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PubMed2001

Hydroxyurea for sickle cell disease.

BACKGROUND: Sickle cell disease is one of the most common inherited diseases world wide. It is associated with life long morbidity and a reduced life expectancy. Hydroxyurea, a chemotherapeutic drug taken by mouth, raises fetal haemoglobin and, as such, is expected to ameliorate some of the clinical problems of sickle cell disease. OBJECTIVES: To assess the effects of hydroxyurea therapy in sickle cell disease patients of all types, of any age, regardless of setting. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group specialised register of controlled trials for haemoglobinopathies, which comprises references identified from comprehensive electronic database searches, hand-searching relevant journals, and hand-searching abstract books of conference proceedings. Date of the most recent search(es): November 2000. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing the use of oral hydroxyurea for one month or longer with placebo, standard therapy or other interventions for the treatment of patients with sickle cell disease. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality and extracted data from the two studies included. MAIN RESULTS: Twenty trials were found of which two trials, which reported results from a total of 324 adults and children were suitable for inclusion in the review. From the data provided in the published reports only one study (the MSH study to the United States of America) could be analysed. This study showed marked differences in favour of hydroxyurea treatment as compared with placebo in terms of annual crisis rate, use of transfusions, and life-threatening complications (in particular, the acute sickle chest syndrome). No serious adverse effects were reported from either study. REVIEWER'S CONCLUSIONS: While hydroxyurea appears both effective and safe in the severely affected SS adults over a two year period; further studies are required to elucidate its role in other patient groups and for other conditions.

Antisickling Agents↗
PubMed2004

Macrolide antibiotics for cystic fibrosis.

BACKGROUND: Chronic severe infection with Pseudomonas aeruginosa, affects many people with cystic fibrosis (CF). There is evidence from the laboratory and from other disease processes that macrolide antibiotics, whilst not directly active against Pseudomonas aeruginosa, may have indirect actions against this organism. OBJECTIVES: We aimed to test the hypotheses that, in people with CF, macrolide antibiotics:(1) improve clinical status compared to placebo or another antibiotic;(2) do not have unacceptable adverse effects. If benefit was demonstrated, we aimed to assess the optimal type, dose and duration of macrolide therapy. 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 macrolide antibiotics for unpublished or follow-up data (December 2003). Most recent search of the Group's register: January 2004 SELECTION CRITERIA: Published or unpublished randomised controlled trials of macrolide antibiotics compared to placebo, another class of antibiotic or another macrolide antibiotic. Studies comparing regimens of the same macrolide antibiotic at different doses will also be included. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. Three groups were contacted for missing data and we hope to include these in future reviews. MAIN RESULTS: Searches identified 14 studies, four were included in this review (296 participants). Two studies enrolled adults, one children (a significant number of whom were not colonised with Pseudomonas aeruginosa) and one both adults and children. All the clinical studies reported small but significant improvements in respiratory function with azithromycin versus placebo. Meta-analysis at the one-month and six-month time points demonstrates a significant benefit with respect to relative change in FEV1 (at six months, for n = 104, azithromycin and n = 114, placebo; WMD 5.82% (95% CI 2.45 to 9.20)). The largest study reported a significant increase in mild adverse events (nausea, diarrhoea and wheezing). REVIEWERS' CONCLUSIONS: There is clear evidence from these studies of a small but significant improvement in respiratory function following treatment with azithromycin. The largest study employed a three times a week dose and, in this study, treatment with azithromycin was associated with a significant increase in mild adverse events. Further studies are needed to clarify the precise role of azithromycin in the treatment of CF lung disease.

Anti-Bacterial Agents↗
PubMed2000

Antifungal therapies for allergic bronchopulmonary aspergillosis in people with cystic fibrosis.

BACKGROUND: Allergic Bronchopulmonary Aspergillosis (ABPA) is an allergic reaction to colonisation of the lungs with the fungus Aspergillus fumigatus and affects around 10% people with cystic fibrosis. ABPA is associated with an accelerated decline in lung function. Corticosteroids, in high doses, are the main treatment for ABPA although the long-term benefits are not clear and their many side effects are well documented. A group of compounds, the azoles, have activity against Aspergillus fumigatus and have been proposed as an alternative treatment for ABPA. Of this group, Itraconazole is the most active. A separate antifungal compound, Amphotericin B has been employed in aerosolised form to treat invasive infection with Aspergillus fumigatus, and may have potential for the treatment of ABPA. Antifungal therapy for ABPA in cystic fibrosis needs to be evaluated. OBJECTIVES: The review tested the hypotheses that antifungal interventions for the treatment of ABPA in cystic fibrosis: 1. improve clinical status compared to placebo or standard therapy (no placebo); 2. do not have unacceptable adverse effects. If benefit was demonstrated, the optimal type, duration and dose of antifungal therapy was assessed. SEARCH STRATEGY: We searched 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. In addition, pharmaceutical companies were approached. SELECTION CRITERIA: Randomised controlled trials, published or unpublished, where antifungal treatments have been compared to either placebo or no treatment, or where different doses of the same treatment have been used in the treatment of ABPA in patients with cystic fibrosis. DATA COLLECTION AND ANALYSIS: No completed randomised controlled trials were identified. MAIN RESULTS: No completed randomised controlled trials were identified. REVIEWER'S CONCLUSIONS: At present, there are no randomised controlled trials to evaluate the use of antifungal therapies for the treatment of ABPA in people with cystic fibrosis. Trials with clear outcome measures are needed to properly evaluate this potentially useful treatment for cystic fibrosis.

Adult↗
PubMed2001

Interprofessional education: effects on professional practice and health care outcomes.

BACKGROUND: As patient care becomes more complex, effective collaboration between health and social care professionals is required. However, evidence suggests that these professionals do not collaborate well together. Interprofessional education (IPE) offers a possible way forward in this area. OBJECTIVES: To assess the usefulness of IPE interventions compared to education in which the same professions were learning separately from one another. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register, MEDLINE (1968 to 1998) and Cinahl (1982 to 1998). We also hand searched the Journal of Interprofessional Care (1992 to 1998), the Centre for the Advancement of Interprofessional Education Bulletin (1987 to 1998), conference proceedings, the 'grey literature' held by relevant organisations, and reference lists of articles. SELECTION CRITERIA: Randomised trials, controlled before and after studies and interrupted time series studies of IPE interventions designed to improve collaborative practice between health/social care practitioners and/or the health/well being of patients/clients. The participants included chiropodists/podiatrists, complementary therapists, dentists, dietitians, doctors/physicians, hygienists, psychologists, psychotherapists, midwives, nurses, pharmacists, physiotherapists, occupational therapists, radiographers, speech therapists and/or social workers. The outcomes included objectively measured or self reported (validated instrument) patient/client outcomes and reliable (objective or validated subjective) health care process measures. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the eligibility of potentially relevant studies. MAIN RESULTS: The total yield from the search strategy was 1042, of which 89 were retained for further consideration. However none of these studies met the inclusion criteria. REVIEWER'S CONCLUSIONS: Despite finding a large body of literature on the evaluation of IPE, these studies lacked the methodological rigour needed to begin to convincingly understand the impact of IPE on professional practice and/or health care outcomes.

Attitude of Health Personnel↗
PubMed2002

Interventions for involutional lower lid entropion.

BACKGROUND: Entropion is a condition in which the eyelid margin turns in against the eyeball. The involutional or senile type of entropion is one of the most common lower lid malpositions in the elderly. The interventions described and currently used for the treatment of this condition are surgical in nature, although non-surgical temporary medical treatment for the early stages of entropion has also been reported. The relative effectiveness of these interventions has not yet been resolved. OBJECTIVES: The purpose of this review is to examine the effect of interventions for involutional entropion and to assess whether any method is superior to the others. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register - CENTRAL/CCTR, which contains the Cochrane Eyes and Vision Group specialised register (Cochrane Library Issue 3, 2000), MEDLINE (1966 to October 2000), EMBASE (1980 to September 2000), the metaRegister of Controlled Trials (mRCT), oculoplastic textbooks, conference proceedings and bibliographies of relevant reports. We contacted investigators and experts in the field for details of other published and unpublished studies. SELECTION CRITERIA: The criteria for including studies in this review were randomised controlled trials where one intervention for involutional lower lid entropion has been compared to another method of treatment in people older than 60 years of age with involutional lower lid entropion. DATA COLLECTION AND ANALYSIS: Both reviewers assessed the search results according to the criteria for including studies in the review. No studies were found that met these criteria, and therefore no data were collected and no meta-analysis was performed. MAIN RESULTS: Since no studies met our selection criteria no results were produced. REVIEWER'S CONCLUSIONS: No conclusions could be reached about the effectiveness of interventions for involutional lower lid entropion, although retrospective case series studies suggest that some forms of treatment may be associated with higher recurrence rates than others. Lack of suitable data highlights the need for randomised controlled trials in the fields of entropion management.

Aged↗
PubMed2001

Chinese medicinal herbs for asymptomatic carriers of hepatitis B virus infection.

BACKGROUND: About 350 million people are chronically infected carriers of hepatitis B virus and are at a higher risk of serious illness and death from cirrhosis of the liver and liver cancer. Chinese medicinal herbs have been used widely for more than 2000 years to treat chronic liver disease. OBJECTIVES: To assess whether Chinese medicinal herbs are effective and safe for treating asymptomatic carriers of hepatitis B virus. SEARCH STRATEGY: The trials registers of the Cochrane Hepato-Biliary Group, the Cochrane Library and the Cochrane Complementary Medicine Field were searched in combination with MEDLINE, EMBASE, and handsearches of Chinese journals and conference proceedings. SELECTION CRITERIA: Randomised or quasi-randomised trials (minimum follow-up three months) in asymptomatic carriers of hepatitis B virus. Chinese medicinal herbs (single herb or compound of herbs) compared with placebo, no intervention, general non-specific treatment, or interferon treatment. Trials of Chinese medicinal herbs plus interferon versus interferon alone were also included. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers. Analysis was performed by intention-to-treat where possible. Pre-specified subgroup analyses were: ethnic origin, age at time of infection, and single herb or compound of herbs. MAIN RESULTS: Three randomised clinical trials (307 patients) that followed patients for three months or more after the end of treatment were included. The methodological quality was poor. The herbal compound 'Jianpi Wenshen recipe' had significant effects on viral markers compared to interferon: relative risk 2.40 (95% CI 1.01 to 5.72) for clearance of serum HBsAg, 2.03 (95% CI 0.98 to 4.20) for clearance of HBeAg, and 2.54 (95% CI 1.13 to 5.70) for seroconversion of HBeAg to anti-HBe. Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo. Analysis of pooling eight randomised clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers. Data on long-term clinical outcomes and quality of life were lacking. REVIEWER'S CONCLUSIONS: Based on one low quality trial, the medicinal herb 'Jianpi Wenshen recipe' may have an antiviral activity in asymptomatic carriers of hepatitis B virus. However, rigorous randomised, double-blind, placebo-controlled trials are needed before herbs should be used for this condition.

Astragalus propinquus↗
PubMed2002

Laparoscopic colposuspension for urinary incontinence in women.

BACKGROUND: Laparoscopic colposuspension is a relatively new operation for the treatment of women with stress urinary incontinence with the presumed advantages over traditional Burch colposuspension of avoiding major incisions, shorter hospital stay, and quicker return to normal activities. A variety of approaches and methods are used. OBJECTIVES: To determine the effects of laparoscopic colposuspension surgery on urinary incontinence. SEARCH STRATEGY: We searched the Cochrane Incontinence Group specialised register. The date of the most recent search was April 2001. Additional trials were sought from other sources such as reference lists, conference proceedings, reviews and unpublished research. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in women with symptomatic or urodynamic diagnosis of stress or mixed incontinence that included laparoscopic surgery in at least one arm of the study. DATA COLLECTION AND ANALYSIS: Trials were evaluated for methodological quality and appropriateness for inclusion by the reviewers. Data were extracted by two of the reviewers and cross checked by another. Trial data were analysed by intervention. Where appropriate, a summary statistic was calculated. MAIN RESULTS: Eight eligible trials were identified. Five included 233 women receiving a laparoscopic and 254 women an open colposuspension. Whilst the women's subjective impression of cure seemed similar for both procedures up to 18 months there was some evidence of poorer results on objective outcomes. A single trial suggested poorer long-term performance, but this may reflect surgical inexperience of laparoscopic colposuspension. No significant differences were observed for post-operative urgency, voiding dysfunction or de novo detrusor instability. Trends were shown towards a higher complication rate, longer operating time, less intraoperative blood loss, less postoperative pain, shorter hospital stay, quicker return to normal activities, and shorter duration of catheterisation for laparoscopic compared with open colposuspension. Significantly higher subjective and objective (dry on 'ultrashort' pad test) one year cure rates were found for women randomised to two paravaginal sutures compared with one suture in a single trial (89% vs 65% and 83% vs 58% respectively). One study compared sutures with mesh and staples for laparoscopic colposuspension but it was too small to allow a reliable comparison. One study compared transperitoneal with extraperitoneal access for laparoscopic colposuspension but it was also small and of poor quality. REVIEWER'S CONCLUSIONS: The long-term performance of laparoscopic colposuspension is uncertain. Currently available evidence suggests that it may be poorer than open colposuspension. Like other laparoscopically performed operations, laparoscopic colposuspension leads to a quicker recovery, but takes longer to perform and may be associated with more surgical complications. If it is performed, two paravaginal sutures appear to be more effective than one. The place of laparoscopic colposuspension in clinical practice should become clearer when ongoing trials are reported and when there are more data available describing long-term cure results.

Female↗
PubMed2001

Interventions for promoting smoke alarm ownership and function.

BACKGROUND: Residential fires caused at least 67 deaths and 2,500 non-fatal injuries to children aged 0-16 in the United Kingdom in 1998. Smoke alarm ownership is associated with a reduced risk of residential fire death. OBJECTIVES: We evaluated interventions to promote residential smoke alarms, to assess their effect on smoke alarm ownership, smoke alarm function, fires and burns and other fire-related injuries. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, Cochrane Injuries Group database, MEDLINE, EMBASE, PsycLIT, CINAHL, ERIC, Dissertation Abstracts, International Bibliography of Social Sciences, ISTP, FIREDOC and LRC. Conference proceedings, published case studies, and bibliographies were systematically searched, and investigators and relevant organisations were contacted, to identify trials. SELECTION CRITERIA: Randomised, quasi-randomised or nonrandomised controlled trials completed or published after 1969 evaluating an intervention to promote residential smoke alarms. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. MAIN RESULTS: We identified 26 trials, of which 13 were randomised. Overall, counselling and educational interventions had only a modest effect on the likelihood of owning an alarm (OR=1.26; 95% CI: 0.87 to 1.82) or having a functional alarm (OR=1.19; 0.85 to 1.66). Counselling as part of primary care child health surveillance had greater effects on ownership (OR=1.96; 1.03 to 3.72) and function (OR=1.72; 0.78 to 3.80). Results were sensitive to trial quality, however, and effects on fire-related injuries were not reported. In two non randomised trials, direct provision of free alarms significantly increased functioning alarms and reduced fire-related injuries. Media and community education showed little benefit in non randomised trials. REVIEWER'S CONCLUSIONS: Counselling as part of child health surveillance may increase smoke alarm ownership and function, but its effects on injuries are unevaluated. Community smoke alarm give-away programmes apparently reduce fire-related injuries, but these trials were not randomised and results must be interpreted cautiously. Further efforts to promote smoke alarms in primary care or through give-away programmes should be evaluated by adequately designed randomised controlled trials measuring injury outcomes.

Burns↗
PubMed2004

Air versus oxygen for resuscitation of infants at birth.

BACKGROUND: 100% oxygen is the commonly recommended gas for the resuscitation of infants at birth. There is growing evidence from both animal and human studies that room air is as effective as 100% oxygen and that 100% oxygen may have adverse effects on breathing physiology and cerebral circulation. There is also the theoretical risk of tissue damage due to free oxygen radicals when 100% oxygen is given. The use of room air has, therefore, been suggested as a safer and possibly more effective alternative. OBJECTIVES: In newborn infants requiring resuscitation, does the use of room air reduce the incidence of death, neurological disability and short term morbidity when compared with the use of 100% oxygen? SEARCH STRATEGY: This included searches of the Oxford Database of Perinatal Trials, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2004) and MEDLINE PubMed 1966 to December 2003, and handsearches of reference lists of relevant articles and conference proceedings. SELECTION CRITERIA: All randomised and quasi-randomised studies comparing the use of room air or any other concentration of oxygen versus 100% oxygen in the resuscitation of infants at birth. DATA COLLECTION AND ANALYSIS: Three authors assessed the methodological quality of eligible trials and extracted data independently. When appropriate, meta-analysis was conducted to provide a pooled estimate of effect. For categorical data the relative risk (RR), risk difference (RD) and number needed to treat (NNT) with 95% confidence intervals (CI) were calculated. Continuous data were analysed using weighted mean difference (WMD). MAIN RESULTS: Five studies were identified which enrolled a total of 1302 infants. In two studies allocation was randomised and the caregivers were blinded to intervention group. In the other three studies, allocation was quasi-randomised and the caregivers were not blinded. Pooled analysis of the four trials reporting effect on death showed a significant reduction in the rate of death in the group resuscitated with room air [typical RR 0.71 (0.54, 0.94), typical RD -0.05 (-0.08, -0.01), NNT 20 (12, 100)]. There were no significant differences between the groups with respect to rates of grade 2 or 3 hypoxic ischaemic encephalopathy. One of the four trials reported a statistically significant difference in median 5 minute Apgar scores, favouring the group allocated to room air. However, the absolute difference between the medians was small and there were no significant differences in the median 10 minute Apgar scores in the three trials reporting this outcome. One trial followed up a selected subgroup of survivors to 18-24 months. There were no significant differences in rates of adverse neurodevelopmental outcomes including cerebral palsy and failure to achieve various milestones; however, the proportion of eligible patients seen was less than 70%. Analyses that were planned for this review, but not able to be carried out because of lack of published data, included a sub-analysis stratified by gestational age and assessments of the effect on bronchopulmonary dysplasia and retinopathy of prematurity. REVIEWERS' CONCLUSIONS: There is insufficient evidence at present on which to recommend a policy of using room air over 100% oxygen, or vice versa, for newborn resuscitation. A reduction in mortality has been seen in infants resuscitated with room air, and no evidence of harm has been demonstrated. However, the small number of identified studies and their methodologic limitations dictate caution in interpreting and applying these results. We note the use of back-up 100% oxygen in more than a quarter of infants randomised to room air. Therefore, on the basis of currently available evidence, if one chooses room air as the initial gas for resuscitation, supplementary oxygen should continue to be made available.

Air↗
PubMed2005

Air versus oxygen for resuscitation of infants at birth.

BACKGROUND: 100% oxygen is the commonly recommended gas for the resuscitation of infants at birth. There is growing evidence from both animal and human studies that room air is as effective as 100% oxygen and that 100% oxygen may have adverse effects on breathing physiology and cerebral circulation. There is also the theoretical risk of tissue damage due to free oxygen radicals when 100% oxygen is given. The use of room air has, therefore, been suggested as a safer and possibly more effective alternative. OBJECTIVES: In newborn infants requiring resuscitation, does the use of room air reduce the incidence of death, neurological disability and short term morbidity when compared with the use of 100% oxygen? SEARCH STRATEGY: This included searches of the Oxford Database of Perinatal Trials, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2004) and MEDLINE PubMed 1966 to December 2003, and handsearches of reference lists of relevant articles and conference proceedings. SELECTION CRITERIA: All randomised and quasi-randomised studies comparing the use of room air or any other concentration of oxygen versus 100% oxygen in the resuscitation of infants at birth. DATA COLLECTION AND ANALYSIS: Three authors assessed the methodological quality of eligible trials and extracted data independently. When appropriate, meta-analysis was conducted to provide a pooled estimate of effect. For categorical data the relative risk (RR), risk difference (RD) and number needed to treat (NNT) with 95% confidence intervals (CI) were calculated. Continuous data were analysed using weighted mean difference (WMD). MAIN RESULTS: Five studies were identified which enrolled a total of 1302 infants. In two studies allocation was randomised and the caregivers were blinded to intervention group. In the other three studies, allocation was quasi-randomised and the caregivers were not blinded. Pooled analysis of the four trials reporting effect on death showed a significant reduction in the rate of death in the group resuscitated with room air [typical RR 0.71 (0.54, 0.94), typical RD -0.05 (-0.08, -0.01), NNT 20 (12, 100)]. There were no significant differences between the groups with respect to rates of grade 2 or 3 hypoxic ischaemic encephalopathy. One of the four trials reported a statistically significant difference in median 5 minute Apgar scores, favouring the group allocated to room air. However, the absolute difference between the medians was small and there were no significant differences in the median 10 minute Apgar scores in the three trials reporting this outcome. One trial followed up a selected subgroup of survivors to 18-24 months. There were no significant differences in rates of adverse neurodevelopmental outcomes including cerebral palsy and failure to achieve various milestones; however, the proportion of eligible patients seen was less than 70%. Analyses that were planned for this review, but not able to be carried out because of lack of published data, included a sub-analysis stratified by gestational age and assessments of the effect on bronchopulmonary dysplasia and retinopathy of prematurity. AUTHORS' CONCLUSIONS: There is insufficient evidence at present on which to recommend a policy of using room air over 100% oxygen, or vice versa, for newborn resuscitation. A reduction in mortality has been seen in infants resuscitated with room air, and no evidence of harm has been demonstrated. However, the small number of identified studies and their methodologic limitations dictate caution in interpreting and applying these results. We note the use of back-up 100% oxygen in more than a quarter of infants randomised to room air. Therefore, on the basis of currently available evidence, if one chooses room air as the initial gas for resuscitation, supplementary oxygen should continue to be made available.

Air↗
PubMed2000

Compression for preventing recurrence of venous ulcers.

BACKGROUND: Up to 1% of adults will suffer from leg ulceration at some time. The majority of leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or weakness of the valves in the veins of the leg. Prevention and treatment of venous ulcers is aimed at reducing the pressure either by removing / repairing the veins, or by applying compression bandages / stockings to reduce the pressure in the veins. The vast majority of venous ulcers are healed using compression bandages. Once healed they often recur and so it is customary to continue applying compression in the form of bandages, tights, stockings or socks in order to prevent recurrence. Compression bandages or hosiery (tights, stockings, socks) are often applied for ulcer prevention. OBJECTIVES: To assess the effects of compression hosiery (socks, stockings, tights) or bandages in preventing the recurrence of venous ulcers. To determine whether there is an optimum pressure/type of compression to prevent recurrence of venous ulcers. SEARCH STRATEGY: Searches of 19 databases including the Cochrane Wounds Group trials register and the Cochrane Controlled Trials Register, handsearching of journals, conference proceedings, and bibliographies up to June 2000. SELECTION CRITERIA: Randomised controlled trials evaluating compression bandages or hosiery for prevention of venous leg ulcers. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of study quality were undertaken by two reviewers independently. MAIN RESULTS: No trials compared recurrence rates with and without compression. One trial (300 patients) compared high (UK Class 3) compression hosiery with moderate (UK Class 2) compression hosiery. A intention to treat analysis found no significant reduction in recurrence at five years follow up associated with high compression hosiery compared with moderate compression hosiery (relative risk of recurrence 0.82, 95% confidence interval 0.61 to 1.12). This analysis would tend to underestimate the effectiveness of the high compression hosiery because a significant proportion of people changed from high compression to medium compression hosiery. Compliance rates were significantly higher with medium compression than with high compression hosiery. One trial (166 patients) found no difference in recurrence between two types of medium (UK Class 2) compression hosiery (relative risk of recurrence with Medi was 0.74, 95% confidence interval 0.45 to 1.2). Both trials reported that not wearing compression hosiery was strongly associated with ulcer recurrence and this is circumstantial evidence that compression reduces ulcer recurrence. No trials were found which evaluated compression bandages for preventing ulcer recurrence. REVIEWER'S CONCLUSIONS: No trials compared compression with vs no compression for prevention of ulcer recurrence. Not wearing compression was associated with recurrence in both studies identified in this review. This is circumstantial evidence of the benefit of compression in reducing recurrence. Recurrence rates may be lower in high compression hosiery than in medium compression hosiery and therefore patients should be offered the strongest compression with which they can comply. Further trials are needed to determine the effectiveness of hosiery prescribed in other settings, i.e. in the UK community, in countries other than the UK.

Adult↗
PubMed2004

Interventions for tears of the rotator cuff in adults.

BACKGROUND: Tears of the rotator cuff tendons, which surround the joints of the shoulder, are one of the most common causes of pain and disability in the upper extremity. OBJECTIVES: To review the efficacy and safety of common interventions for tears of the rotator cuff in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised trail register (July 2002), the Cochrane Controlled Trials Register (The Cochrane Library issue 2, 2002), MEDLINE (1966 to December 2001), EMBASE (1974 to December 2001), Biological Abstracts (1980 to December 2001), LILACS (1982 to December 2001), CINAHL (November 1982 to December 2001), Science Citation Index and reference lists of articles. We also contacted authors and handsearched conference proceedings focusing on shoulder conditions. SELECTION CRITERIA: Randomised or quasi-randomised clinical trials involving tears of the rotator cuff were the focus of this review. All trials involving conservative interventions or surgery were included (non-steroidal anti-inflammatory drugs, intra-articular or subacromial glucocorticosteroid injection, oral glucocorticosteroid treatment, physiotherapy, and open or arthroscopic surgery). DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed suitability for inclusion, methodological quality and extracted data. Dichotomous data were presented as relative risks (RR) and 95% confidence intervals (CI), using the fixed effects model. MAIN RESULTS: Eight trials involving 455 people were included and 393 patients analysed. Trials were grouped in eight categories of conservative or surgical treatment. The median quality score of all trials combined was 16 out of a possible 24 points, with a range of 12-18. In general, included trials differed on diagnostic criteria for rotator cuff tear, there was no uniformity in reported outcome measures, and data which could be summarised were rarely reported. Only results from two studies comparing open repair to arthroscopic debridement could be pooled. There is weak evidence for the superiority of open repair of rotator cuff tears compared with arthroscopic debridement. REVIEWER'S CONCLUSIONS: There is little evidence to support or refute the efficacy of common interventions for tears of rotator cuff in adults. As well as the need for further well designed clinical trials, uniform methods of defining interventions for rotator cuff tears and validated outcome measures are also essential.

Adult↗
PubMed2000

Surgery for the resolution of symptoms in malignant bowel obstruction in advanced gynaecological and gastrointestinal cancer.

BACKGROUND: Intestinal obstruction commonly occurs in progressive advanced gynaecological and gastrointestinal cancers. Management of these patients is difficult due to the patients deteriorating mobility and function (performance status), the lack of further chemotherapeutic options and the high mortality and morbidity associated with palliative surgery. There are marked variations in clinical practice concerning surgery in these patients between different countries, gynaecological oncology units, and general hospitals as well as referral patterns from oncologists under whom these patients are often admitted under. There is therefore a need for all the present information to be collated, analysed (with appropriate palliative care outcomes) to establish if surgery is of benefit and what further research is needed. OBJECTIVES: The objective was to locate, appraise and summarise evidence from scientific studies on intestinal obstruction due to advanced gynaecological and gastrointestinal cancer, in order to assess the efficacy of surgery. SEARCH STRATEGY: A comprehensive list of studies was provided by an extensive search of electronic databases, relevant journals, bibliographic databases, conference proceedings, reference lists, the grey literature, personal contact and the world wide web. SELECTION CRITERIA: As the review concentrates on the 'best evidence' available of the role of surgery in malignant bowel obstruction in advanced gynaecological and gastrointestinal cancer the inclusion criteria were kept broad (included both prospective and retrospective studies) so as to include all studies relevant to the question. DATA COLLECTION AND ANALYSIS: Data extraction forms were used to collect data from the studies included in the review. Two researchers extracted the data independently to reduce error. Due to the methodological quality of the studies, only a qualitative assessment was possible. MAIN RESULTS: The role of surgery in malignant bowel obstruction remains controversial, and no firm conclusions from the many retrospective case series can be made. Control of symptoms varies from 42% to over 80%, though it is often unclear how symptoms were measured and whether the tools used to collect symptom scores are validated. There is a large range in the rates of re-obstruction, from 10-50%, though time to re-obstruction was often not included. There is a wide range of postoperative morbidity and mortality, although again the definition of both these surgical outcomes varied between many of the papers. REVIEWER'S CONCLUSIONS: The role of surgery in malignant bowel obstruction needs careful evaluation, using validated outcome measures of symptom control and quality of life scores. Further information would include re-obstruction rates together with the morbidity associated with the various surgical procedures. Currently, bowel obstruction is managed empirically, and there are marked variations in clinical practice by different units. There needs to be a greater standardisation of management so that comparisons between different series can be made.

Female↗
PubMed2001

Elective versus symptomatic intravenous antibiotic therapy for cystic fibrosis.

BACKGROUND: Pseudomonas aeruginosa is the commonest micro-organism associated with respiratory infections in cystic fibrosis. Retrospective studies have suggested that survival is increased by using an aggressive policy of intravenous antipseudomonal antibiotics at regular intervals, irrespective of symptoms. OBJECTIVES: To determine whether there is evidence that an elective (regular) versus symptomatic intravenous antibiotic regime is associated with an improvement in clinical status and survival rates in patients with cystic fibrosis. To identify any adverse effects associated with the use of elective intravenous antibiotics, including an increase in the development of resistant organisms. SEARCH STRATEGY: The Cochrane Cystic Fibrosis and Genetics Disorders Group Specialist Trials Register was used. This comprises references identified from comprehensive electronic database searches, hand searching relevant journals and abstracts from conference proceedings. Date of the most recent search of the Group's specialised register: October 2000. SELECTION CRITERIA: All randomised or pseudo-randomised controlled trials describing the use of elective compared with symptomatic intravenous antibiotic policies for any duration or dose regimen. Elective versus symptomatic intravenous antibiotic regimes against any organisms were considered. Patients with cystic fibrosis were of any age or disease severity. DATA COLLECTION AND ANALYSIS: Trials were independently assessed for inclusion criteria, methodological quality and data extraction by the two reviewers. MAIN RESULTS: Three trials were identified by the initial search. Two trials reporting results from a total of 79 patients were included in the review. Differences in study design and objectives meant that data could not be pooled for meta-analysis. Neither trial demonstrated significant differences in outcome measures between intervention and comparison groups. REVIEWER'S CONCLUSIONS: Studies are insufficient to identify conclusive evidence favouring a policy of elective intravenous antibiotic administration, despite its widespread use. Neither are the potential risks adequately evaluated. The results should be viewed with caution as patient numbers are small. Clearly there is a need for a well-designed, adequately powered, multi-centred randomised controlled trial to evaluate these issues.

Anti-Bacterial Agents↗
PubMed2002

Physical training for cystic fibrosis.

BACKGROUND: Physical training may form an important part of the care package for patients with cystic fibrosis. OBJECTIVES: To determine whether a prescribed regime of physical training produces improvement or prevents deterioration in physiological and clinical outcomes in cystic fibrosis compared to no training. SEARCH STRATEGY: We searched 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: August 2001. SELECTION CRITERIA: All randomised controlled clinical trials in which a prescribed regime of physical training is compared to no physical training in patients with cystic fibrosis. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion, assessed methodological quality and extracted data. MAIN RESULTS: Of the sixteen trials identified six trials, which included 184 patients, met the inclusion criteria. Exercise tolerance in the short term, during an acute admission was improved in patients who received physical training. In a three year study there was no improvement in exercise tolerance at the end of the study period. Over three years there was a significantly greater mean annual rate of decline in FVC in the control group compared to the exercise group WMD 2.17 (95%CI 0.47, 3.87). Changes in other lung function parameters showed a similar trend, but these were not statistically significant. REVIEWER'S CONCLUSIONS: Conclusions about the efficacy of physical training in cystic fibrosis are limited by the small size, short duration and incomplete reporting of most of the trials included in this review. Physical training is already part of the care package offered to most patients with cystic fibrosis and there is no evidence to actively discourage this. Further research is needed to assess comprehensively the net benefit of the addition of physical training to the care of cystic fibrosis patients.

Cystic Fibrosis↗
PubMed2003

Non-invasive ventilation for cystic fibrosis.

BACKGROUND: The use of non-invasive ventilation (NIV) has been proposed as a means to temporarily reverse or slow the progression of worsening respiratory failure in cystic fibrosis (CF). OBJECTIVES: To compare the effect of NIV versus no NIV in people with CF. 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. The reference lists of each trial were searched for additional publications that may contain other trials. Date of most recent search: January 2002. SELECTION CRITERIA: Relevant randomised controlled trials in which a form of pressure preset or volume preset NIV versus no NIV was used in people with acute or chronic respiratory failure in CF. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trials for inclusion criteria, methodological quality and data extraction. MAIN RESULTS: Six trials were identified and four trials met the inclusion criteria with a total of 55 participants. All of these trials only evaluated single treatment sessions. Two trials (36 participants) evaluated the use of NIV for airway clearance compared with an alternative physiotherapy method. These trials showed that airway clearance may be easier and people with CF may prefer to use NIV for airway clearance. There was no evidence that NIV increases sputum expectoration or improves lung function. Two trials (19 participants) evaluated the use of NIV for overnight ventilatory support. Of the primary outcomes examined in this review, only lung function was evaluated within the two trials. Due to the small numbers of participants and the differing statistical techniques used within the review and the primary trials, there were discrepancies in the results obtained by the RevMan analysis and the original trial analysis. No clear differences were found between NIV compared with either oxygen or room air. REVIEWER'S CONCLUSIONS: Non-invasive ventilation may be a useful adjunct to other airway clearance techniques, particularly in people with CF who have difficulty expectorating sputum. Non-invasive ventilation when used in addition to oxygen may improve gas exchange during sleep to a greater extent than oxygen therapy alone in moderate to severe disease. These benefits of NIV have only been demonstrated in single treatment sessions and its efficacy, safety and acceptability in the longer term are unknown. There is a need for long-term randomised controlled trials to determine the clinical effects of non-invasive ventilation in CF.

Cystic Fibrosis↗
PubMed2003

High versus low medium chain triglyceride content of formula for promoting short term growth of preterm infants.

BACKGROUND: In-hospital growth of most very low birth weight infants remains below the 10th percentile of reference intrauterine growth curves (Ehrenkranz 1999). To improve growth, fat is added to preterm formula in the form of medium chain triglycerides (MCT) or long chain triglycerides (LCT). MCT are easily accessible to the preterm infant with an immature digestive system while LCT are important in the development of the retina and visual acuity. Both have been incorporated into preterm formulas in varying amounts, but their effect on the preterm infant's short term growth is unclear. OBJECTIVES: To determine among preterm, formula fed infants, does high MCT as opposed to low MCT (high LCT) formula promote higher short term growth rates. SEARCH STRATEGY: MEDLINE (1966-2002), CINAHL (1982-2002), Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2001), conference proceedings, and reference lists of articles were searched. SELECTION CRITERIA: All randomized trials comparing the effects of exclusive feeding of high versus low MCT formula (for a minimum of one week) on the short term growth of healthy, preterm infants. DATA COLLECTION AND ANALYSIS: Two reviewers assessed each study's quality and extracted data on growth parameters as well as adverse effects from included studies. All data used in analysis were continuous, and therefore weighted mean differences with 95% confidence intervals were reported. MAIN RESULTS: Eight randomized trials studying a total of 182 infants were included. There was no evidence of difference in short term growth parameters when high and low MCT formulas were compared. The meta-analysis of weight gain based on five studies yielded a WMD of -0.35 g/kg/d (95% CI -1.44, 0.74). Similarly, meta-analysis of weight gain in g/d based on two studies showed no evidence of difference (WMD 2.09 g/d, 95% CI -1.46, 5.64). Length gain, based on five studies, showed a non-significant WMD of 0.14 cm/wk (95% CI -0.04, 0.31). Head circumference gain, based on data from five studies, showed a non-significant WMD -0.03 cm/wk (95% CI -0.15, 0.08). Only one study reported skin fold thickness gain, with a mean difference -0.15 mm/wk (95% CI -0.41, 0.11), again not significant. Subgroup analyses according to % MCT in the high MCT formula, by 10% intervals, showed no evidence of effect of high MCT on short term weight gain within any subgroup. There are conflicting data (two studies) as to formula tolerance. There is no evidence of effect on incidence of necrotizing enterocolitis (NEC), based on small numbers in two trials. No studies were located addressing long term growth parameters or neurodevelopmental outcomes. REVIEWER'S CONCLUSIONS: There is no evidence of difference between MCT and LCT on short term growth, gastrointestinal intolerance, or necrotizing enterocolitis. Therefore, neither formula type could be concluded to improve short term growth or have less adverse effects. Further studies are necessary because the results from the included eight studies are imprecise due to small numbers and do not address important long term outcomes. Additional research should aim to clarify effects on formula tolerance and on long term growth and neurodevelopmental outcomes, and include larger study populations to better evaluate effect on NEC incidence.

Dietary Fats↗
PubMed2001

Interventions for the treatment of burning mouth syndrome.

BACKGROUND: The complaint of a burning sensation in the mouth can be said to be a symptom of other disease or a syndrome in its own right of unknown aetiology. In patients where no underlying dental or medical causes are identified and no oral signs are found, the term burning mouth syndrome (BMS) should be used. The prominent feature is the symptom of burning pain which can be localised just to the tongue and/or lips but can be more widespread and involve the whole of the oral cavity. Reported prevalence rates in general populations vary from 0.7% to 15%. Many of these patients show evidence of anxiety, depression and personality disorders. OBJECTIVES: The objectives of this review are to determine the effectiveness and safety of any intervention versus placebo for relief of symptoms and improvement in quality of life and to assess the quality of the studies. SEARCH STRATEGY: Electronic databases (The Cochrane Library, the Cochrane Oral Health Group's Specialised Register, MEDLINE, EMBASE), Clinical Evidence Issue No. 3, conference proceedings and bibliographies of identified publications were searched to identify the relevant literature, irrespective of language of publication. SELECTION CRITERIA: Studies were selected if they met the following criteria: study design - randomised controlled trials (RCTs) and controlled clinical trials (CCTs) which compared a placebo against one or more treatments; participants - patients with burning mouth syndrome, that is, oral mucosal pain with no dental or medical cause for such symptoms; interventions - all treatments that were evaluated in placebo-controlled trials; primary outcome - relief of burning/discomfort DATA COLLECTION AND ANALYSIS: Articles were screened independently by two reviewers to confirm eligibility and extract data. The reviewers were not blinded to the identity of the studies. The quality of the included trials was assessed independently by two reviewers, with particular attention given to allocation concealment, blinding and the handling of withdrawals and drop-outs. Due to differences in patient type, treatment and outcome measures, statistical pooling of the data was inappropriate. MAIN RESULTS: Six trials were included in the review. The interventions examined were antidepressants (two trials), cognitive behavioural therapy (one trial), analgesics (one trial), hormone replacement therapy (one trial) and vitamin complexes (one trial). The participants included in the six identified trials reported suffering from BMS from six months to 20 years. Diagnostic criteria were not always clearly reported. Out of the six trials included in the review, only two interventions demonstrated a reduction in BMS symptoms; vitamin complexes and cognitive behavioural therapy. Neither of these studies reported using blind outcome assessment. Although none of the other treatments examined in the included studies demonstrated a significant reduction in BMS symptoms, this may be due to methodological flaws in the trial design, or small sample size, rather than a true lack of effect. REVIEWER'S CONCLUSIONS: Given the chronic nature of BMS, the need to identify an effective mode of treatment for sufferers is vital. However, there is little research evidence that provides clear guidance for those treating patients with BMS. Further trials, of high methodological quality, need to be undertaken in order to establish effective forms of treatment for patients suffering from BMS.

Analgesics↗