-
International Breastfeeding Journal Jun 2024Many individuals who experience preterm birth struggle with early breast milk supply, which can translate into suboptimal longer-term breastfeeding outcomes. Further... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Many individuals who experience preterm birth struggle with early breast milk supply, which can translate into suboptimal longer-term breastfeeding outcomes. Further investigations into the potential role of early non-pharmacological and pharmacological interventions in improving breast milk production soon after birth is growing. While natural galactagogues, such as brewer's yeast, are widely perceived by women to be safer than pharmaceutical galactagogues and are taken by many women, evidence to support their efficacy is largely absent. The BLOOM study has been designed to determine the efficacy and safety of brewer's yeast and beta-glucans, derived from Saccharomyces cerevisiae, when administered soon after birth for increasing early breast milk supply in mothers who have delivered preterm.
METHODS
The BLOOM study is a multicentre, double-blinded, randomised controlled trial that will assess if brewer's yeast or beta-glucan can increase early breast milk production following preterm birth. Target population are mothers of preterm infants born at less than 34 weeks' gestation who intend to provide breast milk for their infant, are less than 72 h following birth and able to give informed consent. Participants will be randomly allocated into three parallel groups at 1:1:1 ratio (n = 33 per group) to receive either brewer's yeast, beta-glucan or placebo capsules for seven days. The primary outcome is total expressed breast milk volume over a 24-hour period on day 7 of intervention. Participants and their infants will be followed until the infant reaches term corrected age or is discharged home from the neonatal unit (whichever occurs first).
DISCUSSION
The use of brewer's yeast as a galactagogue to enhance milk production is extremely common amongst breastfeeding mothers, however, there are no trials evaluating its efficacy and safety. This will be the first randomised controlled trial to evaluate the efficacy and safety of two commonly used galactagogues, brewer's yeast and beta-glucan, compared with placebo in improving maternal breast milk supply following preterm birth. The trial will also evaluate whether early intervention with galactagogues soon after a preterm birth improves longer-term breastfeeding outcomes.
TRIAL REGISTRATION
Australian and New Zealand Clinical Trials Registry ACTRN12622000968774 (registered on 8 July 2022) and UTN U1111-1278-8827.
Topics: Humans; beta-Glucans; Female; Milk, Human; Infant, Newborn; Double-Blind Method; Premature Birth; Breast Feeding; Saccharomyces cerevisiae; Infant, Premature; Adult; Pregnancy; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
PubMed: 38902831
DOI: 10.1186/s13006-024-00650-z -
Italian Journal of Pediatrics Jun 2024Researches have found that alteration of intestinal flora may be closely related to the development of autism spectrum disorder (ASD). However, whether probiotics... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Researches have found that alteration of intestinal flora may be closely related to the development of autism spectrum disorder (ASD). However, whether probiotics supplementation has a protective effect on ASD remains controversial. This meta-analysis aimed to analyze the outcome of probiotics in the treatment of ASD children.
METHODS
The Pubmed, Cochrane Library, Web of Science and Embase were searched until Sep 2022. Randomized controlled trials (RCTs) relevant to the probiotics and placebo treatment on ASD children were screened. Quality assessment of the included RCTs was evaluated by the Cochrane collaboration's tool. The primary outcomes were ASD assessment scales, including ABC (aberrant behavior checklist) and CBCL (child behavior checklist) for evaluating the behavior improvement, SRS (social responsiveness scale) for social assessment, DQ (developmental quotient) for physical and mental development and CGI-I (clinical global impression improvement) for overall improvement. The secondary outcome was total 6-GSI (gastrointestinal severity index).
RESULTS
In total, 6 RCTs from 6 studies with 302 children were included in the systemic review. Total 6-GSI (MD=-0.59, 95%CI [-1.02,-0.17], P < 0.05) decreased significantly after oral administration of probiotics. Whereas, there was no statistical difference in ABC, CBCL, SRS, DQ and CGI-I between probiotics and placebo groups in ASD children.
CONCLUSION
Probiotics treatment could improve gastrointestinal symptoms, but there was no significant improvement in ASD.
Topics: Humans; Probiotics; Autism Spectrum Disorder; Child; Randomized Controlled Trials as Topic; Treatment Outcome; Gastrointestinal Microbiome
PubMed: 38902804
DOI: 10.1186/s13052-024-01692-z -
Journal of Physiotherapy Jun 2024What is the effect of a 4-week regimen of Mulligan manual therapy (MMT) plus exercise compared with exercise alone for managing cervicogenic headache? Is MMT plus...
Mulligan manual therapy added to exercise improves headache frequency, intensity and disability more than exercise alone in people with cervicogenic headache: a randomised trial.
QUESTION
What is the effect of a 4-week regimen of Mulligan manual therapy (MMT) plus exercise compared with exercise alone for managing cervicogenic headache? Is MMT plus exercise more effective than sham MMT plus exercise? Are any benefits maintained at 26 weeks of follow-up?
DESIGN
A three-armed, parallel-group, randomised clinical trial with concealed allocation, blinded assessment of some outcomes and intention-to-treat analysis.
PARTICIPANTS
Ninety-nine people with cervicogenic headache as per International Classification of Headache Disorders (ICHD-3).
INTERVENTIONS
Participants were randomly allocated to 4 weeks of: MMT with exercise, sham MMT with exercise or exercise alone.
OUTCOME MEASURES
The primary outcome was headache frequency. Secondary outcomes were headache intensity, headache duration, medication intake, headache-related disability, upper cervical rotation range of motion, pressure pain thresholds and patient satisfaction. Outcome measures were collected at baseline and at 4, 13 and 26 weeks.
RESULTS
MMT plus exercise reduced headache frequency more than exercise alone immediately after the intervention (MD between groups in change from baseline: 2 days/month, 95% CI 2 to 3) and this effect was still evident at 26 weeks (MD 4 days, 95% CI 3 to 4). There were also benefits across all time points in several secondary outcomes: headache intensity, headache duration, headache-related disability, upper cervical rotation and patient satisfaction. Pressure pain thresholds showed benefits at all time points at the zygapophyseal joint and suboccipital areas but not at the upper trapezius. The outcomes in the sham MMT with exercise group were very similar to those of the exercise alone group.
CONCLUSIONS
In people with cervicogenic headache, adding MMT to exercise improved: headache frequency, intensity and duration; headache-related disability; upper cervical rotation; and patient satisfaction. These benefits were not due to placebo effects.
TRIAL REGISTRATION
CTRI/2019/06/019506.
PubMed: 38902195
DOI: 10.1016/j.jphys.2024.06.002 -
Diabetes & Metabolic Syndrome Jun 2024With the prevalence of diabetes reaching an epidemic level, there is a growing interest in the investigation of its remission. Proglucagon-derived peptides (PGDP) have...
BACKGROUND
With the prevalence of diabetes reaching an epidemic level, there is a growing interest in the investigation of its remission. Proglucagon-derived peptides (PGDP) have been shown to have a glucose-regulating effect. However, whether they play a role in diabetes remission remains poorly understood.
AIM
To investigate changes in plasma levels of PGDP in glycaemic responders versus non-responders.
METHODS
The study was a randomised placebo-controlled trial comprising 18 adults with prediabetes (registered at www.
CLINICALTRIALS
gov as NCT03889210). Following an overnight fast, participants consumed ketone β-hydroxybutyrate (KEβHB)-supplemented beverage and placebo beverage in crossover manner. Serial blood samples were collected from baseline to 150 min at 30-min intervals. The endpoints were changes in glucagon-like peptide-1 (GLP-1), glicentin, oxyntomodulin, glucagon, and major proglucagon fragment (MPGF). Participants were stratified into the 'responders' and 'non-responders' subgroups based on their glycaemic changes following the ingestion of KEβHB. The area under the curve (AUC) was calculated to estimate the accumulated changes in the studied PGDP and compared using paired-t test between the KEβHB and placebo beverages.
RESULTS
Responders had a significantly greater reduction in plasma glucose compared with non-responders following acute ketosis (p < 0.001). The AUC for oxyntomodulin was significantly lower following the KEβHB beverage compared with the placebo (p = 0.045) in responders, but not in non-responders (p = 0.512). No significant differences in AUCs were found for GLP-1, glicentin, glucagon, and MPGF in either responders or non-responders.
CONCLUSION
Oxyntomodulin is involved in lowering plasma glucose and may play an important role in diabetes remission.
PubMed: 38901179
DOI: 10.1016/j.dsx.2024.103052 -
Clinical Nutrition ESPEN Jun 2024Among the side effects of chemotherapy, there is dysgeusia, which is an alteration or damage to the taste perception that negatively impacts the biopsychosocial sphere...
BACKGROUND/OBJECTIVE
Among the side effects of chemotherapy, there is dysgeusia, which is an alteration or damage to the taste perception that negatively impacts the biopsychosocial sphere of the patient. Therefore, it is important to recognize and manage it appropriately. The objective of this study is to identify clinical pharmacological strategies to reduce dysgeusia in chemotherapy patients.
METHODS
A systematic literature review was conducted following the PRISMA guidelines between February and May 2023, utilizing PubMed, Embase, Cochrane Library, CINAHL, and the British Nursing Database. Methodological quality and bias risk assessment were performed using the JBI framework, while evidence certainty was evaluated using the Oxford OCEBM methodology.
RESULTS
Out of 1225 consulted records, 12 articles were included. The results underscore the efficacy of diverse pharmacological interventions in mitigating dysgeusia among chemotherapy patients. These include zinc supplementation with a daily dosage ranging between 50 and 220 mg (p ≤ 0.005), lactoferrin at 250 mg thrice daily (p < 0.001), delta-9-tetrahydrocannabinol at 2 mg per day (p < 0.05), and cannabidiol at 150 mg per day (p = 0.04). All studies analysed showed a low risk of bias. The zinc and Delta-9-Tetrahydrocannabinoid treatment proved particularly promising, compared to the other treatments considered, where sample sizes were smaller and the placebo effect was not always clear.
CONCLUSION
Among the various pharmacological strategies identified, those that appear most promising concern the integration of zinc and Delta-9-Tetrahydrocannabinoid. Future studies should further explore the treatments identified in this review to expand the evidence base in this relatively underexplored field.
PubMed: 38900642
DOI: 10.1016/j.clnesp.2024.05.026 -
Kidney International Reports Jun 2024Beta-carotene (BC) protects the body against free radicals that may damage the kidney and lead to the development of acute kidney injury and chronic kidney disease...
INTRODUCTION
Beta-carotene (BC) protects the body against free radicals that may damage the kidney and lead to the development of acute kidney injury and chronic kidney disease (CKD). Previous studies in animal models have demonstrated a potential protective effect of 30 mg/kg BC supplementation on renal ischemia or reperfusion injury and subsequently improved kidney function. The extension of these findings to humans, however, remains unclear.
METHODS
Our study leverages previously collected data from the Physicians' Health Study I (PHS I), a large-scale, long-term, randomized trial of middle-aged and older US male physicians testing 50 mg BC every other day for primary prevention of cardiovascular disease and cancer. We examined the impact of randomized BC supplementation on self-reported incident CKD identified by self-reports stating "yes" to kidney disease from annual follow-up questionnaires from randomization in 1982 through the end of the randomized BC intervention at the end of 1995, and on CKD defined as an estimated glomerular filtration rate (eGFR) < 60 ml/min per 1.73 m at the end of 1995. Analyses compared incident CKD between BC supplementation and placebo using Cox proportional hazards regression models and logistic regression. We also examined whether smoking status (current vs. former or never smoker) or other factors modified the effect of randomized BC supplementation on CKD.
RESULTS
A total of 10,966 participants were randomized to BC, and 10,952 participants were randomized to a placebo group. Baseline characteristics between randomized BC groups were similar. There was no significant benefit between BC supplementation and self-reported incident CKD after adjusting for age and randomized aspirin treatment (hazard ratio [HR] = 0.97, 95% confidence interval [CI]: 0.86-1.08, -value = 0.56). Stratified by smoking status, there was no significant benefit of BC supplementation and self-reported incident CKD either among former or never smokers (HR = 0.95, 95% CI: 0.84-1.07, -value = 0.41) or current smokers (HR = 1.08, 95% CI: 0.78-1.50, -value = 0.64). Smoking status did not modify the association between BC supplementation and incident CKD (-interaction = 0.47). In subgroup analysis among those with available serum creatinine at the study end (5480 with BC and 5496 with placebo), there was no significant benefit between BC supplementation and CKD based on eGFR < 60 ml/min per 1.73 m (odds ratio [OR] = 0.96, 95% CI: 0.85-1.08, -value = 0.49).
CONCLUSION
Long-term randomized BC supplementation did not affect the risk of incident CKD in middle-aged and older male physicians.
PubMed: 38899218
DOI: 10.1016/j.ekir.2024.04.001 -
Pain Research & Management 2024Common postoperative complications following surgery, particularly acute appendicitis surgery, include postoperative pain and vomiting, which can cause discomfort and... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Common postoperative complications following surgery, particularly acute appendicitis surgery, include postoperative pain and vomiting, which can cause discomfort and delay recovery time.
METHODS
A randomized double-blinded placebo-controlled clinical trial was conducted with 80 cases of acute appendicitis of American Society of Anesthesiologists (ASA) physical status I or II and aged 18-60 y/o scheduled for appendectomy under general anesthesia. Patients were randomly divided into two equal groups: group A received 4 mg of ondansetron IV (2 ml) and group B received 2 ml of normal slain IV (placebo). Pain according to VAS, nausea and vomiting according to clinical symptoms, shivering and sedation according to the Bedside Shivering Assessment Scale (BSAS), and the Ramsay Sedation Scale (RSS) at 2, 6, 12, and 24 hours after surgery were evaluated and compared between the groups.
RESULTS
There was a significant decline in the severity of pain only at 2 hours after surgery between the ondansetron and control groups (5.3 ± 1.0 vs. 6.0 ± 1.0; =0.01), not showing a difference between the groups at 6, 12, and 24 hours after appendectomy. Postoperative nausea and vomiting at 2 (5% vs. 25%; =0.03) and 6 (7.5% vs. 27.5%; =0.04) hours after appendectomy in the ondansetron group. At different times, the ondansetron and control groups did not differ in terms of pethidine consumption or sedation.
CONCLUSIONS
In conclusion, our study found that ondansetron was effective in reducing postoperative vomiting after acute appendicitis surgery. However, it did not show a clinically significant effect on postoperative pain. This trial is registered with IRCT20230722058883N1.
Topics: Humans; Double-Blind Method; Ondansetron; Adult; Male; Female; Pain, Postoperative; Appendicitis; Young Adult; Middle Aged; Adolescent; Postoperative Nausea and Vomiting; Appendectomy; Pain Measurement; Antiemetics; Treatment Outcome; Time Factors
PubMed: 38899063
DOI: 10.1155/2024/6429874 -
Life Sciences Jun 2024The cardiac surgery-related ischemia-reperfusion-related oxidative stress triggers the release of cytotoxic reactive oxygen and nitrogen species, contributing to organ...
The effect of a selenium-based anti-inflammatory strategy on postoperative functional recovery in high-risk cardiac surgery patients - A nested sub-study of the sustain CSX trial.
AIM
The cardiac surgery-related ischemia-reperfusion-related oxidative stress triggers the release of cytotoxic reactive oxygen and nitrogen species, contributing to organ failure and ultimately influencing patients' short- and long-term outcomes. Selenium is an essential co-factor for various antioxidant enzymes, thereby contributing to the patients' endogenous antioxidant and anti-inflammatory defense mechanisms. Given these selenium's pleiotropic functions, we investigated the effect of a high-dose selenium-based anti-inflammatory perioperative strategy on functional recovery after cardiac surgery.
MATERIALS AND METHODS
This prospective study constituted a nested sub-study of the SUSTAIN CSX trial, a double-blinded, randomized, placebo-controlled multicenter trial to investigate the impact of high-dose selenium supplementation on high-risk cardiac surgery patients' postoperative recovery. Functional recovery was assessed by 6-min walk distance, Short Form-36 (SF-36) and Barthel Index questionnaires.
KEY FINDINGS
174 patients were included in this sub-study. The mean age (SD) was 67.3 (8.9) years, and 78.7 % of the patients were male. The mean (SD) predicted 30-day mortality by the European System for Cardiac Operative Risk Evaluation II score was 12.6 % (9.4 %). There was no difference at hospital discharge and after three months in the 6-min walk distance between the selenium and placebo groups (131 m [IQR: not performed - 269] vs. 160 m [IQR: not performed - 252], p = 0.80 and 400 m [IQR: 299-461] vs. 375 m [IQR: 65-441], p = 0.48). The SF-36 and Barthel Index assessments also revealed no clinically meaningful differences between the selenium and placebo groups.
SIGNIFICANCE
A perioperative anti-inflammatory strategy with high-dose selenium supplementation did not improve functional recovery in high-risk cardiac surgery patients.
PubMed: 38897349
DOI: 10.1016/j.lfs.2024.122841 -
Brazilian Journal of Medical and... 2024The purpose of this study was to verify the association between angiotensin-converting enzyme (ACE) genotypes DD, DI, and II and caffeine (CAF) ingestion on endurance... (Randomized Controlled Trial)
Randomized Controlled Trial
ACE gene polymorphisms (rs4340) II and DI are more responsive to the ergogenic effect of caffeine than DD on aerobic power, heart rate, and perceived exertion in a homogeneous Brazilian group of adolescent athletes.
The purpose of this study was to verify the association between angiotensin-converting enzyme (ACE) genotypes DD, DI, and II and caffeine (CAF) ingestion on endurance performance, heart rate, ratio of perceived exertion (RPE), and habitual caffeine intake (HCI) of adolescent athletes. Seventy-four male adolescent athletes (age: DD=16±1.7; DI=16±2.0; II=15±1.7 years) ingested CAF (6 mg/kg) or placebo (PLA) one hour before performing the Yo-Yo Intermittent Recovery level 1 (Yo-Yo IR1) test. No difference was found among groups for HCI. However, CAF increased the maximal distance covered and VO2max in DI and II genotype carriers compared to PLA (DD: Δ=31 m and 0.3 mL·kg-1·min-1; DI: Δ=286 m and 1.1 mL·kg-1·min-1; II: Δ=160 m and 1.4 mL·kg-1·min-1). Heart rate of DI and II genotype carriers increased with CAF compared to PLA, while RPE was higher in the II and lower in the DD genotypes. The correlations between HCI and maximal distance covered or VO2max were significant in the II genotype carriers with CAF. CAF increased endurance capacity, heart rate, and RPE in adolescent athletes with allele I, while endurance performance and aerobic power had a positive correlation to HCI in the II genotype group. These findings suggested that DD genotype were less responsive to CAF and that genetic variations should be taken into account when using CAF supplementation to enhance exercise performance.
Topics: Humans; Adolescent; Male; Heart Rate; Caffeine; Genotype; Athletes; Physical Exertion; Peptidyl-Dipeptidase A; Athletic Performance; Physical Endurance; Polymorphism, Genetic; Brazil; Oxygen Consumption; Performance-Enhancing Substances
PubMed: 38896643
DOI: 10.1590/1414-431X2024e13217 -
Nutrients Jun 2024This study assessed the impact of acute caffeine intake on muscular strength, power, and endurance performance between resistance-trained male and female individuals... (Randomized Controlled Trial)
Randomized Controlled Trial
Sex Differences in the Ergogenic Response of Acute Caffeine Intake on Muscular Strength, Power and Endurance Performance in Resistance-Trained Individuals: A Randomized Controlled Trial.
BACKGROUND
This study assessed the impact of acute caffeine intake on muscular strength, power, and endurance performance between resistance-trained male and female individuals according to load in upper- and lower-body exercises.
METHODS
Here, 76 resistance-trained individuals (38 females, 38 males) participated in a study comparing caffeine and a placebo. Each received either 3 mg/kg of caffeine or a placebo 60 min before tests measuring muscular strength and power through bench press and back squat exercises at different intensities (25%, 50%, 75%, 90% 1RM). Muscular endurance at 65% 1RM was also assessed by performing reps until reaching task failure.
RESULTS
Compared to placebo, caffeine increased mean, peak and time to reach peak velocity and power output ( < 0.01, η = 0.242-0.293) in the muscular strength/power test in males and females. This effect was particularly observed in the back squat exercise at 50%, 75% and 90% 1RM (2.5-8.5%, < 0.05, g = 1.0-2.4). For muscular endurance, caffeine increased the number of repetitions, mean velocity and power output ( < 0.001, η = 0.177-0.255) in both sexes and exercises (3.0-8.9%, < 0.05, g = 0.15-0.33).
CONCLUSIONS
Acute caffeine intake resulted in a similar ergogenic effect on muscular strength, power, and endurance performance in upper- and lower-body exercises for male and female resistance-trained participants.
Topics: Humans; Caffeine; Female; Male; Muscle Strength; Resistance Training; Physical Endurance; Young Adult; Adult; Sex Factors; Performance-Enhancing Substances; Muscle, Skeletal; Double-Blind Method; Sex Characteristics
PubMed: 38892692
DOI: 10.3390/nu16111760