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Ondansetron is effective for gastroenteritis with vomiting in children

Clinical question Is ondansetron (Zofran) safe and effective for dehydrated children with gastroenteritis?

Bottom line Ondansetron given to children who are mildly to moderately dehydrated because of diarrhea and vomiting improves their ability to comply with oral rehydration and reduces the need for intravenous hydration. (Level of evidence = 1b)

Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006;354:1698-1705.

Synopsis Although oral rehydration is the treatment of choice for children with gastroenteritis, it can be a challenge when the child can’t keep anything down. This leads to overuse of intravenous hydration, particularly given the time pressures in the emergency department (ED). These authors considered any mildly to moderately dehydrated child who had had at least one episode of diarrhea and one episode of vomiting in the previous 4 hours for their study. Those with a body weight of less than 8 kg (17.6 pounds), those who were severely dehydrated using standardized symptoms (eg, clammy or cool skin, very dry mucosa, no tears, moderate tachycardia, no urine for at least 6 hours, limp, and lethargic) and those with significant comorbidities were excluded. Of the 243 children asked to enroll, 215 randomly received ondansetron or placebo (allocation concealed). The dose of ondansetron was 2 mg for children who weighed between 8 kg and 15 kg, 4 mg for those who weighed 15 kg to 30 kg, and 8 mg for those who weighed more than 30 kg. The dose was repeated if the child vomited within 15 minutes of administration. The mean age was 28 months; 57% were male; they had a mean of nine episodes of vomiting and six episodes of diarrhea in the previous 24 hours. Groups were similar at baseline, and analysis was by intention to treat. Children receiving ondansetron were less likely to vomit while being given liquids (14% vs 35%; P = .001; number needed to treat [NNT] = 5), had fewer vomiting episodes (0.18 vs 0.65; P <.001), and were less likely to require intravenous rehydration (14% vs 31%; P = .003; NNT = 5). There was no difference in the number of children requiring hospitalization or the percentage returning to the ED. The drug was well tolerated, although there was a mean of 0.9 additional episodes of diarrhea for those children who received ondansetron.

Naltrexone and behavioral interventions reduce alcohol dependence equally

Clinical question What interventions are most effective in the treatment of alcohol dependence?

Bottom line Naltrexone and specialist-delivered combined behavioral intervention (CBI) are equally effective in the short-term (16-week) treatment of alcohol dependence. This study found no evidence of efficacy for acamprosate alone or evidence of incremental efficacy for combinations of naltrexone, acamprosate, and CBI. The beneficial effects of naltrexone and CBI compared with the other interventions were no longer significantly different after 1 year. Primary care clinicians wishing to help patients with alcohol dependence can expect equal short-term success by prescribing naltrexone or by referring for specialty intervention. (Level of evidence = 1b)

Anton RF, O’Malley SS, Ciraulo DA, et al, for the COMBINE Study Research Group. Combined pharmacotherapies and behavioral interventions for alcohol dependence. The COMBINE study: A randomized controlled trial. JAMA. 2006;295:2003-2017.

Synopsis Behavioral interventions and at least two medications—naltrexone and acamprosate—are effective in the treatment of alcohol dependence. Whether combining pharmacotherapy with behavioral therapy will improve outcomes is unknown. These investigators randomly assigned (concealed allocation) 1,383 adults (428 women and 955 men; median age, 44 years) meeting DSM-IV criteria for alcohol dependence into nine groups for 16 weeks of outpatient treatment. Eight of the groups received medical management (MM), a nine-session intervention lasting 20 minutes to 45 minutes that focused on medication compliance and abstinence. Four of these groups also received CBI consisting of up to 20 50-minute sessions with an alcohol-treatment specialist. Patients in all eight groups received either naltrexone, acamprosate, placebo, or acamprosate plus naltrexone. Naltrexone was given once per day, beginning with 25 mg and titrated to 100 mg, as tolerated. Acamprosate was administered as 1,000 mg 3 times per day. The ninth group received CBI alone without medications or MM. All subjects were assessed regularly for up to 1 year after enrollment. Individuals assessing outcomes were blinded to patients’ group assignment. Follow-up occurred for 94% of patients at 16 weeks and for 82% at 1 year. Serum transferrin protein levels (percent carbohydrate-deficient transferrin [%CDT]) served as a veracity check for self-reported drinking. All analyses were by intention to treat. During treatment, patients receiving naltrexone plus MM, CBI plus MM, or both naltrexone and CBI plus MM had a significantly higher percent of abstinent days than those receiving placebo or MM only (77% to 81% vs 75%). Naltrexone also significantly reduced the risk of heavy drinking days. Therapy with naltrexone plus CBI was not significantly better than that with naltrexone or CBI alone. There were no significant differences found in any outcomes for acamprosate compared with placebo. At 1 year of follow-up, however, there were no longer any significant differences between the groups in any of the outcomes measured.

Outcomes are not improved by early initiation of statins following ACS

Clinical question Does early initiation of statin therapy following the onset of acute coronary syndromes (ACS) reduce the short-term risk of death, recurrent MI, or stroke?

Bottom line Initiation of statin therapy within 14 days of the onset of ACS does not reduce the risk of death, recurrent MI, or stroke at up to 4 months. (Level of evidence = 1a)

Briel M, Schwartz GG, Thompson PL, et al. Effects of early treatment with statins on short-term clinical outcomes in acute coronary syndromes. A meta-analysis of randomized controlled trials. JAMA. 2006;295:2046-2056.

Synopsis During the initial period following the onset of ACS, the risk is high for recurrent events and death due to vessel occlusions from vulnerable coronary plaques. To study the efficacy of statins in reducing the short-term risk of adverse clinical outcomes, these investigators thoroughly searched (without any language restrictions) electronic databases, including the Cochrane Registry, reference lists of identified articles, recently published editorials, and topical reviews, and contacted authors of significant publications. Eligible trials met the following criteria: Randomized trial design comparing statin treatment with usual care; initiation of treatment within 14 days of onset of ACS; and follow-up for at least 30 days. Two authors independently assessed trial eligibility and quality. Twelve studies, comprising 13,024 individuals with mean ages ranging from 53 to 69 years, met inclusion criteria. Early statin therapy did not significantly reduce the risk of death, MI, or stroke at either 1 or 4 months following ACS. In addition, there were no significant risk reductions for secondary outcomes including total death, total MI, total stroke, cardiovascular death, fatal or nonfatal MI, or revascularization procedures. The authors found similar results among all the trials. A formal analysis found little evidence of publication bias.

Levels of evidence are explained at http://www.infopoems.com/levels.html.