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PubMed2000

Oral zinc for arterial and venous leg ulcers.

BACKGROUND: Leg ulcers affect up to 1 per cent of people at some time in their life. Management includes care of the ulcer using dressings and treatment of underlying medical problems such as malnutrition, lack of minerals, vitamins, poor blood supply or infection. OBJECTIVES: To assess the effectiveness of oral zinc in healing arterial or venous leg ulcers. SEARCH STRATEGY: Searches of 19 databases, hand searching of journals and conference proceedings from 1948 onwards, and examination of bibliographies. The company manufacturing zinc sulphate tablets was asked for references to relevant trials. SELECTION CRITERIA: Randomised controlled trials comparing oral zinc sulphate with placebo or no treatment in patients with arterial or venous leg ulcers. There was no restriction on date or language. The main outcome measure used was complete healing of the ulcers. Trials were eligible for inclusion if they measured ulcer healing objectively, by time to complete healing, proportion of ulcers healed during the study, or healing rates of ulcers. DATA COLLECTION AND ANALYSIS: All data extraction and assessment of trial quality were done by both authors independently. MAIN RESULTS: There were six eligible trials. All are small and serum zinc was measured at baseline or during the trial in 4 trials. Overall there is no evidence of a beneficial effect of treatment with zinc sulphate on the number of ulcers healed at the end of the trials. There is some evidence that oral zinc might have a beneficial effect on healing of venous ulcers in people with a 'low' serum zinc level at baseline. REVIEWER'S CONCLUSIONS: Overall, oral zinc sulphate does not appear to aid healing of leg ulcers, although it might be beneficial in those with venous leg ulcers and low serum zinc. Further research is needed to ascertain the serum zinc concentration below which treatment with zinc might be beneficial, and the dose required. [This abstract was prepared centrally]

Administration, Oral↗
PubMed2006

Therapeutic ultrasound for pressure ulcers.

BACKGROUND: Pressure ulcers have been recorded as occurring in 5 to 32% of patients admitted to a UK District General Hospital (the precise rate depends on case-mix) and 4 to 7% in the community. They represent a major burden of sickness and reduced quality of life for patients and their carers, and are costly to health service providers. Pressure ulcers are treated by using wound dressings, relieving pressure on the wound, by treating concurrent conditions which may delay healing, and by the use of physical therapies such as electrical stimulation, laser therapy and ultrasound. OBJECTIVES: To assess the effect of therapeutic ultrasound on the healing of pressure ulcers. SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Register and the Cochrane Central Register of Controlled Trials in May 2006. In addition we hand searched journals, conference proceedings, bibliographies and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing therapeutic ultrasound with sham ultrasound or standard treatment. DATA COLLECTION AND ANALYSIS: Two authors independently checked the result of the search to identify relevant RCTs. Details of eligible studies were extracted and summarised using a data extraction sheet. Attempts were made to obtain missing information by contacting authors. Data extraction was checked by a second author. Meta-analysis was used to combine the results of trials where the interventions and outcome measures were sufficiently similar. MAIN RESULTS: Three trials involving 146 people were included. Two RCTs compared ultrasound therapy with sham ultrasound and the third compared a combination of ultrasound and ultraviolet light with laser and with standard treatment. Neither of the two RCTs comparing ultrasound with sham found a significant difference in healing rates. The trials were pooled, in the absence of significant heterogeneity. There was no evidence of benefit associated with the use of ultrasound in the treatment of pressure ulcers. In the three-arm comparison there was no statistically significant difference in ulcers healed. AUTHORS' CONCLUSIONS: There is no evidence of benefit of ultrasound therapy in the treatment of pressure ulcers. However, the possibility of beneficial or harmful effect cannot be ruled out due to the small number of trials, some with methodological limitations and small numbers of participants. Further research is needed.

Humans↗
PubMed2000

Dietary interventions for phenylketonuria.

BACKGROUND: Phenylketonuria is an inherited disease for which the main treatment is the dietary restriction of the amino acid phenylalanine. The diet has to be initiated in the neonatal period to prevent or reduce mental handicap however the diet is very restrictive and unpalatable and can be difficult to follow. Whether the diet can be relaxed or discontinued during adolescence or should be continued for life remains a contraversial issue which we aim to address in this review. OBJECTIVES: To assess the effects of a phenylalanine restricted diet commenced early in life for patients with phenylketonuria. To assess the possible adverse effects of relaxation or termination of the diet on intelligence, neuropsychological outcomes and mortality, and to assess the effect on growth, nutritional status and eating behaviour and quality of life. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Trials Register which is 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 1998). The manufacturers of dietary products for phenylketonuria were also contacted. Date of the most recent search of the Group's specialised register: November 1999. SELECTION CRITERIA: All randomised or pseudorandomised controlled trials comparing a phenylalanine restricted diet to either relaxation or termination of dietary restrictions in patients with phenylketonuria. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the trial eligibility, methodological quality and extracted the data. MAIN RESULTS: Four studies were included in this review including a total of 251 patients. Few statistically significant differences were found between treatment and comparison groups for any of the outcomes apart from for blood phenylalanine level and intelligence quotient. Blood phenylalanine levels were significantly lower in those subjects with phenylketonuria following a phenylalanine restricted diet compared to those on a less restricted or relaxed diet (weighted mean difference at three months -672.203, 95% Confidence interval (CI) -813.799 to - 530.608). Intelligence quotient was significantly higher in subjects who continued on the phenylalanine restricted diet compared to those who terminated the diet (weighted mean difference after 12 months -5.00, 95% CI -9.595 to -0.405). However this is based on the results of only one study. REVIEWER'S CONCLUSIONS: The results of non-randomised studies have concluded that a phenylalanine restricted diet is effective in reducing blood phenylalanine levels and improving intelligence quotient and neuropsychological outcome. No randomised controlled trials have assessed the effect of a phenylalanine restricted diet versus no dietary restrictions from diagnosis. In view of evidence from non-randomised studies, such a trial would now be unethical and it is recommended that phenylalanine restricted diet should be commenced at the time of diagnosis. There is uncertainty about the precise level of phenylalanine restriction and when, if ever, the diet should be relaxed. These questions should be addressed by randomised controlled trials with careful consideration given to which patients to include.

Humans↗
PubMed2000

Vaccines for preventing infection with Pseudomonas aeruginosa in people with cystic fibrosis.

OBJECTIVES: To assess the effectiveness of vaccination against Pseudomonas aeruginosa in patients with cystic fibrosis. SEARCH STRATEGY: The Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register 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 of the Group's specialised register: November 1999. SELECTION CRITERIA: All randomised or pseudorandomised trials (published or unpublished) comparing Pseudomonas aeruginosa vaccines (oral, parenteral or intranasal) with control vaccines or no intervention in patients with cystic fibrosis. DATA COLLECTION AND ANALYSIS: We planned to assess the following outcomes: time to infection with Pseudomonas aeruginosa, pulmonary function, body mass index, Schwachman score, frequency of pulmonary infective exacerbations, days of antibiotic usage, days unable to carry out normal daily activities, adverse events, mortality, antibody levels to Pseudomonas aeruginosa and T cell proliferation and cytokine production in response to Pseudomonas aeruginosa. MAIN RESULTS: One trial which included 17 vaccinated patients, with follow up reported to 10 years met the inclusion criteria. Finding only a single trial, and the lack of information on our predefined outcomes limited analysis. REVIEWER'S CONCLUSIONS: There is a paucity of randomised controlled trials assessing the effectiveness of vaccination against Pseudomonas aeruginosa in cystic fibrosis. Increased understanding of modulation of the immune response by vaccination has led to the development of alternative vaccines. We suggest that there is an urgent need for newer vaccines to be evaluated in adequately-powered, multicentre randomised controlled trials examining clinically relevant end-points in addition to immunological variables. Such a trial should assess effectiveness over several years, and include follow-up of vaccinees who become colonised with Pseudomonas aeruginosa.

Bacterial Vaccines↗
PubMed2001

Patient education for preventing diabetic foot ulceration.

BACKGROUND: Ulceration of the feet, which can result in loss of limbs and even death, is one of the major health problems for people with diabetes mellitus. OBJECTIVES: To assess the effectiveness of patient education on the prevention of foot ulcers in patients with diabetes mellitus. SEARCH STRATEGY: Eligible studies were identified by searching the Wounds Group Specialised Trials Register, which is compiled from regular searches of the major health care databases including MEDLINE, Cinahl and EMBASE, hand searching of wound care journals and relevant conference proceedings. For this review the Register was searched up to March 2001. SELECTION CRITERIA: Prospective randomised controlled trials (RCTs) which evaluated educational programmes for the prevention of foot ulcers in people with diabetes mellitus. There was no restriction on language of the publications. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of study quality were undertaken by two reviewers independently. MAIN RESULTS: The methodological quality of the 8 included RCTs was poor. The internal validity score (range 0 - 10) of individual RCTs ranged from 2 to 4. Four trials compared the effect of intensive with brief educational interventions; 2 of these reported clinical endpoints. One study involving high-risk patients reported a reduction in ulcer incidence (Peto OR: 0.28 (95% CI 0.13,0.59)) and amputation rate (Peto OR: 0.32 (0.14,0.71)) after 1 year. The other RCT did not find an effect at seven years follow-up. Participants' foot care knowledge significantly improved with education in 2 trials. In one trial, foot care knowledge was significantly worse at 6 months, although foot care behaviour improved significantly. Non-calcaneal callus was significantly reduced by education in one trial. One RCT did not find that patient foot care education, as part of a general diabetes education program reduced foot ulceration compared with usual care. Patient education as part of a complex intervention targeted at both people with diabetes and doctors reduced the number of serious foot lesions at one year, in one RCT (OR: 0.41(0.16-1.00)) and improved foot care behaviour. Evidence from 2 RCTs comparing the effect of patient-tailored education in addition to usual care was conflicting. REVIEWER'S CONCLUSIONS: RCTs evaluating education for people with diabetes, aimed at preventing diabetic foot ulceration, are mostly of poor methodological quality. Existing data suggests that patient education may reduce foot ulceration and amputations, especially in high-risk patients. Foot care knowledge and behaviour of patients seem positively influenced by patient education in the short term. Because of conflicting results and the methodological shortcomings more RCTs are needed.

Diabetic Foot↗
PubMed2000

Oral non-steroidal anti-inflammatory drug therapy for cystic fibrosis.

BACKGROUND: Maintenance of optimal lung function is an important therapeutic goal in cystic fibrosis as it is lung damage that, in the long term, is responsible for most premature death among affected people. It has been hypothesised that lung damage results from inflammation and that prolonged use of non-steroidal anti-inflammatory drugs may prevent progressive pulmonary deterioration and respiratory morbidity in cystic fibrosis. It is thus important to establish the current level of evidence about the potential benefits and harms of treatment with non-steroidal anti-inflammatory drugs. OBJECTIVES: The aim of this systematic review is to assess the effectiveness of treatment with non-steroidal anti-inflammatory agents in cystic fibrosis. SEARCH STRATEGY: Trials were ascertained from the Cochrane Cystic Fibrosis and Genetic Disorders Specialised Register of Controlled Trials which includes published and unpublished trials identified through electronic databases such as Medline and Embase as well as those identified from handsearching of journals and conference proceedings. Pharmaceutical companies manufacturing non-steroidal anti-inflammatory drugs were also contacted to identify any trials of non-steroidal anti-inflammatory drugs in cystic fibrosis. Date of the most recent search of the Group's specialised register: November 1999. SELECTION CRITERIA: All randomised or pseudorandomised controlled trials, published and unpublished, comparing non-steroidal anti-inflammatory drugs, administered orally at any dose for a period of at least two months, to placebo in patients with cystic fibrosis. DATA COLLECTION AND ANALYSIS: The following outcomes were assessed: objective measures of lung function, nutritional status, radiological assessment of pulmonary involvement, use of intravenous antibiotics, hospital admissions, survival, frequency of major and minor adverse effects and compliance with therapy. MAIN RESULTS: Three trials involving 145 patients aged from five to 39 years with a maximum follow up of four years met the inclusion criteria. Methodological quality was deemed good or adequate in two. Two trials, both reporting effectiveness of ibuprofen in subjects with mild lung disease, were from the same centre and included some patients in common, while the third assessed piroxicam in subjects with more severe impairment of respiratory function. Variation in outcomes reported and their summary measures precluded calculation of pooled treatment estimates. Only one trial reported within-subject changes in pulmonary function and the findings of this trial suggested that there was a greater absolute annual decline in percentage predicted forced expiratory volume in one second among controls than among those treated with ibuprofen. In a post-hoc sub-group analysis this effect was confined to children aged five to 13 years. In addition, in this one trial long term use of high dose ibuprofen was associated with reduced intravenous antibiotic usage, improved nutritional and radiological pulmonary status. No major adverse effects were reported but the power of the trials to identify clinically important differences in the incidence of adverse effects was low. REVIEWER'S CONCLUSIONS: While there is preliminary evidence to suggest that non-steroidal anti-inflammatory drugs may prevent pulmonary deterioration in subjects with mild lung disease due to cystic fibrosis, currently their routine use cannot be recommended. Further trials are required to confirm that their use prevents pulmonary deterioration and is associated with improved nutritional status. Such trials should also address the age group of subjects most likely to benefit, the prevalence of important adverse effects and the optimal dosage schedule as well as any reduction in concomitant therapy. Multi-centre trials will add to the validity of findings by enhancing their generalisability. The question of whether anti-inflammatory treatment prevents lung damage in pre-symptomatic

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2000

Nebulised hypertonic saline for cystic fibrosis.

BACKGROUND: The lung disease in cystic fibrosis is characterised by impaired mucociliary clearance, recurrent bronchial infection and airway inflammation. Hypertonic saline has been shown to enhance mucociliary clearance in-vitro and this may act to lessen the destructive inflammatory process in the airways. OBJECTIVES: To determine if nebulised hypertonic saline treatment improved lung function, exercise tolerance, quality of life and decreased the incidence of exacerbations of respiratory infections in patients with cystic fibrosis. SEARCH STRATEGY: Studies were identified from the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register. Titles and abstracts were reviewed to identify all controlled trials. Review articles and bibliographies identified from this process were surveyed for additional citations & RCTs. Identification of unpublished work was obtained from abstract books from the three major Cystic Fibrosis conferences (International Cystic Fibrosis Conference, The European Cystic Fibrosis Conference and the North American Cystic Fibrosis Conference). Trial authors were contacted for additional information when only abstracts were available to review. Date of the most recent search of the Group's specialised register: November 1999. SELECTION CRITERIA: All controlled trials that assessed the effect of hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in subjects with cystic fibrosis of any age or severity were reviewed. Studies in languages other than English were included. DATA COLLECTION AND ANALYSIS: All identified trials were independently reviewed by both reviewers & all data collected. Trial quality was scored by the Cochrane assessment of allocation concealment & the Jadad scale of methodological quality. MAIN RESULTS: Twelve controlled trials of hypertonic saline were identified. Seven trials met the inclusion criteria; these involved 143 subjects with an age range of 6 to 46 years. Of these, six were published studies and one in abstract form. The durations of the trials were limited to immediate effects on mucociliary clearance to a maximum of three weeks. In two studies, involving thirty five subjects, a score for the feeling of cleared chest was made using visual analogue scales. This analysis showed a weighted mean difference of -0.98 (95% confidence Interval -1.6, -0.34), favouring hypertonic saline over isotonic saline. In two trials with 22 subjects hypertonic saline improved mucociliary clearance as measured by isotope clearance from the lungs in 90 minutes demonstrating a weighted mean difference of -11.3 (95% confidence Interval -18.6, -4.0), and as area under the clearance time curve; weighted mean difference of -212 (95%CI -272, -152), also favouring hypertonic saline over isotonic saline. Lung function as measured by improvement in FEV1 was observed in one study of 27 subjects. The percentage increase in FEV1 at two weeks increased by a mean 15.0% with hypertonic saline and 2.8% with isotonic saline (p=0.004). Adverse events were adequately described in only one trial and none were serious. REVIEWER'S CONCLUSIONS: Nebulised hypertonic saline improves mucociliary clearance immediately after administration which may have a longer term beneficial effect in cystic fibrosis. The maximum time data were recorded for was only three weeks. Most of the patients had mild to moderate lung disease and the effect on severe lung disease remains unclear. Further studies of hypertonic saline should be carried out to determine the effect on pulmonary function tests, quality of life, frequency of exacerbations of respiratory disease and efficacy comparisons with nebulised deoxyribonuclease, with larger numbers and for longer duration. At this stage there is insufficient evidence to support the use of hypertonic saline in routine treatment for patients with cystic fibrosis.

Administration, Inhalation↗
PubMed2005

Nebulised hypertonic saline for cystic fibrosis.

BACKGROUND: Lung disease in cystic fibrosis is characterised by impaired mucociliary clearance. Hypertonic saline has been shown to enhance mucociliary clearance in vitro and this may act to lessen the destructive inflammatory process in the airways. OBJECTIVES: To investigate the effects of treatment with nebulised hypertonic saline on people with cystic fibrosis compared to placebo and or other treatments that enhance mucociliary clearance. SEARCH STRATEGY: 'We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. Most recent search of the Trials Register: September 2004. SELECTION CRITERIA: All controlled trials assessing the effect of hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with cystic fibrosis of any age or severity. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed all identified trials and all data collected. Trial quality was assessed along with allocation concealment. MAIN RESULTS: Fourteen controlled trials were identified. Nine trials met the inclusion criteria involving 235 participants with an age range of 6 years to 46 years. Two short-term trials of immediate effect on mucociliary clearance demonstrated that hypertonic saline increased isotope clearance compared to control. Lung function, measured by improvement in forced expiratory volume at one second (FEV1 litre per minute), was observed in four trials. When 3% to 7% saline was used in a volume of 10 ml twice-a-day, in comparison to placebo, hypertonic saline led to a significant increase in FEV1, weighted mean difference 12.20 (95%CI 4.28 to 20.10). Two further trials compared a similar concentration and volume of hypertonic saline to recombinant deoxyribonuclease. Over a three-week period one trial showed a non-significant difference, mean difference 1.60 (95% CI -7.96 to 11.16). However, in a further trial, after 12 weeks treatment in participants with moderate to severe lung disease, recombinant deoxyribonuclease led to a greater increase in FEV1 than hypertonic saline (5 ml twice-daily), mean difference 8.00 (95%CI 2.00 to 14.00). No serious adverse events were noted. AUTHORS' CONCLUSIONS: Nebulised hypertonic saline improves mucociliary clearance in short-term clinical trials and appears to increase lung function compared to control. In comparison to recombinant deoxyribonuclease it may be less effective at improving lung function after three months. Currently there is insufficient evidence to support the use of hypertonic saline as routine treatment for people with cystic fibrosis.

Administration, Inhalation↗
PubMed2000

Tyrosine supplementation for phenylketonuria.

BACKGROUND: Phenylketonuria is an inherited disease for which the main treatment is the dietary restriction of the amino acid phenylalanine. The diet has to be initiated in the neonatal period to prevent or reduce mental handicap however the diet is very restrictive and unpalatable and can be difficult to follow. A deficiency of the amino acid tyrosine has been suggested as a cause of some of the neuropsychological problems exhibited in PKU. Therefore, this review aims to assess the efficasy of tyrosine supplementation for phenylketonuria. OBJECTIVES: To assess the effects of tyrosine supplementation alongside or instead of phenylalanine restricted diet for patients with phenylketonuria who commenced on diet at diagnosis and either continued on the diet or relaxed the diet later in life. To assess the evidence that tyrosine supplementation alongside, or instead of phenylalanine restricted diet improves intelligence, neuropsychological performance, growth and nutritional status, mortality rate and quality of life. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Trials Register which is 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 1998). The manufacturers of prescribable dietary products used in the treatment of phenylketonuria were also contacted for further references. Date of the most recent search of the Group's specialised register: November 1999. SELECTION CRITERIA: All randomised or pseudo-randomised trials investigating the use of tyrosine supplementation versus placebo in patients with phenylketonuria in addition to, or instead of, a phenylalanine restricted diet. Patients treated for maternal phenylketonuria were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the trial eligibility, methodological quality and extracted the data. MAIN RESULTS: Two trials were included with a total of 47 patients. The blood tyrosine concentrations were significantly higher in the patients receiving tyrosine supplements than those in the placebo group (weighted mean difference 22.526, 95% Confidence interval (CI) 12.182 - 32.870). No significant differences were found between any of the other outcomes measured. REVIEWER'S CONCLUSIONS: From the available evidence no recommendations can be made about whether tyrosine supplementation should be introduced into routine clinical practice. Further randomised controlled studies are required to provide further evidence.

Dietary Supplements↗
PubMed2004

Corticosteroid therapy for nephrotic syndrome in children.

BACKGROUND: In nephrotic syndrome protein leaks from the blood to the urine through the glomeruli resulting in hypoproteinaemia and generalised oedema. Children with untreated nephrotic syndrome frequently die from infections. The majority of children with nephrotic syndrome respond to corticosteroids. However about 70% of children experience a relapsing course with recurrent episodes of oedema and proteinuria. Corticosteroid usage has reduced the mortality rate in childhood nephrotic syndrome to around 3%, with infection remaining the most important cause of death. However corticosteroids have known adverse effects such as obesity, poor growth, hypertension, diabetes mellitus, osteoporosis and adrenal suppression. The original treatment schedules for childhood nephrotic syndrome were developed in an ad hoc manner. The optimal doses and durations of corticosteroid therapy that are most beneficial and least harmful have not been clarified. OBJECTIVES: The aim of this review was to determine the benefits and harms of different corticosteroid regimens in preventing relapse in children with steroid sensitive nephrotic syndrome (SSNS). SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (Cochrane Library, Issue 2, 2002), Cochrane Renal Group Specialised Register (July 2002), MEDLINE (1966 - July 2002) and EMBASE (1980 - July 2002) without language restriction, reference lists of articles, abstracts from conference proceedings and contact with known investigators in the area. SELECTION CRITERIA: Randomised controlled trials were included if they were carried out in children (aged three months to 18 years) in their initial or subsequent episode of SSNS, if they compared different durations, total doses or other dose strategies using prednisone or other corticosteroid agent and if they had outcome data at six months or more. DATA COLLECTION AND ANALYSIS: Two reviewers independently reviewed all eligible studies for inclusion, assessed study quality and extracted data. The principle outcome measure was the number of children with and without relapse after six and 12-24 months. Secondary outcomes sought included the number of children who developed frequently relapsing nephrotic syndrome and adverse events. A random effects model was used to estimate summary effect measures (relative risk (RR), risk difference (RD)) after testing for heterogeneity. Meta-regression was used to explore potential between-study differences due to the baseline risk of relapse, study quality and types of interventions used. MAIN RESULTS: Nineteen trials have been included in this review. A meta-analysis of six trials, which compared two months of prednisone with three months or more in the first episode, showed that the longer duration significantly reduced the risk of relapse at 12 - 24 months (RR 0.70; 95% CI 0.58 to 0.84) without an increase in adverse events. There was an inverse linear relationship between the duration of treatment and risk of relapse (RR = 1.26 - 0.112 duration; r(2) = 0.56; p = 0.03). The number of children who became frequent relapsers and the mean relapse rate/patient/year were also significantly reduced without increase in serious adverse events. In children with frequently relapsing nephrotic syndrome, deflazacort was significantly more effective in maintaining remission than prednisone (RR 0.44; 95% CI 0.25 to 0.78). REVIEWERS' CONCLUSIONS: Children in their first episode of SSNS should be treated for at least three months with an increase in benefit being demonstrated for up to seven months of treatment. In a population with a baseline risk for relapse following the first episode of 60% with two months of prednisone, daily prednisone for four weeks followed by alternate day therapy for six months would be expected to reduce the number of children experiencing a relapse by about 33%. In children who relapse frequently, deflazacort deserves further study.

Adolescent↗
PubMed2005

Corticosteroid therapy for nephrotic syndrome in children.

BACKGROUND: In nephrotic syndrome protein leaks from the blood to the urine through the glomeruli resulting in hypoproteinaemia and generalised oedema. While the majority of children with nephrotic syndrome respond to corticosteroids, 70% experience a relapsing course. Corticosteroid usage has reduced the mortality rate to around 3%, however they have known serious adverse effects. OBJECTIVES: To determine the benefits and harms of corticosteroid regimens in preventing relapse in children with steroid sensitive nephrotic syndrome (SSNS). SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Renal Group Specialised Register, MEDLINE and EMBASE without language restriction, reference lists of articles, abstracts from conference proceedings and contact with known investigators. Date of most recent search: October 2004 SELECTION CRITERIA: Randomised controlled trials performed in children (three months to 18 years) in their initial or subsequent episode of SSNS, comparing different durations, total doses or other dose strategies using any corticosteroid agent, with outcome data at six months or more. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Statistical analyses were performed using a random effects model and results expressed as relative risk (RR) with 95% confidence intervals (CI).Meta-regression was used to explore potential between-study differences due to baseline risk of relapse, study quality and interventions. MAIN RESULTS: Nineteen trials were identified. Six trials comparing two months of prednisone with three months or more in the first episode showed longer duration significantly reduced the risk of relapse at 12 to 24 months (RR 0.70; 95% CI 0.58 to 0.84). There was an inverse linear relationship between treatment duration and risk of relapse (RR = 1.26 - 0.112 duration; P = 0.03). There was a significant reduction in the number of frequent relapsers and the mean relapse rate/patient/year. Deflazacort was significantly more effective in maintaining remission than prednisone in children who frequently relapsed (RR 0.44; 95% CI 0.25 to 0.78). There were no increases in adverse events. AUTHORS' CONCLUSIONS: Children in their first episode of SSNS should be treated for at least three months with an increase in benefit being demonstrated for up to seven months of treatment For a baseline risk for relapse following the first episode of 60% with two months of prednisone, daily prednisone for four weeks followed by alternate-day therapy for six months would reduce the number of children relapsing by 33%. Deflazacort deserves further study for frequent relapsers.

Adolescent↗
PubMed2003

Mechanical bowel preparation for elective colorectal surgery.

BACKGROUND: For more than a century the presence of bowel content during surgery has been related to anastomotic leakage. Mechanical bowel preparation has been considered an efficient agent against leakage and infections complications. This dogma is not based on solid evidence, but more on observational data and expert's opinions. OBJECTIVES: To determine the security and effectiveness of prophylactic mechanical bowel preparation for morbidity and mortality rates in colorectal surgery. The following hypothesis was tested: "The use of mechanical bowel preparation before elective colorectal surgery reduces the incidence of postoperative complications". SEARCH STRATEGY: All publications describing mechanical bowel preparation before elective colorectal surgery was sought through computerized searches of EMBASE, LILACS, MEDLINE, and Cochrane Library; by hand-searching in relevant medical journals, from major gastroenterological congresses, without limitation for date and language, using the search strategy described by the Colorectal Cancer Review Group. In addition, randomised clinical trials will be searched through personal communication with colleagues and from conference proceedings SELECTION CRITERIA STUDIES: All randomised, clinical trials, that were performed in order to answer the hypothesis. PARTICIPANTS: Patients submitted elective colorectal surgery. INTERVENTIONS: Any strategy in mechanical bowel preparation compared with no mechanical bowel preparation. PRIMARY OUTCOME MEASURES: 1. Anastomosis leakage- stratified for rectum and colon 2. Overall anastomotic leakage SECONDARY OUTCOME MEASURES: 3. Mortality 4. Peritonitis 5. Re operation 6. Wound Infection 7 Infectious extra-abdominal complication 8. Non-infection extra-abdominal 9. Overall surgical site infections DATA COLLECTION AND ANALYSIS: Data was independently extracted by two reviewers and cross-checked. The methodological quality of each trial was assessed by the same two reviewers. Details of the randomisation (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the number of patients lost to follow-up was recorded. The results of each RCT was summarised in 2 x 2 tables for each outcome. For analysis the Peto-Odds ratio was used as defaults (no statistical heterogeneity was observed) MAIN RESULTS: Of the 1159 patients with anastomosis (6 RCTs), 576 were allocated for mechanical bowel preparation (groups 1) and 583 for no preparation (groups 2) before elective colorectal surgery. Of 1204 patients totally enrolled 595 were in groups 1 and 609 in groups 2. PRIMARY OUTCOMES: 1) Anastomotic leakage - stratified:A) Low anterior resection: 12.5% (6 of 48 patients in 1) compared with 12% (6 of 50 patients in 2); Peto OR 1.17, 95% CI: 0.35 - 3.96 (non-significant) B) Colonic surgery: 1.16% (2 of 172 patients in 1) compared with 0.6% (1 of 166 patients in 2); Peto OR 1.75, 95% CI: 0.18 - 17.02 2) Overall anastomotic leakage: 5.5% (32 of 576 patients in 1) compared with 2.9% (17 of 583 patients in 2); Peto OR 1.94, 95% CI: 1.09 - 3.43 (P=0.02) SECONDARY OUTCOMES: 3) Mortality: 0.6% (2 of 329 patients in 1) compared with 0% (0 of 326 patients in 2); Peto OR 7.95, 95% CI: 0.49 - 128.34 (non-significant) 4) Peritonitis: 5.1% ( 13 of 254 patients in 1) compared with 2.8% (7 of 252 patients in 2); Peto OR 1.90, 95% CI: 0.78 -4.64) (non significant) 5) Reoperation: 3.3% ( 11 of 329 patients) compared with 2.5% (8 of 326 patients); Peto OR 1.40, 95% CI: 0.56 - 3.49) (non-significant) 6) Wound infection: 7.4% (44 of 595 patients in 1) compared with 5.7% (35 of 609 patients in 2); Peto OR 1.34, 95% CI: 0.85 - 2.13 (non-significant) 7) Infectious extra-abdominal complication: 8.3% ( 14 of 168 patients in 1) compared with 9.4% (15 of 159 patients in 2); Peto OR, 95%: 0.87 (0.41 - 1.87) 8) Non-infection extra-abdominal complication: 8.0% ( 20 of 250 patients in 1) compared with 7.0% (17 of 246 patients in 2); Peto OR 1.19, 95% CI: 0.61 - 2.32 (non-significant) - 9) Surgical site infection: 9.8% (31 of 325 patients in 1) compared with 8.3% (27 of 322 patients in 2); Peto OR 1.20, 95% CI: 0.70 - 2.05 (non-significant) - REVIEWER'S CONCLUSIONS: The results failed to support the hypothesis that bowel preparation reduces anastomotic leak rates and other complications. There was no a priori hypothesis that bowel preparation may increase anastomotic leak rates, so this was not stated. Thus, the routine use of mechanical bowel preparation in patients undergoing elective colorectal surgery is questioned.

Colorectal Surgery↗
PubMed2005

Mechanical bowel preparation for elective colorectal surgery.

BACKGROUND: For over a century the presence of bowel content during surgery has been linked to anastomotic leakage. Mechanical bowel preparation has been considered an efficient agent against leakage and infectious complications. This dogma is not based on solid evidence, but on observational data and expert's opinions. OBJECTIVES: To determine the effectiveness and safety of prophylactic mechanical bowel preparation for morbidity and mortality rates in elective colorectal surgery. SEARCH STRATEGY: We searched MEDLINE, EMBASE, LILACS, and the Cochrane Central Register of Controlled Trials. We also searched relevant medical journals, and conference proceedings from major gastroenterological congresses and contacted experts in the field. We used the search strategy described by the Colorectal Cancer Review Group, without limitations for date of publication and language. I SELECTION CRITERIA: Randomised, clinical trials that compared any strategy in mechanical bowel preparation with no mechanical bowel preparation. DATA COLLECTION AND ANALYSIS: Data were independently extracted by the reviewers and cross-checked. The same reviewers assessed the methodological quality of each trial. Details of the randomisation (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the number of patients lost to follow-up was recorded. For analysis the Peto odds ratio (OR) was used as defaults. MAIN RESULTS: Of the 1592 patients (9 trials), 789 were allocated to mechanical bowel preparation (Group A) and 803 to no preparation (Group B) before elective colorectal surgery. For anastomotic leakage (main outcome) the results were: - Low anterior resection: 9.8% (11 of 112 patients in Group A) compared with 7.5% (9 of 119 patients in Group B); Peto OR 1.45, 95% confidence interval (CI): 0.57 to 3.67 (non-significant); - Colonic surgery: 2.9% (Group A) compared with 1.6% (Group B) ; Peto OR 1.80, 95% CI: 0.68 to 4.75 (non-significant); Overall anastomotic leakage: 6.2% (Group A) compared with 3.2% (Group B); Peto OR 2.03, 95% CI: 1.276 to 3.26 (p=0.003). For the secondary outcome of wound infection the result was: 7.4% (Group A) compared with 5.4% (Group B); Peto OR 1.46, 95% CI: 0.97 - to 2.18 (p=0.07); Sensitivity analyses excluding studies with dubious randomisation, studies published as abstracts only, and studies involving children did not change the overall conclusions AUTHORS' CONCLUSIONS: There is no convincing evidence that mechanical bowel preparation is associated with reduced rates of anastomotic leakage after elective colorectal surgery. On the contrary, there is evidence that this intervention may be associated with an increased rate of anastomotic leakage and wound complications. It is not possible to be conclusion on the latter issue because of the clinical heterogeneity of trial inclusion criteria, methodological inadequacies in trial (in particular, poor reporting of concealment and allocation), potential performance biases, and failure of intention-to-treat analyses. Nevertheless, the dogma that mechanical bowel preparation is necessary before elective colorectal surgery should be reconsidered.

Colorectal Surgery↗
PubMed2004

Mobilisation strategies after hip fracture surgery in adults.

BACKGROUND: Hip fracture, which happens in predominantly elderly populations, often results in a reduction in mobility. Care programmes after hip fracture surgery include strategies for mobilisation, such as early weight bearing and gait retraining. Other mobilisation strategies, such as exercises and physical training, are used at various stages in rehabilitation including after discharge from hospital. OBJECTIVES: To evaluate the effects of different mobilisation strategies and programmes after hip fracture surgery. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group Specialised Register (May 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2004), MEDLINE and other databases, conference proceedings and reference lists of articles. SELECTION CRITERIA: All randomised or quasi-randomised trials comparing different mobilisation strategies/programmes after hip fracture surgery. DATA COLLECTION AND ANALYSIS: The reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Our third update, which extended the review scope to cover the whole rehabilitation period, included four new trials. Most of the 10 included trials were small and all had methodological limitations, including inadequate follow up. Seven trials evaluated mobilisation strategies started soon after hip fracture surgery. One trial (273 participants) found no statistically significant differences in unfavourable outcomes for weight bearing started at two versus 12 weeks after internal fixation of a displaced intracapsular fracture. Of two trials (188 participants) comparing a more with a less intensive regimen of physiotherapy, one reported a lack of demonstrable difference in recovery of the two patient groups, and the other found a higher level of drop-out in the more intensive group with no difference in length of hospital stay. One trial (80 participants) comparing two-week programmes of weight-bearing versus non-weight-bearing exercise found some short-term improvement in mobility and balance in the weight-bearing exercise group. One trial (80 participants) found improved mobility, leg extension power and Barthel score in those given a quadriceps muscle strengthening exercise programme. One trial (40 participants) found no statistically significant difference in recovery of mobility and time to hospital discharge after a treadmill versus conventional gait retraining programme. One trial (27 participants) comparing neuromuscular stimulation of the quadriceps muscle with placebo found a greater recovery of pre-fracture mobility in the stimulation group. The interventions tested by the three remaining trials started after hospital discharge. One trial (28 participants) found improved outcome after 12 weeks of intensive physical training. One trial (120 participants) found improved outcome after home-based exercises started around 22 weeks from injury. One trial (44 participants) found home-based weight-bearing exercises starting at seven months produced no statistically significant differences aside, perhaps, for greater quadriceps strength. REVIEWERS' CONCLUSIONS: There is insufficient evidence from randomised trials to determine the effectiveness of the various mobilisation strategies examined in this review that start either in the early post-operative period or during the later rehabilitation period. Further research is required to establish the possible benefits of the additional provision of interventions primarily aimed at enhancing mobility.

Adult↗
PubMed2001

Arthroplasties (with and without bone cement) for proximal femoral fractures in adults.

BACKGROUND: Numerous types of arthroplasties may be used in the surgical treatment of a hip fracture (proximal femoral fracture). The main differences between the implants are the design of the stems, whether the stem is fixed in place with or without cement, whether a second articulating joint is included within the prosthesis (bipolar prosthesis) or whether the whole hip joint is replaced. OBJECTIVES: To review all randomised trials that have compared different arthroplasties for the treatment of hip fractures in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register. Additional trials were identified by searching reference lists of relevant articles, conference proceedings, and contact with trialists. Date of most recent search: January 2001. SELECTION CRITERIA: All randomised and quasi-randomised trials comparing different arthroplasties (and or cement), for the treatment of hip fractures. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, by use of a ten-item checklist and extracted data. MAIN RESULTS: Thirteen trials involving 1464 patients were included. One trial investigated two comparisons. Cemented prostheses, when compared with uncemented (four trials, 391 participants) were associated with a lower risk of failure to regain mobility (relative risk (RR) 0.60, 95% confidence interval (CI) 0.44, 0.82) and of post-operation pain at a year or later (RR 0.51, 95% CI 0.31, 0.81). For this comparison, there were no significant differences in any other outcome. Comparison of unipolar hemiarthroplasty with bipolar hemiarthroplasty (six trials, 742 participants) showed no significant differences between the two types of implant. Two trials of 269 patients compared different types of hemiarthroplasty with a total hip replacement and two trials of 151 patients compared either different types of prosthesis head or different bipolar prostheses. Because of the limited number of cases and the use of different prostheses, no definite conclusions could be made from these four studies. REVIEWER'S CONCLUSIONS: Cementing prostheses in place seems to reduce pain post-operatively and results in better mobility, but because of the under-reporting of outcomes and the small number of patients involved, no definite conclusions can be made. The role of bipolar prostheses and total hip replacement is uncertain. Further well-conducted randomised trials are required.

Adult↗
PubMed2004

Arthroplasties (with and without bone cement) for proximal femoral fractures in adults.

BACKGROUND: Numerous types of arthroplasties may be used in the surgical treatment of a hip fracture (proximal femoral fracture). The main differences between the implants are the design of the stems, whether the stem is fixed in place with or without cement, whether a second articulating joint is included within the prosthesis (bipolar prosthesis) or whether the whole hip joint is replaced. OBJECTIVES: To review all randomised trials that have compared different arthroplasties for the treatment of hip fractures in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register which is compiled by regular searches of the Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE and CINAHL. Additional trials were identified by searching reference lists of relevant articles, conference proceedings, and contact with trialists. Date of most recent search: October 2003. SELECTION CRITERIA: All randomised and quasi-randomised trials comparing different arthroplasties (and/or cement), for the treatment of hip fractures. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, by use of a ten-item checklist and extracted data. MAIN RESULTS: Fifteen trials involving 1670 patients were included. One trial involved two comparisons. Cemented prostheses, when compared with uncemented (five trials, 482 participants) were associated with a lower risk of failure to regain mobility (relative risk (RR) 0.60; 95% confidence interval (CI) 0.44 to 0.82) and of post-operation pain at a year or later (RR 0.51, 95% CI 0.31 to 0.81). For this comparison, there were no significant differences in any other outcome. Comparison of unipolar hemiarthroplasty with bipolar hemiarthroplasty (seven trials, 857 participants) showed no significant differences between the two types of implant. Two trials of 269 patients compared different types of hemiarthroplasty with a total hip replacement and two trials of 151 patients compared either different types of prosthesis head or different bipolar prostheses. Because of the limited number of cases and the use of different prostheses, no definite conclusions could be made from these four studies. REVIEWERS' CONCLUSIONS: Cementing prostheses in place seems to reduce pain post-operatively and results in better mobility, but because of the under-reporting of outcomes and the small number of patients involved, no definite conclusions can be made. The role of bipolar prostheses and total hip replacement is uncertain. Further well-conducted randomised trials are required.

Adult↗
PubMed2006

Arthroplasties (with and without bone cement) for proximal femoral fractures in adults.

BACKGROUND: Numerous types of arthroplasties may be used in the surgical treatment of a hip fracture (proximal femoral fracture). The main differences between the implants are in the design of the stems, whether the stem is fixed in place with or without cement, whether a second articulating joint is included within the prosthesis (bipolar prosthesis) or whether a partial (hemiarthroplasty) or total whole hip replacement is used. OBJECTIVES: To review all randomised controlled trials that have compared different arthroplasties for the treatment of hip fractures in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2005), MEDLINE, EMBASE, the UK National Research Register, several orthopaedic journals, conference proceedings and reference lists of articles. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials comparing different arthroplasties and their insertion with or without cement, for the treatment of hip fractures. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality, by use of a ten-item checklist, and extracted data. MAIN RESULTS: Seventeen trials involving 1920 patients were included. One trial involved two comparisons. Cemented prostheses, when compared with uncemented (six trials, 549 participants) were associated with less pain at a year or later (16/52 versus 28/52; RR 0.51, 95% CI 0.31 to 0.81) and a tendency to better mobility. No significant difference in surgical complications was found. Comparison of unipolar hemiarthroplasty with bipolar hemiarthroplasty (seven trials, 857 participants, 863 fractures) showed no significant differences between the two types of implant. Two trials involving 232 patients compared uncemented hemiarthroplasty with a total hip replacement. Both studies reported increased pain for the uncemented prosthesis and one study found better mobility and a lower long-term revision rate for those treated with a THR. Two trials involving 214 participants compared cemented hemiarthroplasty versus total hip replacement. Both trials generally found little difference between prostheses. THR was associated with a slightly longer surgical time but a tendency to better functional outcome in one trial. AUTHORS' CONCLUSIONS: There is limited evidence that cementing a prosthesis in place may reduce post-operative pain and lead to better mobility. There is insufficient evidence to determine the roles of bipolar prostheses and total hip replacement. Further well-conducted randomised trials are required.

Adult↗
PubMed2003

Internal fixation versus arthroplasty for intracapsular proximal femoral fractures in adults.

BACKGROUND: Displaced intracapsular fractures may be treated by either reduction and internal fixation which preserves the femoral head, or by replacement of the femoral head with an arthroplasty. OBJECTIVES: To review all randomised trials that have compared internal fixation and arthroplasty. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (January 2002), MEDLINE (1966 to January 2002), EMBASE (1988 to 2002, Week 2), Current Contents (1993 to 2002, Week 4), PREMEDLINE (January 2002) and selected orthopaedic journals and conference proceedings, and reference lists of relevant articles. We contacted trialists where possible. SELECTION CRITERIA: All randomised and quasi-randomised trials comparing internal fixation with arthroplasty for intracapsular hip fractures in adults. DATA COLLECTION AND ANALYSIS: Trial quality was assessed by use of a 10 item scale. Data from the majority of trials were independently extracted by three reviewers with the remaining extracted by two. Additional information was sought from trialists. After grouping into three broad categories, comparable groups of trials were subgrouped and where appropriate, data were pooled using the fixed effects model. MAIN RESULTS: Thirteen trials involving 2091 patients were included. Internal fixation had a reduced length of surgery, operative blood loss, need for blood transfusion and risk of deep wound infection. Arthroplasty had a lower re-operation rate in comparison with fixation. No definite differences for hospital stay, mortality, degree of residual pain, regain of mobility or regain of same residential state were found. REVIEWER'S CONCLUSIONS: Internal fixation is associated with less initial operative trauma but has an increased risk of re-operation on the hip. Definite conclusions cannot be made for differences in pain and residual disability between the two groups. Future studies should concentrate on better reporting of final outcome measures and there is still a need for studies to define which patient groups are better served by the different treatment methods.

Adult↗