The blind leading the blind: Problems with the ?double-blind? design in clinical biofeedback research

1983 ◽  
Vol 8 (1) ◽  
pp. 1-2 ◽  
Author(s):  
Richard S. Surwit ◽  
Francis J. Keefe
Keyword(s):  
Double Blind ◽  
Clinical Biofeedback ◽  
Double Blind Design ◽  
Biofeedback Research

scholarly journals Cerebellar rTMS in PSP: a Double-Blind Sham-Controlled Study Using Mobile Health Technology

2021 ◽  
Author(s):  
Andrea Pilotto ◽  
Maria Cristina Rizzetti ◽  
Alberto Lombardi ◽  
Clint Hansen ◽  
Michele Biggi ◽  
...  
Keyword(s):  
Digital Technology ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Health Technology ◽  
Controlled Study ◽  
Double Blind ◽  
Non Invasive ◽  
Lower Back ◽  
Before And After ◽  
Double Blind Design ◽  
Theta Burst

AbstractThere are no effective treatments in progressive supranuclear palsy (PSP). The aim of this study was to test the efficacy of theta burst repetitive transcranial magnetic stimulation (rTMS) on postural instability in PSP. Twenty PSP patients underwent a session of sham or real cerebellar rTMS in a crossover design. Before and after stimulation, static balance was evaluated with instrumented (lower back accelerometer, Rehagait®, Hasomed, Germany) 30-s trials in semitandem and tandem positions. In tandem and semitandem tasks, active stimulation was associated with increase in time without falls (both p=0.04). In the same tasks, device-extracted parameters revealed significant improvement in area (p=0.007), velocity (p=0.005), acceleration and jerkiness of sway (p=0.008) in real versus sham stimulation. Cerebellar rTMS showed a significant effect on stability in PSP patients, when assessed with mobile digital technology, in a double-blind design. These results should motivate larger and longer trials using non-invasive brain stimulation for PSP patients.

scholarly journals The Composition and Diversity of the Gut Microbiota in Children Is Modifiable by the Household Dogs: Impact of a Canine-Specific Probiotic

2021 ◽  
Vol 9 (3) ◽  
pp. 557
Author(s):  
Carlos Gómez-Gallego ◽  
Mira Forsgren ◽  
Marta Selma-Royo ◽  
Merja Nermes ◽  
Maria Carmen Collado ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Home Environment ◽  
Double Blind ◽  
Before And After ◽  
Probiotic Intervention ◽  
Probiotic Product ◽  
Acid Producing Bacteria ◽  
Double Blind Design ◽  
To Receive ◽  
Gut Microbiota Composition

The development of the infant gut microbiota is initiated during pregnancy and continued through early life and childhood, guided by the immediate environment of the child. Our aim was to characterize the shared microbiota between dogs and children as well as to determine whether introduction to dogs of a dog-specific probiotic combination modifies the transfer process. We studied 31 children from allergic families with pet dog(s) and 18 control families without a dog. Altogether 37 dogs were randomized for a 4-week period in a double-blind design to receive canine-derived probiotic product containing a mixture of L. fermentum, L. plantarum, and L. rhamnosus, or placebo. Fecal samples from children and dogs were taken before and after the treatment. Distinctive gut microbiota composition was observed in children with dogs compared to those without a dog, characterized by higher abundance of Bacteroides and short-chain fatty acid producing bacteria such as Ruminococcus and Lachnospiraceae. Probiotic intervention in dogs had an impact on the composition of the gut microbiota in both dogs and children, characterized by a reduction in Bacteroides. We provide evidence for a direct effect of home environment and household pets on children microbiota and document that modification of dog microbiota by specific probiotics is reflected in children’s microbiota.

scholarly journals Antioxidant and anti-nociceptive effects of Phyllanthus amarus on improving exercise recovery in sedentary men: a randomized crossover (double-blind) design

2014 ◽  
Vol 11 (1) ◽  
pp. 9 ◽  
Author(s):  
Thapanee Roengrit ◽  
Panakaporn Wannanon ◽  
Piyapong Prasertsri ◽  
Yupaporn Kanpetta ◽  
Bung-orn Sripanidkulchai ◽  
...  
Keyword(s):  
Phyllanthus Amarus ◽  
Exercise Recovery ◽  
Double Blind ◽  
Double Blind Design

Changes in psychopathology and dyskinesia after neuroleptic withdrawal in a double-blind design

1993 ◽  
Vol 10 (3) ◽  
pp. 267-271 ◽  
Author(s):  
Lisa Dixon ◽  
Gunvant Thaker ◽  
Robert Conley ◽  
David Ross ◽  
Nicola Cascella ◽  
...  
Keyword(s):  
Double Blind ◽  
Double Blind Design ◽  
Neuroleptic Withdrawal

Effects of acute caffeine withdrawal on habituated male runners

1994 ◽  
Vol 76 (3) ◽  
pp. 1043-1048 ◽  
Author(s):  
R. K. Hetzler ◽  
N. Warhaftig-Glynn ◽  
D. L. Thompson ◽  
E. Dowling ◽  
A. Weltman
Keyword(s):  
Repeated Measures ◽  
Lactate Threshold ◽  
Substrate Utilization ◽  
Caffeine Intake ◽  
Loading Dose ◽  
Testing Session ◽  
O2 Uptake ◽  
Double Blind ◽  
Caffeine Withdrawal ◽  
Double Blind Design

This study investigated the effects of caffeine withdrawal on six trained caffeine-habituated male runners: age 29.8 +/- 5.8 (SD) yr, height 180.4 +/- 5.4 cm, weight 77.3 +/- 6.7 kg, maximal O2 uptake 63.0 +/- 5.4 ml.kg-1.min-1, and daily caffeine intake 674 +/- 128 mg. The subjects received a loading dose (5 mg/kg body wt) of caffeine 48 h before each testing session. They were then given (using a repeated-measures double-blind design) additional doses of caffeine (5 mg/kg body wt) or a placebo 36, 24, 12, and 2 h before testing. They ran at a velocity corresponding to their lactate threshold for 60 min in a caffeine withdrawal or caffeinated condition. Caffeine withdrawal resulted in no significant differences in absolute O2 uptake, O2 uptake relative to maximal O2 uptake, respiratory exchange ratios, or free fatty acid concentrations. Glycerol concentrations were significantly attenuated in the withdrawal condition. No significant differences were revealed in calculated substrate utilization. It was concluded that caffeine withdrawal significantly affects lipolysis but not substrate utilization during prolonged running.

A randomised pilot trial of the anti-von Willebrand factor aptamer ARC1779 in patients with type 2b von Willebrand disease

2010 ◽  
Vol 104 (09) ◽  
pp. 563-570 ◽  
Author(s):  
Petra Paulinska ◽  
Petra Jilma-Stohlawetz ◽  
James Gilbert ◽  
Renta Hutabarat ◽  
Paul Knöbl ◽  
...  
Keyword(s):  
Pilot Trial ◽  
Coagulation Factor ◽  
Von Willebrand Disease ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Maximal Increase ◽  
Double Blind Design ◽  
Von Willebrand

SummaryDesmopressin aggravates thrombocytopenia in type 2B von Willebrand disease (VWF type 2B) by release of large and hyper-adhesive von Wille-brand Factor (VWF) multimers. This pilot study investigated whether the anti-VWF aptamer ARC1779 can prevent desmopressin-induced thrombocytopenia and interferes with the excessive VWF turnover in patients with VWF type 2B. Concentration effect curves of ARC1779 were established for five patients in vitro and two patients with VWF type 2B were treated by infusion of ARC1779, desmopressin, or their combination in a randomised, controlled, double-blind design. ARC1779 concentrations in the range of 1–3 μg/ml blocked free A1 domain binding sites by 90% in vitro. In vivo, desmopressin alone induced a profound (-90%) drop in platelet counts in one of the patients. ARC1779 (4–5 μg/ml) completely inhibited VWF A1 domains and prevented this desmopress-in-induced platelet drop. Desmopressin alone increased VWF antigen two- to three-fold, accompanied by concordant changes in VWF Ristocetin cofactor activity (RCo) and coagulation factor VIII activity. ARC1779 substantially enhanced the desmopressin-induced maximal increase in these parameters, and improved multimer patterns. No treatment related adverse events were observed and no bleeding occurred despite marked thrombocytopenia. These data provide first proof of concept in humans and evidence that ARC1779 is a potent inhibitor of VWF. ARC1779 prevented the rapid consumption of VWF multimers together with agglutinated platelets that occurred in response to desmopressin challenge in patients with VWD type 2B.Clinical Trial registration number: NCT00632242.

scholarly journals The Effect of Extract Supplements of Moringa Oleifera Leaves Plus Royal Jelly on Hemoglobin (Hb) Levels of Anemia Pregnant Mother in Takalar Regency

2020 ◽  
Vol 1 (2) ◽  
pp. 22-29
Author(s):  
Yulni Yulni ◽  
Veni Hadju ◽  
Burhanuddin Bahar ◽  
Citrakesumasari Citrakesumasari ◽  
Rahayu Indriasari ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Leaf Extract ◽  
Moringa Oleifera ◽  
Royal Jelly ◽  
P Value ◽  
Double Blind ◽  
Significant Difference ◽  
Before And After ◽  
The Difference ◽  
Double Blind Design

The aim of this study was to determine the effect of Moringa oleifera leaf extract supplements, Moringa oleifera leaf extract plus royal jelly and placebo on hemoglobin levels in anemic pregnant women. This research is a randomized controlled double blind design study which was conducted in Polombangkeng Utara District, Takalar Regency for 2 months. The subjects of this study were pregnant women with anemia, the majority of which were 20-35 years old, primigravida parity, income less than UMR, unemployment, higher education, pregnancy distance of more than 2 years with p value> 0.05. Then divided into three groups, namely Moringa capsules plus royal jelly (KRJ) (n = 24), Moringa capsules (KTR) (n = 24) and placeco (PLC) (n = 21). Before and after the intervention, measurements of hemoglobin levels were carried out using the Hemocue tool and interviewing the characteristics of the respondents. The results showed that the average Hb level increased from each group (mean SD): KRJ 10.06 ± 0.75 to 11.42 ± 1.23, P = 0.001, KTR 10.40 ± 0.46 to 11.15 ± 0 , 90 P = 0.001 and PLC 10.43 ± 0.42 becomes 11.14 ± 0.88 P = 0.002. but there was no significant difference from the difference in the average increase in Hb levels in the three groups, but there was a tendency that KRJ was superior to the KTR and PLC groups with an increase of 1.36 gr / dl, KTR 0.75 gr / dl and PLC 0.71 gr / dl. So it can be concluded that KRJ is better than KTR and PLC in increasing Hb levels in anemic pregnant women in Takalar Regency.

The Comparative Amnestic Effects of Midazolam, Propofol, Thiopental, and Fentanyl at Equisedative Concentrations 

1997 ◽  
Vol 87 (4) ◽  
pp. 749-764 ◽  
Author(s):  
Robert A. Veselis ◽  
Ruth A. Reinsel ◽  
Vladimir A. Feshchenko ◽  
Marek Wronski
Keyword(s):  
Memory Impairment ◽  
Pharmacodynamic Modeling ◽  
Target Concentration ◽  
Double Blind ◽  
Regression Methods ◽  
Drug Concentrations ◽  
Computer Controlled ◽  
Double Blind Design ◽  
To Receive ◽  
Relative Potencies

Background The authors evaluated the effects of midazolam, propofol, thiopental, and fentanyl on volunteer participants' memory for words and pictures at equisedative concentrations. Methods Sixty-seven healthy volunteers were randomized to receive intravenous infusions of midazolam (n = 11), propofol (n = 11), thiopental (n = 10), fentanyl with ondansetron pretreatment (n = 11), ondansetron alone (n = 8), or placebo (n = 16) in a double-blind design. Three increasing and then two decreasing sedative concentrations were achieved by computer-controlled infusion in each volunteer. Measures of sedation, memory, and drug concentration were obtained at each target concentration. Drug concentrations were normalized to equisedative effects using both Emax and logistic regression methods of pharmacodynamic modeling. The serum concentrations at 50% memory effect (Cp50s) were determined using four different memory end points. The relative potencies compared with midazolam for memory impairment were determined. Results Equisedative concentrations were midazolam, 64.5 +/- 9.4 ng/ml; propofol, 0.7 +/- 0.2 microg/ml; thiopental, 2.9 /- 1.0 microg/ml; and fentanyl, 0.9 +/- 0.2 ng/ml. The Cp50s for 50% loss of memory for words were midazolam, 56 +/- 4 ng/ml; propofol, 0.62 +/- 0.04 microg/ml; thiopental, 4.5 +/- 0.3 microg/ml; and fentanyl, 3.2 +/- 0.4 ng/ml. Compared with midazolam, relative potencies (with 95% confidence intervals) were propofol, 0.96 (0.44-1.78); thiopental, 0.76 (0.52-0.94); and fentanyl, 0.34 (0.05-0.76). Large effects on memory were only produced by propofol and midazolam. Conclusions At equal sedation, propofol produces the same degree of memory impairment as midazolam. Thiopental has mild memory effects whereas fentanyl has none. Ondansetron alone has no sedative or amnesic effects.

scholarly journals Dexamethasone decreases migraine recurrence observed after treatment with a triptan combined with a nonsteroidal anti-inflammatory drug

2001 ◽  
Vol 59 (3B) ◽  
pp. 708-711 ◽  
Author(s):  
Abouch V. Krymchantowski ◽  
Jackeline Soraya Barbosa
Keyword(s):  
Recurrence Rate ◽  
Tolfenamic Acid ◽  
Case Control Studies ◽  
Double Blind ◽  
Oral Formulations ◽  
Single Use ◽  
Anti Inflammatory ◽  
Refractory Migraine ◽  
Double Blind Design ◽  
Effective Drugs

BACKGROUND AND OBJECTIVES: Triptans are effective drugs for the acute treatment of migraine. However, 30-40% of the patients commonly present recurrence before 24 hours therefore requiring another dose. Nonsteroidal anti-inflammatory drugs (NSAID) such as tolfenamic acid and naproxen sodium combined with sumatriptan have demonstrated efficacy in reducing recurrence observed with the single use of this drug. Steroids also have been suggested to treat refractory migraine and status migranosus. The aim of this study was to evaluate whether patients presenting frequent recurrence with the combination triptan plus NSAID, would decrease it with the association of dexamethasone. METHOD: Twenty three patients, 17 women and 6 men with migraine according to IHS criteria were prospectively studied. All patients presented frequent recurrence ( > or = 60%, mean recurrence rate 74,8%) with the single use of sumatritpan 100mg or zolmitriptan 2,5mg or rizatriptan 10mg in at least 5 consecutive attacks, and didn't present a reduction of the recurrence rate superior than 20% with the combination of tolfenamic acid 200mg or rofecoxib 25mg in at least 5 other consecutive attacks (mean recurrence rate 60%). The patients had to treat 6 consecutive moderate or severe migraine attacks with their usual combination plus 4mg of dexamathasone with a maximum of twice a week, and fill out a diary reporting headache parameters. RESULTS: Twenty patients, 16 women and 4 men completed the study. Of those who completed the study, 11 took rizatriptan plus rofecoxib, 4 rizatriptan plus tolfenamic acid, 3 zolmitriptan plus rofecoxib, 1 zolmitriptan plus tolfenamic acid and 1 patient took sumatriptan plus tolfenamic acid, having the 20 patients taken as a third medication, a single tablet of 4mg of dexamethasone. All patients took oral formulations and none presented vomiting after that. Among all 20 patients, one female and one male patient presented recurrence in 3 out of the 6 attacks (50%) while the remaining 18 patients revealed recurrence in 1 or 2 treated attacks (mean 23,4%) (p<0,001). CONCLUSION: We concluded that the judicious use of oral dexamethasone might be useful for a limited population of migraine patients still presenting recurrence with the combination of a triptan and a NSAID. Case-control studies and studies with a randomized double-blind design are necessary to confirm these observations.

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