scholarly journals Efficacy of Lactobacillus Administration in School-Age Children with Asthma: A Randomized, Placebo-Controlled Trial

Nutrients ◽  
2018 ◽  
Vol 10 (11) ◽  
pp. 1678 ◽  
Author(s):  
Chian-Feng Huang ◽  
Wei-Chu Chie ◽  
I-Jen Wang

Probiotics may have immunomodulatory effects. However, these effects in asthma remain unclear and warrant clinical trials. Here, we evaluated the effects of Lactobacillus paracasei (LP), Lactobacillus fermentum (LF), and their combination (LP + LF) on the clinical severity, immune biomarkers, and quality of life in children with asthma. This double-blind, prospective, randomized, placebo-controlled trial included 160 children with asthma aged 6–18 years (trial number: NCT01635738), randomized to receive LP, LF, LP + LF, or a placebo for 3 months. Their Global Initiative for Asthma–based asthma severity, Childhood Asthma Control Test (C-ACT) scores, Pediatric Asthma Severity Scores, Pediatric Asthma Quality of Life Questionnaire scores, peak expiratory flow rates (PEFRs), medication use, the levels of immune biomarkers (immunoglobulin E (IgE), interferon γ, interleukin 4, and tumor necrosis factor α) at different visits, and the associated changes were evaluated. Compared with the placebo group by generalized estimating equation model, children receiving LP, LF, and LP + LF had lower asthma severity (p = 0.024, 0.038, and 0.007, respectively) but higher C-ACT scores (p = 0.005, < 0.001, and < 0.001, respectively). The LP + LF group demonstrated increased PEFR (p < 0.01) and decreased IgE levels (p < 0.05). LP, LF, or their combination (LP + LF) can aid clinical improvement in children with asthma.

2020 ◽  
Vol 77 (8) ◽  
pp. 859-865
Author(s):  
Slavica Konevic ◽  
Nela Djonovic ◽  
Dusan Djuric ◽  
Ljiljana Markovic-Denic ◽  
Dobrila Vasic ◽  
...  

Background/Aim. Asthma is the most common chronic disease in children and adolescents and has shown an apparent increase in incidence in recent years. The first purpose of the study was to evaluate the influence of education about proper use of inhalers on quality of life in children with asthma. Secondly, we aimed to understand which aspects of quality of life in children with asthma can be significantly improved after education and to identify factors that may affect the level of that improvement. Methods. In this prospective, before-and-after interventional study, a total of 147 children with asthma were enrolled. The Pediatric Asthma Quality of Life Questionnaire (PAQLQ) was used to measure the functional problems that are most troublesome to children with asthma. We used the Asthma Control Test (ACT), based on a series of question about symptoms and daily functioning, to identify patients with poorly controlled asthma. Forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF) were also determined. Trained educators estimated patients? inhaler technique and collected questionnaire information. Results. Multivariate analysis of covariance indicated significant differences between PAQLQ and ACT scores which all were significantly higher after education about proper use of inhalers (p < 0.001). A number of children demonstrating a correct inhalation technique improved from 28 (19%) to 127 (86.4%) (p < 0.001). Asthma severity accounted for the largest proportion of variability PAQLQ and ACT scores (38.4%). Conclusion. Inhaler technique improvement contributes to better asthma control in children with asthma rather than to their quality of life. Asthma severity proved to be a major contributor to variations in PAQLQ and ACT scores and significant obstacle for quality of life improvement in children with asthma.


2020 ◽  
Vol 11 ◽  
pp. 215013272096127
Author(s):  
Monika Battula ◽  
Preethi Arunashekar ◽  
Vinoth Ponnurangam Nagarajan

Objectives: The study aims to assess the quality of life (QOL) in newly diagnosed asthmatic children and their caregivers before and after treatment using mini pediatric asthma quality of life questionnaire (PAQLQ) and pediatric asthma caregivers quality of life questionnaire (PACQLQ) and to compare their quality of life with ACS (asthma clinical severity score). Materials and Methods: This prospective study was done among 99 children and their caregivers, who were interviewed using mini PAQLQ and PACQLQ on 2 occasions: at the time of inclusion and 4 weeks after treatment. During their clinic visit, asthma clinical severity scoring was done, and children were treated according to GINA (Global Initiative for Asthma). Results: After 4 weeks of treatment, there was a significant change in all domains of mini PAQLQ ( P < .001) and PACQLQ ( P < .001). In children, the change in the emotional domain after treatment was minimal when compared to other domains. When ACS was compared with mini PAQLQ and PACQLQ, children with well-controlled asthma had a better quality of life than partially-controlled asthmatic children ( P < .001) and there wasn’t a significant change in the quality of life of the caregivers after treatment ( P = .321) Conclusion: During treatment, QOL of newly diagnosed asthmatic children and their caregivers showed significant improvement but children lagged in their emotional domain. Despite medical intervention, these children also require psychological support and counseling. Also, caregivers didn’t perceive a change in their QOL when compared with ACS and it indicates that parent’s and child health-related quality of life should be taken as independent dimensions.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Hongyu Yue ◽  
Shuang Zhou ◽  
Huangan Wu ◽  
Xuan Yin ◽  
Shanshan Li ◽  
...  

Abstract Background Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%. Discussion This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068


Thorax ◽  
2019 ◽  
Vol 74 (4) ◽  
pp. 354-361 ◽  
Author(s):  
Fraser Brims ◽  
Samal Gunatilake ◽  
Iain Lawrie ◽  
Laura Marshall ◽  
Carole Fogg ◽  
...  

PurposeMalignant pleural mesothelioma (MPM) has a high symptom burden and poor survival. Evidence from other cancer types suggests some benefit in health-related quality of life (HRQoL) with early specialist palliative care (SPC) integrated with oncological services, but the certainty of evidence is low.MethodsWe performed a multicentre, randomised, parallel group controlled trial comparing early referral to SPC versus standard care across 19 hospital sites in the UK and one large site in Western Australia. Participants had newly diagnosed MPM; main carers were additionally recruited. Intervention: review by SPC within 3 weeks of allocation and every 4 weeks throughout the study. HRQoL was assessed at baseline and every 4 weeks with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30. Primary outcome: change in EORTC C30 Global Health Status 12 weeks after randomisation.ResultsBetween April 2014 and October 2016, 174 participants were randomised. There was no significant between group difference in HRQoL score at 12 weeks (mean difference 1.8 (95% CI −4.9 to 8.5; p=0.59)). HRQoL did not differ at 24 weeks (mean difference −2.0 (95% CI −8.6 to 4.6; p=0.54)). There was no difference in depression/anxiety scores at 12 weeks or 24 weeks. In carers, there was no difference in HRQoL or mood at 12 weeks or 24 weeks, although there was a consistent preference for care, favouring the intervention arm.ConclusionThere is no role for routine referral to SPC soon after diagnosis of MPM for patients who are cared for in centres with good access to SPC when required.Trial registration numberISRCTN18955704.


BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031339 ◽  
Author(s):  
Michael Schaefer ◽  
Paul Enck

IntroductionSeveral studies suggest that gut microbiota may play an important role in allergic diseases. The present trial aims to examine effects of the probioticEnterococcus faecalison symptoms of allergic rhinitis in patients. Effects of this probiotic on the immune system have been reported by several studies, but the majority of the previous trials were animal studies. In addition, it is well known that symptoms in allergic rhinitis are prone to exhibit high placebo responses. Moreover, recent studies report that even placebos without deception (open-label placebos) are highly effective in reducing symptoms of allergic rhinitis. Our study design combines both new approaches to assess effects on allergic symptoms in patients. The objective of this study is to compare the effects of a probiotic treatment (E. faecalis) with effects seen by open-label placebo, concealed placebo treatment and no treatment control.Methods and analysisA total of 120 patients with allergic rhinitis will be randomly assigned to one of four different groups: a double-blind probiotic/placebo group (groups 1 and 2), an open-label placebo group (group 3) and a no-treatment group (group 4) to control for spontaneous variation of symptoms. The primary outcome is the evaluation of allergic symptoms using the Combined Symptoms Medication Score. Furthermore, health-related quality of life is examined (Rhinitis Quality of Life Questionnaire). Secondary outcomes include a visual analogue scale on allergic burden and a second quality of life questionnaire. This report describes the study design of the randomised controlled trial.Ethics and disseminationThe study design was approved by the ethical committee of the UKT Department of Psychosomatic Medicine and Psychotherapy, Tübingen, Germany. The trial is registered at the German Clinical Trials Register (www.drks.de, DRKS00015804). The trial results will be published in peer-reviewed journals and at conferences.Trial registration numberGerman Clinical Trials Register (www.drks.de, DRKS00015804); Pre-results.


2012 ◽  
Vol 27 (2) ◽  
pp. 133-141 ◽  
Author(s):  
Venkatesan Prem ◽  
Ramesh Chandra Sahoo ◽  
Prabha Adhikari

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.


2016 ◽  
Vol 29 (3) ◽  
pp. 137-142 ◽  
Author(s):  
Rohan Mahabaleshwarkar ◽  
Yhenneko J. Taylor ◽  
Hazel Tapp ◽  
Michael F. Dulin

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