Synthetic Food Colors and Hyperactivity in Children: A Double-Blind Challenge Experiment

PEDIATRICS ◽  
1978 ◽  
Vol 62 (6) ◽  
pp. 975-983
Author(s):  
J. Preston Harley ◽  
Charles G. Matthews ◽  
Peter Eichman
Keyword(s):  
Classroom Behavior ◽  
Matched Control ◽  
Neuropsychological Test ◽  
Control Group ◽  
Comparable Data ◽  
Double Blind ◽  
Multiple Trials ◽  
To Receive ◽  
Male Subjects ◽  
Comparison Measures

Nine hyperactive male subjects, selected on the basis of showing a favorable "response" to the Feingold diet in an earlier study, were maintained on a strict elimination (Feingold) diet for 11 weeks, and were given multiple trials of placebo and challenge food materials. Parental and teacher ratings, classroom behavior observations, and neuropsychological test scores obtained during baseline, placebo, and challenge conditions, in general, were not found to be adversely affected by the artificial color challenge materials. As expected, comparable data gathered on a matched control group showed them to receive substantially better ratings than the hyperactive subjects on the majority of the comparison measures employed. Possible explanations for the discrepancy between the dramatic clinical-anecdotal reports that have been given and the much more equivocal findings from format experimental projects are presented.

The Effects of a Caffeine Placebo and Experimenter Expectation on Blood Pressure, Heart Rate, Well-Being, and Cognitive Performance

2001 ◽  
Vol 6 (1) ◽  
pp. 15-25 ◽  
Author(s):  
Harald Walach ◽  
Stefan Schmidt ◽  
Yvonne-Michelle Bihr ◽  
Susanne Wiesch
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Cognitive Task ◽  
Well Being ◽  
Control Group ◽  
Double Blind ◽  
Main Effect ◽  
The Difference ◽  
Being There ◽  
To Receive

We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” were significantly less likely to believe the experimental instruction, and that mostly if they had been instructed to receive coffee. Contrary to the literature we could not show an effect of instruction, but there was an effect of experimenters. It is likely, however, that these experimenter effects were not due to experimental manipulations, but to the difference in personalities.

scholarly journals Aspirin-Persantin Prophylaxis in Elective total hip Replacement

1977 ◽  
Author(s):  
A.J. Silvergleid ◽  
R. Bernstein ◽  
D.S. Burton ◽  
J.B. Tanner ◽  
J.F. Silverman ◽  
...  
Keyword(s):  
Total Hip Replacement ◽  
Hip Replacement ◽  
Treated Group ◽  
Control Group ◽  
Double Blind ◽  
Total Hip ◽  
Blind Area ◽  
Effective Prophylaxis ◽  
Clinically Significant ◽  
To Receive

A prospective, double-blind clinical study was performed to evaluate the combination of dipyridamole(Persantin)225 mg/day and acetyl salicyclic acid (ASA) 1 g/day prophylaxis of post-operative venous thromboembolism in elective total hip replacement. Patients were stratified according to age, and randomly assigned to receive drug or placebo. All patients were followed with 125I-labelledfibrinogen scanning for one week post-operatively, or until fully mobile. Venography was performed in 67/129 patients; in 27 patients the venogram was obtained to confirm a positive fibrinogen scan, in 40 patients an elective venogram was obtained on the 7th post-operative day to evaluate the operated thigh (a blind area for scanning). Thrombosis (by scan or venogram) was found in 16/66(24%) in the control group, and in 21/63(33%) in the treated group. Overall incidence was 37/129 (29%). Correlation of scan with venography was 90%. There were no clinically significant pulmonary emboli in either group. We conclude that the combination of ASA and dipridamole as given in this study is not effective prophylaxis in elective total hip replacement.

scholarly journals Pharmacokinetics (PK) and Safety of Intravenous (IV) Brincidofovir (BCV) in Healthy Adult Subjects

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S311-S311 ◽  
Author(s):  
Mary Beth Wire ◽  
Marion Morrison ◽  
Maggie Anderson ◽  
Thangam Arumugham ◽  
John Dunn ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Geometric Mean ◽  
Compartmental Analysis ◽  
Repeat Dose ◽  
Double Blind Study ◽  
Double Blind ◽  
Dose Administration ◽  
To Receive ◽  
Male Subjects ◽  
Support Evaluation

Abstract Background BCV is a lipid conjugate nucleotide that has shown rapid viral clearance in patients with adenovirus infection and improved survival in animal models of smallpox. In preclinical studies in rats, IV BCV dosed twice weekly for up to 29 days was not associated with gastrointestinal (GI), hematopoietic, hepatic, or renal toxicity. This study evaluated the safety and PK of IV BCV in healthy subjects. Methods In this double-blind study, subjects were randomized 3:1 to receive IV BCV or placebo in sequential single ascending dose cohorts (Table 1). Plasma PK samples were collected over 7 days and assayed by HPLC-MS. Plasma BCV PK parameters were determined by non-compartmental analysis and dose proportionality was assessed. Safety assessments were collected over 14 days. Results Forty healthy male subjects (18–46 years, 83% White) were enrolled and completed the study. Plasma BCV Cmax and AUC∞ increased in proportion to dose (Table 1). AEs and alanine aminotransferase (ALT) elevations were dose- and infusion duration-related (Table 1). GI AEs were mild. All AEs and ALT elevations were transient and no serious AEs occurred. Conclusion Single doses of BCV 10–50 mg administered as a 2h IV infusion were well tolerated and not associated with significant clinical or laboratory abnormalities. BCV IV 10 mg and BCV IV 50 mg achieved geometric mean plasma BCV AUC∞ similar to and 4.5-fold, respectively, values achieved with BCV oral 100 mg tablets (Cmax = 251 ng/mL and AUC∞ = 1394 ng hours/mL). These data support evaluation of repeat dose administration in healthy subjects and virally-infected patients. Disclosures M. B. Wire, Chimerix: Employee and Shareholder, Salary. M. Morrison, Chimerix: Employee and Shareholder, Salary.M. Anderson, Chimerix: Employee and Shareholder, Salary. T. Arumugham, Chimerix: Employee and Shareholder, Salary. J. Dunn, Chimerix: Employee and Shareholder, Salary. O. Naderer, Chimerix: Employee and Shareholder, Salary.

Netupitant/palonosetron (NEPA) for prevention of delayed chemotherapy-induced nausea and vomiting (CINV) in multiple cycles of chemotherapy.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 211-211
Author(s):  
Lee Steven Schwartzberg ◽  
Richard J. Gralla ◽  
Kimia Kashef ◽  
Hope Rugo
Keyword(s):  
Oral Dose ◽  
Single Oral Dose ◽  
Complete Response ◽  
Control Group ◽  
Double Blind ◽  
Report Data ◽  
Multiple Cycles ◽  
To Receive ◽  
Delayed Phase ◽  
Significant Nausea

211 Background: Prevention of CINV in the delayed phase (24-120 h post-chemotherapy) and over multiple cycles of chemotherapy remains a challenge. NEPA, a fixed combination of the NK1 receptor antagonist (RA) netupitant (300 mg) and the 5-HT3 RA palonosetron (PALO; 0.5 mg), has demonstrated efficacy in multiple studies, in both acute and delayed phases, during the first cycle of moderately or highly emetogenic chemotherapy (MEC and HEC, respectively) regimens. Two clinical trials evaluated NEPA over multiple cycles of chemotherapy. We report data for the delayed phase for each cycle. Methods: Both studies were Phase 3, double-blind, active-controlled studies. In study 1 (MEC), patients were randomized 1:1 to receive a single oral dose of NEPA (n = 724) or PALO 0.5 mg (n = 725) on Day 1; following cycle 1, patients could participate in a multi-cycle extension phase. In study 2 (MEC or HEC), patients were randomized 3:1 to receive a single oral dose of NEPA on Day 1 (n = 309) or oral aprepitant (APR) 125 mg plus oral PALO 0.5 mg on Day 1, then APR 80 mg/d on days 2 and 3 of each cycle (n = 103). In both studies, all patients also received dexamethasone. Efficacy endpoints included complete response (CR; no emesis, no rescue medication) and no significant nausea. Results: In both studies, CR rates were consistently numerically higher with NEPA (Study 1 range: 77%-89%; Study 2 range: 83%-93%) than with PALO (Study 1; range: 69%-83%) or APR/PALO (Study 2; range: 78%-88%) in each cycle up to cycle 6 (Table). In both studies, rates of no significant nausea in the NEPA group were similar to or higher than in the control group. NEPA was well tolerated in both studies; treatment-related adverse events included constipation and headache. Conclusions: These studies demonstrate sustained efficacy of NEPA (administered as a single dose on Day 1) across multiple cycles of MEC or HEC for prevention of CINV in the delayed phase. Clinical trial information: 2009-016775-30; 2010-023297-39. [Table: see text]

Developmental Moderators of a Single-Session Incremental Theory of Personality Intervention on Aggressive Behavior

2020 ◽  
pp. 088626052096923
Author(s):  
Esther Calvete ◽  
Liria Fernández-González ◽  
Ainara Echezarraga ◽  
Izaskun Orue ◽  
Javier Muga ◽  
...  
Keyword(s):  
Aggressive Behavior ◽  
Controlled Trial ◽  
Control Group ◽  
Aggressive Behaviors ◽  
Single Session ◽  
Double Blind ◽  
Incremental Theory ◽  
Preventative Interventions ◽  
To Receive ◽  
Trial Participants

This study examines two indicators of developmental level (testosterone and grade) as moderators of the effects of a single-session incremental theory of personality intervention on both traditional and online aggressive behaviors. A sample of 535 Spanish adolescents (boys: 50%; age: 12–17 years) participated in a double-blind, randomized controlled trial. Participants were randomized to receive the incremental theory of personality intervention or an alternative educational control condition. The intervention consisted of teaching the belief that people can change. Aggressive behaviors were measured at baseline, one-week posttest, and six-month and twelve-month follow-ups. Testosterone level moderated the effectiveness of the intervention for online aggressive behavior so that, among adolescents with low and medium testosterone levels, those in the control group increased online aggressive behavior, whereas adolescents receiving the intervention remained at similar levels of perpetration. Grade moderated the effectiveness of the intervention on both forms of aggressive behavior, being only effective in Grade 8. Overall, the findings indicate that some preventative interventions can be more effective among adolescents with lower levels of development.

A Perioperative Course of Gabapentin Does Not Produce a Clinically Meaningful Improvement in Analgesia after Cesarean Delivery

2015 ◽  
Vol 123 (2) ◽  
pp. 320-326 ◽  
Author(s):  
David T. Monks ◽  
David W. Hoppe ◽  
Kristi Downey ◽  
Vibhuti Shah ◽  
Paul Bernstein ◽  
...  
Keyword(s):  
Cesarean Delivery ◽  
Analgesic Efficacy ◽  
Control Group ◽  
Double Blind ◽  
Meaningful Improvement ◽  
Analgesic Regimen ◽  
Parallel Group ◽  
Superiority Trial ◽  
Perioperative Course ◽  
To Receive

Abstract Background: Studies examining the efficacy of a single preoperative dose of gabapentin for analgesia after cesarean delivery (CD) have been inconclusive. The authors hypothesized that a perioperative course of gabapentin would improve analgesia after CD. Methods: This single-center, randomized, double-blind, placebo-controlled, parallel-group, superiority trial was designed to determine the analgesic efficacy of a perioperative course of gabapentin when added to a multimodal analgesic regimen. Women scheduled for elective CD during spinal anesthesia were randomized to receive a perioperative oral course of either gabapentin (600 mg preoperatively followed by 200 mg every 8 h for 2 days) or placebo. Postoperative pain was measured at 24 and 48 h, at rest and on movement, on a visual analogue scale (VAS, 0 to 100 mm). The primary outcome was pain on movement at 24 h. Neonatal outcomes, opiate consumption, VAS satisfaction (0 to 100 mm), adverse effects, and persistent pain were also assessed. Results: Baseline characteristics were similar between groups. There was a statistically significant but small reduction in VAS pain score (mean [95% CI]) on “movement” (40 mm [36 to 45] vs. 47 mm [42 to 51]; difference, −7 mm [−13 to 0]; P = 0.047) at 24 h in the gabapentin (n = 100) compared with control group (n = 97). There was more sedation in the gabapentin group at 24 h (55 vs. 39%, P = 0.026) but greater patient VAS satisfaction (87 vs. 77 mm, P = 0.003). Conclusions: A perioperative course of gabapentin produces a clinically insignificant improvement in analgesia after CD and is associated with a higher incidence of sedation.

scholarly journals The Influence of Adrenaline on Postoperative Analgesia after Subarachnoid Morphine

1993 ◽  
Vol 21 (1) ◽  
pp. 79-84 ◽  
Author(s):  
M. J. Paech
Keyword(s):  
Side Effects ◽  
Postoperative Analgesia ◽  
Saline Group ◽  
Control Group ◽  
Double Blind Study ◽  
Gynaecological Surgery ◽  
Normal Saline Group ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive

A randomised, double-blind study was conducted to investigate the postoperative effects of subarachnoid morphine, with or without adrenaline, after major gynaecological surgery. Seventy-five women having spinal anaesthesia combined with either sedation or general anaesthesia were randomised to receive subarachnoid morphine 0.25 mg with (group MA) or without (group M) adrenaline 200 ūg; or normal saline (group C). Groups M (n=22) and MA (n=25) differed significantly from control (n=23) with respect to the quality and duration of postoperative analgesia (P<0.0002) and to a higher incidence of pruritus (P<0.02). Groups were similar with respect to the incidence of other postoperative side-effects and respiratory data, although the latter showed a trend to less hypoxaemia in the control group. There was no significant difference in any outcome between groups MA and M. It was concluded that, under the study conditions in a post-gynaecological surgery population, the addition of adrenaline to subarachnoid morphine was of no benefit.

Withdrawal of Long-Term Phenothiazines from Chronically Hospitalized Psychiatric Patients

1964 ◽  
Vol 9 (4) ◽  
pp. 290-298 ◽  
Author(s):  
G. Marjerrison ◽  
D. Irvine ◽  
C. N. Stewart ◽  
R. Williams ◽  
H. Matheu ◽  
...  
Keyword(s):  
Urinary Excretion ◽  
Time Course ◽  
Psychiatric Patients ◽  
Behavioural Change ◽  
Control Group ◽  
Double Blind ◽  
Single Measure ◽  
Double Blind Design ◽  
To Receive

A study was conducted of the effect of substituting placebo medication for active phenothiazine medication under double-blind conditions, in a population of chronically hospitalized psychotic patients who had all been undergoing long-term phenothiazine treatment. Behavioural change was assessed monthly by psychiatric nurses using a ward behaviour inventory, which had been specially constructed to be sensitive to kinds of behaviour likely to affect the clinical prescription of phenothiazines. At the fifth month of the study, differences were noted between the placebo-substituted group and a control group continuing to receive their originally-prescribed phenothiazine compounds. Significant worsening in the Placebo group did not appear until the fifth monthly rating, and at that time significant improvement in the control (medication unchanged) group also first became evident. These results support the hypothesis that the continued long-term use of phenothiazine compounds in chronically-hospitalized psychotics is effective in the sustained reduction of psychopathological behaviour. An investigation of trifluoperazine and chlorprothixene within the same double-blind design indicated that both were significantly more effective than placebo in maintaining the behavioural level typical of the prior long-term medication with phenothiazines. Using the FPN test as one measure of the time course of urinary excretion of some of the phenothiazine metabolites, no relationship was demonstrated in the placebo-substituted group between FPN changes and behavioural worsening. The FPN test, rated blind, was able to discriminate the placebo-substituted group from the group continuing to receive their usual phenothiazines; as a single measure of the time course of urinary excretion of phenothiazine metabolites, however, FPN changes were not related to behavioural worsening within the placebo-substituted group.

scholarly journals A Standardized Transcutaneous Electric Acupoint Stimulation for Relieving Tobacco Urges in Dependent Smokers

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Caroline Lambert ◽  
Ivan Berlin ◽  
Tat-Leang Lee ◽  
Siew Wan Hee ◽  
Audrey S. L. Tan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Smoking Cessation ◽  
Control Group ◽  
Double Blind ◽  
Standardized Protocol ◽  
Urge To Smoke ◽  
The Difference ◽  
To Receive ◽  
Transcutaneous Electric Acupoint Stimulation ◽  
Acupoint Stimulation

The efficacy of acupuncture in smoking cessation, and its effect on the urge to smoke are unclear. We evaluated the effect of a standardized protocol of transcutaneous electric acupoint stimulations (TEAS) on alleviating the urge to smoke. Ninety-eight smokers were recruited in two double-blind studies. Participants abstained from smoking for 26 h, and were randomized to receive TEAS alternating between 2 and 100 Hz at four acupoints (LI4 and PC8, PC6 and TE5) at four different intensities (10, 5, Intermittent 5 or 0 mA). The urge to smoke was assessed by the Questionnaire of Smoking Urges (QSU-Brief). In Experiment 1, the 10 mA group (n= 20) was compared with the 5 mA group (n= 20); the increase in smoking urges did not differ significantly. Considering the possibility that 5 mA may be an active intervention, in Experiment 2, a true placebo (0 mA), and a proxy of placebo [Intermittent 5 mA (i5 mA)] were compared with 10 mA TEAS. In this experiment, 10 mA (n= 20) TEAS showed a tendency to alleviate smoking urges compared with 0 mA (n= 16), and i5 mA (n= 19) TEAS. Only when the data of smokers with Fagerstöm Test for Nicotine Dependence score ≥5 were analyzed that the difference between the 10 mA group and the control group (0 and i5 mA) became significant. Based on these preliminary findings, we conclude that TEAS applied on the skin may antagonize the increase in urge to smoke in abstinent-dependent smokers. It seems warranted to assess the efficacy of TEAS in smoking cessation clinical trials involving a larger population of dependent smokers.

scholarly journals Chinese Medicine Shensongyangxin Is Effective for Patients with Bradycardia: Results of a Randomized, Double-Blind, Placebo-Controlled Multicenter Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Yunfang Liu ◽  
Ning Li ◽  
Zhenhua Jia ◽  
Feng Lu ◽  
Jielin Pu
Keyword(s):  
Heart Rate ◽  
Multicenter Trial ◽  
Controlled Study ◽  
Control Group ◽  
Placebo Control ◽  
Trial Group ◽  
Average Heart Rate ◽  
Double Blind ◽  
End Of Treatment ◽  
To Receive

To evaluate the efficacy and safety of Shensong Yangxin (SSYX) in patients with bradycardia arrhythmias, a randomized, double-blind, and placebo-controlled study was conducted. Patients with bradycardia were randomly assigned to receive either SSYX (trial group,n=115) or placebo (control group,n=104) for 4 weeks. ECG, 24-hour continuous ECG recording, echocardiography, and hepatic and renal function were evaluated at baseline and after treatment. Results showed that the average heart rate, the fastest heart rate, and the lowest heart rate in the trial group were all significantly higher than those in the control group at the end of treatment (P<0.05or 0.01, resp.). Compared with pretreatment, the average heart rate, the fastest heart rate, and the lowest heart rate in the trial group all increased significantly after treatment (P<0.05or 0.01, resp.). Both the efficacy and the symptom scores in the trial group were significantly better than those in the control group after treatment (both havingP<0.01). No severe adverse effects were reported. In conclusion, SSYX treatment significantly increased the heart rate in patients with bradycardia without severe side effects. The exact mechanisms remain to be further explored.

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