CAN A PREBIOTIC FORMULATION REDUCE FRAILTY LEVELS IN OLDER PEOPLE?

2018 ◽  
pp. 1-5
Author(s):  
O. Theou ◽  
K. Jayanama ◽  
J. Fernández-Garrido ◽  
C. Buigues ◽  
L. Pruimboom ◽  
...  
Keyword(s):  
Placebo Group ◽  
Older People ◽  
Frailty Index ◽  
Intervention Group ◽  
Secondary Analysis ◽  
Nursing Home Residents ◽  
Double Blind ◽  
Standardized Response Mean ◽  
Cohen’S D ◽  
Cohen's D

Objective: The purpose of this study was to examine whether a prebiotic formulation reduces frailty index (FI) levels in older people. Design: We conducted secondary analysis of a placebo-controlled, randomized, double-blind design study. Setting/Participants: The study included non-demented people over the age of 65 who were living in nursing homes and were able to walk. Fifty participants completed the study (75.3±7.3 years, 70% females). Intervention: Participants were randomly assigned to either a group who received daily Darmocare Pre® (inulin and fructooligosaccharides) for 13 weeks or a placebo group (maltodextrin). Measurement: The primary outcome in this secondary analysis was change in level of a 62-item FI compared to baseline. Results: At the 13-week follow-up, the placebo group had higher FI levels (preFI 0.23±0.11, postFI 0.24±0.12, p=0.012) and the intervention group had lower FI levels (preFI 0.22±0.09, postFI 0.20±0.08, p<0.001). There was an average increase of 0.01±0.01 in the FI score in the placebo group (0.4 deficits; Cohen’s d 0.61; standardized response mean 0.59) and an average reduction of 0.02±0.02 in the intervention group (1.1 deficits; Cohen’s d -1.35; standardized response mean -1.16). Among the 28 participants in the intervention group, FI levels were reduced for 25 people; five of them had an FI reduction greater than 0.03. The moderately/severely frail participants (FI >0.3, N=5) had the greatest reduction in their FI (0.04±0.01). Conclusion: A prebiotic intervention can reduce frailty levels in nursing home residents especially in those with higher levels of frailty.

Zao Ren An Shen capsule for insomnia: A double-blind, randomized, placebo-controlled trial

SLEEP ◽  
2021 ◽  
Author(s):  
Yoann Birling ◽  
Xiaoshu Zhu ◽  
Nicole Avard ◽  
Caterina Tannous ◽  
Paul P Fahey ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Adverse Events ◽  
Chinese Herbal Medicine ◽  
Controlled Trial ◽  
Double Blind ◽  
Subjective Sleep ◽  
Chinese Herbal ◽  
Cohen’S D ◽  
Cohen's D ◽  
Insomnia Severity

Abstract Study Objectives The aim of this study was to test the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for the treatment of insomnia. Methods We conducted a double-blind randomized placebo-controlled trial. After a one-week placebo run-in, a total of 85 people with insomnia were randomly allocated to receive ZRAS or placebo for four weeks. The primary outcomes were insomnia severity assessed with the Insomnia Severity Index (ISI) and the number of participants with adverse events. Secondary outcomes included objective and subjective sleep parameters, psychological status, fatigue level, quality of life, acceptability, and tolerability. Results A non-significant (p &gt; 0.05) difference of 0.7 points in ISI in favor of ZRAS capsule was found at the end of the treatment. The number of participants with adverse events was not significantly different (p &gt; 0.05) between the two groups. Except for subjective sleep onset latency, which had a non-significant (p &gt; 0.05) medium effect (Cohen’s d = 0.5), the effects in secondary efficacy outcomes were all small (Cohen’s d &lt; 0.4) and non-significant (p &gt; 0.05). The acceptability and tolerability were high in the active group. Conclusions ZRAS capsule is safe, acceptable, and tolerable, yet not more effective than placebo in the treatment of insomnia. As previous evidence showed that Chinese herbal medicine was effective for insomnia, these results may be explained by the dose of the product, which was lower than the dose generally used in the clinic.

CAN AN INTERVENTION WITH TESTOSTERONE AND NUTRITIONAL SUPPLEMENT IMPROVE THE FRAILTY LEVEL OF UNDER-NOURISHED OLDER PEOPLE?

2016 ◽  
pp. 1-6
Author(s):  
O. THEOU ◽  
L. WIJEYARATNE ◽  
C. PIANTADOSI ◽  
K. LANGE ◽  
V. NAGANATHAN ◽  
...  
Keyword(s):  
Older People ◽  
Controlled Trial ◽  
Frailty Index ◽  
Intervention Group ◽  
Nutritional Supplement ◽  
Community Dwelling ◽  
Self Report ◽  
Control Group ◽  
Testosterone Undecanoate ◽  
High Calorie

Objective: To examine whether a testosterone and a high calorie nutritional supplement intervention can reduce frailty scores in undernourished older people using multiple frailty tools. Design: Randomized controlled trial. Setting/Participants: 53 community-dwelling, undernourished men and women aged >65 years from South Australia, Victoria and New South Wales. Intervention: Intervention group received oral testosterone undecanoate and a high calorie supplement (2108-2416 kJ/day) whereas the control group received placebo testosterone and low calorie supplement (142-191 kJ/day). Measurements: Frailty was operationalized using three frailty indices (FI-lab, FI-self-report, FI-combined) and the frailty phenotype. Results: There were no significant differences in changes in frailty scores at either 6 or 12 months follow up between the two treatment groups for all scales. Participants at the intervention group were 4.8 times more likely to improve their FI-combined score at both time points compared to the placebo group. Conclusion: A testosterone and a high calorie nutritional supplement intervention did not improve the frailty levels of under-nourished older people. Even so, when frailty was measured using a frailty index combining self-reported and lab data we found that participants who received the intervention were more likely to show persistent improvement in their frailty scores.

scholarly journals Effect of oral glucose administration on pain in neonates undergoing peripheral blood collection

2007 ◽  
Vol 47 (4) ◽  
pp. 185
Author(s):  
Effa Triani ◽  
Munar Lubis ◽  
Chairoel Yoel
Keyword(s):  
Placebo Group ◽  
Peripheral Blood ◽  
Intervention Group ◽  
Mean Difference ◽  
Blood Sampling ◽  
Blood Collection ◽  
Oral Glucose ◽  
Time Data ◽  
Double Blind ◽  
Glucose Administration

Background Peripheral blood sampling with heel sticks in neonatescould represent minor invasive procedure which generates pain.The oral glucose administration can reduce the pain in neonatesduring this procedure.Objective To compare the pain sense after oral glucoseadministration or placebo during peripheral blood sampling withheel sticks in neonates.Methods A double blind randomized clinical trial study wasconducted from January to March 2004 in three teaching hospitalsin Medan. The population of this study was divided into twogroups (glucose and placebo) and each group consisted of 32neonates. The intervention group got 1 ml of 40% glucose andthe placebo group got 1 ml of sterile water. Blood sample wastaken with sterile hemolet with heel sticks from healthy atermneonates. The pain was measured using NIPS score and measuredin first 30 seconds after heel sticking. The heart and respiratoryrate measurement was done before and during the interventionand we also counted crying time. Data were analyzed with studentt–test.Results The significant mean difference of NIPS score in glucosegroup was 2.22 (SD 0.83) vs 4.72 (SD 0.96) in placebo group(P<0.0001). There was significant mean difference of crying time,i.e. 0.16 (SD 0.37) in glucose group vs 2.05 (SD 0.77) in placebogroup (P<0.0001). There was significant differences of heart ratebefore and during heel sticking in both groups.Conclusion There were some differences of pain sense in neonateswho received 40% glucose compared to those who received sterilewater during peripheral blood sampling.

scholarly journals Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a m ulticenter, placebo controlled, double blind, randomized clinical trial

2020 ◽  
Author(s):  
Carlos Torrecilla ◽  
Jaime Fernández-Concha ◽  
José R. Cansino ◽  
Juan A. Mainez ◽  
José H. Amón ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ph Control ◽  
Public Hospitals ◽  
Urine Ph ◽  
Double Blind ◽  
Double J Stent ◽  
Oral Composition

Abstract Background: Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks.Participants, design and intervention: A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. Outcome measurements and statistical analysis: The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 – none; 3 – global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events.Results: The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the intervention group and 18.91 (102.27) in the placebo group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups.Conclusions: Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation.Trial registration: This trial was registered at www.clinicaltrials.gov under the name “Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent” with date 2nd November 2017, code NCT03343275, and URL:https://clinicaltrials.gov/ct2/show/record/NCT03343275?term=NCT03343275&draw=2&rank=1

scholarly journals Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a m ulticenter, placebo controlled, double blind, randomized clinical trial

2020 ◽  
Author(s):  
Carlos Torrecilla ◽  
Jaime Fernández-Concha ◽  
José R. Cansino ◽  
Juan A. Mainez ◽  
José H. Amón ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ph Control ◽  
Public Hospitals ◽  
Urine Ph ◽  
Double Blind ◽  
Double J Stent ◽  
Oral Composition

Abstract Background: Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks.Methods: A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 – none; 3 – global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events.Results: The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91 (102.27) in the intervention group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups. Conclusions: Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation.Trial registration: This trial was registered at www.clinicaltrials.gov under the name “Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent” with date 2nd November 2017, code NCT03343275, and URL:https://clinicaltrials.gov/ct2/show/record/NCT03343275?term=NCT03343275&draw=2&rank=1

scholarly journals Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a m ulticenter, placebo controlled, double blind, randomized clinical trial

2020 ◽  
Author(s):  
Carlos Torrecilla ◽  
Jaime Fernández-Concha ◽  
José R. Cansino ◽  
Juan A. Mainez ◽  
José H. Amón ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ph Control ◽  
Public Hospitals ◽  
Urine Ph ◽  
Double Blind ◽  
Double J Stent ◽  
Oral Composition

Abstract Background: Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks. Methods: A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 – none; 3 – global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events. Results: The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91 (102.27) in the intervention group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups. Conclusions: Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation. Trial registration: This trial was registered at www.clinicaltrials.gov under the name “Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent” with date 2nd November 2017, code NCT03343275, and URL: https://clinicaltrials.gov/ct2/show/record/NCT03343275?term=NCT03343275&draw=2&rank=1 Keywords: double J stent; encrustation; nutraceutical; L-methionine; phytin; pH.

scholarly journals Effect of Continues Midwifery Support in Labor on the Childbirth Experience and Self-Esteem of Primipara Women: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Nasrin Soleimani ◽  
Mansoureh Refaei ◽  
Farideh Kazemi
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Esteem ◽  
Control Group ◽  
Randomized Controlled ◽  
Childbirth Experience ◽  
Cohen’S D ◽  
The Mean ◽  
Cohen's D

Abstract Background: The World Health Organization states that mothers during labor and delivery should be supported by people with whom they feel comfortable, because one of the non-pharmacological methods of relieving labor pain is the continued support of midwives in labor. The primary objectives of this study were to determine the effect of continuous midwifery support in labor on delivery experience and self-esteem of nulliparous women 6 weeks after delivery.Methods: This randomized controlled trial was performed in 2021 on 70 pregnant women admitted to the delivery ward who met the inclusion criteria. Participants were randomly allocated to two groups through balanced block randomization with a block size of 4. Participants completed a demographic and midwifery information questionnaire before entering the study. In the intervention group, in addition to routine labor care, the researcher was present at the mother's bedside and was present with the mother continuously throughout the labor and up to 2 hours after delivery and provided the necessary support. The control group received only routine labor and postpartum care. Six weeks after delivery, participants in both groups were contacted to complete the CEQ and Rosenberg self-esteem questionnaires. Finally, data were collected and analyzed. Significance level was considered 0.05.Results: By controlling the effect of duration of the first and second stages of labor as potential confounders, the mean (sd) of childbirth experience 6 weeks after delivery was 70.92 (7.07) in the intervention group and 59.69 (7.08) in the control group, and this difference was statistically significant (p <0.001). The amount of effect size indicates a very strong effect of the intervention on improving the childbirth experience (Cohen’s d = 1.69; 95% CI: 1.12, 2.26). Comparison of the mean of maternal self-esteem showed that this rate in the intervention group was 2 scores higher than the control group and this difference was statistically significant (p = 0.05). Cohen's d indicates the average effect of intervention on mothers' self-esteem score (Cohen's d = 0.56; 95% CI: 0.06, 1.05).Conclusions: Continuous support of the midwife in labor and up to 2 hours after delivery can lead to a better childbirth experience and increase the mother's self-esteem up to 6 weeks after delivery.Trial registration: IRCT ID: IRCT20201102049233N1, First Registration date: 2021-06-04

Effects of synbiotic supplementation on the components of metabolic syndrome in military personnel: a double-blind randomised controlled trial

2020 ◽  
pp. bmjmilitary-2020-001459
Author(s):  
Karim Parastouei ◽  
S Saeidipoor ◽  
M Sepandi ◽  
S Abbaszadeh ◽  
M Taghdir
Keyword(s):  
Metabolic Syndrome ◽  
Lipid Profile ◽  
Military Personnel ◽  
Fasting Blood Glucose ◽  
Double Blind ◽  
Cohen’S D ◽  
Synbiotic Supplementation ◽  
Randomised Controlled ◽  
Cohen's D ◽  
The Military

IntroductionMetabolic syndrome comprises a set of risk factors for chronic diseases including abdominal obesity, increased fasting blood glucose (FBG), altered lipid profile and elevated blood pressure (BP). Due to high prevalence of metabolic syndrome and its complications in the military personnel, the relevant problems should be identified and controlled. Therefore, the present study was conducted to determine the effect of synbiotic supplements on the components of metabolic syndrome in the military personnel with metabolic syndrome.MethodologySixty military personnel with metabolic syndrome were included in this double-blind randomised controlled clinical trial. During the intervention, they were asked to consume one capsule of synbiotic supplement or placebo per day for 8 weeks. Body Mass Index (BMI), waist circumference, BP, FBG and lipid profile were measured before and after the intervention.ResultsThe results of the study showed that the synbiotic supplementation had a large significant adjusted effect on the BMI (Cohen’s d=0.82 (95% CI 0.29 to 1.34)). It also had a medium significant adjusted effect on the FBG (Cohen’s d=0.52 (95% CI 0.004 to 1.03)) as well as triglyceride (Cohen’s d=0.65 (95% CI 0.13 to 1.17)).ConclusionFindings of the study revealed that synbiotic supplementation may lead to a significant improvement in the BMI, triglyceride and FBG levels in the military personnel. Thus, consumption of synbiotic supplements is recommended as an adjuvant therapy in the military personnel with metabolic syndrome.

Liberation from Ventilation: An Intervention Study in Public Adult Intensive Care Units in the Eastern Cape Province of South Africa

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Benedict Raphael Oamen ◽  
Portia Jordan ◽  
Wilma Ten Ham-Baloyi ◽  
Emmanuel Zamo Hlungwane
Keyword(s):  
Critical Care ◽  
Intensive Care ◽  
Educational Intervention ◽  
Intervention Study ◽  
Intervention Group ◽  
Knowledge Score ◽  
Critical Care Nurses ◽  
Cohen’S D ◽  
Post Test ◽  
Cohen's D

Implementing evidence-based guidelines is one way of addressing the knowledge gap of critical care nurses regarding the ventilator liberation of critically ill adult patients in South Africa. A quasi-experimental intervention study using a pre-test/post-test design to measure critical care nurses’ knowledge on ventilator liberation of adult patients in intensive care units was conducted. The critical care nurses were purposively sampled into three groups and their knowledge was measured before an educational intervention, and three months after. Data was collected with pre/post-test questionnaires, n1=115 pre-test and n2=90 post-test, respectively. An educational intervention using a PowerPoint presentation, printed copies of the guidelines, posters as reminders, and informal monitoring visits (Intervention Group One) had an insignificant effect (p=0.371; Cohen’s d <0.20) on the improvement of the respondents’ knowledge score (62,93 versus 65,22). Handing out printed copies of guidelines alone (Intervention Group Two) had a small effect (p=0.033; Cohen’s d=0.49 small) but did not improve respondents’ knowledge score (60,34 versus 53,41). The absence of an educational intervention (Control Group) had an insignificant effect (p=0.884; Cohen’s d <0.20) on the improvement of respondents’ knowledge score (59,60 versus 60,33). Across the three groups, intensive care unit experience had a moderate effect (p=0,018; Cohen’s d=0.67 medium) on the way critical care nurses responded to the pre/post-test questionnaires. Respondents lacked knowledge of ventilator liberation practices in the study context, and this can be addressed using combined educational intervention methods. Sequel studies using different educational intervention methods are recommended that take into account the diversity within the study population.

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