scholarly journals Metal excretion and magnesium retention in patients with intermittent claudication treated with intravenous disodium EDTA

1996 ◽  
Vol 42 (12) ◽  
pp. 1938-1942 ◽  
Author(s):  
B Guldager ◽  
P J Jørgensen ◽  
P Grandjean
Keyword(s):  
Intermittent Claudication ◽  
Controlled Trial ◽  
Serum Zinc ◽  
Blood Lead ◽  
Treated Group ◽  
The Body ◽  
Control Group ◽  
Disodium Edta ◽  
Double Blind ◽  
Blood Concentrations

Abstract Sixty patients with intermittent claudication participated in a double-blind placebo-controlled trial of 20 courses of intravenous chelation therapy with 3 g of disodium EDTA vs placebo during 5-9 weeks. After the first infusion, the 24-h urinary excretion of lead and zinc was approximately 25-fold higher in the EDTA-treated group; relative differences for copper and calcium were smaller. Urinary magnesium excretion in the EDTA-treated group was one-third less than in the control group. After the treatment period, the blood lead concentration had decreased by approximately 73% and the serum zinc concentration by approximately 34%; other changes in blood concentrations were negligible. The loss of essential minerals and the possible redistribution of lead in the body may constitute a disadvantage that should be taken into account in repeated intravenous EDTA treatment.

scholarly journals The Evaluation of the Body Weight Lowering Effects of Herbal Extract THI on Exercising Healthy Overweight Humans: A Randomized Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Soo Hyun Cho ◽  
Yoosik Yoon ◽  
Young Yang
Keyword(s):  
Body Weight ◽  
Controlled Trial ◽  
Safety Evaluation ◽  
Hdl Cholesterol ◽  
Treated Group ◽  
The Body ◽  
Herbal Extract ◽  
Double Blind ◽  
The Difference ◽  
Group 2

We investigated the effects of herbal extracts, a mixture of Scutellariae Radix and Platycodi Radix containing the active ingredients Baicalin and Saponin (target herbal ingredient (THI)), on lowering body weight. The present study was a prospective, randomized, double-blind, and placebo-controlled trial carried out at the outpatient department of a hospital over a period of 2 months. Group 1 patients (n=30) received THI, and group 2 patients (n=23) received placebo three times a day before meals. Weight, waist circumference, BMI, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and glucose were measured at baseline and again at the 2nd month. For safety evaluation, various hematological and biochemical parameters were assessed. Values of mean change of weight in the THI-treated group were−1.16±1.41 kg and in the placebo-treated group were−0.24±1.70 kg, respectively. The difference in mean change of weight in the THI-treated group compared with that in the placebo-treated group was statistically significant (P<0.05). The incidence of subjective and objective adverse drug reactions was insignificant (P>0.05). THI was statistically significant in its effectiveness on the weight loss.

scholarly journals Potent protective effects of polysaccharide peptide on vascular endothelium and cardiac remodelling in post myocardial infarction patients: A prospective double-blind randomized controlled trial

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
HA Liemena ◽  
D Sargowo ◽  
FW Nugroho ◽  
MR Fadlan ◽  
P Sugita
Keyword(s):  
Myocardial Infarction ◽  
Vascular Endothelium ◽  
Controlled Trial ◽  
Treated Group ◽  
Control Group ◽  
Protective Effects ◽  
Double Blind ◽  
Research And Innovation ◽  
Tnf Α ◽  
Reverse Remodelling

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Indonesia"s Ministry of Research and Technology/National Research and Innovation Agency grants Background Inflammation and oxidative stress contribute to endothelial dysfunction leading to progression of atherosclerosis and myocardial infarction (MI). Purpose To evaluate the effect of polysaccharide peptide of Ganoderma lucidum mycelium extracts (β-1,3/1,6-D-Glucan) as protective vascular endothelium and cardiac reverse remodelling in post MI. Methods This is a prospective, randomized double-blind clinical trial in 45 post MI patients. Treated group (TG) was given 3 divided dose of 540 mg β-1,3/1,6-D-Glucan daily for 90 days, and control group (CG) received placebo. Variable measured were EPC,CEC,IL-1,IL-6,TNF-α,hsCRP,NO,SOD,MDA and echocardiography parameters. Results β-1,3/1,6-D-Glucan administration significantly increased EPCs (P = 0.000), but not significantly reduced CECs (P = 0.069). Significant suppression was found in IL-1, IL-6 and TNF-α (all P &lt; 0.05), but not in hsCRP (P = 0.064). TG exhibited significant elevation of NO (P = 0.02) and SOD (P = 0.023), and reduction of MDA (P = 0.001). TG revealed significant improvement of LVEF, LVMI, LVIDd, RWT, RWMA and LV diastolic dysfunction (all P &lt; 0.05); but not in FS and TAPSE (P = 0.24, P = 0.20; respectively). Conclusions Polysaccharide peptide exhibits potent protective vascular endothelium and cardiac reverse remodelling in post MI patients, hence promising as add-on medication on top of standard medical regiment. Result comparison between study groupsVariableMeanPretestMean Difference Post-testP valuePolysaccharide peptide (β-1,3/1,6-D-Glucan)PlaceboVascular Endothelium BiomarkersCECsEPCs87.99 ± 76.7398.32 ± 44.52-48.01 ± 64.0714.90 ± 24.05-13.84 ± 58.67-17.65 ± 27.870.0690.000Oxidative Stress MarkersSODMDANitric Oxide2.93 ± 0.5419.68 ± 9.9737.98 ± 14.440.26 ± 0.74-5.52 ± 10.756.04 ± 9.27-0.23 ± 0.685.75 ± 10.29-0.62 ± 3.300.0230.0010.02Proinflammatory BiomarkershsCRPTNF-αIL-1IL-62512.90 ± 1332.11348.58 ± 85.0392.14 ± 29.62259.40 ± 125.52-6.78 ± 1099.60-44.98 ± 100.94-15.77 ± 27.06-29.63 ± 104.30-1.42 ± 795.35-1.34 ± 104.893.42 ± 33.1475.77 ± 130.830.0640.0060.0420.005Echocardiographic ParametersLVEFFSLVMITAPSELVIDdRWT57.20 ± 11.3930.85 ± 7.07114.07 ± 59.612.14 ± 0.354.86 ± 0.820.54 ± 0.352.30 ± 9.770.73 ± 7.59-4.55 ± 14.460.99 ± 0.49-0.49 ± 0.45-0.14 ± 0.29-2.08 ± 3.353.74 ± 9.2711.48 ± 23.94-0.17 ± 0.340.23 ± 0.430.03 ± 0.040.0080.2480.0430.2020.0000.017Abstract Figure. Comparison among pre- and post-treatment

scholarly journals Effect of cyproheptadine on weight gain in malnourished children: a randomized, controlled trial

2010 ◽  
Vol 4 (6) ◽  
pp. 977-982 ◽  
Author(s):  
Sanguansak Rerksuppaphol ◽  
Lakkana Rerksuppaphol
Keyword(s):  
Weight Gain ◽  
Adverse Events ◽  
Physical Examination ◽  
Controlled Trial ◽  
Treated Group ◽  
The Body ◽  
Control Group ◽  
Body Fat Percentage ◽  
Fat Percentage ◽  
Malnourished Children

Abstract Background: Cyproheptadine has been used therapeutically as an appetite stimulant in various chronic illnesses. However, no clinical data are available on the therapeutic effect of cyproheptadine in malnourished children without underlying pathological conditions. Objective: Investigate the short-term effect of cyproheptadine on weight gain in malnourished children who appear otherwise normal on physical examination. Methods: Seventy malnourished children who were otherwise normal on physical examination were recruited to participate in a randomized, double-blind, placebo-controlled trial. Thirty-seven children were randomized to a treatment regimen of cyproheptadine (0.1 mg/kg/dose, three times/day for eight weeks), and 33 children were randomized to receive placebo over a period of eight weeks. Subjects were evaluated at a baseline visit and at four visits at two-week intervals. Parameters assessed included baseline demographics, anthropometrics (weight, height, skin-fold thickness, waist and hip circumferences, and fat composition by bioelectric impedance analysis), adverse events, and pill counts. Data were analyzed by Student’s t-test and Chi-square test; a p- value < 0.05 was considered significant. Results: No significant differences were observed in baseline demographic characteristics and anthropometric parameters between the groups. The cyproheptadine-treated group showed a significantly greater weight gain over the baseline compared with the control group. The absolute weight gain was significantly higher in the cyproheptadine-treated group than in the control group at the end of study. No significant difference was observed in the change in the body fat percentage between the groups. No serious adverse events were reported. Adverse events included mild sedation, nausea, diarrhea, abdominal pain, and headache. No significant differences in the frequency of adverse events were observed between the groups. Conclusions: Cyproheptadine treatment was well tolerated and resulted in significant weight gain in malnourished children, without increasing the body fat percentage.

scholarly journals Impact of Althaea Officinalis extract in patients with atopic eczema: a double-blind randomized controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Negar Khalighi ◽  
Farahzad Jabbari-Azad ◽  
Maral Barzegar-Amini ◽  
Jalil Tavakkol-Afshari ◽  
Pouran Layegh ◽  
...  
Keyword(s):  
Atopic Eczema ◽  
Controlled Trial ◽  
Similar Efficacy ◽  
The Body ◽  
Control Group ◽  
Double Blind ◽  
Prick Test ◽  
Flower Extract ◽  
Althaea Officinalis ◽  
The Impact

Abstract Background Althaea Officinalis introduced as an emerging anti-inflammatory agent with immunomodulatory effects that may suppress the symptoms of atopic eczema. In this study, we aimed to investigate the impact of liposomal formulation of Althaea Officinalis flower extract compared with steroids for atopic eczema treatment. Methods In this randomized, double-blind controlled trial phase II, forty patients with moderate to severe allergic atopic eczema confirmed by skin prick test were enrolled in the study from October 2018 to January 2019. Steroids on the lesions of the left side of the body and topical Althaea Officinalis extract (intervention) or eucerin as a topical placebo on the lesions of the right side of the body were tested. SCORAD (SCORing Atopic Dermatitis) was assessed at the baseline, and two, and four weeks after completing the trial. Data were analyzed by SPSS version 22. Results In the active treatment group, after two weeks, the SCORAD was significantly lower in the left side (recovery with steroid treatment) (p < 0.001), and after 4 weeks the SCORAD was lower on both sides, and there were no significant differences between two sides (similarity between Althaea Officinalis and steroid effects). In the control group, the SCORAD score was significantly lower on the left side (steroid) after two and four weeks (p < 0.001). There was no side effect and reaction to drugs. Conclusions Considering the potential side effects of steroids, and the similar efficacy of Althaea Officinalis flower extract, using this component may be accompanied by higher benefits in patients with atopic eczema. Trial registration IRCT2016102323235N5.

scholarly journals Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽  
2021 ◽  
Vol 41 (3) ◽  
pp. 294-304 ◽  
Author(s):  
Messoud Ashina ◽  
Uwe Reuter ◽  
Timothy Smith ◽  
Judith Krikke-Workel ◽  
Suzanne R Klise ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Study Drug ◽  
Statistical Testing ◽  
Control Group ◽  
Double Blind ◽  
Treatment Groups ◽  
Primary Endpoints ◽  
Registration Number ◽  
Secondary Endpoints ◽  
Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

scholarly journals Single High-Dose Vitamin D Supplementation as an Approach for Reducing Ultramarathon-Induced Inflammation: A Double-Blind Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1280
Author(s):  
Jan Mieszkowski ◽  
Andżelika Borkowska ◽  
Błażej Stankiewicz ◽  
Andrzej Kochanowicz ◽  
Bartłomiej Niespodziński ◽  
...  
Keyword(s):  
Vitamin D ◽  
Inflammatory Marker ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Oncostatin M ◽  
Control Group ◽  
High Dose ◽  
Double Blind ◽  
Single High Dose ◽  
High Dose Vitamin

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.

scholarly journals Consumption of a Double-Fortified Salt Affects Perceptual, Attentional, and Mnemonic Functioning in Women in a Randomized Controlled Trial in India

2017 ◽  
Vol 147 (12) ◽  
pp. 2297-2308 ◽  
Author(s):  
Michael J Wenger ◽  
Laura E Murray-Kolb ◽  
Julie EH Nevins ◽  
Sudha Venkatramanan ◽  
Gregory A Reinhart ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Status ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Deficiency Anemia ◽  
Control Group ◽  
Attention And Memory ◽  
Double Blind ◽  
Iron Deficient ◽  
Mnemonic Function

Abstract Background: Iron deficiency and iron deficiency anemia have been shown to have negative effects on aspects of perception, attention, and memory. Objective: The purpose of this investigation was to assess the extent to which increases in dietary iron consumption are related to improvements in behavioral measures of perceptual, attentional, and mnemonic function. Methods: Women were selected from a randomized, double-blind, controlled food-fortification trial involving ad libitum consumption of either a double-fortified salt (DFS) containing 47 mg potassium iodate/kg and 3.3 mg microencapsulated ferrous fumarate/g (1.1 mg elemental Fe/g) or a control iodized salt. Participants' blood iron status (primary outcomes) and cognitive functioning (secondary outcomes) were assessed at baseline and after 10 mo at endline. The study was performed on a tea plantation in the Darjeeling district of India. Participants (n = 126; 66% iron deficient and 49% anemic at baseline) were otherwise healthy women of reproductive age, 18–55 y. Results: Significant improvements were documented for iron status and for perceptual, attentional, and mnemonic function in the DFS group (percentage of variance accounted for: 16.5%) compared with the control group. In addition, the amount of change in perceptual and cognitive performance was significantly (P < 0.05) related to the amount of change in blood iron markers (mean percentage of variance accounted for: 16.0%) and baseline concentrations of blood iron markers (mean percentage of variance accounted for: 25.0%). Overall, there was evidence that the strongest effects of change in iron status were obtained for perceptual and low-level attentional function. Conclusion: DFS produced measurable and significant improvements in the perceptual, attentional, and mnemonic performance of Indian female tea pickers of reproductive age. This trial was registered at clinicaltrials.gov as NCT01032005.

Controlled Study of the Use of Local Steroid Injection in the Treatment of Trigger Finger and Thumb

1992 ◽  
Vol 17 (1) ◽  
pp. 69-70 ◽  
Author(s):  
M. A. LAMBERT ◽  
R. J. MORTON ◽  
J. P. SLOAN
Keyword(s):  
Local Anaesthetic ◽  
Steroid Injection ◽  
Controlled Trial ◽  
Trigger Finger ◽  
Controlled Study ◽  
Control Group ◽  
Methylprednisolone Acetate ◽  
Double Blind ◽  
Local Steroid Injection ◽  
Control Injection

A controlled double-blind prospective study of injection of methylprednisolone acetate plus local anaesthetic against a control injection of a local anaesthetic in the treatment of trigger finger and thumb has shown a 60% success rate for the steroid injection against 16% for the control group (p < 0.05). This is the first controlled trial of local steroid therapy in this condition.

scholarly journals Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA)

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037842
Author(s):  
Wei Chen ◽  
Naya Huang ◽  
Haiping Mao ◽  
Xiao Yang ◽  
Qian Zhou ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Cardiovascular Outcomes ◽  
Control Group ◽  
Type I ◽  
Dialysis Patients ◽  
Double Blind ◽  
Randomised Controlled

IntroductionThe prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.Methods and analysesThis prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.Trial registration numberNCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.Protocol versionThe protocol version number and date are YLT-1604-V2.0 and 15 December 2016.

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