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The Cochrane Database of Systematic... Mar 2018Metastatic breast cancer is not a curable disease, but women with metastatic disease are living longer. Surgery to remove the primary tumour is associated with an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Metastatic breast cancer is not a curable disease, but women with metastatic disease are living longer. Surgery to remove the primary tumour is associated with an increased survival in other types of metastatic cancer. Breast surgery is not standard treatment for metastatic disease, however several recent retrospective studies have suggested that breast surgery could increase the women's survival. These studies have methodological limitations including selection bias. A systematic review mapping all randomised controlled trials addressing the benefits and potential harms of breast surgery is ideal to answer this question.
OBJECTIVES
To assess the effects of breast surgery in women with metastatic breast cancer.
SEARCH METHODS
We conducted searches using the MeSH terms 'breast neoplasms', 'mastectomy', and 'analysis, survival' in the following databases: the Cochrane Breast Cancer Specialised Register, CENTRAL, MEDLINE (by PubMed) and Embase (by OvidSP) on 22 February 2016. We also searched ClinicalTrials.gov (22 February 2016) and the WHO International Clinical Trials Registry Platform (24 February 2016). We conducted an additional search in the American Society of Clinical Oncology (ASCO) conference proceedings in July 2016 that included reference checking, citation searching, and contacting study authors to identify additional studies.
SELECTION CRITERIA
The inclusion criteria were randomised controlled trials of women with metastatic breast cancer at initial diagnosis comparing breast surgery plus systemic therapy versus systemic therapy alone. The primary outcomes were overall survival and quality of life. Secondary outcomes were progression-free survival (local and distant control), breast cancer-specific survival, and toxicity from local therapy.
DATA COLLECTION AND ANALYSIS
Two review authors independently conducted trial selection, data extraction, and 'Risk of bias' assessment (using Cochrane's 'Risk of bias' tool), which a third review author checked. We used the GRADE tool to assess the quality of the body of evidence. We used the risk ratio (RR) to measure the effect of treatment for dichotomous outcomes and the hazard ratio (HR) for time-to-event outcomes. We calculated 95% confidence intervals (CI) for these measures. We used the random-effects model, as we expected clinical or methodological heterogeneity, or both, among the included studies.
MAIN RESULTS
We included two trials enrolling 624 women in the review. It is uncertain whether breast surgery improves overall survival as the quality of the evidence has been assessed as very low (HR 0.83, 95% CI 0.53 to 1.31; 2 studies; 624 women). The two studies did not report quality of life. Breast surgery may improve local progression-free survival (HR 0.22, 95% CI 0.08 to 0.57; 2 studies; 607 women; low-quality evidence), while it probably worsened distant progression-free survival (HR 1.42, 95% CI 1.08 to 1.86; 1 study; 350 women; moderate-quality evidence). The two included studies did not measure breast cancer-specific survival. Toxicity from local therapy was reported by 30-day mortality and did not appear to differ between the two groups (RR 0.99, 95% CI 0.14 to 6.90; 1 study; 274 women; low-quality evidence).
AUTHORS' CONCLUSIONS
Based on existing evidence from two randomised clinical trials, it is not possible to make definitive conclusions on the benefits and risks of breast surgery associated with systemic treatment for women diagnosed with metastatic breast cancer. Until the ongoing clinical trials are finalised, the decision to perform breast surgery in these women should be individualised and shared between the physician and the patient considering the potential risks, benefits, and costs of each intervention.
Topics: Breast Neoplasms; Combined Modality Therapy; Female; Humans; Mastectomy; Neoplasm Metastasis; Prognosis; Randomized Controlled Trials as Topic
PubMed: 29542106
DOI: 10.1002/14651858.CD011276.pub2 -
The Cochrane Database of Systematic... Oct 2014Exercise training is commonly recommended for individuals with fibromyalgia. This review examined the effects of supervised group aquatic training programs (led by an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Exercise training is commonly recommended for individuals with fibromyalgia. This review examined the effects of supervised group aquatic training programs (led by an instructor). We defined aquatic training as exercising in a pool while standing at waist, chest, or shoulder depth. This review is part of the update of the 'Exercise for treating fibromyalgia syndrome' review first published in 2002, and previously updated in 2007.
OBJECTIVES
The objective of this systematic review was to evaluate the benefits and harms of aquatic exercise training in adults with fibromyalgia.
SEARCH METHODS
We searched The Cochrane Library 2013, Issue 2 (Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, Health Technology Assessment Database, NHS Economic Evaluation Database), MEDLINE, EMBASE, CINAHL, PEDro, Dissertation Abstracts, WHO international Clinical Trials Registry Platform, and AMED, as well as other sources (i.e., reference lists from key journals, identified articles, meta-analyses, and reviews of all types of treatment for fibromyalgia) from inception to October 2013. Using Cochrane methods, we screened citations, abstracts, and full-text articles. Subsequently, we identified aquatic exercise training studies.
SELECTION CRITERIA
Selection criteria were: a) full-text publication of a randomized controlled trial (RCT) in adults diagnosed with fibromyalgia based on published criteria, and b) between-group data for an aquatic intervention and a control or other intervention. We excluded studies if exercise in water was less than 50% of the full intervention.
DATA COLLECTION AND ANALYSIS
We independently assessed risk of bias and extracted data (24 outcomes), of which we designated seven as major outcomes: multidimensional function, self reported physical function, pain, stiffness, muscle strength, submaximal cardiorespiratory function, withdrawal rates and adverse effects. We resolved discordance through discussion. We evaluated interventions using mean differences (MD) or standardized mean differences (SMD) and 95% confidence intervals (95% CI). Where two or more studies provided data for an outcome, we carried out meta-analysis. In addition, we set and used a 15% threshold for calculation of clinically relevant differences.
MAIN RESULTS
We included 16 aquatic exercise training studies (N = 881; 866 women and 15 men). Nine studies compared aquatic exercise to control, five studies compared aquatic to land-based exercise, and two compared aquatic exercise to a different aquatic exercise program.We rated the risk of bias related to random sequence generation (selection bias), incomplete outcome data (attrition bias), selective reporting (reporting bias), blinding of outcome assessors (detection bias), and other bias as low. We rated blinding of participants and personnel (selection and performance bias) and allocation concealment (selection bias) as low risk and unclear. The assessment of the evidence showed limitations related to imprecision, high statistical heterogeneity, and wide confidence intervals. Aquatic versus controlWe found statistically significant improvements (P value < 0.05) in all of the major outcomes. Based on a 100-point scale, multidimensional function improved by six units (MD -5.97, 95% CI -9.06 to -2.88; number needed to treat (NNT) 5, 95% CI 3 to 9), self reported physical function by four units (MD -4.35, 95% CI -7.77 to -0.94; NNT 6, 95% CI 3 to 22), pain by seven units (MD -6.59, 95% CI -10.71 to -2.48; NNT 5, 95% CI 3 to 8), and stiffness by 18 units (MD -18.34, 95% CI -35.75 to -0.93; NNT 3, 95% CI 2 to 24) more in the aquatic than the control groups. The SMD for muscle strength as measured by knee extension and hand grip was 0.63 standard deviations higher compared to the control group (SMD 0.63, 95% CI 0.20 to 1.05; NNT 4, 95% CI 3 to 12) and cardiovascular submaximal function improved by 37 meters on six-minute walk test (95% CI 4.14 to 69.92). Only two major outcomes, stiffness and muscle strength, met the 15% threshold for clinical relevance (improved by 27% and 37% respectively). Withdrawals were similar in the aquatic and control groups and adverse effects were poorly reported, with no serious adverse effects reported. Aquatic versus land-basedThere were no statistically significant differences between interventions for multidimensional function, self reported physical function, pain or stiffness: 0.91 units (95% CI -4.01 to 5.83), -5.85 units (95% CI -12.33 to 0.63), -0.75 units (95% CI -10.72 to 9.23), and two units (95% CI -8.88 to 1.28) respectively (all based on a 100-point scale), or in submaximal cardiorespiratory function (three seconds on a 100-meter walk test, 95% CI -1.77 to 7.77). We found a statistically significant difference between interventions for strength, favoring land-based training (2.40 kilo pascals grip strength, 95% CI 4.52 to 0.28). None of the outcomes in the aquatic versus land comparison reached clinically relevant differences of 15%. Withdrawals were similar in the aquatic and land groups and adverse effects were poorly reported, with no serious adverse effects in either group. Aquatic versus aquatic (Ai Chi versus stretching in the water, exercise in pool water versus exercise in sea water)Among the major outcomes the only statistically significant difference between interventions was for stiffness, favoring Ai Chi (1.00 on a 100-point scale, 95% CI 0.31 to 1.69).
AUTHORS' CONCLUSIONS
Low to moderate quality evidence relative to control suggests that aquatic training is beneficial for improving wellness, symptoms, and fitness in adults with fibromyalgia. Very low to low quality evidence suggests that there are benefits of aquatic and land-based exercise, except in muscle strength (very low quality evidence favoring land). No serious adverse effects were reported.
Topics: Adult; Exercise Therapy; Female; Fibromyalgia; Humans; Hydrotherapy; Male; Muscle Strength; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 25350761
DOI: 10.1002/14651858.CD011336 -
The Cochrane Database of Systematic... Jan 2015Knee osteoarthritis (OA) is a major public health issue because it causes chronic pain, reduces physical function and diminishes quality of life. Ageing of the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Knee osteoarthritis (OA) is a major public health issue because it causes chronic pain, reduces physical function and diminishes quality of life. Ageing of the population and increased global prevalence of obesity are anticipated to dramatically increase the prevalence of knee OA and its associated impairments. No cure for knee OA is known, but exercise therapy is among the dominant non-pharmacological interventions recommended by international guidelines.
OBJECTIVES
To determine whether land-based therapeutic exercise is beneficial for people with knee OA in terms of reduced joint pain or improved physical function and quality of life.
SEARCH METHODS
Five electronic databases were searched, up until May 2013.
SELECTION CRITERIA
All randomised controlled trials (RCTs) randomly assigning individuals and comparing groups treated with some form of land-based therapeutic exercise (as opposed to exercise conducted in the water) with a non-exercise group or a non-treatment control group.
DATA COLLECTION AND ANALYSIS
Three teams of two review authors independently extracted data, assessed risk of bias for each study and assessed the quality of the body of evidence for each outcome using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach. We conducted analyses on continuous outcomes (pain, physical function and quality of life) immediately after treatment and on dichotomous outcomes (proportion of study withdrawals) at the end of the study; we also conducted analyses on the sustained effects of exercise on pain and function (two to six months, and longer than six months).
MAIN RESULTS
In total, we extracted data from 54 studies. Overall, 19 (20%) studies reported adequate random sequence generation and allocation concealment and adequately accounted for incomplete outcome data; we considered these studies to have an overall low risk of bias. Studies were largely free from selection bias, but research results may be vulnerable to performance and detection bias, as only four of the RCTs reported blinding of participants to treatment allocation, and, although most RCTs reported blinded outcome assessment, pain, physical function and quality of life were participant self-reported.High-quality evidence from 44 trials (3537 participants) indicates that exercise reduced pain (standardised mean difference (SMD) -0.49, 95% confidence interval (CI) -0.39 to -0.59) immediately after treatment. Pain was estimated at 44 points on a 0 to 100-point scale (0 indicated no pain) in the control group; exercise reduced pain by an equivalent of 12 points (95% CI 10 to 15 points). Moderate-quality evidence from 44 trials (3913 participants) showed that exercise improved physical function (SMD -0.52, 95% CI -0.39 to -0.64) immediately after treatment. Physical function was estimated at 38 points on a 0 to 100-point scale (0 indicated no loss of physical function) in the control group; exercise improved physical function by an equivalent of 10 points (95% CI 8 to 13 points). High-quality evidence from 13 studies (1073 participants) revealed that exercise improved quality of life (SMD 0.28, 95% CI 0.15 to 0.40) immediately after treatment. Quality of life was estimated at 43 points on a 0 to 100-point scale (100 indicated best quality of life) in the control group; exercise improved quality of life by an equivalent of 4 points (95% CI 2 to 5 points).High-quality evidence from 45 studies (4607 participants) showed a comparable likelihood of withdrawal from exercise allocation (event rate 14%) compared with the control group (event rate 15%), and this difference was not significant: odds ratio (OR) 0.93 (95% CI 0.75 to 1.15). Eight studies reported adverse events, all of which were related to increased knee or low back pain attributed to the exercise intervention provided. No study reported a serious adverse event.In addition, 12 included studies provided two to six-month post-treatment sustainability data on 1468 participants for knee pain and on 1279 (10 studies) participants for physical function. These studies indicated sustainability of treatment effect for pain (SMD -0.24, 95% CI -0.35 to -0.14), with an equivalent reduction of 6 (3 to 9) points on 0 to 100-point scale, and of physical function (SMD -0.15 95% CI -0.26 to -0.04), with an equivalent improvement of 3 (1 to 5) points on 0 to 100-point scale.Marked variability was noted across included studies among participants recruited, symptom duration, exercise interventions assessed and important aspects of study methodology. Individually delivered programmes tended to result in greater reductions in pain and improvements in physical function, compared to class-based exercise programmes or home-based programmes; however between-study heterogeneity was marked within the individually provided treatment delivery subgroup.
AUTHORS' CONCLUSIONS
High-quality evidence indicates that land-based therapeutic exercise provides short-term benefit that is sustained for at least two to six months after cessation of formal treatment in terms of reduced knee pain, and moderate-quality evidence shows improvement in physical function among people with knee OA. The magnitude of the treatment effect would be considered moderate (immediate) to small (two to six months) but comparable with estimates reported for non-steroidal anti-inflammatory drugs. Confidence intervals around demonstrated pooled results for pain reduction and improvement in physical function do not exclude a minimal clinically important treatment effect. Since the participants in most trials were aware of their treatment, this may have contributed to their improvement. Despite the lack of blinding we did not downgrade the quality of evidence for risk of performance or detection bias. This reflects our belief that further research in this area is unlikely to change the findings of our review.
Topics: Arthralgia; Exercise Therapy; Humans; Osteoarthritis, Knee; Randomized Controlled Trials as Topic
PubMed: 25569281
DOI: 10.1002/14651858.CD004376.pub3 -
The Cochrane Database of Systematic... Jan 2015Terminally ill people experience a variety of symptoms in the last hours and days of life, including delirium, agitation, anxiety, terminal restlessness, dyspnoea, pain,... (Review)
Review
BACKGROUND
Terminally ill people experience a variety of symptoms in the last hours and days of life, including delirium, agitation, anxiety, terminal restlessness, dyspnoea, pain, vomiting, and psychological and physical distress. In the terminal phase of life, these symptoms may become refractory, and unable to be controlled by supportive and palliative therapies specifically targeted to these symptoms. Palliative sedation therapy is one potential solution to providing relief from these refractory symptoms. Sedation in terminally ill people is intended to provide relief from refractory symptoms that are not controlled by other methods. Sedative drugs such as benzodiazepines are titrated to achieve the desired level of sedation; the level of sedation can be easily maintained and the effect is reversible.
OBJECTIVES
To assess the evidence for the benefit of palliative pharmacological sedation on quality of life, survival, and specific refractory symptoms in terminally ill adults during their last few days of life.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 11), MEDLINE (1946 to November 2014), and EMBASE (1974 to December 2014), using search terms representing the sedative drug names and classes, disease stage, and study designs.
SELECTION CRITERIA
We included randomised controlled trials (RCTs), quasi-RCTs, non-RCTs, and observational studies (e.g. before-and-after, interrupted-time-series) with quantitative outcomes. We excluded studies with only qualitative outcomes or that had no comparison (i.e. no control group or no within-group comparison) (e.g. single arm case series).
DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles and abstracts of citations, and full text of potentially eligible studies. Two review authors independently carried out data extraction using standard data extraction forms. A third review author acted as arbiter for both stages. We carried out no meta-analyses due to insufficient data for pooling on any outcome; therefore, we reported outcomes narratively.
MAIN RESULTS
The searches resulted in 14 included studies, involving 4167 adults, of whom 1137 received palliative sedation. More than 95% of people had cancer. No studies were randomised or quasi-randomised. All were consecutive case series, with only three having prospective data collection. Risk of bias was high, due to lack of randomisation. No studies measured quality of life or participant well-being, which was the primary outcome of the review. Five studies measured symptom control, using four different methods, so pooling was not possible. The results demonstrated that despite sedation, delirium and dyspnoea were still troublesome symptoms in these people in the last few days of life. Control of other symptoms appeared to be similar in sedated and non-sedated people. Only one study measured unintended adverse effects of sedative drugs and found no major events; however, four of 70 participants appeared to have drug-induced delirium. The study noticed no respiratory suppression. Thirteen of the 14 studies measured survival time from admission or referral to death, and all demonstrated no statistically significant difference between sedated and non-sedated groups.
AUTHORS' CONCLUSIONS
There was insufficient evidence about the efficacy of palliative sedation in terms of a person's quality of life or symptom control. There was evidence that palliative sedation did not hasten death, which has been a concern of physicians and families in prescribing this treatment. However, this evidence comes from low quality studies, so should be interpreted with caution. Further studies that specifically measure the efficacy and quality of life in sedated people, compared with non-sedated people, and quantify adverse effects are required.
Topics: Adult; Conscious Sedation; Deep Sedation; Humans; Hypnotics and Sedatives; Palliative Care; Selection Bias; Terminal Care; Terminally Ill
PubMed: 25879099
DOI: 10.1002/14651858.CD010206.pub2 -
The Cochrane Database of Systematic... Sep 2021Bipolar disorder is a chronic mental disorder with repetitive mania/hypomania as well as depressive episodes, which eventually results in marked impairment in overall... (Review)
Review
BACKGROUND
Bipolar disorder is a chronic mental disorder with repetitive mania/hypomania as well as depressive episodes, which eventually results in marked impairment in overall functioning and health-related quality of life. A worldwide prevalence rate of 2.4% has been reported. The risk of suicide is higher in people with bipolar disorder than those with other mental disorders. Therefore, effective management of bipolar disorder in the maintenance period is warranted to minimize the risk of relapse or recurrence. Although lithium has been the standard treatment of bipolar disorder for many years, it is associated with adverse effects and teratogenicity. Lamotrigine is approved to be expected for prevention of recurrence for the maintenance treatment of bipolar disorder. In addition, lamotrigine is as effective as lithium. Therefore, we performed a systematic review to confirm the efficacy and safety of lamotrigine in the maintenance treatment of bipolar disorder.
OBJECTIVES
To assess the efficacy and tolerability of lamotrigine in the maintenance treatment of bipolar disorder.
SEARCH METHODS
We searched Ovid MEDLINE, Embase, PsycINFO, the Cochrane Common Mental Disorders Group's Specialized Register (CCMDCTR) and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to 21 May 2021. We also searched international trial registries and contacted experts in the field.
SELECTION CRITERIA
We included randomized controlled trials enrolling adults with bipolar disorder who were treated with lamotrigine, placebo or lithium.
DATA COLLECTION AND ANALYSIS
Two reviews authors independently checked the eligibility of studies and extracted data using a standardized form. Data extracted included study characteristics, participant characteristics, intervention details, settings, and outcome measures in the term of efficacy and tolerability. Study information were then entered into RevMan web.
MAIN RESULTS
We included 11 studies with a total of 2314 participants in this review; 1146 were randomized to lamotrigine, 869 were randomized to placebo and, 299 to lithium. We rated all studies as having an unclear risk of bias in at least one domain of Cochrane's tool for assessing risk of bias, with the most commonly observed weakness being selection bias (random sequence generation and allocation concealment). We judged five studies to be at a high risk of detection bias (blinding of outcome assessment). These potential biases pose as major threat to the validity of the included studies in this review. Outcomes of efficacy showed a possible advantage of lamotrigine over placebo. The estimated risk ratio (RR) for recurrence of manic symptom at one year as measured by the Young Mania Rating Scale (YMRS) was 0.67, (95% confidence interval (CI) 0.51 to 0.87; 3 studies, 663 participants; low-certainty evidence) in favor of lamotrigine. The RR of clinical worsening with the need for additional psychotropic treatment (RR 0.82, 95% CI 0.70 to 0.98; 4 studies, 756 participants) based on moderate-certainty evidence. The possible benefits of lamotrigine were also seen for the outcome of treatment withdrawal due to any reason at 6-12 months after treatment (RR 0.88, 95% CI 0.78 to 0.99; 4 studies, 700 participants; moderate-certainty evidence). Regarding tolerability, our analyses showed that the incidence rates of adverse effects were similar between the lamotrigine group and the placebo group (short-term effect: RR 1.07, 95% CI 0.81 to 1.42; 5 studies, 1138 participants; very low-certainty evidence; long-term effect: RR 0.97, 95% CI 0.77 to 1.23; 4 studies, 756 participants; moderate-certainty evidence). In the comparison between lamotrigine and lithium, efficacy was similar between groups except for recurrence of mania episode at one year. Recurrence of manic symptoms was higher in the lamotrigine group than that of the lithium group (RR 2.13, 95% CI 1.32 to 3.44; 3 studies, 602 participants; moderate-certainty evidence). Analysis of adverse effects at 6-12 months showed that a lower proportion of participants experienced at least one adverse effect when treated with lamotrigine compared to lithium (RR 0.70, 95% CI 0.51 to 0.96; 4 studies, 691 participants; moderate-certainty evidence).
AUTHORS' CONCLUSIONS
Low- to moderate-certainty evidence collectively suggests that lamotrigine may be superior to placebo as a treatment modality for bipolar disorder. In comparison to lithium, people with bipolar disorder seem to tolerate lamotrigine better in the long run; however, the demonstrated efficacy in the maintenance of bipolar disorder was similar between the two groups.
Topics: Adult; Anticonvulsants; Bipolar Disorder; Humans; Lamotrigine; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 34523118
DOI: 10.1002/14651858.CD013575.pub2 -
European Journal of Medical Research Apr 2022In this study, we attempted to assess the efficacy and safety of acupuncture for allergic rhinitis (AR), and to test the robustness of the estimated effects. (Meta-Analysis)
Meta-Analysis
BACKGROUND
In this study, we attempted to assess the efficacy and safety of acupuncture for allergic rhinitis (AR), and to test the robustness of the estimated effects.
METHODS
The Cochrane methodology standard was followed to conduct this systematic review. Randomized controlled trials (RCTs) comparing acupuncture with other therapies for AR were included. Furthermore, trial sequential analysis was conducted to test the robustness of pooled results. Thirty trials with 4413 participants were included.
RESULTS
Acupuncture improved the nasal symptoms on Total Nasal Symptom Score (TNSS) and quality of life measured by Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in adults with AR, compared to acupuncture with no intervention. Acupuncture was also shown to be more effective than sham acupuncture for nasal symptom (RQLQ subscale, n = 489, MD - 0.60, 95% CI - 1.16 to - 0.04) and quality of life (RQLQ, n = 248, - 8.47 95% CI - 14.91, - 2.03). No clear difference was observed between acupuncture and cetirizine or loratadine. Interestingly, trial sequential analysis (TSA) failed to confirm the aforementioned results. The effect of acupuncture for children/adolescents with AR remains unclear due to insufficient data. The performance bias and attrition bias are serious in most studies that were included. Selection bias may also have affected the quality of the evidence.
CONCLUSION
Acupuncture may have an advantage over no intervention and sham acupuncture in improving nasal symptoms and quality of life for adults with AR. The effect of acupuncture and cetirizine or loratadine for AR may be similar. Additional trials are necessary to confirm these results.
Topics: Acupuncture Therapy; Adolescent; Adult; Cetirizine; Child; Humans; Loratadine; Quality of Life; Rhinitis, Allergic; Surveys and Questionnaires
PubMed: 35462555
DOI: 10.1186/s40001-022-00682-3 -
The Cochrane Database of Systematic... Mar 2019Cognitive impairment, a defining feature of dementia, plays an important role in the compromised functional independence that characterises the condition. Cognitive... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cognitive impairment, a defining feature of dementia, plays an important role in the compromised functional independence that characterises the condition. Cognitive training (CT) is an approach that uses guided practice on structured tasks with the direct aim of improving or maintaining cognitive abilities.
OBJECTIVES
• To assess effects of CT on cognitive and non-cognitive outcomes for people with mild to moderate dementia and their caregivers.• To compare effects of CT with those of other non-pharmacological interventions, including cognitive stimulation or rehabilitation, for people with mild to moderate dementia and their caregivers.• To identify and explore factors related to intervention and trial design that may be associated with the efficacy of CT for people with mild to moderate dementia and their caregivers.
SEARCH METHODS
We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialised Register, on 5 July 2018. ALOIS contains records of clinical trials identified through monthly searches of several major healthcare databases and numerous trial registries and grey literature sources. In addition to this, we searched MEDLINE, Embase, PsycINFO, CINAHL, LILACS, Web of Science Core Collection, ClinicalTrials.gov, and the World Health Organization's trials portal, ICTRP, to ensure that searches were comprehensive and up-to-date.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that described interventions for people with mild to moderate dementia and compared CT versus a control or alternative intervention.
DATA COLLECTION AND ANALYSIS
We extracted relevant data from published manuscripts and through contact with trial authors if required. We assessed risk of bias using the Cochrane 'Risk of bias' tool. We divided comparison conditions into active or passive control conditions and alternative treatments. We used a large number of measures and data to evaluate 19 outcomes at end of treatment, as well as 16 outcomes at follow-up in the medium term; we pooled this information in meta-analyses. We calculated pooled estimates of treatment effect using a random-effects model, and we estimated statistical heterogeneity using a standard Chi² statistic. We graded the evidence using GradePro.
MAIN RESULTS
The 33 included trials were published between 1988 and 2018 and were conducted in 12 countries; most were unregistered, parallel-group, single-site RCTs, with samples ranging from 12 to 653 participants. Interventions were between two and 104 weeks long. We classified most experimental interventions as 'straight CT', but we classified some as 'augmented CT', and about two-thirds as multi-domain interventions. Researchers investigated 18 passive and 13 active control conditions, along with 15 alternative treatment conditions, including occupational therapy, mindfulness, reminiscence therapy, and others.The methodological quality of studies varied, but we rated nearly all studies as having high or unclear risk of selection bias due to lack of allocation concealment, and high or unclear risk of performance bias due to lack of blinding of participants and personnel.We used data from 32 studies in the meta-analysis of at least one outcome. Relative to a control condition, we found moderate-quality evidence showing a small to moderate effect of CT on our first primary outcome, composite measure of global cognition at end of treatment (standardised mean difference (SMD) 0.42, 95% confidence interval (CI) 0.23 to 0.62), and high-quality evidence showing a moderate effect on the secondary outcome of verbal semantic fluency (SMD 0.52, 95% CI 0.23 to 0.81) at end of treatment, with these gains retained in the medium term (3 to 12 months post treatment). In relation to many other outcomes, including our second primary outcome of clinical disease severity in the medium term, the quality of evidence was very low, so we were unable to determine whether CT was associated with any meaningful gains.When compared with an alternative treatment, we found that CT may have little to no effect on our first primary outcome of global cognition at end of treatment (SMD 0.21, 95% CI -0.23 to 0.64), but the quality of evidence was low. No evidence was available to assess our second primary outcome of clinical disease severity in the medium term. We found moderate-quality evidence showing that CT was associated with improved mood of the caregiver at end of treatment, but this was based on a single trial. The quality of evidence in relation to many other outcomes at end of treatment and in the medium term was too low for us to determine whether CT was associated with any gains, but we are moderately confident that CT did not lead to any gains in mood, behavioural and psychological symptoms, or capacity to perform activities of daily living.
AUTHORS' CONCLUSIONS
Relative to a control intervention, but not to a variety of alternative treatments, CT is probably associated with small to moderate positive effects on global cognition and verbal semantic fluency at end of treatment, and these benefits appear to be maintained in the medium term. Our certainty in relation to many of these findings is low or very low. Future studies should take stronger measures to mitigate well-established risks of bias, and should provide long-term follow-up to improve our understanding of the extent to which observed gains are retained. Future trials should also focus on direct comparison of CT versus alternative treatments rather than passive or active control conditions.
Topics: Activities of Daily Living; Aged; Aged, 80 and over; Cognition; Cognitive Dysfunction; Dementia; Humans; Middle Aged; Randomized Controlled Trials as Topic; Task Performance and Analysis; Therapy, Computer-Assisted
PubMed: 30909318
DOI: 10.1002/14651858.CD013069.pub2 -
The Cochrane Database of Systematic... Apr 2018Recent progress in understanding the genetic basis of breast cancer and widely publicized reports of celebrities undergoing risk-reducing mastectomy (RRM) have increased... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Recent progress in understanding the genetic basis of breast cancer and widely publicized reports of celebrities undergoing risk-reducing mastectomy (RRM) have increased interest in RRM as a method of preventing breast cancer. This is an update of a Cochrane Review first published in 2004 and previously updated in 2006 and 2010.
OBJECTIVES
(i) To determine whether risk-reducing mastectomy reduces death rates from any cause in women who have never had breast cancer and in women who have a history of breast cancer in one breast, and (ii) to examine the effect of risk-reducing mastectomy on other endpoints, including breast cancer incidence, breast cancer mortality, disease-free survival, physical morbidity, and psychosocial outcomes.
SEARCH METHODS
For this Review update, we searched Cochrane Breast Cancer's Specialized Register, MEDLINE, Embase and the WHO International Clinical Trials Registry Platform (ICTRP) on 9 July 2016. We included studies in English.
SELECTION CRITERIA
Participants included women at risk for breast cancer in at least one breast. Interventions included all types of mastectomy performed for the purpose of preventing breast cancer.
DATA COLLECTION AND ANALYSIS
At least two review authors independently abstracted data from each report. We summarized data descriptively; quantitative meta-analysis was not feasible due to heterogeneity of study designs and insufficient reporting. We analyzed data separately for bilateral risk-reducing mastectomy (BRRM) and contralateral risk-reducing mastectomy (CRRM). Four review authors assessed the methodological quality to determine whether or not the methods used sufficiently minimized selection bias, performance bias, detection bias, and attrition bias.
MAIN RESULTS
All 61 included studies were observational studies with some methodological limitations; randomized trials were absent. The studies presented data on 15,077 women with a wide range of risk factors for breast cancer, who underwent RRM.Twenty-one BRRM studies looking at the incidence of breast cancer or disease-specific mortality, or both, reported reductions after BRRM, particularly for those women with BRCA1/2 mutations. Twenty-six CRRM studies consistently reported reductions in incidence of contralateral breast cancer but were inconsistent about improvements in disease-specific survival. Seven studies attempted to control for multiple differences between intervention groups and showed no overall survival advantage for CRRM. Another study showed significantly improved survival following CRRM, but after adjusting for bilateral risk-reducing salpingo-oophorectomy (BRRSO), the CRRM effect on all-cause mortality was no longer significant.Twenty studies assessed psychosocial measures; most reported high levels of satisfaction with the decision to have RRM but greater variation in satisfaction with cosmetic results. Worry over breast cancer was significantly reduced after BRRM when compared both to baseline worry levels and to the groups who opted for surveillance rather than BRRM, but there was diminished satisfaction with body image and sexual feelings.Seventeen case series reporting on adverse events from RRM with or without reconstruction reported rates of unanticipated reoperations from 4% in those without reconstruction to 64% in participants with reconstruction.In women who have had cancer in one breast, removing the other breast may reduce the incidence of cancer in that other breast, but there is insufficient evidence that this improves survival because of the continuing risk of recurrence or metastases from the original cancer. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention, when considering RRM.
AUTHORS' CONCLUSIONS
While published observational studies demonstrated that BRRM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies are suggested. BRRM should be considered only among those at high risk of disease, for example, BRCA1/2 carriers. CRRM was shown to reduce the incidence of contralateral breast cancer, but there is insufficient evidence that CRRM improves survival, and studies that control for multiple confounding variables are recommended. It is possible that selection bias in terms of healthier, younger women being recommended for or choosing CRRM produces better overall survival numbers for CRRM. Given the number of women who may be over-treated with BRRM/CRRM, it is critical that women and clinicians understand the true risk for each individual woman before considering surgery. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention when considering RRM.
Topics: Breast Neoplasms; Female; Genes, BRCA1; Genes, BRCA2; Genetic Predisposition to Disease; Humans; Observational Studies as Topic; Patient Satisfaction; Postoperative Complications; Prophylactic Mastectomy; Risk Assessment; Unilateral Breast Neoplasms
PubMed: 29620792
DOI: 10.1002/14651858.CD002748.pub4 -
The Cochrane Database of Systematic... Feb 2015Low-back pain (LBP) is responsible for considerable personal suffering due to pain and reduced function, as well as the societal burden due to costs of health care and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Low-back pain (LBP) is responsible for considerable personal suffering due to pain and reduced function, as well as the societal burden due to costs of health care and lost work productivity. For the vast majority of people with LBP, no specific anatomical cause can be reliably identified. For these people with non-specific LBP there are numerous treatment options, few of which have been shown to be effective in reducing pain and disability. The muscle energy technique (MET) is a treatment technique used predominantly by osteopaths, physiotherapists and chiropractors which involves alternating periods of resisted muscle contractions and assisted stretching. To date it is unclear whether MET is effective in reducing pain and improving function in people with LBP.
OBJECTIVES
To examine the effectiveness of MET in the treatment of people with non-specific LBP compared with control interventions, with particular emphasis on subjective pain and disability outcomes.
SEARCH METHODS
CENTRAL, MEDLINE, EMBASE, five other databases and two trials registers were searched from inception to May and June 2014 together with reference checking and citation searching of relevant systematic reviews.
SELECTION CRITERIA
Randomised controlled trials assessing the effect of MET on pain or disability in patients with non-specific LBP were included.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed the risk of bias and extracted the data. Meta-analysis was performed where clinical homogeneity was sufficient. The quality of the evidence for each comparison was assessed with the GRADE approach.
MAIN RESULTS
There were 12 randomised controlled trials with 14 comparisons included in the review, with a total sample of 500 participants across all comparisons. Included studies were typically very small (n = 20 to 72), all except one were assessed as being at high risk of bias, and all reported short-term outcomes. For the purposes of pooling, studies were divided into seven clinically homogenous comparisons according to the patient population (acute or chronic LBP) and the nature of the control intervention. Most of the comparisons (five out of seven) included only one study, one comparison had two studies, and one comparison included seven studies.The meta-analyses provided low-quality evidence that MET provided no additional benefit when added to other therapies on the outcomes of chronic pain and disability in the short-term (weighted mean difference (WMD) for pain 0.00, 95% CI -2.97 to 2.98 on a 100-point scale; standardised mean difference (SMD) for disability -0.18, 95% CI -0.43 to 0.08, 7 studies, 232 participants). There was low-quality evidence that MET produced no clinically relevant differences in pain compared to sham MET (mean difference (MD) 14.20, 95% CI -10.14 to 38.54, 1 study, 20 participants). For the comparison of MET to other conservative therapies for acute non-specific LBP, there was very low-quality evidence of no clinically relevant difference for the outcomes of pain (MD -10.72, 95% CI -32.57 to 11.13, 2 studies, 88 participants) and functional status (MD 0.87, 95% CI -6.31 to 8.05, 1 study, 60 participants). For the comparison of MET to other conservative therapies for chronic non-specific LBP, there was low-quality evidence of no clinically relevant difference for the outcomes of pain (MD -9.70, 95% CI -20.20 to 0.80, 1 study, 30 participants) and functional status (MD -4.10, 95% CI -9.53 to 1.33, 1 study, 30 participants). There was low-quality evidence of no clinically relevant difference for the addition of MET to other interventions for acute non-specific LBP for the outcome of pain (MD -3, 95% CI -11.37 to 5.37, 1 study, 40 participants) and low-quality evidence of an effect in favour of MET for functional status (MD -17.6, 95% CI -27.05 to -8.15, 1 study, 40 participants). For chronic non-specific LBP, there was low-quality evidence of an effect in favour of MET for the addition of MET to other interventions for the outcomes of pain (MD -34.1, 95% CI -38.43 to -29.77, 1 study, 30 participants) and functional status (MD -22, 95% CI -27.41 to -16.59, 1 study, 30 participants). Lastly, there was low-quality evidence of no difference for the addition of MET to another manual intervention compared to the same intervention with other conservative therapies for the outcomes of pain (MD 5.20, 95% CI -3.03 to 13.43, 1 study, 20 participants) and functional status (MD 6.0, 95% CI -0.49 to 12.49, 1 study, 20 participants).No study reported on our other primary outcome of general well-being. Seven studies reported that no adverse events were observed, whereas the other five studies did not report any information on adverse events.
AUTHORS' CONCLUSIONS
The quality of research related to testing the effectiveness of MET is poor. Studies are generally small and at high risk of bias due to methodological deficiencies. Studies conducted to date generally provide low-quality evidence that MET is not effective for patients with LBP. There is not sufficient evidence to reliably determine whether MET is likely to be effective in practice. Large, methodologically-sound studies are necessary to investigate this question.
Topics: Acute Pain; Chronic Pain; Humans; Low Back Pain; Manipulation, Osteopathic; Muscle Contraction; Randomized Controlled Trials as Topic; Selection Bias
PubMed: 25723574
DOI: 10.1002/14651858.CD009852.pub2 -
Journal of Thoracic Oncology : Official... Mar 2023Thymic epithelial tumors are rare and are classified as thymoma, thymic carcinoma, and thymic neuroendocrine tumors. The objective of this systematic review was to... (Review)
Review
INTRODUCTION
Thymic epithelial tumors are rare and are classified as thymoma, thymic carcinoma, and thymic neuroendocrine tumors. The objective of this systematic review was to evaluate the treatment options for patients with thymic epithelial tumors.
METHODS
This systematic review was developed by Ontario Health (Cancer Care Ontario)'s Program in Evidence-Based Care and by the Lung Cancer Disease Site Group. MEDLINE, EMBASE, and the Cochrane Library were searched for studies comparing surgical, radiotherapy, or systemic treatments against any combination of these treatments in patients with thymic epithelial tumors. Meta-analyses were conducted with clinically homogenous studies.
RESULTS
A total of 106 studies were included, mainly from observational studies. There was an overall survival benefit with postoperative radiotherapy for patients with thymic carcinoma (hazard ratio = 0.65, 95% confidence interval: 0.47-0.89) and for patients with thymoma (hazard ratio = 0.70, 95% confidence interval: 0.59-0.82), especially for those with a high risk for mortality. Patients with thymic carcinoma or thymoma had a response to chemotherapy. Selection bias affected the results for studies that evaluated neoadjuvant chemotherapy or minimally invasive surgical techniques. Furthermore, the overall survival benefit found for adjuvant chemotherapy may have been confounded by the administration of postoperative radiotherapy.
CONCLUSIONS
For patients with thymoma or thymic carcinoma, the literature is of low quality and subject to bias. There were overall survival benefits with postoperative radiotherapy. The results of this systematic review were used to inform treatment recommendations in a clinical practice guideline. Future large-scale prospective studies that control for confounders are needed.
Topics: Humans; Thymoma; Prospective Studies; Lung Neoplasms; Thymus Neoplasms; Neoplasms, Glandular and Epithelial
PubMed: 36343922
DOI: 10.1016/j.jtho.2022.10.016