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Multicentre Trials (multicentre + trials)
Selected AbstractsTreatment of high-risk diabetic patients with angiotensin II receptor blockersDIABETES OBESITY & METABOLISM, Issue 6 2001R. Estacio Summary In the United States, , 16 million people have diabetes; 90,95% have type 2 diabetes. They are at increased risk of developing hypertension and cardiovascular disease (CVD). The benefits of treating hypertension in diabetic patients and the potential to delay complications and reduce mortality have been demonstrated in clinical trials. Increasing evidence shows that angiotensin-converting enzyme (ACE) inhibitors and angiotensin II (Ang II) receptor blockers (ARBs) may be equally effective in delaying progressive renal disease in diabetic patients. Large, multicentre trials are ongoing to confirm the efficacy and superior safety profile of ARBs in this population. [source] Effect of concurrent zidovudine use on the resistance pathway selected by abacavir-containing regimensHIV MEDICINE, Issue 6 2004ER Lanier Objectives Abacavir (ABC) selects for four mutations (K65R, L74V, Y115F and M184V) in HIV-1 reverse transcriptase (RT), both in vitro and during monotherapy in vivo. The aim of this analysis was to compare the selection of these and other nucleoside reverse transcriptase inhibitor (NRTI)-associated mutations by ABC-containing therapies in the presence and absence of concurrent lamivudine (3TC) and/or zidovudine (ZDV) and to assess the effect of these mutations on phenotypic susceptibility to the NRTIs. Design This study was a retrospective analysis of the patterns of NRTI-associated mutations selected following virological failure in six multicentre trials conducted during the development of ABC. Methods Virological failure was defined as confirmed vRNA above 400 HIV-1 RNA copies/mL. RT genotype and phenotype were determined using standard methods. Results K65R was selected infrequently by ABC-containing regimens in the absence of ZDV (13 of 127 patients), while L74V/I was selected more frequently (51 of 127 patients). Selection of both K65R and L74V/I was significantly reduced by co-administration of ZDV with ABC (one of 86 and two of 86 patients, respectively). Y115F was uncommon in the absence (seven of 127 patients) or presence (four of 86 patients) of ZDV. M184V was the most frequently selected mutation by ABC alone (24 of 70 patients) and by ABC plus 3TC (48 of 70 patients). Thymidine analogue mutations were associated with ZDV use. The K65R mutation conferred the broadest phenotypic cross-resistance of the mutations studied. Conclusions The resistance pathway selected upon virological failure of ABC-containing regimens is significantly altered by concurrent ZDV use, but not by concurrent 3TC use. These data may have important implications for the efficacy of subsequent lines of NRTI therapies. [source] Lung volume reduction surgery: The Thoracic Society of Australia and New ZealandINTERNAL MEDICINE JOURNAL, Issue 2 2001G. I. Snell Abstract Lung volume reduction surgery involves the removal of emphysematous lung tissue with the aim of palliating symptoms in selected patients with severe emphysema. This form of surgery is being practised in Australia with favourable short-term outcomes, similar to those reported in the literature. Large multicentre trials are currently underway in North America and the United Kingdom to clarify issues of safety and long-term efficacy. As a result, it is too early to apply an evidence-based approach to this procedure. In the meantime, local audits of practice need to be undertaken to define patient subgroups at higher risk of morbidity and mortality. (Intern Med J 2001; 31: 112,115) [source] Meta-analysis: isosorbide-mononitrate alone or with either beta-blockers or endoscopic therapy for the management of oesophageal varicesALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2010L. L. Gluud Aliment Pharmacol Ther 2010; 32: 859,871 Summary Background, The evidence concerning the use of isosorbide-mononitrate (IsMn) for oesophageal varices is equivocal. Aim, To assess the effects of IsMn for patients with oesophageal varices and no previous bleeding (primary prevention) or previous variceal bleeding (secondary prevention). Methods, Systematic review with meta-analyses of randomized trials on IsMn alone or with beta-blockers or endoscopic therapy for oesophageal varices. Electronic and manual searches were combined. Randomized trials on primary and secondary prevention were included. The primary outcome measure was mortality. Intention-to-treat random effects meta-analyses were performed. The robustness of the results was assessed in trial sequential analyses. Results, Ten randomized trials on primary and 17 on secondary prevention were included. Evidence of bias was identified. No apparent effect of IsMn on mortality compared with placebo or beta-blockers or IsMn plus beta-blockers vs. beta-blockers was identified. Compared with endoscopic therapy, IsMn plus beta-blockers had no apparent effect on bleeding, but did seem to reduce mortality in secondary prevention (RR 0.73, 95% CI 0.59,0.89), but not in primary prevention. The effect of IsMn plus beta-blockers on mortality in secondary prevention was not confirmed in trial sequential analysis. Conclusions, Isosorbide-mononitrate used alone or in combination with beta blockers does not seem to offer any reduction in bleeding in the primary or secondary prevention of oesophageal varices. Compared with endoscopic therapy, there may be a survival advantage in using IsMn and beta-blockers, but additional large multicentre trials are needed to verify this finding. [source] Interventions for treating traumatized permanent front teeth: avulsed (knocked out) and replantedAUSTRALIAN DENTAL JOURNAL, Issue 2 2010P Day Background:, Dental trauma is common. One of the most severe injuries is when a permanent tooth is knocked completely out (avulsed) of the mouth. In most circumstances the tooth should be replanted as quickly as possible. There is uncertainty on how best to prepare teeth for replantation. Objectives:, To compare the effects of a range of interventions for managing traumatized permanent teeth with avulsion injuries. Search strategy:, The Cochrane Oral Health Group's Trials Register (to 28th October 2009); CENTRAL (The Cochrane Library 2009, Issue 4); MEDLINE (1950 to October 2009); EMBASE (1980 to October 2009); http://www.clinicaltrials.gov/;www.controlled-trials.com/ and reference lists of articles were searched. There were no language restrictions. Selection criteria:, Only randomized controlled trials (RCTs), that included a minimum follow-up period of 12 months, for interventions for avulsed and replanted permanent teeth were considered. Data collection and analysis:, Two review authors independently extracted data and assessed trial quality and the risk of bias in studies to be included. Main results:, Three studies, involving a total of 162 patients and 231 teeth were identified. Study one (with a high risk of bias) investigated the effect of extra-oral endodontics. This showed no significant difference in radiographic resorption compared with intra-oral endodontics provided at week 1 for teeth avulsed for longer than 60 minutes dry time. Study two (which had a moderate risk of bias) investigated a 10-minute soaking in thymosin alpha 1 prior to replantation and then its further use as a daily gingival injection for the first 7 days. They reported a strong benefit at 48 months (14% with periodontal healing in the control group versus 77% for the experimental group). Study three (with a high risk of bias) investigated a 20-minute soaking with gentamycin sulphate (4 × 107 U/L) for both groups prior to replantation and then the use of hyperbaric oxygen daily in the experimental group for 80 minutes for the first 10 days. They reported a strong benefit at 12 months (43% periodontal healing versus 88% for the experimental group). There was no formal reporting of adverse events. Authors' conclusions:, The available evidence suggests that extra-oral endodontics is not detrimental for teeth replanted after more than 60 minutes dry time. Studies with moderate/high risk of bias indicate that soaking in thymosin alpha 1 and gentamycin sulphate followed by hyperbaric oxygen may be advantageous. However, they have not previously been reported as interventions for avulsed teeth and need further validation. More evidence with low risk of bias is required and, with the low incidence of avulsed teeth, collaborative multicentre trials are indicated. Plain language summary:, Treatments for managing knocked out and replanted front teeth. Injuring your front teeth during childhood is common. One of the most severe injuries occurs when the tooth is knocked totally out of the mouth (avulsed). Often the best option is to replant the tooth as quickly as possible. This is true only for permanent teeth. Once replanted the tooth can heal in two ways if managed correctly. Ideally the ligament around the root reforms and the tooth can be expected to last as long as any other tooth; this is known as ,periodontal healing'. When there is too much damage to the ligament, healing occurs by bony replacement and the tooth is replaced by bone and lost over a few years. This is called ,bony healing'. Bony healing causes significant problems in the medium term for children and treatments for this are the subject of a different Cochrane review. A missing front upper tooth or teeth, as a result of not replanting an avulsed tooth or as a treatment for bony healing, can have a major effect on dental and facial ,good looks'. This can affect the individual's self-esteem and general social interaction, as well as how others think and see them. This Cochrane review investigated what treatments encourage the tooth to repair by periodontal healing. Three studies were found. The benefits of these treatments require further investigation before specific medicaments can be advised. This is because the studies had weakness in their design which may have influenced the benefits they found. The following general treatment principle can be concluded which reinforces current treatment guidelines: For teeth with little chance of periodontal healing, a root canal treatment can be carried out before the tooth is replanted without further detrimental effects. [source] Quality control in urodynamics: a review of urodynamic traces from one centreBJU INTERNATIONAL, Issue 3 2003J. Sullivan OBJECTIVE To investigate quality control in our unit and to enable other units to compare their results, as experience from central reviews of urodynamic traces for multicentre trials has suggested that poor quality control is common. PATIENTS AND METHODS All consecutive male urodynamic tests conducted over 1 year were reviewed. A list of criteria to assess the quality of the records was devised, based upon International Continence Society guidelines on ,good urodynamic practice', and on other sources. Eligible traces were analysed for aspects of quality control, e.g. baseline pressures and coughs to test pressure transmission. The data were analysed to establish how often quality criteria were met, and identify areas for improvement. RESULTS In 100 eligible traces, the baseline detrusor pressure was 0,10 cmH2O in 86, and , 5 to +10 cmH2O in 94%. Baseline intravesical and abdominal pressure were 30,50 cmH2O in 68% and 73% of cases, respectively. Coughs were present before filling in 94%, during filling in 95%, before voiding in 72% and after voiding in 87% of cases. The cough-test frequency was sufficient in 30% of traces. In 11 the intravesical pressure line fell out during voiding. CONCLUSION Most of the traces assessed met the quality criteria defined, but significant defects were not uncommon. Some of the problems identified suggest areas of urodynamic technique which should be studied in more detail. We intend to modify our quality control practices, and hope to show an improvement on re-audit. We hope that other urodynamic departments will be encouraged to review their practice, and we aim to improve our results. [source] | ||||||||||