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PubMed2006

Ad libitum or demand/semi-demand feeding versus scheduled interval feeding for preterm infants.

BACKGROUND: Feeding preterm infants in response to their hunger and satiation cues (ad libitum or demand/semi demand) rather than at scheduled intervals might help in the establishment of independent oral feeding, increase nutrient intake and growth rates, and allow earlier hospital discharge. OBJECTIVES: To assess the effect of a policy of feeding preterm infants on an ad libitum or demand/semi-demand basis versus feeding prescribed volumes at scheduled intervals on growth rates and the time to hospital discharge. SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2006), MEDLINE (1966 - March 2006), EMBASE (1980 - March 2006), CINAHL (1982 - March 2006), conference proceedings, and previous reviews. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials (including cluster randomised trials) that compared a policy of feeding preterm infants on an ad libitum or demand/semi-demand basis versus feeding at scheduled intervals. DATA COLLECTION AND ANALYSIS: The standard methods of the Cochrane Neonatal Review Group with separate evaluation of trial quality and data extraction by two review authors. The primary outcomes of interest were growth rates and age at hospital discharge. MAIN RESULTS: We found seven randomised controlled trials that compared ad libitum or demand/semi-demand regimes with scheduled interval regimes in preterm infants in the transition phase from intragastric tube to oral feeding. The trials were generally small and of variable methodological quality. The duration of the intervention and the duration of data collection and follow up in most of the trials is not likely to have allowed detection of measurable effects on growth. The single trial that assessed growth for longer than one week found that the rate of weight gain was lower in the ad libitum fed infants [mean difference -3.30 (95% confidence interval -6.2 to -0.4) grams per kilogram per day]. Two trials reported that feeding preterm infants using an ad libitum or demand/semi-demand feeding regime allowed earlier discharge from hospital, but the other trials did not confirm this finding. We were not able to undertake meta-analyses because of differences in study design and in the way the findings were reported. AUTHORS' CONCLUSIONS: There are insufficient data at present to guide clinical practice. A large randomised controlled trial is needed to determine if ad libitum of demand/semi-demand feeding of preterm infants affects clinically important outcomes. This trial should focus on infants in the transition phase from intragastric tube to oral feeding and should be of sufficient duration to assess effects on growth and time to oral feeding and hospital discharge.

Enteral Nutrition↗
PubMed2005

Preoperative fasting for preventing perioperative complications in children.

BACKGROUND: Children, like adults, are required to fast before general anaesthesia with the aim of reducing the volume and acidity of their stomach contents. It is thought that fasting reduces the risk of regurgitation and aspiration of gastric contents during surgery. Recent developments have encouraged a shift from the standard 'nil-by-mouth-from-midnight' fasting policy to more relaxed regimens. Practice has been slow to change due to questions relating to the duration of a total fast, the type and amount of intake permitted. OBJECTIVES: To systematically assess the effects of different fasting regimens (duration, type and volume of permitted intake) and the impact on perioperative complications and patient wellbeing (aspiration, regurgitation, related morbidity, thirst, hunger, pain, comfort, behaviour, nausea and vomiting) in children. SEARCH STRATEGY: We searched Cochrane Wounds Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, CINAHL, the National Research Register, relevant conference proceedings and article reference lists and contacted experts. SELECTION CRITERIA: Randomised and quasi randomised controlled trials of preoperative fasting regimens for children were identified. DATA COLLECTION AND ANALYSIS: Data extraction and trial quality assessment was conducted independently by two authors. Trial authors were contacted for additional information including adverse events. MAIN RESULTS: Forty-three randomised controlled comparisons (from 23 trials) involving 2350 children considered to be at normal risk of regurgitation or aspiration during anaesthesia. Only one incidence of aspiration and regurgitation was reported. Children permitted fluids up to 120 minutes preoperatively were not found to experience higher gastric volumes or lower gastric pH values than those who fasted. The children permitted fluids were also less thirsty and hungry, better behaved and more comfortable than those who fasted. Clear fluids preoperatively did not result in a clinically important difference in the children's gastric volume or pH. Evidence relating to the preoperative intake of milk was sparse. The volume of fluid permitted during the preoperative period did not appear to impact on children's intraoperative gastric volume or pH contents. AUTHORS' CONCLUSIONS: There is no evidence that children who are not permitted oral fluids for more than six hours preoperatively benefit in terms of intraoperative gastric volume and pH over children permitted unlimited fluids up to two hours preoperatively. Children permitted fluids have a more comfortable preoperative experience in terms of thirst and hunger. This evidence applies only to children who are considered to be at normal risk of aspiration/regurgitation during anaesthesia.

Adolescent↗
PubMed2006

Strontium ranelate for preventing and treating postmenopausal osteoporosis.

BACKGROUND: Strontium ranelate is a new anti-osteoporosis therapy therefore, its benefits and harms need to be known. OBJECTIVES: To determine the efficacy and safety of strontium ranelate for the treatment and prevention of postmenopausal osteoporosis. SEARCH STRATEGY: We searched MEDLINE (1996 to March 2005), EMBASE (1996 to week 9 2005), the Cochrane Library (1996 to Issue 1 2005), reference lists of relevant articles and conference proceedings from the last two years. Additional data was sought from authors and industry sponsors. SELECTION CRITERIA: We included randomized controlled trials (RCTs) of at least one year duration comparing strontium ranelate versus placebo reporting fracture incidence, bone mineral density (BMD), health related quality of life and/or safety outcomes in postmenopausal women. Treatment (versus prevention) population was defined as women with prevalent vertebral fractures and/or lumbar spine BMD T score < -2.5 SD. DATA COLLECTION AND ANALYSIS: Two reviewers independently determined study eligibility, assessed trial quality and extracted the relevant data. Disagreements were resolved by consensus. RCTs were grouped by dose of strontium ranelate and treatment duration. Where possible, meta-analysis was conducted using the random effects model. MAIN RESULTS: A total of four trials met our inclusion criteria, three of which investigated the effects of strontium ranelate compared to placebo in a treatment population (doses ranged from 0.5 to 2 g daily) and one, in a prevention population (doses 0.125, 0.5 and 1 g daily). In osteoporotic, postmenopausal women a 37% reduction in vertebral fractures (two trials, n = 5082, RR 0.63, 95% CI 0.56 to 0.71) and a 14% reduction in non-vertebral fractures (two trials, n = 6572, RR 0.86, 95% CI 0.75 to 0.98) was demonstrated over a three year period with 2 g of strontium ranelate daily. An increase in BMD at all sites was shown with the same dose: lumbar spine BMD (two trials, n = 1614, WMD adjusted for strontium content 5.44, 95% CI 3.41 to 7.46 and WMD not adjusted 11.29, 95% CI 10.22 to 12.37 over two years), femoral neck and total hip (two trials, n = 4230, WMD 8.25, 95% CI 7.84 to 8.66 and WMD 9.83, 95% CI 9.39 to 10.26 respectively over three years). One gram of strontium ranelate daily in postmenopausal women without osteoporosis increased BMD at all sites over a two year period: lumbar spine (one trial, n = 59, WMD adjusted for strontium content 2.39, 95% CI 0.15 to 4.63 and WMD not adjusted 6.68, 95% CI 5.16 to 8.20), femoral neck (one trial, n= 60, WMD 2.52, 95%CI 0.96 to 4.09) and total hip (one trial, n = 60, WMD 1.02, 95% CI 0.48 to 1.56). In both the treatment and prevention populations, lower doses of strontium ranelate were superior to placebo with the highest dose of strontium ranelate demonstrating the greatest reduction in vertebral fractures and increase in BMD. There is some evidence to suggest that 2 g of strontium ranelate daily compared to placebo may have a beneficial effect on health related quality of life in postmenopausal women after three years of treatment. Two grams of strontium ranelate daily increased the risk of diarrhea (RR 1.38%, 95% CI 1.02 to 1.87); however, adverse events did not affect the risk of discontinuing strontium ranelate nor did it increase the risk of serious side effects, gastritis or death. Additional data obtained suggests that the risk of vascular system disorders including venous thromboembolism (two trials, n = 6669, 2.2% versus 1.5%, OR 1.5, 95% CI 1.1 to 2.1) and pulmonary embolism (two trials, n = 6669, 0.8% versus 0.4%, OR 1.7, 95% CI 1.0 to 3.1) as well as nervous system disorders such as headaches (3.9% versus 2.9%), seizures (0.3% versus 0.1%), memory loss (2.4% versus 1.9%) and disturbance in consciousness (2.5% versus 2.0%) is slightly increased with taking 2 g of strontium ranelate daily over a 3 to 4 year period. AUTHORS' CONCLUSIONS: There is silver level evidence to support the efficacy of strontium ranelate for the reduction of vertebral fractures (and to a lesser extent non-vertebral fractures) in postmenopausal osteoporotic women and an increase in BMD (all sites) in postmenopausal women with and without osteoporosis. Diarrhea may occur however, adverse events leading to study withdrawal were not significantly increased in the strontium ranelate group. Potential risks to the vascular and neurological system associated with taking 2 g of strontium ranelate daily need to be further explored and quantified.

Bone Density↗
PubMed2006

Strontium ranelate for preventing and treating postmenopausal osteoporosis.

BACKGROUND: Strontium ranelate is a new treatment for osteoporosis therefore, its benefits and harms need to be known. OBJECTIVES: To determine the efficacy and safety of strontium ranelate for the treatment and prevention of postmenopausal osteoporosis. SEARCH STRATEGY: We searched MEDLINE (1996 to March 2005), EMBASE (1996 to week 9 2005), the Cochrane Library (1996 to Issue 1 2005), reference lists of relevant articles and conference proceedings from the last two years. Additional data was sought from authors. SELECTION CRITERIA: We included randomized controlled trials (RCTs) of at least one year duration comparing strontium ranelate versus placebo reporting fracture incidence, bone mineral density (BMD), health related quality of life or safety in postmenopausal women. Treatment (versus prevention) population was defined as women with prevalent vertebral fractures and/or lumbar spine BMD T score < -2.5 SD. DATA COLLECTION AND ANALYSIS: Two reviewers independently determined study eligibility, assessed trial quality and extracted the relevant data. Disagreements were resolved by consensus. RCTs were grouped by dose of strontium ranelate and treatment duration. Where possible, meta-analysis was conducted using the random effects model. MAIN RESULTS: Four trials met the inclusion criteria. Three included a treatment population (0.5 to 2 g of strontium ranelate daily) and one a prevention population (0.125 g, 0.5 g and 1 g daily). A 37% reduction in vertebral fractures (RR 0.63, 95% CI 0.56, 0.71) and a 14% reduction in non-vertebral fractures (RR 0.86, 95% CI 0.75, 0.98) were demonstrated over three years with 2 g of strontium ranelate daily in a treatment population. An increase in BMD was shown at all BMD sites after two to three years in both populations. Lower doses of strontium ranelate were superior to placebo and the highest dose demonstrated the greatest reduction in vertebral fractures and increase in BMD. An increased risk of diarrhea with 2 g of strontium ranelate was found; however, adverse events did not affect the risk of discontinuing treatment nor did it increase the risk of serious side effects, gastritis or death. Additional data suggests that the risk of vascular and nervous system side-effects is slightly increased with taking 2 g of strontium ranelate daily over three to four years. AUTHORS' CONCLUSIONS: There is silver level evidence (www.cochranemsk.org) to support the efficacy of strontium ranelate for the reduction of fractures (vertebral and to a lesser extent non-vertebral) in postmenopausal osteoporotic women and an increase in BMD in postmenopausal women with/without osteoporosis. Diarrhea may occur however, adverse events leading to study withdrawal were not significantly increased with taking 2 g of strontium ranelate daily. Potential vascular and neurological side-effects need to be further explored.

Bone Density↗
PubMed2006

Pre-discharge "car seat challenge" for preventing morbidity and mortality in preterm infants.

BACKGROUND: Physiological monitoring studies indicate that some preterm infants experience episodes of oxygen desaturation, apnoea, or bradycardia when seated in standard car safety seats. The American Academy of Pediatrics recommends that all preterm infants should be assessed for cardiorespiratory stability in their car seat prior to discharge - the "car seat challenge". We aimed to assess the evidence to support this practice, specifically to determine whether the use of the car seat challenge prevents morbidity and mortality in preterm infants. OBJECTIVES: To assess the available evidence from randomised controlled trials that pre-discharge cardiorespiratory monitoring in a car safety seat prevents morbidity and mortality in preterm infants. SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2005), MEDLINE (1966 - September 2005), EMBASE (1980 - September 2005), CINAHL (1982 - September 2005), conference proceedings, and previous reviews. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials that compared pre-discharge cardiorespiratory monitoring in a car seat versus no monitoring in preterm infants in the week prior to planned discharge from hospital. DATA COLLECTION AND ANALYSIS: The standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by two review authors, and synthesis of data using relative risk, risk difference and weighted mean difference. MAIN RESULTS: We did not find any randomised controlled trials that fulfilled the eligibility criteria. AUTHORS' CONCLUSIONS: It is unclear whether undertaking a pre-discharge car seat challenge is beneficial or harmful to preterm infants. Further studies are needed to determine whether the car seat challenge accurately predicts the risk of clinically significant adverse events in preterm infants travelling in car seats. If this is shown to be the case then a large randomised controlled trial is needed to provide an unbiased assessment of its utility in pre-discharge assessment.

Humans↗
PubMed2006

Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding.

BACKGROUND: There is conflicting evidence regarding the clinical efficacy of proton pump inhibitors (PPI) initiated prior to endoscopy in patients with upper gastrointestinal bleeding. OBJECTIVES: We aimed to systematically review evidence from randomised controlled trials (RCTs) that studied PPI treatment initiated before endoscopy in patients with upper gastrointestinal bleeding. SEARCH STRATEGY: A search was undertaken according to the Cochrane Upper Gastrointestinal and Pancreatic Diseases model using CENTRAL, (The Cochrane Library), MEDLINE, EMBASE and CINAHL databases and major conference proceedings up to September 2005. The literature search was re-run in February 2006. SELECTION CRITERIA: Types of studies: Randomised controlled trials (RCTs). TYPES OF PARTICIPANTS: Hospitalised patients with unselected upper gastrointestinal bleeding. Types of interventions: Active treatment with a PPI (oral or intravenous) and control treatment with either placebo or an histamine-(2) receptor antagonist (H(2)RA). Types of outcome measures: Assessed at 30 days: mortality, rebleeding and surgery. Also assessed were stigmata of recent haemorrhage at index endoscopy, length of hospital stay and blood transfusion requirements. DATA COLLECTION AND ANALYSIS: At least two reviewers assessed the eligibility criteria of each study and extracted data regarding outcomes and factors affecting methodological quality. MAIN RESULTS: Five RCTs were included for review. No further RCTS were identified in an updated literature search. Four trials comprising a total of 1512 patients in total reported data for all randomised patients. There was no statistical heterogeneity among trials for the outcomes of mortality, rebleeding and surgery. There were no statistically significant differences in rates of mortality, rebleeding or surgery between PPI and control treatment. Pooled mortality rates were 6.1% and 5.5% respectively (odds ratio (OR)1.12; 95% CI 0.72 to 1.73). Pooled rebleeding rates were 13.9% and 16.6% respectively (OR 0.81; 95%CI 0.61 to 1.09). Pooled rates for surgery were 9.9% and 10.2% respectively (OR 0.96 95% CI 0.68 to 1.35). PPI treatment compared to control significantly reduced the proportion of patients with stigmata of recent haemorrhage at index endoscopy; pooled rates were 37.2% and 46.5% respectively (OR 0.67; 95% CI 0.54 to 0.84). For the continuous outcomes, namely length of hospital stay and blood transfusion requirements, quantitative analysis could not be performed. AUTHORS' CONCLUSIONS: PPI treatment initiated prior to endoscopy in patients with upper gastrointestinal bleeding significantly reduces the proportion of patients with stigmata of recent haemorrhage at index endoscopy. However, there is no evidence that PPI treatment affects clinically important outcomes, namely mortality, rebleeding or need for surgery.

Anti-Ulcer Agents↗
PubMed2006

Drugs for preventing tuberculosis in people at risk of multiple-drug-resistant pulmonary tuberculosis.

BACKGROUND: The emergence and spread of multiple-drug-resistant tuberculosis (MDR-TB), caused by strains of Mycobacterium tuberculosis resistant to at least isoniazid and rifampicin, is a potential threat to global tuberculosis control. Treatment is prolonged, expensive, more toxic than treatment of susceptible tuberculosis, and often unsuccessful. Experts are still undecided on the management of people exposed to MDR-TB. OBJECTIVES: To evaluate antituberculous drugs given to people exposed to MDR-TB in preventing active tuberculosis. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (January 2006), CENTRAL (The Cochrane Library 2006, Issue 1), MEDLINE (1966 to January 2006); EMBASE (1974 to January 2006), LILACS (1982 to January 2006), conference proceedings, and reference lists. We also contacted researchers and organizations. SELECTION CRITERIA: Randomized controlled trials comparing antituberculous drug regimens with an alternative antituberculous drug regimen, placebo, or no intervention given to people exposed to MDR-TB for preventing active tuberculosis. DATA COLLECTION AND ANALYSIS: Two authors independently inspected titles and abstracts identified by the search in order to identify potentially relevant publications for inclusion and analysis. MAIN RESULTS: No randomized controlled trials met the inclusion criteria. AUTHORS' CONCLUSIONS: The balance of benefits and harms associated with treatment for latent tuberculosis infection in people exposed to MDR-TB is far from clear. Antituberculous drugs should only be offered within the context of a well-designed randomized controlled trial, or when people are given the details of the current evidence on benefits and harms, along with the uncertainties.

Antitubercular Agents↗
PubMed2005

Zuclopenthixol dihydrochloride for schizophrenia.

BACKGROUND: Zuclopenthixol dihydrochloride, given orally, is commonly used for managing the signs and symptoms of schizophrenia. OBJECTIVES: To determine the effects of zuclopenthixol dhydrochloride for treatment of schizophrenia. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's register (December 2004). This register is compiled of methodical searches of BIOSIS, CINAHL, Dissertation abstracts, EMBASE, LILACS, MEDLINE, PSYNDEX, PsycINFO, RUSSMED, Sociofile, supplemented with hand searching of relevant journals and numerous conference proceedings. To identify further trials we also contacted a pharmaceutical company and authors of relevant studies. SELECTION CRITERIA: We included all randomised controlled trials comparing zuclopenthixol dihydrocodine with antipsychotics or with placebo (or no intervention) for treatment of schizophrenia and/or schizophrenia-like psychoses. DATA COLLECTION AND ANALYSIS: We independently inspected citations and abstracts, ordered papers, re-inspected and quality assessed articles and extracted data. For dichotomous data we calculated relative risks (RR) and the 95% confidence intervals (CI) and the number needed to treat (NNT) or number needed to harm statistics. For continuous data we calculated weighted mean differences with 95% CIs for non-skewed data. MAIN RESULTS: We included eighteen trials involving 1578 people. Two trials compared zuclopenthixol with placebo and neither reported global or mental state outcomes. People allocated zuclopenthixol did have increased risk of experiencing extraparamydal symptoms compared with placebo (n=64, RR 5.37, CI 1.12 to 29.34 NNH 2 CI 2 to 31). Ten short trials (total n=478) compared zuclopenthixol with other typical antipsychotics. Risk of being unchanged or worse was decreased by allocation to zuclopenthixol (n=357, 7 RCTs, RR 0.72 CI 0.53 to 0.98, NNT 10 CI 6 to 131). No findings suggest any clear difference between zuclopenthixol and other typical antipsycotics across a whole range of adverse effects, including movement disorders (n=280, 6 RCTs, RR needing additional antiparkinsonian medication 1.07 CI 0.86 to 1.33) and general agitation (n=162, 3 RCTs, RR needing treatment with hypnotic/sedative drugs 1.09 CI 0.76 to 1.56). Fewer people allocated zuclopenthixol left in the short term compared with those given other typical antipsychotics (n=424, 22% vs 30%, 8 RCTs, RR 0.70 CI 0.51 to 0.95, NNT 12 CI 7 to 67). Three short trials (total n=233) compared zuclopenthixol with atypical antipsychotics. Zuclopenthixol was associated with no greater risk of being unchanged or worse compared with risperidone (n=98, 1 RCT, RR 1.30 CI 0.80 to 2.11). People allocated zuclopenthixol were prescribed antiparkinsonian medication more frequently compared to those treated with risperidone (n=98, 1 RCT, RR 1.92 CI 1.12 to 3.28, NNH 3 CI 3 to 17). Weight gain was equal for people allocated zuclopenthixol and those given sulpiride (n=61, 1 RCT, WMD 1.60 CI 8.35 to 5.15). Many people left these short studies early (45% zuclopenthixol vs 30% risperidone, n=159, 2 RCTs, RR 1.48 CI 0.98 to 2.22). The two isomers of zuclopenthixol, when compared in four short studies (total n=140), did not result in clearly different outcomes. AUTHORS' CONCLUSIONS: There is an indication that zuclopenthixol causes movement disorders, perhaps more so than the newer generation of drugs, though no more frequently than the older generation of antipsychotics. There is some suggestion from this review that oral zuclopenthixol may have some clinical advantage, at least in the short term, over other older drugs in terms of global state. If an older drug is going to be prescribed, zuclopenthixol dihydrochloride is a viable option but may be best taken with additional medication to offset movement disorders that occur in about half the people taking this drug. There is no information on service, functional, behavioural outcomes and important outcomes such as relapse, for such a widely used drug this would indicate the need for further studies. We feel that it should remain a choice in the treatment of those for whom older generation drugs are indicated.

Antipsychotic Agents↗
PubMed2006

Antiemetics for reducing vomiting related to acute gastroenteritis in children and adolescents.

BACKGROUND: Vomiting caused by acute gastroenteritis is very common in children and adolescents. Treatment of vomiting in children can be problematic and the use of antiemetics remains a controversial issue. There have been concerns expressed about apparently unacceptable levels of side effects such as sedation and extrapyramidal reactions, which are associated with some of the earlier generation of antiemetics. OBJECTIVES: To assess the effectiveness of antiemetics on gastroenteritis induced vomiting in children and adolescents. SEARCH STRATEGY: We searched the Cochrane Central register of Controlled Trials (CENTRAL), which includes the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register (searched 28 July 2005), MEDLINE (1966 to July 2005) and EMBASE (1980 to July 2005). Published abstracts from conference proceedings from the United European Gastroenterology Week and Digestive Disease Week were handsearched. Members of the Cochrane UGPD Group were contacted for details of any ongoing or relevant unpublished clinical trials. SELECTION CRITERIA: Randomised controlled trials comparing antiemetics and/or placebo in children and adolescents, under the age of 18, with vomiting due to gastroenteritis. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects data was collected from the studies. MAIN RESULTS: Two trials involving 181 participants were included. Although no data were available for the precise time to cessation of vomiting (the primary outcome specified in the protocol for this review), one trial reported that the proportion of patients without vomiting over a 24 hour period was higher in the ondansetron and metoclopramide groups than placebo. In the second trial, ondansetron ensured complete anti-emesis for 8/12 (67%) patients within the first 4 hours and in 7/12 (58%) patients in the first 24 hr period. A few secondary outcomes were reported in the included trials. AUTHORS' CONCLUSIONS: The small number of included trials provided some, albeit weak and unreliable, evidence which appeared to favor the use of ondansetron and metoclopramide over placebo to reduce the number of episodes of vomiting due to gastroenteritis in children. The increased incidence of diarrhea noted with both ondansetron and metoclopramide was considered to be as a result of retention of fluids and toxins that would otherwise have been eliminated through the process of vomiting.

Acute Disease↗
PubMed2006

Antiemetics for reducing vomiting related to acute gastroenteritis in children and adolescents.

BACKGROUND: Vomiting caused by acute gastroenteritis is very common in children and adolescents. Treatment of vomiting in children can be problematic and the use of antiemetics remains a controversial issue. There have been concerns expressed about apparently unacceptable levels of side effects such as sedation and extrapyramidal reactions, which are associated with some of the earlier generation of antiemetics. OBJECTIVES: To assess the effectiveness of antiemetics on gastroenteritis induced vomiting in children and adolescents. SEARCH STRATEGY: We searched the Cochrane Central register of Controlled Trials (CENTRAL), which includes the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register (searched 28 July 2005), MEDLINE (1966 to July 2005) and EMBASE (1980 to July 2005). Published abstracts from conference proceedings from the United European Gastroenterology Week and Digestive Disease Week were handsearched. Members of the Cochrane UGPD Group were contacted for details of any ongoing or relevant unpublished clinical trials. The search was re-run on 12th July 2006 and one new trial was found. SELECTION CRITERIA: Randomised controlled trials comparing antiemetics and/or placebo in children and adolescents, under the age of 18, with vomiting due to gastroenteritis. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects data was collected from the studies. MAIN RESULTS: Three trials involving 396 participants were included. Although no data were available for the precise time to cessation of vomiting (the primary outcome specified in the protocol for this review), one trial reported that the proportion of patients without vomiting over a 24 hour period was higher in the ondansetron and metoclopramide groups than placebo. In the second trial, ondansetron ensured complete anti-emesis for 8/12 (67%) patients within the first 4 hours and in 7/12 (58%) patients in the first 24 hr period. A few secondary outcomes were reported in the included trials. The third trial reported that 14% of patients who received ondansetron vomited during oral rehydration (which was given over one hour period after randomization) compared to 35% of the placebo group. AUTHORS' CONCLUSIONS: The small number of included trials provided some, albeit weak and unreliable, evidence which appeared to favor the use of ondansetron and metoclopramide over placebo to reduce the number of episodes of vomiting due to gastroenteritis in children. The increased incidence of diarrhea noted with both ondansetron and metoclopramide was considered to be as a result of retention of fluids and toxins that would otherwise have been eliminated through the process of vomiting.

Acute Disease↗
PubMed2005

Artemether-lumefantrine (six-dose regimen) for treating uncomplicated falciparum malaria.

BACKGROUND: The World Health Organization recommends artemether-lumefantrine for treating uncomplicated malaria. We sought evidence of superiority of the six-dose regimen over existing treatment regimens as well as its effectiveness in clinical situations. OBJECTIVES: To evaluate the six-dose regimen of artemether-lumefantrine for treating uncomplicated falciparum malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (April 2005), CENTRAL (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to April 2005), EMBASE (1974 to April 2005), LILACS (1982 to April 2005), conference proceedings, and reference lists of articles. We also contacted experts in malaria research and the pharmaceutical company that manufactures artemether-lumefantrine. SELECTION CRITERIA: Randomized controlled trials comparing six doses of artemether-lumefantrine administered orally with standard treatment regimens (single drug or combination), or supervised with unsupervised treatment, for uncomplicated falciparum malaria. DATA COLLECTION AND ANALYSIS: Two authors independently applied inclusion criteria to potentially relevant trials, assessed trial quality, and extracted data, including adverse events. Total failure by day 28 (day 42 for sulfadoxine-pyrimethamine and day 63 for mefloquine) was the primary outcome. MAIN RESULTS: Nine trials (4547 participants) tested the six-dose regimen. Total failure at day 28 for artemether-lumefantrine was lower when compared with amodiaquine (270 participants, 1 trial), amodiaquine plus sulfadoxine-pyrimethamine (507 participants, 1 trial), but not with chloroquine plus sulfadoxine-pyrimethamine (201 participants, 2 trials). In comparisons with artemisinin derivative combinations, artemether-lumefantrine performed better than amodiaquine plus artesunate (668 participants, 2 trials), worse than mefloquine plus artesunate (270 participants, 4 trials), and no differently to dihydroartemisinin-napthoquine-trimethoprim (89 participants, 1 trial). AUTHORS' CONCLUSIONS: The six-dose regimen of artemether-lumefantrine appears more effective than antimalarial regimens not containing artemisinin derivatives.

Antimalarials↗
PubMed2006

Systemic antimicrobial prophylaxis for percutaneous endoscopic gastrostomy.

BACKGROUND: Percutaneous endoscopic gastrostomies (PEG) maintain nutrition in the short or long term. A PEG is a feeding tube, placed surgically through the anterior abdominal wall, which delivers a liquid diet, or medication, via a clean or sterile delivery system. Those undergoing PEG placement are often vulnerable to infection because of age, compromised nutritional intake, immunosuppression and underlying disease processes such as malignancy and diabetes mellitus. The increasing incidence of methicillin-resistant Staphylococcus aureus (MRSA) contributes both an additional risk to the placement procedure, and also to the debate surrounding antibiotic prophylaxis for PEG placement. The aim of surgical antimicrobial prophylaxis is to establish a bactericidal concentration of an antimicrobial drug in the patients serum and tissues, via a brief course of an appropriate agent, by the time of PEG placement. OBJECTIVES: The review seeks to establish whether prophylactic use of systemic antimicrobials reduces the risk of peristomal infection in people undergoing placement of percutaneous endoscopic gastrostomies. SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Register (July 2006); The Cochrane Central Register of Controlled Trials (The Cochrane Library 2006, Issue 2); handsearched wound care journals relevant conference proceedings, and bibliographies of relevant publications identified by these strategies for further studies; and contacted manufacturers and distributors of PEG products. SELECTION CRITERIA: Randomised controlled trials (RCTs) evaluating the use of prophylactic antimicrobials for PEG placement, with no restrictions for language, date or publication status. DATA COLLECTION AND ANALYSIS: Both authors performed data extraction and assessment of study quality. Meta-analysis was performed where appropriate. MAIN RESULTS: We identified 10 eligible RCTs evaluating prophylactic antimicrobials in 1100 patients. All trials reported peristomal infection as an outcome, and a pooled analysis resulted in a statistically significant reduction in the incidence of peristomal infection with prophylactic antibiotics (pooled OR 0.31, 95% CI 0.22 to 0.44). AUTHORS' CONCLUSIONS: Administration of systemic prophylactic antibiotics for PEG placement reduces peristomal infection.

Anti-Infective Agents↗
PubMed2006

Antibiotics for treating community acquired pneumonia in people with sickle cell disease.

BACKGROUND: As a consequence of their condition, people with sickle cell disease are at high risk of developing an acute infection of the pulmonary parenchyma called community-acquired pneumonia. Many different bacteria can cause this infection and antibiotic treatment is generally needed to resolve it. There is no standardized approach to antibiotic therapy and treatment is likely to vary from country to country. Thus, there is a need to identify the efficacy and safety of different antibiotic treatment approaches for people with sickle cell disease suffering from community-acquired pneumonia. OBJECTIVES: To determine the efficacy and safety of the antibiotic treatment approaches (monotherapy or combined) for people with sickle cell disease suffering from community-acquired pneumonia. SEARCH STRATEGY: We searched The Group's Haemoglobinopathies Trials Register (December 2005), which comprises references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. We also searched The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 4, 2005), MEDLINE (1966 to December 5th, 2005), EMBASE (1974 to December 7th, 2005), and LILACS (1982 to December 2005). Date of most recent search: December 2005 SELECTION CRITERIA: We searched for published or unpublished randomized controlled trials. DATA COLLECTION AND ANALYSIS: We intended to summarise data by standard Cochrane Collaboration methodologies, but no eligible randomized controlled trials were identified. MAIN RESULTS: We were unable to find any randomized controlled trials on antibiotic treatment approaches for community-acquired pneumonia in people with sickle cell disease. AUTHORS' CONCLUSIONS: We were unable to identify randomized controlled trials on efficacy and safety of the antibiotic treatment approaches for people with sickle cell disease suffering from community-acquired pneumonia. Randomized controlled trials are needed to establish the optimum antibiotic treatment for this condition.

Anemia, Sickle Cell↗
PubMed2006

Artemether-lumefantrine (four-dose regimen) for treating uncomplicated falciparum malaria.

BACKGROUND: The World Health Organization recommends artemether-lumefantrine, an expensive drug, as a treatment for uncomplicated malaria. We sought evidence of the superiority of the four-dose regimen over existing treatments. OBJECTIVES: To evaluate the four-dose regimen of artemether-lumefantrine for treating uncomplicated falciparum malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (October 2005), CENTRAL (The Cochrane Library 2005, Issue 3), MEDLINE (1966 to October 2005), EMBASE (1988 to October 2005), LILACS (1982 to October 2005), conference proceedings, and reference lists of articles. We also contacted experts in malaria research and the pharmaceutical company that manufactures artemether-lumefantrine. SELECTION CRITERIA: Randomized controlled trials comparing four doses of artemether-lumefantrine with standard treatment regimens (single drug or combination), or six doses of artemether-lumefantrine, for treating uncomplicated falciparum malaria. DATA COLLECTION AND ANALYSIS: Two authors independently applied inclusion criteria to potentially relevant trials, assessed trial quality, and extracted data, including adverse events. Total failure by day 28 (day 42 for sulfadoxine-pyrimethamine and day 63 for mefloquine) was the primary outcome. MAIN RESULTS: Seven trials (2057 participants) tested a four-dose regimen. More people tended to fail treatment with artemether-lumefantrine than with other drugs, including sulfadoxine-pyrimethamine (247 participants, 1 trial), halofantrine (86 participants, 1 trial), and mefloquine (233 participants, 1 trial; difference statistically significant for mefloquine). When compared with chloroquine, artemether-lumefantrine was better in two trials (378 participants), but over 50% of the participants treated with chloroquine had total failure by day 28. Fewer people failed treatment with the six-dose regimen compared to the four-dose regimen (RR 7.71, 95% CI 2.99 to 19.88; 306 participants, 1 trial). AUTHORS' CONCLUSIONS: The four-dose regimen of artemether-lumefantrine seems to be less effective than regimens against which it has been tested. The six-dose regimen is superior to four-dose regimen.

Antimalarials↗
PubMed2006

Vaccines for preventing malaria (pre-erythrocytic).

BACKGROUND: Vaccines against all stages of the malaria parasite are in development, mainly for Plasmodium falciparum, which causes the most serious form of malaria. Pre-erythrocytic vaccines act to prevent or delay a malaria attack by attacking the sporozoite and liver stages before the parasite reaches the bloodstream. OBJECTIVES: To assess the efficacy and safety of pre-erythrocytic malaria vaccines against any type of human malaria. SEARCH STRATEGY: In March 2006, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2006, Issue 1), MEDLINE, EMBASE, LILACS, and the Science Citation Index. We also searched conference proceedings and reference lists of articles, and contacted organizations and researchers in the field. SELECTION CRITERIA: Randomized controlled trials comparing pre-erythrocytic vaccines with placebo, control vaccine, or routine antimalarial control measures in people of any age receiving an artificial challenge or natural exposure to malaria infection. DATA COLLECTION AND ANALYSIS: Both authors independently assessed trial quality and extracted data. Results of meta-analyses were expressed as relative risks with 95% confidence intervals (CI) using an intention-to-treat analysis. MAIN RESULTS: Nine safety and efficacy trials, and two safety trials, with over 3000 participants were included. In semi-immune children, RTS,S vaccine reduced clinical episodes of malaria by 26% (95% CI 13% to 37%) and severe malaria by 58% (95% CI 15% to 79%) for up to 18 months. Prevalence of parasitaemia was also reduced by 26% (95% CI 11% to 38%) at six months after immunization. RTS,S also reduced clinical malaria episodes by 63% (95% CI 18% to 83%) in semi-immune adult men in the second year of follow up after a booster dose. No severe adverse events were judged to be related to RTS,S vaccine, although the frequencies of injection site pain, swelling, arm motion limitation, headache, and malaise were increased in the vaccine groups. There was no evidence for effect of the CS-NANP vaccines (307 participants, 3 trials), CS102 peptide vaccine (14 participants, 1 trial), or the ME-TRAP vaccine (372 participants, 1 trial). AUTHORS' CONCLUSIONS: RTS,S vaccine was effective in preventing a significant number of clinical malaria episodes, including good protection against severe malaria in children for 18 months. No severe adverse events were attributable to the vaccine. Progression of this vaccine towards licensing is justified while efforts to increase its efficacy continue. The other vaccines do not look promising and further research is a priority.

Adult↗
PubMed2006

Vaccines for preventing malaria (blood-stage).

BACKGROUND: A malaria vaccine is needed because of the heavy burden of mortality and morbidity due to this disease. This review describes the results of trials of blood (asexual)-stage vaccines. Several are under development, but only one (MSP/RESA, also known as Combination B) has been tested in randomized controlled trials. OBJECTIVES: To assess the effect of blood-stage malaria vaccines in preventing infection, disease, and death. SEARCH STRATEGY: In March 2006, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2006, Issue 1), MEDLINE, EMBASE, LILACS, and the Science Citation Index. We also searched conference proceedings and reference lists of articles, and contacted organizations and researchers in the field. SELECTION CRITERIA: Randomized controlled trials comparing blood-stage vaccines (other than SPf66) against P. falciparum, P. vivax, P. malariae, or P. ovale with placebo, control vaccine, or routine antimalarial control measures in people of any age receiving a challenge malaria infection. DATA COLLECTION AND ANALYSIS: Both authors independently assessed trial quality and extracted data. Results for dichotomous data were expressed as relative risks (RR) with 95% confidence intervals (CI). MAIN RESULTS: Five trials of MSP/RESA vaccine with 217 participants were included; all five reported on safety, and two on efficacy. No severe or systemic adverse effects were reported at doses of 13 to 15 microg of each antigen (39 to 45 microg total). One small efficacy trial with 17 non-immune participants with blood-stage parasites showed no reduction or delay in parasite growth rates after artificial challenge. In the second efficacy trial in 120 children aged five to nine years in Papua New Guinea, episodes of clinical malaria were not reduced, but MSP/RESA significantly reduced parasite density only in children who had not been pretreated with an antimalarial drug (sulfadoxine-pyrimethamine). Infections with the 3D7 parasite subtype of MSP2 (the variant included in the vaccine) were reduced (RR 0.38, 95% CI 0.26 to 0.57; 719 participants) while those with the other main subtype, FC27, were not (720 participants). AUTHORS' CONCLUSIONS: The MSP/RESA (Combination B) vaccine shows promise as a way to reduce the severity of malaria episodes, but the effect of the vaccine is MSP2 variant-specific. Pretreatment for malaria during a vaccine trial makes the results difficult to interpret, particularly with the relatively small sample sizes of early trials. The results show that blood-stage vaccines may play a role and merit further development.

Antigens, Protozoan↗
PubMed2006

Calcimimetics for secondary hyperparathyroidism in chronic kidney disease patients.

BACKGROUND: Calcimimetic agents have recently been evaluated in the treatment of secondary hyperparathyroidism (SHPT) as add-on therapy to calcitriol and vitamin D analogues and dietary phosphate binders. OBJECTIVES: To evaluate the benefits and harms of calcimimetics for the prevention of secondary hyperparathyroid bone disease (including osteitis fibrosa cystica and adynamic bone disease) in dialysis patients with chronic kidney disease (CKD). SEARCH STRATEGY: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and conference proceedings were searched for randomised controlled trials (RCTs) evaluating any calcimimetic against placebo or another agent in pre-dialysis or dialysis patients with CKD. SELECTION CRITERIA: We included all RCTs of any calcimimetic agent, cinacalcet HCl (AMG-073, Sensipar), NPS R-467 or NPS R-568 administered to patients with CKD for the treatment of SHPT. DATA COLLECTION AND ANALYSIS: Data were extracted on all relevant patient-centred and surrogate outcomes. Analysis was by a random effects model and results expressed as relative risk (RR) or weighted mean difference (MD) with 95% confidence intervals. MAIN RESULTS: Eight studies (1429 patients) were identified, which compared a calcimimetic agent plus standard therapy to placebo plus standard therapy. The end of treatment values of parathyroid hormone (pg/mL) (MD -290.79, 95% CI -360.23 to -221.34), serum calcium (mg/dL) (MD -0.85, 95% CI -1.14 to -0.56), serum phosphorus (mg/dL) (MD -0.29, 95% CI -0.50 to -0.08) and the calcium by phosphorus product (mg(2)/dL(2))(MD -7.90, 95% CI -10.25 to -5.54) were significantly lower with calcimimetics compared to placebo. No significant effects on patient-based endpoints were demonstrated except for the risk of hypotension which was significantly reduced with calcimimetics compared to placebo (RR 0.53, 95%CI 0.36 to 0.79). AUTHORS' CONCLUSIONS: Calcimimetic treatment of SHPT leads to significant improvements in biochemical parameters that observational studies have shown to be associated with increased mortality, cardiovascular risk and osteitis fibrosa, but patient-based benefits have not yet been demonstrated in trials. For patients with SHPT, the benefits of calcimimetics over standard therapy remain uncertain until further RCTs become available.

Calcium↗