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Physiological Reports Jun 2024Methylphenidate (MPH) has been previously shown to increase resting energy expenditure (REE) in individuals of normal weight; however, the effects on individuals living... (Randomized Controlled Trial)
Randomized Controlled Trial
Methylphenidate (MPH) has been previously shown to increase resting energy expenditure (REE) in individuals of normal weight; however, the effects on individuals living with obesity are currently unknown. Ten individuals living with obesity were randomly assigned to undergo 60 days of MPH administration with a daily dose of 0.5 mg/kg body weight or a placebo control. REE was measured before and after the 60-day intervention. There was a trend toward significance for group × time interaction on REE (p = 0.082) with a large effect size (η = 0.331), with MPH administration increasing REE compared to a decrease in placebo control. Preliminary findings from this pilot study show that MPH has the potential to counter the adaptive thermogenic process commonly seen in weight loss. This is a unique finding among pharmacotherapies, as no approved obesity drugs measurably impact REE.
Topics: Humans; Methylphenidate; Male; Female; Obesity; Pilot Projects; Energy Metabolism; Adult; Double-Blind Method; Middle Aged; Central Nervous System Stimulants
PubMed: 38924673
DOI: 10.14814/phy2.16085 -
ACR Open Rheumatology Jun 2024Using the modified Rodnan skin score (mRSS) as a surrogate for disease activity, a phase 2a study in patients with systemic sclerosis (SSc) measured efficacy of the...
OBJECTIVE
Using the modified Rodnan skin score (mRSS) as a surrogate for disease activity, a phase 2a study in patients with systemic sclerosis (SSc) measured efficacy of the autotaxin inhibitor ziritaxestat. Mathematical modeling of mRSS was used to predict disease progression, examine candidate trial designs, and predict the probability of successfully discriminating treatment effect.
METHODS
Patients with SSc receiving 600 mg of ziritaxestat or placebo for 24 weeks were included, in addition to data up to week 52 of the open-label extension (OLE). Longitudinal mRSS data were described using a disease progression model; drug effect was a binary variable. Parameters used to predict the OLE mRSS outcome were estimated using data from the 24-week double-blind phase and validated with observed data. Three trial designs were simulated to identify which had the highest probability of detecting a treatment effect. Power to detect a treatment effect was quantified using the simulations.
RESULTS
Maximum decreases from baseline in mRSS were 50.4% (ziritaxestat) and 34.7% (placebo). Study designs based on 300 patients randomized 2:1 or 1:1 to 600 mg of ziritaxestat or placebo had similar probabilities of detecting a significant treatment effect. Power to detect a treatment effect was >80% for all simulations.
CONCLUSION
Disease progression and drug effect could be predicted beyond the range of observed data. This modeling and simulation approach may inform future trial design, including study duration, and predict the probability of success.
PubMed: 38923416
DOI: 10.1002/acr2.11678 -
Revista Gaucha de Enfermagem 2024To analyze the effectiveness of Bach flower therapy compared to placebo in reducing perceived stress levels in primary health care nursing professionals. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To analyze the effectiveness of Bach flower therapy compared to placebo in reducing perceived stress levels in primary health care nursing professionals.
METHOD
Pragmatic, parallel randomized clinical trial conducted with 87 primary care nursing professionals with self-identified stress, from October 2021 to June 2022, in the cities of Osasco and São Paulo, Brazil. The intervention group (n=43) received the collective flower formula, and the placebo group (n=44) received only the diluent. Data analysis was performed using the linear mixed model, and effect size was measured by partial Eta squared, significance level 5%.
RESULTS
Data analysis showed a significant reduction in perceived stress levels within groups (p=0.038). However, there was no significant difference between the study groups (p=0.750). Participants in the intervention group reported a greater perception of changes than participants in the placebo group, but without statistical significance (p=0,089).
CONCLUSION
The floral formula was not more effective than the placebo formula in reducing perceived stress. There was a significant stress reduction among nursing professionals in both study groups, although with a small effect size.
Topics: Humans; Female; Male; Adult; Flowers; Primary Care Nursing; Middle Aged; Occupational Stress; Phytotherapy; Stress, Psychological; Brazil
PubMed: 38922232
DOI: 10.1590/1983-1447.2024.20230132.en -
Journal of Cardiovascular Development... Jun 2024To assess the acute effect of empagliflozin versus dapagliflozin administration on flow-mediated vasodilation in patients with type 2 diabetes mellitus.
AIM
To assess the acute effect of empagliflozin versus dapagliflozin administration on flow-mediated vasodilation in patients with type 2 diabetes mellitus.
DESIGN
A double-blind clinical trial, at the Experimental and Clinical Therapeutics Institute, University Health Sciences Center, at the Universidad de Guadalajara, in inpatients with T2D according to the 2023 ADA criteria.
METHODS
Thirty patients (15 males and 15 females), aged between 35 and 65 years, were included in this study, according to the 2023 ADA criteria. The eligible patients were randomly assigned to three groups: empagliflozin 25 mg once daily, dapagliflozin 10 mg once daily, or placebo once daily. Anthropometric parameters were taken using validated techniques. FMD was measured using a high-resolution semiautomatic ultrasound UNEX-EF 38G (UNEX Co., Ltd., Nagoya, Japan). Arterial tension was determined with the OMRON electronic digital sphygmomanometer (HEM 907 XL, Kyoto, Japan).
RESULTS
The group of patients who received empagliflozin had a significantly lower baseline flow-mediated dilation (FMD) compared to the group receiving dapagliflozin ( = 0.017); at the end of this study, the empagliflozin group achieved a comparable FMD to the dapagliflozin group ( = 0.88).
CONCLUSION
After the treatment period, the empagliflozin and dapagliflozin groups achieved similar FMD, suggesting a class effect.
PubMed: 38921682
DOI: 10.3390/jcdd11060182 -
Journal of Cardiovascular Development... Jun 2024Trimethyl--oxide (TMAO) has been linked to peripheral artery disease (PAD). Taurisolo is a natural, balanced phytocomplex containing resveratrol, quercetin, catechins,...
Trimethyl--oxide (TMAO) has been linked to peripheral artery disease (PAD). Taurisolo is a natural, balanced phytocomplex containing resveratrol, quercetin, catechins, procianidins, gallic acid, and caffeic acid. Numerous studies have shown that Taurisolo reduces the damage of TMAO and exerts a protective effect on endothelial cells (ECs). The aim of this randomized, double-blind, single-center study was to evaluate the effects of Taurisolo on claudication in patients with PAD (Rutheford grade I, category II, Fontaine Classification: Stage IIA, American Medical Association Whole Person Impairment Classification: Class 0-WPI 0%) in two parallel groups of 31 patients. The primary outcomes were an increase in the pain-free walking distance and the ankle/brachial pressure index at the beginning and at the end of the treatment with Taurisolo. The secondary endpoint was the serum TMAO changes. The claudication distance improved by 14.1% in the Taurisolo group and by 2.0% in the placebo group, while the maximal distance increased by 15.8% and 0.6% only, respectively (both < 0.05). The TMAO plasma levels decreased from 3.97 ± 2.13 micromole/L to 0.87 ± 0.48 ( < 0.0001) in the treated group. All these changes were highly significant both in univariate mixed models as well as in the adjusted model. Ultimately, Taurisolo might be an effective intervention to ameliorate intermittent claudication.
PubMed: 38921674
DOI: 10.3390/jcdd11060174 -
Journal of Functional Morphology and... May 2024Hypoxia increases inspiratory muscle work and consequently contributes to a reduction in exercise performance. We evaluate the effects of inspiratory muscle warm-up...
Hypoxia increases inspiratory muscle work and consequently contributes to a reduction in exercise performance. We evaluate the effects of inspiratory muscle warm-up (IMW) on a 10 km cycling time trial in normoxia (NOR) and hypoxia (HYP). Eight cyclists performed four time trial sessions, two in HYP (FiO: 0.145) and two in NOR (FiO: 0.209), of which one was with IMW (set at 40% of maximal inspiratory pressure-MIP) and the other was with the placebo effect (PLA: set at 15% MIP). Time trials were unchanged by IMW (NOR: 893.8 ± 31.5 vs. NOR: 925.5 ± 51.0 s; HYP: 976.8 ± 34.2 vs. HYP: 1008.3 ± 56.0 s; > 0.05), while ventilation was higher in HYP (107.7 ± 18.3) than HYP (100.1 ± 18.9 L.min; ≤ 0.05), and SpO was lower (HYP: 73 ± 6 vs. HYP: 76 ± 6%; ≤ 0.05). A post-exercise-induced reduction in inspiratory strength was correlated with exercise elapsed time during IMW sessions (HYP: r = -0.79; ≤ 0.05; NOR: r = -0.70; ≤ 0.05). IMW did not improve the 10 km time trial performance under normoxia and hypoxia.
PubMed: 38921633
DOI: 10.3390/jfmk9020097 -
Dentistry Journal Jun 2024Dentin hypersensitivity (DH) is a common challenge in pediatric patients with molar incisor hypomineralization (MIH), stemming from enamel porosity or exposed dentin...
Dentin hypersensitivity (DH) is a common challenge in pediatric patients with molar incisor hypomineralization (MIH), stemming from enamel porosity or exposed dentin after enamel breakdown. This three-arm randomized controlled clinical trial aims to evaluate the effectiveness of three different desensitizing treatment protocols. The study was conducted on 39 children, aged 6-14 years old, with MIH and DH. Group A received casein phosphopeptide plus amorphous calcium phosphate fluoride (CPP-ACPF) mousse and sham light therapy, Group B received placebo mousse and photo-bio-modulation therapy (PMBT), and Group C received both CPP-ACPF mousse and PMBT. DH evaluation using a visual analogue scale was performed at multiple time points. Both CPP-ACPF mousse and PMBT individually demonstrated desensitizing effects on dental elements affected by MIH. While PMBT had a greater immediate effect, the combination of the two therapies proved most effective in reducing DH. The VAS scores were statistically lower in group C compared to groups A and B, both after the first session ( = 0.0001) and after 28 days ( = 0.0005). This study suggests promising avenues for managing DH in MIH patients, highlighting the potential of combined therapies, specifically CPP-ACPF mousse and PMBT, for enhanced clinical outcomes.
PubMed: 38920887
DOI: 10.3390/dj12060186 -
Frontiers in Endocrinology 2024Aromatherapy is a holistic healing method to promote health and well-being by using natural plant extracts. However, its precise mechanism of action and influence on the... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Aromatherapy is a holistic healing method to promote health and well-being by using natural plant extracts. However, its precise mechanism of action and influence on the endocrine system remains unclear. Since recent studies reported that a neuropeptide, oxytocin, can attenuate anxiety, we hypothesized that if oxytocin secretion is promoted through aromatherapy, it may improve mood and anxiety. The present study is aimed to investigate the relationship between oxytocin and the effects of aromatherapy with lavender oil on anxiety level, by measuring salivary oxytocin levels in healthy men and women.
METHODS
We conducted a randomized open crossover trial in 15 men and 10 women. Each participant received a placebo intervention (control group) and aromatherapy with lavender oil (aromatherapy group). For the aromatherapy group, each participant spent a 30-min session in a room with diffused lavender essential oil, followed by a 10-min hand massage using a carrier oil containing lavender oil. Anxiety was assessed using the State-Trait Anxiety Inventory (STAI) before the intervention, 30-min after the start of intervention, and after hand massage, in both groups. Saliva samples were collected at the same time points of the STAI.
RESULTS
In women, either aromatherapy or hand massage was associated with a reduction in anxiety levels, independently. Moreover, salivary oxytocin levels were increased after aromatherapy. On the other hand, in men, anxiety levels were decreased after aromatherapy, as well as after hand massage, regardless of the use of lavender oil. However, there were no significant differences in changes of salivary oxytocin levels between the control and aromatherapy groups during the intervention period. Interestingly, there was a positive correlation between anxiety levels and salivary oxytocin levels before the intervention, but a negative correlation was observed after hand massage with lavender oil.
CONCLUSION
The results of the present study indicate that in women, aromatherapy with lavender oil attenuated anxiety with increase in oxytocin level in women, whereas in men, there was no clear relationship of aromatherapy with anxiety or oxytocin levels but, there was a change in correlation between anxiety and oxytocin. The results of the present study suggest that the effect of aromatherapy can vary depending on sex.
Topics: Humans; Oxytocin; Aromatherapy; Female; Male; Saliva; Anxiety; Adult; Oils, Volatile; Lavandula; Plant Oils; Young Adult; Cross-Over Studies; Sex Characteristics
PubMed: 38919481
DOI: 10.3389/fendo.2024.1380779 -
Health Science Reports Jun 2024The primary objective of this systematic review and meta-analysis was to assess the impact of dextrose prolotherapy on individuals diagnosed with knee osteoarthritis... (Review)
Review
BACKGROUND AND AIMS
The primary objective of this systematic review and meta-analysis was to assess the impact of dextrose prolotherapy on individuals diagnosed with knee osteoarthritis (KOA).
METHODS
To conduct a thorough investigation, a variety of leading international databases were checked, including PubMed (Medline), Scopus, Web of Sciences, EMBASE (Elsevier), ClinicalTrials.gov, and the Cochrane Library. The search covered a period from January 2000 to the end of June 2023, which facilitated the collection of relevant studies.
RESULTS
The findings of the study revealed that when the studies utilizing the Western Ontario McMaster Universities Index tool (WOMAC) were combined, patients with KOA who received prolotherapy experienced an improvement in function compared with those who received other treatments (SMD: 0.20; 95% Confidence Interval [1]: -0.11, 0.51; value SMD = 0.221; : 78.49%; < 0.001). Additionally, there was a decrease in mean pain and stiffness among patients who received prolotherapy compared with those who received other treatments or a placebo [(SMD: -0.95; 95% CI: -1.14, -0.76; value SMD < 0.001; : 59.35%; = 0.070) and (SMD: -0.21; 95% CI: -0.32, -0.10; value SMD < 0.001; : 88.11%; < 0.001)]. Furthermore, based on the Visual Analog Scale (VAS) score, there was a reduction of 0.81 units out of 10 in mean pain for patients with KOA who received prolotherapy (SMD: -0.81; 95% CI: -5.63, 4.10; value SMD = 0.693; : 48.54%; = 0.08).
CONCLUSION
Drawing from the data analysis performed in this meta-analysis, it is apparent that dextrose prolotherapy exhibits promising effectiveness in reducing joint pain and stiffness, as well as improving functional performance in individuals suffering from KOA. Furthermore, it is recommended that forthcoming studies incorporate follow-up periods to guide decisions concerning the duration of prolotherapy's effects.
PubMed: 38915358
DOI: 10.1002/hsr2.2145 -
Deutsches Arzteblatt International May 2024Patients with advanced pancreatic cancer have -limited survival and few treatment options. We studied whether mistletoe extract (ME), in addition to comprehensive... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Patients with advanced pancreatic cancer have -limited survival and few treatment options. We studied whether mistletoe extract (ME), in addition to comprehensive oncological treatment and palliative care, prolongs overall survival (OS) and -improves health-related quality of life (HRQoL).
METHODS
The double-blind, placebo-controlled MISTRAL trial was conducted in Swedish oncology centers. The main inclusion criteria were advanced exocrine pancreatic cancer and Eastern Cooperative Oncology Group (ECOG) performance status 0-2. The subjects were randomly assigned to ME (n=143) or placebo (n=147) and were stratified by study site and by eligibility (yes/no) for palliative chemotherapy (June 2016-December 2021). ME or placebo was injected subcutaneously three times a week for nine months. The primary endpoint was overall survival (OS); one of the secondary endpoints was the HRQoL dimension global health/QoL (EORTC-QLQ-C30), as assessed at seven time points over nine months. Trial registration: EudraCT 2014-004552-64, NCT02948309.
RESULTS
No statistically significant benefit of adding ME to standard treatment was seen with respect to either OS or global health/QoL. The adjusted hazard ratio for OS was 1.13 [0.89; 1.44], with a median survival time of 7.8 and 8.3 months for ME and placebo, respectively. The figures for the HRQoL dimension "global health/QoL" were similar in the two groups (p=0.86). The number, severity, and outcome of the reported adverse events were similar as well, except for more common local skin reactions at ME injection sites (66% vs. 1%).
CONCLUSION
ME is unlikely to have a clinically significant effect on OS or the HRQoL dimension global health/QoL when administered in patients with advanced pancreatic cancer in addition to comprehensive cancer care.
PubMed: 38915151
DOI: 10.3238/arztebl.m2024.0080