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PubMed2003

Inhaled bronchodilators for acute chest syndrome in people with sickle cell disease.

BACKGROUND: Bronchodilators are used to treat bronchial hyper-responsiveness in asthma. Bronchial hyper-responsiveness may be a component of the acute chest syndrome in people with sickle cell disease. Therefore, bronchodilators may be useful in the treatment of acute chest syndrome. OBJECTIVES: To assess the benefits and risks associated with the use of bronchodilators in people with acute chest syndrome. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings. Additional searches were carried out on MEDLINE (1966 to 2002) and EMBASE (1981 to 2002).Date of the most recent search of the Group's haemoglobinopathies register: May 2002. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials. Trials using quasi-randomisation methods will be included in future updates of this review if there is sufficient evidence that the treatment and control groups are similar at baseline. DATA COLLECTION AND ANALYSIS: We found no trials investigating the use of bronchodilators for acute chest syndrome in people with sickle cell disease. MAIN RESULTS: We found no trials investigating the use of bronchodilators for acute chest syndrome in people with sickle cell disease. REVIEWER'S CONCLUSIONS: If bronchial hyper-responsiveness is an important component of some episodes of acute chest syndrome in people with sickle cell disease, the use of inhaled bronchodilators may be indicated. There is need for a well-designed, adequately powered randomised controlled trial to assess the benefits and risks of the addition of inhaled bronchodilators to established therapies for acute chest syndrome in people with sickle cell disease.

Acute Disease↗
PubMed2005

Oxygen therapy for cystic fibrosis.

BACKGROUND: The most serious complications of cystic fibrosis (CF) relate to respiratory insufficiency. Oxygen supplementation therapy has been a standard of care for individuals with chronic lung diseases associated with hypoxemia for decades. It is common for physicians to prescribe oxygen therapy for people with CF when hypoxemia occurs. However, it is unclear if empiric evidence is available to provide indications for this therapy with its financial costs and often profound impact on lifestyle. OBJECTIVES: To assess whether oxygen therapy improves the longevity or quality of life of individuals 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 Group's Trials Register: April 2005. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials comparing oxygen, administered at any concentration, by any route, in people with documented CF for any time period. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study quality and extracted data. MAIN RESULTS: Nine published studies (149 participants) are included in this review, of which only one examined long-term oxygen therapy (28 participants). There was no statistically significant improvement in survival, lung, or cardiac health. Four studies examined the effect of oxygen supplementation during sleep by polysomnography. Although oxygenation improved, there were no demonstrable improvements in qualitative sleep parameters and modest hypoventilation was noted. In three studies, oxygen supplementation was evaluated during exercise. Hypoxemia was prevented, but mild hypercapnia resulted. Work performance was not improved, as measured in one study, but was improved in a second study. Furthermore, in two studies, exercise duration was enhanced by oxygen supplementation. In the study examining the impact of oxygen supplementation after exercise, recovery time was enhanced. AUTHORS' CONCLUSIONS: There are no published data to guide the prescription of chronic oxygen supplementation to people with advanced lung disease due to CF. Short-term oxygen therapy during sleep and exercise improves oxygenation but is associated with modest and probably clinically inconsequential hypercapnia. During exercise, there are improvements in exercise duration and peak performance. There is a need for larger, well-designed clinical trials to assess the benefits of long-term oxygen therapy in people with CF administered continuously or during exercise or sleep or both.

Cystic Fibrosis↗
PubMed2004

Pneumococcal vaccines for sickle cell disease.

BACKGROUND: People with sickle cell disease are particularly susceptible to pneumococcal infection, which may be fatal. Infants (children aged up to 23 months) are at particularly high risk, but conventional polysaccharide pneumococcal vaccines may be ineffective in this age group. New conjugate pneumococcal vaccines are now available, which may help to reduce the incidence of infection in people with sickle cell disease. OBJECTIVES: To determine the efficacy of pneumococcal vaccines for reducing morbidity and mortality in people with sickle cell disease. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register, comprising of references identified from comprehensive electronic database searches and hand searching relevant journals and abstract books of conference proceedings. In addition, we contacted relevant pharmaceutical companies and experts in the field.Date of most recent search of Group's trials register: November 2003. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials comparing a polysaccharide or conjugate pneumococcal vaccine regimen with a different regimen or no vaccination in people with sickle cell disease. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected studies for inclusion, extracted data and assessed trial quality. MAIN RESULTS: Nine trials were identified in the searches and five trials, with a total of 547 participants, met the inclusion criteria. Only one trial reported incidence of pneumococcal infection, and this demonstrated that the polysaccharide pneumococcal vaccine used (PPV14) failed to significantly reduce the risk of infection in children under three years of age, but was associated with only minor adverse events. Three trials of conjugate pneumococcal vaccines found that immune response was increased compared to control groups, including in infants, although clinical outcomes were not measured in these trials. REVIEWER'S CONCLUSIONS: Previous trials have shown that conjugate pneumococcal vaccines are safe and effective in normal healthy patients, even those under the age of two years. The controlled trials included in this review have demonstrated immunogenicity (the body's response, without which there is no protection) of these vaccines, and observational studies in people with sickle cell disease support these findings. We therefore recommend that conjugate pneumococcal vaccines are used in people with sickle cell disease. Randomised trials in patients with sickle cell disease will be needed to determine the optimal vaccination regimen when further, potentially more effective vaccines become available. Such trials should measure clinical outcomes of effectiveness.

Anemia, Sickle Cell↗
PubMed2004

Interventions for preventing infection in nephrotic syndrome.

BACKGROUND: Infection is one of the most common complications and still remains a significant cause of morbidity and occasionally mortality in patients, especially children with nephrotic syndrome. Many different prophylactic interventions have been used or recommended for reducing the risks of infection in nephrotic syndrome in clinical practice. Whether the existing evidence is scientifically rigorous and which prophylactic intervention can be recommended for routine use based on the current evidence is still unknown. OBJECTIVES: To assess the benefits and harms of any prophylactic interventions for reducing the risk of infection in children and adults with nephrotic syndrome. SEARCH STRATEGY: We searched the Cochrane Renal Group Specialised Register (January 2003), The Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library Issue 1, 2003), MEDLINE and Pre-MEDLINE (1966 - February 2003), EMBASE (1980 - February 2003), China Biological Medicine Database (CBMdisc, 1979 - December 2002), reference lists of nephrology textbooks, review articles, relevant trials and abstracts from nephrology scientific meetings without language restriction. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs comparing any prophylactic interventions (pharmacological or non-pharmacological) for preventing any infection in children and adults with nephrotic syndrome. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed and extracted information. Information was collected on method, participants, interventions and outcomes ( appearance of infection, mortality, quality of life and adverse events). MAIN RESULTS: Five RCTs conducted in China, including 308 children with nephrotic syndrome were identified. No trials were identified in adults. All trials compared one kind of prophylactic pharmacotherapy (IVIG, thymosin or a compound of Chinese medicinal herbs - TIAOJINING) in addition to baseline treatment with baseline treatment alone. No RCTs were identified comparing antibiotic or non-pharmacological prophylaxis, or pneumococcal vaccination. Three trials showed a significantly better effect of IVIG on preventing nosocomial or unspecified infection in children with nephrotic syndrome (RR 0.39, 95% CI 0.18 to 0.82). Thymosin and TIAOJINING were also effective for reducing the risks of infection in children with nephrotic syndrome with RR 0.50 (95%CI 0.26 to 0.97) and 0.59 (95%CI 0.43 to 0.81) respectively. No serious adverse events were reported. REVIEWERS' CONCLUSIONS: IVIG, thymosin and TIAOJINING may have positive effects on prevention of nosocomial or unspecified infection with no obvious serious adverse events in children with nephrotic syndrome. However the methodological quality of all trials was poor, the sample sizes small and all studies were from China, and thus there is no strong evidence on the effectiveness of these interventions.

Bacterial Infections↗
PubMed2003

Totally implantable vascular access devices for cystic fibrosis.

BACKGROUND: Totally implantable vascular access devices are widely used in people with cystic fibrosis to provide intermittent venous access for therapeutic infusions. Their use is associated with some complications such as thrombosis, embolism and infection. OBJECTIVES: To assess if totally implantable venous access devices are a safe and effective route for providing venous access for intermittent administration of intravenous antibiotics in people with cystic fibrosis, also to assess strategies to reduce possible complications of totally implantable venous access devices (e.g. anticoagulants to reduce the risk of thrombosis). SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings. Date of the most recent search: May 2003. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials which compared the use of totally implantable venous access devices in people with cystic fibrosis to other means of vascular access, trials which compared the different types of these devices against each other and trials which assessed strategies to reduce complications of these devices. DATA COLLECTION AND ANALYSIS: No relevant trials were identified. MAIN RESULTS: No trials were included in this review. REVIEWER'S CONCLUSIONS: Totally implantable vascular access devices are widely used in people with cystic fibrosis to provide intermittent venous access for therapeutic infusions. Reports of their use in people with cystic fibrosis suggest that they are safe and effective. These reports also suggest that certain interventions might reduce the risk of complications; however, it is disappointing that these reports have not been assessed by randomised controlled trials. This systematic review identifies the need for a multicentre randomised controlled trial assessing both efficacy and possible adverse effects of totally implantable venous access devices in cystic fibrosis.

Catheters, Indwelling↗
PubMed2004

Antioxidant supplements for preventing gastrointestinal cancers.

BACKGROUND: Oxidative stress may cause gastrointestinal cancers. The evidence on whether antioxidant supplements are effective in preventing gastrointestinal cancers is contradictory. OBJECTIVES: To assess the beneficial and harmful effects of antioxidant supplements in preventing gastrointestinal cancers. SEARCH STRATEGY: We identified trials through the trials registers of the four Cochrane Review Groups on gastrointestinal diseases, The Cochrane Central Register of Controlled Trials on The Cochrane Library (Issue 1, 2003), MEDLINE, EMBASE, LILACS, and SCI-EXPANDED from inception to February 2003, and The Chinese Biomedical Database (March 2003). We scanned reference lists and contacted pharmaceutical companies. SELECTION CRITERIA: Randomised trials comparing antioxidant supplements to placebo/no intervention examining the incidence of gastrointestinal cancers. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion and extracted data. The outcome measures were incidence of gastrointestinal cancers, overall mortality, and adverse events. Outcomes were reported as relative risks (RR) with 95% confidence interval (CI) based on fixed and random effects meta-analyses. MAIN RESULTS: We identified 14 randomised trials (170,525 participants), assessing beta-carotene (9 trials), vitamin A (4 trials), vitamin C (4 trials), vitamin E (5 trials), and selenium (6 trials). Trial quality was generally high. Heterogeneity was low to moderate. Neither the fixed effect (RR 0.96, 95% CI 0.88 to 1.04) nor random effects meta-analyses (RR 0.90, 95% CI 0.77 to 1.05) showed significant effects of supplementation with antioxidants on the incidences of gastrointestinal cancers. Among the seven high-quality trials reporting on mortality (131,727 participants), the fixed effect (RR 1.06, 95% CI 1.02 to 1.10) unlike the random effects meta-analysis (RR 1.06, 95% CI 0.98 to 1.15) showed that antioxidant supplements significantly increased mortality. Two low-quality trials (32,302 participants) found no significant effect of antioxidant supplementation on mortality. The difference between the mortality estimates in high- and low-quality trials was significant by test of interaction (z = 2.10, P = 0.04). Beta-carotene and vitamin A (RR 1.29, 95% CI 1.14 to 1.45) and beta-carotene and vitamin E (RR 1.10, 95% CI 1.01 to 1.20) significantly increased mortality, while beta-carotene alone only tended to do so (RR 1.05, 95% CI 0.99 to 1.11). Increased yellowing of the skin and belching were non-serious adverse effects of beta-carotene. In four trials (three with unclear/inadequate methodology), selenium showed significant beneficial effect on gastrointestinal cancer incidences. REVIEWERS' CONCLUSIONS: We could not find evidence that antioxidant supplements prevent gastrointestinal cancers. On the contrary, they seem to increase overall mortality. The potential cancer preventive effect of selenium should be studied in adequately conducted randomised trials.

Antioxidants↗
PubMed2006

Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis.

BACKGROUND: Lower respiratory tract infection with Pseudomonas aeruginosa (P. aeruginosa) occurs in most people with cystic fibrosis. Once chronic infection is established, P. aeruginosa is virtually impossible to eradicate and is associated with increased mortality and morbidity. Early infection may be easier to eradicate. OBJECTIVES: To determine whether antibiotic treatment of early P. aeruginosa infection in children and adults with cystic fibrosis eradicates the organism and improves clinical and microbiological outcome. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of most recent search: May 2004 SELECTION CRITERIA: We included randomised controlled trials of people with cystic fibrosis, in whom P. aeruginosa had recently been isolated from respiratory secretions. We compared combinations of inhaled, oral or intravenous antibiotics with placebo or usual treatment (or both) or other combinations of inhaled, oral or intravenous antibiotics. We excluded non-randomised trials, cross-over trials, and those utilising historical controls. DATA COLLECTION AND ANALYSIS: Both authors independently assessed selected trials, assessed methodological quality and extracted data. MAIN RESULTS: The search identified 15 trials. Three trials (69 participants) were eligible for inclusion. There is evidence from two randomised controlled trials, of questionable methodological quality, that treatment of early P. aeruginosa infection with inhaled tobramycin results in microbiological eradication of the organism from respiratory secretions more often than placebo and that this effect may persist for up to 12 months, however incomplete data from one of the trials precludes an accurate analysis. One randomised controlled trial of oral ciprofloxacin and nebulised colisitin versus usual treatment was identified. This trial was of poor methodological quality. The results suggested treatment of early infection results in microbiological eradication of P. aeruginosa more often than usual treatment, after two years, RR 0.24 (95% CI 0.06 to 0.96). There is insufficient evidence to determine whether antibiotic strategies for the eradication of early P. aeruginosa decrease mortality or morbidity, improve quality of life, or are associated with adverse effects compared to placebo or standard treatment. AUTHORS' CONCLUSIONS: From the three trials included in this review, there is some evidence that antibiotic treatment of early P. aeruginosa results in short-term eradication but it remains uncertain whether there is clinical benefit to people with cystic fibrosis.

Anti-Bacterial Agents↗
PubMed2004

Granulocyte-Colony Stimulating Factor (G-CSF) as an adjunct to antibiotics in the treatment of pneumonia in adults.

BACKGROUND: Granulocyte colony stimulating factor (G-CSF) is a naturally-occurring cytokine that has been shown to increase neutrophil function and number. Exogenous administration of recombinant G-CSF (filgrastim, pegfilgrastim or lenograstim) has found extensive use in the treatment of febrile neutropaenia, but its role in the treatment of infection in non-neutropaenic hosts is less well defined. OBJECTIVES: We explored the role of G-CSF as an adjunct to antibiotics in the treatment of pneumonia in non-neutropaenic adults. SEARCH STRATEGY: We searched the following electronic databases in 2003 and updated the search in 2004: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1, 2004); MEDLINE (January 1966 to March Week 1, 2004); EMBASE (1998 to December 2003); online databases of clinical trials; and reference lists of articles. We also contacted study authors, manufacturers and distributors of G-CSF. SELECTION CRITERIA: We considered randomised controlled trials (RCTs) which included hospitalised adult patients with either community acquired pneumonia or hospital-acquired pneumonia. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. The primary outcome measure was 28 day mortality. Secondary outcome measures included other markers of mortality as well as markers of adverse events, including organ dysfunction. An assessment of methodological quality was made for each study. MAIN RESULTS: Six studies with a total of 1984 people were identified. G-CSF use appeared to be safe with no increase in the incidence of total serious adverse events (pooled odds ratio (OR) 0.91; 95% confidence interval (CI): 0.73 to 1.14) or organ dysfunction. However, the use of G-CSF was not associated with improved 28 day mortality (pooled OR 0.86; 95% CI: 0.56 to 1.31). REVIEWERS' CONCLUSIONS: There is no current evidence supporting the routine use of G-CSF in the treatment of pneumonia. Studies in which G-CSF is administered prophylactically or earlier in therapy may be of interest.

Adult↗
PubMed2004

Phytomedicines (medicines derived from plants) for sickle cell disease.

BACKGROUND: Sickle cell disease (SCD) is a common recessively inherited disorder of haemoglobin affecting peoples originating from sub-Saharan Africa, the Middle East and Mediterranean basin, the Indian subcontinent, the Caribbean and South America. The homozygous state (SS) is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass much of what the populations most affected would encounter in terms of plant-remedies from traditional healers. There has been little in the way of systematic appraisal of their benefits. OBJECTIVES: To assess the benefits and risks of phytomedicines in people with SCD of all types, of any age, in any setting. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders group specialised register of controlled trials of haemoglobinopathies, which comprises references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We performed an additional search of the bibliographic database of Allied and Complementary Medicine (AMED). Date of most recent search of the trials register: September 2003. SELECTION CRITERIA: All randomised or quasi-randomised trials with participants of all ages with SCD, in all settings, comparing the administration of phytomedicines, by any mode to placebo or standard treatment, including blood transfusion and hydroxyurea. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality and extracted data from the study. MAIN RESULTS: Reports of two trials were found, of which only one, including 82 participants, was eligible for inclusion in this review. This Phase IIB (pivotal) study suggests that a phytomedicine, NIPRISAN, was effective in reducing episodes of SCD crisis associated with severe pain over a six-month period. NIPRISAN did not appear to affect the risk of severe complications or the level of anaemia. No serious adverse effects were reported. REVIEWERS' CONCLUSIONS: While NIPRISAN, as a phytomedicine, appeared to be safe and effective, over a six-month follow-up period of this study, in reducing crises associated with severe pain, further studies are required to assess its role in the management of people with sickle cell disease. The results of Phase III, multicentre trials are awaited.

Anemia, Sickle Cell↗
PubMed2004

Recombinant Factor VIIa concentrate versus plasma derived concentrates for the treatment of acute bleeding episodes in people with Haemophilia A and inhibitors.

BACKGROUND: In some people with haemophilia, therapeutic clotting agents are recognised as a foreign protein and anti-FVIII antibodies, known as 'inhibitors', are produced. This review investigates which treatment most effectively arrests acute bleeding in people with haemophilia A and inhibitors. OBJECTIVES: To determine the clinical effectiveness of recombinant FVIIa concentrate in comparison to plasma-derived concentrates for the treatment of acute bleeding episodes in people with haemophilia A and inhibitors. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises of references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. Date of the most recent search of the Group's trials register: September 2003. SELECTION CRITERIA: Randomised (RCTs) and quasi-randomised controlled clinical trials comparing Recombinant FVIIa concentrate to human plasma-derived concentrates (high-dose human or recombinant FVIII concentrate; prothrombin complex concentrates (PCCs); activated prothrombin complex concentrate (aPCC)) in people with haemophilia A. Comparisons with animal derived products were excluded. DATA COLLECTION AND ANALYSIS: No studies were found that were eligible for inclusion in this review. MAIN RESULTS: A total of four studies were identified by the searches, however, none of these were eligible for inclusion in this review. REVIEWERS' CONCLUSIONS: No RCTs on the relative effectiveness of Recombinant FVIIa concentrate compared to human plasma-derived concentrates in people with haemophilia A and inhibitors were identified for inclusion in this review. The research evidence on which to base clinical decisions is therefore limited to case reports, and other less robust evidence. There is need for a well-designed, adequately-powered randomised controlled trial to assess the relative benefits and risks of using Recombinant FVIIa concentrate compared to human plasma-derived concentrates in people with haemophilia A and inhibitors.

Acute Disease↗
PubMed2004

Single dose oral paracetamol (acetaminophen) for postoperative pain.

BACKGROUND: Paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for the relief of mild and moderate pain arising from headache, musculoskeletal conditions and dysmenorrhoea. A prior Cochrane systematic review concluded that paracetamol is also effective for postoperative pain, but additional trials have since been published. This review sought to evaluate the efficacy and safety of paracetamol using current data, and to compare the findings with other analgesics evaluated in the same way. OBJECTIVES: To assess the efficacy of single dose oral paracetamol for the treatment of acute postoperative pain. SEARCH STRATEGY: We searched the Cochrane Library (Issue 3, 2002), the trials register of the Cochrane Pain, Palliative and Supportive Care group (November 2002); MEDLINE (1966 to May 1996); PubMed (1996 to August 2001); EMBASE (1980 to 1996); the Oxford Pain Relief Database (1950 to 1994); and reference lists of articles in order to update an existing version of the review. SELECTION CRITERIA: Randomised, double-blind, placebo-controlled clinical trials of paracetamol for acute postoperative pain in adults. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. The area under the 'pain relief versus time' curve was used to derive the proportion of patients with paracetamol or placebo experiencing least 50% pain relief over four to six hours using validated equations. The number-needed-to-treat (NNT) was calculated using 95% confidence intervals. Information on adverse effects was also collected. MAIN RESULTS: Forty-seven reports that enrolled 4186 patients (2561 patients were treated with a single oral dose of paracetamol and 1625 with placebo) met the inclusion criteria and were included in the analyses. The NNTs for at least 50% pain relief over four to six hours following a single dose of paracetamol were as follows: 325 mg NNT 3.8 (2.2 to 13.3); 500 mg NNT 3.5 (2.7 to 4.8); 600/650 mg NNT 4.6 (3.9 to 5.5); 975/1000 mg NNT 3.8 (3.4 to 4.4); and 1500 mg NNT 3.7 (2.3 to 9.5). Sub-group analysis showed no significant differences between smaller and larger trials, or lower and higher quality trials. Drug-related study withdrawals were rarely reported. Studies reported a variable incidence of adverse effects that were generally mild and transient. There were no statistically significant differences in the frequency of reported adverse effects between paracetamol 975/1000 mg and placebo. REVIEWER'S CONCLUSIONS: Single doses of paracetamol are effective analgesics for acute postoperative pain and give rise to few adverse effects.

Acetaminophen↗
PubMed2005

Protein substitute for children and adults with phenylketonuria.

BACKGROUND: Phenylketonuria is an inherited disease characterised by an absence or deficiency of the enzyme phenylalanine hydroxylase. The aim of treatment is to lower blood phenylalanine concentrations to prevent developmental delay. Current treatment is based on a low phenylalanine diet in combination with a protein substitute (mixtures of amino acids free from or low in phenylalanine). Guidance regarding the dosage and distribution of this protein substitute, over a 24-hour period, is unclear and there is variation in recommendation between treatment centres. OBJECTIVES: To assess in children and adults with phenylketonuria, who are adhering to a low phenylalanine diet, the benefits and adverse effects of protein substitute, its dosage and distribution of dose. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also contacted manufacturers of the phenylalanine-free and low phenylalanine protein substitutes for any data from published and unpublished randomised controlled trials. Date of the most recent search of the Group's Trials Register: August 2005. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing: any dose of protein substitute with no protein substitute; an alternative dosage; or the same dose, but given as frequent small doses throughout the day compared with the same total daily dose given as larger boluses less frequently. DATA COLLECTION AND ANALYSIS: Both authors independently extracted data and assessed trial quality. MAIN RESULTS: The searches identified 20 trials, of which one, including a total of 28 participants, was eligible for inclusion in the review. This was a two-phase trial, with only phase one being a randomised controlled trial. As data from both phases were combined in the analysis presented in the published paper, we are currently unable to include any data from the randomised controlled trial in the analysis of this review. AUTHORS' CONCLUSIONS: No conclusions could be made about the short- or long-term use of protein substitute in phenylketonuria due to the lack of adequate trial data. A randomised controlled trial is needed to investigate the use of protein substitute in phenylketonuria. Until further evidence is available current practice in the use of protein substitute should continue to be observed and monitored with care.

Adult↗
PubMed2006

Acupuncture for neck disorders.

BACKGROUND: Neck pain is one of the three most frequently reported complaints of the musculoskeletal system. Treatments for neck pain are varied, as are the perceptions of benefits. Acupuncture has been used as an alternative to more traditional treatments for musculoskeletal pain. This review summarizes the most current scientific evidence on the effectiveness of acupuncture for acute, subacute and chronic neck pain. OBJECTIVES: To determine the effects of acupuncture for individuals with neck pain. SEARCH STRATEGY: We searched CENTRAL (2006, issue 1) and MEDLINE, EMBASE, MANTIS, CINAHL from their beginning to February 2006. We searched reference lists and the acupuncture database TCMLARS in China. SELECTION CRITERIA: Any published trial using randomized (RCT) or quasi-randomized (quasi-RCT) assignment to the intervention groups, either in full text or abstract form, were included. DATA COLLECTION AND ANALYSIS: Two reviewers made independent decisions for each step of the review: article inclusion, data abstraction and assessment of trial methodological quality. Study quality was assessed using the Jadad criteria. Consensus was used to resolve disagreements. When clinical heterogeneity was absent, we combined studies using random-effects meta-analysis models. MAIN RESULTS: We did not find any trials that examined the effects of acupuncture for acute or subacute pain, but we found 10 trials that examined acupuncture treatments for chronic neck pain. Overall, methodological quality had a mean of 2.3/5 on the Jadad Scale. For chronic mechanical neck disorders, there was moderate evidence that acupuncture was more effective for pain relief than some types of sham controls, measured immediately post-treatment. There was moderate evidence that acupuncture was more effective than inactive, sham treatments measured immediately post-treatment and at short-term follow-up (pooled standardized mean difference (SMD) -0.37, 95% confidence interval (CI) -0.61 to -0.12). There was limited evidence that acupuncture was more effective than massage at short-term follow-up. For chronic neck disorders with radicular symptoms, there was moderate evidence that acupuncture was more effective than a wait-list control at short-term follow-up. AUTHORS' CONCLUSIONS: There is moderate evidence that acupuncture relieves pain better than some sham treatments, measured at the end of the treatment. There is moderate evidence that those who received acupuncture reported less pain at short term follow-up than those on a waiting list. There is also moderate evidence that acupuncture is more effective than inactive treatments for relieving pain post-treatment and this is maintained at short-term follow-up.

Acupuncture Therapy↗
PubMed2006

Sodium channel blockers for cystic fibrosis.

BACKGROUND: People with cystic fibrosis (CF) have increased transport of the salt, sodium across their airway lining. Over-absorption of sodium results in the dehydration of the liquid that lines the airway surface and is a primary defect in people with CF. OBJECTIVES: To determine whether the topical administration of drugs that block sodium transport improves the respiratory condition of 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, handsearching relevant journals and abstract books of conference proceedings. We contacted principal investigators known to work in the field, previous authors and pharmaceutical companies who manufacture ion transport agents for unpublished or follow-up data. Most recent search of the Group's register: March 2006 SELECTION CRITERIA: Published or unpublished randomised controlled trials (RCTs) or quasi-randomised controlled trials of sodium channel blockers compared to placebo or another sodium channel blocker or the same sodium channel blocker at a different dosing regimen. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data. Meta-analysis was limited due to differing study designs. MAIN RESULTS: Four RCTs, with a total of 205 participants, examining the topical administration of the short-acting sodium channel blocker, amiloride, compared to placebo were identified as eligible for inclusion in the review. For three studies, interventions for six months were completed and it was possible to calculate relative change in respiratory function (FVC). There was a significant difference found in relative change in FVC in favour of placebo (GIV analysis of weighted mean difference for FVC; 1.51% (95% confidence interval -2.77 to -0.25). There were no significant differences identified in other clinically relevant outcomes. AUTHORS' CONCLUSIONS: We found no evidence that the topical administration of a short-acting sodium channel blocker improves respiratory condition in people with cystic fibrosis and some limited evidence of deterioration in lung function.

Cystic Fibrosis↗
PubMed2006

Antiangiogenic therapy with interferon alfa for neovascular age-related macular degeneration.

BACKGROUND: Antiangiogenic therapy is a new approach to the treatment of neovascular age-related macular degeneration. Interferon alfa is one antiangiogenic agent thought to function by inhibiting the migration and proliferation of vascular endothelial cells. It has been used in the treatment of hepatitis, solid tumors and hematologic malignancies. OBJECTIVES: The aim of this review was to investigate interferon alfa as a treatment modality for neovascular age-related macular degeneration. SEARCH STRATEGY: We searched and identified trials from the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Group Trials Register, in The Cochrane Library (Issue 2, 2005), MEDLINE (1966 to 2005/06 week 1), EMBASE (1980 to 2005/week 23), LILACS (Latin American and Caribbean Health Science Literature Database) (June 2005) and the reference lists of included studies. SELECTION CRITERIA: This review included randomized controlled trials evaluating interferon alfa therapy in people with neovascular age-related macular degeneration who were followed for at least one year. DATA COLLECTION AND ANALYSIS: Both review authors independently extracted data and assessed trial quality. No data synthesis was conducted as only one trial met the inclusion criteria. MAIN RESULTS: The one included trial enrolled and randomized 481 participants from 45 centers worldwide into four groups. The study allowed for analysis of the number of participants who had lost three or more lines of vision at 52 weeks in three interferon alfa-2a groups versus placebo. The results show an odds ratio of 1.60 (95% Confidence Interval 1.01 to 2.53) indicating that interferon is associated with a 60% increased odds of losing three or more lines at 52 weeks. This finding is marginally statistical with a P value of 0.04 and indicates that the treatment has the potential for harm rather than benefit. AUTHORS' CONCLUSIONS: At present there is not enough evidence to recommend the use of interferon alfa-2a for the treatment of age-related macular degeneration.

Angiogenesis Inhibitors↗
PubMed2006

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

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

Anemia, Sickle Cell↗
PubMed2006

Weight reduction for primary prevention of stroke in adults with overweight or obesity.

BACKGROUND: Obesity is seen as a worldwide chronic disease with high prevalence that has been associated with increased morbidity from many conditions including stroke, which is the third leading cause of death in developed countries and a leading cause of severe long-term disability. The causal association between overweight or obesity and stroke is unclear and there is no definite study clarifying the role of obesity treatment in the prevention of a first stroke (primary prevention). Given the prevalence of stroke and the enormous health and economic cost of the disease, it is important to establish the possible impact of weight reduction per se on stroke incidence. OBJECTIVES: To assess the effects of weight reduction in people with overweight or obesity on stroke incidence. SEARCH STRATEGY: MEDLINE, EMBASE, The Cochrane Library, LILACS, databases of ongoing trials and reference lists were used to identify relevant trials. The last search was conducted in April 2006. SELECTION CRITERIA: Randomised controlled trials comparing any intervention for weight reduction (single or combined) with placebo or no intervention in overweight or obese people. DATA COLLECTION AND ANALYSIS: No trials were found in the literature for inclusion in this review. MAIN RESULTS: There are currently no results to be reported. AUTHORS' CONCLUSIONS: Obesity seems to be associated with an increased risk of stroke and it has been suggested that weight loss may lead to a reduction of stroke occurrence. However, this hypothesis is not based on strong scientific evidence resulting from randomised controlled clinical trials. This systematic review identified the urgent need for well-designed, adequately-powered, multi centre randomised controlled trials assessing the effects of weight reduction in persons with overweight or obesity on stroke occurrence.

Adult↗
PubMed2006

Rimonabant for overweight or obesity.

BACKGROUND: Worldwide, the prevalence of obesity and overweight in industrialized countries and in a substantial number of developing countries is increasing at an alarming rate. Rimonabant is a selective cannabinoid-1 receptor antagonist that has been investigated for its efficacy in reducing body weight and associated risk factors in obese people. Phase III trials are now under way to test the use of rimonabant for long-term weight-loss. Given the prevalence of overweight and obesity, it is important to establish the efficacy and safety of rimonabant. OBJECTIVES: To assess the effects of rimonabant in overweight and obese people. SEARCH STRATEGY: MEDLINE, EMBASE, The Cochrane Library, LILACS, databases of ongoing trials and reference lists were used to identify relevant trials. The last search was conducted in June 2006. SELECTION CRITERIA: Randomised controlled trials comparing rimonabant with placebo or other weight loss interventions in overweight or obese adults. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed all potentially relevant citations for inclusion and methodological quality. The primary outcome measures were weight loss change, morbidity and adverse effects occurrence. MAIN RESULTS: Four studies evaluating rimonabant 20 mg versus rimonabant 5 mg versus placebo in addition to a hypocaloric diet lasting at least one year were included. Compared with placebo, rimonabant 20 mg produced a 4.9 kg greater reduction in body weight in trials with one-year results. Improvements in waist circumference, high-density lipoprotein cholesterol, triglyceride levels and systolic and diastolic blood pressure were also seen. However, the results with rimonabant 5 mg demonstrated a weight reduction which was only 1.3 kg greater when compared with placebo. No clinically relevant effects on plasma lipids and blood pressure were found. Rimonabant 20 mg caused significant more adverse effects both of general and serious nature, especially of nervous system, psychiatric or gastro-intestinal origin. Attrition rates were approximately 40% at the end of one year. AUTHORS' CONCLUSIONS: The use of rimonabant after one year produces modest weight loss of approximately 5%. Even modest amounts of weight loss may be potentially beneficial. The observed results should be interpreted with some caution, though, since the evaluated studies presented some deficiencies in methodological quality. Studies with longer follow-ups after the end of treatment and of more rigorous quality should be done before definitive recommendations can be made regarding the role of this new medication in the management of overweight or obese patients.

Adult↗