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PubMed2000

Minimal enteral nutrition for promoting feeding tolerance and preventing morbidity in parenterally fed infants.

BACKGROUND: Because of concern that feedings may increase the risk of necrotizing enterocolitis, some high-risk infants have received prolonged periods of parenteral nutrition without enteral feedings. Providing minimal enteral feedings during this period of parenteral nutrition was developed as a strategy to enhance feeding tolerance and decrease time to reach full feedings. OBJECTIVES: For high-risk neonates receiving parenteral feedings, to assess the effect of minimal enteral nutrition (MEN) compared to no enteral nutrient intake on measures of feeding tolerance and neonatal outcome. SEARCH STRATEGY: Searches were performed of the Oxford Database of Perinatal Trials, MEDLINE, abstracts and conference proceedings, references from relevant publications in the English language, and studies identified by personal communication. SELECTION CRITERIA: Only randomized or quasi-randomized clinical trials were considered. Trials were included if they enrolled high-risk infants randomly assigned to receive minimal enteral feedings (defined as dilute or full strength feedings providing <= 25 kcal/kg/d for >= 5d) or no enteral nutrient intake (no feedings or water only). DATA COLLECTION AND ANALYSIS: The two reviewers reached consensus for inclusion of trials. Data regarding clinical outcomes were extracted and evaluated by the two reviewers independently of each other. Authors were contacted as needed and feasible to clarify or provide missing data. The specific data that were needed were requested in writing. MAIN RESULTS: Among infants given minimal enteral nutrition (MEN), there was an overall reduction in days to full enteral feeding, total days that feedings were held, and total hospital stay. There was no discernible effect on necrotizing enterocolitis. REVIEWER'S CONCLUSIONS: The evidence of benefit from MEN in these analyses is not convincing for a variety of reasons--the inherent difficulty of assessing enteral feedings in high-risk infants, the small size and methodologic limitations of the studies to date, unexplained heterogeneity with respect to some of the apparent benefits, the potential for bias to affect the findings in unblinded studies, and the unexcluded possibility that MEN might increase necrotizing enterocolitis. For these reasons, it is unclear whether MEN should be used in lieu of an equal period of time without enteral feedings.

Enteral Nutrition↗
PubMed2005

Trophic feedings for parenterally fed infants.

BACKGROUND: Because of concern that feedings may increase the risk of necrotizing enterocolitis, some high-risk infants have received prolonged periods of parenteral nutrition without enteral feedings. Providing trophic feedings (small volume feedings given at the same rate for at least 5 days) during this period of parenteral nutrition was developed as a strategy to enhance feeding tolerance and decrease time to reach full feedings. Whether trophic feedings result in better outcomes than initially withholding feedings or providing progressively increasing feedings can be established only in proper clinical trials. OBJECTIVES: 1. For high-risk neonates receiving parenteral feedings, to assess the effect of trophic feeding compared to no enteral nutrient intake on measures of feeding tolerance and neonatal outcome.2. For high-risk neonates receiving parenteral feedings to assess the effect of trophic feedings compared to a specific initial feeding regimen involving a greater enteral nutrient intake on measures of feeding tolerance and neonatal outcome. SEARCH STRATEGY: Searches were performed of MEDLINE (1966 - June 2004), CINAHL (1982 - June 2004), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2004), abstracts and conference proceedings, references from relevant publications in the English language, and studies identified by personal communication. SELECTION CRITERIA: Only randomized or quasi-randomized clinical trials were considered. Trials were included if they enrolled high-risk infants randomly assigned to receive trophic feedings (defined as dilute or full strength feedings providing < = 25 kcal/kg/d for > = 5d) compared to either 1) no enteral nutrient intake (no feedings or water only) or 2) a specific feeding regimen involving a greater enteral intake of formula or human milk than with trophic feedings. DATA COLLECTION AND ANALYSIS: The two reviewers reached consensus for inclusion of trials. Data regarding clinical outcomes were extracted and evaluated by the two reviewers independently of each other. Authors were contacted as needed and feasible to clarify or provide missing data. The specific data that were needed were requested in writing. MAIN RESULTS: 1. Trophic feedings vs. no feedings (10 trials): Among infants given trophic feedings, there was an overall reduction in days to full feeding (weighted mean difference [WMD] = -2.6 [95% confidence limits = -4.1, -1.0]), total days that feedings were held (WMD = -3.1 [-4.6, -1.6]), and total hospital stay (WMD = -11.4 [-17.2, -5.7] compared to infants given no enteral nutrient intake. Tests for heterogeneity were significant in analyses of days to full enteral feedings, days to regain birth weight, days of phototherapy, and hospital stay. There was no significant difference in necrotizing enterocolitis, although the findings do not exclude an important effect (relative risk = 1.16 [0.75, 1.79]; risk difference = 0.02 [-0.03, 0.06].2. Trophic feedings vs. advancing feedings (one trial): Infants given trophic feedings required more days to reach full enteral feeding (13.4 [8.2, 18.6]) and tended to have a longer hospital stay (11.0 [-1.4, 23.4]) than did infants given advancing feedings. With only eight total cases of necrotizing enterocolitis, trophic feedings were associated with a marginally significant reduction in necrotizing enterocolitis (relative risk =0.14 [0.02, 1.07]; risk difference = -0.09 [-0.16, -0.01]. AUTHORS' CONCLUSIONS: In both comparisons, the group with the greater enteral intake (trophic feedings in the first comparison and advancing feedings in the second comparison) required significantly less time to reach full feedings and had a significant or near significant reduction in hospital stay. In both comparisons, the group with the greater intake also had a higher incidence of necrotizing enterocolitis although the difference was not statistically significant. The concern is greatest for the advancing feeding regimen. Even when trophic feedings were compared to no feedings, the relative risk for necrotizing enterocolitis was 1.16 (0.75 - 1.79), a finding consistent with a 16% increase in necrotizing enterocolitis and a number needed to harm of 50. A true increase of this magnitude might outweigh any short- or long-term benefits of trophic feedings. Moreover, the 95% confidence interval does not exclude the possibility that trophic feedings increase necrotizing enterocolitis by as much as 79% with a number needed to harm of 17. Whether no feedings, trophic feedings, or advancing feedings should initially be used is difficult to discern for a variety of reasons--the inherent difficulty of assessing enteral feedings in high-risk infants, the limited sample size and methodologic limitations of most studies to date, unexplained heterogeneity with respect to a number of outcomes, the potential for bias to affect the findings in unblinded studies, and the large number of infants who must be studied to assess the effect on necrotizing enterocolitis. One or more large, well designed, multi-center trials are needed to compare these approaches to early feeding with respect to important clinical outcomes. A conclusive evaluation would assess effects on not only the survival rate without necrotizing enterocolitis prior to discharge from the neonatal unit but also on the survival rate without severe gastrointestinal or neurodevelopmental disability at >= 18 months age.

Enteral Nutrition↗
PubMed2004

Interventions for isolated diaphyseal fractures of the ulna in adults.

BACKGROUND: Isolated fractures of the shaft of the ulna, which are often sustained when the forearm is raised to shield against a blow, are generally treated on an out-patient basis. OBJECTIVES: To assess the effects of various forms of treatment for isolated fractures of the ulnar shaft in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (November 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2003), MEDLINE (1966 to November week 2 2003), EMBASE (1981 to 2003 week 51) and CINAHL (1982 to December week 2 2003), Current Controlled Trials (accessed November 2003), the UK National Research Register (up to Issue 4, 2003 ), various conference proceedings and bibliographies of relevant articles. Date of the most recent search: December 2003. SELECTION CRITERIA: Randomised or quasi-randomised trials of conservative and surgical treatment of isolated fractures of the ulnar shaft in adults. Excluded were fractures of the proximal ulna and Monteggia fracture dislocations. DATA COLLECTION AND ANALYSIS: Independent quality assessment and data extraction were performed by the reviewers. Requests for more information were sent to trialists. Given the limited and generally poor quality evidence available, quantitative analysis was kept to a minimum. MAIN RESULTS: One new trial comparing two types of plates used for the surgical fixation of these fractures was included in the fifth update of this review. Thus there are now three trials, involving a total of 135 patients. All three trials were methodologically flawed, particularly the two trials of conservative treatment. One of these compared short arm pre-fabricated functional braces with long arm plaster casts. There was no statistically significant difference in the time it took for fracture union. Patient satisfaction and return to work were better in the brace group. The other, a quasi-randomised trial, compared Ace Wrap elastic bandage, short arm plaster cast and long arm plaster cast. The large loss to follow-up in this trial makes any data analysis tentative. However the need for replacement of the Ace wrap by other methods due to pain does indicate the potential for a serious problem with this intervention. There were no statistically significant differences in anatomical or functional outcomes nor complications between the two plate groups in the surgical trial. REVIEWERS' CONCLUSIONS: There is insufficient evidence from randomised trials to determine which method of treatment is the most appropriate for isolated fractures of the ulnar shaft in adults. There is a need to establish the incidence of this injury and the outcome and associated costs of the various forms of treatment. Well designed randomised trials of current forms of conservative treatment are recommended.

Adult↗
PubMed2006

Portosystemic shunts versus endoscopic therapy for variceal rebleeding in patients with cirrhosis.

BACKGROUND: Randomised clinical trials have compared portosystemic shunting procedures with endoscopic therapy for variceal haemorrhage, but there is no consensus as to which approach is preferable. OBJECTIVES: To compare the effects of shunts (total surgical shunt (TS); distal spleno-renal shunts (DSRS) or transjugular intrahepatic porto-systemic shunts (TIPS) with endoscopic therapy (ET, sclerotherapy and/or banding) for prevention of variceal rebleeding in patients with cirrhosis. SEARCH STRATEGY: The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Library, MEDLINE, EMBASE, conference proceedings, and the references of identified trials were searched (last search February 2004). Researchers in the field and in industry were contacted. SELECTION CRITERIA: Randomised clinical trials comparing TS, DSRS or TIPS with ET in patients who had recovered from a variceal haemorrhage and were known to be cirrhotic. DATA COLLECTION AND ANALYSIS: Data were collected to allow intention-to-treat analysis where possible. For each outcome, a pooled estimate of treatment effect (log hazard ratio for time to outcome, Peto odds ratio for binary outcomes, and differences in means for continuous outcomes) across trials was calculated. MAIN RESULTS: Twenty-two trials evaluating 1409 patients were included. All trials had problems of method. Shunt therapy compared with ET demonstrated significantly less rebleeding (OR 0.24, 95% CI 0.18 to 0.30) at the cost of significantly increased acute hepatic encephalopathy (OR 2.07, 95% CI 1.59 to 2.69) and chronic encephalopathy (OR 2.09, 95% CI 1.20 to 3.62). There were no significant differences regarding mortality (hazard ratio 1.00, 95% CI 0.82 to 1.21) and duration of in-patient stay (weighed mean difference 0.78 day, 95% CI -1.48 to 3.05). The proportion of patients with shunt occlusion or dysfunction was 3.1% (95% CI 0.4 to 10.7%) following TS (two trials), 7.8% (95% CI 3.8 to 13.9%) following DSRS (four trials), and 59% (range 18% to 72%) following TIPS (14 trials). AUTHORS' CONCLUSIONS: All shunts resulted in a significantly lower rebleeding rate at the expense of a higher incidence of encephalopathy. TIPS was complicated by a high incidence of shunt dysfunction. No survival advantage was demonstrated with any shunt.

Endoscopy↗
PubMed2000

Physical medicine modalities for mechanical neck disorders.

OBJECTIVES: Multiple physical medicine modalities are commonly included as part of therapeutic interventions for mechanical neck disorders (neck pain). The objective of this review was to assess the effects of physical medicine modalities for pain in adults with mechanical neck disorders. SEARCH STRATEGY: We searched Medline, Embase, Chirolars, Index to Chiropractic Literature, Cinahl, Science Citation Index, Conference Proceedings Index, National Technical Information Services and reference lists of the retrieved articles from 1985 to December 1993 and we contacted content experts. SELECTION CRITERIA: Randomised trials and controlled trials of physical medicine modalities in adults with mechanical neck disorder. DATA COLLECTION AND ANALYSIS: Three reviewers independently assessed trial quality and two reviewers independently extracted data. Investigators were contacted to obtain information or data that could not be found in the published reports. MAIN RESULTS: Thirteen trials were included. The overall quality of the included trials was generally good. Two trials using electromagnetic therapy produced a significant reduction in pain (p <0.01) with three to four weeks of daily (eight hours per day) therapy sessions; and three using laser therapy did not differ significantly from a placebo (p=0.20) for six to 10 sessions of treatment. Not enough scientific testing exists to clearly determine the effectiveness of other therapies. This includes treatments such as exercise, traction, acupuncture, heat / cold applications, electrotherapies, cervical orthoses and chronic pain / cognitive behavioural rehabilitation strategies. REVIEWER'S CONCLUSIONS: There is little information available from trials to support the use of physical medicine modalities for mechanical neck pain. There is some support for the use of electromagnetic therapy and against the use of laser therapy with respect to pain reduction.

Adult↗
PubMed2000

Patient education for mechanical neck disorders.

BACKGROUND: To track down the best estimate of efficacy of the various conservative management strategies for mechanical neck disorders, a four-part systematic review was prepared. Part four investigates the efficacy of patient education strategies as the therapeutic intervention. OBJECTIVES: This review of patient education is one of four reviews of conservative management of mechanical neck disorders. The other reviews address manual, physical and drug therapies. The objective of this review was to assess the effects of patient education for pain in adults with mechanical neck disorders. SEARCH STRATEGY: We searched Medline, Embase, Chirolars, Index to Chiropractic Literature, Cinahl, Science Citation Index, Conference Proceedings Index, National Technical Information Services from 1985 to December 1993, reference lists of the retrieved articles and we contacted experts in the field. SELECTION CRITERIA: Randomised trials or controlled clinical trials of patient educational strategies for adults with mechanical neck disorders. DATA COLLECTION AND ANALYSIS: Three reviewers independently assessed trial quality and two reviewers independently extracted data. Investigators were contacted to obtain data that could not be found in the published reports. MAIN RESULTS: Three trials were included. Their methodological quality varied from weak to strong. One trial did not find a significant reduction in pain using group instructional strategies (neck school) and exercise with or without psychological counselling compared to no treatment (standardised mean difference 0.07, 95% confidence interval -0.51 to 0.66, and -0.37, 95% confidence interval -0.95 to 0.22, respectively). Another trial did not find a significant reduction in pain using individualised patient education (advice), anti-inflammatories and analgesics compared with placebo (standardised mean difference 0.24, 95% confidence interval -0.58 to 1.07). The third trial found that advice which included demonstrated mobilization exercises, verbal and written instruction on posture correction, the use of a collar, heat sources, muscle relaxation and analgesics gave significant pain relief compared with general advice about mobilisation after a period of rest and use of analgesics at 4 weeks of treatment (standardised mean difference -0.62, 95% confidence interval -1.05 to -0.19) but at 6 weeks of treatment there was no longer any difference (s.m.d. -0.37, 95% confidence interval -0.8 to 0.05). The first two trials lacked statistical power and the third was methodologically weak. REVIEWER'S CONCLUSIONS: Patient education utilising individualised or group instructional strategies has not been shown to be beneficial in reducing pain for mechanical neck disorders.

Adult↗
PubMed2000

Newer atypical antipsychotic medication versus clozapine for schizophrenia.

BACKGROUND: Clozapine is an atypical antipsychotic drug, which is claimed to have superior efficacy and to cause fewer movement disorders. However, clozapine carries a significant risk of serious blood disorders. Newer atypical antipsychotics are safer alternatives that might share the benefits of clozapine. It is thus of interest to compare the effectiveness of newer atypical antipsychotics with the effectiveness of clozapine. OBJECTIVES: To evaluate the clinical effects of newer atypical antipsychotic drugs in comparison to clozapine for schizophrenia. SEARCH STRATEGY: Publications in all languages were searched from the following databases: Biological Abstracts/BIOSIS (1980-1999), The Cochrane Schizophrenia Group's Register of Trials (1998), The Cochrane Library CENTRAL Register (Issue 4, 1999), EMBASE (1980-1998), MEDLINE (1966-1999), LILACS/CD-ROM (1998), and PsycLIT/PsycINFO (1974-1999). Trials were also sought from recent conference proceedings and reference lists of included papers. Authors of recent trials and the manufacturers of clozapine, iloperidone, olanzapine, quetiapine, remoxipride, risperidone, sertindole, ziprasidone and zotepine were contacted. SELECTION CRITERIA: All randomised controlled trials comparing clozapine with newer atypical antipsychotic drugs were included by independent assessment by two reviewers. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers. Relative risks (RR) and 95% confidence intervals (CI) of homogenous dichotomous data were calculated. A random effects model was used for heterogeneous dichotomous data. Where possible the number needed to treat (NNT) statistic with 95%CI were also calculated. Weighted or standardised means were calculated for continuous data. Due to the small number of included studies, sensitivity analyses or funnel plot statistics were not undertaken for this version of the review. MAIN RESULTS: The current review includes eight studies (22 papers), of which three studies are 4-6 weeks in duration and only one study is of more than 12 weeks' duration. Newer atypical drugs seemed to be broadly similar to clozapine using a clinical global index or trialists' definitions of improvement, but this result was obtained from a relatively small number of studies. Due to the small number of studies and patients, wide confidence intervals were seen when their effectiveness as measured by symptom rating scales was compared. Social functioning was better in patients on newer atypical medication (risperidone) than in those on clozapine, but this finding is based on a single underpowered trial and has to be interpreted with caution. Clozapine and newer atypical drugs showed their adverse effect profile to be dissimilar: while clozapine produced more fatigue, hypersalivation, nausea, and orthostatic dizziness, new atypical drugs, with the exception of olanzapine, produced more extrapyramidal symptoms. The impact of these drugs and their effects on patients' day-to-day quality of life, service use, hospital admission, and pharmacoeconomics was not measured. REVIEWER'S CONCLUSIONS: The equal effectiveness and tolerability of new atypical drugs in comparison with clozapine is not yet demonstrated. Lack of statistical power to determine the comparative efficacy and effectiveness of newer atypical drugs makes it difficult to judge whether newer drugs are more effective, less effective or equivalent. Trials of sufficient power, with longer duration, measuring clinically important outcomes, are needed to assess the true comparative clinical effectiveness, tolerability and cost effectiveness of newer drugs in relation to clozapine.

Antipsychotic Agents↗
PubMed2004

Quetiapine for schizophrenia.

BACKGROUND: Quetiapine is an atypical antipsychotic with, theoretically, a low propensity for movement disorder adverse effects. It is used for the treatment of schizophrenia and other psychoses. OBJECTIVES: To determine the effects of quetiapine for schizophrenia in comparison to placebo, and other antipsychotics. SEARCH STRATEGY: Electronic searches of the Cochrane Schizophrenia Group's Register of Trials (February 2003), Biological Abstracts (1982-2000), CINAHL (1982-2000), the Cochrane Library (2000, Issue 1),EMBASE (1980-2000), MEDLINE (1966-2000), PsycLIT (1974-2000), SIGLE on CD (1980-1997), SocioFile (1974-1997) and many conference proceedings and hand searches of specific journals were undertaken. We contacted AstraZeneca Pharmaceuticals for information regarding unpublished trials. The review was updated in February 2003. SELECTION CRITERIA: All randomised controlled trials where adults with schizophrenia or similar illnesses were assigned to quetiapine, placebo or other neuroleptic drugs and where clinically relevant outcomes were reported. DATA COLLECTION AND ANALYSIS: Citations and, where possible, abstracts were inspected independently by reviewers, papers ordered, re-inspected and quality assessed. We independently extracted data. We analysed data using fixed effects relative risk (RR) and estimated the 95% confidence interval (CI). Only homogeneous data were interpreted as favouring treatment or control. Where possible we calculated the number needed to treat (NNT) or number needed to harm statistics (NNH). We calculated relative risk (RR) for dichotomous data, and weighted mean differences (WMD) for continuous data. MAIN RESULTS: Despite the fact that 3443 people were randomised in 12 quetiapine studies, there are almost no data on service utilisation, economic outcomes, social functioning and quality of life. Over half of those within the quetiapine versus placebo comparison were lost to follow up (53% quetiapine vs 61% placebo, n=716, 4RCTs, RR 0.84 CI 0.7 to 0.9, NNT 11 CI 7 to 55) so it is impossible to interpret any ratings of global or mental state within this comparison with confidence. People allocated quetiapine, however, did not have more movement disorders than those given placebo (n=395, 2 RCTs, RR needing medication for EPSE 0.62 CI 0.3 to 1.2). The same applies to the comparison of >/= 250 mg/day quetiapine with < 250 mg/day quetiapine (49% dropout >/= 250 mg/day vs 58% < 250 mg/day, n=1066, 3 RCTs, RR 0.84 CI 0.8 to 0.9, NNT 11 CI 7 to 29). It should be noted that two deaths occurred in the higher dose group (n=618, 1 RCT, RR 0.1 CI 0.0 to 2.1). When quetiapine was compared with typical antipsychotics, about 36% of both groups failed to complete the short-term studies (n=1624, 6 RCTs, RR 0.87 CI 0.8 to 1.0). Average change in global state was heterogeneous and equivocal (n=762, 3 RCTs, WMD in short term 0.19 CI 0.00 to 0.38, I squared 76%). Mental state measures were also equivocal (n=1247, RR not improved 0.97 CI 0.9 to 1.1) including specific measures of negative symptoms (n=305, 1 RCT, MD change in SANS short term 0.94 CI -0.2 to 2.0). Movement disorders were less prevalent for those allocated quetiapine (n=1117, 4 RCTs, RR needing medication for extrapyramidal adverse effects 0.47 CI 0.4 to 0.6, NNT 4 CI 4 to 5, I squared 88%). Dry mouth (n=649, 2 RCTs, RR short term 2.85 CI 1.5 to 5.6, NNH 17 CI 7 to 65) and sleepiness (n=959, 3 RCTs, RR 1.51 CI 1.1 to 2.2, NNH 18 CI 8 to 181) may also be more prevalent for people given quetiapine compared with the older drugs. In the quetiapine versus risperidone comparison, over 30% of people left the study before completion (n=728, 1 RCT, RR 0.94 CI 0.7 to 1.2). Four people, all treated with quetiapine, died during the study (n=728, 1 RCT, RR 2.86 CI 0.2 to 52.8). Continuous mental state measures did not show clear differences between the two drugs (n=637, 1 RCT, MD PANSS 1.2 CI -2.0 to 4.4). However, considerably fewer people given quetiapine needed medication for extrapyramidal side effects compared with those allocated to risperidone (n=712, 1 RCT, RR 0.27 CI 0.2 to 0.5, NNT 11 CI 10 to 16). Quetiapine caused more dizziness (n=728, 1 RCT, RR 1.85 CI 1.0 to 3.3, NNH 18 CI 7 to 487), more dry mouth (n=728, 1 RCT, RR 2.11 CI 1.2 to 3.8, NNH 14 CI 6 to 82) and more sleepiness than risperidone (n=728, 1 RCT, RR 2.03 CI 1.4 to 2.9, NNH 7 CI 4 to 17). REVIEWERS' CONCLUSIONS: Quetiapine is effective for the treatment of schizophrenia, but it is not much different from first-generation antipsychotics and risperidone with respect to treatment withdrawal and efficacy. In comparison to first-generation antipsychotics and risperidone, quetiapine has a lower risk of movement disorders but higher risks of dizziness, dry mouth and sleepiness. More clearly reported pragmatic randomised controlled trials should be carried out to determine its position in everyday clinical practice. Studies of medium and long-term effects, including cost-effectiveness, quality of life, social functioning and service utilisation, in comparison with the effects of typical and atypical antipsychotics should be priority areas.

Adult↗
PubMed2000

Amphotericin B lipid soluble formulations vs amphotericin B in cancer patients with neutropenia.

BACKGROUND: Patients with cancer who are treated with chemotherapy or receive a bone marrow transplant have an increased risk of acquiring fungal infections. Such infections can be life-threatening. Antifungal drugs are therefore often given prophylactically to such patients, or when they have a fever. OBJECTIVES: To compare the effect and adverse effects of AmBisome and other lipid soluble formulations of amphotericin B with conventional amphotericin B in cancer patients with neutropenia. SEARCH STRATEGY: MEDLINE and Cochrane Library. Unpublished trials from conference proceedings and contact to industry. SELECTION CRITERIA: Randomised trials comparing lipid soluble formulations of amphotericin B with conventional amphotericin B. DATA COLLECTION AND ANALYSIS: Data on mortality, invasive fungal infection, nephrotoxicity, serum creatinine and dropouts were extracted by both authors independently. MAIN RESULTS: AmBisome vs conventional amphotericin B (3 trials, 1149 patients): AmBisome tended to be more effective than conventional amphotericin B for invasive fungal infection (relative risk 0.63, 95% confidence interval 0.39 to 1.01, P=0.053) whereas there was no significant difference in mortality (relative risk 0.74, 95% CI 0.52 to 1.07). AmBisome decreased significantly the incidence of nephrotoxicity, defined as a 100% increase in serum creatinine (relative risk 0.51, 95% CI 0.40 to 0.64). Fewer patients dropped out on AmBisome but the difference was not significant (relative risk 0.78, 95% CI 0.56 to 1. 08). Amphotericin B in Intralipid vs conventional amphotericin B (4 trials, 145 patients): There were no significant differences in clinical effect whereas the patients treated with the lipid soluble formulation experienced significantly less nephrotoxicity (relative risk 0.34, 95% CI 0.15 to 0.75) and smaller increases in serum creatinine (weighted mean difference 32 micromol/l, 95% CI 21 to 43 micromol/l). Amphotericin B colloidal dispersion (ABCD) vs conventional amphotericin B (1 trial, 213 patients): There was lower nephrotoxicity with ABCD (relative risk 0.38, 95% CI 0.25 to 0.59). REVIEWER'S CONCLUSIONS: AmBisome is a better drug than conventional amphotericin B but its high cost prohibits routine use in most settings. Furthermore, the advantages of AmBisome may be smaller than indicated in our review if conventional amphotericin B is administered under optimal circumstances. It is not clear whether other lipid formulations of amphotericin B could offer a worthwhile advantage compared to conventional amphotericin B.

Amphotericin B↗
PubMed2004

Therapeutic hypothermia for head injury.

BACKGROUND: Induced hypothermia has been used in the treatment of head injury for many years. Encouraging results from small trials and laboratory studies led to renewed interest in the area and some larger trials. OBJECTIVES: To estimate the effects of mild induced hypothermia in moderate and severe head injury on mortality, long-term functional outcome, complications, and short-term control of intracranial pressure (ICP). SEARCH STRATEGY: We searched the Injuries Group Specialised register (last searched in 2001), MEDLINE, EMBASE and the Cochrane Controlled Trials Register. We handsearched conference proceedings and checked reference lists of relevant articles, including a systematic review published in 2003. SELECTION CRITERIA: Randomised controlled trials of mild hypothermia to 34-35 masculine Celsius for at least 12 hours versus control (open or normothermia) in patients with any closed head injury requiring hospitalisation. Two reviewers independently assessed all trials. DATA COLLECTION AND ANALYSIS: Data on death, Glasgow outcome scale, complications and ICP were sought and extracted, either from published material or by contacting the investigators. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each trial on an intention-to-treat basis. Quantitative synthesis of data on complications other than pneumonia or ICP was not attempted. Trials of immediate and deferred hypothermia were analysed separately. MAIN RESULTS: We found 14 trials with 1094 participants. Active immediate hypothermia was associated with an OR for death of 0.80, (1061 patients, OR 0.80, 95% CI 0.61 to 1.04), and 0.75 for odds of being dead or severely disabled, (746 patients, OR 0.75, 95% CI 0.56 to 1.00). Hypothermia treatment was associated with a statistically significant increase in odds of pneumonia (281 patients, OR 1.95, 95% CI 1.18 to 3.23). The trial of deferred hypothermia (33 patients) reported a huge but not statistically significant reduction in the odds of death at six months, (OR 0.21, 95% CI 0.04 to 1.05). For death or severe disability, deferred hypothermia was associated with an OR of 0.10 (95% CI 0.01 to 1.00). REVIEWERS' CONCLUSIONS: There is no evidence that hypothermia is beneficial in the treatment of head injury. The earlier, encouraging, trial results have not been repeated in larger trials. The reasons for this are unclear. Hypothermia increases the risk of pneumonia and has other potentially harmful side-effects. Therefore, it would seem inappropriate to use this intervention outside of controlled trials in subgroups of patients for whom there is good reason to think the treatment would be beneficial.

Craniocerebral Trauma↗
PubMed2004

Sucrose for analgesia in newborn infants undergoing painful procedures.

BACKGROUND: Management of pain for neonates is less than optimal. The administration of sucrose with and without non-nutritive sucking (pacifiers) has been the most frequently studied non-pharmacological intervention for relief of procedural pain in neonates. OBJECTIVES: To determine the efficacy, effect of dose, and safety of sucrose for relieving procedural pain as assessed by validated individual pain indicators and composite pain scores. SEARCH STRATEGY: Standard methods as per the Neonatal Collaborative Review Group. A MEDLINE search was carried out for relevant randomized controlled trials (RCTs) published from January 1966 - March 2004, EMBASE from 1980-2004 and search of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2004). Key words and (MeSH) terms included infant/newborn, pain, analgesia and sucrose. Language restrictions were not imposed. Bibliographies, personal files, the most recent relevant neonatal and pain journals and recent major pediatric pain conference proceedings were searched manually. Unpublished studies, or studies reported only as abstracts, were not included. Additional information from published studies was obtained. SELECTION CRITERIA: RCTs in which term and/or preterm neonates (postnatal age maximum of 28 days after reaching 40 weeks corrected gestational age) received sucrose via oral syringe, NG-tube, dropper or pacifier for procedural pain from heel lance or venepuncture. In the control group, water, pacifier or positioning/containing were used. Studies in which the painful stimulus was circumcision were excluded. DATA COLLECTION AND ANALYSIS: Trial quality was assessed according to the methods of the Neonatal Collaborative Review Group. Quality measures included blinding of randomization, blinding of intervention, completeness of follow up and blinding of outcome measurement. Data were abstracted and independently checked for accuracy by the three investigators. STATISTICAL ANALYSIS: The statistical package (RevMan 4.2) of the Cochrane Collaboration was used. For meta-analysis, a weighted mean difference (WMD) with 95% confidence intervals (CI) using the fixed effects model was reported for continuous outcome measures. MAIN RESULTS: Forty-four studies were identified for possible inclusion in this review. Seven studies reported only as abstracts, and sixteen additional studies were excluded, leaving 21 studies (1,616 infants) included in this review. Sucrose in a wide variety of dosages was generally found to decrease physiologic (heart rate) and behavioural (the mean percent time crying, total cry duration, duration of first cry, and facial action) pain indicators and composite pain scores in neonates undergoing heel stick or venepuncture. When pain scores (Premature Infant Pain Profiles) were pooled across 3 studies (Gibbins 2001; Johnston 1999a; Stevens 1999), they were significantly reduced in infants who were given sucrose (dose range 0.012 g to 0.12 g) compared to the control group, [WMD -1.64 (95% CI -2.47,- 0.81); p = 0.0001] at 30 seconds and [WMD -2.05, (95% CI -3.08, -1.02); p = 0.00010] at 60 seconds after heel lance. When results for change in heart rate were pooled for two studies (Haouari 1995, Isik 2000), there were no significant differences between changes in heart rate for infants given sucrose (dose range 0.5 g to 0.6 g) compared to the control group, [WMD 0.90 (95% CI -5.81, 7.61); p = 0.8] at one minute and [WMD -6.20 (95% CI -15.27, 2.88); p = 0.18] at three minutes after heel lance. REVIEWERS' CONCLUSIONS: Sucrose is safe and effective for reducing procedural pain from single painful events (heel lance, venepuncture). There was inconsistency in the dose of sucrose that was effective (dose range of 0.012 g to 0.12 g), and therefore an optimal dose to be used in preterm and/or term infants could not be identified. The use of repeated administrations of sucrose in neonates needs to be investigated as does the use of sucrose in combination with other behavioural (e.g., facilitated tucking, kangaroo care) and pharmacologic (e.g., morphine, fentanyl) interventions. Use of sucrose in neonates who are of very low birth weight, unstable and/or ventilated also needs to be addressed.

Analgesics↗
PubMed2005

Reminiscence therapy for dementia.

BACKGROUND: Reminiscence Therapy (RT) involves the discussion of past activities, events and experiences with another person or group of people, usually with the aid of tangible prompts such as photographs, household and other familiar items from the past, music and archive sound recordings. Reminiscence groups typically involve group meetings in which participants are encouraged to talk about past events at least once a week. Life review typically involves individual sessions, in which the person is guided chronologically through life experiences, encouraged to evaluate them, and may produce a life story book. Family care-givers are increasingly involved in reminiscence therapy. Reminiscence therapy is one of the most popular psychosocial interventions in dementia care, and is highly rated by staff and participants. There is some evidence to suggest it is effective in improving mood in older people without dementia. Its effects on mood, cognition and well-being in dementia are less well understood. OBJECTIVES: The objective of the review is to assess the effects of reminiscence therapy for older people with dementia and their care-givers. SEARCH STRATEGY: The trials were identified from a search of the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group on 4 May 2004 using the term "reminiscence". The CDCIG Specialized Register contains records from all major health care databases (MEDLINE, EMBASE, PsycLIT, CINAHL) and many ongoing trials databases and is regularly updated. We contacted specialists in the field and also searched relevant Internet sites. We hand-searched Aging and Mental Health, the Gerontologist, Journal of Gerontology, Current Opinion in Psychiatry, Current Research in Britain: Social Sciences, British Psychological Society conference proceedings and Reminiscence database. SELECTION CRITERIA: Randomised controlled trials and quasi-randomized trials of reminiscence therapy for dementia. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. MAIN RESULTS: Five trials are included in the review, but only four trials with a total of 144 participants had extractable data. The results were statistically significant for cognition (at follow-up), mood (at follow-up) and on a measure of general behavioural function (at the end of the intervention period). The improvement on cognition was evident in comparison with both no treatment and social contact control conditions. Care-giver strain showed a significant decrease for care-givers participating in groups with their relative with dementia, and staff knowledge of group members' backgrounds improved significantly. No harmful effects were identified on the outcome measures reported. AUTHORS' CONCLUSIONS: Whilst four suitable randomized controlled trials looking at reminiscence therapy for dementia were found, several were very small studies, or were of relatively low quality, and each examined different types of reminiscence work. Although there are a number of promising indications, in view of the limited number and quality of studies, the variation in types of reminiscence work reported and the variation in results between studies, the review highlights the urgent need for more and better designed trials so that more robust conclusions may be drawn.

Aged↗
PubMed2003

Cyproterone acetate for hirsutism.

BACKGROUND: Hirsutism is a distressing and relatively common endocrine problem in women which may prove difficult to manage. Cyproterone acetate, an anti-androgen, is frequently used to treat hirsutism, usually in combination with ethinyl estradiol. OBJECTIVES: The objective of this review was to investigate the effectiveness of cyproterone acetate alone, or in combination with ethinyl estradiol, in reducing hair growth in women with hirsutism secondary to ovarian hyperandrogenism. SEARCH STRATEGY: The Cochrane Menstrual Disorders and Subfertility Group trials register was searched (last search - 4 June 2002). The Cochrane Menstrual Disorders and Subfertility Group register is based on regular searches of MEDLINE (1966 to 2002), EMBASE (1980 to 2002), CINAHL (1982 to 2002), PsycINFO (1987 to 2002) and CENTRAL (Issue 2, 2002 of the Cochrane Library) the handsearching of several journals and conference proceedings, and searches of several key grey literature sources. All publications of randomised controlled trials of cyproterone acetate with or without estrogen versus placebo or other drug therapies for hirsutism were identified. SELECTION CRITERIA: All randomised controlled studies comparing:- cyproterone acetate to placebo- cyproterone acetate with ethinyl estradiol to placebo- cyproterone acetate with ethinyl estradiol to cyproterone acetate alone- cyproterone acetate (with or without estradiol) to other medical therapies for treatment of hirsutism. DATA COLLECTION AND ANALYSIS: Eleven studies were identified which fulfilled the inclusion criteria. Nine randomised studies were included in the review, and two were excluded because of insufficient information. Only one study had more than 100 women included in the analysis. The major outcomes included: subjective improvement in hirsutism, changes in Ferriman Gallwey scores, changes in linear hair growth and hair shaft diameter, alterations in endocrine parameters, side effects to treatment, withdrawals during therapy MAIN RESULTS: There were no clinical trials comparing cyproterone acetate alone with placebo. There was one small study comparing cyproterone acetate in combination with ethinyl estradiol to placebo. In this study there was a significant subjective reduction in hair growth with cyproterone acetate therapy, although the confidence limits were large. There were no studies comparing cyproterone acetate alone with cyproterone acetate in combination with ethinyl estradiol to treat hirsutism. In studies where cyproterone acetate was compared to other drug modalities (ketoconazole, spironolactone, flutamide, finasteride, GnRH analogues) no difference in clinical outcome was noted. There were, however, endocrinological differences in androgen and estrogen levels between different drug therapies. There were insufficient data to assess differences in side effects between women treated with cyproterone acetate and other medical therapy. REVIEWER'S CONCLUSIONS: Cyproterone acetate combined with estradiol results in a subjective improvement in hirsutism compared to placebo. Clinical differences in outcome between cyproterone acetate and other medical therapies were not demonstrated in the studies included in this review. This may be because of the small size of the studies, lack of standardized assessment and lack of objective determinants of improvement in hirsutism. The endocrinological effects of the different drug therapies reflect the mode of action. Larger carefully designed studies are needed to compare efficacy and safety profiles between drug therapies for hirsutism.

Androgen Antagonists↗
PubMed2000

Interventions for shoulder pain.

OBJECTIVES: To review the efficacy of common interventions for shoulder pain. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Group trials register, Cochrane Controlled Trials Register, Medline, Embase, Cinahl, and Science Citation Index) up to May 1998, and hand searched major textbooks, bibliographies of relevant literature, the fugitive literature, and the subject indices of relevant journals including: American College of Rheumatology;British College of Rheumatologists; the Biennial Conference of the Manipulative Physiotherapy Association of Australia;International Federation of Manual Therapists conference proceedings; British Orthopaedic Association;and American Orthopaedic Association. SELECTION CRITERIA: Each identified study was assessed for possible inclusion by two independent reviewers based on the blinded methods sections. The determinants for inclusion were that the trial include an intervention of interest (non-steroidal anti-inflammatory drugs, intra-articular or subacromial glucocorticosteroid injection, oral glucocorticosteroid treatment, physiotherapy, manipulation under anaesthesia, hydrodilatation, or surgery); that treatment allocation was randomized; and that the outcome assessment was blinded. DATA COLLECTION AND ANALYSIS: Methodological quality was assessed by two independent, blinded reviewers. Data relating to selection criteria, outcome measurement and treatment effect was extracted from the blinded trials. Range of motion scores were entered as degrees of restriction to movement, and all pain and overall effect scores were transformed to 100 point scales. For continuous outcome measures, where standard deviation was not reported it was either calculated from the raw data or converted from standard error of the mean. If neither of these were reported, authors were contacted in an effort to obtain the missing values. Effect sizes were calculated and combined in a pooled analysis if study population, endpoint and intervention were comparable. MAIN RESULTS: Thirty one trials met inclusion criteria. Mean methodological quality score was 16.8 (9.5 - 22) out of possible score of 40. Selection criteria varied widely even for the same diagnostic label. There was no uniformity in outcome measures used and their measurement properties were rarely reported. Effect sizes for individual trials were small (-1.4 to 3. 0). The results of only three studies investigating rotator cuff tendonitis could be pooled. Benefit of subacromial steroid injection over placebo for improving range of abduction (weighted difference between means (WMD) 35 degrees, 95% CI 14 to 55) was the only positive finding. REVIEWER'S CONCLUSIONS: There is little evidence to support or refute the efficacy of common interventions for shoulder pain. As well as, the need for further well designed clinical trials, more research is needed to establish a uniform method of defining shoulder disorders and developing outcome measures which are valid, reliable and responsive in these study populations.

Humans↗
PubMed2000

Interventions for treating oral lichen planus.

BACKGROUND: Oral lichen planus is a chronic autoimmune disease of unknown aetiology that affects the inner surface of the mouth. The symptomatic forms are painful,tend to worsen with age and with remissions being rare. Current treatment is palliative and not curative, many topical and systemic agents have been tried with little hard evidence for efficacy. OBJECTIVES: To assess the effectiveness and safety of any form of palliative therapy against placebo for the treatment of symptomatic oral lichen planus. SEARCH STRATEGY: Electronic databases, handsearching of conference proceedings and specific journals, researchers in the field, drug manufacturers. SELECTION CRITERIA: Any placebo-controlled trial of palliative therapy for symptomatic oral lichen planus, using a randomised or quasi-randomised design that measured changes in symptoms and/or clinical signs. DATA COLLECTION AND ANALYSIS: Change in symptoms (pain, discomfort) and clinical signs (visual impression, lesion measurements) at the end of therapy. Odds ratio of improvement vs no improvement for each trial outcome and pooling where appropriate. MAIN RESULTS: A total of nine RCTs were identified. The nine interventions were grouped into four separate classes (cyclosporines, retinoids, steroids and phototherapy) for comparison. No therapy was replicated exactly, the closest replication involved two trials using high and low dose cyclosporine mouthwash. Only trials recording the same outcomes in each therapeutic class were pooled. The largest number of pooled trials was three. Large odds ratios with very wide confidence intervals indicating a statistically significant treatment benefit were seen in all trials. However this has to be tempered by considerations of the small study sizes, the lack of replication, the difficulty in measuring outcome changes and the very high likelihood of publication bias. Only systemic agents were associated with treatment toxicities, all other side-effects were mild and mainly limited to local mucosal reactions. REVIEWER'S CONCLUSIONS: The review provides only weak evidence for the superiority of the assessed interventions over placebo for palliation of symptomatic OLP. The results highlight the need for larger placebo-controlled RCTs with more carefully selected and standardised outcome measures before between-treatment comparisons can be properly interpreted.

Cyclosporins↗
PubMed2000

Laser therapy for venous leg ulcers.

OBJECTIVES: To assess the effectiveness of low level laser therapy in the treatment of venous leg ulcers. SEARCH STRATEGY: Searches of 19 databases, hand searching of journals and conference proceedings from 1948 onwards, and examination of bibliographies. SELECTION CRITERIA: Randomised controlled trials comparing low level laser therapy with: sham laser; no laser; non-coherent light. There was no restriction on date or language. The main outcome measure used was complete healing of the ulcers. DATA COLLECTION AND ANALYSIS: Data extraction was done by one reviewer and checked by a second. Meta analysis was used to combine the results of trials where the interventions and outcome measures were sufficiently similar. MAIN RESULTS: There were 4 eligible trials. Two RCTs compared laser therapy with sham, 1 with ultraviolet therapy and 1 with non-coherent, unpolarised red light. Neither of the two RCTs comparing laser with sham found a significant difference in healing rates; there was no significant of laser evident when the trials were pooled. A three-arm study compared: - laser therapy alone - laser therapy plus infrared light - non-coherent, unpolarised red light. Significantly more ulcers completely healed in the group receiving a combination of laser and infrared light compared with non-coherent, unpolarised red light. A fourth trial compared laser and ultraviolet light and found no difference. REVIEWER'S CONCLUSIONS: We have found no evidence of any benefit associated with low level laser therapy on venous leg ulcer healing. One small study suggests that a combination of laser and infrared light may promote the healing of venous ulcers, however more research is needed.

Humans↗
PubMed2000

Neoadjuvant and adjuvant therapy for operable hepatocellular carcinoma.

OBJECTIVES: To determine the efficacy and adverse effects of different neoadjuvant and adjuvant therapies compared to surgery alone or surgery and placebo/supportive therapy when given to improve relapse and survival rates for operable hepatocellular carcinoma. SEARCH STRATEGY: Electronic databases, conference proceedings, bibliographies of identified publications. SELECTION CRITERIA: All truly randomised and quasi-randomised clinical trials that compared hepatocellular carcinoma patients who were given and not given neoadjuvant/adjuvant therapy as a supplement to curative liver resection. DATA COLLECTION AND ANALYSIS: Study data was extracted independently by two reviewers and discrepancies were resolved by consensus. A total of eight randomised controlled clinical trials were identified, totaling 548 randomised patients. Seven of the eight trials reported survival and disease-free survival curves and the results of hypothesis testing (log-rank test). The remaining trial reported only the mean survival times. None reported the hazard ratio and only one did a sample size calculation. The survival and disease-free survival curves were compared using their one, two and three-year survival rates, median survival times and the result of the hypothesis tests. MAIN RESULTS: The size of the randomised clinical trials ranged from 40 to 115 subjects. Both preoperative (neoadjuvant) and postoperative (adjuvant), systemic and locoregional (+/- embolization), chemo- and immunotherapy interventions were tested. None were comparable in terms of both treatment regimen and participants selected, so no pooling was done. Only one regimen using preoperative transcatheter arterial chemoembolization with doxorubicin was approximately duplicated. Seven of the eight trials reported no survival benefit from adjuvant therapy. Only one trial reported a statistically significant difference for survival and disease-free survival for the treatment arm, but the results of both its arms were very poor when compared to other studies. Two of the trials that did not report any absolute survival advantage reported statistically significant differences in disease-free survival. Five of the eight trials did not perform intention-to-treat analysis. The highest toxicity rate was in a trial using oral 1-hexylcarbamoyl 5-fluorouracil which resulted in 12 out of 38 subjects stopping because of adverse events. REVIEWER'S CONCLUSIONS: There is no evidence for efficacy of any of the adjuvant protocols reviewed. In order to detect a realistic treatment advantage, larger trials will have to be conducted.

Antineoplastic Agents↗
PubMed2000

Systemic treatments for metastatic cutaneous melanoma.

BACKGROUND: Systemic therapies for metastatic cutaneous melanoma, the most aggressive of all skin cancers, remain disappointing. Few lasting remissions are achieved and the therapeutic aim remains one of palliation. Many agents are used alone or in combination with varying degrees of toxicity and cost. It is unclear whether evidence exists to support these complex regimens over best supportive care / placebo. OBJECTIVES: To review the benefits from the use of systemic therapies in metastatic cutaneous melanoma compared to best supportive care/placebo, and to establish whether a 'standard' therapy exists which is superior to other treatments. SEARCH STRATEGY: Randomised controlled trials were identified from the MEDLINE, EMBASE and CCTR/CENTRAL databases. References, conference proceedings, and Science Citation Index/Scisearch were also used to locate trials. Cancer registries and trialists were also contacted. SELECTION CRITERIA: Randomised controlled trials of adults with histologically proven metastatic cutaneous melanoma in which systemic anti-cancer therapy was compared with placebo or supportive care. DATA COLLECTION AND ANALYSIS: Study selection was performed by two independent reviewers. Data extraction forms were used for studies which appeared to meet the selection criteria and, where appropriate, full text articles were retrieved and reviewed independently. MAIN RESULTS: No randomised controlled trials were found comparing a systemic therapy with placebo or best supportive care in metastatic cutaneous melanoma. REVIEWER'S CONCLUSIONS: There is no evidence from randomised controlled clinical trials to show superiority of systemic therapy over best supportive care / placebo in the treatment of malignant cutaneous melanoma. Given that patients with metastatic melanoma frequently receive systemic therapy, it is our pragmatic view that a future systematic review could compare any systemic treatment, or combination of treatments, to single agent dacarbazine.

Antineoplastic Agents↗