was also associated with MA use. Many of the included studies were cross-sectional making it difficult to assess causation. Future research should utilize prospective study designs so that temporal relationships between risk factors and MA use can be established.

Diabetes education for children with type 1 diabetes mellitus and their families.

OBJECTIVES: To determine the effectiveness of diabetes education on metabolic control, diabetes-related hospitalizations, complications, and knowledge, quality of life and other psychosocial outcomes for children with type 1 diabetes and their families. DATA SOURCES: A systematic and comprehensive literature review was conducted in 21 electronic databases of medical and health education literature to identify randomized controlled trials (RCTs) and observational studies evaluating the effectiveness of diabetes education. REVIEW METHODS: Study selection, quality assessment, and data extraction were conducted independently by several investigators in duplicate. A descriptive analysis is presented. RESULTS: From 12,756 citations, 80 studies were identified and included in the review (53 RCTs or CCTs, 27 observational studies). The methodological quality of studies was generally low. Most studies (35/52) that examined the effect of educational interventions on HbA1c found no evidence of increased effectiveness of the interventions over the education provided as part of standard care. Successful interventions were heterogeneous and included cognitive behavioral therapy, family therapy, skills training and general diabetes education. Most studies reported a positive effect on health service utilization (i.e., reduced use), although less than half were statistically significant. There was no clear evidence that educational interventions had an effect on short-term complications. The effect of educational interventions on diabetes knowledge was unclear with 12/30 studies reporting a significant improvement. Interventions which had varying effects on knowledge scores included diabetes camp, general diabetes education, and cognitive behavioral therapy. In the area of self management/regimen adherence, 10/21 studies reported improving this outcome significantly. Successful interventions included general diabetes education and cognitive behavioral therapy. Educational interventions were successful in improving various psychosocial outcomes. The results of two studies examining refinements to intensive therapy education suggest that educational interventions may enhance the effects of intensive diabetes management in reducing HbA1c. CONCLUSIONS Due to the heterogeneity of reported diabetes education interventions, outcome measures, and duration of followup, there is insufficient evidence to identify a particular intervention that is more effective than standard care to improve diabetes control or quality of life or to reduce short-term complications.