Antibiotika-assoziierte Diarrhoen betreffen vor allem ältere, in einer Klinik behandelte Patienten unter oraler oder parenteraler Therapie mit Breitspektrumantibiotika. Sind die Diarrhoen durch Clostridium difficile verursacht, kann das Krankheitsbild lebensbedrohlich werden. Können Präparationen, die Mikroorganismen der gesunden Darmflora enthalten, solche Diarrhoen verhindern? Eine britische Studie hat das untersucht.
Introduction Antibiotic associated diarrhoea (AAD) and Clostridium difficile associated diarrhoea (CDD) occur in 5–39% of pts exposed to antibiotics. Despite previous papers proposing a beneficial role of probiotics, there has been no large randomised controlled trial evaluating their preventative effect. Methods This large RCT funded by the HTA was aimed at finding the efficacy and cost-effectiveness of a high dose, multi-strain probiotic for prevention of AAD and CDD in older people admitted to hospital. Pts aged > 65yrs, exposed to one or more oral/parenteral antibiotics without pre-existing diarrhoea, recent CDD or risk of probiotic adverse effects were eligible. Of 17,420 patients screened, 2,981(17.1%)were recruited and allocated sequentially by a computer-generated random allocation sequence stratified by centre. 1,493(50.1%)were allocated to probiotic and 1,488(49.9%)to placebo arm. Two strains of lactobacilli and two strains of bifidobacteria with a total of 6x1010 organisms/day were taken as a daily single capsule for 21 days. The placebo was inert maltodextrin powder. Occurrence of AAD or CDD within 12 weeks of recruitment was assessed by research nurses, blinded to arm allocation. Results ITT analysis included 2,941(98.7%)participants. Potential risk factors for antibiotic-associated diarrhoea at baseline were similar in both arms. The frequency of AAD was similar in the probiotic (159/1470, 10.8%)and placebo arms (153/1471, 10.4%), RR: 1.04; 95%CI0.84–1.28; P = 0.72.CDD was an uncommon cause of AAD and occurred in 12/1470(0.8%)participants in the probiotic and 17/1471(1.2%)in the placebo arm (RR 0.71; 95%CI0.34–1.47; P = 0.35).Adverse events and other outcomes were similar in both arms. Total health care costs per patient did not differ significantly between probiotics (£8020.11; 95%CI£7622.31-£8417.90) and placebo (£8011.37; 95%CI£7600.53-£8422.22).The incremental cost-effectiveness ratio of £45,636/QALY was robust to changes in key parameters. Conclusion This study found no evidence that probiotic administration was effective in the elderly in preventing AAD, although there was a trend towards reduced CDD in the probiotic arm. Disclosure of Interest S. Allen: None Declared, K. Wareham: None Declared, D. Wang: None Declared, C. Bradley: None Declared, B. Sewell: None Declared, H. Hutchings: None Declared, W. Harris: None Declared, A. Dhar Grant/Research Support from: NIHR Grant Holder, Speaker bureau with: Shire Pharmaceuticals, Warner Chilcott UK, H. Brown: None Declared, A. Foden: None Declared, M. Gravenor: None Declared, S. Plummer Employee of: Research Director of Obsidian Research Limited and Director of Cultech Limited, D. Mack: None Declared, C. Phillips: None Declared
Aim: To examine the effects of glibenclamide and repaglinide on glucose stimulated insulin release, incretins, oxidative stress and cell adhesion molecules in patients with type 2 diabetes suboptimally treated with metformin.Methods: A randomized clinical trial was performed recruiting 27 subjects (HbA(1c) between 7.5 and 10.5%) free from cardiovascular and renal disease. Glucose, insulin, C-peptide, glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), total antioxidant status, F-2-isoprostane, interleukin-6 and cell adhesion molecules were measured during an oral glucose load at baseline and after eight weeks of treatment. The areas under the curve were analysed at 45, 60 and 120 min (AUC(45), AUC(60), AUC(120)).Results: Significant improvements in glucose were observed with repaglinide (HBA(1c): -1.5%, fasting glucose: -2.8 mmol/L, 2-h glucose: -3.7 mmol/L, AUC(120): -18.9%) and glibenclamide (-1.0%, -2.2 mmol/L, -2.5 mmol/L, -17.5%). Repaglinide was also associated with an increase in the AUC(60) and AUC(120) for insulin (+56%, +61%) and C-peptide (+41%, +36%). GLP-1, GIP, IL-6, ICAM-1 and E-selectin levels did not change in either group. No association was observed between GLP-1, GIP-1 and plasma markers of oxidative stress.Conclusion: Repaglinide is associated with improved postprandial glycaemic control via insulin and C-peptide release. We observed no direct effects of glibenclamide or repaglinide on plasma levels of GLP-1 or GIP. We observed no associations of GLP-1 and GIP with plasma markers of oxidative stress. (C) 2011 Elsevier Ireland Ltd. All rights reserved.
Background. Irritable bowel syndrome (IBS) is a chronic, difficult to treat condition. The efficacy of Aloe vera in treating IBS symptoms is not yet proven. The purpose of this study was to determine if Aloe vera is effective in improving quality of life. Methods. A multicentre, randomised, double-blind, cross-over placebo controlled study design. Patients were randomised to Aloe vera, wash-out, placebo or placebo, washout, Aloe vera. Each preparation (60 mL) was taken orally twice a day. Patient quality of life was measured using the Gastrointestinal Symptoms Rating Score, Irritable Bowel Syndrome Quality of Life, EuroQol and the Short-Form-12 at baseline and treatment periods 1 and 2. Results. A total of 110 patients were randomised, but only 47 completed all questionnaires and both study arms. Statistical analysis showed no difference between the placebo and Aloe vera treatment in quality of life. Discussion. This study was unable to show that Aloe vera was superior to placebo in improving quality of life. Drop outs and other confounding factors may have impacted on the power of the study to detect a clinically important difference. Conclusion. This study failed to find Aloe vera superior to placebo in improving quality of life proven Irritable Bowel Syndrome patients.
INTRODUCTION:Over 50% of children admitted with burns are aged under 3 years. US studies suggest that up to 26% of childhood burns are non-accidental, although UK reports are lower (1-16%).OBJECTIVES:To determine the social health outcomes of burned children as regards the number of children abused, neglected or "in need" before the age of 6 years compared with matched controls.METHODS:A retrospective matched cohort study. 145 children aged under 3 years admitted for burns in 1994-1997 were matched with controls for sex, age and enumeration district and followed up until 2003. Electronic routine databases provided study data on local authority care episodes and Social Services referrals by age 6 years.RESULTS:89.0% of cases had accidental burns and four cases (2.8%) had non-accidental burns. No case was attributed to neglect. By their sixth birthday cases were statistically more likely to have been referred to Social Services with 14 (9.7%) of the burned children having been abused or neglected versus two (1.4%) controls (95% CI 0.030 to 0.13, p = 0.004). Forty six (32%) cases versus 26 (18%) controls were defined as "in need" (95% CI 0.047 to 0.23, p = 0.006).CONCLUSION:Although most burns were deemed accidental, 2.8% were categorised as non-accidental at presentation. Almost a third of the burned children went on to be "in need". Children with a burn appear to be at higher risk of further abuse or neglect compared with controls. A burn therefore could be a surrogate marker indicating need for closer supervision and follow-up by professionals.
Hand injuries are the main cause of work-related disability in young adults. We have devised the Modified Hand Injury Scoring System to quantify hand, wrist and forearm injuries. This study aims to determine its value in predicting ability and time taken to return to work after such injury. Prospectively-assigned MHISS at presentation was compared with demographic, injury, employment and quality of life information 40–52 months after acute hand or forearm injury. MHISS score was the only variable investigated found to predict ability to return to work. Factors not associated included age at injury, occupation, hand injury side or dominance, main earner status and compensation-seeking. Median time to return to work increased from 30 to 760 days for Mild and Major MHISS categories respectively. Injury severity quantified using MHISS is an important determinant of return to work after hand or forearm injury. Only 60% of patients return to work following a Major injury and may take over a year to do so. Such information may allow the patient to make early informed personal financial and retraining decisions after their injury.
ObjectiveTo compare TVTTM, PelvicolTM and autologous fascial slings (AFSs).DesignA multicentre randomised control trial.SettingFour units in the UK.PopulationWomen requiring primary surgery for stress urinary incontinence (SUI).MethodsA total of 201 women with urodynamically proven stress incontinence were randomised into three groups and assessed at baseline, 6 weeks, 6 months and 1 year.Main outcome measureThe primary outcome was patient-reported improvement rates. Secondary outcomes included operative complications/time, intermittent self-catheterisation (ISC) and re-operation rates. The quality-of-life tools used were the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) and EuroQoL.ResultsFifty women had a PelvicolTM sling, 79 had AFSs and 72 had TVTTM. At 6 months the PelvicolTM arm had poorer improvement rates (73%) than TVTTM (92%)/AFS (95%); P = 0.003. At 1 year only 61% of the PelvicolTM slings remained as improved, versus 93% of TVTs and 90% of AFSs (P < 0.001). PelvicolTM has poorer dry rates (22%) than TVTTM (55%)/AFS (48%) (P = 0.001) at 1 year; hence, the PelvicolTM arm was suspended following interim analysis. There is no difference in the success rates between TVTTM and AFS. One in five women in the PelvicolTM arm had further surgery for SUI by 1 year, but none required further surgery in the other arms. AFS took longer to do (54 minutes versus 35 minutes for TVTTM/36 minutes for PelvicolTM) and had higher ISC rates (9.9 versus 0% PelvicolTM/TVTTM 1.5%). Hospital stay was shortest for TVTTM (2 days). Most BFLUTS domains showed improvement in all three arms. The improvement for women in the PelvicolTM arm, however, was less than for women in the other arms in several key domains.ConclusionsPelvicolTM cannot be recommended for the management of SUI. TVTTM does not have greater efficacy than AFS, but does utilise fewer resources.
The aim of this study was to assess the efficacy, side effects and drop out rate of extra-corporeal magnetic energy stimulation of pelvic floor muscles for urodynamic stress incontinence of urine in women. It was a prospective non-controlled study at 2 district general hospitals in South Wales. It included 48 female patients with urodynamic stress incontinence of urine, who had 16, twice weekly treatment sessions. Pad test was the primary outcome measure and continence diary, King's Health and EuroQol quality of life questionnaires, side effects and drop out were the secondary outcome measures. Assessment was made on recruitment, at the end of treatment sessions and at 3 months follow up. Thirty one patients completed treatment sessions and 27 attended for follow up at 3 months. There was no significant change in outcome measures at the end of treatment or at 3 months follow up. Side effects were encountered by 52.1% of patients and the drop out rate was 35.4%.
OBJECTIVES:To determine the efficacy and safety of botulinum toxin-B (BTX-B) in two groups of patients with urodynamically proven idiopathic detrusor overactivity (IDO) or neurogenic DO (NDO) refractory to conservative treatment.METHODS:This was a nonrandomized, prospective study. We diluted 5000 U of BTX-B in 20 mL of normal saline and injected it at 20 sites around the bladder, avoiding the trigone. The data collected at recruitment and 10 and 26 weeks postoperatively included number of incontinent episodes, frequency, and nocturia, King's Health Questionnaire score, and the urodynamic parameters of volume at the first overactive contraction and maximal cystometric capacity.RESULTS:A total of 25 patients were recruited, 20 with IDO and 5 with NDO. Only 7 patients, all with IDO, reported symptomatic improvement at the 10-week assessment. The symptoms had returned in these 7 patients at a median of 136 days (range 106 to 151) after injection. Of the remaining 20 patients, 16 (13 with IDO and 3 with NDO) thought an initial improvement had occurred but it had worn off or was wearing off by the first assessment. Two patients (both with NDO) reported no improvement.CONCLUSIONS:BTX-B had a limited duration of action, with most of its symptomatically beneficial effects wearing off by 10 weeks in most of our patients. The short duration of action for BTX-B suggests it is unlikely to gain widespread use in the treatment of DO.
Osteoporotic fractures in older people are a major and increasing public health problem. We examined the effect of vitamin D supplementation on fracture rate in people living in sheltered accommodation.
This randomised control trial compares full-length autologous slings (Group A: 81 women) with a modified “sling-on-a-string” (Group B: 84 women) technique for the treatment of stress urinary incontinence (SUI). Primary outcomes are quality of life (QoL) scores; Group A/Group B. The IIQ-7 scores decrease from 1.91/1.85 at baseline to 0.65/0.72 at 12 months and 0.85/0.92 at +5 years. The UDI-6 scores decrease from 1.85/1.61 at baseline to 0.66/0.62 at 12 months and 1.22/1.08 at +5 years. The incidence of SUI is 13% at 3 months but averages 53% at +5 years. Both techniques offer similar improvements. The shorter sling is quicker, less painful and with less hospital readmissions. The ‘sling-on-a-string’ technique is as effective as the standard technique with better short-term sequelae. The incidence of SUI post-autologous slings rises over the long term.
randomised, double blind, controlled trial of geriatric for power of fallers participants median age 84 years. Median length of stay days In a pre-selected sub-group, median admission vitamin D level Median study drug adherence with no significant difference between study groups p=0.71). Mann-Whitney or time to first fall between There were 205 first fractures in the intervention group during 2,846 person years of follow-up (annual fracture incidence of 7.15%), and 218 first fractures in controls over 2,860 person years of follow-up (annual incidence of 7.6%). The hazard ratio of 0.95 (95% CI: 0.8-1.2) for intervention compared to control was not statistically significant. Nor was it on a per protocol analysis, or if analysis was confined to osteoporotic fractures, hip fractures, or subgroups stratified by mobility, mental state or visual acuity. Serum 25(OH) vitamin D and parathyroid hormone (PTH) levels were measured in 102 people who had taken >5 doses. Mean serum 25(OH)D was 80nmol/l in the intervention group and 54nmo/l in controls; a statistically significant difference of 26nmol/l (95%CI: 16.5-35.5nmol/l). Mean PTH levels were 5.0pmol/l in the intervention arm, and 6.9pmol/l in controls; a statistically significant difference of 1.9pmol/l (95% CI: 0.3-3.5pmol/l). of oral vitamin D2 is not sufficient to affect fracture incidence among older people living in institutional care. Introduction We set out to identify clinical predictors of MRSA colonisation in patients admitted with hip fracture, and to show how these might be used to prevent surgical site infection. Methods In a prospective study we assessed 440 patients, sequentially admitted to the trauma unit with hip fracture. We documented pre-fracture residence, admissions to hospital during the previous year, type of surgery performed, and antibiotic prophylaxis given at the time of surgery. We screened patients for MRSA on admission. Results Mean age was 80.2 years. 5.2% (21/403) were colonised with MRSA; usually (61.9 %) nasally. 3.6 % of patients from home, 10.9 % from residential homes, and 17.4 % from nursing homes were colonised with MRSA. 80.9% of colonised patients had been admitted to the hospital within the previous year. The high prevalence of previous hospitalisation among people from care homes explained their higher rates of MRSA carriage. 'Hospital admission in the previous year' had a sensitivity of 81% for prediction of MRSA carriage, compared to just 48% for 'admission from a care home', and 85% for people with either one of these predictors. Conclusions Where a patient gives a history of hospitalisation within the previous year it is clearly sensible to consider the use of teicoplanin for perioperative prophylaxis. A similar approach to prophylaxis may be justified in people admitted from institutional care. Introduction As an indicator of mobility the sit-to-stand movement has been assessed clinically but has limitations. The sit-to-walk (STW) movement is a more challenging everyday movement that may reveal early changes in mobility. This study aimed to test the validity of a clinical tool to measure time events in the STW movement. Methods Fifty six subjects were recruited from three populations, Young, (n=20, mean age 33.2+/-8), Elderly (n=18, mean age 70.3+/-5.4) and Elderly at risk of falling (EARF), (n=18, mean age 79.6+/-7.5). Ethical approval was granted from North Glasgow University Hospitals NHS Trust local research ethics committee. Duration of three phases of movement were recorded simultaneously from a three dimensional motion analysis system (which acted as the "gold standard") and four switches located on the seat and ground during the STW movement for each subject. There were few constraints placed on the movement. Results The EARF were significantly (p<0.001) slower in all phases of the movement, the elderly were significantly slower than the young in the single stance phase (p=0.049). The measurement techniques were very similar (ICC scores ranged from 0.94 to 1.00). Conclusions Differences between the groups suggest a possible role for this movement in mobility tests. The difference between young and elderly subjects indicate subtle age related changes which could be used to detect early mobility problems. A clinical method to measure temporal variables was validated. treatment are warranted in these homes, where CAPE score may predict low BMD.