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PubMed2002

Early compared with delayed oral fluids and food after caesarean section.

BACKGROUND: It is customary for fluids and/or food to be withheld for a period of time after abdominal operations. After caesarean section, practices vary considerably. These discrepancies raise concern as to the bases of different practices. OBJECTIVES: To assess the effect of early versus delayed introduction of fluids and/or food after caesarean section. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (January 2002) and the Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2001). SELECTION CRITERIA: Clinical trials with random allocation comparing early versus delayed oral fluids and/or food after caesarean section were considered. The participants were women within the first 24 hours after caesarean section. The criteria for 'early' feeding were as defined by the individual trial authors - usually within six to eight hours of surgery. DATA COLLECTION AND ANALYSIS: Trials considered were evaluated for methodological quality and appropriateness for inclusion. For dichotomous data, relative risks and 95% confidence intervals were calculated. Continuous data were compared using weighted mean difference and 95% confidence interval. Sub-group analyses were performed for general anaesthesia, regional analgesia and where anaesthesia was mixed or undefined. MAIN RESULTS: Of 12 studies considered, six were included in this review. Four were excluded and two are pending further information. The methodological quality of the studies was variable. Only one to three studies contributed usable data to each outcome. Three studies were limited to surgery under regional analgesia, while three included both regional analgesia and general anaesthesia. Early oral fluids or food were associated with: reduced time to first food intake (one study, 118 women; the intervention was a slush diet and food was introduced according to clinical parameters; weighted mean difference -7.20 hours, 95% confidence interval -13.26 to -1.14); reduced time to return of bowel sounds (one study, 118 women; -4.30 hours, -6.78 to -1.82); reduced postoperative hospital stay following surgery under regional analgesia (two studies, 220 women; -0.75 days, -1.37 to -0.12 - random effects model); and a trend to reduced abdominal distension (three studies, 369 women; relative risk 0.78, 95% confidence interval 0.55 to 1.11). No significant differences were identified with respect to nausea, vomiting, time to bowel action/ passing flatus, paralytic ileus and number of analgesic doses. REVIEWER'S CONCLUSIONS: There was no evidence from the limited randomised trials reviewed, to justify a policy of withholding oral fluids after uncomplicated caesarean section. Further research is justified.

Administration, Oral↗
PubMed2005

Prophylactic oral betamimetics for reducing preterm birth in women with a twin pregnancy.

BACKGROUND: Twin pregnancies are associated with a high risk of neonatal mortality and morbidity due to an increased rate of preterm birth. Betamimetics can decrease contraction frequency or delay preterm birth in singleton pregnancies by 24 to 48 hours. The efficacy of oral betamimetics in women with a twin pregnancy is unproven. OBJECTIVES: To assess the effects of prophylactic oral betamimetics administered to women with twin pregnancies. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (May 2004), CENTRAL (The Cochrane Library, Issue 2, 2004), MEDLINE (January 1966 to May 2004), EMBASE (January 1985 to May 2004), and reference lists. SELECTION CRITERIA: Randomized controlled trials in twin pregnancies comparing oral betamimetics with placebo or any intervention with the specific aim of preventing preterm birth. DATA COLLECTION AND ANALYSIS: Standard methods of The Cochrane Collaboration and the Cochrane Pregnancy and Childbirth Group were used. Trials were independently assessed for methodological quality by at least two authors, who extracted data using a data collection form. MAIN RESULTS: Five trials (344 twin pregnancies) were included. All trials compared oral betamimetics to placebo. Betamimetics reduced the incidence of preterm labour (one trial, 50 twin pregnancies, relative risk (RR) 0.40; 95% confidence interval (CI) 0.19 to 0.86). However, betamimetics did not reduce preterm birth less than 37 weeks' gestation (four trials, 276 twin pregnancies, RR 0.85; 95% CI 0.65 to 1.10) or less than 34 weeks' gestation (one trial, 144 twin pregnancies, RR 0.47; 95% CI 0.15 to 1.50). Mean neonatal birthweight in the betamimetic group was significantly higher than in the placebo group (three trials, 478 neonates, weighted mean difference 111.2 grams; 95% CI 22.2 to 200.2). Nevertheless, there was no evidence of an effect of betamimetics in reduction of low birthweight (two trials, 366 neonates, RR 1.19; 95% CI 0.77 to 1.85) or small-for-gestational age neonates (two trials, 178 neonates, RR 0.92; 95% CI 0.52 to 1.65). Two trials (388 neonates) showed that betamimetics significantly reduced the incidence of respiratory distress syndrome but the difference was not significant when the analysis was adjusted for correlation of babies from twins. Three trials (452 neonates) showed no evidence of an effect of betamimetics in reducing neonatal mortality (RR 0.80; 95% CI 0.35 to 1.82). AUTHORS' CONCLUSIONS: There is insufficient evidence to support or refute the use of prophylactic oral betamimetics for preventing preterm birth in women with a twin pregnancy.

Administration, Oral↗
PubMed2001

Ticlopidine versus oral anticoagulation for coronary stenting.

BACKGROUND: A 2-4 week course of ticlopidine plus aspirin following coronary stenting is considered effective in preventing thrombotic occlusion of the stented vessel and safe in regards to bleeding and peripheral vascular complications. However, rare, although potentially life-threatening haematological complications have been reported with this drug regimen. OBJECTIVES: To evaluate the efficacy and safety of ticlopidine plus aspirin versus oral anticoagulants after coronary stenting SEARCH STRATEGY: Electronic search of the Cochrane Library, Medline, Embase from 1991 to June 1999; references from trials and experts. SELECTION CRITERIA: Randomised controlled trials comparing ticlopidine plus aspirin versus oral anticoagulants (either with or without aspirin) after elective or bail out coronary stenting. DATA COLLECTION AND ANALYSIS: Three reviewers assessed trial quality and compiled data on outcomes including: total mortality, non fatal myocardial infarction and revascularization occurring within the first 30 days after hospitalization, stent thrombosis on angiography, major and minor bleeding, neutropenia, thrombocytopenia, thrombotic thrombocytopenic purpura. MAIN RESULTS: Four trials (n=2436 patients) were included. Ticlopidine plus aspirin compared to oral anticoagulants significantly reduced the risk of non-fatal acute myocardial infarction and revascularization at 30 days, combined negative events (mortality, myocardial infarction, revascularization at 30 days) (RR: 0.41; 95% CI: 0.25-0.69; NNT for 30 days: 22; 95% CI: 14-45), and major bleeding (RR in high quality studies: 0.24; 95% CI: 0.07-0.79). Ticlopidine plus aspirin compared to oral anticoagulants significantly increased the risk of eutropenia, thrombocytopenia and neutropenia (RR 5; 95% CI: 1.08-13.07; NNT for 30 days: 142; 95% CI: 76-1000). Ticlopidine plus aspirin vs oral anticoagulation did not affect all cause mortality. Ticlopidine plus aspirin significantly reduced the risk of stent thrombosis (angiography) which was seen only on studies with blinded outcome assessment (RR: 0.14; 95% CI: 0.03-0.60; NNT for 30 days: 33; 95% CI:16-166). Minor bleeding was reported only in one study and no studies recorded thrombotic thrombocytopenic purpura (TTP). REVIEWER'S CONCLUSIONS: Ticlopidine plus aspirin after coronary stenting is effective in reducing the risk of the revascularization, non fatal myocardial infarction and bleeding complications when compared with oral anticoagulants. No effect is observed on total mortality. However, the haematological side effects of ticlopidine are still a matter of concern, and strict monitoring of blood-cell counts is recommended. Physicians should also be aware of the possibility of rare although potentially life-threatening complications such as TTP

Administration, Oral↗
PubMed2004

Interventions for recurrent idiopathic epistaxis (nosebleeds) in children.

BACKGROUND: Recurrent idiopathic epistaxis (nosebleeds) in children is repeated nasal bleeding in patients up to the age of 16 for which no specific cause has been identified. Although nosebleeds are very common in children, and most cases are self-limiting or settle with simple measures (such as pinching the nose), more severe recurrent cases can require treatment from a healthcare professional. However, there is no consensus on the effectiveness of the different clinical interventions currently used in managing this condition. OBJECTIVES: To assess the effects of different interventions for the management of recurrent idiopathic epistaxis in children. SEARCH STRATEGY: We searched the Cochrane ENT Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 3, 2003), MEDLINE (January 1966 to August 2003), EMBASE (January 1980 to August 2003), CINAHL (January 1982 to August 2003), and reference lists of relevant articles. SELECTION CRITERIA: We identified all randomised controlled trials (with or without blinding) in which any surgical or medical intervention for the treatment of recurrent idiopathic epistaxis in children was evaluated in comparison with either no treatment, a placebo, or another intervention, and in which the frequency and severity of episodes of nasal bleeding following treatment was stated or calculable. The full text articles of all the retrieved trials of possible relevance were reviewed by the two reviewers and the inclusion criteria applied independently. DATA COLLECTION AND ANALYSIS: Trials were graded for methodological quality using the Cochrane approach. Data extraction was performed in a standardised manner by one reviewer and rechecked by the other, and where necessary investigators were contacted to obtain missing information. A meta-analysis was not undertaken because of the heterogeneity of the treatments, procedures and quality of the included trials. A narrative overview of the results is therefore presented. MAIN RESULTS: Three studies - two randomised controlled trials (RCTs) and one controlled clinical trial (CCT) - involving 256 participants satisfied the inclusion criteria. One RCT compared Naseptin antiseptic cream with no treatment, the second RCT compared Vaseline(R) petroleum jelly with no treatment, and the CCT compared Naseptin antiseptic cream with silver nitrate cautery. Overall, results were inconclusive, with no statistically significant difference found between the compared treatments. No serious adverse effects were reported from any of the interventions, although children receiving silver nitrate cautery reported that it was a painful experience (despite the use of local anaesthetic). REVIEWER'S CONCLUSIONS: The optimal management of children with recurrent idiopathic epistaxis is unknown. High quality randomised controlled trials comparing interventions either with placebo or no treatment, and with a follow-up period of at least a year, are needed to assess the relative merits of the various treatments currently in use.

Administration, Intranasal↗
PubMed2006

Silver based wound dressings and topical agents for treating diabetic foot ulcers.

BACKGROUND: Foot ulceration affects 15-20% of people with diabetes. It is a major precursor to amputation in this patient group, and early and appropriate treatment provides the greatest opportunity for healing. The use of silver for its antimicrobial properties has re-emerged, and modern wound dressings that release a sustained amount of free silver ions, are now widely used in wound management. OBJECTIVES: To evaluate the effects of silver-containing dressings and topical agents on infection rates and healing of diabetes related foot ulcers. SEARCH STRATEGY: Searches were made of the Cochrane Wounds Group Specialised Register (August 2005), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 3 2005) MEDLINE (1966 to October week 2 2004), EMBASE (1980 to October week 2 2004) and CINAHL (1982 to October week 2 2004). The Journal of Wound Care (Volume 12/13 Issues 1-10) was hand-searched. Manufacturers, researchers and local and international wound groups were contacted in order to identify unpublished trials. Web sites for wound groups and World Wide Wounds (www.worldwidewounds.com) were searched. SELECTION CRITERIA: Randomised controlled trials and non-randomised controlled clinical trials were considered for inclusion. Studies were included if they involved participants with Type 1 or Type 2 diabetes and related foot ulcers, met the requirements for randomisation, allocation and concealment where appropriate, and compared the intervention with a placebo or a sham dressing, an alternative non silver based dressing or no dressing, and reported outcomes that represent healing rate or infection. DATA COLLECTION AND ANALYSIS: Two authors independently evaluated the papers identified by the search strategy against the inclusion criteria but identified no trials eligible for inclusion in the review. It was not possible to perform planned subgroup and sensitivity analysis in the absence of data. In future, if eligible trials become available, a random effects model will be applied for meta-analysis in the presence of statistical heterogeneity (estimated using the I(2) statistic). Dichotomous outcomes will be reported as risk ratios with 95% confidence intervals (CI), and continuous outcomes as weighted mean differences (WMD) with 95% CI. Statistical significance will be set at P value < 0.05 for all outcomes and the magnitude of the effect will be estimated by calculating the number needed to treat (NNT) with 95% CI. MAIN RESULTS: No studies were identified that met with the inclusion criteria AUTHORS' CONCLUSIONS: Despite the widespread use of dressings and topical agents containing silver for the treatment of diabetic foot ulcers, no randomised trials or controlled clinical trials exist that evaluate their clinical effectiveness. Trials are needed to determine clinical and cost-effectiveness and long term outcomes including adverse events.

Administration, Topical↗
PubMed2004

Single dose oral diclofenac for postoperative pain.

BACKGROUND: Diclofenac is a benzene-acetic acid derivative that acts, like other NSAIDs, by inhibiting cyclo-oxygenase isoforms that mediate the body's production of the prostaglandins implicated in pain and inflammation. Diclofenac is widely available as a sodium or potassium salt. Diclofenac potassium tablets are known as 'immediate-release' diclofenac as absorption takes place in the gastrointestinal tract whereas 'delayed-release' (enteric-coated) diclofenac tablets resist dissolution until reaching the duodenum. An existing review showed that diclofenac was an effective treatment for acute postoperative pain but did not address the distinction between potassium and sodium salts due to lack of data. The aim of this update is to gather and add appropriate information published subsequently and, data permitting, examine any potential differences between the two different diclofenac formulations. OBJECTIVES: To assess single dose oral diclofenac for the treatment of acute postoperative pain and determine whether there are differences between the different formulations. SEARCH STRATEGY: We searched the Cochrane Library (Issue 2, 2003), MEDLINE (1966 to May 1996), EMBASE (1980 to 1996), Biological Abstracts (1985 to 2003), the Oxford Pain Relief Database (1950 to 1994), PubMed (1996 to 2003) and reference lists of articles. SELECTION CRITERIA: Randomised, double-blind, placebo-controlled clinical trials of single dose, oral diclofenac sodium or diclofenac potassium for acute postoperative pain in adults. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trials for inclusion in the review, quality and extracted data. The area under the pain relief versus time curve was used to derive the proportion of patients prescribed diclofenac or placebo with at least 50% pain relief over four to six hours using validated equations. The number needed to treat (NNT) was calculated. Information on adverse effects was also collected. MAIN RESULTS: One additional trial was included and added to the six trials included in the original review. All seven trials provided data for quantitative analysis: 581 patients were treated with diclofenac and 364 were treated with placebo. The NNT for at least 50% relief over four to six hours with diclofenac 25 mg, 50 mg and 100 mg compared with placebo was 2.8 (95% CI 2.1 to 4.3), 2.3 (2.0 to 2.7) and 1.9 (1.6 to 2.2) respectively. Though higher doses produced lower (better) NNTs, statistical significance was not achieved. There was no significant difference between diclofenac 50 mg and placebo in the proportion of patients experiencing dizziness, headache, nausea or vomiting. The weighted median duration of analgesia was 2 hours for placebo, 6.7 hours for diclofenac 50 mg and 7.2 hours for diclofenac 100 mg. Sensitivity analyses for drug formulation, pain model, trial size and quality did not reveal any statistically significant differences. REVIEWERS' CONCLUSIONS: Oral diclofenac is an effective single-dose treatment for moderate to severe postoperative pain. There was no significant difference between diclofenac and placebo in the incidence of adverse effects, or between diclofenac sodium and potassium, different pain models, smaller and larger trials and trials of higher and lower quality.

Administration, Oral↗
PubMed2004

Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients.

BACKGROUND: Fever occurring in a neutropenic patient remains a common life-threatening complication of cancer chemotherapy. The common practice is to admit the patient to hospital and treat empirically with intravenous broad-spectrum antibiotics. Oral therapy could be an alternative approach for selected patients. OBJECTIVES: To compare the efficacy of oral antibiotics versus intravenous (IV) antibiotic therapy in febrile neutropenic cancer patients. SEARCH STRATEGY: We searched the Cochrane Cancer Network Register of trials (November 2002), the Cochrane Library (issue 2, 2002), MEDLINE (1966 to 2002), EMBASE (January 1980 to 2002) and LILACS (1982 to 2002). We searched several databases for ongoing trials. We checked the conference proceedings of the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) 1995 to 2002 and all references of included studies and major reviews were scanned. SELECTION CRITERIA: Randomised controlled trials comparing oral antibiotic/s to intravenous antibiotic/s for the treatment of neutropenic cancer patients with fever. The comparison between the two could be started initially (initial oral), or following an initial course of intravenous antibiotic treatment (sequential). DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial eligibility, methodological quality and extracted data. Data concerning mortality, treatment failures and adverse events were extracted from included studies assuming an "intention-to-treat" basis for the outcome measures whenever possible. Relative risks (RR) with 95% confidence intervals (CI) for dichotomous data were estimated. MAIN RESULTS: Fifteen trials (median mortality 0, range 0 to 8.8%) were included in the analyses. The mortality rate was similar comparing oral to intravenous antibiotic treatment (RR 0.91, 95% CI 0.51 to 1.62, 7 trials, 1223 patients). Treatment failure rates were also similar (RR 0.94, 95% CI 0.84 to 1.05, all trials). No significant heterogeneity was shown for all comparisons but adverse events. This effect was stable in a wide range of patients. Quinolones alone or combined with another antibiotics were used with comparable results. Adverse reactions, mostly gastrointestinal were more common with oral antibiotics. REVIEWERS' CONCLUSIONS: Based on the present data, oral treatment is an acceptable alternative to intravenous antibiotic treatment in febrile neutropenic cancer patients (excluding patients with acute leukaemia) who are haemodynamically stable, without organ failure, not having pneumonia, infection of a central line or a severe soft-tissue infection. The wide confidence interval for mortality allows the present use of oral treatment in groups of patients with an expected low risk for mortality, and further research should be aimed at clarifying the definition of low risk patients.

Administration, Oral↗
PubMed2000

Zuclopenthixol decanoate for schizophrenia and other serious mental illnesses.

BACKGROUND: There is a clear link between stopping antipsychotic medications and a relapse of psychotic symptoms. A series of long-acting intra-muscular preparations has been developed since the 1960s in the hope of reducing the frequency of relapse and, hence, overall disability. These depot preparations, active for weeks at a time, are frequently used for those who find taking oral medication on a regular basis difficult or unacceptable. It has, however, been a consistent concern that any reduction in relapse rate afforded by depot preparations may be offset by an increase in adverse effects such as drug-induced movement disorders. OBJECTIVES: To compare zuclopenthixol decanoate to oral zuclopenthixol and other antipsychotic preparations for the treatment of schizophrenia and similar serious mental illness. SEARCH STRATEGY: Electronic searches of Biological Abstracts (1982-1998), CINAHL (1982-1998), The Cochrane Library (Issue 2, 1998), The Cochrane Schizophrenia Group's Register (April 1998), EMBASE (1980-1998), MEDLINE (1966-1998), and PsycLIT (1974-1998) were searched. References of all eligible studies were searched for further trials. The manufacturer of zuclopenthixol was contacted. SELECTION CRITERIA: Inclusion criteria were that the clinical study should be randomised, focus on people with schizophrenia or other serious mental illness with psychotic symptoms, and compare the use of zuclopenthixol decanoate to oral zuclopenthixol or other antipsychotic preparations. DATA COLLECTION AND ANALYSIS: Data was extracted independently by two reviewers (EC, MF). Authors of trials were contacted for additional and missing data. Odds ratios (ORs) and 95% confidence intervals (CIs) of homogenous dichotomous data were calculated with the Peto method. Where possible the number needed to treat (NNT) and its 95% confidence interval was also calculated. MAIN RESULTS: Four studies relating to zuclopenthixol decanoate were included. All compared zuclopenthixol decanoate with other depot preparations. Zuclopenthixol decanoate prevented or postponed relapses when compared to other depots (NNT 8, CI 5-53). However, zuclopenthixol decanoate may induce more adverse effects (NNH 5, CI 3-31) although it decreases need for anticholinergic medication when compared to a group of other depot preparations (NNT 9, CI 5-38). For the risk of leaving the study early, there was also a trend for benefit to those allocated to zuclopenthixol decanoate. None of the studies reported outcomes on service utilisation, costs, or quality of life. REVIEWER'S CONCLUSIONS: Choice of which depot to use must always take into account clinical judgement and the preferences of the recipients of care and their carers. Limited trial data suggests, however, that there are real differences between zuclopenthixol decanoate and other depots and these differences largely favour the former. This review highlights the need for good controlled clinical trials to fully address the effects of zuclopenthixol decanoate for those with schizophrenia. Future studies should report service utilisation data, as well as satisfaction with care and economic outcomes. Duration of such trials should be of a longer duration than the included studies (12 months or more).

Administration, Oral↗
PubMed2006

Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children.

BACKGROUND: Otitis media with effusion (OME) is common and may cause hearing loss with associated developmental delay. Treatment remains controversial. OBJECTIVES: To examine evidence for or against treating children with hearing loss associated with OME with systemic or topical intranasal steroids. SEARCH STRATEGY: We searched the Cochrane Ear, Nose and Throat Disorders Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library Issue 4 2005, MEDLINE (1966 to 2006), EMBASE (1974 to 2006), and the CINAHL, LILACS, Zetoc, IndMED, SAMED, KoreaMed, MEDCARIB and Cambridge Scientific Abstracts databases in January 2006. SELECTION CRITERIA: Randomised controlled trials of oral and topical intranasal steroids, either alone or in combination with another agent such as an antibiotic, were included. EXCLUSIONS: publications in abstract form only; uncontrolled, non-randomised or retrospective studies; studies reporting outcomes with ears (rather than children). DATA COLLECTION AND ANALYSIS: Data were extracted from the published reports by the authors independently using standardised data extraction forms and methods. The methodological quality of the included studies was independently assessed by the authors as described in the Cochrane Handbook. Dichotomous results were expressed as an odds ratio using a fixed-effect model together with the 95% confidence intervals. Continuous data were analysed using the weighted mean difference in a fixed-effect model. Tests for heterogeneity between studies were performed using a Mantel-Haenszel approach. In trials with a cross-over design, post cross-over treatment data were not used. MAIN RESULTS: No study prospectively documented hearing loss associated with OME prior to randomisation. Follow up was mainly short term. The odds ratio for OME persisting after short-term follow up in children treated with oral steroids compared to control was 0.22 (95% CI 0.08 to 0.63). The odds ratio for OME persisting after short-term follow up for children treated with oral steroids plus antibiotic compared to control plus antibiotic was 0.37 (95% CI 0.25 to 0.56). However, there was significant heterogeneity between studies included in the latter comparison (P < 0.01). Trends favoured steroids for most other comparisons, but confidence intervals included unity. There was no evidence of benefit for steroid treatment for OME or hearing loss associated with OME in the longer term. AUTHORS' CONCLUSIONS: Both oral and topical intranasal steroids alone or in combination with an antibiotic lead to a quicker resolution of OME in the short term, however, there is no evidence of longer term benefit.

Administration, Intranasal↗
PubMed2006

Oral versus intravenous rehydration for treating dehydration due to gastroenteritis in children.

BACKGROUND: Dehydration associated with gastroenteritis is a serious complication. Oral rehydration is an effective and inexpensive treatment, but some physicians prefer intravenous methods. OBJECTIVES: To compare oral with intravenous therapy for treating dehydration due to acute gastroenteritis in children. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (March 2006), CENTRAL (The Cochrane Library 2006, Issue 1), MEDLINE (1966 to March 2006), EMBASE (1974 to March 2006), LILACS (1982 to March 2006), and reference lists. We also contacted researchers, pharmaceutical companies, and relevant organizations. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials comparing intravenous rehydration therapy (IVT) with oral rehydration therapy (ORT) in children up to 18 years of age with acute gastroenteritis. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed quality using the Jadad score. We expressed dichotomous data as a risk difference (RD) and number needed to treat (NNT), and continuous data as a weighted mean difference (WMD). We used meta-regression for subgroup analyses. MAIN RESULTS: Seventeen trials (1811 participants), of poor to moderate quality, were included. There were more treatment failures with ORT (RD 4%, 95% confidence interval (CI) 1 to 7, random-effects model; 1811 participants, 18 trials; NNT = 25). Six deaths occurred in the IVT group and two in the ORT groups (4 trials). There were no significant differences in weight gain (369 participants, 6 trials), hyponatremia (248 participants, 2 trials) or hypernatremia (1062 participants, 10 trials), duration of diarrhea (960 participants, 8 trials), or total fluid intake at six hours (985 participants, 8 trials) and 24 hours (835 participants, 7 trials). Shorter hospital stays were reported for the ORT group (WMD -1.20 days, 95% CI -2.38 to -0.02 days; 526 participants, 6 trials). Phlebitis occurred more often in the IVT group (NNT 50, 95% CI 25 to 100) and paralytic ileus more often in the ORT group (NNT 33, 95% CI 20 to 100, fixed-effect model), but there was no significant difference between ORT using the low osmolarity solutions recommended by the World Health Organization and IVT (729 participants, 6 trials). AUTHORS' CONCLUSIONS: Although no clinically important differences between ORT and IVT, the ORT group did have a higher risk of paralytic ileus, and the IVT group was exposed to risks of intravenous therapy. For every 25 children (95% CI 14 to 100) treated with ORT one would fail and require IVT.

Administration, Oral↗
PubMed2006

Early erythropoietin for preventing red blood cell transfusion in preterm and/or low birth weight infants.

BACKGROUND: Hematocrit falls after birth in preterm infants due to physiological factors and blood letting. Low plasma levels of erythropoietin (EPO) in preterm infants provide a rationale for the use of EPO to prevent or treat anemia. OBJECTIVES PRIMARY OBJECTIVE: To assess the effectiveness and safety of early initiation of EPO (initiated before eight days after birth) in reducing red blood cell transfusions in preterm and/or low birth weight infants. SECONDARY OBJECTIVES: Subgroup analyses of low (< 500 IU/kg/week) and high (> 500 IU/kg/week) doses of EPO and, within these subgroups, analyses of the use of low (< 5 mg/kg/day) and high (> 5 mg/kg/day) doses of supplemental iron, in reducing red blood cell transfusions in these infants. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), MEDLINE, EMBASE, CINAHL, abstracts from scientific meetings published in Pediatric Research and reference lists of identified trials and reviews were searched in November 2005. No language restrictions were applied. SELECTION CRITERIA: Randomised or quasi-randomized controlled trials of early initiation of EPO treatment (started before 8 days of age) vs. placebo or no intervention in preterm (< 37 weeks) and/or low birth weight (< 2500 g) neonates. For inclusion, the studies needed to provide information on at least one outcome of interest. DATA COLLECTION AND ANALYSIS: Data were abstracted by the two authors on pre-tested data collection forms. Data were entered by one review author (AO) and checked for accuracy by the other (SA). Data were analysed using RevMan 4.2.8. The statistical methods included 'typical' relative risk (RR), risk difference (RD), number needed to treat to benefit (NNTB) and needed to treat to harm (NNTH) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes reported with their 95% confidence intervals (CI). A fixed effects model was used for meta-analyses. Heterogeneity tests, including the I(-)squared (I(2)) statistic, were performed to assess the appropriateness of pooling the data. MAIN RESULTS: Twenty-three studies enrolling 2074 preterm infants in 18 countries were included in the review. All studies except one applied transfusion guidelines. The quality of the trials varied. Most trials were of small sample size. Only one study clearly stated that infants were excluded if they had received red blood cell transfusion prior to study entry (Arif 2005). A total of 16 studies, including 1825 infants reported on the primary outcome of "use of one or more red cell transfusions". The summary estimates were significant [typical RR; 0.80 (95% CI 0.75, 0.86); typical RD; -0.13 (95% CI -0.17, -0.09); typical NNTB; 8 (95% CI 6, 11)]. There was statistically significant heterogeneity [for RR (p< 0.004), I(2) = 56.7%; for RD (p = 0.003), I(2 ) = 56.0%]. Similar results were obtained in secondary analyses based on different combinations of high doses of EPO and high and low iron supplementation. There were insufficient data to draw conclusions for low doses EPO in combination with high or low dose of iron. Two studies (n = 188) reported a significant reduction in the number of donors to whom the infant was exposed [typical WMD; -0.63 (95% CI -1.07, -0.19)]. A significant reduction in the total volume (ml/kg) of blood transfused per infant [typical WMD; -6 ml (95% CI -1, -11)] and in the number of transfusions per infant [typical WMD -0.27 (95% CI -0.12, -0.42 )] was noted. There was a significant increase in the risk of stage > 3 retinopathy of prematurity (ROP) in the EPO group [typical RR; 1.71 (95% CI 1.15, 2.54); typical RD; 0.05 (95% CI 0.01, 0.09); NNTH; 20 (95% CI 11, 100)]. The non-significant results for ROP (any stage reported) showed a similar trend. The increased risk for ROP may be associated with use of higher doses of supplemental of iron in the EPO group than in the control group. The rates for mortality, sepsis, intraventricular haemorrhage, periventricular leukomalacia, necrotizing enterocolitis, bronchopulmonary dysplasia, neutropenia, hypertension, length of hospital stay or long-term neurodevelopmental outcomes were not significantly change by the administration of EPO. AUTHORS' CONCLUSIONS: Early administration of EPO reduces the use one or more red blood cell transfusions, the volume of red blood cells transfused, and the number of donors and transfusions the infant is exposed to following study entry. The small reductions are of limited clinical importance. Any donor exposure is likely not avoided as most studies included infants, who had received red cell transfusions prior to trial entry. There was a significant increase in the rate of ROP (stage >3). Animal data and observational studies in humans support a possible association between treatment with EPO and the development of ROP. EPO does not significantly decrease or increase any of the other important neonatal adverse outcomes including mortality. The incidence of ROP should be ascertained in the studies that have already been conducted but did not report on this outcome. Any ongoing research should deal with the issue of ROP and evaluate the current clinical practice that will limit donor exposure through satellite units. Research efforts should focus on limiting donor exposure (to as few donors as possible) during the first few days of life in sick neonates, when red blood cell transfusions are most likely to be required and cannot be prevented by early (or late) EPO treatment. Due to the limited benefits and the increased risk of ROP, early administration of EPO is not recommended.

Age Factors↗
PubMed2005

Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials.

OBJECTIVE: To determine the efficacy and tolerability of topical pimecrolimus and tacrolimus compared with other treatments for atopic dermatitis. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Electronic searches of the Cochrane Library, Medline, and Embase. STUDY SELECTION: Randomised controlled trials of topical pimecrolimus or tacrolimus reporting efficacy outcomes or tolerability. DATA EXTRACTION EFFICACY: investigators' global assessment of response; patients' global assessment of response; proportions of patients with flares of atopic dermatitis; and improvements in quality of life. Tolerability: overall rates of withdrawal; withdrawal due to adverse events; and proportions of patients with burning of the skin and skin infections. DATA SYNTHESIS: 4186 of 6897 participants in 25 randomised controlled trials received pimecrolimus or tacrolimus. Both drugs were significantly more effective than a vehicle control. Tacrolimus 0.1% was as effective as potent topical corticosteroids at three weeks and more effective than combined treatment with hydrocortisone butyrate 0.1% (potent used on trunk) plus hydrocortisone acetate 1% (weak used on face) at 12 weeks (number needed to treat (NNT) = 6). Tacrolimus 0.1% was also more effective than hydrocortisone acetate 1% (NNT = 4). In comparison, tacrolimus 0.03% was more effective than hydrocortisone acetate 1% (NNT = 5) but less effective than hydrocortisone butyrate 0.1% (NNT = -8). Direct comparisons of tacrolimus 0.03% and tacrolimus 0.1% consistently favoured the higher strength formulation, but efficacy differed significantly between the two strengths only after 12 weeks' treatment (rate ratio 0.80, 95% confidence interval 0.65 to 0.99). Pimecrolimus was far less effective than betamethasone valerate 0.1% (NNT = -3 at three weeks). Pimecrolimus and tacrolimus caused significantly more skin burning than topical corticosteroids. Rates of skin infections in any of the comparisons did not differ. CONCLUSIONS: Both topical pimecrolimus and topical tacrolimus are more effective than placebo treatments for atopic dermatitis, but in the absence of studies that show long term safety gains, any advantage over topical corticosteroids is unclear. Topical tacrolimus is similar to potent topical corticosteroids and may have a place for long term use in patients with resistant atopic dermatitis on sites where side effects from topical corticosteroids might develop quickly. In the absence of key comparisons with mild corticosteroids, the clinical need for topical pimecrolimus is unclear. The usefulness of either treatment in patients who have failed to respond adequately to topical corticosteroids is also unclear.

Administration, Topical↗
PubMed2006

Topical treatments for cutaneous warts.

BACKGROUND: Viral warts are common and usually harmless but very troublesome. A very wide range of local treatments are used. OBJECTIVES: To assess the effects of different local treatments for cutaneous, non-genital warts in healthy people. SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register (March 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to March 2005), EMBASE (1980 to March 2005) and a number of other biomedical databases. The references of all trials and selected review articles were also searched. In addition, we contacted pharmaceutical companies involved in local treatments for warts and experts in the field SELECTION CRITERIA: Randomised controlled trials of local treatments for cutaneous non-genital viral warts in immunocompetent (healthy) people. DATA COLLECTION AND ANALYSIS: Data was extracted and two authors independently selected the trials and assessed methodological quality. MAIN RESULTS: Sixty trials were identified that fulfilled the criteria for inclusion. The evidence provided by these studies was generally weak due to poor methodology and reporting. In 21 trials with placebo groups that used participants as the unit of analysis, the average cure rate of placebo preparations was 27% (range 0 to 73%) after an average period of 15 weeks (range 4 to 24 weeks). The best available evidence was for simple topical treatments containing salicylic acid, which were clearly better than placebo. Data pooled from five placebo-controlled trials showed a cure rate of 117/160 (73%) compared with 78/162 (48%) in controls, which translates to a risk ratio of 1.60 (95% confidence interval 1.16 to 2.23), using a random effects model. Evidence for the absolute efficacy of cryotherapy was surprisingly lacking. Two trials comparing cryotherapy with salicylic acid and one comparing duct tape with cryotherapy showed no significant difference in efficacy. Evidence for the efficacy of the remaining treatments reviewed was limited. AUTHORS' CONCLUSIONS: There is a considerable lack of evidence on which to base the rational use of topical treatments for common warts. The reviewed trials are highly variable in method and quality. Cure rates with placebo preparations are variable but nevertheless considerable. There is certainly evidence that simple topical treatments containing salicylic acid have a therapeutic effect. There is less evidence for the efficacy of cryotherapy, but reasonable evidence that it is only of equivalent efficacy to simpler and safer treatments. The benefits and risks of topical dinitrochlorobenzene and 5-fluorouracil, intralesional bleomycin and interferons, photodynamic therapy and other miscellaneous treatments remain to be determined.

Administration, Topical↗
PubMed2005

Oral 5-aminosalicylic acid for maintenance of medically-induced remission in Crohn's Disease.

BACKGROUND: Prevention of relapses is a major issue in the management of Crohn's disease. Corticosteroids, the mainstay of treatment of acute exacerbations are not effective in the maintenance of remission and its chronic use is limited by numerous adverse events. A number of randomised controlled trials comparing various 5-ASA agents with either placebo or other drugs have had conflicting results. OBJECTIVES: To conduct a systematic review to evaluate the efficacy of oral 5-ASA agents for the maintenance of medically-induced remission in Crohn's disease. SEARCH STRATEGY: We searched MEDLINE (1966 to January 2004), EMBASE (1984-January 2004), the Cochrane Central Register of Controlled Trials from the Cochrane Library (Issue 1, 2004) and the IBD Review Group Specialized Trials Register. We hand-searched the articles cited in each publication. SELECTION CRITERIA: We included randomised controlled trials which compared oral 5-ASA agents with either placebo or sulphasalazine, with treatment durations of at least 6 months. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of methodological quality of each study were independently performed by two reviewers. Any disagreement among reviewers was resolved by consensus. The main outcome measure was the occurrence of relapse as defined by the primary studies. Odds ratios of relapse rates and their 95% confidence intervals were calculated. MAIN RESULTS: 5-ASA VERSUS PLACEBO. In the main analysis, we used as the denominator the total number of patients randomised. We assumed that participants who dropped out of the study, and on whom there was no post withdrawal information, had relapsed during the study period. Using the fixed effects model, the odds ratio for 6 studies where participants were followed up for 12 months was 1.00 (95%CI, 0.80 to 1.24). Using the random effects model in a sensitivity analysis had little effect on the results with an OR of 0.93 (95% CI, 0.65 to 1.33). For the seventh study where follow up was for 24 months, the odds ratio was 0.98; 95% CI, 0.51 to 1.90. In further sensitivity analyses, we analysed only participants who completed the study and ignored the dropouts. The odds ratio (fixed effects model) for the 6 studies where follow up was for 12 months was 0.74 (95% CI, 0.57 to 0.96), but using the random effects model, the OR was 0.68 (95% CI 0.45 to 1.02). The OR for the seventh study where follow up was for 24 months (Gendre 1993a), was 0.86; 95% CI, 0.42 to 1.78. 5-ASA VERSUS SULPHASALAZINE. We did not find any study that satisfied the inclusion criteria. AUTHORS' CONCLUSIONS: We found no evidence in this review to suggest that 5-ASA preparations are superior to placebo for the maintenance of medically-induced remission in patients with Crohn's disease. Therefore it appears that additional randomised trials of this regime are not justified.

Administration, Oral↗
PubMed2003

Systematic review of isolation policies in the hospital management of methicillin-resistant Staphylococcus aureus: a review of the literature with epidemiological and economic modelling.

OBJECTIVE: To review the evidence for the effectiveness of different isolation policies and screening practices in reducing the incidence of methicillin-resistant Staphylococcus aureus (MRSA) colonisation and infection in hospital in-patients. To develop transmission models to study the effectiveness and cost-effectiveness of isolation policies in controlling MRSA. DATA SOURCES: MEDLINE, EMBASE, CINAHL, The Cochrane Library and SIGLE (1966-2000). Hand-searching key journals. No language restrictions. REVIEW METHODS: Key data were extracted from articles reporting MRSA-related outcomes and describing an isolation policy in a hospital with epidemic or endemic MRSA. No quality restrictions were imposed on studies using isolation wards (IW) or nurse cohorting (NC). Other studies were included if they were prospective or employed planned comparisons of retrospective data. Stochastic and deterministic models investigated long-term transmission dynamics, studying the effect of a fixed capacity IW, producing economic evaluations using local cost data. RESULTS: A total of 46 studies were accepted: 18 IWs, 9 NC, 19 other isolation policies. Most were interrupted time series, with few planned formal prospective studies. All but one reported multiple interventions. Consideration of potential confounders, measures to prevent bias, and appropriate statistical analysis were mostly lacking. No conclusions could be drawn in a third of studies. Most others provided evidence consistent with reduction of MRSA acquisition. Six long interrupted time series provided the strongest evidence. Four of these provided evidence that intensive control measures which included patient isolation were effective in controlling MRSA. In two others IW use failed to prevent endemic MRSA. There was no robust economic evaluation. Models showed that improving the detection rate or ensuring adequate isolation capacity reduced endemic levels, with substantial savings achievable. CONCLUSIONS: Major methodological weaknesses and inadequate reporting in published research mean that many plausible alternative explanations for reductions in MRSA acquisition associated with interventions cannot be excluded. No well-designed studies allow the role of isolation measures alone to be assessed. Nonetheless, there is evidence that concerted efforts that include isolation can reduce MRSA even when endemic. Little evidence was found to suggest that current isolation measures recommended in the UK are ineffective, and these should continue to be applied until further research establishes otherwise. The studies with the strongest evidence, together with the results of the modelling, provide testable hypotheses for future research. Guidelines to facilitate design of future research are produced.

Cost-Benefit Analysis↗
PubMed2000

Vaginal misoprostol for cervical ripening and labour induction in late pregnancy.

BACKGROUND: Although not yet registered for such use, misoprostol has been widely used for obstetric and gynaecological indications, such as induction of abortion and of labour. OBJECTIVES: The objective of this review was to assess the effects of vaginal misoprostol for third trimester cervical ripening or induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and reference lists of articles were searched. SELECTION CRITERIA: Randomised trials comparing vaginal misoprostol with other methods of cervical ripening or labour induction, placebo or no treatment in women due for third trimester induction of labour. DATA COLLECTION AND ANALYSIS: Trial quality assessment and data extraction were done by both reviewers. MAIN RESULTS: Twenty-six studies were included. Compared to placebo, misoprostol was associated with increased cervical ripening (relative risk of unfavourable or unchanged cervix after 12 to 24 hours with misoprostol 0.20, 95% confidence interval 0.07 to 0.61). It was also associated with a reduced need for oxytocin (relative risk 0.47, 95% confidence interval 0.23 to 0.96). Misoprostol was more effective than prostaglandin E2 for labour induction (relative risk of failure to achieve vaginal delivery in 24 hours 0.70, 95% confidence interval 0.62 to 0.79). Oxytocin augmentation was used less often with misoprostol than with prostaglandin E2 (relative risk 0.64, 95% confidence interval 0.58 to 0.71). Uterine hyperstimulation and meconium stained liquor were more common with misoprostol than with prostaglandin E2. Lower doses of misoprostol compared to higher doses did not show significant differences except for more need for oxytocin augmentation and less uterine hyperstimulation without fetal heart rate changes. REVIEWER'S CONCLUSIONS: Vaginal misoprostol appears to be more effective in inducing labour than conventional methods of cervical ripening and labour induction. The apparent increase in uterine hyperstimulation is of concern. The studies were not large enough to exclude the possibility of rare but serious adverse effects.

Cervical Ripening↗
PubMed2002

Drug management for acute tonic-clonic convulsions including convulsive status epilepticus in children.

BACKGROUND: Tonic-clonic (grand mal) convulsions and convulsive status epilepticus (currently defined as a grand mal convulsion lasting at least 30 minutes) are medical emergencies and demand urgent and appropriate anticonvulsant treatment. Diazepam, lorazepam, phenobarbitone, phenytoin and paraldehyde may all be regarded as drugs of first choice. OBJECTIVES: To review the evidence comparing diazepam, lorazepam, phenobarbitone, phenytoin and paraldehyde in treating acute tonic-clonic convulsions and convulsive status epilepticus in children. SEARCH STRATEGY: We searched the Cochrane Epilepsy Group's specialized register (4 July 2002); the Cochrane Controlled Trials Register (Cochrane Library Issue 2, 2002); MEDLINE (28 May 2002) and EMBASE (January 2002). SELECTION CRITERIA: Randomized controlled trials comparing lorazepam and other anticonvulsant drugs used for the treatment of convulsive status epilepticus in children. DATA COLLECTION AND ANALYSIS: This was a review of published, aggregate data. The main outcome measures included cessation of the presenting tonic-clonic convulsion/episode of convulsive status epilepticus; the number of additional drugs required to stop the convulsion; people demonstrating respiratory depression and people requiring admission to the intensive care unit because of respiratory depression. MAIN RESULTS: Only one trial was found, in which children were allocated lorazepam or diazepam. The main results are as follows. (1) One or two intravenous doses stopped the convulsion in 19 of 27 (70%) lorazepam and 22 of the 34 (65%) intravenous diazepam-treated children. The relative risk (RR) with 95% confidence intervals (CIs) was 1.09(95% CI 0.77 to 1.54). A single dose of rectal lorazepam stopped the convulsion in six of six, compared to six of 19 children treated with rectal diazepam, RR 3.17(95% CI 1.63 to 6.14). (2) Six of the 27 (22%) intravenous lorazepam and 12 of the 34 (35%) intravenous diazepam-treated children respectively, experienced a further convulsion within 24 hours after presentation RR 0.63(95% CI 0.27 to 1.46). (3) Only one of 27 children (4%) who received intravenous lorazepam compared to five of 34 children (15%) who received intravenous diazepam required additional antiepileptic drugs to terminate the presenting seizure RR 0.25(95% CI 0.03 to 2.03). (4) A lower incidence of respiratory depression occurred in the lorazepam-treated group: one of 27 (4%) children compared to seven of 34 in the diazepam-treated group (21%), RR 0.21(95% CI 0.02 to 1.37). REVIEWER'S CONCLUSIONS: This review provides no evidence to suggest that intravenous lorazepam should be preferred to diazepam as the first-line drug in treating acute tonic-clonic convulsions including convulsive status epilepticus in children. There was some evidence from this review that rectal lorazepam may be more effective and safer than rectal diazepam, but the data were insufficient to indicate that lorazepam should replace diazepam as the first choice rectal drug in treating acute tonic-clonic convulsions and convulsive status epilepticus.

Administration, Rectal↗
PubMed2002

Ursodeoxycholic acid for primary biliary cirrhosis.

BACKGROUND: Primary biliary cirrhosis is a rare autoimmune liver disease and an effective treatment has been difficult to establish. Some randomised clinical trials have found an effect of ursodeoxycholic acid for primary biliary cirrhosis. OBJECTIVES: Evaluate the beneficial effects and adverse effects of peroral ursodeoxycholic acid for primary biliary cirrhosis versus placebo or no intervention. SEARCH STRATEGY: The Controlled Trials Register of The Cochrane Hepato-Biliary Group, The Cochrane Library, MEDLINE, EMBASE and the full text of the identified studies were searched until April 2001. The electronic searches were done by entering the search terms 'ursodeoxycholic acid', 'UDCA', 'primary biliary cirrhosis', and 'PBC'. SELECTION CRITERIA: Randomised clinical trials evaluating ursodeoxycholic acid administered perorally at any dose versus placebo or no intervention in patients with primary biliary cirrhosis diagnosed by any method. Only trials using an adequate method for randomisation were included, regardless of blinding and language. DATA COLLECTION AND ANALYSIS: The methodologic quality of the randomised clinical trials was evaluated by components and the Jadad-score. The following outcomes were extracted: mortality, liver transplantation, pruritus, other clinical symptoms (jaundice, portal pressure, (bleeding) oesophageal varices, ascites, hepatic encephalopathy, hepato-renal syndrome, autoimmune conditions), liver biochemistry, liver function, liver biopsy findings, quality of life, and adverse events. All analyses were performed according to the intention-to-treat method. MAIN RESULTS: A total of 16 randomised clinical trials evaluating ursodeoxycholic acid against placebo (n = 15) or no intervention (n = 1) in 1422 patients were identified. The median Jadad-score was 3 (range 1-5). A number of trials described as double blind had problems with the blinding. Neither mortality (odds ratio = 0.94; 95% confidence interval (CI) 0.60 to 1.48), liver transplantation (odds ratio = 0.83; 95% CI 0.52 to 1.32), mortality or liver transplantation (odds ratio = 0.90; 95% CI 0.65 to 1.26), pruritus, fatigue, autoimmune conditions, quality of life, liver histology, or portal pressure were significantly affected by ursodeoxycholic acid (given in doses of 8-15 mg/kg/day for three months to five years). However, ursodeoxycholic acid significantly (P < 0.05) reduced ascites, jaundice, and biochemical variables such as serum bilirubin and liver enzymes. Ursodeoxycholic acid was not significantly associated with adverse events. Including data after patients had been switched onto open label ursodeoxycholic acid confirmed the findings regarding the lack of a significant effect of ursodeoxycholic acid on mortality and mortality or liver transplantation. A significant (P = 0.04) effect was, however, observed on the incidence of liver transplantation (odds ratio = 0.68; 95% CI 0.48 to 0.98). REVIEWER'S CONCLUSIONS: Ursodeoxycholic acid has a marginal therapeutic effect for primary biliary cirrhosis. On the positive side, ursodeoxycholic acid has few side effects. The general usage of ursodeoxycholic acid for primary biliary cirrhosis needs reevaluation.

Administration, Oral↗