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Health Technology Assessment... May 2016Ulcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients' quality of life. The burden for... (Review)
Review
Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model.
BACKGROUND
Ulcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients' quality of life. The burden for the NHS is substantial.
OBJECTIVES
To evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities.
DATA SOURCES
Peer-reviewed publications, European Public Assessment Reports and manufacturers' submissions. The following databases were searched from inception to December 2013 for clinical effectiveness searches and from inception to January 2014 for cost-effectiveness searches for published and unpublished research evidence: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and NHS Economic Evaluation Database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science and Bioscience Information Service Previews. The US Food and Drug Administration website and the European Medicines Agency website were also searched, as were research registers, conference proceedings and key journals.
REVIEW METHODS
A systematic review [including network meta-analysis (NMA)] was conducted to evaluate the clinical effectiveness and safety of named interventions. The health economic analysis included a review of published economic evaluations and the development of a de novo model.
RESULTS
Ten randomised controlled trials were included in the systematic review. The trials suggest that adult patients receiving infliximab (IFX) [Remicade(®), Merck Sharp & Dohme Ltd (MSD)], adalimumab (ADA) (Humira(®), AbbVie) or golimumab (GOL) (Simponi(®), MSD) were more likely to achieve clinical response and remission than those receiving placebo (PBO). Hospitalisation data were limited, but suggested more favourable outcomes for ADA- and IFX-treated patients. Data on the use of surgical intervention were sparse, with a potential benefit for intervention-treated patients. Data were available from one trial to support the use of IFX in paediatric patients. Safety issues identified included serious infections, malignancies and administration site reactions. Based on the NMA, in the induction phase, all biological treatments were associated with statistically significant beneficial effects relative to PBO, with the greatest effect associated with IFX. For patients in response following induction, all treatments except ADA and GOL 100 mg at 32-52 weeks were associated with beneficial effects when compared with PBO, although these were not significant. The greatest effects at 8-32 and 32-52 weeks were associated with 100 mg of GOL and 5 mg/kg of IFX, respectively. For patients in remission following induction, all treatments except ADA at 8-32 weeks and GOL 50 mg at 32-52 weeks were associated with beneficial effects when compared with PBO, although only the effect of ADA at 32-52 weeks was significant. The greatest effects were associated with GOL (at 8-32 weeks) and ADA (at 32-52 weeks). The economic analysis suggests that colectomy is expected to dominate drug therapies, but for some patients, colectomy may not be considered acceptable. In circumstances in which only drug options are considered, IFX and GOL are expected to be ruled out because of dominance, while the incremental cost-effectiveness ratio for ADA versus conventional treatment is approximately £50,300 per QALY gained.
LIMITATIONS
The health economic model is subject to several limitations: uncertainty associated with extrapolating trial data over a lifetime horizon, the model does not consider explicit sequential pathways of non-biological treatments, and evidence relating to complications of colectomy was identified through consideration of approaches used within previous models rather than a full systematic review.
CONCLUSIONS
Adult patients receiving IFX, ADA or GOL were more likely to achieve clinical response and remission than those receiving PBO. Further data are required to conclusively demonstrate the effect of interventions on hospitalisation and surgical outcomes. The economic analysis indicates that colectomy is expected to dominate medical treatments for moderate to severe UC.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42013006883.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Adalimumab; Antibodies, Monoclonal; Biosimilar Pharmaceuticals; Colitis, Ulcerative; Cost-Benefit Analysis; Gastrointestinal Agents; Hospitalization; Humans; Infliximab; Models, Econometric; Quality of Life; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic; State Medicine
PubMed: 27220829
DOI: 10.3310/hta20390 -
The Cochrane Database of Systematic... Mar 2014In people with acute ischaemic stroke, platelets become activated and can cause blood clots to form and block an artery in the brain, resulting in damage to part of the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In people with acute ischaemic stroke, platelets become activated and can cause blood clots to form and block an artery in the brain, resulting in damage to part of the brain. Such damage gives rise to the symptoms of stroke. Antiplatelet therapy might reduce the volume of brain damaged by ischaemia and also reduce the risk of early recurrent ischaemic stroke, thereby reducing the risk of early death and improving long-term outcomes in survivors. However, antiplatelet therapy might also increase the risk of fatal or disabling intracranial haemorrhage.
OBJECTIVES
To assess the efficacy and safety of immediate oral antiplatelet therapy (that is started as soon as possible and no later than two weeks after stroke onset) in people with acute presumed ischaemic stroke.
SEARCH METHODS
We searched the Cochrane Stroke Group Trials Register (last searched 16 October 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2013), MEDLINE (June 1998 to May 2013), and EMBASE (June 1998 to May 2013). In 1998, for a previous version of this review, we searched the register of the Antiplatelet Trialists' Collaboration, MedStrategy and contacted relevant drug companies.
SELECTION CRITERIA
Randomised trials comparing oral antiplatelet therapy (started within 14 days of the stroke) with control in people with definite or presumed ischaemic stroke.
DATA COLLECTION AND ANALYSIS
Two review authors independently applied the inclusion criteria and assessed trial quality. For the included trials, they extracted and cross-checked the data.
MAIN RESULTS
We included eight trials involving 41,483 participants. No new trials have been added since the last update.Two trials testing aspirin 160 mg to 300 mg once daily, started within 48 hours of onset, contributed 98% of the data. The risk of bias was low. The maximum follow-up was six months. With treatment, there was a significant decrease in death or dependency at the end of follow-up (odds ratio (OR) 0.95, 95% confidence interval (CI) 0.91 to 0.99). For every 1000 people treated with aspirin, 13 people would avoid death or dependency (number needed to treat 79). Antiplatelet therapy was associated with a small but definite excess of symptomatic intracranial haemorrhages, but this small hazard was significantly outnumbered by the benefit, the reduction in recurrent ischaemic stroke and pulmonary embolus.
AUTHORS' CONCLUSIONS
Antiplatelet therapy with aspirin 160 mg to 300 mg daily, given orally (or by nasogastric tube or per rectum in people who cannot swallow) and started within 48 hours of onset of presumed ischaemic stroke, reduced the risk of early recurrent ischaemic stroke without a major risk of early haemorrhagic complications; long-term outcomes were improved.
Topics: Aspirin; Brain Ischemia; Dipyridamole; Humans; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Risk; Stroke; Ticlopidine; Time-to-Treatment
PubMed: 24668137
DOI: 10.1002/14651858.CD000029.pub3 -
Molecules (Basel, Switzerland) Aug 2022Hydroxyapatite (HA) is a well-known calcium phosphate ingredient comparable to human bone tissue. HA has exciting applications in many fields, especially biomedical... (Review)
Review
Hydroxyapatite (HA) is a well-known calcium phosphate ingredient comparable to human bone tissue. HA has exciting applications in many fields, especially biomedical applications, such as drug delivery, osteogenesis, and dental implants. Unfortunately, hydroxyapatite-based nanomaterials are synthesized by conventional methods using reagents that are not environmentally friendly and are expensive. Therefore, extensive efforts have been made to establish a simple, efficient, and green method to form nano-hydroxyapatite (NHA) biofunctional materials with significant biocompatibility, bioactivity, and mechanical strength. Several types of biowaste have proven to be a source of calcium in forming HA, including using chicken eggshells, fish bones, and beef bones. This systematic literature review discusses the possibility of replacing synthetic chemical reagents, synthetic pathways, and toxic capping agents with a green template to synthesize NHA. This review also shed insight on the simple green manufacture of NHA with controlled shape and size.
Topics: Animals; Bone and Bones; Cattle; Drug Delivery Systems; Durapatite; Humans; Nanostructures; Osteogenesis
PubMed: 36080349
DOI: 10.3390/molecules27175586 -
The Cochrane Database of Systematic... Feb 2017Non-invasive ventilation may be a means to temporarily reverse or slow the progression of respiratory failure in cystic fibrosis by providing ventilatory support and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Non-invasive ventilation may be a means to temporarily reverse or slow the progression of respiratory failure in cystic fibrosis by providing ventilatory support and avoiding tracheal intubation. Using non-invasive ventilation, in the appropriate situation or individuals, can improve lung mechanics through increasing airflow and gas exchange and decreasing the work of breathing. Non-invasive ventilation thus acts as an external respiratory muscle. This is an update of a previously published review.
OBJECTIVES
To compare the effect of non-invasive ventilation versus no non-invasive ventilation in people with cystic fibrosis for airway clearance, during sleep and during exercise.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings. We searched the reference lists of each trial for additional publications possibly containing other trials.Most recent search: 08 August 2016.
SELECTION CRITERIA
Randomised controlled trials comparing a form of pressure preset or volume preset non-invasive ventilation to no non-invasive ventilation used for airway clearance or during sleep or exercise in people with acute or chronic respiratory failure in cystic fibrosis.
DATA COLLECTION AND ANALYSIS
Three reviewers independently assessed trials for inclusion criteria and methodological quality, and extracted data.
MAIN RESULTS
Ten trials met the inclusion criteria with a total of 191 participants. Seven trials evaluated single treatment sessions, one evaluated a two-week intervention, one evaluated a six-week intervention and one a three-month intervention. It is only possible to blind trials of airway clearance and overnight ventilatory support to the outcome assessors. In most of the trials we judged there was an unclear risk of bias with regards to blinding due to inadequate descriptions. The six-week trial was the only one judged to have a low risk of bias for all other domains. One single intervention trial had a low risk of bias for the randomisation procedure with the remaining trials judged to have an unclear risk of bias. Most trials had a low risk of bias with regard to incomplete outcome data and selective reporting.Six trials (151 participants) evaluated non-invasive ventilation for airway clearance compared with an alternative chest physiotherapy method such as the active cycle of breathing techniques or positive expiratory pressure. Three trials used nasal masks, one used a nasal mask or mouthpiece and one trial used a face mask and in one trial it is unclear. Three of the trials reported on one of the review's primary outcome measures (quality of life). Results for the reviews secondary outcomes showed that airway clearance may be easier with non-invasive ventilation and people with cystic fibrosis may prefer it. We were unable to find any evidence that non-invasive ventilation increases sputum expectoration, but it did improve some lung function parameters.Three trials (27 participants) evaluated non-invasive ventilation for overnight ventilatory support compared to oxygen or room air using nasal masks (two trials) and nasal masks or full face masks (one trial). Trials reported on two of the review's primary outcomes (quality of life and symptoms of sleep-disordered breathing). Results for the reviews secondary outcome measures showed that they measured lung function, gas exchange, adherence to treatment and preference, and nocturnal transcutaneous carbon dioxide. Due to the small numbers of participants and statistical issues, there were discrepancies in the results between the RevMan and the original trial analyses. No clear differences were found between non-invasive ventilation compared with oxygen or room air except for exercise performance, which significantly improved with non-invasive ventilation compared to room air over six weeks.One trial (13 participants) evaluated non-invasive ventilation on exercise capacity (interface used was unclear) and did not reported on any of the review's primary outcomes. The trial found no clear differences between non-invasive ventilation compared to no non-invasive ventilation for any of our outcomes.Three trials reported on adverse effects. One trial, evaluating non-invasive ventilation for airway clearance, reported that a participant withdrew at the start of the trial due to pain on respiratory muscle testing. One trial evaluating non-invasive ventilation for overnight support reported that one participant could not tolerate an increase in inspiratory positive airway pressure. A second trial evaluating non-invasive ventilation in this setting reported that one participant did not tolerate the non-invasive ventilation mask, one participant developed a pneumothorax when breathing room air and two participants experienced aerophagia which resolved when inspiratory positive airway pressure was decreased.
AUTHORS' CONCLUSIONS
Non-invasive ventilation may be a useful adjunct to other airway clearance techniques, particularly in people with cystic fibrosis who have difficulty expectorating sputum. Non-invasive ventilation, used in addition to oxygen, may improve gas exchange during sleep to a greater extent than oxygen therapy alone in moderate to severe disease. The effect of NIV on exercise is unclear. These benefits of non-invasive ventilation have largely been demonstrated in single treatment sessions with small numbers of participants. The impact of this therapy on pulmonary exacerbations and disease progression remain unclear. There is a need for long-term randomised controlled trials which are adequately powered to determine the clinical effects of non-invasive ventilation in cystic fibrosis airway clearance and exercise.
Topics: Cystic Fibrosis; Humans; Masks; Noninvasive Ventilation; Randomized Controlled Trials as Topic; Respiratory Insufficiency; Sputum
PubMed: 28218802
DOI: 10.1002/14651858.CD002769.pub5 -
The Cochrane Database of Systematic... Feb 2010Fatigue is reported to occur in up to 92% of patients with multiple sclerosis (MS) and has been described as the most debilitating of all MS symptoms by 28% to 40% of MS... (Review)
Review
BACKGROUND
Fatigue is reported to occur in up to 92% of patients with multiple sclerosis (MS) and has been described as the most debilitating of all MS symptoms by 28% to 40% of MS patients.
OBJECTIVES
To assess whether carnitine (enteral or intravenous) supplementation can improve the quality of life and reduce the symptoms of fatigue in patients with MS-related fatigue and to identify any adverse effects of carnitine when used for this purpose.
SEARCH STRATEGY
A literature search was performed using Cochrane MS Group Trials Register (21 May 2009), Cochrane Central Register of Controlled Trials (CENTRAL) "The Cochrane Library 2009, issue 2, MEDLINE (PubMed) (1966-21 May 2009), EMBASE (1974-21 May 2009). Reference lists of review articles and primary studies were also screened. A hand search of the abstract book of recent relevant conference symposia was also conducted. Personal contact with MS experts and a manufacturer (Source Naturals, United States) of carnitine formulation was contacted to determine if they knew of other clinical trials. No language restrictions were applied.
SELECTION CRITERIA
Full reports of published and unpublished randomized controlled trials and quasi-randomized trials of any carnitine intervention in adults with a clinical diagnosis of fatigue associated with multiple sclerosis were included.
DATA COLLECTION AND ANALYSIS
Data from the eligible trials was extracted and coded using a standardized data extraction form and entered into RevMan 5. Discrepancies were to be resolved by discussion with a third reviewer however this was not necessary. The quality items to be assessed were method of randomization, allocation concealment, blinding (participants, investigators, outcome assessors and data analysis), intention-to-treat analysis and completeness of follow up.
MAIN RESULTS
The search identified one randomized cross-over trial. In this study patients were exposed to both acetyl L-carnitine (ALCAR(tm)) 2 grams daily and amantadine 200 mg daily in adult patients with relapsing-remitting and secondary progressive MS. The effects of carnitine on fatigue are not clear based on the one included crossover RCT. There was no difference between carnitine and amantadine for the number of patients withdrawing from the study due to an adverse event (relative risk ratio 0.20; 95% confidence interval 0.03 to 1.55. Mortality, serious adverse events, total adverse events, and quality of life were not reported.
AUTHORS' CONCLUSIONS
There is insufficient evidence that carnitine for the treatment of MS-related fatigue offers a therapeutic advantage over placebo or active comparators.
Topics: Acetylcarnitine; Adult; Fatigue; Humans; Multiple Sclerosis; Randomized Controlled Trials as Topic; Vitamin B Complex
PubMed: 20166093
DOI: 10.1002/14651858.CD007280.pub2 -
PloS One 2016Bradford Hill's viewpoints were used to conduct a weight-of-the-evidence assessment of the association between Parkinson's disease (PD) and rural living, farming and... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Bradford Hill's viewpoints were used to conduct a weight-of-the-evidence assessment of the association between Parkinson's disease (PD) and rural living, farming and pesticide use. The results were compared with an assessment based upon meta-analysis. For comparison, we also evaluated the association between PD and cigarette smoking as a "positive control" because a strong inverse association has been described consistently in the literature.
METHODS
PubMed was searched systematically to identify all published epidemiological studies that evaluated associations between Parkinson's disease (PD) and cigarette smoking, rural living, well-water consumption, farming and the use of pesticides, herbicides, insecticides, fungicides or paraquat. Studies were categorized into two study quality groups (Tier 1 or Tier 2); data were abstracted and a forest plot of relative risks (RRs) was developed for each risk factor. In addition, when available, RRs were tabulated for more highly exposed individuals compared with the unexposed. Summary RRs for each risk factor were calculated by meta-analysis of Tier 1, Tier 2 and all studies combined, with sensitivity analyses stratified by other study characteristics. Indices of between-study heterogeneity and evidence of reporting bias were assessed. Bradford Hill's viewpoints were used to determine if a causal relationship between PD and each risk factor was supported by the weight of the evidence.
FINDINGS
There was a consistent inverse (negative) association between current cigarette smoking and PD risk. In contrast, associations between PD and rural living, well-water consumption, farming and the use of pesticides, herbicides, insecticides, fungicides or paraquat were less consistent when assessed quantitatively or qualitatively.
CONCLUSION
The weight of the evidence and meta-analysis support the conclusion that there is a causal relationship between PD risk and cigarette smoking, or some unknown factor correlated with cigarette smoking. There may be risk factors associated with rural living, farming, pesticide use or well-water consumption that are causally related to PD, but the studies to date have not identified such factors. To overcome the limitations of research in this area, future studies will have to better characterize the onset of PD and its relationship to rural living, farming and exposure to pesticides.
Topics: Agriculture; Humans; Parkinson Disease; Pesticides; Risk Factors; Rural Population; Smoking; Water Wells
PubMed: 27055126
DOI: 10.1371/journal.pone.0151841 -
PloS One 2021To analyze the performance of psoriatic arthritis (PsA) screening tools, examine their implementation in daily practice, and reach a consensus about the best screening...
OBJECTIVE
To analyze the performance of psoriatic arthritis (PsA) screening tools, examine their implementation in daily practice, and reach a consensus about the best screening tool for implementation in daily practice in different medical settings.
METHODS
A systematic literature review (SLR), structured telephone interviews to hospitals, and a multidisciplinary nominal group meeting were all conducted. The SLR employed sensitive search strategies using Medline, Embase, and the Cochrane Library up to January 2020. Two reviewers independently selected articles that reported data on PsA screening tools and that included sufficient data to at least calculate the sensitivity and specificity of those tools (e.g., questionnaires, algorithms, specific questions, and biomarkers). The hospital interviews collected data regarding the process of suspected PsA diagnosis and referral to rheumatology, the implementation of PsA screening tools, and barriers and facilitators to implementation of those tools. In the nominal group meeting, a multidisciplinary team of experts discussed all these data and subsequently recommended a screening tool for implementation.
RESULTS
The SLR included 41 moderate-quality studies that analyzed 14 PsA screening tools, most of which were questionnaire-based tools. All of these studies reported a moderate-good performance but presented different characteristics regarding the time to completion or the number and type of items or questions. The implementation of screening tools was low (30.5%). The experts ultimately recommended regular use of a PsA screening tool, preferably the PURE-4 questionnaire.
CONCLUSIONS
The implementation of PsA screening tools like the PURE-4 questionnaire in daily practice likely improves the prognosis of PsA patients.
Topics: Arthritis, Psoriatic; Humans; Mass Screening; Surveys and Questionnaires
PubMed: 33720981
DOI: 10.1371/journal.pone.0248571 -
The Cochrane Database of Systematic... 2001Osteoarthritis (OA) is the most common form of arthritis, and it is often associated with significant disability and an impaired quality of life. (Review)
Review
BACKGROUND
Osteoarthritis (OA) is the most common form of arthritis, and it is often associated with significant disability and an impaired quality of life.
OBJECTIVES
To review all randomized controlled trials (RCTs) evaluating the effectiveness and toxicity of glucosamine in osteoarthritis (OA).
SEARCH STRATEGY
We searched MEDLINE, Embase, and Current Contents up to November 1999, and the Cochrane Controlled Trials Register. We also wrote letters to content experts, and hand searched reference lists of identified RCTs and pertinent review articles.
SELECTION CRITERIA
Relevant studies met the following criteria: 1) RCTs evaluating the effectiveness and safety of glucosamine in OA, 2) Both placebo based and comparative studies were eligible, 3) Both single blinded and double-blinded studies were eligible.
DATA COLLECTION AND ANALYSIS
Data abstraction was performed independently by two investigators and the results were compared for degree of agreement. Gotzsche's method and a validated tool (Jadad 1995) were used to score the quality of the RCTs. Continuous outcome measures were pooled using standardized mean differences. Dichotomous outcome measures were pooled using Peto Odds Ratios.
MAIN RESULTS
Collectively, the 16 identified RCTs provided evidence that glucosamine is both effective and safe in OA. In the 13 RCTs in which glucosamine was compared to placebo, glucosamine was found to be superior in all RCTs, except one. In the four RCTs in which glucosamine was compared to an NSAID, glucosamine was superior in two, and equivalent in two.
REVIEWER'S CONCLUSIONS
Further research is necessary to confirm the long term effectiveness and toxicity of glucosamine therapy in OA. Most of the trials reviewed only evaluated the Rotta preparation of glucosamine sulfate. It is not known whether different glucosamine preparations prepared by different manufacturers are equally effective in the therapy of OA.
Topics: Double-Blind Method; Glucosamine; Humans; Osteoarthritis; Randomized Controlled Trials as Topic; Single-Blind Method
PubMed: 11279782
DOI: 10.1002/14651858.CD002946 -
Tobacco Control Jul 2018Retailers that primarily or exclusively sell electronic cigarettes (e-cigarettes) or vaping products represent a new category of tobacco retailer. We sought to identify...
OBJECTIVE
Retailers that primarily or exclusively sell electronic cigarettes (e-cigarettes) or vaping products represent a new category of tobacco retailer. We sought to identify (a) how vape shops can be identified and (b) sales and marketing practices of vape shops.
DATA SOURCES
A medical librarian iteratively developed a search strategy and in February 2017 searched seven academic databases (ABI/INFORM Complete, ECONLit, Embase, Entrepreneurship, PsycINFO, PubMed/MEDLINE and Scopus). We hand searched and .
STUDY SELECTION
We used dual, independent screening. Records were eligible if published in 2010 or later, were peer-reviewed journal articles and focused on vape shops.
DATA EXTRACTION
We used dual, independent data abstraction and assessed risk of bias. Of the 3605 records identified, 22 were included.
DATA SYNTHESIS
We conducted a narrative systematic review. Researchers relied heavily on Yelp to identify vape shops. Vape shop owners use innovative marketing strategies that sometimes diverge from those of traditional tobacco retailers. Vape shop staff believe strongly that their products are effective harm-reduction products. Vape shops were more common in areas with more White residents.
CONCLUSIONS
Vape shops represent a new type of retailer for tobacco products. Vape shops have potential to promote e-cigarettes for smoking cessation but also sometimes provide inaccurate information and mislabelled products. Given their spatial patterning, vape shops may perpetuate inequities in tobacco use. The growing literature on vape shops is complicated by researchers using different definitions of vape shops (eg, exclusively selling e-cigarettes vs also selling traditional tobacco products).
Topics: Electronic Nicotine Delivery Systems; Humans; Marketing; Vaping
PubMed: 29208738
DOI: 10.1136/tobaccocontrol-2017-054015 -
The Cochrane Database of Systematic... Sep 2015Psychosis is three times more common in people with an intellectual disability than in those without an intellectual disability. A low intelligence quotient (IQ) is a... (Review)
Review
BACKGROUND
Psychosis is three times more common in people with an intellectual disability than in those without an intellectual disability. A low intelligence quotient (IQ) is a defining characteristic for intellectual disability and a risk factor for poor outcome in psychosis. Clozapine is recommended for treatment-resistant psychosis. The effect of psychotropic medication can be different in people with intellectual disability; for example, they may be more prone to side effects. People with an intellectual disability and psychosis form a special subgroup and we wanted to examine if there is randomised controlled trial (RCT) data in this population to support the use of clozapine.
OBJECTIVES
To determine the effects of clozapine for treating adults with a dual diagnosis of intellectual disability and psychosis.
SEARCH METHODS
We searched CENTRAL, Ovid MEDLINE, Embase and eight other databases up to December 2014. We also searched two trials registers, the Cochrane Schizophrenia Group's Register of Trials, and contacted the manufacturers of clozapine.
SELECTION CRITERIA
RCTs that assessed the effects of clozapine, at any dose, for treating adults (aged 18 years and over) with a dual diagnosis of intellectual disability and psychotic disorder, compared with placebo or another antipsychotic medication.
DATA COLLECTION AND ANALYSIS
Three review authors independently screened all titles, abstracts and any relevant full-text reports against the inclusion criteria.
MAIN RESULTS
Of the 1224 titles and abstracts screened, we shortlisted 38 full-text articles, which we subsequently excluded as they did not meet the inclusion criteria. These studies were not RCTs. Consequently, no studies are included in this Cochrane review.
AUTHORS' CONCLUSIONS
There are currently no RCTs that assess the efficacy and side effects of clozapine in people with intellectual disabilities and psychoses. Given the use of clozapine in this vulnerable population, there is an urgent need for a RCT of clozapine in people with a dual diagnosis of intellectual disability and psychosis to fill the evidence gap.
Topics: Adult; Antipsychotic Agents; Clozapine; Humans; Intellectual Disability; Psychotic Disorders
PubMed: 26397173
DOI: 10.1002/14651858.CD010625.pub2