Olanzapine or chlorpromazine plus lithium in first episode psychotic mania: An 8-week randomised controlled trial

2015 ◽  
Vol 30 (8) ◽  
pp. 975-982 ◽  
Author(s):  
P. Conus ◽  
M. Berk ◽  
S.M. Cotton ◽  
L. Kader ◽  
C. Macneil ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Safety Profile ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Vital Signs ◽  
Treatment Strategies ◽  
First Episode ◽  
Safety And Efficacy ◽  
Randomised Controlled ◽  
Over Time

AbstractBackgroundTreatment strategies for mental disorders may vary according to illness stage. However no data currently exist to guide treatment in first episode psychotic mania. The aim of this study was to compare the safety and efficacy profile of chlorpromazine and olanzapine, as add-on to lithium, in patients with a first episode of psychotic mania, expecting better safety profile and adherence to olanzapine but similar efficacy for both treatments.MethodsData from 83 patients were collected in an 8-week randomised controlled trial on clinical variables, side effects, vital signs, and weight. Analyses of treatment differences over time were based on intent-to-treat principles. Kaplan-Meier estimated survival curves were used to analyse time-to-event data and mixed effects models repeated measures analysis of variance were used to determine treatment group differences over time on safety and efficacy measures.ResultsEthics committee approval to delay informed consent procedure until recovery from the acute episode allowed the inclusion of 83 patients highly representative of those treated in the public sector. Contrary to our hypotheses, safety profile of both medications was similar. A signal for higher rate (P=.032) and earlier occurrence (P= .043) of mania remission was observed in the olanzapine group which did not survive correction for multiple comparisons.ConclusionsOlanzapine and chlorpromazine have a similar safety profile in a uniquely representative cohort of patients with first episode psychotic mania. The possibility for a greater impact of olanzapine on manic symptoms leading to earlier remission of the episode needs exploration in a large sample.

Safety and efficacy of the double balloon catheter and the prostaglandin pessary: A multicentre randomised controlled trial

Authorea ◽  
2020 ◽  
Author(s):  
Yang Huang Grace Ng ◽  
Anisah Aisyah Aminuddin ◽  
Toh Lick Tan ◽  
Ramesh Kuppusamy ◽  
Shephali Tagore ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Balloon Catheter ◽  
Safety And Efficacy ◽  
Double Balloon ◽  
Randomised Controlled

scholarly journals Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES)

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e043699
Author(s):  
Morten Riemenschneider ◽  
Lars G Hvid ◽  
Steffen Ringgaard ◽  
Mikkel K E Nygaard ◽  
Simon F Eskildsen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Treatment Strategy ◽  
Controlled Trial ◽  
Treatment Strategies ◽  
Control Group ◽  
Disease Course ◽  
Disability Progression ◽  
Randomised Controlled

IntroductionIn the relapsing remitting type of multiple sclerosis (MS) reducing relapses and neurodegeneration is crucial in halting the long-term impact of the disease. Medical disease-modifying treatments have proven effective, especially when introduced early in the disease course. However, patients still experience disease activity and disability progression, and therefore, supplemental early treatment strategies are warranted. Exercise appear to be one of the most promising supplemental treatment strategies, but a somewhat overlooked ‘window of opportunity’ exist early in the disease course. The objective of this study is to investigate exercise as a supplementary treatment strategy early in the disease course of MS.Methods and analysisThe presented Early Multiple Sclerosis Exercise Study is a 48-week (plus 1-year follow-up) national multicentre single-blinded parallel group randomised controlled trial comparing two groups receiving usual care plus supervised high-intense exercise or plus health education (active control). Additionally, data will be compared with a population-based control group receiving usual care only obtained from the Danish MS Registry. The primary outcomes are annual relapse rate and MRI derived global brain atrophy. The secondary outcomes are disability progression, physical and cognitive function, MS-related symptoms, and exploratory MRI outcomes. All analyses will be performed as intention to treat.Ethics and disseminationThe study is approved by The Central Denmark Region Committees on Health Research Ethics (1-10-72-388-17) and registered at the Danish Data Protection Agency (2016-051-000001 (706)). All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.Trial registration numberNCT03322761.

scholarly journals Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e039981
Author(s):  
Maleea Denise Holbert ◽  
Roy M Kimble ◽  
Mark Chatfield ◽  
Bronwyn R Griffin
Keyword(s):  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Geometric Mean ◽  
First Aid ◽  
Self Report ◽  
Thermal Burn ◽  
Pain Scores ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).

scholarly journals Vitamin D intake, serum 25-hydroxyvitamin D status and response to moderate vitamin D3 supplementation: a randomised controlled trial in East African and Finnish women

2018 ◽  
Vol 119 (4) ◽  
pp. 431-441 ◽  
Author(s):  
Folasade A. Adebayo ◽  
Suvi T. Itkonen ◽  
Taina Öhman ◽  
Essi Skaffari ◽  
Elisa M. Saarnio ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomised Controlled Trial ◽  
Ethnic Differences ◽  
Repeated Measures ◽  
Controlled Trial ◽  
East African ◽  
Hydroxyvitamin D ◽  
Vitamin D Intake ◽  
25 Hydroxyvitamin D ◽  
Randomised Controlled

AbstractInsufficient vitamin D status (serum 25-hydroxyvitamin D (S-25(OH)D)<50 nmol/l) is common among immigrants living at the northern latitudes. We investigated ethnic differences in response of S-25(OH)D to vitamin D3 supplementation, through a 5-month randomised controlled trial, in East African and Finnish women in Southern Finland (60°N) from December 2014 to May 2015. Vitamin D intakes (dietary and supplemental) were also examined. Altogether, 191 subjects were screened and 147 women (East Africans n 72, Finns n 75) aged 21–64 years were randomised to receive placebo or 10 or 20 µg of vitamin D3/d. S-25(OH)D concentrations were assessed by liquid chromatography–tandem MS. At screening, 56 % of East Africans and 9 % of Finns had S-25(OH)D<50 nmol/l. Total vitamin D intake was higher in East Africans than in Finns (24·2 (sd 14·3) v. 15·2 (sd 13·4) µg/d, P<0·001). Baseline mean S-25(OH)D concentrations were higher in Finns (60·5 (sd=16·3) nmol/l) than in East Africans (51·5 (sd 15·4) nmol/l) (P=0·001). In repeated-measures ANCOVA (adjusted for baseline S-25(OH)D), mean S-25(OH)D increased by 8·5 and 10·0 nmol/l with a 10-µg dose and by 10·7 and 17·1 nmol/l with a 20-µg dose for Finns and East Africans, respectively (P>0·05 for differences between ethnic groups). In conclusion, high prevalence of vitamin D insufficiency existed among East African women living in Finland, despite higher vitamin D intake than their Finnish peers. Moderate vitamin D3 supplementation was effective in increasing S-25(OH)D in both groups of women, and no ethnic differences existed in the response to supplementation.

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