Nalmefene in the treatment of pathological gambling: multicentre, double-blind, placebo-controlled study

SummaryPathological gambling is a disabling disorder experienced by about 1% of adults. We randomised 233 participants (41.6% women) 1:1:1 to nalmefene (20 or 40 mg) or placebo. In analyses performed using an intention-to-treat (ITT) population, nalmefene failed to show statistically significant differences from placebo on primary and secondary outcomes. Post hoc analyses of only participants who received a full titration of the medication for at least 1 week demonstrated that nalmefene 40 mg/day resulted in significantly greater reductions on the primary outcome measure. These findings suggest that medication dosing may be an important consideration in achieving symptom control.

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Double-Blind Randomized Placebo-Controlled Study of Homoeopathic Prophylaxis of Migraine

Cephalalgia ◽

10.1046/j.1468-2982.1997.1705600.x ◽

1997 ◽

Vol 17 (5) ◽

pp. 600-604 ◽

Cited By ~ 63

Author(s):

TE Whitmarsh ◽

DM Coleston-Shields ◽

TJ Steiner

Keyword(s):

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Migraine Prophylaxis ◽

Controlled Study ◽

Attack Frequency ◽

Double Blind ◽

Over The Counter ◽

Ihs Criteria ◽

The Uk

Homoeopathic remedies for migrane are widely available over the counter, statutorily offered by the national health service in the UK, and apparently popular with patients. Do they work? Sixty-three outpatients with migraine with or without aura b IHS criteria entered a 4-month randomized placebo-controlled, double-blind, parallel-groups trial of individualized homoeopathic prophylaxis, the first month being baseline with all patients on placebo. Three patients (4.8%) dropped out, leaving 30 in each treatment group. There were chance differences in attack frequency and severity between the groups at baseline (attacks were more frequent but less severe in the placebo group). Both groups improved on therapy but neither to a great extent on the primary outcome measure of attack frequency (verum: —19%; placebo: -16%). Reduction was mostly in mild attacks on placebo, more in moderate and severe attacks on homoeopathy. Few adverse events were reported. Overall, there was no significant benefit over placebo of homoeopathic treatment. The course of change differed between groups, and suggested that improvement reversed in the last month of treatment on placebo. On this evidence we cannot recommend homoeopathy for migraine prophylaxis, but cannot conclude that it is without effect.

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Evaluating the use of benzodiazepines following recent bereavement

The British Journal of Psychiatry ◽

10.1192/bjp.178.1.36 ◽

2001 ◽

Vol 178 (1) ◽

pp. 36-41 ◽

Cited By ~ 13

Author(s):

James Warner ◽

Chris Metcalfe ◽

Michael King

Keyword(s):

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Double Blind ◽

Double Blind Placebo ◽

Negative Effect ◽

Controlled Evaluation ◽

Current Advice

BackgroundThere is no evidence to support current advice not to use benzodiazepines after bereavement.AimsTo determine the role of benzodiazepines in the management of bereavement.MethodWe conducted a randomised, double-blind, placebo-controlled evaluation of the use of diazepam after recent bereavement. Participants were randomised to either 2 mg diazepam or identically packaged placebo up to three times daily. The primary outcome measure was the Bereavement Phenomenology Questionnaire.ResultsThirty subjects were randomised. No evidence was found of an effect of benzodiazepines on the course of the first 6 months of bereavement (estimated mean difference of combined follow-up assessments=0.3 in favour of placebo; 95% CI –6.2 to +6.7).ConclusionWe found no evidence of a positive or negative effect of benzodiazepines on the course of bereavement.

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Day hospital versus intensive out-patient mentalisation-based treatment for borderline personality disorder: multicentre randomised clinical trial

The British Journal of Psychiatry ◽

10.1192/bjp.2019.9 ◽

2019 ◽

Vol 216 (2) ◽

pp. 79-84 ◽

Cited By ~ 4

Author(s):

Maaike L. Smits ◽

Dine J. Feenstra ◽

Hester V. Eeren ◽

Dawn L. Bales ◽

Elisabeth M. P. Laurenssen ◽

...

Keyword(s):

Borderline Personality Disorder ◽

Personality Disorder ◽

Outcome Measures ◽

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Borderline Personality ◽

Treatment Intensity ◽

Day Hospital ◽

Secondary Outcomes

BackgroundTwo types of mentalisation-based treatment (MBT) have been developed and empirically evaluated for borderline personality disorder (BPD): day hospital MBT (MBT-DH) and intensive out-patient MBT (MBT-IOP). No trial has yet compared their efficacy.AimsTo compare the efficacy of MBT-DH and MBT-IOP 18 months after start of treatment. MBT-DH was hypothesised to be superior to MBT-IOP because of its higher treatment intensity.MethodIn a multicentre randomised controlled trial (Nederlands Trial Register: NTR2292) conducted at three sites in the Netherlands, patients with BPD were randomly assigned to MBT-DH (n = 70) or MBT-IOP (n = 44). The primary outcome was symptom severity (Brief Symptom Inventory). Secondary outcome measures included borderline symptomatology, personality functioning, interpersonal functioning, quality of life and self-harm. Patients were assessed every 6 months from baseline to 18 months after start of treatment. Data were analysed using multilevel modelling based on intention-to-treat principles.ResultsSignificant improvements were found on all outcome measures, with moderate to very large effect sizes for both groups. MBT-DH was not superior to MBT-IOP on the primary outcome measure, but MBT-DH showed a clear tendency towards superiority on secondary outcomes.ConclusionsAlthough MBT-DH was not superior to MBT-IOP on the primary outcome measure despite its greater treatment intensity, MBT-DH showed a tendency to be more effective on secondary outcomes, particularly in terms of relational functioning. Patients receiving MBT-DH and MBT-IOP, thus, seem to follow different trajectories of change, which may have important implications for clinical decision-making. Longer-term follow-up and cost-effectiveness considerations may ultimately determine the optimal intensity of specialised treatments such as MBT for patients with BPD.

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Efficiency and safety of ondansetron in preventing postanaesthesia shivering

Annals of The Royal College of Surgeons of England ◽

10.1308/rcsann.2016.0152 ◽

2016 ◽

Vol 98 (6) ◽

pp. 358-366 ◽

Cited By ~ 1

Author(s):

k He ◽

H Zhao ◽

HC Zhou

Keyword(s):

Lower Risk ◽

Randomised Controlled Trials ◽

Primary Outcome ◽

Outcome Measure ◽

Meta Analysis ◽

Primary Outcome Measure ◽

Cochrane Library ◽

Significant Difference ◽

Secondary Outcomes ◽

Randomised Controlled

Introduction Shivering is one of the most frequent complications of operation during the postanaesthesia period. Ondansetron has been proved to be valid in preventing postanaesthesia shivering (PAS) in several studies. However, its efficiency and safety are still disputable. We therefore performed an updated meta-analysis of randomised controlled trials (RCTs) for evaluation and to clarify this issue. Methods A literature search using the PubMed, Embase™ and Cochrane Library databases was performed (from inception to January 2015). RCTs that evaluated the efficiency and safety of ondansetron in the prevention of PAS were included in the meta-analysis. The primary outcome measure was incidence of PAS, and secondary outcomes included subgroup analysis and the side effects of ondansetron. Results A total of 8 RCTs containing 905 subjects were identified as suitable for this review. Compared with placebo, ondansetron was associated with a significant reduction of PAS (relative risk [RR]: 0.33, 95% confidence interval [CI]: 0.19–0.58, p=0.0001) while no difference was detected between ondansetron and pethidine (RR: 0.89, 95% CI: 0.41–1.94, p=0.78). There was no significant difference between ondansetron and placebo or pethidine in terms of risk of bradycardia but ondansetron was associated with a lower risk of hypotension (RR: 0.26, 95% CI: 0.08–0.79, p=0.020) than placebo. There was no difference in hypotension when ondansetron was compared with pethidine. Conclusions Ondansetron can prevent PAS effectively and reduce the risk of hypotension.

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The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2016-015111 ◽

2017 ◽

Vol 7 (8) ◽

pp. e015111 ◽

Cited By ~ 3

Author(s):

Mohamed Abdel-Fattah ◽

Graeme MacLennan ◽

Mary Kilonzo ◽

R Phil Assassa ◽

Kirsty McCormick ◽

...

Keyword(s):

Primary Outcome ◽

Outcome Measure ◽

Single Incision ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Female Stress Urinary Incontinence ◽

Midurethral Slings ◽

Secondary Outcomes ◽

Randomised Controlled

IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.

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Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients

Multiple Sclerosis Journal ◽

10.1191/1352458504ms1082oa ◽

2004 ◽

Vol 10 (4) ◽

pp. 434-441 ◽

Cited By ~ 318

Author(s):

Derick T Wade ◽

Petra Makela ◽

Philip Robson ◽

Heather House ◽

Cynthia Bateman

Keyword(s):

Multiple Sclerosis ◽

Primary Outcome ◽

Primary Outcome Measure ◽

Controlled Study ◽

Double Blind ◽

Specific Effects ◽

Whole Plant ◽

Parallel Group ◽

Troublesome Symptom ◽

Vas Scores

The objective was to determine whether a cannabis-based medicinal extract (CBME) benefits a range of symptoms due to multiple sclerosis (MS). A parallel group, double-blind, randomized, placebo-controlled study was undertaken in three centres, recruiting 160 outpatients with MS experiencing significant problems from at least one of the following: spasticity, spasms, bladder problems, tremor or pain. The interventions were oromucosal sprays of matched placebo, or whole plant CBME containing equal amounts of delta-9- tetrahydrocannabinol (THC) and cannabidiol (CBD) at a dose of 2.5- 120 mg of each daily, in divided doses. The primary outcome measure was a Visual Analogue Scale (VAS) score for each patient’s most troublesome symptom. Additional measures included VAS scores of other symptoms, and measures of disability, cognition, mood, sleep and fatigue. Following CBME the primary symptom score reduced from mean (SE) 74.36 (11.1) to 48.89 (22.0) following CBME and from 74.31 (12.5) to 54.79 (26.3) following placebo [ns]. Spasticity VAS scores were significantly reduced by CBME (Sativex) in comparison with placebo (P- 0.001). There were no significant adverse effects on cognition or mood and intoxication was generally mild.

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Efficacy of Chlorhexidine Varnish for the Prevention of Adult Caries

Journal of Dental Research ◽

10.1177/0022034511424154 ◽

2011 ◽

Vol 91 (2) ◽

pp. 150-155 ◽

Cited By ~ 21

Author(s):

A.S. Papas ◽

W.M. Vollmer ◽

C.M. Gullion ◽

J. Bader ◽

R. Laws ◽

...

Keyword(s):

Primary Outcome ◽

Tooth Surface ◽

Placebo Control ◽

Double Blind ◽

Intention To Treat ◽

Significant Difference ◽

Registration Number ◽

Secondary Outcomes ◽

Study Participants ◽

To Receive

The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D1-2FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries ( Clinicaltrials.gov registration number NCT00357877).

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Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-218547 ◽

2020 ◽

pp. annrheumdis-2020-218547

Author(s):

Pascal Richette ◽

Augustin Latourte ◽

Jérémie Sellam ◽

Daniel Wendling ◽

Muriel Piperno ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Study ◽

Hand Osteoarthritis ◽

Double Blind ◽

Osteoarthritis Pain ◽

Inflammatory Drugs ◽

The Mean ◽

Secondary Outcomes ◽

And Function ◽

To Receive

ObjectiveTo evaluate the efficacy of tocilizumab, an antibody against IL-6 receptor, in patients with hand osteoarthritis.MethodsThis was a multicentre, 12-week, randomised, double-blind, placebo-controlled study from November 2015 to October 2018. Patients with symptomatic hand osteoarthritis (pain ≥40 on a 0–100 mm visual analogue scale (VAS) despite analgesics and non-steroidal anti-inflammatory drugs; at least three painful joints, Kellgren-Lawrence grade ≥2) were randomised to receive two infusions 4 weeks apart (weeks 0 and 4) of tocilizumab (8 mg/kg intravenous) or placebo. The primary endpoint was changed in VAS pain at week 6. Secondary outcomes included the number of painful and swollen joints, duration of morning stiffness, patients’ and physicians’ global assessment and function scores.ResultsOf 104 patients screened, 91 (45 to tocilizumab and 46 to placebo; 82% women; mean age 64.4 (SD 8.7) years) were randomly assigned and 79 completed the 12-week study visit. The mean change between baseline and week 6 on the VAS for pain (primary outcome) was −7.9 (SD 19.4) and −9.9 (SD 20.1) in the tocilizumab and placebo groups (p=0.7). The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12. Overall, adverse events were slightly more frequent in the tocilizumab than placebo group.ConclusionTocilizumab was no more effective than placebo for pain relief in patients with hand osteoarthritis.

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Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy study: a before−after study protocol

npj Primary Care Respiratory Medicine ◽

10.1038/s41533-020-00209-5 ◽

2020 ◽

Vol 30 (1) ◽

Author(s):

Leonieke J. Breunis ◽

Marlou L. A. de Kroon ◽

Lyzette T. Laureij ◽

Lieke de Jong-Potjer ◽

Eric A. P. Steegers ◽

...

Keyword(s):

Alcohol Use ◽

Study Protocol ◽

Primary Outcome ◽

Outcome Measure ◽

Target Population ◽

Primary Outcome Measure ◽

Web Based ◽

Maximum Duration ◽

Secondary Outcomes ◽

Group Sessions

AbstractDespite existing interventions, tobacco smoking and alcohol consumption during pregnancy are common. The Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy intervention combines monthly group sessions, access to a web-based platform and incentives upon biochemically validated cessation for a maximum duration of 6 months to promote cessation of smoking and alcohol use before and during pregnancy. To inform development of the SAFER pregnancy intervention, two focus groups with the target population were held beforehand, with results reported here alongside the final SAFER pregnancy study protocol. In a before−after study we aim to include 66 women who are pregnant or have a wish to become pregnant and who smoke and/or consume alcohol (i.e. target population of the SAFER pregnancy intervention). The primary outcome measure is cessation of smoking and/or alcohol use at 34−38 weeks of gestation, or after six group sessions if women did not become pregnant during the study period. Secondary outcomes focus on the barriers and facilitators for implementation of the SAFER pregnancy intervention.

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Effectiveness of aripiprazole v. Haloperidol in acute bipolar mania

The British Journal of Psychiatry ◽

10.1192/bjp.187.3.235 ◽

2005 ◽

Vol 187 (3) ◽

pp. 235-242 ◽

Cited By ~ 122

Author(s):

Eduard Vieta ◽

Michel Bourin ◽

Raymond Sanchez ◽

Ronald Marcus ◽

Elyse Stock ◽

...

Keyword(s):

Primary Outcome ◽

Rating Scale ◽

Outcome Measure ◽

Treatment Options ◽

Manic Episode ◽

Primary Outcome Measure ◽

Young Mania ◽

Double Blind ◽

Number Of Patients ◽

To Receive

BackgroundDespite several treatment options, adherence to therapy is poor in patients with bipolar disorder.AimsA double-blind, controlled comparison of aripiprazole and haloperidol in patients with bipolar I disorder experiencing acute manic or mixed episodes.MethodPatients (n=347) were randomised to receive aripiprazole or haloperidol in this 12-week, multicentre study. The primary outcome measure was the number of patients in response (550% improvement from baseline in Young Mania Rating Scale score) and receiving therapy at week 12.ResultsAt week 12, significantly more patients taking aripiprazole (49. 7%) were in response and receiving therapy compared with those taking haloperidol (28. 4%; P<0. 001). Continuation rates differed markedly between treatments (week 12: aripiprazole, 50. 9%; haloperidol, 29. 1%). Extrapyramidal adverse events were more frequent with haloperidol than aripiprazole (62. 7% v. 24. 0%).ConclusionsAripiprazole showed superior levels of response and tolerability to haloperidol in the treatment of an acute manic episode for up to 12 weeks.

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