scholarly journals Effect of GutGard in the Management ofHelicobacter pylori: A Randomized Double Blind Placebo Controlled Study

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Sreenivasulu Puram ◽  
Hyung Chae Suh ◽  
Seung Un Kim ◽  
Bharathi Bethapudi ◽  
Joshua Allan Joseph ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Treated Group ◽  
Controlled Study ◽  
Root Extract ◽  
Double Blind ◽  
Exact Probability ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
The Difference ◽  
H Pylori

A randomized, double blind placebo controlled study was conducted to evaluate the efficacy of GutGard (root extract ofGlycyrrhiza glabra) in the management ofHelicobacter pylori(H. pylori) gastric load. Participants diagnosed withH. pyloriinfection were randomly assigned to two groups to orally receive 150 mg of GutGard (n=55) or placebo (n=52) once daily for 60 days.H. pyloriinfection was assessed using13C-urea breath test (13C-UBT) at days 0, 30, and 60. Stool Antigen test (HpSA) was also performed on days 0, 30, and 60. Repeated measures of analysis of variance (RMANOVA), chi-square, and Fisher's exact probability tests were used to compare the treatment outcomes. A significant interaction effect between group and time (P=0.00) and significant difference in mean Delta Over Baseline (DOB) values between GutGard (n=50) and placebo (n=50) treated groups after intervention period were observed. On day 60, the results of HpSA test were negative in 28 subjects (56%) in GutGard treated group whereas in placebo treated group only 2 subjects (4%) showed negative response; the difference between the groups was statistically significant. On day 60, the results of13C-UBT were negative in 24 (48%) in GutGard treated group and the difference between the groups was statistically significant. The findings suggest GutGard is effective in the management ofH. pylori.

scholarly journals RANDOMISED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF FOLIC ACID ADJUNCT FOR 8 WEEKS IN HYPERHOMOCYSTEINAEMIC HYPERTENSIVE PATIENTS IN ZARIA, NIGERIA

2018 ◽  
Vol 8 (5) ◽  
pp. 338-348 ◽  
Author(s):  
Obiageli U ONYEMELUKWE ◽  
Bilkisu B MAIHA ◽  
Lydia O AYANWUYI ◽  
Tukur DAHIRU
Keyword(s):  
Blood Pressure ◽  
Folic Acid ◽  
Repeated Measures ◽  
Controlled Study ◽  
Base Line ◽  
Double Blind ◽  
Adjunct Therapy ◽  
Hypertensive Patients ◽  
Double Blind Placebo ◽  
Significant Difference

Objectives: This study was aimed at determining the effect of folic acid adjunct therapy on homocysteine (HCY) and blood pressure (BP) levels in hypertensive subjects. Method: The study was a double blind placebo-controlled trial on 100 hypertensive patients randomised into 50 folate and 50 placebo groups, where the folate group had 5 mg folic acid daily for 8 weeks. Fasting plasma homocysteine, folate and blood pressure levels were determined at baseline, at 4 and at 8 weeks. The Mixed Model Repeated Measures analysis of variance was applied for data analysis. Results: Hyperhomocysteinaemia was found at baseline in the folate (21.3 ± 5.7 µmol/L) and placebo (21.6 ± 4.9 µmol/L) groups which did not differ statistically (p > 0.05). Folic acid adjunct therapy, reduced homocysteine levels at 4 weeks by 2.0 µmol/L (9.2 %, p < 0.05) and at 8 weeks by 1.2 µmol/L (5.6 %, p < 0.05), with no significant (p > 0.05) systolic and diastolic blood pressure lowering effect. High base-line folate levels were found in both folate (113.8 ± 51.2 ng/ml) and placebo groups (109.5 ± 51.4 ng/ml) with no statistically significant difference (p > 0.05). Conclusion: Short-term daily folic acid supplementation over 8 weeks had a significant homocysteine reduction effect with no significant reduction in systolic and diastolic blood pressures of hypertensive subjects in Zaria, Nigeria. Hyperhomocysteinaemia could not be accounted for by suboptimal folate levels. Keywords: Hypertension, Homocysteine, Blood pressure, Folate, Placebo, Nigeria.

scholarly journals A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Compound Glycyrrhizin Capsules Combined with a Topical Corticosteroid in Adults with Chronic Eczema

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Wei Xu ◽  
Yan Li ◽  
Mei Ju ◽  
Wei Lai ◽  
Xueyan Lu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Topical Corticosteroid ◽  
Group Versus ◽  
Treated Group ◽  
Lower Limbs ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Chronic Eczema

Background. Glycyrrhizin is widely used in skin disorders, such as psoriasis, alopecia areata, and allergic diseases, but has not been extensively studied in patients with chronic eczema. Objective. To evaluate the efficacy and safety of oral compound glycyrrhizin (OCG) plus topical corticosteroid (TCS) in adults with chronic eczema. Methods. This was a multicenter, randomized, double-blind, placebo-controlled study in patients with chronic eczema (n = 199). Randomized participants from 6 centers in China received either 75 mg OCG capsules or placebo capsules three times a day and TCS (i.e., 0.1% mometasone furoate ointment) once a day for 28 days. Efficacy was determined by analyzing the mean change from the baseline using standardized measures including the Investigator’s Global Assessment (IGA) score, Eczema Area and Severity Index (EASI), and the visual analogue scale score (VAS) of itching. Results. Decreases in absolute EASI were significantly greater in the OCG-treated group versus placebo on day 14 (−3.41 ± 1.41 vs. −2.71 ± 1.25, P<0.001) and day 28 (−7.39 ± 1.71 vs. −6.64 ± 1.75, P=0.003). OCG-treated patients also saw greater benefit in other EASI metrics including EASI-50 (96.8% vs. 87.9%, P=0.021) and EASI-75 (47.9% vs. 21.2%, P<0.001) on day 28 compared with placebo. The absolute IGA score reductions were also significantly greater in the OCG group than the placebo (all P<0.05). In addition, proportions of patients who achieve clear (0) IGA scores or almost clear (1) IGA scores were significantly higher in the treated group than placebo on day 14 (22.8% vs. 6.2%, P=0.001) and day 28 (93.5% vs. 79.4%, P=0.005). Moreover, the proportions of patients with reduced pruritus were significantly greater in the treated group than placebo on day 28 (94.7% vs. 83.8%, P=0.016) and eczema recurrence was notably less in the OCG group versus placebo (3.19% vs. 12.12%, P=0.021). Eleven patients experienced adverse events, but there was no significant difference in the proportion of patients affected (3.0% vs. 8.5%, P>0.05). The most common adverse events were edema of both lower limbs. Conclusion. For adults with chronic eczema, OCG capsules combined with TCS is an effective and well-tolerated treatment, suggesting that OCG may be a useful nonsteroidal agent with an additional effect for the treatment of chronic eczema by TCS.

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.

scholarly journals Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study

Gut ◽  
2018 ◽  
Vol 67 (12) ◽  
pp. 2107-2115 ◽  
Author(s):  
Sofie Ingdam Halkjær ◽  
Alice Højer Christensen ◽  
Bobby Zhao Sheng Lo ◽  
Patrick Denis Browne ◽  
Stig Günther ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Controlled Study ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Faecal Microbiota Transplantation ◽  
Faecal Samples ◽  
Significant Difference

ObjectiveIBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.DesignWe performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.ResultsA significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.ConclusionIn this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.Trial registration numberNCT02788071.

Economic evaluation of the randomised, double-blind, placebo-controlled study of subcutaneous ketamine in the management of chronic cancer pain

2018 ◽  
Vol 33 (1) ◽  
pp. 74-81 ◽  
Author(s):  
Nikki McCaffrey ◽  
Thomas Flint ◽  
Billingsley Kaambwa ◽  
Belinda Fazekas ◽  
Debra Rowett ◽  
...  
Keyword(s):  
Palliative Care ◽  
Cost Effectiveness ◽  
Cancer Pain ◽  
Sensitivity Analyses ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Cost Effective Treatment ◽  
Significant Difference ◽  
The Cost

Background: Treating chronic, uncontrolled, cancer pain with subcutaneous ketamine in patients unresponsive to opioids and co-analgesics remains controversial, especially in light of recent evidence demonstrating ketamine does not have net clinical benefit in this setting. Aim: To evaluate the cost-effectiveness of subcutaneous ketamine versus placebo in this patient population. Design and setting: A within-trial cost-effectiveness analysis of the Australian Palliative Care Clinical Studies Collaborative’s randomised, double-blind, placebo-controlled trial of ketamine was conducted from a healthcare provider perspective. Mean costs and outcomes were estimated from participant-level data over 5 days including positive response, health-related quality of life (HrQOL) measured with the Functional Assessment of Chronic Illness Therapy–Palliative Care (FACIT-Pal), ketamine costs, medication usage and in-patient stays. Results: There was no statistically significant difference in responder rates, but higher toxicity and worse HrQOL for ketamine participants (mean change −3.10 (standard error (SE) 1.76), ketamine n = 93; 4.53 (SE 1.38), placebo n = 92). Estimated total mean costs were AU$706 higher per ketamine participant (AU$6608) compared with placebo (AU$5902), attributable to the cost of higher in-patient costs as well as costs of ketamine administration. The results were robust to sensitivity analyses accounting for different medication use costing methods and removal of cost outliers. Conclusion: The findings suggest subcutaneous ketamine in conjunction with opioids and standard adjuvant therapy is neither an effective nor cost-effective treatment for refractory pain in advanced cancer patients.

scholarly journals A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3794
Author(s):  
Yu Hwa Park ◽  
Do Hoon Kim ◽  
Jung Suk Lee ◽  
Hyun Il Jeong ◽  
Kye Wan Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Placebo Group ◽  
Serum Uric Acid ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Food Ingredient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

scholarly journals Beta alanine supplementation effects on metabolic contribution and swimming performance

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Matheus Silva Norberto ◽  
Ricardo Augusto Barbieri ◽  
Danilo Rodrigues Bertucci ◽  
Ronaldo Bucken Gobbi ◽  
Eduardo Zapaterra Campos ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Energy Demand ◽  
Swimming Performance ◽  
Controlled Study ◽  
Double Blind ◽  
Repeated Measures Anova ◽  
Beta Alanine ◽  
Before And After ◽  
The Difference ◽  
And Performance

Abstract Background Investigations of β-alanine supplementation shows effects on metabolic (aerobic and anaerobic) participation and performance on swimming by a possible blood acidosis buffering. Considering this background, the objective of the present study was to analyze the effects of β-alanine supplementation on metabolic contribution and performance during 400-m swim. Methods Thirteen competitive swimmers underwent a 6-week, double-blind placebo-controlled study, ingesting 4.8 g.day− 1 of β-alanine or placebo. Before and after the supplementation period, the total anaerobic contribution (TAn) and 30-s all-out tethered swimming effort (30TS) were assessed. Anaerobic alactic (AnAl) and lactic energy (AnLa) was assumed as the fast component of excess post-exercise oxygen consumption and net blood lactate accumulation during exercise (∆[La−]), respectively. Aerobic contribution (Aer) was determined by the difference between total energy demand and TAn. In addition to conventional statistical analysis (Repeated measures ANOVA; p > 0.05), a Bayesian repeated measures ANOVA was used to evidence the effect probability (BFincl). Results No differences and effects were found between groups, indicating no supplementation effects. Repeated measures ANOVA, with confirmation of effect, was indicate reduce in ∆Lactate (p: 0.001; BFincl: 25.02); absolute AnLa (p: 0.002; BFincl: 12.61), fatigue index (p > 0.001; BFincl: 63.25) and total anaerobic participation (p: 0.008; BFincl: 4.89). Conclusions Thus, the results demonstrated that all changes presented were evidenced as a result of exposure to the training period and β-alanine supplementation doesn’t affect metabolic contribution and performance during 400-m freestyle.

Efficacy of Phenazone in the Treatment of Acute Migraine Attacks: A Double-Blind, Placebo-Controlled, Randomized Study

Cephalalgia ◽  
2004 ◽  
Vol 24 (10) ◽  
pp. 888-893 ◽  
Author(s):  
H Göbel ◽  
A Heinze ◽  
U Niederberger ◽  
T Witt ◽  
V Zumbroich
Keyword(s):  
Adverse Events ◽  
Randomized Study ◽  
Controlled Study ◽  
Acute Migraine ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Number Of Patients ◽  
Significant Difference ◽  
Main Target

In this study we compared the efficacy of 1000 mg phenazone with that of placebo in the treatment of acute migraine attacks in a randomized double-blind, placebo-controlled study of 208 patients. The main target criterion was the number of patients with a pain reduction from severe or moderate to slight or no pain 2 h after taking the pain medication. The percentage of patients satisfying the main target criterion was 48.6% for phenazone and 27.2% ( P < 0.05) for placebo. Freedom from pain after 2 h was reported by 27.6% with phenazone treatment and 13.6% ( P < 0.05) with placebo. Compared with placebo, the phenazone treatment also resulted in a significant improvement in the associated migraine symptoms of nausea, phonophobia and photophobia. Of patients treated with phenazone 11.4%, and 5.8% of those treated with placebo reported adverse events. There was no significant difference between the groups with regard to numbers of patients with adverse events. No serious adverse events occurred. The results show that phenazone at a dosage of 1000 mg is effective and well tolerated in the treatment of acute migraine attacks.

scholarly journals Effect of Anodal-tDCS on Event-Related Potentials: A Controlled Study

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Ahmed Izzidien ◽  
Sriharasha Ramaraju ◽  
Mohammed Ali Roula ◽  
Peter W. McCarthy
Keyword(s):  
Parietal Lobe ◽  
Event Related Potentials ◽  
Controlled Study ◽  
Oddball Paradigm ◽  
Anodal Tdcs ◽  
Neurologically Impaired ◽  
Double Blind ◽  
Significant Difference ◽  
Related Potentials ◽  
The Difference

We aim to measure the postintervention effects of A-tDCS (anodal-tDCS) on brain potentials commonly used in BCI applications, namely, Event-Related Desynchronization (ERD), Event-Related Synchronization (ERS), and P300. Ten subjects were given sham and 1.5 mA A-tDCS for 15 minutes on two separate experiments in a double-blind, randomized order. Postintervention EEG was recorded while subjects were asked to perform a spelling task based on the “oddball paradigm” while P300 power was measured. Additionally, ERD and ERS were measured while subjects performed mental motor imagery tasks. ANOVA results showed that the absolute P300 power exhibited a statistically significant difference between sham and A-tDCS when measured over channel Pz (p=0.0002). However, the difference in ERD and ERS power was found to be statistically insignificant, in controversion of the the mainstay of the litrature on the subject. The outcomes confirm the possible postintervention effect of tDCS on the P300 response. Heightening P300 response using A-tDCS may help improve the accuracy of P300 spellers for neurologically impaired subjects. Additionally, it may help the development of neurorehabilitation methods targeting the parietal lobe.

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