scholarly journals Effect of fermented Rhus verniciflua stokes extract on liver function parameters in healthy Korean adults: a double-blind randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jung Hyun Kwak ◽  
Hyo-Jeong Lee ◽  
Seok-Tae Jeong ◽  
Ju Yeon Lee ◽  
Minho Lee ◽  
...  
Keyword(s):  
Liver Disease ◽  
Liver Function ◽  
Serum Lipid ◽  
Lipid Profiles ◽  
Controlled Study ◽  
Double Blind ◽  
Once Daily ◽  
Korean Adults ◽  
Rhus Verniciflua ◽  
Significant Difference

Abstract Background Fermented Rhus verniciflua Stokes extract (FRVE) reported an anti-hepatic lipidemic property mediated by the upregulation of AMP-activated protein kinase (AMPK) in cell and animal models. However, it remains unclear whether there is an effect of FRVE on liver disease-related parameters and serum lipid levels in humans. We investigated the effects of FRVE intake for 12 weeks on liver disease-related parameters and serum lipid profiles in Korean adults. Methods A randomized, double-blind, placebo-controlled study was conducted among 79 subjects. An aqueous extract of fermented Rhus verniciflua Stokes that was filtered and fermented was prepared. For 12 weeks, the test group (n = 39) consumed two capsules of FRVE (main components: fustin 129 mg and fisetin 59 mg) once daily. The control group (n = 40) consumed two placebo pills (main component: lactose 627.0 mg) once daily. A 1:1 randomization of control and test was performed using computer-generated randomization. Both before and after FRVE intake, anthropometric parameters, liver function-related parameters, and clinical laboratory parameters were measured. The effects between the test and control groups were compared using the Mann-Whitney U test and independent t-test, and the difference between baseline and follow-up values was compared using Wilcoxon rank-sum test and paired t-test. Results There was no significant difference when comparing the change values of liver disease-related parameters and serum lipid profiles in between groups. Conclusions In our study, we did not confirm the significance in liver function parameters and serum lipid profiles. Trial registration The study protocol was registered in the Clinical Research Information Service (CRIS: https://cris.nih.go.kr/cris/index.jsp) under number KCT0005687. Registered on 2 December 2020

Abstract 14476: A Randomized, Double-blind Comparison Study of Royal Jelly to Improve Endothelial Function in Healthy Volunteers

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Koichiro Fujisue ◽  
Kenichi Tsujita
Keyword(s):  
Liver Function ◽  
Endothelial Function ◽  
Healthy Volunteers ◽  
Alanine Aminotransferase ◽  
Royal Jelly ◽  
Lipid Profiles ◽  
Controlled Study ◽  
Double Blind ◽  
Relative Change ◽  
Glutamyl Transpeptidase

Backgrounds: Royal jelly is a creamy substance secreted by honeybees. It has been reported that royal jelly has benefits on dyslipidemia and metabolic syndrome. However, the effects of royal jelly on atherogenesis remains unknown. We prospectively evaluated the effects of royal jelly on endothelial function, which can reflect early atherogenesis, in healthy volunteers. Methods: This was a single center, double-blind, 1:1 randomized placebo-controlled study. One-hundred healthy volunteers were randomly assigned to receive royal jelly 690 mg daily (equivalent 2040 mg of fresh royal jelly) or placebo from October 2018 and December 2019. Royal jelly or placebo were administered for 28 days. Endothelial function assessed by reactive hyperemia peripheral arterial tonometry (RH-PAT) and blood chemistries were compared between baseline and 28 days after enrollment. Primary endpoint was the change of RH-PAT index. Secondary endpoint was the change of liver function and lipid profiles. Results: The mean (SD) age of the participants was 35.0 (9.3) and 36.1 (9.1) years, and male was 45% and 50% in the placebo and the royal jelly group, respectively. The relative change of RH-PAT index was significantly higher in the royal jelly group compared with placebo control (21.4 ± 53.1% vs. 0.05 ± 40.9%, P = 0.037). The relative change of alanine aminotransferase and γ-glutamyl transpeptidase were significantly lower in the royal jelly group than the placebo group (alanine aminotransferase: –6.06 ± 22.2% vs. 11.6 ± 46.5%, P = 0.02; γ-glutamyl transpeptidase: -3.45 ± 17.8% vs. 4.62 ± 19.4%, P = 0.045). Lipid profiles were not significantly different between two study groups. Conclusions: Royal jelly improved endothelial function assessed by RH-PAT and liver function in healthy volunteer. It can be expected that royal jelly has anti-atherogenic property through improving endothelial function.

The Effect of Low Dose Corticosteroids and Theophylline on the Risk of Acute Exacerbations of COPD. The TASCS Randomised Controlled Trial

2020 ◽  
pp. 2003338
Author(s):  
Christine R. Jenkins ◽  
Fu-Qiang Wen ◽  
Allison Martin ◽  
Peter J. Barnes ◽  
Bartolome Celli ◽  
...  
Keyword(s):  
Low Dose ◽  
Controlled Trial ◽  
Oral Prednisone ◽  
Controlled Study ◽  
Chronic Obstructive ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Exacerbation Rate ◽  
Once Daily ◽  
Significant Difference

BackgroundThe highest burden of Chronic Obstructive Pulmonary Disease (COPD) occurs in low and middle income countries. Low cost oral medications, if effective, could enable affordable, accessible COPD treatment.MethodsIn this randomised, 3 arm, double-blind, double dummy, placebo controlled study conducted in 37 centres in China, symptomatic patients with moderate/very severe COPD were randomised 1:1:1 to low dose (LD) theophylline 100 mg bd+prednisone 5 mg once daily; LD theophylline 100 mg bd+placebo once daily; or placebo bd+placebo once daily for 48 weeks. The primary endpoint was annualised exacerbation rate.Findings1670 subjects were randomised, and 1242 completed the study (1142 with acceptable Week 48 data). Subjects (75.7% male) were mean age 64.4 years, with mean (sd) baseline post-bronchodilator Forced Expiratory Volume in 1 s (FEV1) 1.1 (0.4)L, 42.2% predicted and mean (sd) St Georges Respiratory Questionnaire (SGRQ) score 45.8 (20.1). There were negligible differences between annualised exacerbation rates across the three treatments, being 0.89 (95%CI=0.78–1.02) on Prednisone-LD Theophylline; 0.86 (0.75–0.99) on LD Theophylline plus placebo, and 1.00 (0.87–1.14) on double placebo. The Rate Ratio between the first and the pooled comparative arms was 0.96 (0.83–1.12), and for LD Theophylline+placebo versus placebo was 0.866, 95% CI 0.728; 1.029, p=0.101 and for LD Theophylline+Low dose oral Prednisone versus placebo was 0.895, 95% CI 0.755; 1.061, p=0.201. Secondary outcomes of hospitalisations, FEV1, SGRQ and COPD Assessment Test (CAT) score showed no statistically significant difference between treatment arms. Serious adverse events (SAEs) other than exacerbations were <2% and did not differ between the treatment arms.ConclusionsLD theophylline alone or in combination with prednisone did not reduce exacerbation rates or clinically important secondary endpoints compared to placebo.

Multicentre Double-Blind Placebo-Controlled Study of Intravenous and Oral S-Adenosyl-L-Methionine (SAMe) in Cholestatic Patients with Liver Disease

1992 ◽  
Vol 4 (S4) ◽  
pp. 90-100 ◽  
Author(s):  
G. Manzillo ◽  
F. Piccinino ◽  
C. Surrenti ◽  
M. Frezza ◽  
G. A. Giudici ◽  
...  
Keyword(s):  
Liver Disease ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

Abstract TP146: Vagus Nerve Stimulation Paired With Rehabilitation To Improve Upper Limb Function

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Jesse Dawson ◽  
Theresa J Kimberley ◽  
Gerard E Francisco ◽  
Patricia Smith ◽  
Steven C Cramer ◽  
...  
Keyword(s):  
Vagus Nerve ◽  
Upper Extremity ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Human Study ◽  
Controlled Study ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Upper Limb Function ◽  
Significant Difference

Introduction: Vagus Nerve Stimulation (VNS) paired with rehabilitation induces movement specific plasticity in rat motor cortex and improves forepaw function in a rat ischemic model compared to rehabilitation alone. A 20 subject first-in-human study in the UK indicated acceptable safety and feasibility of this approach in patients with arm weakness after stroke and showed a significant difference in favour of VNS paired with rehabilitation in the per-protocol analysis (Upper Extremity Fugl Meyer difference of 9.6 points for VNS vs. 3.0 Control; p = 0.038). We conducted a new, double-blind sham controlled study to further assess this technique. Methods: Subjects with chronic moderate to severe upper extremity hemiparesis secondary to ischemic stroke (Upper Extremity Fugl Meyer (UEFM) 20-50) were enrolled at four sites (3 US, 1 UK). After baseline assessments subjects were implanted with a vagus nerve stimulation device if all eligibility criteria were met. Following implantation, randomization was made to either paired VNS (1/2 second, 30 Hz., 0.8 mA, 100 uS stimulation with task-specific movement) or sham control (stimulation only on first 5 movements). All received the same intensive and task-specific rehabilitation and had 18 treatment sessions (2-hourly, 3 times a week for 6-weeks, approximately 50 repetitions per task and 300 to 400 repetition movements per session). Outcomes were assessed on the first and 30 th day following completion of the 6-week therapy course. Results: Sixteen patients (8 female) were implanted (8 VNS, 8 Control). Mean age (SD) was 63.2(6.9), with an average (SD) of 21.7 months (12.9) post stroke. One study related serious adverse event was reported (a wound infection that resolved with IV antibiotics). Blinded results (change in UEFM, WMFT, and UEFM responders for both groups) will be available and presented. Conclusions: A pivotal study of VNS paired with rehabilitation movements will be justified if preliminary results are confirmed.

Sulphadiazine/Trimethoprim Once Daily in Maxillary Sinusitis: A Randomized Double-Blind Comparison with Sulphamethoxazole/Trimethoprim B.I.D.

1981 ◽  
Vol 9 (6) ◽  
pp. 478-481 ◽  
Author(s):  
Pierre Federspil ◽  
Peter Bamberg
Keyword(s):  
Maxillary Sinusitis ◽  
Favourable Result ◽  
Double Blind Study ◽  
Double Blind ◽  
Once Daily ◽  
Days Of Therapy ◽  
Significant Difference ◽  
Blind Comparison ◽  
Cure Rates

In a randomized double-blind study fifty-four patients suffering from acute maxillary sinusitis were treated for 10 days with daily doses of sulphadiazine/trimethopim (1 g) and sulphamethoxazole/trimethoprim (1.92 g), respectively. The efficacy was evaluated clinically at two follow-up visits. X-ray investigations were performed at admission and after the therapy. Of thirty-nine patients finally evaluated, thirty-seven showed a favourable result. After 6–8 days of therapy there was significant difference in cure rates in favour of sulphadiazine/trimethoprim (p < 0.05) while the outcome as evaluated after treatment was similar for both drugs.

scholarly journals Involvement of N-methyl-d-aspartate receptors in plasticity induced by paired corticospinal-motoneuronal stimulation in humans

2018 ◽  
Vol 119 (2) ◽  
pp. 652-661 ◽  
Author(s):  
Siobhan C. Dongés ◽  
Jessica M. D’Amico ◽  
Jane E. Butler ◽  
Janet L. Taylor
Keyword(s):  
Biceps Brachii ◽  
Motor Evoked Potentials ◽  
Controlled Study ◽  
Spinal Level ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Human Spinal Cord ◽  
Significant Difference ◽  
Antidromic Potentials ◽  
Dependent Mechanism

Plasticity can be induced at human corticospinal-motoneuronal synapses by delivery of repeated, paired stimuli to corticospinal axons and motoneurons in a technique called paired corticospinal-motoneuronal stimulation (PCMS). To date, the mechanisms of the induced plasticity are unknown. To determine whether PCMS-induced plasticity is dependent on N-methyl-d-aspartate receptors (NMDARs), the effect of the noncompetitive NMDAR antagonist dextromethorphan on PCMS-induced facilitation was assessed in a 2-day, double-blind, placebo-controlled experiment. PCMS consisted of 100 pairs of stimuli, delivered at an interstimulus interval that produces facilitation at corticospinal-motoneuronal synapses that excite biceps brachii motoneurons. Transcranial magnetic stimulation elicited corticospinal volleys, which were timed to arrive at corticospinal-motoneuronal synapses just before antidromic potentials elicited in motoneurons with electrical brachial plexus stimulation. To measure changes in the corticospinal pathway at a spinal level, biceps responses to cervicomedullary stimulation (cervicomedullary motor evoked potentials, CMEPs) were measured before and for 30 min after PCMS. Individuals who displayed a ≥10% increase in CMEP size after PCMS on screening were eligible to take part in the 2-day experiment. After PCMS, there was a significant difference in CMEP area between placebo and dextromethorphan days ( P = 0.014). On the placebo day PCMS increased average CMEP areas to 127 ± 46% of baseline, whereas on the dextromethorphan day CMEP area was decreased to 86 ± 33% of baseline (mean ± SD; placebo: n = 11, dextromethorphan: n = 10). Therefore, dextromethorphan suppressed the facilitation of CMEPs after PCMS. This indicates that plasticity induced at synapses in the human spinal cord by PCMS may be dependent on NMDARs. NEW & NOTEWORTHY Paired corticospinal-motoneuronal stimulation can strengthen the synaptic connections between corticospinal axons and motoneurons at a spinal level in humans. The mechanism of the induced plasticity is unknown. In our 2-day, double-blind, placebo-controlled study we show that the N-methyl-d-aspartate receptor (NMDAR) antagonist dextromethorphan suppressed plasticity induced by paired corticospinal-motoneuronal stimulation, suggesting that an NMDAR-dependent mechanism is involved.

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