Reduced glycosuria during guar gum supplementation in non-insulin-dependent diabetics. A double-blind, randomised cross-over study.
Explore the source record for details and available documents.
Aged↗
SEARCH · Search PubMed
Results for “Randomised controlled trials as topic”
Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
Psychological interventions for adults with asthma.
BACKGROUND: Many people have asthma, and for some their symptoms may be triggered by psychological factors. In addition compliance with medical therapy may have a psychological dimension. Therefore, psychological interventions aim to reduce the burden of symptoms and improve management of the disease. OBJECTIVES: To assess the effectiveness of psychological interventions for adults with asthma. SEARCH STRATEGY: The Cochrane Airways Group Specialised Register and PsycINFO were searched with pre-defined terms up until August 2005. SELECTION CRITERIA: Randomised controlled trials published in any language assessing the effects of a psychological intervention compared with a form of control in adult participants were included in the review. DATA COLLECTION AND ANALYSIS: Two reviewers assessed the relevance of abstracts identified by electronic searching and retrieved agreed studies for further scrutiny. The studies that met the inclusion criteria were assembled and data extracted. MAIN RESULTS: Fourteen studies, involving 617 particpants, were included in the review, however study quality was poor and sample sizes were frequently small. However, some pooled effects were analysed. The use of 'as needed' medications was reduced in two studies, (47 patients), by relaxation therapy (OR 4.47, CI 1.22 to 16.44). There was no significant difference in FEV1 for relaxation therapy in four studies of 150 patients, (SMD -0.01, CI -0.41 to 0.40). Quality of life, measured using the Asthma Quality of Life Questionnaire in two studies, (48 patients), showed a positive effect following CBT (WMD 0.71, CI 0.23 to 1.19). Peak Expiratory Flow outcome data in two studies, (51 patients), indicated a significant difference in favour of bio-feedback therapy (SMD 0.66, CI 0.09 to 1.23). The remainder of the findings between studies were conflicting. This may have been due to the different types of interventions used and the deficiencies in trial design. AUTHORS' CONCLUSIONS: This review was unable to draw firm conclusions for the role of psychological interventions in asthma due to the absence of an adequate evidence base. Larger, well-conducted and reported randomised trials are required in this area, in order to determine the effects of these techniques in the treatment of asthma in adults.
Adult↗
Intramuscular penicillin for the prevention of early onset group B streptococcal infection in newborn infants.
BACKGROUND: Early-onset group B streptococcal disease (EOGBSD) is the most frequent cause of serious infection in the newborn period. Current strategies used to prevent EOGBSD are focused upon maternal antibiotic prophylaxis to reduce transmission of GBS to the infant. Observational studies have suggested that the administration of intramuscular penicillin to the newborn immediately following delivery may be an effective strategy to reduce the incidence of EOGBSD. OBJECTIVES: To determine if the administration of intramuscular penicillin to newborns at birth is a safe and effective method to prevent morbidity and mortality from EOGBSD. SEARCH STRATEGY: The standard search strategy of the Neonatal Review Group was used. This included searches of electronic databases: Oxford Database of Perinatal Trials, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 1, 2004), and MEDLINE (1966 - Dec 2003); and previous reviews including cross references, expert informants and journal hand searching in the English language as well as conference and symposia proceedings published in Pediatric Research. SELECTION CRITERIA: Randomised trials in which intramuscular penicillin was administered as prophylaxis for EOGBSD within four hours of birth.Outcomes considered were EOGBSD, neonatal mortality, late-onset GBSD, neonatal sepsis, and other secondary outcomes such as neurodevelopmental status and length of hospital stay. DATA COLLECTION AND ANALYSIS: The search for and assessment of trials for inclusion, quality assessment and data extraction were undertaken independently by the reviewers. Meta-analysis was not undertaken as data from only one trial is included in this review. Data were analysed using relative risk (RR) with 95% confidence intervals (CI). MAIN RESULTS: One randomised controlled trial was included in this review. In this trial of 1187 infants of birthweight 501 to 2000 grams, there were no significant differences found for the outcomes of EOGBSD (RR 0.73; 95%CI 0.32, 1.62), or neonatal mortality (RR 0.78; 95% CI 0.55, 1.11). No other outcomes were able to be assessed. REVIEWERS' CONCLUSIONS: This review does not support the routine use of intramuscular penicillin to prevent EOGBSD in newborn infants. There is a discrepancy between this finding and the results of a number of larger non-randomised trials. Explanations for this are proposed. There is a need for this intervention to be tested as a component of the existing prevention strategies in widespread use.
Humans↗
Effectiveness of psychotherapeutic treatment of personality disorder.
BACKGROUND: Psychiatrists have been criticised for failing to develop adequate treatment for personality disorder. Psychotherapeutic treatments are promising, but their effectiveness is uncertain. AIMS: To investigate the evidence for effectiveness of psychotherapeutic treatment for personality disorder. METHOD: Systematic literature review. RESULTS: There is evidence for the effectiveness of psychotherapy for personality disorder. Problems of case identification, comorbidity, randomisation, specificity of treatment and outcome measurement are inadequately addressed. Authors mainly relied on cohort studies. Evidence neither suggests superiority of one type of therapy over another nor indicates which subgroups of patients should be offered psychotherapy as in-patient, day patient, or out-patient. CONCLUSIONS: New research strategies are needed to show that personality change is both measurable and clinically meaningful. Effectiveness studies using randomised controlled designs are required. The literature suggests that effective treatment should be long-term, integrated, theoretically coherent and focused on compliance.
Cohort Studies↗
Lowering blood homocysteine with folic acid-based supplements: meta-analysis of randomised trials.
The objective of this study was to determine the size of reduction in homocysteine concentrations produced by dietary supplementation with folic acid and with vitamins B12 or B6. Meta-analysis of individual data on 1114 people in 12 randomised controlled trials assessed the effects of folic acid-based supplements on blood homocysteine concentrations. Multivariate regression analysis was used to determine the effects on homocysteine concentration of different doses of folic acid and of the addition of vitamin B12 or B6. The results showed that the proportional and absolute reductions in blood homocysteine produced by folic acid supplements were greater at higher pre-treatment blood homocysteine concentrations (p<0.001) and at lower pre-treatment blood folate concentrations (p<0.001). After standardisation to pre-treatment blood concentrations of homocysteine of 12 micromol/L and of folate of 12 nmol/L (approximate average concentrations for Western populations), dietary folic acid reduced blood homocysteine concentrations by 25 percent (95% confidence interval 23%-28%; p<0.001), with similar effects in the range of 0.5-5 mg folic acid daily. Vitamin B12 (mean 0.5 mg daily) produced an additional 7 percent (3%-10%) reduction in blood homocysteine. Vitamin B6 (mean 16.5 mg daily) did not have a significant additional effect. In conclusion, typically in Western populations, daily supplementation with both 0.5-5 mg folic acid and about 0.5 mg vitamin B12 would be expected to reduce blood homocysteine concentrations by about a quarter to a third (for example, from about 12 micromol/L to 8-9 micromol/L). Large scale randomised trials of such regimens in high risk populations are now needed to determine whether lowering blood homocysteine concentration reduces the risk of vascular disease.
Adult↗
Peginterferon alfa-2a (40KD) (Pegasys) for the treatment of patients with chronic hepatitis C.
Compared with conventional interferon alfa, peginterferon alfa-2a (40KD) has improved pharmacokinetics, provides sustained therapeutic plasma levels, and can be administered once weekly. In randomised, multinational trials, peginterferon alfa-2a (40KD) 180 microg once weekly was significantly more effective than three times weekly interferon alfa-2a in patients with chronic hepatitis C, including patients with cirrhosis. Peginterferon alfa-2a (40KD) and ribavirin 1000/1200 mg/day for 48 weeks produced significantly higher sustained responses than three times weekly interferon alfa-2b and ribavirin 1000/1200 mg/day in patients with chronic hepatitis C including those with HCV genotype 1, genotypes 2/3 and those with high or low viral loads at baseline. The drug is well tolerated when given alone or in combination with ribavirin. Health-related quality of life was significantly less impaired during treatment with peginterferon alfa-2a (40KD) than interferon alfa-2a in randomised trials. Peginterferon alfa-2a (40KD) is widely approved for use in patients with chronic hepatitis C.
Antiviral Agents↗
Duration of antibiotic treatment in surgical infections of the abdomen. Minimal antibiotic therapy: technology assessment instead of clinical trials.
In modern medicine which already uses maximal resources, additional improvements involve huge extra efforts. With increasing complexity of diseases, specific treatments have only a limited influence on the "whole process". In complex clinical situations (including sepsis and SIRS) the available methodology to identify groups of patients who may benefit from a specific treatment are weak. This is why prospective randomised "megatrials" may be needed to detect small differences in outcome. We suggest that careful prospective assessment of cohorts of well stratified patients, subjected to a specific and standardised treatment, may replace prospective controlled trials.
Anti-Bacterial Agents↗
Interventions for helping patients to follow prescriptions for medications.
BACKGROUND BACKGROUND: Efforts to assist patients with adherence to prescribed, self-administered medications might improve the benefits and efficiency of health care. OBJECTIVES OBJECTIVE: To update an ongoing review summarising the results of randomised controlled trials (RCTs) of interventions to help patients follow prescriptions for medications, focusing on trials that measured both adherence and clinical outcomes. SEARCH STRATEGY: Computerised searches to July 1998 in MEDLINE, CINAHL, The Cochrane Library, International Pharmaceutical Abstracts (IPA), PsychInfo, Sociofile, and HSTAR; bibliographies in articles on patient adherence; articles in the reviewers' personal collections; and contact with authors. SELECTION CRITERIA: Articles were selected if they reported an unconfounded RCT of an intervention to improve adherence with prescribed medications, measuring both medication adherence and treatment outcome, with at least 80% follow-up of each group studied and, for long-term treatments, at least six months follow-up for studies with positive initial findings. DATA COLLECTION AND ANALYSIS: Information on study design features, interventions and controls, and findings were extracted by one reviewer (PM) and a research assistant and confirmed by two of the other reviewers. The studies were too disparate to warrant meta-analysis. MAIN RESULTS: For short-term treatments, one study, of counselling and written information, showed an effect on adherence and clinical outcome. Ten of 19 interventions for long-term treatments reported in 17 RCTs were associated with improvements in adherence, but only nine interventions led to improvements in treatment outcomes. Almost all of the interventions that were effective for long-term care were complex, including combinations of more convenient care, information, counselling, reminders, self-monitoring, reinforcement, family therapy, and other forms of additional supervision or attention. Even the most effective interventions did not lead to large improvements in adherence and treatment outcomes. Two studies showed that telling patients about adverse effects of treatment did not affect their adherence. REVIEWER'S CONCLUSIONS: The full benefits of medications cannot be realised at currently achievable levels of adherence. Current methods of improving adherence for chronic health problems are mostly complex and not very effective. More studies of innovative approaches to assist patients to follow medication prescriptions are needed.
Drug Prescriptions↗
Conjugate vaccines for preventing Haemophilus influenzae type b infections.
BACKGROUND: Haemophilus influenzae (H. influenzae) is an important cause of meningitis and pneumonia in children, causing an estimated three million cases of serious disease and hundreds of thousands of deaths annually worldwide. The introduction of H. influenzae type b (Hib) vaccines into routine immunisation schedules in developed countries has been followed by a rapid decline in disease occurrence, but vaccine cost is a significant barrier to use in developing countries. There is a need to determine the size of the effects of the vaccine, to enable cost-effectiveness comparisons with competing priorities in developing countries. OBJECTIVES: 1. To determine the effects of conjugate Hib vaccine in preventing Hib disease or death in children under five years.2. To determine any serious adverse outcomes. SEARCH STRATEGY: Searches of the Cochrane Central Register of Controlled Trials (CENTRAL) (issue 1, 2003); MEDLINE (January 1966 to April 2003), EMBASE (1990 to April 2003); and scanning of reference lists and contacting of authors of trial reports. Reports in all languages were considered. SELECTION CRITERIA: All randomised controlled trials or quasi-randomised trials of conjugate H. influenzae type b vaccines compared with placebo or no treatment in children who were followed until at least two years of age. DATA COLLECTION AND ANALYSIS: Two investigators independently selected eligible studies and extracted data. Differences were resolved by discussion. MAIN RESULTS: Five studies were included in the review, and four in meta-analyses. The overall quality of the trials was good. The relative risk for invasive Hib disease was 0.20 (95% confidence interval 0.07 to 0.54; random effects model), but there was statistically significant unexplained variation (heterogeneity) in the effects of the four trials in the meta-analysis (p = 0.002). The size of the effects found in the trials did not appear to differ consistently with different vaccine types, the number of vaccine doses, age at first vaccination or use in developed vs developing countries, but the confidence intervals for the effect estimates were wide.Hib-related mortality data showed a non-significant trend towards benefit (relative risk was 0.29; 95% confidence interval 0.07 to 1.20; random effects model). The relative risk for all cause mortality in the single trial from which data were available was 1.01 (95% confidence interval 0.38 to 2.67, random effects model). No serious adverse effects were reported in any of the trials, involving a total of 257,000 infants. REVIEWER'S CONCLUSIONS: Hib vaccine is safe and effective. The size of the effect could plausibly be anywhere between a 46% and 93% reduction in Hib invasive disease, before the effect of herd immunity is taken into account. In resource-poor settings, decisions to use the vaccine will depend on its cost, the local burden of Hib disease and competing priorities. Insufficient evidence from randomised controlled trials was identified of the effects of Hib conjugate vaccine on either Hib-specific or on all-cause mortality.
Bacterial Capsules↗
Corticosteroids for myasthenia gravis.
BACKGROUND: Although widely accepted as an appropriate immunosuppressive therapy, the efficacy of glucocorticosteroid treatment has only rarely been tested in controlled studies. OBJECTIVES: To assess the efficacy of glucocorticosteroids or adrenocorticotrophic hormone (ACTH) medication in autoimmune myasthenia gravis. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Group Trials Register in July 2004, MEDLINE (from January 1966 to June 2004) and EMBASE (from January 1980 to June 2004). We also checked the bibliographies in reviews and the randomised trials and contacted their authors to identify additional published and unpublished data. SELECTION CRITERIA: From the articles identified we selected those open or controlled studies which allowed us to assess the outcome of treated and untreated patients at definite endpoints. Types of studies: quasi-randomised or randomised controlled trials. TYPES OF PARTICIPANTS: patients with myasthenia gravis of all ages and all degrees of severity. Types of interventions: any form of glucocorticosteroids or adrenocorticotrophic hormone treatment. Types of outcome measures:Primary outcome(1) improvement after at least three months in either the weakest muscles or all muscles. Secondary outcomes(1) proportion of patients improved after at least six months(2) proportion of patients in remission(3) number of episodes of worsening during the first six months(4) acetylcholine receptor antibody titres after at least three months of therapy. DATA COLLECTION AND ANALYSIS: Three authors extracted the data from the selected articles and one other checked them. MAIN RESULTS: A trial of adrenocorticotrophic hormone (43 patients) did not show any advantage compared with placebo for the treatment of ocular myasthenia gravis. Two double-blind trials compared prednisone with placebo for generalised myasthenia gravis. In the first (13 patients), the improvement was slightly greater in the prednisone group at six months. In the second (20 patients) which was a short-term trial, the improvement was significantly greater at two weeks. Two trials compared glucocorticosteroids with azathioprine (41 and 10 patients respectively). In one of these the rate of treatment failure was greater in the prednisone group. In a trial of glucocorticosteroids versus intravenous immunoglobulin (33 patients) no differences in treatment responses were encountered during a treatment period of 14 days. An open trial (39 patients) evaluating different corticosteroid doses revealed a shorter time to improvement in the high-dose group. However only limited evidence can be drawn from the available randomised controlled trials due to numerous and important methodological flaws. AUTHORS' CONCLUSIONS: Limited evidence from randomised controlled trials suggests that corticosteroid treatment offers significant short-term benefit in myasthenia gravis compared with placebo. This supports the conclusions of observational studies and expert opinion. Limited evidence from randomised controlled trials does not show any difference in efficacy between corticosteroids and either azathioprine or intravenous immunoglobulin.
Adrenal Cortex Hormones↗
Behavioural and cognitive-behavioural interventions for outwardly-directed aggressive behaviour in people with learning disabilities.
BACKGROUND: Outwardly directed aggressive behaviour is a significant part of problem behaviours presented by people with learning disabilities. Prevalence rates between 3.3% to 36% have been reported in the literature. Such behaviours run a long term course and are a major cause of social exclusion OBJECTIVES: To determine the efficacy of behavioural and cognitive behavioural interventions for outwardly-directed aggressive behaviour for people with learning disabilities. SEARCH STRATEGY: The Cochrane Library (CENTRAL), MEDLINE, EMBASE, CINAHL, ERIC and PsycINFO were searched using a strategy combining (Learning or synonyms) and (Disabilities or synonyms) and (Behaviour or synonyms) and (treatment or synonyms) to late 2002. Where appropriate, research filters were used. SELECTION CRITERIA: Studies were selected if more than 4 participants, children or adults, were allocated by random or quasi-random methods to either intervention or standard treatment/wait list. DATA COLLECTION AND ANALYSIS: References identified by electronic searches, examinations of bibliography and personal contacts were screened against inclusion criteria by two independent reviewers. MAIN RESULTS: Three studies based on adult populations with learning disabilities were deemed to be suitable for inclusion but data were only available in a form suitable for meta-analysis in two studies. Direct interventions based on cognitive-behavioural methods (modified relaxation, assertiveness training with problem solving, and anger management) appear to have some impact on reduction of aggressive behaviour at the end of treatment but not at follow up (up to six months) as rated by individuals and their carers. REVIEWERS' CONCLUSIONS: The existing evidence on the efficacy of cognitive behavioural and behavioural interventions on outwards directed aggression in children and adults with ID is scant. There is a paucity of methodologically sound clinical trials. Given the impact of such behaviours on the affected individual, his or her carers and on service providers, effective interventions are essential. It is also important to investigate cost efficacy of treatment models against existing treatments. We recommend that randomised controlled trials of sufficient power are carried out using primary outcomes of reduction in outward directed aggression, improvement in quality of life and cost efficacy as measured by standardised scales.
Aggression↗
Zhiling decoction for vascular dementia.
BACKGROUND: Zhiling decoction has a fixed composition of 15 Chinese herbs. The properties of each of these herbs and in combination provide the therapeutic rationale for a possible action of Zhiling decoction in dilating cerebral vessels and increasing cerebral blood flow, as well as reducing serum cholesterol. Thus the aim of this review is to evaluate efficacy and safety of Zhiling decoction for the treatment of vascular dementia. OBJECTIVES: To assess the efficacy and safety of Zhiling decoction for vascular dementia. SEARCH STRATEGY: The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group was searched on 2 January 2004 using the term Zhiling. This Register contains records from all major health care databases and many ongoing trials databases and is updated regularly. In addition the reviewers hand searched 83 Chinese Traditional Medicine Journals (1993 to 2003). SELECTION CRITERIA: Randomised trials comparing Zhiling decoction with placebo in people with vascular dementia. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials where possible. MAIN RESULTS: In the absence of any suitable randomised placebo-controlled trials in this area, we were unable to perform a meta-analysis. REVIEWERS' CONCLUSIONS: The currently available evidence is insufficient to assess the potential for Zhiling decoction in the treatment of vascular dementia. The little objective data concerning the management of Zhiling decoction versus Naofukang suggests that Zhiling decoction may be effective in treating vascular dementia. There is no evidence for or against Zhiling as a treatment for vascular dementia. Further randomised, double-blind, placebo-controlled trials are urgently needed in order to define the relative efficacy and acceptability of Zhiling in vascular dementia.
Dementia, Vascular↗
Acupuncture for nausea and vomiting: an update of clinical and experimental studies.
The objective of this overview is to summarize existing knowledge about the effects of acupuncture-point stimulation on nausea and vomiting. Systematic reviews on postoperative nausea and vomiting, chemotherapy-induced nausea and vomiting, and pregnancy-related nausea and vomiting exist. Several randomised trials, but no reviews, exist for motion sickness. For postoperative nausea and vomiting, results from 26 trials showed acupuncture-point stimulation was effective for both nausea and vomiting. For chemotherapy-induced nausea and vomiting, results of 11 trials differed according to modality with acupressure appearing effective for first-day nausea, electroacupuncture appearing effective for first-day vomiting, and noninvasive electrostimulation appearing no more effective than placebo for any outcome. For pregnancy-related nausea and vomiting, results were mixed. Experimental studies showed effects of P6-stimulation on gastric myoelectrical activity, vagal modulation and cerebellar vestibular activities in functional magnetic resonance imaging. There is good clinical evidence from more than 40 randomised controlled trials that acupuncture has some effect in preventing or attenuating nausea and vomiting. A growing number of experimental studies suggest mechanisms of action.
Acupuncture Therapy↗
Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: quantitative review of randomised trials.
BACKGROUND: Facilitated percutaneous coronary intervention for ST-segment-elevation myocardial infarction (STEMI) is defined as the use of pharmacological substances before a planned immediate intervention, to improve coronary patency. We undertook a meta-analysis of randomised controlled trials (published and unpublished) to compare facilitated and primary percutaneous coronary intervention. METHODS: We identified 17 trials of patients with STEMI assigned to facilitated (n=2237) or primary (n=2267) percutaneous coronary intervention. We identified short-term outcomes (up to 42 days) of death, stroke, non-fatal reinfarction, urgent target vessel revascularisation, and major bleeding. Grade 3 flow rates for prethrombolysis and post-thrombolysis in myocardial infarction (TIMI) were also analysed. FINDINGS: The facilitated approach resulted in a greater than two-fold increase in the number of patients with initial TIMI grade 3 flow, compared with the primary approach (832 patients [37%] vs 342 [15%], odds ratio 3.18, 95% CI 2.22-4.55); however, final rates did not differ (1706 [89%] vs 1803 [88%]; 1.19, 0.86-1.64). Significantly more patients assigned to the facilitated approach than those assigned to the primary approach died (106 [5%] vs 78 [3%]; 1.38, 1.01-1.87), had higher non-fatal reinfarction rates (74 [3%] vs 41 [2%]; 1.71, 1.16-2.51), and had higher urgent target vessel revascularisation rates (66 [4%] vs 21 [1%]; 2.39, 1.23-4.66); the increased rates of adverse events seen with the facilitated approach were mainly seen in thrombolytic-therapy-based regimens. Facilitated intervention was associated with higher rates of major bleeding than primary intervention (159 [7%] vs 108 [5%]; 1.51, 1.10-2.08). Haemorrhagic stroke and total stroke rates were higher in thrombolytic-therapy-containing facilitated regimens than in primary intervention (haemorrhagic stroke 15 [0.7%] vs two [0.1%], p=0.0014; total stroke 24 [1.1%] vs six [0.3%], p=0.0008). INTERPRETATION: Facilitated percutaneous coronary intervention offers no benefit over primary percutaneous coronary intervention in STEMI treatment and should not be used outside the context of randomised controlled trials. Furthermore, facilitated interventions with thrombolytic-based regimens should be avoided.
Aged↗
Value of penicillin in the prevention of pain, swelling and trismus following the removal of ectopic mandibular third molars.
A double-blind randomised placebo-controlled study of the value of systemic penicillin in preventing pain, swelling and trismus following the removal of impacted mandibular third molars and indicates that penicillin may be used justifiably in the more difficult cases.
Clinical Trials as Topic↗
Influence of methodology on outcomes of randomised clozapine trials.
The aim of this study was to clarify the impact of various methodological quality factors on reported outcome of randomised clozapine trials. Trials comparing the atypical antipsychotic clozapine with other antipsychotic drugs were identified in extensive electronic searches. Two independent reviewers extracted data on methodology and primary outcomes, and assessed trial quality by use of three sets of criteria (Cochrane, Delphi, and Jadad). There was no association between trial quality, as measured by any of the criteria sets, and primary measures of outcome. Trials with the best score for randomisation and concealment according to the Delphi scale had a significantly lower relative risk for relapse in clozapine-treated groups, and studies with well reported random order generation according to Jadad criteria tended to have better odds ratios for clinical improvement on clozapine. These findings strengthen the evidence of true clozapine superiority in these aspects. No other quality items correlated to the primary outcomes. Inadequate randomisation techniques may be a source of bias in clozapine studies, but much more research is needed on the connections between trial quality and trial outcome.
Antipsychotic Agents↗
Preventing the occurrence of pressure ulceration in hospitalised elderly patients.
OBJECTIVE: To determine which factors contribute to the development of pressure ulcers and to evaluate the role of topical agents in preventing their occurrence. METHOD: An observational, prospective survey covered 36 care of the elderly wards and involved 1121 patients at high or very high risk of pressure ulceration. The patients, of whom 667 (59.6%) received a gentle application of a topical agent to at-risk areas, were followed up for eight weeks. RESULTS: Of the patients, 15.7% developed a pressure ulcer. The use of a corpitolinol 60-based topical agent (Sanyrène/Corpitol) significantly reduced the incidence of pelvic pressure ulcers (p=0.04) when used with recognised prevention strategies. This was identified by undertaking a logistic regression analysis. The resulting odds ratio of 0.61 indicates that the intervention helped to reduce the number of pressure ulcers by 40%. CONCLUSION: The results of this observational study can provide a useful guide to the design of further randomised controlled trials.
Activities of Daily Living↗
[Recent progress on the therapy for chronic obstructive pulmonary disease (COPD)--usefulness and practice of the step-by-step pharmacologic therapy].
Recently, a step-by-step pharmacologic therapy for chronic obstructive pulmonary disease (COPD) has been recommended by several principal organizations. The characteristic of this therapy is that it is a stepwise approach organized according to the severity of disease and is mainly composed of bronchodilators including beta 2-agonists and anticholinergic agents, theophylline, and oral corticosteroids, and the goal of this therapy is to induce bronchodilation, decrease the inflammatory reaction, and facilitate expectoration. Since the effectiveness of one of the inhaled corticosteroids has been also indicated by the multicentre randomised trial in a few years, they may have an important role in the long-term treatment of COPD.
Administration, Inhalation↗