O020 CONSUMPTION OF A FERMENTED DAIRY PRODUCT CONTAINING THE PROBIOTIC LACTOBACILLUS CASEI DN-114 001 REDUCES THE DURATION OF RESPIRATORY INFECTIONS IN THE ELDERLY IN A RANDOMISED CONTROLLED TRIAL

Pharyngitis and tonsillitis are the most common acute respiratory infections (ARIs) in children aged ≤5 years. The analysis of published data showed that some probiotics could decrease the frequency and number of days with ARIs. This study evaluated the safety and efficacy of Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 to reduce the duration and severity of ARI symptoms. This randomised controlled trial included children aged from 6 months to 5 years, with pharyngitis or tonsillitis, who were randomised to receive a probiotic product containing L. reuteri ATCC PTA 5289 and L. reuteri DSM 17938 or placebo, as drops, ingested orally for 10 days as adjuvants to the use of non-steroidal anti-inflammatory drugs. The main outcomes were the duration and severity of ARI symptoms. The secondary outcomes were changes in salivary immunoglobulin A and inflammatory biomarkers. There was no fever on day 2 and subsequent days in the L. reuteri group (37.3 ±0.5 °C vs 38.6±0.3 °C, P<0.05). Beginning on day 3, the severity of sore throat (5±0.9 vs 8±1.2, P<0.05) was lower in the L. reuteri group. Significant differences in the days with runny nose, nasal congestion, days of non-programmed visits to the medical office or emergency department, levels in tumoral necrosis factor-alpha (TNF-alpha) and related costs of treatment were observed in the L. reuteri group. The frequency of adverse events was similar between the groups. Therefore, L. reuteri ATCC PTA 5289 combined with L. reuteri DSM 17938 is a safe and effective adjunct to reduce the symptoms of pharyngitis or tonsillitis in children.

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Documentation-based clinical decision support to improve antibiotic prescribing for acute respiratory infections in primary care: a cluster randomised controlled trial

Journal of Innovation in Health Informatics ◽

10.14236/jhi.v17i4.742 ◽

2009 ◽

Vol 17 (4) ◽

pp. 231-240 ◽

Cited By ~ 6

Author(s):

Jeffrey Linder ◽

Jeffrey Schnipper ◽

Ruslana Tsurikova ◽

Tony Yu ◽

Lynn Volk ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Respiratory Infections ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Clinical Decision ◽

Antibiotic Prescribing ◽

Acute Respiratory Infections ◽

Cluster Randomised ◽

Randomised Controlled

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Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial

Gut ◽

10.1136/gutjnl-2020-321585 ◽

2020 ◽

pp. gutjnl-2020-321585 ◽

Cited By ~ 3

Author(s):

Suzanne E Mahady ◽

Karen L Margolis ◽

Andrew Chan ◽

Galina Polekhina ◽

Robyn L Woods ◽

...

Keyword(s):

Risk Factors ◽

Randomised Controlled Trial ◽

Absolute Risk ◽

Controlled Trial ◽

Bleeding Risk ◽

The Elderly ◽

Community Dwelling ◽

Gi Bleeding ◽

Prophylactic Use ◽

Randomised Controlled

ObjectiveThere is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial.DesignData were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010–2017 (‘ASPirin in Reducing Events in the Elderly (ASPREE)’, n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm.ResultsOver a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.ConclusionAspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin.Trial registration numberASPREE. NCT01038583.

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P1927A European randomised controlled trial for m-health guided cardiac rehabilitation in the elderly; results of the EU-CaRE RCT study

European Heart Journal ◽

10.1093/eurheartj/ehz748.0674 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

E P De Kluiver ◽

A E Van Der Velde ◽

E P Meindersma ◽

L F Prins ◽

M Wilhelm ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Cardiac Rehabilitation ◽

Controlled Trial ◽

The Elderly ◽

Lv Function ◽

Random Factor ◽

Index Event ◽

The Difference ◽

Randomised Controlled ◽

The Eu

Abstract Introduction Knowledge about effectiveness of cardiac rehabilitation (CR) in the elderly is limited. Participation rates in supervised CR are consistently lower in the elderly and innovative interventions are needed. The EU has granted a CR study project; a randomised controlled trial conducted in 5 European countries, investigating the effectiveness of mobile telemonitoring guided CR (mCR) in elderly cardiac patients who declined regular CR. Methods Patients ≥65 years with indication for CR who declined regular CR were eligible for inclusion. Patients were randomised between regular care (without CR) and a 6-month mCR programme: dedicated programmed smartphone, heartrate monitoring (target HR zones) and coaching. The primary endpoint is the difference in VO2peak between 6-months follow-up and baseline. Results Between 2015 and 2018 179 patients were included. Baseline characteristics between groups (table 1) did not differ significantly, except for hypertension. The difference in VO2peak was significantly better in the mCR group (table 1). After correction (mixed linear model) for baseline VO2 peak (fixed factor) and centre (random factor) this difference remained significant. Mean number of registered activity sessions was 4.79 (95% CI; 4.07–5.50) per patient per week. Table 1. Baseline and primary outcome parameters Baseline Control Programme (n=90) mCR Programme (n=89) P-value Gender (m/f) 76/14 69/20 0.238 Age (mean±SD) 73.57±5.46 72.38±5.37 0.121 Diabetes 15 (16.7%) 23 (25.8%) 0.133 Hypertension 60 (66.7%) 73 (82.0%) 0.019* Hypercholesteremia 71 (78.3%) 74 (83.1%) 0.468 Normal LV-function 48/89 (53.9%) 53/89 (59.6%) 0.497 Index event (CABG/Valve/PCI/none) 0.735 Cardiac history prior to index event 48/89 (53.9%) 53/89 (59.6%) 0.702 Non cardiac comorbidity 40 (44.4%) 44 (49.4%) 0.503 Results Baseline VO2peak (ml/kg/min) (95% CI) 19.83 (18.65–21.01) 18.78 (18.67–19.89) 0.191 Delta VO2peak at 6 months (ml/kg/min) (95% CI) 0.20 4 (−0.34–0.83) 1.62 (0.86–2.39) 0.005* Corrected delta VO2peak at 6 months (ml/kg/min) 0.50 (−1.04–2.04) 1.65 (0.11–3.2) 0.015* *Significant. Conclusions The application of mCR in elderly patients who declined regular CR results in a better physical condition after 6 months. Compliance to mCR was excellent. Acknowledgement/Funding European Union's Horizon 2020 research and innovation programme under grant agreement number 634439, and funding from the Swiss Government.

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