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PubMed2001

Dietary treatment for familial hypercholesterolaemia.

BACKGROUND: Familial hypercholesterolaemia is an inherited disorder characterised by a raised blood cholesterol, the presence of xanthomatosis and premature ischaemic heart disease. The aim of treatment is the reduction of blood LDL cholesterol concentrations in order to reduce the risk of ischaemic heart disease. Current treatment is based on a cholesterol lowering diet alone or in combination with drug therapy. Many of the drugs found to be effective in treating adults with this disease are not licensed for use in children, therefore diet is the main treatment of children with familial hypercholesterolaemia. In addition to the cholesterol-lowering diet, several other dietary interventions have been suggested and consensus has yet to be reached on the most appropriate dietary treatment for children and adults with familial hypercholesterolaemia. OBJECTIVES: To examine the evidence that in children and adults with familial hypercholesterolaemia, a cholesterol lowering diet is more effective at lowering cholesterol and reducing incidence of ischaemic heart disease than no intervention or than other dietary interventions. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Trials Register, a specialist trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings. Additional studies were identified from handsearching the Journal of Inherited Metabolic Disease (from inception, 1978 to 2000) and from the reference lists of identified studies. SELECTION CRITERIA: Randomised controlled trials (RCTs), both published and unpublished, where a cholesterol lowering diet in children and adults with familial hypercholesterolaemia has been compared to other forms of dietary treatment or to no dietary intervention. Trials which include patients with familial hypercholesterolaemia alongside patients with non-familial hypercholesterolaemia were only included if the group of familial patients was well defined and the results for these patients were available. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the trial eligibility and methodological quality and one reviewer extracted the data, with independent verification of data extraction by a colleague. MAIN RESULTS: Only short term outcomes could be assessed in this review due to the length of the five eligible studies. Compliance to treatment, quality of life, mortality and evidence of ischaemic or atheromatous disease were not assessed in the studies identified. No differences were found between the cholesterol-lowering diet and all other diets for all of the short term outcomes assessed. REVIEWER'S CONCLUSIONS: No conclusions can be made about the effectiveness of the cholesterol-lowering diet, or any of the other dietary interventions suggested for familial hypercholesterolaemia, due to the lack of adequate data. A large, parallel, randomised controlled trial is needed to investigate the effectiveness of the cholesterol-lowering diet and other dietary interventions for FH. It is also possible that data from trials including subjects with both familial and non-familial hypercholesterolaemia could alter the results of future updates of this review and until further evidence is available current dietary treatment of FH should continue to be observed and monitored with care.

Adult↗
PubMed2001

Eversion versus conventional carotid endarterectomy for preventing stroke.

BACKGROUND: Carotid endarterectomy is conventionally undertaken by a longitudinal arteriotomy. Eversion carotid endarterectomy (CEA), which employs a transverse arteriotomy and reimplantation of the carotid artery, is reported to be associated with low perioperative stroke and restenosis rates but an increased risk of complications associated with a distal intimal flap. OBJECTIVES: The objective of this review was to determine whether eversion CEA was safe and more effective than conventional CEA. The null-hypothesis was that there was no difference between the eversion and the conventional CEA techniques (performed either with primary closure or patch angioplasty). SEARCH STRATEGY: The reviewers searched MEDLINE and the Cochrane Stroke Group Trials Register (last searched: December 1999), and hand searched eight surgical journals and conference proceedings. Researchers were contacted to identify additional published and unpublished studies. SELECTION CRITERIA: All randomised trials comparing eversion to conventional techniques in patients undergoing carotid endarterectomy were examined in this review. Outcomes were stroke and death, carotid restenosis/occlusion and local complications. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers to assess eligibility and describe trial characteristics, and by one reviewer for the meta-analyses. Discrepancies were resolved by discussion. When possible, unpublished data were obtained from investigators. MAIN RESULTS: Five trials were included for a total of 2465 patients and 2590 arteries. Three trials included bilateral carotid endarterectomies. In one trial, arteries rather than patients were randomised so that it was not clear how many patients had been randomised in each group, therefore, information on the risk of stroke and death from this study were considered in a separate analysis. There were no significant differences in the rate of perioperative stroke and/or death (1.7% vs 2.6%, odds ratio [OR] 0.44, 95% confidence interval [CI] 0.10-1.82) and stroke during follow-up (1.4% vs 1.7%, OR: 0.84, 95% CI: 0.43-1.64) between eversion and conventional CEA techniques. Eversion CEA was associated with a significantly lower rate of restenosis >50% during follow-up (2.5% vs 5.2%, OR: 0.48, 95% CI: 0.32 -0.72). However, there was no evidence that the eversion technique for CEA was associated with a lower rate of neurological events when compared to conventional CEA. There were no statistically significant differences in local complications between the eversion and conventional group. No data were available to define the cost-benefit of eversion CEA technique. REVIEWER'S CONCLUSIONS: Eversion CEA may be associated with low risk of arterial occlusion and restenosis. However, numbers are too small to definitively assess benefits or harms. Reduced restenosis rates did not appear to be associated with clinical benefit in terms of reduced stroke risk, either perioperatively or later. Until further evidence is available, the choice of the CEA technique should depend on the experience and familiarity of the individual surgeon.

Confidence Intervals↗
PubMed2001

Chinese medicinal herbs for chronic hepatitis B.

BACKGROUND: Hepatitis B virus infection is a serious health problem worldwide. Traditional Chinese medicinal herbs have been widely used to treat chronic liver diseases, and many controlled trials have been done to investigate their efficacy. OBJECTIVES: To assess the efficacy and safety of traditional Chinese medicinal herbs for chronic hepatitis B infection. SEARCH STRATEGY: Searches were applied to the following electronic databases: the CHBG Trials Register, the Cochrane Complementary Medicine Field Trials Register, the Cochrane Library, MEDLINE, EMBASE and BIOSIS. Five Chinese journals and conference proceedings were handsearched. No language restriction was used. SELECTION CRITERIA: Randomised or quasi-randomised trials with at least three months follow-up. Trials of Chinese medicinal herbs (single or compound) compared with placebo, no intervention, general non-specific treatment or interferon treatment were included. Trials of Chinese medicinal herbs plus interferon versus interferon alone were also included. Trials could be double-blind, single-blind or not blinded. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers. The methodological quality of trials was evaluated using the Jadad-scale plus allocation concealment. Intention-to-treat analyses were performed. MAIN RESULTS: Nine randomised trials, including 936 patients, met the inclusion criteria. Methodological quality was considered adequate in only one trial. There was a significant funnel plot asymmetry (regression coefficient=3.37, standard error 1.40, P=0.047). Ten different medicinal herbs were tested in the nine trials. Compared to non-specific treatment or placebo, Fuzheng Jiedu Tang (compound of herbs) showed significantly positive effects on clearance of serum HBsAg, HBeAg, and HBV DNA; Polyporus umbellatus polysaccharide on serum HBeAg and HBV DNA; Phyllanthus amarus on serum HBeAg. Phyllanthus compound and kurorinone showed no significant effect on clearance of serum HBeAg and HBV DNA and on alanine aminotransferase normalisation compared to interferon treatment. There were no significant effects of the other examined herbs. REVIEWER'S CONCLUSIONS: Some Chinese medicinal herbs may work in chronic hepatitis B. However, the evidence is too weak to recommend any single herb. Rigorously designed, randomised, double-blind, placebo-controlled trials are required.

Drugs, Chinese Herbal↗
PubMed2003

Extended versus limited lymph nodes dissection technique for adenocarcinoma of the stomach.

BACKGROUND: Surgeons disagree about the merits and risks of radical lymph node clearance during gastrectomy for cancer. OBJECTIVES: To evaluate survival and peri-operative mortality after limited or extended lymph node removal during gastrectomy for cancer. SEARCH STRATEGY: We searched MEDLINE, EMBASE, CancerLit, LILACS, Central Medical Journal Japanese Database and the Cochrane register, references from relevant articles and conference proceedings. We contacted known workers in the field. SELECTION CRITERIA: Studies published after 1970 which reported 5 year survival or postoperative mortality rates, and clearly defined the node dissection performed, were considered. We excluded studies which overtly included patients receiving perioperative chemotherapy, and comparisons with clear systematic treatment allocation bias. Randomised controlled trials (RCTs), non-randomised comparisons and observational studies were considered separately. DATA COLLECTION AND ANALYSIS: Three reviewers selected trials for inclusion. Quality assessment and data extraction were performed independently by two reviewers. Results of trials of similar design were pooled. Meta-analysis was performed separately for randomised and non-randomised comparisons. MAIN RESULTS: Two randomised and two non-randomised comparisons of limited (D1) versus extended (D2) node dissection and 11 cohort studies of either D1 or D2 resection were analysed. Meta-analysis of randomised trials did not reveal any survival benefit for extended lymph node dissection (Risk ratio = 0.95 (95% CI 0.83 - 1.09), but showed increased postoperative mortality (RR 2.23, 95% CI 1.45 - 3.45). Pre-specified subgroup analysis suggested a possible benefit in stage T3+ tumours (RR = 0.68, 95% CI 0.42-1.10). Non-randomised comparisons showed no significant survival benefit for extended dissection (RR 0.92, 95% CI 0.83 -1.02), but decreased mortality (RR 0.65, 95% CI 0.45-0.93). Subgroup analysis showed apparent benefit in UICC stage II and IIIa. Observational studies of D2 resection reported much better mortality and survival than those of D1 surgery, but the settings were strikingly different. REVIEWER'S CONCLUSIONS: D2 dissection carries increased mortality risks associated with spleen and pancreas resection, and probably with inexperience and low case volumes. Randomised studies show no evidence of overall survival benefit, but possible benefit in T3+ tumours. These results may be confounded by surgical learning curves and poor surgeon compliance. Non-randomised comparisons suggest a possible survival benefit for D2 in intermediate UICC stages. Observational studies show high 5 year survival and low operative mortality after D2 dissection in experienced units, and poor results after D1 dissection in non-specialist units. Further studies, with precautions to eliminate learning curve effects, contamination and non-compliance, are needed to evaluate D2 dissection in intermediate stage gastric cancer.

Adenocarcinoma↗
PubMed2004

Extended versus limited lymph nodes dissection technique for adenocarcinoma of the stomach.

BACKGROUND: Surgeons disagree about the merits and risks of radical lymph node clearance during gastrectomy for cancer. OBJECTIVES: To evaluate survival and peri-operative mortality after limited or extended lymph node removal during gastrectomy for cancer. SEARCH STRATEGY: We searched MEDLINE, EMBASE, CancerLit, LILACS, Central Medical Journal Japanese Database and the Cochrane register, references from relevant articles and conference proceedings. We contacted known workers in the field. SELECTION CRITERIA: Studies published after 1970 which reported 5 year survival or postoperative mortality rates, and clearly defined the node dissection performed, were considered. We excluded studies which overtly included patients receiving perioperative chemotherapy, and comparisons with clear systematic treatment allocation bias. Randomised controlled trials (RCTs), non-randomised comparisons and observational studies were considered separately. DATA COLLECTION AND ANALYSIS: Three reviewers selected trials for inclusion. Quality assessment and data extraction were performed independently by two reviewers. Results of trials of similar design were pooled. Meta-analysis was performed separately for randomised and non-randomised comparisons. MAIN RESULTS: Two randomised and two non-randomised comparisons of limited (D1) versus extended (D2) node dissection and 11 cohort studies of either D1 or D2 resection were analysed. Meta-analysis of randomised trials did not reveal any survival benefit for extended lymph node dissection (Risk ratio = 0.95 (95% CI 0.83 - 1.09), but showed increased postoperative mortality (RR 2.23, 95% CI 1.45 - 3.45). Pre-specified subgroup analysis suggested a possible benefit in stage T3+ tumours (RR = 0.68, 95% CI 0.42-1.10). Non-randomised comparisons showed no significant survival benefit for extended dissection (RR 0.92, 95% CI 0.83 -1.02), but decreased mortality (RR 0.65, 95% CI 0.45-0.93). Subgroup analysis showed apparent benefit in UICC stage II and IIIa. Observational studies of D2 resection reported much better mortality and survival than those of D1 surgery, but the settings were strikingly different. REVIEWERS' CONCLUSIONS: D2 dissection carries increased mortality risks associated with spleen and pancreas resection, and probably with inexperience and low case volumes. Randomised studies show no evidence of overall survival benefit, but possible benefit in T3+ tumours. These results may be confounded by surgical learning curves and poor surgeon compliance. Non-randomised comparisons suggest a possible survival benefit for D2 in intermediate UICC stages. Observational studies show high 5 year survival and low operative mortality after D2 dissection in experienced units, and poor results after D1 dissection in non-specialist units. Further studies, with precautions to eliminate learning curve effects, contamination and non-compliance, are needed to evaluate D2 dissection in intermediate stage gastric cancer.

Adenocarcinoma↗
PubMed2000

Early versus delayed initiation of progressive enteral feedings for parenterally fed low birth weight or preterm infants.

BACKGROUND: Enteral feedings in very-low-birth-weight or sick preterm infants are often delayed for several days or weeks after birth even though delayed enteral feeding could diminish the functional adaptation of the gastrointestinal tract and result in feeding intolerance later. Early initiation of feedings, if well-tolerated, may promote growth and shorten the duration of parenteral nutrition and hospital stay without increasing the risk for necrotizing enterocolitis (NEC). OBJECTIVES: For parenterally fed low-birth-weight infants, to assess the effects of early enteral feedings initiated shortly after birth compared to delayed enteral feedings (with similar schedules for advancing feedings in each group). SEARCH STRATEGY: Searches were performed of the Oxford Database of Perinatal Trials, the Cochrane Neonatal Review Group registry, 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 1) they enrolled low birth weight or preterm infants who were all given parenteral nutrition; 2) the infants were randomly assigned to either early enteral feedings (mean or median age <=4 days) or late enteral feedings (>4 days) of formula or breast milk; 3) except when feeding intolerance developed, the feedings were progressively advanced starting within 72 hours after initiating feedings; and 4) the goals for total nutrient intake were similar for both groups. (We did not require the duration or total intake of parenteral nutrients to be similar for both groups because these variables may be affected by the age at which feedings are initiated.) DATA COLLECTION AND ANALYSIS: The two reviewers reached consensus for inclusion of trials. Data regarding clinical outcomes were extracted and evaluated by two reviewers (JET and KAK) independently. Authors were contacted as needed and feasible to clarify or provide missing data. The specific data that were needed were requested in writing and by telephone. MAIN RESULTS: Only two small studies were identified (one with 60 patients and one with 12 patients). Five randomized trials were excluded because parenteral nutrition was not provided or because the groups were assigned to receive different parenteral intakes as well as different enteral intakes. An additional unpublished small trial was excluded because both groups were fed "late" according to our categorization. Because there were no clinical outcomes which were reported in both of the included studies, no meta analysis of the results was performed. Based on the results of the individual studies, early feedings had no significant effect on weight gain, necrotizing enterocolitis, mortality, or age at discharge, although important effects cannot be excluded with the small number of patients studied. Some benefits of early feedings were noted in the larger trial (Davey) -- fewer days on parenteral nutrition, fewer infants who were treated with gastric suction and interruption of feedings, fewer infants with sepsis evaluations, and fewer infants with percutaneous central venous catheters. REVIEWER'S CONCLUSIONS: The benefits and hazards of early and delayed feedings have received very little study in clinical trials, and the effects on major clinical outcomes, including necrotizing enterocolitis and death, remain uncertain. With the availability of parenteral nutrition in contemporary neonatal units, it is unclear whether high-risk infants should receive early or delayed feedings.

Enteral Nutrition↗
PubMed2000

Vancomycin for prophylaxis against sepsis in preterm neonates.

BACKGROUND: Nosocomial, late onset sepsis occurs in up to 50% of infants of less than 1000gm at birth. The commonest organism isolated is coagulase negative staphylococcus (CoNS). A number of studies have evaluated the efficacy or prophylactic low dose vancomycin given either as a continuous infusion added to the infant's hyperalimentation fluid or by intermittent intravenous administration and these studies in very low birth weight infants are the subject of this review. OBJECTIVES: To evaluate the safety and efficacy of vancomycin prophylaxis for the prevention of late-onset sepsis, coagulase negative staphylococcal sepsis, mortality, and effects on length of stay, total vancomycin exposure, evidence of vancomycin toxicity, and the development of vancomycin resistant organisms in the preterm neonate. SEARCH STRATEGY: Searches were made of Medline, (MeSH terms: Vancomycin and Sepsis; limits: age groups, newborn infants), HealthStar and EMBase, electronic abstracts, personal files and conference proceedings. SELECTION CRITERIA: Randomized controlled trials which compared the incidence of sepsis and mortality in preterm neonates receiving vancomycin prophylaxis versus a control group receiving no prophylaxis. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including the overall incidence of sepsis, the incidence of coagulase negative staphylococcal sepsis, mortality, length of stay, total vancomycin exposure, evidence of vancomycin toxicity, and the development of vancomycin resistant organisms were excerpted from previous clinical trials. Data analysis was done in accordance with the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: The administration of prophylactic vancomycin reduced the incidence of both total neonatal nosocomial sepsis and coagulase negative staphylococcal sepsis in eligible preterm infants. Mortality, length of stay, and evidence of vancomycin toxicity were not significantly different between the two groups. There was insufficient evidence to ascertain the risks of development of vancomycin resistant organisms in the nurseries involved in these trials. REVIEWER'S CONCLUSIONS: The use of prophylactic vancomycin in low doses reduces the incidence of nosocomial sepsis in the neonate. The methodologies of these studies may have contributed to the low rate of sepsis in the treated groups, as the blood cultures drawn from central lines may have failed to grow due to the low levels of vancomycin in the infusate. Although there is a theoretical concern regarding the development of resistant organisms with the administration of prophylactic antibiotic, there is insufficient evidence to ascertain the risks of development of vancomycin resistant organisms. Few clinically important benefits have been demonstrated for very low birth weight infants treated with prophylactic vancomycin. It therefore appears that routine prophylaxis with vancomycin should not be undertaken at present.

Anti-Bacterial Agents↗
PubMed2001

Anticoagulants (heparin, low molecular weight heparin and oral anticoagulants) for intermittent claudication.

BACKGROUND: Anticoagulant treatment for intermittent claudication might improve functional capacity, and prevent acute cardiovascular complications caused by peripheral obstructive arterial disease. OBJECTIVES: To assess the effects of anticoagulant drugs (heparin, low molecular weight heparin (LMWH) and oral anticoagulants) in patients with intermittent claudication (Fontaine stage II) in terms of improving walking capacity (pain-free walking distance or absolute walking distance), mortality, cardiovascular events, ankle/brachial pressure index, progression to surgery, amputation-free survival and side effects of these drugs. SEARCH STRATEGY: Randomised trials of anticoagulants for intermittent claudication were sought using the search strategy described by the Cochrane Peripheral Vascular Diseases Review Group. Additional trials were sought through: reference lists resulting from this search; recent conference proceedings; contact with authors of published trials and pharmaceutical companies producing anticoagulants. SELECTION CRITERIA: All randomised trials of anticoagulants used to treat patients with intermittent claudication. DATA COLLECTION AND ANALYSIS: Thirteen trials were initially considered eligible for inclusion in the review. Two studies evaluated oral anticoagulants, five evaluated standard heparin, and six evaluated LMWHs. Only three studies (two evaluating oral anticoagulants, one evaluating heparin) met the high quality methodological inclusion criteria and were included in the primary analysis. Four other studies were included in the sensitivity analysis. The reviewers extracted the data independently. MAIN RESULTS: No significant difference was observed between heparin treatment and control groups for pain-free walking distance or maximum walking distance at the end of treatment. There were no data to indicate that LMWHs benefit walking distance. Revascularisation or amputation-free survival rates were reported in one study only with a five year follow-up. No study reported a significant effect on overall mortality or cardiovascular events and the pooled odds ratios were not significant for these outcomes either. Major and minor bleeding events were significantly more frequent in the group treated with oral anticoagulants compared to control, with a non-significant increase in fatal bleeding events. No major bleeding events were reported in the study evaluating heparin, while a non-significant increase in minor bleeding events was reported. REVIEWER'S CONCLUSIONS: No benefit of heparin, LMWHs or oral anticoagulants has been established for intermittent claudication. An increased risk of major bleeding events has been observed especially with oral anticoagulants. The use of anticoagulants for intermittent claudication cannot be recommended at this stage.

Administration, Oral↗
PubMed2005

Single versus combination intravenous antibiotic therapy for people with cystic fibrosis.

BACKGROUND: Choice of antibiotic, and the use of single or combined therapy are controversial areas in the treatment of respiratory infection in cystic fibrosis (CF). Advantages of combination therapy include wider range of modes of action, possible synergy and reduction of resistant organisms; advantages of monotherapy include lower cost, ease of administration and reduction of drug-related toxicity. Current evidence does not provide a clear answer and the use of intravenous antibiotic therapy in CF requires further evaluation. OBJECTIVES: To assess the effectiveness of single compared to combination intravenous antibiotic therapy for treating people with CF. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Most recent search of the Group's register: January 2004. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing a single intravenous antibiotic with a combination of that antibiotic plus a second antibiotic in people with CF. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Twenty-seven trials were identified, of which eight trials (with 356 participants) comparing a single agent to a combination of the same antibiotic and one other, were included. There was a wide variation in the individual antibiotics used in each trial. In total, the trials included seven comparisons of a beta-lactam antibiotic (penicillin-related or third generation cephalosporin) with a beta-lactam-aminoglycoside combination and three comparisons of an aminoglycoside with a beta-lactam-aminoglycoside combination. These two groups of trials were analysed as separate subgroups. There was considerable heterogeneity amongst these trials, leading to difficulties in performing the review and interpreting the results. The meta-analysis did not demonstrate any significant differences between monotherapy and combination therapy, in terms of lung function; symptom scores; adverse effects; and bacteriological outcome measures. These results should be interpreted cautiously. Six of the included trials were published between 1977 and 1988; these were single centre trials with flaws in the randomisation process and small sample size. Overall, the methodological quality was poor. AUTHORS' CONCLUSIONS: The results of this review are inconclusive. The review raises important methodological issues. There is a need for an RCT which needs to be well designed in terms of adequate randomisation allocation, blinding, power and long-term follow up. Results need to be standardised to a consistent method of reporting, in order to validate the pooling of results from multiple trials.

Aminoglycosides↗
PubMed2000

Once daily versus multiple daily dosing with intravenous aminoglycosides for cystic fibrosis.

BACKGROUND: Patients with cystic fibrosis, who are chronically colonised with the organism Pseudomonas aeruginosa, often require repeated courses of intravenous aminoglycoside antibiotics for the management of pulmonary exacerbations. The properties of aminoglycosides suggest that they could be given in higher concentrations less often. OBJECTIVES: To assess the effectiveness and safety of once-daily versus multiple-daily dosing of intravenous aminoglycoside antibiotics for the management of pulmonary exacerbations in cystic fibrosis. SEARCH STRATEGY: We searched the Cystic Fibrosis specialist trials register held at the Cochrane Cystic Fibrosis and Genetic Disorders Group's editorial base, which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings. Date of the most recent search: February 2000. SELECTION CRITERIA: All randomised controlled trials, whether published or unpublished, in which once-daily dosing of aminoglycosides has been compared with multiple-daily dosing in terms of efficacy and/or toxicity, in patients with cystic fibrosis. DATA COLLECTION AND ANALYSIS: Both reviewers independently extracted data and assessed trial quality. Authors of one study were contacted to obtain missing information. MAIN RESULTS: Two trials reporting results from a total of 70 patients were included in this review. Both trials compared once-daily dosing with thrice-daily dosing reporting data on Forced Expiratory Volume at one second (FEV1), Forced Vital Capacity (FVC), nutritional status and side effects. There was no significant difference in efficacy or in the incidence of ototoxicity and nephrotoxicity between treatment groups. REVIEWER'S CONCLUSIONS: Despite a lack of difference between the two groups we feel that these results should be viewed with caution as the numbers of patients involved was small and lacks the power to detect a difference between the groups. This systematic review has highlighted the need for a well designed, adequately-powered, multicentre, randomised controlled trial assessing the efficacy of once-daily versus multiple-daily dosing of intravenous aminoglycosides for pulmonary exacerbations in cystic fibrosis.

Adolescent↗
PubMed2005

Conventional chest physiotherapy compared to other airway clearance techniques for cystic fibrosis.

BACKGROUND: Cystic fibrosis is an inherited life-limiting disorder, characterised by pulmonary infections and thick airway secretions. Chest physiotherapy has been integral to clinical management in facilitating removal of airway secretions. Conventional chest physiotherapy techniques (CCPT) have depended upon assistance during treatments, while more contemporary airway clearance techniques are self-administered, facilitating independence and flexibility. OBJECTIVES: To compare CCPT with other airway clearance techniques in terms of their effects on respiratory function, individual preference, adherence, quality of life and other outcomes. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. We also searched CINAHL from 1982 to 2002 and AMED from 1985 to 2002. Date of most recent search: January 2004. SELECTION CRITERIA: Randomised or quasi-randomised clinical trials including those with a cross-over design where CCPT was compared with other airway clearance techniques. Studies of less than seven days duration were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers allocated quality scores to relevant studies and independently extracted data. If we were unable to extract data, we invited authors to submit their data. We excluded studies from meta-analysis when data were lost or study design precluded comparison. For some continuous outcomes, we used the generic inverse variance method for meta-analysis of data from cross-over trials and data from parallel-designed trials were incorporated for comparison. We also examined efficacy of specific techniques and effects of treatment duration. MAIN RESULTS: Seventy-eight publications were identified by the searches. Twenty-nine of these were included, representing 15 data sets with 475 participants. There was no difference between CCPT and other airway clearance techniques in terms of respiratory function measured by standard lung function tests. Studies undertaken during acute exacerbations demonstrated relatively large gains in respiratory function irrespective of airway clearance technique. Longer-term studies demonstrated smaller improvements or deterioration over time. Ten studies reported individual preferences for technique, with participants tending to favour self-administered techniques. Heterogeneity in the measurement of preference precluded these data from meta-analysis. AUTHORS' CONCLUSIONS: This review demonstrated no advantage of CCPT over other airway clearance techniques in terms of respiratory function. There was a trend for participants to prefer self-administered airway clearance techniques. Limitations of this review included a paucity of well-designed, adequately-powered, long-term trials.

Cystic Fibrosis↗
PubMed2005

Sedatives for opiate withdrawal in newborn infants.

BACKGROUND: Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. OBJECTIVES: To assess the effectiveness and safety of using a sedative compared to a non-opiate control for NAS due to withdrawal from opiates, and to determine which type of sedative is most effective and safe. SEARCH STRATEGY: The standard search strategy of the Neonatal Review Group was used. This update included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2005), MEDLINE 1966-March 2005 and abstracts of conference proceedings. SELECTION CRITERIA: Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to sedative or control. Control could include another sedative or non-pharmacological treatment. DATA COLLECTION AND ANALYSIS: Each author assessed study quality and extracted data independently. Primary outcomes included treatment failure (failure to achieve symptom control or use of additional drug treatment), seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. MAIN RESULTS: Six studies enrolling a total of 305 patients met inclusion criteria (Coyle 2002; Finnegan 1984; Kahn 1969; Kaltenbach 1986; Khoo 1995; Madden 1977); however, two (Finnegan 1984; Kaltenbach 1986) may be sequential reports that include some identical patients. Methodological concerns included the use of quasi-random allocation methods in four studies, and sizeable, largely unexplained differences in reported numbers allocated to each group in three studies. Phenobarbitone compared to supportive care alone has not been shown to reduce treatment failure or time to regain birthweight (one study). However, the duration of supportive care given to infants was significantly reduced (MD -162.1 mins/day, 95% CI -249.2, -75.1). Comparing phenobarbitone to diazepam, meta-analysis of two studies found phenobarbitone produced a significant reduction in treatment failure (typical RR 0.39, 95% CI 0.24, 0.62). There was no significant difference in duration of treatment or hospital stay. Comparing phenobarbitone with chlorpromazine, one study found no significant difference in treatment failure rate. No data for neurodevelopment reported by treatment group of allocation were available. No trials were eligible that assessed clonidine for NAS. In infants treated with an opiate, a small quasi-random study reported a reduced severity of withdrawal. Infants were weaned from an opiate more quickly which allowed earlier hospital discharge and reduced hospital costs. These findings may reflect the low dose of opiate used for initial treatment and the policy of discharging infants home on phenobarbitone but not morphine. AUTHORS' CONCLUSIONS: In newborn infants with NAS, there is no evidence that phenobarbitone compared with supportive care alone reduces treatment failure; however, phenobarbitone may reduce the daily duration of supportive care needed. Phenobarbitone, compared to diazepam, reduces treatment failure. In infants treated with an opiate, the addition of phenobarbitone may reduce withdrawal severity. Further trials are required to determine if this finding is applicable when a higher initial dose of opiate is used, and determine the effects of phenobabritone on infant development. There is insufficient evidence to support the use of chlorpromazine or clonidine in newborn infants with NAS. Clonidine and chlorpromazine should only be used in the context of a randomised clinical trial. This review should be taken in conjunction with the review "Opiate treatment for opiate withdrawal in newborn infants" (Osborn 2002a) which indicates that an opiate is the preferred initial therapy for NAS.

Chlorpromazine↗
PubMed2001

Interventions for the treatment of twin-twin transfusion syndrome.

BACKGROUND: Twin-twin transfusion syndrome, a condition affecting monochorionic twin pregnancies, is associated with a high risk of perinatal mortality and morbidity. A number of treatments have been introduced to treat the condition but it is unclear which intervention improves maternal and fetal outcome. OBJECTIVES: The objective of this review was to evaluate the impact of treatment modalities in twin-twin transfusion syndrome. SEARCH STRATEGY: We searched The Cochrane Pregnancy and Childbirth Trials Register and Cochrane Controlled Trials Register. We also searched conference proceedings and made personal contact with experts active in the area of the review. Date of last search: August 2000. SELECTION CRITERIA: Randomised and quasi-randomised studies of amnioreduction versus laser coagulation, septostomy versus laser coagulation or septostomy versus amnioreduction. DATA COLLECTION AND ANALYSIS: Eligibility was assessed by one reviewer. Study authors were contacted for additional information. MAIN RESULTS: No studies were included. REVIEWER'S CONCLUSIONS: There is no current evidence from randomised trials to influence practice. Three ongoing randomised studies have been identified.

Amniocentesis↗
PubMed2005

Speech and language therapy for dysarthria due to non-progressive brain damage.

BACKGROUND: Dysarthria is a common sequel of non-progressive brain damage (typically stroke and traumatic brain damage). Impairment-based therapy and a wide variety of compensatory management strategies are undertaken by speech and language therapists with this patient population. OBJECTIVES: To determine the efficacy of speech and language therapy interventions for adults with dysarthria following non-progressive brain damage. SEARCH STRATEGY: We searched the trials registers of the following Cochrane Groups: Stroke, Injuries, Movement Disorders and Infectious Diseases. We also searched the trials register of the Cochrane Rehabilitation and Related Therapies Field. The trials registers were last searched in September 2004. The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2004), MEDLINE (1966 to September 2004), EMBASE (1980 to September 2004), CINAHL (1983 to September 2004), PsycINFO (1974 to October 2004), and Linguistics and Language Behavior Abstracts (1983 to December 2004) were searched electronically. We handsearched the International Journal of Language and Communication Disorders (1966 to 2005, Issue 1) and selected conference proceedings, and scanned the reference lists of relevant articles. We approached colleagues and speech and language therapy training institutions to identify other possible published and unpublished studies. SELECTION CRITERIA: Unconfounded randomised controlled trials (RCTs). DATA COLLECTION AND ANALYSIS: One author assessed trial quality. Two co-authors were available to examine any potential trials for possible inclusion in the review. MAIN RESULTS: No trials of the required standard were identified. AUTHORS' CONCLUSIONS: There is no evidence of the quality required by this review to support or refute the effectiveness of speech and language therapy interventions for dysarthria following non-progressive brain damage. Despite the recent commencement of a RCT of optimised speech and language therapy for communication difficulties after stroke, there continues to be an urgent need for good quality research in this area.

Adult↗
PubMed2000

Telemedicine versus face to face patient care: effects on professional practice and health care outcomes.

BACKGROUND: Telemedicine is the use of telecommunications technology for medical diagnosis and patient care. From its beginnings telemedicine has been used in a variety of health care fields, although widespread interest among healthcare providers has only now become apparent with the development of more sophisticated technology. OBJECTIVES: To assess the effects of telemedicine as an alternative to face-to-face patient care. SEARCH STRATEGY: We searched the Effective Practice and Organisation of Care Group's specialised register, The Cochrane Library, MEDLINE (1966-August 1999), EMBASE (to 1996), Cinahl (to August 1999), Inspec (to August 1996), Healthstar (1983-1996), OCLC, Sigle (to 1999), Assia, SCI (1981-1997), SSCI (1981-1997), DHSS-Data. We hand searched the Journal of Telemedicine and Telecare (1995-1999), Telemedicine Journal (1995-1999) and reference lists of articles. We also hand searched conference proceedings and contacted experts in countries identified as having an interest in telemedicine. SELECTION CRITERIA: Randomised trials, controlled before and after studies and interrupted time series comparing telemedicine with face-to-face patient care. The participants were qualified health professionals and patients receiving care through telemedicine. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Seven trials involving more than 800 people were included. One trial was concerned with telemedicine in the emergency department, one with video-consultations between primary health care and the hospital outpatients department, and the remainder were concerned with the provision of home care or patient self-monitoring of chronic disease. The studies appeared to be well conducted, although patient numbers were small in all but one. Although none of the studies showed any detrimental effects from the interventions, neither did they show unequivocal benefits and the findings did not constitute evidence of the safety of telemedicine. None of the studies included formal economic analysis. All the technological aspects of the interventions appear to have been reliable, and to have been well accepted by patients. REVIEWER'S CONCLUSIONS: Establishing systems for patient care using telecommunications technologies is feasible, but there is little evidence of clinical benefits. The studies provided variable and inconclusive results for other outcomes such as psychological measures, and no analysable data about the cost effectiveness of telemedicine systems. The review demonstrates the need for further research and the fact that it is feasible to carry out randomised trials of telemedicine applications. Policy makers should be cautious about recommending increased use and investment in unevaluated technologies.

Communication↗
PubMed2006

Palliative radiotherapy regimens for non-small cell lung cancer.

BACKGROUND: Palliative radiotherapy to the chest is often used in patients with lung cancer, but radiotherapy regimens are more often based on tradition than research results. OBJECTIVES: To discover the most effective and least toxic regimens of palliative radiotherapy for non-small cell lung cancer, and whether higher doses increase survival. SEARCH STRATEGY: The electronic databases MEDLINE, EMBASE, Cancerlit and the Cochrane Central Register of Controlled Trials, reference lists, handsearching of journals and conference proceedings, and discussion with experts were used to identify potentially eligible trials, published and unpublished. SELECTION CRITERIA: Randomised controlled clinical trials comparing different regimens of palliative radiotherapy in patients with non-small cell lung cancer. DATA COLLECTION AND ANALYSIS: Fourteen randomised trials were reviewed. There were important differences in the doses of radiotherapy investigated, the patient characteristics and the outcome measures. Because of this heterogeneity no meta-analysis was attempted. MAIN RESULTS: There is no strong evidence that any regimen gives greater palliation. Higher dose regimens give more acute toxicity, especially oesophagitis. There is evidence for a modest increase in survival (5% at 1 year and 3% at 2 years) in patients with better performance status (PS) given higher dose radiotherapy. Some regimens are associated with an increased risk of radiation myelitis. AUTHORS' CONCLUSIONS: The majority of patients should be treated with short courses of palliative radiotherapy, of 1 or 2 fractions. Care should be taken with the dose to the spinal cord. The use of high dose palliative regimens should be considered for and discussed with selected patients with good performance status. More research is needed into reducing the acute toxicity of large fraction regimens and into the role of radical compared to high dose palliative radiotherapy. In the future, large trials comparing different RT regimens may be difficult to set up because of the increasing use of systemic chemotherapy. Trials looking at how best to integrate these two modalities, particularly in good PS patients, need to be carried out.

Carcinoma, Non-Small-Cell Lung↗
PubMed2002

Follow-up strategies for patients treated for non-metastatic colorectal cancer.

BACKGROUND: It is common clinical practise to follow patients with colorectal cancer (CRC) for several years following their definitive surgery and/or adjuvant therapy. Despite this widespread practice there is considerable controversy about how often patients should be seen, what tests should be performed and whether these varying strategies have any significant impact on patient outcomes. OBJECTIVES: To review the available evidence concerning the benefits of intensive follow-up of colorectal cancer patients with respect to survival. Secondary endpoints include time to diagnosis of recurrence, quality of life and the harms and costs of surveillance and investigations. SEARCH STRATEGY: Relevant trials were identified by electronic searches of MEDLINE, EMBASE, CINAHL, CANCERLIT, Cochrane Controlled Trials Register, Science Citation Index, conference proceedings, trial registers, reference lists and contact with experts in the field. SELECTION CRITERIA: Only randomised controlled trials comparing different follow-up strategies for patients with non-metastatic CRC treated with curative intent were included. DATA COLLECTION AND ANALYSIS: Trial eligibility and methodological quality were assessed independently by the three reviewers. MAIN RESULTS: Five trials were included. There was evidence that an overall survival benefit at 5 years exists for patients undergoing more intensive follow-up (OR = 0.67, 95% confidence interval 0.53 - 0.84; RD = -0.07, CI -0.12 - -0.02). The absolute number of recurrences was similar (OR = 0.91; 95% confidence interval 0.72 - 1.14; RD = 0.00, CI -0.07 - 0.07) and although the weighted mean difference for the time to recurrence was significantly reduced by 6.75 (95% confidence interval -11.06 - -2.44) there was significant heterogeneity between the studies. Analyses demonstrated a mortality benefit for performing more tests versus fewer tests (OR = 0.66; 95% confidence interval 0.46 - 0.95) and liver imaging versus no liver imaging (OR = 0.66; 95% confidence interval 0.46 - 0.95). However when both these results are expressed as a risk difference this significance is lost (RD = -0.06; CI -0.25 - 0.13). No useful data on quality of life, harms or cost-effectiveness were available for further analysis. REVIEWER'S CONCLUSIONS: The results of our review suggest that there is an overall survival benefit for intensifying the follow-up of patients after curative surgery for colorectal cancer. Because of the wide variation in the follow-up programmes used in the included studies it is not possible to infer from the data the best combination and frequency of clinic (or family practice) visits, blood tests, endoscopic procedures and radiological investigations to maximise the outcomes for these patients. Nor is it possible to estimate the potential harms or costs of intensifying follow-up for these patients in order to adopt a cost-effective approach in this clinical area. Large clinical trials underway or about to commence are likely to contribute valuable further information to clarify these areas of clinical uncertainty.

Clinical Protocols↗
PubMed2002

Omega-3 fatty acids (from fish oils) for cystic fibrosis.

BACKGROUND: Epidemiological (population studies) and other studies suggest that a diet rich in omega-3 essential fatty acids (derived from fish oil) may have beneficial anti-inflammatory effects for chronic conditions such as cystic fibrosis. OBJECTIVES: To determine whether there is evidence that omega-3 polyunsaturated fatty acid supplementation reduces morbidity and mortality. To identify any adverse events associated with omega-3 polyunsaturated fatty acid supplementation. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group specialised trials register, which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings. Authors and persons interested in the question were contacted. Date of the most recent search of the Group's specialised register: May 2002. SELECTION CRITERIA: Randomised controlled trials in patients with cystic fibrosis in which omega-3 fatty acid supplements were compared with a placebo oil. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected the trials to be included in the review and assessed the methodological quality of the trials using two approaches: Cochrane assessment of allocation concealment and Jadad quality assessment score. Using data acquisition forms, two reviewers independently extracted data. Missing data has been requested. MAIN RESULTS: The initial literature search identified six trials. Two trials, involving 31 participants satisfied our inclusion criteria and were included in the review. Both compared omega-3 fatty acids to olive oil controls for a six week treatment period. One study (19 participants) showed an improvement in FEV1, FVC, Shwachman score and reduction in sputum volume in the fish oil group at the end of this short treatment period. REVIEWER'S CONCLUSIONS: The review of trials found that regular omega-3 supplements may provide some benefits for people with cystic fibrosis with relatively few adverse effects, although the evidence is insufficient to draw firm conclusions. There is insufficient evidence to recommend routine use of supplements of omega-3 fatty acids in people with cystic fibrosis. The most notable feature highlighted by this review was the lack of data for many of the outcomes likely to be meaningful to people with or making treatment decisions about CF. A large, long-term, multi-centre, randomised controlled study is needed in order to determine if there is a significant therapeutic effect and to assess the influence of disease severity, dosage and duration of treatment. Future researchers should note the need for additional pancreatic enzymes.

Cystic Fibrosis↗