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The Cochrane Database of Systematic... Jun 2015Recent technological developments, such as the near universal spread of mobile phones and portable computers and improvements in the accessibility features of these... (Review)
Review
BACKGROUND
Recent technological developments, such as the near universal spread of mobile phones and portable computers and improvements in the accessibility features of these devices, give children and young people with low vision greater independent access to information. Some electronic technologies, such as closed circuit TV, are well established low vision aids and newer versions, such as electronic readers or off-the shelf tablet computers, may offer similar functionalities with easier portability and at lower cost.
OBJECTIVES
To assess the effect of electronic assistive technologies on reading, educational outcomes and quality of life in children and young people with low vision.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 9), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2014), EMBASE (January 1980 to October 2014), the Health Technology Assessment Programme (HTA) (www.hta.ac.uk/), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 30 October 2014.
SELECTION CRITERIA
We intended to include randomised controlled trials (RCTs) and quasi-RCTs in this review. We planned to include trials involving children between the ages of 5 and 16 years with low vision as defined by, or equivalent to, the WHO 1992 definition of low vision. We planned to include studies that explore the use of assistive technologies (ATs). These could include all types of closed circuit television/electronic vision enhancement systems (CCTV/EVES), computer technology including tablet computers and adaptive technologies such as screen readers, screen magnification and optical character recognition (OCR). We intended to compare the use of ATs with standard optical aids, which include distance refractive correction (with appropriate near addition for aphakic (no lens)/pseudophakic (with lens implant) patients) and monocular/binoculars for distance and brightfield magnifiers for near. We also planned to include studies that compare different types of ATs with each other, without or in addition to conventional optical aids, and those that compare ATs given with or without instructions for use.
DATA COLLECTION AND ANALYSIS
Independently, two review authors reviewed titles and abstracts for eligibility. They divided studies into categories to 'definitely include', 'definitely exclude' and 'possibly include', and the same two authors made final judgements about inclusion/exclusion by obtaining full-text copies of the studies in the 'possibly include' category.
MAIN RESULTS
We did not identify any randomised controlled trials in this subject area.
AUTHORS' CONCLUSIONS
High-quality evidence about the usefulness of electronic AT for children and young people with visual impairment is needed to inform the choice healthcare and education providers and family have to make when selecting a technology. Randomised controlled trials are needed to assess the impact of AT. Research protocols should carefully select outcomes relevant not only to the scientific community, but more importantly to families and teachers. Functional outcomes such as reading accuracy, comprehension and speed should be recorded, as well as the impact of AT on independent learning and quality of life.
Topics: Adolescent; Child; Child, Preschool; Humans; Self-Help Devices; Vision, Low
PubMed: 26086876
DOI: 10.1002/14651858.CD011350.pub2 -
BMC Medical Ethics Dec 2013Psychiatric disorders can pose problems in the assessment of decision-making capacity (DMC). This is so particularly where psychopathology is seen as the extreme end of... (Review)
Review
BACKGROUND
Psychiatric disorders can pose problems in the assessment of decision-making capacity (DMC). This is so particularly where psychopathology is seen as the extreme end of a dimension that includes normality. Depression is an example of such a psychiatric disorder. Four abilities (understanding, appreciating, reasoning and ability to express a choice) are commonly assessed when determining DMC in psychiatry and uncertainty exists about the extent to which depression impacts capacity to make treatment or research participation decisions.
METHODS
A systematic review of the medical ethical and empirical literature concerning depression and DMC was conducted. Medline, EMBASE and PsycInfo databases were searched for studies of depression and consent and DMC. Empirical studies and papers containing ethical analysis were extracted and analysed.
RESULTS
17 publications were identified. The clinical ethics studies highlighted appreciation of information as the ability that can be impaired in depression, indicating that emotional factors can impact on DMC. The empirical studies reporting decision-making ability scores also highlighted impairment of appreciation but without evidence of strong impact. Measurement problems, however, looked likely. The frequency of clinical judgements of lack of DMC in people with depression varied greatly according to acuity of illness and whether judgements are structured or unstructured.
CONCLUSIONS
Depression can impair DMC especially if severe. Most evidence indicates appreciation as the ability primarily impaired by depressive illness. Understanding and measuring the appreciation ability in depression remains a problem in need of further research.
Topics: Comprehension; Decision Making; Depression; Depressive Disorder; Humans; Informed Consent; Judgment; Mental Competency; Patient Participation; Uncertainty
PubMed: 24330745
DOI: 10.1186/1472-6939-14-54 -
PloS One 2012Falls of elderly people may cause permanent disability or death. Particularly susceptible are elderly patients in rehabilitation hospitals. We systematically reviewed... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Falls of elderly people may cause permanent disability or death. Particularly susceptible are elderly patients in rehabilitation hospitals. We systematically reviewed the literature to identify falls prediction tools available for assessing elderly inpatients in rehabilitation hospitals.
METHODS AND FINDINGS
We searched six electronic databases using comprehensive search strategies developed for each database. Estimates of sensitivity and specificity were plotted in ROC space graphs and pooled across studies. Our search identified three studies which assessed the prediction properties of falls prediction tools in a total of 754 elderly inpatients in rehabilitation hospitals. Only the STRATIFY tool was assessed in all three studies; the other identified tools (PJC-FRAT and DOWNTON) were assessed by a single study. For a STRATIFY cut-score of two, pooled sensitivity was 73% (95%CI 63 to 81%) and pooled specificity was 42% (95%CI 34 to 51%). An indirect comparison of the tools across studies indicated that the DOWNTON tool has the highest sensitivity (92%), while the PJC-FRAT offers the best balance between sensitivity and specificity (73% and 75%, respectively). All studies presented major methodological limitations.
CONCLUSIONS
We did not identify any tool which had an optimal balance between sensitivity and specificity, or which were clearly better than a simple clinical judgment of risk of falling. The limited number of identified studies with major methodological limitations impairs sound conclusions on the usefulness of falls risk prediction tools in geriatric rehabilitation hospitals.
Topics: Accidental Falls; Aged; Aged, 80 and over; Databases, Factual; Female; Geriatric Assessment; Humans; Inpatients; Male; Outcome Assessment, Health Care; ROC Curve; Rehabilitation; Risk; Risk Assessment; Sensitivity and Specificity
PubMed: 22815914
DOI: 10.1371/journal.pone.0041061 -
The Cochrane Database of Systematic... Jun 2012Cataract and age-related macular degeneration (AMD) are common causes of decreased vision that often occur simultaneously in people over age 50. Although cataract... (Review)
Review
BACKGROUND
Cataract and age-related macular degeneration (AMD) are common causes of decreased vision that often occur simultaneously in people over age 50. Although cataract surgery is an effective treatment for cataract-induced visual loss, some clinicians suspect that such an intervention may increase the risk of worsening of underlying AMD and thus have deleterious effects on vision.
OBJECTIVES
The objective of this review was to evaluate the effectiveness and safety of cataract surgery in eyes with AMD.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 4), MEDLINE (January 1950 to April 2012), EMBASE (January 1980 to April 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to April 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 16 April 2012.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and quasi-randomized trials of eyes affected by both cataract and AMD in which cataract surgery would be compared to no surgery.
DATA COLLECTION AND ANALYSIS
Two authors independently evaluated the search results against the inclusion and exclusion criteria. Two authors independently extracted data and assessed risk of bias for included studies. We resolved discrepancies by discussion.
MAIN RESULTS
One RCT with 60 participants with visually significant cataract and AMD was included in this review. Participants were randomized to immediate cataract surgery (within two weeks of enrollment) (n = 29) or delayed cataract surgery (six months after enrollment) (n = 31). At six months, four participants were lost to follow-up; two participants from each group. The immediate surgery group showed mean improvement in best-corrected visual acuity (BCVA) compared with the delayed surgery group at six months (mean difference (MD) 0.15 LogMAR, 95% confidence interval (CI) 0.28 to 0.02). There was no significant difference in the development of choroidal neovascularization between groups (1/27 eyes in the immediate surgery group versus 0/29 eyes in the delayed surgery group). Results from Impact of Vision Impairment (IVI) questionnaires suggested that the immediate surgery group faired better with quality of life outcomes than the delayed surgery group (MD in IVI logit scores 1.60, 95% CI 0.61 to 2.59). No postoperative complication was reported. We identified a second potentially relevant study of immediate versus delayed cataract surgery in 54 people with AMD. Results for the study are not yet available, but may be eligible for future updates of this review.
AUTHORS' CONCLUSIONS
At this time, it is not possible to draw reliable conclusions from the available data to determine whether cataract surgery is beneficial or harmful in people with AMD. Physicians will have to make practice decisions based on best clinical judgment until controlled trials are conducted and their findings published.It would be valuable for future research to investigate prospective RCTs comparing cataract surgery to no surgery in patients with AMD to better evaluate whether cataract surgery is beneficial or harmful in this group. However ethical considerations need to be addressed when delaying a potentially beneficial treatment and it may not be feasible to conduct a long-term study where surgery is withheld from the control group. Utilization of pre-existing, standardized systems for grading cataract and AMD and measuring outcomes (visual acuity, change in visual acuity, worsening of AMD and quality of life measures) should be encouraged.
Topics: Cataract; Cataract Extraction; Disease Progression; Humans; Macular Degeneration; Middle Aged; Randomized Controlled Trials as Topic
PubMed: 22696359
DOI: 10.1002/14651858.CD006757.pub3 -
The Cochrane Database of Systematic... Sep 2010Cognitive impairment is a frequent consequence of stroke and can impact on a person's ability to perform everyday activities. There are a number of different... (Review)
Review
BACKGROUND
Cognitive impairment is a frequent consequence of stroke and can impact on a person's ability to perform everyday activities. There are a number of different intervention strategies that occupational therapists may use when working with people who have cognitive impairment post-stroke.
OBJECTIVES
To determine whether occupational therapy improves functional performance of basic activities of daily living (ADL) and specific cognitive abilities in people who have cognitive impairment following a stroke.
SEARCH STRATEGY
We searched the Cochrane Stroke Group Trials Register (last searched May 2009), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2009), MEDLINE (1966 to April 2009), EMBASE (1980 to April 2009), CINAHL (1982 to April 2009), PsycINFO (1840 to April 2009), PsycBITE, OTseeker and Dissertation Abstracts (the latest three were searched up to April 2009). In an effort to identify further published, unpublished, and ongoing trials, we also tracked relevant references through the cited reference search in Science Citation Index (SCI) and Social Science Citation Index (SSCI), reviewed the reference lists of relevant studies and reviews, handsearched relevant occupational therapy journals, and contacted key researchers in the area.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials that evaluated an intervention focused on providing cognitive retraining to adults with clinically defined stroke and confirmed cognitive impairment. The intervention needed either to be provided by an occupational therapist or given under the supervision of an occupational therapist.
DATA COLLECTION AND ANALYSIS
Two review authors independently examined the abstracts that might meet the inclusion criteria, assessed the quality and extracted data. We have presented results using mean differences.
MAIN RESULTS
We included one trial with 33 participants in this review. We found no difference between groups for the two relevant outcomes that were measured: improvement in time judgement skills and improvement in basic ADLs on the Barthel Index.
AUTHORS' CONCLUSIONS
The effectiveness of occupational therapy for cognitive impairment post-stroke remains unclear. The potential benefits of cognitive retraining delivered as part of occupational therapy on improving basic daily activity function or specific cognitive abilities, or both, of people who have had a stroke cannot be supported or refuted by the evidence included in this review. More research is required.
Topics: Activities of Daily Living; Adult; Cognition Disorders; Humans; Occupational Therapy; Randomized Controlled Trials as Topic; Stroke; Stroke Rehabilitation
PubMed: 20824849
DOI: 10.1002/14651858.CD006430.pub2 -
The Cochrane Database of Systematic... Jan 2010Infection with human immunodeficency virus (HIV) and acquired immunodeficency syndrome (AIDS) is a pandemic that has affected millions of people globally. Although major... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Infection with human immunodeficency virus (HIV) and acquired immunodeficency syndrome (AIDS) is a pandemic that has affected millions of people globally. Although major research and clinical initiatives are addressing prevention and cure strategies, issues of quality of life for survivors have received less attention. Massage therapy is proposed to have a positive effect on quality of life and may also have a positive effect on immune function through stress mediation.
OBJECTIVES
The objective of this systematic review was to examine the safety and effectiveness of massage therapy on quality of life, pain and immune system parameters in people living with HIV/AIDS.
SEARCH STRATEGY
A comprehensive search strategy was devised incorporating appropriate terms for HIV/AIDS, randomised controlled trials (RCTs), massage therapy and the pertinent measures of benefit. All electronic databases identified were searched in November 2008, including Cochrane Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, SCIENCE CITATION INDEX, AIDSLINE, AIDSearch, CINAHL, HEALTHSTAR, PsycLIT, AMED, Current Contents, AMI, NLM GATEWAY, LILACS, IndMed, SOCIOFILE, SCI, SSCI, ERIC and DAI. We also reviewed relevant published and unpublished conference abstracts and proceedings and scrutinised reference lists from pertinent journals. There were no language or date restrictions.
SELECTION CRITERIA
Studies were identified by two reviewers based on trial design (RCTs) and participants (ie, people of any age with HIV/AIDS, at any stage of the disease) who had undergone an intervention that included massage therapy for the identified aims of improving quality of life and activity and participation levels, improving immune function, reducing pain and improving other physiological or psychological impairments.
DATA COLLECTION AND ANALYSIS
Two reviewers independently identified included studies and extracted relevant data. Two other reviewers independently reviewed the included studies for risk of bias. All data and risk of bias judgements were entered into Revman (v5) and meta-analyses were conducted where appropriate.
MAIN RESULTS
Twelve papers were identified, from which four were included. The remaining eight papers were excluded predominantly due to inappropriate methodology. The four included studies were highly clinically heterogenous, investigating a range of age groups (ie, children, adolescents and adults) across the disease spectrum from early HIV through late-stage AIDS. The settings were either community or palliative care, and the outcome measures were a combination of quality of life and immunological function. The trials were judged to be at moderate risk of bias mostly because of incomplete reporting. For quality of life measures, the studies reported that massage therapy in combination with other modalities, such as meditation and stress reduction, are superior to massage therapy alone or to the other modalities alone. The quality of life domains with significant effect sizes included self-reported reduced use of health care resources, improvement in self-perceived spiritual quality of life and improvement in total quality of life scores. One study also reported positive changes in immune function, in particular CD4+ cell count and natural killer cell counts, due to massage therapy, and one study reported no difference between people given massage therapy and controls in immune parameters. Adverse or harmful effects were not well reported.
AUTHORS' CONCLUSIONS
There is some evidence to support the use of massage therapy to improve quality of life for people living with HIV/AIDS (PLWHA), particularly in combination with other stress-management modalities, and that massage therapy may have a positive effect on immunological function. The trials are small, however, and at moderate risk of bias. Further studies are needed using larger sample sizes and rigorous design/reporting before massage therapy can be strongly recommended for PLWHA.
Topics: Acquired Immunodeficiency Syndrome; Adolescent; Adult; CD4-Positive T-Lymphocytes; Child; HIV Infections; HIV-1; Humans; Massage; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 20091636
DOI: 10.1002/14651858.CD007502.pub2 -
BMC Geriatrics Jan 2006Pain is a common and major problem among nursing home residents. The prevalence of pain in elderly nursing home people is 40-80%, showing that they are at great risk of... (Review)
Review
BACKGROUND
Pain is a common and major problem among nursing home residents. The prevalence of pain in elderly nursing home people is 40-80%, showing that they are at great risk of experiencing pain. Since assessment of pain is an important step towards the treatment of pain, there is a need for manageable, valid and reliable tools to assess pain in elderly people with dementia.
METHODS
This systematic review identifies pain assessment scales for elderly people with severe dementia and evaluates the psychometric properties and clinical utility of these instruments. Relevant publications in English, German, French or Dutch, from 1988 to 2005, were identified by means of an extensive search strategy in Medline, Psychinfo and CINAHL, supplemented by screening citations and references. Quality judgement criteria were formulated and used to evaluate the psychometric aspects of the scales.
RESULTS
Twenty-nine publications reporting on behavioural pain assessment instruments were selected for this review. Twelve observational pain assessment scales (DOLOPLUS2; ECPA; ECS; Observational Pain Behavior Tool; CNPI; PACSLAC; PAINAD; PADE; RaPID; Abbey Pain Scale; NOPPAIN; Pain assessment scale for use with cognitively impaired adults) were identified. Findings indicate that most observational scales are under development and show moderate psychometric qualities.
CONCLUSION
Based on the psychometric qualities and criteria regarding sensitivity and clinical utility, we conclude that PACSLAC and DOLOPLUS2 are the most appropriate scales currently available. Further research should focus on improving these scales by further testing their validity, reliability and clinical utility.
Topics: Aged; Behavior; Dementia; Humans; Pain; Pain Measurement; Sensitivity and Specificity
PubMed: 16441889
DOI: 10.1186/1471-2318-6-3 -
The Cochrane Database of Systematic... Oct 2005Thumb-in-palm deformity in patients with spastic cerebral palsy is a deformity that impairs the ability to use the thumb and thus severely limits hand function. From the... (Review)
Review
BACKGROUND
Thumb-in-palm deformity in patients with spastic cerebral palsy is a deformity that impairs the ability to use the thumb and thus severely limits hand function. From the variety of operative procedures that have been described, it may be clear that there is no consensus on the surgical treatment of thumb-in-palm deformity.
OBJECTIVES
To review the efficacy of surgical interventions for the thumb-in-palm deformity in patients with spastic cerebral palsy; to review the selection criteria to surgically treat thumb-in-palm deformity in these patients; and to review the outcome assessment used in these studies.
SEARCH STRATEGY
We identified studies for inclusion from searches of several electronic databases: the Cochrane Central Register of Controlled Trials (Issue 4, 2003), MEDLINE (1966 to December 2004), EMBASE (1980 to December 2004) and CINAHL (1982 to December 2004). We also cross-checked the reference lists of these studies to identify additional studies.
SELECTION CRITERIA
We considered a trial eligible for inclusion when it met the following criteria. 1) It was described as a randomized clinical trial, clinical controlled trial or prospective study that compared pre-operative- with post-operative outcome assessment. 2) It concerned patients with thumb-in-palm deformity affected by spastic cerebral palsy. There was no restriction in age. 3) It compared or described any surgical intervention to the thumb. 4) It followed subjects for at least six months. 5) Outcomes described included one or more of the following items: rate of success; functional improvement; active and passive range of motion of the thumb; grasp and release; pinch grip; complications and side effects; and quality of life.
DATA COLLECTION AND ANALYSIS
Two authors assessed each study using a scoring system. Meta-analysis was not possible because the selected studies were poorly designed, and the results were presented in an incompatible form. Therefore, we compiled a descriptive summary of the results of the individual studies. We did not attempt to acquire the raw data for re-analysis.
MAIN RESULTS
We identified 14 prospective studies that compared preoperative and postoperative outcomes as eligible for inclusion in this review. We found no randomized clinical trials or controlled clinical trials. The studies with the best available evidence were prospective studies that compared pre- with post-operative assessment. After assessment, we ultimately included nine studies. Participants In all the included studies the participants were more or less homogeneous regarding the most important prognostic indications. The nine included studies treated 234 patients. Age at operation ranged from 4-48 years (Median approximately 11 years). Interventions Twenty-four different specific interventions were performed, or combined, aiming to 1) stabilize the first metacarpophalangeal joint, 2) weaken the spastic thumb adductors, and 3) augment thumb abduction and extension. Outcome measures All of the included studies assessed whether the thumb had stayed out of the palm at follow-up. Additional outcome measures varied among studies. Selection criteria There was no consensus on the selection criteria for eligibility for surgical treatment. There was also considerable variety in the use of methods of assessment among the studies. There is no standardized method to evaluate the pre- and post-operative data, and most of the assessment methods were not validated. It was impossible to compare the outcomes among studies. Judgement about the effectiveness of one particular surgical intervention was not possible, because different surgical interventions and co-interventions were used within most studies. Nonetheless, generally, the outcome of surgical treatment of thumb-in-palm deformity was considered satisfactory to both patients and to surgeons in all studies.
AUTHORS' CONCLUSIONS
Because the methodological quality of the studies is poor, it is impossible to provide a reliable judgement of the role of surgery for thumb-in-palm deformity. This review has demonstrated the need for randomized clinical trials or controlled clinical trials on the surgical treatment of thumb-in-palm deformity. Surgical reconstruction appears to improve hand function, to facilitate hygiene, and to improve the appearance and quality of life. For patient selection, a validated classification system should be developed to determine the type and extent of the cerebral palsied hand. The influence of age, intelligence, and voluntary muscle control still needs to be investigated. Investigators should focus on one particular surgical intervention or a specific group of interventions to find out which procedures produce the best functional improvement.
Topics: Cerebral Palsy; Hand Deformities, Acquired; Hand Deformities, Congenital; Humans; Prospective Studies; Treatment Outcome
PubMed: 16235349
DOI: 10.1002/14651858.CD004093.pub2 -
The Cochrane Database of Systematic... 2001Nicergoline is an ergot derivative currently in use in over fifty countries for more than three decades, for the treatment of cognitive, affective, and behavioral... (Review)
Review
BACKGROUND
Nicergoline is an ergot derivative currently in use in over fifty countries for more than three decades, for the treatment of cognitive, affective, and behavioral disorders of older people. It was initially considered as a vasoactive drug and mainly prescribed for cerebrovascular disorders. Recent findings suggest other actions which has provided a rationale for the use of nicergoline for the treatment of various forms of dementia, including Alzheimer's Disease.
OBJECTIVES
To determine whether there is evidence of efficacy of nicergoline in the treatment of dementia and other age-associated forms of cognitive decline,and to assess the safety and tolerability of the drug.
SEARCH STRATEGY
1. Electronic databases search. The Cochrane Controlled Trials Register (which contains citations from the MEDLINE, EMBASE, Psych LIT, and hand searches of geriatric, dementia, psychogeriatric journals, and conference abstracts) was searched using the following terms: 'Nicergoline', 'Sermion'. 2. Reference search. The reference lists of all obtained studies was checked. 3. Pharmaceutical company Pharmacia & Upjohn, owners of the rights to produce and market nicergoline in various different countries, was asked to provide data and reports of clinical trials. In case of unavailability of numerical data in published studies, the authors of each paper, were asked for any published or unpublished data.
SELECTION CRITERIA
- All unconfounded, double-blind, randomized, placebo-controlled, published and unpublished trials were sought. Non-randomized trials were excluded. Open trials were considered for inclusion if patients were randomized to the different treatment groups. - All patients diagnosed as having dementia or other cognitive disorder defined according to classification criteria accepted at the time of each study. - Nicergoline given at any dose for more than one day with placebo control. Type of outcome variables: 1. Cognitive function (as measured by psychometric tests). 2. Clinical impression (such as CIBIC or other clinical global measures of change). 3. Functional performance including dependency. 4. Behavioural disturbance. 5. Safety and acceptability as measured by the incidence of adverse effects (including side-effects) leading to withdrawal. 6. Death 7. Effect on carer 8. Use of services 9. Quality of life.
DATA COLLECTION AND ANALYSIS
A comprehensive search of the international literature and the producing company archives has been performed to identify all possible sources of data for this review. Only those trials fulfilling the inclusion criteria of belonging to either category A or B of allocation concealment, as defined by the Cochrane Organisation, were examined for data extraction by one reviewer. If there was doubt then the other reviewer was consulted. Data availability restricted analyses to 'completers' analyses for the outcome measures. Outcomes able to be assessed included: Behaviour, Cognition, Clinical Judgment, Tolerability, EEG.
MAIN RESULTS
The Sandoz Clinical Assessment Geriatric Scale (SCAG) was the outcome used in the largest number of patients (814 patients). The results from these studies were homogeneous in nature despite including patients observed for periods of time ranging from 2 months to 12 months. There was a difference in favour of the active treatment in reducing the behavioural symptoms described by this scale, -5.18 points [-8.03, -2.33]. This scale has a maximum of 133 points. The therapeutic effects of nicergoline seem to be evident by 2 months of treatment and maintained for 6 months. In general other behavioural outcome measures which include the GRS, the IADL, and the MACC and were episodically used in few studies, failed to demonstrate statistically significant results although there was a trend favouring treatment. Cognitive assessment has been performed in a moderate number of patients with the MMSE (261 patients) and the ADAS-Cog (342 patients). No significant heterogeneity was found for these trials, despite the trials extending over periods of treatment of 3 to 12 months. There was a difference between treatment and control groups on the MMSE favouring nicergoline treatment. At 12 months the effect size was 2.86 [0.98, 4.74] The effect size for the ADAS-Cog, used exclusively with Alzheimer's disease patients, did not reveal a significant benefit. At 12 months the trend favoured treatment (-1.64 [-4.62, 1.34]). The other results from various cognitive measures tended to favour nicergoline but this was based on a small number of cases. The clinical impression of change obtained from a total of 921 patients was homogeneous across the studies, despite reflecting changes over periods of time ranging from 2 to 12 months. The Peto odd ratio for improvement in the subjects treated with nicergoline over these varying time periods was 3.33 [2.50, 4.43]. Tolerability assessed in 1427 patients was homogeneous across all studies and demonstrated a mildly increased risk of adverse events on treatment, OR 1.51[1.10, 2.07].
REVIEWER'S CONCLUSIONS
The clinical studies on nicergoline were carried out with diverse criteria and modalities of evaluation. Despite this, the 14 studies included in this review, have presented generally consistent results. Results of this meta-analysis provide some evidence of positive effects of nicergoline on cognition and behaviour and these effects are supported by an effect on clinical global impression. There was some evidence that there were increased risk of adverse effects associated with nicergoline. These results were obtained on older patients with mild to moderate cognitive and behavioural impairment of various clinical origins, including chronic cerebrovascular disorders and Alzheimer's dementia. The few studies specifically performed on patients with Alzheimer's disease were performed with too few people to give a definitive answer to the questions concerning the use of nicergoline for this form of dementia. This drug has not been evaluated using current diagnostic categories such as MCI or in association with therapeutic agents of different nature such as cholinesterase or antioxidant drugs.
Topics: Cognition Disorders; Dementia; Humans; Nicergoline; Nootropic Agents; Randomized Controlled Trials as Topic
PubMed: 11687175
DOI: 10.1002/14651858.CD003159