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.

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 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.

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.

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.

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.

Social interaction following severe closed head injury

1987 ◽  
Vol 17 (1) ◽  
pp. 67-78 ◽  
Author(s):  
L. Elsass ◽  
G. Kinsella
Keyword(s):  
Interpersonal Relationships ◽  
Behavioural Change ◽  
Self Report ◽  
Control Group ◽  
Severely Injured ◽  
Psychiatric Disturbance ◽  
Significant Difference ◽  
Head Injured ◽  
Closed Head

SynopsisThis paper describes research which sought to investigate and describe the interpersonal relationships and vulnerability to psychiatric disturbance in severely closed head injured subjects. The head injured subjects were severely injured, with mild or extremely severely injured individuals being excluded from this study. Self-report by the injured individual was compared with relatives' reports. Fifteen head injured people were individually matched with non-head injured people from the general population who acted as controls. Each subject nominated one ‘close other’ for comparative interview. The dependent variables included interpersonal relationships, non-psychotic psychiatric disturbance and behavioural change.The head injured group differed significantly from the control group in the quantity of interaction but not in the perceived quality of interaction. The groups differed significantly on behavioural change. No significant difference was found between responses given by the head injured and their ‘close other’ compared with the controls. Deficient quantity of interpersonal relationships and greater vulnerability to psychiatric disorders was shown in this sample. Further research on the assessment of long-term social outcome and psychiatric stability in the head injured could assist in the improved long-term rehabilitation of the survivors.

A Controlled Trial of Goal Setting for Long-Term Community Psychiatric Patients

1986 ◽  
Vol 49 (8) ◽  
pp. 264-268 ◽  
Author(s):  
Christine Howell
Keyword(s):  
Goal Setting ◽  
Work Performance ◽  
Goal Attainment ◽  
Psychiatric Patients ◽  
Controlled Trial ◽  
Control Group ◽  
Treatment Technique ◽  
Community Psychiatric ◽  
Experimental Group

Clinical goal setting is a widely advocated, yet poorly documented technique. This paper describes a controlled trial which was carried out with long-term community psychiatric patients. The experimental group received goal setting in the form of goal attainment scaling (GAS), whilst the control group received social reinforcement. The experimental group had a higher goal score and a significantly higher sessional involvement (p<0.05). The goal categories decided by the clinicians as relevant, differed from those wished by the subjects; the latter subsequently attained only low goal scores. There were no significant differences between the two groups on the work performance or social interaction outcome measures. These differences between the two groups were obtained despite the fact that the subjects of the research were the most intransigent to treatment. It is suggested that goal setting is an independent treatment technique which requires further substantiation, particularly amongst occupational therapists who are covertly or overtly employing the technique. Further research must address the question of identifying the characteristics of patients most likely to benefit from goal setting.

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]

Clustered Randomized Controlled Trial of a Hand Hygiene Intervention Involving Pocket-Sized Containers of Alcohol-Based Hand Rub for the Control of Infections in Long-Term Care Facilities

2011 ◽  
Vol 32 (1) ◽  
pp. 67-76 ◽  
Author(s):  
Wing Kin Yeung ◽  
Wai San Wilson Tam ◽  
Tze Wai Wong
Keyword(s):  
Treatment Group ◽  
Hand Hygiene ◽  
Controlled Trial ◽  
Control Group ◽  
Term Care ◽  
Randomized Controlled ◽  
Serious Infections ◽  
Care Facilities ◽  
To Receive

Objective.To investigate the effectiveness of a multifaceted hand hygiene program involving the use of pocket-sized containers of antiseptic gel in long-term care facilities (LTCFs) with elderly residents.Methods.In this clustered randomized controlled trial, Hong Kong LTCFs for elderly persons were recruited via snowball sampling. Staff hand hygiene adherence was directly observed, and residents' infections necessitating hospitalization were recorded. After a 3-month preintervention period, LTCFs were randomized to receive pocket-sized containers of alcohol-based gel, reminder materials, and education for all HCWs (treatment group) or to receive basic life support education and workshops for all healthcare workers (HCWs) (control group). A 2-week intervention period (April 1-15, 2007) was followed by 7 months of postintervention observations.Results.In the 3 treatment LTCFs, adherence to hand rubbing increased from 5 (1.5%) of 333 to 233 (15.9%) of 1,465 hand hygiene opportunities (P = .001) and total hand hygiene adherence increased from 86 (25.8%) of 333 to 488 (33.3%) of 1,465 opportunities (P = .01) after intervention; the 3 control LTCFs showed no significant change. In the treatment group, the incidence of serious infections decreased from 31 cases in 21,862 resident-days (1.42 cases per 1,000 resident-days) to 33 cases in 50,441 resident-days (0.65 cases per 1,000 resident-days) (P = .002), whereas in the control group, it increased from 16 cases in 32,726 resident-days (0.49 cases per 1,000 resident-days) to 85 cases in 81,177 resident-days (1.05 cases per 1,000 resident-days) (P = .004). In the treatment group, the incidence of pneumonia decreased from 0.91 to 0.28 cases per 1,000 resident-days (P = .001) and the death rate due to infection decreased from 0.37 to 0.10 deaths per 1,000 resident-days (P = .01); the control group revealed no significant change.Conclusions.A hand hygiene program involving the use of pocket-sized containers of antiseptic gel and education could effectively increase adherence to hand rubbing and reduce the incidence of serious infections in LTCFs with elderly residents.

Treatment of neuroleptic-induced akathisia with the 5-HT2 antagonist mianserin

1999 ◽  
Vol 174 (3) ◽  
pp. 238-242 ◽  
Author(s):  
Michael Poyurovsky ◽  
Marina Shardorodsky ◽  
Camil Fuchs ◽  
Michael Schneidman ◽  
Abraham Weizman
Keyword(s):  
Placebo Group ◽  
Low Dose ◽  
Rating Scales ◽  
Therapeutic Option ◽  
Response To Treatment ◽  
Double Blind ◽  
Log Odds ◽  
Double Blind Design ◽  
To Receive ◽  
Barnes Akathisia Scale

BackgroundSerotonin (5-HT): dopamine imbalance may underlie neuroleptic-induced akathisia.AimTo evaluate the efficacy of the 5-HT2 antagonist, mianserin in neuroleptic-induced akathisia.MethodsThirty neuroleptic-treated patients with schizophrenia were randomly allocated in a double-blind design to receive either mianserin (15 mg/day) or placebo for five days. Patients were assessed at baseline and on Days 3 and 5 by the Barnes Akathisia Scale (BARS), as well as by other relevant clinical rating scales.ResultsCompared with the placebo group, the mianserin-treated patients showed a significant reduction in all four BARS subscales by Day 5, with mean reductions in the BARS global score of 9.9% and 52.2%, respectively (P=0.006). Response to treatment (a reduction of at least two points on the BARS global subscale), was noted in six patients (40%) in the mianserin group and only one patient (9.1%) in the placebo group (P=0.04, log odds ratio 2.23).ConclusionsMianserin at a low dose may be a promising therapeutic option for patients with acute neuroleptic-induced akathisia.

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