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Journal of Health, Population, and... Jun 2024Even after the peak of the COVID-19 pandemic, the number of mild cases remains high, requiring continuous control. Curcumin, owing to its anti-inflammatory properties,... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Even after the peak of the COVID-19 pandemic, the number of mild cases remains high, requiring continuous control. Curcumin, owing to its anti-inflammatory properties, can suppress vital proliferation and cytokine secretion in animal models. We developed a highly absorbable curcumin, curcuRouge (cR), which is approximately 100 times more orally bioavailable than conventional curcumin. We evaluated the effect of cR on the inhibition of disease progression in asymptomatic or mildly symptomatic COVID-19 patients.
METHODS
This study evaluated the effect of 7-day oral intake of cR (360 mg twice daily). Patients within 5 days of COVID-19 diagnosis were randomly assigned to a placebo or cR group in a double-blind manner.
RESULTS
Primary endpoint events [body temperature (BT) ≥ 37.5 °C and saturation of percutaneous oxygen (SpO2) < 96%] were fewer than expected, and the rate of these events was 2.8% in the cR group (2/71) and 6.0% in the placebo group (4/67); hazard ratio (HR) = 0.532, 95% confidence interval (CI) 0.097-2.902. Patients receiving cR tended to take fewer antipyretic medications than those receiving placebo (HR = 0.716, 95% CI 0.374-1.372). Among patients with a normal range of BT at baseline, the BT change rate was significantly (p = 0.014) lower in the cR group (- 0.34%) versus placebo (- 0.01%).
CONCLUSION
The relative suppression of event rates and antipyretic medications taken, and significant decrease of subclinical BT support the anti-inflammatory effects of cR in asymptomatic or mildly symptomatic patients with COVID-19.
TRIAL REGISTRATION
Japan Registry of Clinical Trials (CRB5200002).
Topics: Humans; Curcumin; Double-Blind Method; Male; Female; Middle Aged; COVID-19 Drug Treatment; Administration, Oral; Adult; COVID-19; Aged; Treatment Outcome; SARS-CoV-2; Biological Availability
PubMed: 38915116
DOI: 10.1186/s41043-024-00584-6 -
Acta Psychologica Jun 2024The study aimed to examine the effect of mental imagery on sports performance. Specifically, it was tested whether imagining flying (i.e., air travel) increases jumping...
OBJECTIVE
The study aimed to examine the effect of mental imagery on sports performance. Specifically, it was tested whether imagining flying (i.e., air travel) increases jumping performance in a group of female volleyball players.
METHODS
The study included 46 female young athletes (mean age = 15.23 years; standard deviation = 2.4) divided into two groups: the experimental group viewed a three-dimensional video that simulated a flying experience, while the control group watched neutral footage. The jump performance of both groups was measured before and after viewing the videos, using the Vertec Like® instrument to assess jump height. Participants were assessed for their flow disposition, mental imagery skills, and image vividness.
RESULTS
Comparing pre-post jump performance scores, the experimental group showed a significant improvement over the control group, with a medium-large effect size (d = 0.634). There was no significant association between flow disposition, mental imagery skills, image vividness, and pre-post jumping performance differences (respectively: β = -0.107, p = .484; β = -0.008, p = .957; β = 0.024, p = .913).
CONCLUSIONS
These findings suggest that the experience of imagining flying, enhanced with an immersive video, has a positive effect on jumping performance in a one-session study with young female volleyball players. This effect does not appear to be associated with pre-existing characteristics or the vividness of the image itself.
PubMed: 38909396
DOI: 10.1016/j.actpsy.2024.104366 -
Scientific Reports Jun 2024The placebo-reward hypothesis postulates that positive effects of treatment expectations on health (i.e., placebo effects) and reward processing share common neural...
The placebo-reward hypothesis postulates that positive effects of treatment expectations on health (i.e., placebo effects) and reward processing share common neural underpinnings. Moreover, experiments in humans and animals indicate that reward uncertainty increases striatal dopamine, which is presumably involved in placebo responses and reward learning. Therefore, treatment uncertainty analogously to reward uncertainty may affect updating from rewards after placebo treatment. Here, we address whether different degrees of uncertainty regarding the efficacy of a sham treatment affect reward sensitivity. In an online between-subjects experiment with N = 141 participants, we systematically varied the provided efficacy instructions before participants first received a sham treatment that consisted of listening to binaural beats and then performed a probabilistic reinforcement learning task. We fitted a Q-learning model including two different learning rates for positive (gain) and negative (loss) reward prediction errors and an inverse gain parameter to behavioral decision data in the reinforcement learning task. Our results yielded an inverted-U-relationship between provided treatment efficacy probability and learning rates for gain, such that higher levels of treatment uncertainty, rather than of expected net efficacy, affect presumably dopamine-related reward learning. These findings support the placebo-reward hypothesis and suggest harnessing uncertainty in placebo treatment for recovering reward learning capabilities.
Topics: Humans; Placebo Effect; Male; Uncertainty; Female; Reinforcement, Psychology; Adult; Reward; Young Adult; Learning; Treatment Outcome; Dopamine; Adolescent
PubMed: 38909105
DOI: 10.1038/s41598-024-64240-z -
The Journal of Nutrition, Health & Aging Jun 2024To assess the impact of medium-term supplementation with dihydrogen and pyrroloquinoline quinone (PQQ) on mitochondrial biomarkers, brain metabolism, and cognition in...
The impact of six-week dihydrogen-pyrroloquinoline quinone supplementation on mitochondrial biomarkers, brain metabolism, and cognition in elderly individuals with mild cognitive impairment: a randomized controlled trial.
OBJECTIVES
To assess the impact of medium-term supplementation with dihydrogen and pyrroloquinoline quinone (PQQ) on mitochondrial biomarkers, brain metabolism, and cognition in elderly individuals diagnosed with mild cognitive impairment.
DESIGN
A parallel-group, randomized, placebo-controlled, double-blind experimental design, maintaining a 1:1 allocation ratio between the experimental group (receiving the dihydrogen-producing minerals and PQQ) and the control group (receiving the placebo) throughout the trial.
SETTING AND PARTICIPANTS
Thirty-four elderly individuals with mild cognitive impairment (mean age 71.9 ± 3.8 years; 28 females) voluntarily provided written consent to participate in this trial. Participants were assigned in a double-blind parallel-group design to receive either a dihydrogen-PQQ mixture (Alpha Hope®, CalerieLife, Irvine, CA) or placebo twice daily for a 6-week intervention period.
METHODS
The primary endpoint was the change in serum brain-derived neurotrophic factor (BDNF) from baseline to the 6-week follow-up; secondary outcomes included cognitive function indices, specific metabolites in brain tissue, brain oxygenation, and the prevalence and severity of side effects. Interaction effects (time vs. intervention) were evaluated using two-way ANOVA with repeated measures and Friedman's 2-way ANOVA by ranks, for normally distributed data with homogeneous variances and non-homogeneous variances, respectively.
RESULTS
Dihydrogen-PQQ resulted in a significant elevation in serum BDNF levels at the six-week follow-up (P = 0.01); conversely, no changes in BDNF levels were observed in the placebo group throughout the study duration (P = 0.27). A non-significant trend in the impact of interventions on BDNF levels was observed (treatment vs. time interaction, P = 0.14), suggesting a tendency for dihydrogen-PQQ to upregulate BDNF levels compared to the placebo. A significant interaction effect was observed for the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) scores in the orientation domain (P = 0.03), indicating the superiority of dihydrogen-PQQ over placebo in enhancing this cognitive aspect. Cerebral oxygenation saturation exhibited a significant increase following the administration of the dihydrogen-PQQ mixture, from 48.4 ± 7.2% at baseline to 52.8 ± 6.6% at 6-week post-administration (P = 0.005). In addition, brain N-acetyl aspartate levels significantly increased at seven out of thirteen locations post-intervention in participants receiving the mixture (P ≤ 0.05).
CONCLUSIONS
Despite the limited number of participants included in the study for interpreting clinical parameters, the dihydrogen-PQQ mixture blend shows promise as a potential dietary intervention for enhancing mental orientation and brain metabolism in individuals with age-related mild cognitive decline.
PubMed: 38908296
DOI: 10.1016/j.jnha.2024.100287 -
Rheumatology and Therapy Jun 2024Ixekizumab, an interleukin 17A (IL-17A) inhibitor, has demonstrated rapid and sustained improvement in the signs and symptoms in patients with active radiographic axial...
INTRODUCTION
Ixekizumab, an interleukin 17A (IL-17A) inhibitor, has demonstrated rapid and sustained improvement in the signs and symptoms in patients with active radiographic axial spondyloarthritis (r-axSpA) in global and Chinese populations. We studied the effect of ixekizumab on patient-reported outcomes (PROs) (including patient global, spinal pain, stiffness, and fatigue) and overall health-related quality of life (HRQoL) of ixekizumab in the phase 3 study in China.
METHODS
In this Chinese phase 3, randomized, double-blind, placebo-controlled study, patients with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W; starting dose 160 mg) or placebo for 16 weeks. At week 16, patients receiving placebo were switched to IXEQ4W, and those receiving IXEQ4W continued, until week 52. Data for patient global, spinal pain, spinal pain at night, stiffness, and fatigue were collected through week 52. Minimally clinical important differences (MCIDs) were determined for spinal pain and spinal pain at night. The subgroup analyses by baseline disease duration since diagnosis and baseline C-reactive protein (CRP) level were conducted post hoc.
RESULTS
Compared with placebo, patients treated with IXEQ4W reported significantly greater improvement with a rapid onset in changes from baseline of PROs (patient global, spinal pain, spinal pain at night, stiffness, and fatigue) through week 16. Improvements were maintained through week 52. A similar trend of improvement was also observed in MCID response in spinal pain and spinal pain at night. The improvement in overall HRQoL was supported by EQ-5D-5L assessment. Subgroup analyses demonstrated that IXEQ4W provided significantly greater efficacy at week 16 compared with placebo, irrespective of baseline disease duration or baseline CRP level.
CONCLUSION
IXEQ4W provided rapid and sustained improvement in clinically relevant PROs and overall HRQoL through 1-year treatment in Chinese patients with r-axSpA. Regardless of the baseline disease duration or baseline CRP level, consistent efficacy was observed.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT04285229.
PubMed: 38907104
DOI: 10.1007/s40744-024-00688-9 -
NPJ Science of Food Jun 2024Sugar beverages are discussed as critical in the development of metabolic endotoxemia. Here, employing a cross-over design study we assessed the effect of diluted cloudy...
Sugar beverages are discussed as critical in the development of metabolic endotoxemia. Here, employing a cross-over design study we assessed the effect of diluted cloudy apple juice (AJ), an iso-caloric and -sweetened placebo (P), or water (W) on post-prandial endotoxemia in healthy, normal weight adults. After obtaining fasting blood, 19 healthy men and women consumed 500 mL AJ, P, or W in a randomized order and blood was taken 120 and 180 min later. Caco-2 cells were incubated with the beverages. Markers of intestinal barrier function were assessed. The intake of P but not of AJ or W was associated with a significant increase in TLR2 ligands and bacterial endotoxin in serum after 120 min and 180 min, respectively. P but not AJ significantly increased bacterial toxin permeation in Caco-2 cells. Our results suggest that the effects of sugar-sweetened beverages on markers of intestinal barrier function markedly differ from those of fruit juices.
PubMed: 38906893
DOI: 10.1038/s41538-024-00283-w -
Sleep Medicine May 2024Insomnia is highly prevalent in stroke patients; however, there is no ideal intervention. This systematic review examined the effect and safety of Chinese herbal...
BACKGROUND
Insomnia is highly prevalent in stroke patients; however, there is no ideal intervention. This systematic review examined the effect and safety of Chinese herbal medicine (CHM) and acupuncture on sleep in adults with stroke.
METHODS
Six databases were searched from inception to June 2023 to identify randomised controlled trials (RCTs). The primary outcome was Pittsburgh Sleep Quality Index (PSQI) scores. Risk of bias and evidence quality was assessed. A pairwise random-effect meta-analysis was performed.
RESULTS
A total of 54 RCTs published in 55 articles were finally included in the systematic review, including 35 of CHM and 19 of acupuncture therapies. Compared with placebo/sham procedure, CHM and acupuncture were more effective in improving PSQI scores. The evidence of moderate quality suggested that CHM outperformed benzodiazepine drugs (BZDs) while it presented an effect similar to that of non-BZDs in improving sleep quality. CHM and acupuncture also provided additional benefits to the patients treated with pharmacological agents alone. However, the evidence specific to individual CHM prescriptions lay in various factors and methodological quality, and the evidence on the comparative effectiveness between acupuncture and other therapies was conflicting or limited.
CONCLUSIONS
Overall, CHM and acupuncture used alone or in combination with pharmacotherapy can safely improve sleep in stroke patients with insomnia. In the future, RCTs on outstanding CHM prescriptions and the comparative effectiveness research between acupuncture and other therapies are needed.
REGISTRATION
PROSPERO No. CRD42020194029 and No. CRD42020194030.
PubMed: 38905930
DOI: 10.1016/j.sleep.2024.05.006 -
Indian Journal of Ophthalmology Jul 2024To evaluate the effect of topical carbonic anhydrase inhibitor (brinzolamide) versus placebo on visual function and waveforms in infantile nystagmus syndrome (INS). (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
To evaluate the effect of topical carbonic anhydrase inhibitor (brinzolamide) versus placebo on visual function and waveforms in infantile nystagmus syndrome (INS).
DESIGN
Prospective, placebo-controlled, double-blind, cross-over study.
METHODS
Setting- A tertiary eye care center. Patients- Cases of idiopathic INS with and without abnormal head posture aged ≥10 years who had not received previous treatment for nystagmus. Intervention- Patients were randomized into two groups. Group 1 was given placebo for 3 months, and after a washout period of 7 days started on topical brinzolamide for the next 3 months. In group 2, the order was reversed. The drops were administered topically three times (every 8 hours) in both eyes. Outcome measure- Binocular best corrected visual acuity (BCVA) using the ETDRS chart, eXpanded nystagmus acuity function (NAFX) score and INS waveforms obtained from eye movement recordings, intraocular pressure (IOP) by Goldmann applanation tonometer, near stereopsis by TNO stereo test, and change in abnormal head posture before and after intervention in the null position.
RESULTS
A total of 29 cases completed the study (23 with abnormal head posture; 6 without abnormal head posture).
UNLABELLED
A significant improvement was noted in INS waveform characteristics, mean NAFX score (P < 0.001), and mean binocular visual acuity (P < 0.001) with topical brinzolamide in comparison to baseline as well as placebo. No significant change in head position and stereopsis was noted. No side effects were reported with 3 months of brinzolamide therapy.
CONCLUSIONS
While brinzolamide shows improvement in visual acuity and NAFX score in idiopathic INS, its clinical significance needs further evidence.
Topics: Humans; Carbonic Anhydrase Inhibitors; Double-Blind Method; Male; Female; Visual Acuity; Prospective Studies; Cross-Over Studies; Thiazines; Sulfonamides; Administration, Topical; Child; Adult; Ophthalmic Solutions; Adolescent; Nystagmus, Congenital; Treatment Outcome; Young Adult; Follow-Up Studies; Middle Aged; Eye Movements; Vision, Binocular
PubMed: 38905461
DOI: 10.4103/IJO.IJO_1010_23 -
Medicine Jun 2024Flibanserin, approved for the treatment of hypoactive sexual desire disorder (HSDD) in females, has demonstrated diverse therapeutic and adverse effect (AE) prospects in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Flibanserin, approved for the treatment of hypoactive sexual desire disorder (HSDD) in females, has demonstrated diverse therapeutic and adverse effect (AE) prospects in the extant randomized controlled trials (RCTs). This meta-analysis aimed to characterize the outcomes of flibanserin use in these patients comprehensively.
METHODS
RCTs involving women with HSDD receiving flibanserin in the intervention arm and placebo in the control arm were sought after throughout the electronic databases. The primary outcomes were the changes from baseline in satisfying sexual events (SSE) per month and sexual desire score per month measured using an electronic diary (eDiary).
RESULTS
From 478 initially screened articles, data from 8 RCTs involving 7906 women with HSDD were analyzed. In premenopausal women, flibanserin 100 mg was superior to placebo in improving the number of SSE per month (mean difference, MD 0.69, 95% CI [0.39, 0.99]), eDiary sexual desire score (MD 1.71, 95% CI [0.43, 2.98]), Female Sexual Function Index (FSFI) desire domain (FSFI-d) score (MD 0.30, 95% CI [0.29, 0.31]), FSFI total score (MD 2.51, 95% CI [1.47, 3.55]), Female Sexual Distress Scale-Revised (FSDS-R) Item 13 score (MD -0.30, 95% CI [-0.31, -0.29]), and FSDS-R total score (MD -3.30, 95% CI [-3.37, -3.23]). Compared to placebo, a higher number of premenopausal women using flibanserin 100 mg achieved improvements in the Patient's Global Impression of Improvement score (OR 1.93, 95% CI [1.58, 2.36], P < .00001) and responded positively at Patient Benefit Evaluation (PBE) (odds ratio, OR 1.76, 95% CI [1.34, 2.31], P < .0001). Postmenopausal women receiving flibanserin 100 mg also benefited in terms of the number of SSE per month, FSFI-d and total scores, FSDS-R Item 13 and total scores, and PBE response. Although flibanserin use was associated with higher risks of dizziness, fatigue, nausea, somnolence, and insomnia, these adverse events were mild in nature; the serious AEs and severe AEs were comparable between the flibanserin and placebo groups.
CONCLUSION
While flibanserin has demonstrated efficacy in the treatment of HSDD in both pre- and postmenopausal women, its therapeutic advantages may be overshadowed by the higher likelihood of AEs.
Topics: Female; Humans; Benzimidazoles; Libido; Premenopause; Randomized Controlled Trials as Topic; Sexual Dysfunctions, Psychological; Treatment Outcome
PubMed: 38905407
DOI: 10.1097/MD.0000000000038592 -
Critical Care Explorations Jul 2024Although clinicians may use methylene blue (MB) in refractory septic shock, the effect of MB on patient-important outcomes remains uncertain. We conducted a systematic... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Although clinicians may use methylene blue (MB) in refractory septic shock, the effect of MB on patient-important outcomes remains uncertain. We conducted a systematic review and meta-analysis to investigate the benefits and harms of MB administration in patients with septic shock.
DATA SOURCES
We searched six databases (including PubMed, Embase, and Medline) from inception to January 10, 2024.
STUDY SELECTION
We included randomized clinical trials (RCTs) of critically ill adults comparing MB with placebo or usual care without MB administration.
DATA EXTRACTION
Two reviewers performed screening, full-text review, and data extraction. We pooled data using a random-effects model, assessed the risk of bias using the modified Cochrane tool, and used Grading of Recommendations Assessment, Development, and Evaluation to rate certainty of effect estimates.
DATA SYNTHESIS
We included six RCTs (302 patients). Compared with placebo or no MB administration, MB may reduce short-term mortality (RR [risk ratio] 0.66 [95% CI, 0.47-0.94], low certainty) and hospital length of stay (mean difference [MD] -2.1 d [95% CI, -1.4 to -2.8], low certainty). MB may also reduce duration of vasopressors (MD -31.1 hr [95% CI, -16.5 to -45.6], low certainty), and increase mean arterial pressure at 6 hours (MD 10.2 mm Hg [95% CI, 6.1-14.2], low certainty) compared with no MB administration. The effect of MB on serum methemoglobin concentration was uncertain (MD 0.9% [95% CI, -0.2% to 2.0%], very low certainty). We did not find any differences in adverse events.
CONCLUSIONS
Among critically ill adults with septic shock, based on low-certainty evidence, MB may reduce short-term mortality, duration of vasopressors, and hospital length of stay, with no evidence of increased adverse events. Rigorous randomized trials evaluating the efficacy of MB in septic shock are needed.
REGISTRATION
Center for Open Science (https://osf.io/hpy4j).
Topics: Methylene Blue; Humans; Shock, Septic; Randomized Controlled Trials as Topic; Length of Stay; Critical Illness
PubMed: 38904978
DOI: 10.1097/CCE.0000000000001110