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Tea tree oil: a systematic review of randomized clinical trials.

AIM: Tea tree oil (TTO) is immensely popular for various topical applications. In vitro studies have repeatedly demonstrated that it has antibiotic activity. This article is an attempt to systematically review the evidence from randomised clinical trials for or against effectiveness of external TTO in dermatological conditions. METHODS: Six electronic databases were searched. Methodological quality was assessed by Jadad score. Data were extracted and validated in a standardised fashion by two independent reviewers. RESULTS: Only 4 trials were located. They suggest that TTO may be effective as a treatment of acne and fungal infections. The evidence is promising but by no means compelling. The adverse effects of TTO are usually mild and transient. They mainly consist of allergic reactions. CONCLUSIONS: It is concluded that, so far, there is no compelling evidence to show that TTO is efficacious in any dermatological condition. However, in view of promising findings, TTO deserves to be investigated more closely.

Administration, Topical↗

Antioxidant vitamin and mineral supplements for age-related macular degeneration.

BACKGROUND: It has been proposed that antioxidants may prevent cellular damage in the retina by reacting with free radicals produced in the process of light absorption. OBJECTIVES: The objective of this review is to assess the effects of antioxidant vitamin and/or mineral supplementation on the progression of age-related macular degeneration. SEARCH STRATEGY: The Cochrane Eyes and Vision Group specialised registered, the Cochrane Controlled Trials Register - Central, MEDLINE, the Science Citation Index, and the reference lists of relevant articles were searched. Investigators of included studies were contacted. The most recent searches were performed in December 1999. SELECTION CRITERIA: All randomised trials comparing an antioxidant vitamin and/or mineral supplement (alone or in combination) to control in people with age-related macular degeneration were included. DATA COLLECTION AND ANALYSIS: The reviewer extracted data and assessed trial quality. Due to the small number of trials identified, and variable methods of collecting and presenting outcome data, no statistical summary measure was calculated. MAIN RESULTS: Four published, two unpublished and two ongoing trials were identified. Published trials to date have been small and results inconsistent. Adverse effects and quality of life for people with age-related macular degeneration have not been addressed. REVIEWER'S CONCLUSIONS: The question as to whether people with age-related macular degeneration should take antioxidant vitamin or mineral supplements to prevent progression of the disease has not been answered by research to date. The results of ongoing trials are awaited.

Antioxidants↗

Preoperative radiotherapy for esophageal carcinoma. Oeosphageal Cancer Collaborative Group.

BACKGROUND: The existing randomized evidence has failed to conclusively demonstrate the benefit or otherwise of preoperative radiotherapy in treating patients with potentially resectable esophageal carcinoma. OBJECTIVES: This meta-analysis aimed to assess whether there is benefit from adding radiotherapy prior to surgery and whether or not any pre-defined patient subgroups benefit more or less from preoperative radiotherapy SEARCH STRATEGY: Medline and CancerLit searches were supplemented by information from trial registers and by hand searching relevant meeting proceedings and by discussion with relevant trialists, organisations and industry. SELECTION CRITERIA: Trials were eligible for inclusion in this meta-analysis provided they randomized patients with potentially resectable carcinoma of the esophagus (of any histological type) to receive radiotherapy or no radiotherapy prior to surgery. Trials must have used a randomization method which precluded prior knowledge of treatment assignment and completed accrual by December 1993, to ensure sufficient follow-up by the time of the first analysis (September 1995). DATA COLLECTION AND ANALYSIS: A quantitative meta-analysis using updated data from individual patients from all properly randomized trials (published or unpublished) comprising 1147 patients (971 deaths) from five randomized trials. This approach was used to assess whether preoperative radiotherapy improves overall survival and whether it is differentially effective in patients defined by age, sex and tumour location. MAIN RESULTS: With a median follow-up of 9 years, in a group patients with mostly squamous carcinomas, the hazard ratio (HR) of 0.89 (95% CI 0.78-1.01) suggests an overall reduction in the risk of death of 11% and an absolute survival benefit of 3% at 2 years and 4% at 5 years. This result is not conventionally statistically significant (p=0.062). No clear differences in the size of the effect by sex, age or tumor location were apparent. REVIEWER'S CONCLUSIONS: Based on existing trials, there was no clear evidence that preoperative radiotherapy improves the survival of patients with potentially resectable esophageal cancer. These results indicate that if such preoperative radiotherapy regimens do improve survival, then the effect is likely to be modest with an absolute improvement in survival of around 3 to 4%. Trials or a meta-analysis of around 2000 patients (90% power, 5% significance level) would be needed to reliably detect such an improvement (from 15 to 20%).

Esophageal Neoplasms↗

Antibiotics for the common cold.

BACKGROUND: The common cold is caused by viruses which cannot be helped by antibiotics. OBJECTIVES: The objective of this review was to assess the effects of antibiotics for the common cold. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, MEDLINE, EMBASE, the Family Medicine Database, and reference lists of articles, and we contacted principal investigators. The most recent search was in December 1998. SELECTION CRITERIA: Randomised trials comparing any antibiotic therapy with placebo in acute upper respiratory tract infections. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Main results: Seven trials involving 2056 people aged between six months and 49 years were included. The overall quality of the included trials was variable. People receiving antibiotics did not do better in terms of cure or improvement than those on placebo (odds ratio 0.95, 95% confidence interval 0.70 to 1.28 fixed effects model). One study found a significant benefit for antibiotics compared with placebo for runny nose (clear or purulent). The only other study to evaluate purulent nasal discharge found no significant benefit for antibiotics. Only one study reported work time lost with 22% of those on antibiotic treatment and 25% of those on placebo but this was not significant. Patients treated with antibiotics had a significant increase in side effects (odds ratio 2.72, 95% confidence interval 1.02 to 7.27, random effects model). REVIEWER'S CONCLUSIONS REVIEWERS' CONCLUSIONS: There is not enough evidence of important benefits from the treatment of upper respiratory tract infections with antibiotics and there is a significant increase in adverse effects associated with antibiotic use.

Anti-Bacterial Agents↗

A comparison of drugs versus placebo for the treatment of dysthymia.

OBJECTIVES: Dysthymia is a depressive disorder of chronic nature but of less severity than major depression, which depressive symptoms are more or less continuous for at least two years. The aim of this review was to conduct a systematic review of all RCTs comparing drugs and placebo for dysthymia. SEARCH STRATEGY: Electronic searches of Cochrane Library, EMBASE, MEDLINE, PsycLIT, Biological Abstracts and LILACS; reference searching; personal communication; conference abstracts; unpublished trials from the pharmaceutical industry; book chapters on the treatment of depression. SELECTION CRITERIA: The inclusion criteria for all randomised controlled trials were that they should focus on the use of drugs versus placebo for dysthymic patients. Exclusion criteria were: non randomised, mixed major depression/ dysthymia (trials not providing separate data) and depression secondary to other disorders (e.g. substance abuse). DATA COLLECTION AND ANALYSIS: The reviewers extracted the data independently. In order to achieve an intention-to-treat analysis, when trials failed to report it was assumed that people who died or dropped out had no improvement. Authors of relevant trials were contacted for additional and missing data. Absence of treatment response as defined by authors was the main measure of outcome used. Relative Risks (RR) and 95% confidence intervals (CI) of dichotomous data were calculated with the Random Effects Model. Where possible, number needed to treat (NNT) and number needed to harm (NNH) were estimated, taking the reciprocal of the absolute risk reduction. MAIN RESULTS: Currently the review includes 15 trials. Similar results were obtained in terms of efficacy for different groups of drugs, such as tricyclic (TCA), selective serotonin reuptake inhibitors (SSRI), monoamine oxidase inhibitors (MAOI) and other drugs (sulpiride, amineptine, and ritanserin). The pooled RR for absence of treatment response was 0. 68 (95% CI 0.59-0.78) for TCA and the NNT was 4.3 (95% CI 3.2-6.5). SSRIs showed similar RR for this outcome: 0.64 (95% CI 0.55-0.74), the NNT being 4.7 (95% CI 3.5-6.9). Concerning MAOIs, the RR was 0. 59 (95% CI 0.48-0.71) and the NNT was 2.9 (95% CI 2.2-4.3). Other drugs (amisulpride, amineptine and ritanserin) showed similar results in terms of absence of treatment response. Using more stringent criteria for improvement - full remission - the results were unchanged. Patients treated on TCA were more likely to report adverse events, compared with placebo. REVIEWER'S CONCLUSIONS: Drugs are effective in the treatment of dysthymia with no differences between and within class of drugs. Tricyclic antidepressants are more likely to cause adverse events and dropouts. As dysthymia is a chronic condition, there remains little information on quality of life and medium or long-term outcome.

Antidepressive Agents↗

Venepuncture versus heel lance for blood sampling in term neonates.

BACKGROUND: Heel lance has been the conventional method of blood sampling in neonates for screening tests. Neonates undergoing this procedure experience pain. Despite various studies evaluating the role of pharmacological and non-pharmacological interventions to date, there are no effective and practical methods to alleviate pain from heel lance. OBJECTIVES: To determine whether venepuncture or heel lance is less painful and more effective for blood sampling in term neonates. SEARCH STRATEGY: Systematic search in accordance with Cochrane Neonatal Collaborative Review Group. All randomized controlled trials which compared pain response to venepuncture vs. heel lance were searched using MEDLINE, Embase, CINAHL, the Cochrane Library, reference lists of identified trials and personal files. No language restrictions were applied. SELECTION CRITERIA: Randomized controlled trials which compared pain response to venepuncture vs. heel lance were selected for this review. DATA COLLECTION AND ANALYSIS: Data regarding the primary outcome of pain response to venepuncture vs. heel lance as assessed by validated pain measures were abstracted. Secondary outcomes including the need of repeat blood sampling, bruising/hematoma at local site, and parental perception of their own anxiety and infant's pain were also abstracted. All data were analysed using Revman 3.1. When possible, meta-analysis was done using relative risk (RR) and event rate difference (ERD), along with their 95% confidence intervals (CI). If ERD was significant, number needed to treat (NNT) was calculated. MAIN RESULTS: Two trials were eligible for inclusion in the review. One study using Neonatal Infant Pain Scale (NIPS) and one study using Neonatal Facial Action Coding System (NFCS) and cry duration showed statistically significantly lower pain scores for venepuncture as compared to heel lance. In one study, maternal anxiety was noted to be higher in the venepuncture group as compared to heel lance group prior to the procedure; however, after observing the procedure, mothers rated their infant's pain to be lower in the venepuncture group. A meta-analysis was performed on the need for at least one additional skin puncture to obtain the required amount of blood using venepuncture as compared to heel lance. The relative risk for requiring more than one skin puncture for venepuncture versus heel lance was 0.19 [95% confidence interval (CI) 0.10, 0.38]. The risk difference was -53% (95% CI -66%, -40%). The number needed to treat (NNT) to avoid one repeat skin puncture was 1.9 (95% CI 1.5, 2.5). REVIEWER'S CONCLUSIONS: Venepuncture, when performed by a trained phlebotomist, appears to be the method of choice for blood sampling in term neonates. For each two venepunctures instead of heel lance, the need for one additional skin puncture can be avoided. In view of the promising results derived from small studies with some methodological limitations, further well designed randomized controlled trials need to be conducted. The interventions should be compared in settings where several individuals perform the venepuncture and/or the heel lance.

Blood Specimen Collection↗

Interventions for suspected placenta praevia.

BACKGROUND: Because placenta praevia is implanted unusually low in the uterus, it may cause major, and/or repeated, antepartum haemorrhage. The traditional policy of care of women with symptomatic placenta praevia includes prolonged stay in hospital and delivery by caesarean section. OBJECTIVES: To assess the impact of any clinical intervention applied specifically because of a perceived likelihood that a pregnant woman might have placenta praevia. SEARCH STRATEGY: A comprehensive electronic search was performed to identify relevant literature. Searched databases included the Trials Register maintained by the Cochrane Pregnancy and Childbirth Group, and the Cochrane Controlled Clinical Trials Register. SELECTION CRITERIA: Any controlled clinical trial that has assessed the impact of an intervention in women diagnosed as having, or being likely to have, placenta praevia. DATA COLLECTION AND ANALYSIS: Data were extracted from the three identified trial reports, unblinded, by the author without consideration of results. MAIN RESULTS: Two comparisons could be made - home versus hospitalisation and cervical cerclage versus no cerclage. Both were associated with reduced lengths of stay in hospital antenatally. Otherwise, there was little evidence of any clear advantage or disadvantage to a policy of home versus hospital care. Cervical cerclage may reduce the risk of delivery before 34 weeks, or the birth of a baby weighing less than 2 kg or having a low 5 minute Apgar score. In general, these possible benefits were more evident in the trial of lesser methodological quality. REVIEWER'S CONCLUSIONS: There are insufficient data from trials to recommend any change in clinical practice. Available data should, however, should encourage further work to address the safety of more conservative policies of hospitalisation for women with suspected placenta praevia, and the possible value of insertion of a cervical suture.

Female↗

Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children.

BACKGROUND: OME is common and may cause hearing loss with associated developmental delay. Treatment remains controversial. The effect of both systemic and intra-nasal steroids on effusions has been assessed by randomised controlled trials. OBJECTIVES: To examine evidence for or against treating children with hearing loss associated with OME with systemic or topical nasal steroids. SEARCH STRATEGY: Searches were conducted in February 2000. We searched the Cochrane Controlled Trials Register using the terms 'otitis-media', 'otitis media with effusion', 'glue ear', or 'OME', and 'steroids', 'glucocorticoids, synthetic', 'glucocorticoids, topical', 'anti-inflammatory agents, steroidal'. EMBASE and MEDLINE were also searched for additional information. SELECTION CRITERIA: Randomised controlled trials of oral and topical nasal steroids, either alone or in combination with another agent such as an antibiotic, were included. EXCLUSIONS: publications in abstract form only since adequate appraisal was not possible; uncontrolled, non-randomised or retrospective studies; studies reporting outcomes with ears (rather than children) as the unit of analysis. DATA COLLECTION AND ANALYSIS: Data were extracted from the published reports by the two authors independently (CCB and JH van der V) using standardised data extraction forms and methodology. The methodological quality of the included studies were independently assessed by the two authors using the scheme described in the Cochrane Handbook. Dichotomous results were expressed as an odds ratio using a fixed effects model together with the 95% confidence intervals. Continuous data were analysed using the weighted mean difference in a fixed effects model. Tests for heterogeneity between studies were performed using a Mantel-Haenszel approach. In trials with a cross over design, post-crossover treatment data were not used. MAIN RESULTS: No study prospectively documented hearing loss associated with OME prior to randomisation. Follow up was short term. No serious or lasting side effects were reported in the four studies that did mention side effects. Most comparisons involved small numbers of subjects. The odds ratio for OME persisting after short term follow up for children treated with oral steroids plus antibiotic compared to control plus antibiotic was 0.32 (95% CI 0.20 to 0.52). However there was significant heterogeneity between studies (p<0.01). Trends favoured steroids for most other comparisons, but confidence intervals included unity. There was no evidence of benefit for steroid treatment in the longer term, and no study assessed effect of steroid treatment on language development. REVIEWER'S CONCLUSIONS: There is evidence that steroids combined with an antibiotic lead to a quicker resolution of OME in the short term. However, there is not evidence for long term benefit from treating hearing loss associated with OME with either oral or topical nasal steroids. These treatments are therefore not recommended at the present time. Future studies should document hearing loss associated with OME before the start of study treatment. Follow up should be longer and ideally include symptom, audiometry and developmental outcomes. Data should not be presented with ears as the unit of analysis.

Administration, Intranasal↗

Interventions for treating melioidosis.

BACKGROUND: Melioidosis is an infectious disease caused by a bacterium (Burkholderia pseudomallei) found particularly in some areas in the tropics. It is a serious condition which can be fatal. Beta lactam antibiotics have dramatically reduced the risk of death, but mortality still remains high. OBJECTIVES: To summarise evidence from randomised trials on the effects of treatment regimens on death and relapse. SEARCH STRATEGY: Cochrane Controlled Trials Register, MEDLINE, EMBASE, BIOSIS from 1966 to September 2000 using MeSH terms "pseudomallei", "melioidosis" together with the terms "randomized-controlled-trial", "random allocation"; reference lists in articles on melioidosis; contact with trialists. SELECTION CRITERIA: Randomised and quasi-randomised trials assessing treatments in patients with melioidosis. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality was assessed by two reviewers independently. MAIN RESULTS: For intravenous therapy in the acute phase, we identified five trials with a total of 519 patients. Chloramphenicol, doxycycline, and co-trimoxazole (trimethoprim-sulphamethoxazole) combination regimens were associated with a mortality of 50% or more (two studies). Patients randomised to regimens that included ceftazidime were more likely to survive (relative risk [RR] 0.46, 95% confidence interval [CI] 0.30 to 0.71). When ceftazidime-containing regimens were compared with beta lactam or alternative beta lactamase inhibitor regimens such as co-amoxiclav (amoxycillin-clavulanic acid) and cefoperazone-sulbactam, mortality rates were similar (RR 1.10, 95% CI 0.83 to 1.46), as was the case in one trial of imipenem. For oral therapy in the maintenance phase, we found two trials of 188 participants. Results showed that treatment with the conventional regimen (chloramphenicol, doxycycline, and trimethoprim-sulphamethoxazole) resulted in fewer fatalities in patients compared to a regimen of amoxycillin-clavulanic acid and doxycycline alone. REVIEWER'S CONCLUSIONS: Regimens for the acute phase of illness should contain ceftazidime or imipenem. It is not yet clear if combinations of treatments in the early phase reduce relapse. For oral therapy after the acute phase of treatment, trials suggest that conventional four drug regimens can be used for treatment.

Administration, Oral↗

Interventions for replacing missing teeth: different types of dental implants.

BACKGROUND: Dental implants are available in different materials, shapes and with different surface characteristics. In particular, numerous implant surface modifications have been developed for enhancing clinical performances. OBJECTIVES: To test the null hypothesis of no difference in clinical performance between various root-formed osseointegrated implant types. SEARCH STRATEGY: The Cochrane Oral Health Group Specialised Trials Register, The Cochrane Controlled Trials Register, MEDLINE and EMBASE were searched. Hand searching included several dental journals. Bibliographies of relevant clinical trials and review articles were checked for studies outside the handsearched journals. In addition, authors of all identified trials and fifty-five oral implant manufacturers were contacted to find unpublished or ongoing RCTs. Two extensive personal libraries (ME and AJ) were consulted. The last electronic search was conducted 8th May 2002. SELECTION CRITERIA: All randomised controlled trials of oral implants comparing implants with different materials, shapes and surface properties having a follow-up of at least one year. DATA COLLECTION AND ANALYSIS: Data were independently extracted, in duplicate, by two reviewers (ME & HW). Authors were contacted for details of randomisation and withdrawals and a quality assessment was carried out. The Cochrane Oral Health Group's statistical guidelines were followed. MAIN RESULTS: Thirty publications, representing 13 different RCTs, were identified. Five of these RCTs (seven publications), which reported results from a total of 326 patients, were suitable for inclusion in the review. Six implant systems were compared: Astra, Branemark, IMZ, ITI, Steri-Oss and Southern with a follow-up ranging from one to three years. All implants were made in commercially pure titanium and had different shapes and surface preparations. On a patient rather than per implant basis there were no statistically significant differences for failures and marginal bone level changes on intra-oral radiographs between various implant systems. REVIEWER'S CONCLUSIONS: There was no evidence that any of the implant systems evaluated was superior to the other. However, these findings are based on a few RCTs all having short follow-up periods and few participants. More RCTs should be conducted, with follow-up of at least five years and including a sufficient number of patients, to detect a true difference if any exists. Such trials should be reported according to the CONSORT guidelines (http://www.consort-statement.org/).

Dental Implantation, Endosseous↗

Limited (information only) patient education programs for adults with asthma.

BACKGROUND: A key component of many asthma management guidelines is the recommendation for patient education and regular medical review. A number of controlled trials have been conducted to measure the effectiveness of asthma education programmes. These programmes improve patient knowledge, but their impact on health outcomes is less well established. At its simplest level, education is limited to the transfer of information about asthma, its causes and its treatment. This review focused on the effects of limited asthma education. OBJECTIVES: The objective of this review was to assess the effects of limited (i.e. information only) asthma education on health outcomes in adults with asthma. SEARCH STRATEGY: We searched the Cochrane Airways Group trials register and reference lists of articles. SELECTION CRITERIA: Randomised and controlled trials of individual asthma education involving information transfer only in adults over 16 years of age. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data were extracted independently by two reviewers. Study authors were contacted for missing information. MAIN RESULTS: Eleven trials were included. They were of variable quality. Limited asthma education did not reduce hospitalisation for asthma (weighted mean difference -0.03 average hospitalisations per person per year, 95% confidence interval -0.09 to 0.03). There was no effect on doctor visits, lung function and medication use. The effects on asthma symptoms were variable. There was no reduction in days lost from normal activity, but perceived asthma symptoms did improve after limited asthma education (odds ratio 0.40, 95% confidence interval 0.18 to 0.86). In one study, limited asthma education was associated with reduced emergency department visits (weighted mean difference -2.76 average visits per person per year, 95% confidence interval -4.34 to 1.18). REVIEWER'S CONCLUSIONS: Use of limited asthma education as it has been practiced does not appear to improve health outcomes in adults with asthma. However the use of information in the emergency department may be effective, but this needs to be confirmed.

Adult↗

Interventions for treating chronic pelvic pain in women.

BACKGROUND: Chronic pelvic pain is common in women in the reproductive age group and it causes disability and distress and results in significant costs to health services. The pathogenesis of chronic pelvic pain is poorly understood. Often, investigation by laparoscopy reveals no obvious cause for pain. There are several possible explanations for chronic pelvic pain including undetected irritable bowel syndrome, the vascular hypothesis where pain is thought to arise from dilated pelvic veins in which blood flow is markedly reduced and altered spinal cord and brain processing of stimuli in women with chronic pelvic pain. As the pathophysiology of chronic pelvic pain is not well understood, its treatment is often unsatisfactory and limited to symptom relief. Currently, the main approaches to treatment include counselling or psychotherapy, attempting to provide reassurance using laparoscopy to exclude serious pathology, progestogen therapy such as medroxyprogesterone acetate, and surgery to interrupt nerve pathways. OBJECTIVES: We aimed to identify and review treatments for chronic pelvic pain in women in the reproductive years. The review included studies of patients with a diagnosis of pelvic congestion syndrome but excluded those with pain known to be caused by i) endometriosis, ii) primary dysmenorrhoea (period pain), iii) pain due to chronic pelvic inflammatory disease, or iv) irritable bowel syndrome. SEARCH STRATEGY: The search strategy adopted by the Cochrane Menstrual Disorders and Subfertility Group was used. SELECTION CRITERIA: Randomised controlled trials (RCTs) with women who had chronic pelvic pain, excluding endometriosis, primary dysmenorrhoea, pain due to chronic pelvic inflammatory disease, or irritable bowel syndrome. The reviewers were prepared to consider studies of any intervention including lifestyle, physical, medical, surgical and psychological treatments. Outcome measures were pain rating scales, quality of life measures, economic analyses and adverse events. DATA COLLECTION AND ANALYSIS: For each included trial, information was collected regarding the method of randomisation, allocation concealment, blinding, whether an intention to treat analysis could possibly be performed and relevant interventions and outcomes (see previous sections). Data were extracted independently by the two reviewers, using forms designed according to the Cochrane guidelines. MAIN RESULTS: Seven studies were identified of which four were of good methodological quality. One study was reported in a brief abstract only and was excluded. Progestagen (Medroxyprogesterone acetate) was associated with a reduction of pain during treatment. Counselling supported by ultrasound scanning was associated with reduced pain and improvement in mood. A multidisciplinary approach was beneficial for some outcome measures. Adhesiolysis was not associated with an improved outcome apart from where adhesions were severe. REVIEWER'S CONCLUSIONS: Further studies to confirm these observations are needed, together with full reporting of those studies which have been undertaken. Given the prevalence and health care costs associated with chronic pelvic pain in women, randomised controlled trials of other medical, surgical and psychological interventions are urgently required.

Chronic Disease↗

Multidisciplinary team interventions for delirium in patients with chronic cognitive impairment.

BACKGROUND: Delirium is common in hospitalized elderly people. In the frail elderly, delirium may occur in 60% of those hospitalized. In the cognitively impaired, 45% have been shown to develop delirium and these patients have longer lengths of stay and a higher rate of complications which, amongst other things, together contribute to an increase in cost of care. The combination of being elderly and chronically cognitively impaired leads to a high risk of delirium with the associated increased risk of prolonged hospital stay, complications, and poor outcomes. The management of delirium has commonly been multifaceted - the primary emphasis has always been on the diagnosis and therapy of the precipitating factors, but as this may not be immediately resolved, symptomatic and supportive care may become of major importance. OBJECTIVES: The objective of this review is to assess the available evidence for the effectiveness, if any, of multidisciplinary team interventions in the coordinated care of patients with delirium superimposed on an underlying chronic cognitive impairment compared with the usual care of older cognitively impaired patients. SEARCH STRATEGY: The Cochrane Controlled Trials Register (Cochrane Library, up to and including Issue 1, 1998) was searched using the terms 'delirium, controlled trial, cognitive'. MEDLINE, EMBASE and Psychlit (Ovid via Winspirs up to Feb 1998) were also searched with the same terms. Other sources including personal communications, ongoing trials, conference proceedings, handsearching and reference lists of published papers and books were all searched for relevant randomized controlled trials. The total yield from searching was 157 from which 8 (eight) were retained for consideration in the review. SELECTION CRITERIA: From the initial search yields, all randomised controlled trials involving the management of elderly patients with delirium were identified. A single reviewer (AMB) discarded irrelevant publications based on the title of the publication and its abstract. In the event that the article could possibly be relevant, it was retrieved for further assessment. All references were compiled in a list with a commentary on type of article, eg review, prospective study etc and this was independently considered by the second reviewer (RR) who agreed to review all randomised controlled studies reported on patients with delirium. Selection for possible inclusion in this review was then made on the basis of the participants reported as having chronic cognitive impairment, who then developed incident delirium and were randomly assigned to either coordinated multidisciplinary care or usual care. The outcomes of interest were length of stay in hospital, morbidity (including complications), patient distress & impact on care environment, mortality, discharge arrangements and follow-up including assessment of cognitive function at 6 months. Studies in which patients with chronic cognitive impairment or dementia, managed for incident delirium, according to ICD 9 criteria (see note) were considered eligible for inclusion in the review. Studies of risk factors and non-randomized studies were excluded. Note: this classification has been widely utilised throughout the English speaking medical literature over the past 20 years: ICD 10 is still being incorporated into clinical coding systems and has not been utilised in studies published in 1996. (ABSTRACT TRUNCATED)

Delirium↗

Allopurinol for chronic prostatitis.

OBJECTIVES: To determine the effects of allopurinol in the treatment of chronic prostatitis SEARCH STRATEGY: Trials were searched in computerized general and specialized databases (MEDLINE, Cochrane Library, Cochrane Prostate Group database), bibliographies of obtained articles, and direct contact with authors. SELECTION CRITERIA: All randomized trials of allopurinol versus placebo used to treat patients with chronic prostatitis. Acute prostatitis, bacterial prostatitis, and asymptomatic prostatitis were excluded. The main outcome measure was the change in patient-reported discomfort. DATA COLLECTION AND ANALYSIS: The reviewers extracted the data independently for the outcomes of change in patient-reported discomfort, investigator graded prostate pain, leukocyte counts, and biochemical indices. MAIN RESULTS: Only one trial with 54 men lasting 240 days (with 330 days of follow-up) met study inclusion criteria. There was a statistically significant change favoring allopurinol in patient-reported discomfort between the study and control groups at follow-up. Between days 45-225, the mean score was -0.95 (s.d. 0.19) for the allopurinol group (7 men), compared with -0.47 (s.d. 0.21) for the placebo group (7 men). The weighted mean difference (WMD) was -0.48 (95%CI -0.690, -0.270). The mean score between days 45-135 was -1.08 (s.d. 1.29) for the 25 men in the allopurinol group, compared with -0.21 (sd 0.97) for the 14 men in the control group. The WMD was -0.87 (95%CI -1.587, -0.153). The allopurinol group had significantly less investigator graded prostate pain and had lower levels of serum urate, urine urate, and expressed prostatic secretion urate and xanthine. No significant differences between the two groups regarding leukocyte counts were found. No patient receiving allopurinol had any significant side effects. Three patients in the placebo group dropped out because of side effects. REVIEWER'S CONCLUSIONS: One small trial of allopurinol for treating chronic prostatitis showed improvements in patient-reported symptom improvement, investigator-graded prostate pain, and biochemical parameters. However, the data provided, the measures used, and the statistics presented do not make these findings convincing that changes in urine and prostatic secretion composition regarding purine and pyrimidine bases resulted in the relief of symptoms. Further studies of allopurinol treatment using standardized and validated outcomes measures and analyses are necessary to determine whether allopurinol is effective.

Allopurinol↗

Anticonvulsants for preventing mortality and morbidity in full term newborns with perinatal asphyxia.

OBJECTIVES: To assess the benefits and harm of administering anticonvulsants to infants of 37 weeks gestation or more following perinatal asphyxia with the primary aims of prevention of death or subsequent severe neurodevelopmental disability and/or the prevention of seizures. SEARCH STRATEGY: Relevant randomised controlled trials were identified using a combination of electronic database searches (MEDLINE), hand searches and a search of the Neonatal Review Group trials register. SELECTION CRITERIA: All randomised, or quasi-randomised, controlled clinical trials with reported data comparing the following outcomes: mortality, neurodevelopmental disability, neonatal seizures and adverse events, following anticonvulsant therapy in term infants (37 weeks or more), compared to controls with or without placebo, following perinatal asphyxia. DATA COLLECTION AND ANALYSIS: Methodological quality and validity of studies were assessed without consideration of the results. Data relevant to the outcome were extracted and analysed. MAIN RESULTS: Five randomised or quasi-randomised controlled trials which met the selection criteria were identified. No studies were of sufficient methodological quality and size to demonstrate a valid, clinically significant change in the risk of mortality or severe neurodevelopmental disability. A meta-analysis combining three studies comparing barbiturates with conventional therapy following perinatal asphyxia demonstrated no difference in risks of death, severe neurodevelopmental disability, or death or severe neurodevelopmental disability. REVIEWER'S CONCLUSIONS: At the present time, anticonvulsant therapy to term infants in the immediate period following perinatal asphyxia cannot be recommended for routine clinical practice, other than in the treatment of prolonged or frequent clinical seizures. Any future studies should be of high quality: randomised control trials with allocation concealment, performance and outcome assessment blinding. Such studies should be of sufficient size, with minimal attrition, to have the power to detect clinically important reductions in mortality and severe neurodevelopmental disability, as the primary outcome measures.

Anticonvulsants↗

Pneumococcal vaccine for asthma.

BACKGROUND: Infection with Streptococcus pneumoniae is an important cause of pneumonia and other serious illnesses, particularly amongst those with certain high-risk medical conditions such as asthma. Although pneumococcal vaccine is routinely advocated for people with asthma, there is uncertainty about the evidence base that underpins this recommendation. OBJECTIVES: To determine the efficacy of pneumococcal vaccine in reducing mortality or morbidity from pneumococcal disease in asthmatics. SEARCH STRATEGY: Randomised controlled trials were identified using the Cochrane Airways Group's register derived from MEDLINE, EMBASE, and CINAHL electronic databases and hand searched respiratory journals and meeting abstracts. SELECTION CRITERIA: Randomised controlled trials, with or without blinding, in which pneumococcal vaccine has been compared with placebo or no treatment in people with clinician diagnosed asthma. DATA COLLECTION AND ANALYSIS: Two reviewers independently reviewed all abstracts and full papers of all articles of potential relevance were retrieved. Methodological quality was rated using the Cochrane approach and the Jadad rating scale. Data extraction was performed by one reviewer and checked independently by a second. We planned to perform quantitative analyses of outcomes on an intention-to-treat basis, where possible. MAIN RESULTS: Of the three papers retrieved, only one satisfied the inclusion criteria and the methodological quality of this study was low (unblinded and inadequate allocation concealment). None of the data could be aggregated in a meta-analysis. Comparisons in a sub-set of 30 asthmatic children prone to recurrent episodes of otitis media, showed that pneumococcal vaccination decreased the incidence of acute asthma exacerbations from 10 to 7 (per child per year). REVIEWER'S CONCLUSIONS: This review found very limited evidence to support the routine use of pneumococcal vaccine in people with asthma. A randomised trial of vaccine efficacy in children and adults with asthma is needed.

Asthma↗