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The Cochrane Database of Systematic... Apr 2016In the 1940s reserpine, refined from a plant extract that had been used for centuries, began to be used as a treatment for people with mental disorders and was one of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In the 1940s reserpine, refined from a plant extract that had been used for centuries, began to be used as a treatment for people with mental disorders and was one of the very first antipsychotic drugs. Its irreversible pharmacological potency and adverse effects meant that it has been withdrawn in the UK and its role has been superceded by 'newer' compounds. The effects of reserpine are of historical interest although there are some reports of it still being used in highly specialist situations in psychiatry. Chlorpromazine is also an old drug but it is still used for treatment of people with schizophrenia.
OBJECTIVES
To investigate the effects of two old medications (reserpine and chlorpromazine) for people with schizophrenia. Reserpine is now rarely used while chlorpromazine remains on the essential list of drugs of the World Health Organization (WHO).
SEARCH METHODS
We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials (24 March 2016).
SELECTION CRITERIA
We included randomised clinical trials focusing on chlorpromazine versus reserpine for schizophrenia that presented useable data.
DATA COLLECTION AND ANALYSIS
We extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE.
MAIN RESULTS
The review currently includes nine studies with an average 60 participants per study. All of these studies are now over 60 years old, conducted between 1955 and 1962. When chlorpromazine was compared with reserpine for people with schizophrenia, improvement in global state was better at short term for those receiving chlorpromazine (n = 781, 6 RCTs, RR 'not improved' 0.75 95% CI 0.62 to 0.92, low-quality evidence). Short-term improvement in paranoid distortion was measured using the Multidimensional Scale for Rating Psychiatric Patients (MSRPP). Data showed no clear difference between treatment groups (n = 19, 1 RCT, RR 1.33 95% CI 0.62 to 2.89, very low-quality evidence). There was no difference in functioning: occupational adjustment, medium term (n = 40, 1 RCT, RR 0.83 95% CI 0.47 to 1.47, moderate-quality evidence) and general behaviour (n = 98, 1 RCT, RR 0.79 CI 0.41 to 1.53, moderate-quality evidence). Adverse events were poorly reported. For 'toxic reaction' there was, again, no obvious difference between the two compounds (n = 210, 3 RCTs, RR 1.68 95% CI 0.43 to 6.54, moderate-quality evidence), and this also applied to leaving the study early (n = 229, 4 RCTs, RR 1.16 95% CI 0.94 to 1.42, moderate-quality evidence).
AUTHORS' CONCLUSIONS
Judged by standards of today, the evidence is largely of limited quality. However, some of these 1950s studies are remarkable in their foresight and clarity. Reserpine did have some effect on global state - but chlorpromazine did seem to perform better. Important issues regarding adverse effects were not really addressed by these trials. Chlorpromazine remains on the WHO list of essential drugs. Reserpine is now almost obsolete, although, probably as a result of evidence other than that reported in the pioneering trials used in this review.
Topics: Antipsychotic Agents; Chlorpromazine; Humans; Randomized Controlled Trials as Topic; Reserpine; Schizophrenia
PubMed: 27124109
DOI: 10.1002/14651858.CD012122.pub2 -
The Cochrane Database of Systematic... Nov 2015Schizophrenia is a highly prevalent and chronic disorder that comprises a wide range of symptomatology. Asenapine is a recently developed atypical antipsychotic that is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Schizophrenia is a highly prevalent and chronic disorder that comprises a wide range of symptomatology. Asenapine is a recently developed atypical antipsychotic that is approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia.
OBJECTIVES
To determine the clinical effects of asenapine for adults with schizophrenia or other schizophrenia-like disorders by comparing it with placebo.
SEARCH METHODS
We searched the Cochrane Schizophrenia Group's Trials Register (July 04, 2014) which is based on regular searches of MEDLINE, EMBASE, CINAHL, BIOSIS, AMED, PubMed, PsycINFO, and registries of clinical trials. There are no language, date, document type, or publication status limitation for inclusion of records into the register. We inspected references of all included studies for further relevant studies.
SELECTION CRITERIA
Our review includes randomised controlled trials (RCTs) comparing asenapine with placebo in adults (however defined) with schizophrenia or related disorders, including schizophreniform disorder, schizoaffective disorder and delusional disorder, again, by any means of diagnosis.
DATA COLLECTION AND ANALYSIS
We inspected citations from the searches and identified relevant abstracts, and extracted data from all included studies. For binary data we calculated risk ratio (RR) with 95% confidence intervals (CI), and for continuous data we calculated mean differences (MD). We used the GRADE approach to produce a 'Summary of findings' table which included our outcomes of interest, where possible. We used a fixed-effect model for our analyses.
MAIN RESULTS
We obtained and scrutinised 41 potentially relevant records, and from these we could include only six trials (n = 1835). Five of the six trials had high risk of attrition bias and all trials were sponsored by pharmaceutical companies. Results showed a clinically important change in global state (1 RCT, n = 336, RR 0.81, 95% CI 0.68 to 0.97, low-quality evidence) and mental state (1 RCT, n = 336, RR 0.72, 95% CI 0.59 to 0.86, very low-quality evidence) at short-term amongst people receiving asenapine. People receiving asenapine demonstrated significant reductions in negative symptoms (1 RCT, n = 336, MD -1.10, 95% CI -2.29 to 0.09, very low-quality evidence) at short-term. Individuals receiving asenapine demonstrated significantly fewer incidents of serious adverse effects (1 RCT, n = 386, RR 0.29, 95% CI 0.14 to 0.63, very low-quality evidence) at medium-term. There was no clear difference in people discontinuing the study for any reason between asenapine and placebo at short-term (5 RCTs, n = 1046, RR 0.91, 95% CI 0.80 to 1.04, very low-quality evidence). No trial reported data for extrapyramidal symptoms or costs.
AUTHORS' CONCLUSIONS
There is some, albeit preliminary, evidence that asenapine provides an improvement in positive, negative, and depressive symptoms, whilst minimising the risk of adverse effects. However due to the low-quality and limited quantity of evidence, it remains difficult to recommend the use of asenapine for people with schizophrenia. We identify a need for large-scale, longer-term, better-designed and conducted randomised controlled trials investigating the clinical effects and safety of asenapine.
Topics: Adult; Antipsychotic Agents; Dibenzocycloheptenes; Heterocyclic Compounds, 4 or More Rings; Humans; Psychotic Disorders; Randomized Controlled Trials as Topic; Schizophrenia; Treatment Outcome
PubMed: 26599405
DOI: 10.1002/14651858.CD011458.pub2 -
Addiction (Abingdon, England) Apr 2016To assess the efficacy and tolerability of adjunctive pharmacotherapy for smoking cessation in adults with serious mental illness (SMI) by means of a systematic review... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND AIMS
To assess the efficacy and tolerability of adjunctive pharmacotherapy for smoking cessation in adults with serious mental illness (SMI) by means of a systematic review and network meta-analysis.
METHOD
We searched Embase, Medline, PsychINFO and the Cochrane Central Register of Controlled Trials from database inception to 1 December 2014 for randomized controlled trials (RCTs) published in English. We included all studies of smokers with SMI (including schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder and depressive psychoses) who were motivated to quit smoking. Pharmacotherapies included nicotine replacement therapy (NRT), bupropion and varenicline delivered as monotherapy or in combination compared with each other or placebo. The efficacy outcome was self-reported sustained smoking cessation, verified biochemically at the longest reported time-point. The tolerability outcome was number of patients discontinuing the trial due to any adverse event.
RESULTS
Seventeen study reports were included, which represented 14 individual RCTs. No trials were found in patients with depressive psychoses, delusional disorder or that compared NRT monotherapy with placebo. A total of 356 and 423 participants were included in the efficacy and tolerability analyses, respectively. From the network meta-analysis, both bupropion and varenicline were more effective than placebo [odds ratio (OR) = 4.51, 95% credible interval (CrI) = 1.45-14.04 and OR = 5.17, 95% CrI = 1.78-15.06, respectively]. Data were insensitive to an assessment of varenicline versus bupropion (OR = 1.15, 95% CrI = 0.24-5.45). There were no significant differences in tolerability. All outcomes were rated by GRADE criteria as very low quality.
CONCLUSIONS
The limited evidence available to date suggests that bupropion and varenicline are effective and tolerable for smoking cessation in adults with serious mental illnesses.
Topics: Bupropion; Humans; Mental Disorders; Nicotinic Agonists; Smoking Cessation; Tobacco Use Cessation Devices; Tobacco Use Disorder; Treatment Outcome; Varenicline
PubMed: 26594837
DOI: 10.1111/add.13236 -
The Cochrane Database of Systematic... May 2015Delusional disorder is commonly considered to be difficult to treat. Antipsychotic medications are frequently used and there is growing interest in a potential role for... (Review)
Review
BACKGROUND
Delusional disorder is commonly considered to be difficult to treat. Antipsychotic medications are frequently used and there is growing interest in a potential role for psychological therapies such as cognitive behavioural therapy (CBT) in the treatment of delusional disorder.
OBJECTIVES
To evaluate the effectiveness of medication (antipsychotic medication, antidepressants, mood stabilisers) and psychotherapy, in comparison with placebo in delusional disorder.
SEARCH METHODS
We searched the Cochrane Schizophrenia Group's Trials Register (28 February 2012).
SELECTION CRITERIA
Relevant randomised controlled trials (RCTs) investigating treatments in delusional disorder.
DATA COLLECTION AND ANALYSIS
All review authors extracted data independently for the one eligible trial. For dichotomous data we calculated risk ratios (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis with a fixed-effect model. Where possible, we calculated illustrative comparative risks for primary outcomes. For continuous data, we calculated mean differences (MD), again with a fixed-effect model. We assessed the risk of bias of the included study and used the GRADE approach to rate the quality of the evidence.
MAIN RESULTS
Only one randomised trial met our inclusion criteria, despite our initial search yielding 141 citations. This was a small study, with 17 people completing a trial comparing CBT to an attention placebo (supportive psychotherapy) for people with delusional disorder. Most participants were already taking medication and this was continued during the trial. We were not able to include any randomised trials on medications of any type due to poor data reporting, which left us with no usable data for these trials. For the included study, usable data were limited, risk of bias varied and the numbers involved were small, making interpretation of data difficult. In particular there were no data on outcomes such as global state and behaviour, nor any information on possible adverse effects.A positive effect for CBT was found for social self esteem using the Social Self-Esteem Inventory (1 RCT, n = 17, MD 30.5, CI 7.51 to 53.49, very low quality evidence), however this is only a measure of self worth in social situations and may thus not be well correlated to social function. More people left the study early if they were in the supportive psychotherapy group with 6/12 leaving early compared to 1/6 from the CBT group, but the difference was not significant (1 RCT, n = 17, RR 0.17, CI 0.02 to 1.18, moderate quality evidence). For mental state outcomes the results were skewed making interpretation difficult, especially given the small sample.
AUTHORS' CONCLUSIONS
Despite international recognition of this disorder in psychiatric classification systems such as ICD-10 and DSM-5, there is a paucity of high quality randomised trials on delusional disorder. There is currently insufficient evidence to make evidence-based recommendations for treatments of any type for people with delusional disorder. The limited evidence that we found is not generalisable to the population of people with delusional disorder. Until further evidence is found, it seems reasonable to offer treatments which have efficacy in other psychotic disorders. Further research is needed in this area and could be enhanced in two ways: firstly, by conducting randomised trials specifically for people with delusional disorder and, secondly, by high quality reporting of results for people with delusional disorder who are often recruited into larger studies for people with a variety of psychoses.
Topics: Cognitive Behavioral Therapy; Humans; Psychotherapy; Randomized Controlled Trials as Topic; Schizophrenia, Paranoid; Self Concept
PubMed: 25997589
DOI: 10.1002/14651858.CD009785.pub2 -
Indian Journal of Psychological Medicine 2015Case reports of delusion of pregnancy have emanated from all over the world, yet the rarity of this phenomenology has precluded systematic large scale descriptive or... (Review)
Review
Case reports of delusion of pregnancy have emanated from all over the world, yet the rarity of this phenomenology has precluded systematic large scale descriptive or cohort studies. This systematic review was conducted to assess the demographic characteristics, clinical profile, treatment outcome and aetiological factors from the published case reports of delusion of pregnancy. Electronic databases including PubMed, PsychInfo and Google Scholar were used to identify case reports relating to delusion of pregnancy published in peer-reviewed English language journals. All such cases were systematically evaluated by investigators, and information was extracted using a structured proforma. A total 40 articles were reviewed which included 84 cases. Demographic characteristics revealed that about half of the patients were aged 20-40 years. The most common diagnoses were schizophrenia (35.7%), bipolar disorders (16.7%) and depression (9.5%). Single foetus was reported by 79.8% of the patients, and 45.2% perceived foetal movements. Good treatment response was noted in 64.3 % of the cases. The prominent aetiological factors that were implicated included psychosocial factors, coenaesthopathological processes, socio-cultural factors and hyperprolactinaemia. Delusion of pregnancy is a heterogeneous symptom which emerges during the course of various neuropsychiatric disorders. A range of aetiopathological mechanisms have been implicated in the causation of this disorder.
PubMed: 25969595
DOI: 10.4103/0253-7176.155609 -
The Cochrane Database of Systematic... Dec 2014During intensive care unit (ICU) admission, patients experience extreme physical and psychological stressors, including the abnormal ICU environment. These experiences... (Review)
Review
BACKGROUND
During intensive care unit (ICU) admission, patients experience extreme physical and psychological stressors, including the abnormal ICU environment. These experiences impact on a patient's recovery from critical illness and may result in both physical and psychological disorders. One strategy that has been developed and implemented by clinical staff to treat the psychological distress prevalent in ICU survivors is the use of patient diaries. These provide a background to the cause of the patient's ICU admission and an ongoing narrative outlining day-to-day activities.
OBJECTIVES
To assess the effect of a diary versus no diary on patients, and their caregivers or families, during the patient's recovery from admission to an ICU.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 1), Ovid MEDLINE (1950 to January 2014), EBSCOhost CINAHL (1982 to January 2014), Ovid EMBASE (1980 to January 2014), PsycINFO (1950 to January 2014), Published International Literature on Traumatic Stress (PILOTS) database (1971 to January 2014); Web of Science Conference Proceedings Citation Index - Science and Social Science and Humanities (1990 to January 2014); seven clinical trial registries and reference lists of identified trials. We applied no language restriction.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) or clinical controlled trials (CCTs) that evaluated the effectiveness of patient diaries, when compared to no ICU diary, for patients or family members to promote recovery after admission to ICU. Outcome measures for describing recovery from ICU included the risk of post-traumatic stress disorder (PTSD), anxiety, depression and post-traumatic stress symptomatology, health-related quality of life and costs.
DATA COLLECTION AND ANALYSIS
We used standard methodological approaches as expected by The Cochrane Collaboration. Two review authors independently reviewed titles for inclusion, extracted data and undertook risk of bias according to prespecified criteria.
MAIN RESULTS
We identified three eligible studies; two describing ICU patients (N = 358), and one describing relatives of ICU patients (N = 30). The study involving relatives of ICU patients was a substudy of family members from one of the ICU patient studies. There was a mixed risk of bias within the included studies. Blinding of participants to allocation was not possible and blinding of the outcome assessment was not adequately achieved or reported. Overall the quality of the evidence was low to very low. The patient diary intervention was not identical between studies. However, each provided a prospectively prepared, day-to-day description of the participants' ICU admission.No study adequately reported on risk of PTSD as described using a clinical interview, family or caregiver anxiety or depression, health-related quality of life or costs. Within a single study there was no clear evidence of a difference in risk for developing anxiety (risk ratio (RR) 0.29, 95% confidence interval (CI) 0.07 to 1.19) or depression (RR 0.38, 95% CI 0.12 to 1.19) in participants who received ICU diaries, in comparison to those that did not receive a patient diary. However, the results were imprecise and consistent with benefit in either group, or no difference. Within a single study there was no evidence of difference in median post-traumatic stress symptomatology scores (diaries 24, SD 11.6; no diary 24, SD 11.6) and delusional ICU memory recall (RR 1.04, 95% CI 0.84 to 1.28) between the patients recovering from ICU admission who received patient diaries, and those who did not. One study reported reduced post-traumatic stress symptomatology in family members of patients recovering from admission to ICU who received patient diaries (median 19; range 14 to 28), in comparison to no diary (median 28; range 14 to 38).
AUTHORS' CONCLUSIONS
Currently there is minimal evidence from RCTs of the benefits or harms of patient diaries for patients and their caregivers or family members. A small study has described their potential to reduce post-traumatic stress symptomatology in family members. However, there is currently inadequate evidence to support their effectiveness in improving psychological recovery after critical illness for patients and their family members.
Topics: Anxiety; Caregivers; Convalescence; Critical Care; Critical Illness; Depression; Family; Humans; Intensive Care Units; Medical Records; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Stress Disorders, Post-Traumatic; Stress, Psychological
PubMed: 25488158
DOI: 10.1002/14651858.CD010468.pub2 -
The Journal of Clinical Psychiatry Apr 2012To perform a meta-analysis of antidepressant-antipsychotic cotreatment versus antidepressant or antipsychotic monotherapy for psychotic depression. (Comparative Study)
Comparative Study Meta-Analysis Review
Are antipsychotics or antidepressants needed for psychotic depression? A systematic review and meta-analysis of trials comparing antidepressant or antipsychotic monotherapy with combination treatment.
OBJECTIVE
To perform a meta-analysis of antidepressant-antipsychotic cotreatment versus antidepressant or antipsychotic monotherapy for psychotic depression.
DATA SOURCES
We performed an electronic search (from inception of databases until February 28, 2011) in PubMed/MEDLINE, Cochrane Library, and PsycINFO, without language or time restrictions. Search terms were (psychosis OR psychotic OR hallucinations OR hallucinating OR delusions OR delusional) AND (depression OR depressed OR major depressive disorder) AND (random OR randomized OR randomly).
STUDY SELECTION
Eight randomized, placebo-controlled acute-phase studies in adults (N = 762) with standardized criteria-defined psychotic depression (including Research Diagnostic Criteria, DSM-III, DSM-IV, or ICD-10) were meta-analyzed, yielding 10 comparisons. Antidepressant-antipsychotic cotreatment was compared in 5 trials with 6 treatment arms (n = 337) with antidepressant monotherapy and in 4 trials with 4 treatment arms (n = 447) with antipsychotic monotherapy.
DATA EXTRACTION
Primary outcome was study-defined inefficacy; secondary outcomes included all-cause discontinuation, specific psychopathology ratings, and side effects. Using random effects models, we calculated relative risk (RR) with 95% confidence intervals (CIs), number-needed-to-treat/harm (NNT/NNH), and effect size (ES).
RESULTS
Antidepressant-antipsychotic cotreatment outperformed antidepressant monotherapy regarding less study-defined inefficacy (no. of comparisons = 6; n = 378; RR = 0.76; 95% CI, 0.59-0.98; P = .03; heterogeneity [I2] = 34%) (NNT = 7; 95% CI, 4-20; P = .009) and Clinical Global Impressions-Severity of Illness scores (no. of comparisons = 4; n = 289; ES = -0.25; 95% CI, -0.49 to -0.02; P = .03; I2 = 0%), with trend-level superiority for depression ratings (no. of comparisons = 5; n = 324; ES = -0.20; 95% CI, -0.44 to 0.03; P = .09; I2 = 10%), but not regarding psychosis ratings (no. of comparisons = 3; n = 161; ES = -0.24; 95% CI, -0.85 to 0.38; P = .45; I2 = 70%). Antidepressant-antipsychotic cotreatment also outperformed antipsychotic monotherapy regarding less study-defined inefficacy (no. of comparisons = 4; n = 447; RR = 0.73; 95% CI, 0.63-0.84; P < .0001; I2 = 0%) (NNT = 5; 95% CI, 4-8; P < .0001) and depression ratings (no. of comparisons = 4; n = 428; ES = -0.49; 95% CI, -0.75 to -0.23; P = .0002; I2 = 27%), while anxiety (P = .11) and psychosis (P = .06) ratings only trended toward favoring cotreatment. All-cause discontinuation and reported side-effect rates were similar, except for more somnolence with antidepressant-antipsychotic cotreatment versus antidepressants (P = .02). Only 1 open-label, 4-month extension study (n = 59) assessed maintenance/relapse-prevention efficacy of antidepressant-antipsychotic cotreatment versus antidepressant monotherapy, without group differences.
CONCLUSIONS
Antidepressant-antipsychotic cotreatment was superior to monotherapy with either drug class in the acute treatment of psychotic depression. These results support recent treatment guidelines, but more studies are needed to assess specific combinations and maintenance/relapse-prevention efficacy.
Topics: Adult; Antidepressive Agents; Antipsychotic Agents; Depressive Disorder, Major; Drug Therapy, Combination; Humans; Psychotic Disorders; Treatment Outcome
PubMed: 22579147
DOI: 10.4088/JCP.11r07324 -
Journal of Critical Care Apr 2012The aim of this study was to review literature exploring the emotional consequences of delirium and delusional memories in intensive care unit patients. (Review)
Review
PURPOSE
The aim of this study was to review literature exploring the emotional consequences of delirium and delusional memories in intensive care unit patients.
METHODS
A systematic review was performed using PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and PsychINFO.
RESULTS
Fourteen articles were eligible for this review. Five of them assessed delirium during intensive care unit admission, and the remainder assessed delusional memories during or after admission. No association was found for delirium and adverse emotional outcome. Data regarding delusional memories and emotional outcome were heterogenic. Some studies presented worse scores on posttraumatic stress disorder screening tools in patients with delusional memories, whereas other studies found better scores in patients with delirium or delusional memories.
CONCLUSIONS
Based on current literature, no relationship could be shown for delirium and emotional outcome. Regarding delusional memories and adverse emotional outcome, results were in contradiction.
Topics: Delirium; Delusions; Emotions; Humans; Intensive Care Units; Memory; Patient Admission
PubMed: 21958975
DOI: 10.1016/j.jcrc.2011.07.074