Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 as adjuvants to improve evolution of pharyngitis/tonsillitis in children: 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.

Download Full-text

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

Download Full-text

Primary care randomised controlled trial of a tailored interactive website for the self-management of respiratory infections (Internet Doctor)

BMJ Open ◽

10.1136/bmjopen-2015-009769 ◽

2016 ◽

Vol 6 (4) ◽

pp. e009769 ◽

Cited By ~ 20

Author(s):

Paul Little ◽

Beth Stuart ◽

Panayiota Andreou ◽

Lisa McDermott ◽

Judith Joseph ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Respiratory Infections ◽

Controlled Trial ◽

The Self ◽

Self Management ◽

Randomised Controlled

Download Full-text

Effect of steroids on inflammatory markers and clinical parameters in congenital open heart surgery: a randomised controlled trial

Cardiology in the Young ◽

10.1017/s1047951115000566 ◽

2015 ◽

Vol 26 (3) ◽

pp. 506-515 ◽

Cited By ~ 13

Author(s):

Muhammad M. Amanullah ◽

Mohammad Hamid ◽

Hashim M. Hanif ◽

Marium Muzaffar ◽

Maria T. Siddiqui ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Interleukin 6 ◽

Heart Surgery ◽

Controlled Trial ◽

Open Heart Surgery ◽

Interleukin 10 ◽

Clinical Parameters ◽

Open Heart ◽

Necrosis Factor Alpha ◽

Randomised Controlled

AbstractBackgroundCardiopulmonary bypass is associated with systemic inflammatory response. Steroids suppress this response, although the therapeutic evidence remains controversial. We hypothesised that intravenous steroids in children undergoing open-heart surgery would decrease inflammation leading to better early post-operative outcomes. We conducted a randomised controlled trial to evaluate the trends in the levels of immunomodulators and their effects on clinical parameters.ObjectiveTo assess the effects of intravenous steroids on early post-operative inflammatory markers and clinical parameters in children undergoing open-heart surgery.Materials and methodsA randomised controlled trial involving 152 patients, from one month up to 18 years of age, who underwent open-heart surgery for congenital heart disease from April 2010–2012 was carried out. Patients were randomised and administered either three scheduled intravenous pulse doses of dexamethasone (1 mg/kg) or placebo. Blood samples were drawn at four time intervals and serum levels of inflammatory cytokines – Interleukin-6, 8, 10, 18, and tumour necrosis factor-alpha – were measured. Clinical parameters were also assessed.ResultsBlood cytokine levels were compared between the dexamethasone (n=65) and placebo (n=64) groups. Interleukin-6 levels were lower at 6 and 24 hours post-operatively (p<0.001), and Interleukin-10 levels were higher 6 hours post-operatively (p<0.001) in the steroid group. Interleukin-8, 18, and tumour necrosis factor-alpha levels did not differ between the groups at any time intervals. The clinical parameters were similar in both the groups.ConclusionDexamethasone caused quantitative suppression of Interleukin-6 and increased Interleukin-10 activation, contributing to reduced immunopathology, but it did not translate into clinical benefit in the short term.

Download Full-text

Comparing treatment effects of a convenient vibratory positional device to CPAP in positional OSA: a crossover randomised controlled trial

Thorax ◽

10.1136/thoraxjnl-2019-213547 ◽

2020 ◽

Vol 75 (4) ◽

pp. 331-337 ◽

Cited By ~ 2

Author(s):

Yingjuan Mok ◽

Alvin Tan ◽

Pon Poh Hsu ◽

Audrey Seow ◽

Yiong Huak Chan ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Sleep Apnoea ◽

Treatment Preference ◽

Patient Treatment ◽

Published Data ◽

Sleep Study ◽

Obstructive Sleep ◽

Device Use ◽

Randomised Controlled

ObjectivesUp to 77% of patients with obstructive sleep apnoea (OSA) have positional OSA (POSA) but traditional positional therapy (PT) methods have failed as they were poorly tolerated. New convenient vibratory PT devices have been invented but while recent studies suggest high treatment efficacy and adherence, there are no published data comparing these devices directly with continuous positive airway pressure (CPAP). Our objective is to evaluate if a convenient vibratory PT device is non-inferior to CPAP in POSA treatment.MethodsIn this crossover randomised controlled trial, we enrolled patients with POSA with significant daytime sleepiness (Epworth Sleepiness Scale (ESS)≥10). POSA diagnosis was based on: (1) total Apnoea/Hypopnoea Index (AHI)>10/hour and non-supine AHI<10/hour (2) supine AHI≥2 × non-supine AHI. Patients used their initial allocated devices (PT or CPAP) for 8 weeks before crossing to the alternative intervention after a 1 week washout. The primary aim is to measure changes in ESS between the two treatments. Secondary outcomes include sleep study parameters and patient treatment preference (ClinicalTrials.gov: NCT03125512).Results40 patients completed the trial between April 2017 and December 2018. Difference in ESS after 8 weeks of device use (PT minus CPAP) was 2.0 (95% CI 0.68 to 3.32), exceeding our predetermined non-inferiority margin of 1.5. AHI on CPAP was lower than with PT (4.0±3.2 vs 13.0±13.8 events/hour, respectively, p=0.001), although both were lower than at baseline. Time spent supine was significantly lower with PT than CPAP (p<0.001). 60% of patients preferred CPAP, 20% preferred PT, while 20% preferred neither device.ConclusionsThe non-inferiority ESS endpoint for PT compared with CPAP was not met and the results were inconclusive. Future trials with larger sample sizes or in less symptomatic patients are warranted to provide further insight into the role of these new vibratory PT devices.

Download Full-text