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JMIR Aging Mar 2023Due to the aging population, there is a need for monitoring well-being and safety while living independently. A low-intrusive monitoring system is based on a person's... (Review)
Review
BACKGROUND
Due to the aging population, there is a need for monitoring well-being and safety while living independently. A low-intrusive monitoring system is based on a person's use of energy or water.
OBJECTIVE
The study's objective was to provide a systematic overview of studies that monitor the health and well-being of older people using energy (eg, electricity and gas) and water usage data and study the outcomes on health and well-being.
METHODS
CENTRAL, Embase, MEDLINE (Ovid), Scopus, Web of Science, and Google Scholar were searched systematically from inception until November 8, 2021. The inclusion criteria were that the study had to be published in English, have full-text availability, target independent-living people aged 60 years and older from the general population, have an observational design, and assess the outcomes of a monitoring system based on energy (ie, electricity, gas, or water) usage on well-being and safety. The quality of the studies was assessed by the QualSyst systematic review tool.
RESULTS
The search strategy identified 2920 articles. The majority of studies focused on the technical algorithms underlying energy usage data and related sensors. One study was included in this review. This study reported that the smart energy meter data monitoring system was considered unobtrusive and was well accepted by the older people and professionals involved. Energy usage in a household acted as a unique signature and therefore provided useful insight into well-being and safety. This study lacked statistical power due to the small number of participants and the low number of observed events. In addition, the quality of the study was rated as low.
CONCLUSIONS
This review identified only 1 study that evaluated the impact of an energy usage monitoring system on the well-being and safety of older people. The absence of reliable evidence impedes any definitive guidance or recommendations for practice. Because this emerging field has not yet been studied thoroughly, many questions remain open for further research. Future studies should focus on the further development of a monitoring system and the evaluation of the implementation and outcomes of these systems.
TRIAL REGISTRATION
PROSPERO CRD42022245713; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=245713.
PubMed: 37000477
DOI: 10.2196/41187 -
Frontiers in Aging Neuroscience 2022Aerobic and resistance training are common complementary therapies to improve motor symptoms in people with Parkinson's disease (PD), and there is still a lack of advice...
BACKGROUND/OBJECTIVES
Aerobic and resistance training are common complementary therapies to improve motor symptoms in people with Parkinson's disease (PD), and there is still a lack of advice on which intensity and period of aerobic or resistance training is more appropriate for people with PD. Therefore, a network meta-analysis was conducted to assess the comparative efficacy of aerobic and resistance training of different intensities and cycles on motor symptoms in patients with Parkinson's disease.
METHODS
Based on several biomedical databases, a search strategy system was conducted to retrieve randomized controlled trials (RCTs) without language restrictions. A network meta-analysis with a frequentist approach was conducted to estimate the efficacy and probability rankings of aerobic and resistance training on Parkinson's patients. What's more, a range of analyses and assessments, such as routine meta-analyses and risk of bias, were performed as well.
RESULTS
Twenty trials with 719 patients evaluating 18 different therapies were identified. Through the Unified Parkinson's Disease Motor Rating Scale, (UPDRS III); 6-minute walk test, (6MWT); 10-meter walk test, (TWM); and time up and go (TUG) and Quality of Life Scale-39 (PDQ-39), to explore the effects of different intensity resistance and aerobic exercise on PD. As a result, short period high intensity resistance movement (standard mean difference (SMD) = -0.95, 95% confidence interval (CI) -1.68 to -0.22) had significantly decreased the Unified Parkinson's Disease Motor Rating Scale (UPDRS III). Short period high intensity resistance exercise showed similar superiority in other indices; also, aerobic and resistance training of different cycle intensities produced some efficacy in PD patients, both in direct and indirect comparisons.
CONCLUSION
For patients with moderate to mild Parkinson's symptoms, short periods high intensity resistance training may provide complementary therapy for PD, and aerobic or resistance training of varying intensity and periodicity may be recommended as exercise prescription for PD patients. However, more large scale and high quality clinical trials are needed to confirm the effectiveness of this exercise therapy in the future.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/PROSPERO/, identifier: CRD42022324824.
PubMed: 35978948
DOI: 10.3389/fnagi.2022.935176 -
The Cochrane Database of Systematic... Sep 2021Mucopolysaccharidosis type VI (MPS VI) or Maroteaux-Lamy syndrome is a rare genetic disorder caused by the deficiency of arylsulphatase B. The resultant accumulation of... (Review)
Review
BACKGROUND
Mucopolysaccharidosis type VI (MPS VI) or Maroteaux-Lamy syndrome is a rare genetic disorder caused by the deficiency of arylsulphatase B. The resultant accumulation of dermatan sulphate causes lysosomal damage. The clinical symptoms are related to skeletal dysplasia (i.e. short stature and degenerative joint disease). Other manifestations include cardiac disease, impaired pulmonary function, ophthalmological complications, hepatosplenomegaly, sinusitis, otitis, hearing loss and sleep apnea. Intellectual impairment is generally absent. Clinical manifestation is typically by two or three years of age; however, slowly progressive cases may not present until adulthood. Enzyme replacement therapy (ERT) with galsulfase is considered a new approach for treating MPS VI.
OBJECTIVES
To evaluate the effectiveness and safety of treating MPS VI by ERT with galsulfase compared to other interventions, placebo or no intervention.
SEARCH METHODS
Eletronic searches were performed on the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register. Date of the latest search: 09 June 2021. Further searches of the following databases were also performed: CENTRAL, MEDLINE, LILACS, the Journal of Inherited Metabolic Disease, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov. Date of the latest search: 20 August 2021.
SELECTION CRITERIA
Randomized and quasi-randomized controlled clinical studies of ERT with galsulfase compared to other interventions or placebo.
DATA COLLECTION AND ANALYSIS
Two authors independently screened the studies, assessed the risk of bias, extracted data and assessed the certainty of the the evidence using the GRADE criteria.
MAIN RESULTS
One study was included involving 39 participants who received either ERT with galsulfase (recombinant human arylsulphatase B) or placebo. This small study was considered overall to have an unclear risk of bias in relation to the design and implementation of the study, since the authors did not report how both the allocation generation and concealment were performed. Given the very low certainty of the evidence, we are uncertain whether at 24 weeks there was a difference between groups in relation to the 12-minute walk test, mean difference (MD) of 92.00 meters (95% confidence interval (CI) 11.00 to 172.00), or the three-minute stair climb, MD 5.70 (95% CI -0.10 to 11.50). In relation to respiratory tests, we are uncertain whether galsulfase makes any difference as compared to placebo in forced vital capacity in litres (FVC (L) (absolute change in baseline), given the very low certainty of the evidence. Cardiac function was not reported in the included study. We found that galsulfase, as compared to placebo, may decrease urinary glycosaminoglycan levels at 24 weeks, MD -227.00 (95% CI -264.00 to -190.00) (low-certainty evidence). We are uncertain whether there are differences between the galsulfase and placebo groups in relation to adverse events (very low-certainty evidence). In general, the dose of galsulfase was well tolerated and there were no differences between groups. These events include drug-related adverse events, serious and severe adverse events, those during infusion, drug-related adverse events during infusion, and deaths. More infusion-related reactions were observed in the galsulfase group and were managed with interruption or slowing of infusion rate or administration of antihistamines or corticosteroids drugs. No deaths occurred during the study. AUTHORS' CONCLUSIONS: The results of this review are based only on one small study (a 24-week randomised phase of the study and prior to the open-label extension). We are uncertain whether galsulfase is more effective than placebo, for treating people with MPS VI, in relation to the 12-minute walk test or the three-minute stair climb, as the certainty of the evidence has been assessed as very low. We found that galsulfase may reduce urinary glycosaminoglycans levels. We are also uncertain whether there are any differences between treatment groups in relation to cardiac or pulmonary functions, liver or spleen volume, overnight apnea-hypopnea, height and weight, quality of life and adverse effects. Further studies are needed to obtain more information on the long-term effectiveness and safety of ERT with galsulfase.
Topics: Adult; Enzyme Replacement Therapy; Humans; Mucopolysaccharidosis VI; N-Acetylgalactosamine-4-Sulfatase; Quality of Life; Recombinant Proteins
PubMed: 34533215
DOI: 10.1002/14651858.CD009806.pub3 -
The Cochrane Database of Systematic... Jul 2021Pulmonary transplantation is the final treatment option for people with end-stage respiratory diseases. Evidence suggests that exercise training may contribute to...
BACKGROUND
Pulmonary transplantation is the final treatment option for people with end-stage respiratory diseases. Evidence suggests that exercise training may contribute to speeding up physical recovery in adults undergoing lung transplantation, helping to minimize or resolve impairments due to physical inactivity in both the pre- and post-transplant stages. However, there is a lack of detailed guidelines on how exercise training should be carried out in this specific sub-population.
OBJECTIVES
To determine the benefits and safety of exercise training in adult patients who have undergone lung transplantation, measuring the maximal and functional exercise capacity; health-related quality of life; adverse events; patient readmission; pulmonary function; muscular strength; pathological bone fractures; return to normal activities and death.
SEARCH METHODS
We searched the Cochrane Kidney and Transplant Specialised Register up to 6 October 2020 using relevant search terms for this review. Studies in the CKTR are identified through CENTRAL, MEDLINE, and EMBASE searches, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.
SELECTION CRITERIA
Randomised controlled trials (RCTs) were included comparing exercise training with usual care or no exercise training, or with another exercise training program in terms of dosage, modality, program length, or use of supporting exercise devices. The study population comprised of participants older than 18 years who underwent lung transplantation independent of their underlying respiratory pathology.
DATA COLLECTION AND ANALYSIS
Two authors independently reviewed all records identified by the search strategy and selected studies that met the eligibility criteria for inclusion in this review. In the first instance, the disagreements were resolved by consensus, and if this was not possible the decision was taken by a third reviewer. The same reviewers independently extracted outcome data from included studies and assessed risk of bias. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
MAIN RESULTS
Eight RCTs (438 participants) were included in this review. The median sample size was 60 participants with a range from 16 to 83 participants. The mean age of participants was 54.9 years and 51.9% of the participants were male. The median duration of the exercise training programs for the groups undergoing the intervention was 13 weeks, and the median duration of training in the active control groups was four weeks. Overall the risk of bias was considered to be high, mainly due to the inability to blind the study participants and the selective reporting of the results. Due to small number of studies included in this review, and the heterogeneity of the intervention and outcomes, we did not obtain a summary estimate of the results. Two studies comparing resistance exercise training with no exercise reported increases in muscle strength and bone mineral density (surrogate outcomes for pathological bone fractures) with exercise training (P > 0.05), but no differences in adverse events. Exercise capacity, health-related quality of life (HRQoL), pulmonary function, and death (any cause) were not reported. Three studies compared two different resistant training programs. Two studies comparing squats using a vibration platform (WBVT) compared to squats on the floor reported an improvement in 6-minute walk test (6MWT) (28.4 metres, 95% CI 3 to 53.7; P = 0.029; and 28.3 metres, 95% CI 10.0 to 46.6; P < 0.05) with the WBVT. Supervised upper limb exercise (SULP) program improved 6MWT at 6 months compared to no supervised upper limb exercise (NULP) (SULP group: 561.2 ± 83.6 metres; NULP group: 503.5 ± 115.2 metres; P = 0.01). There were no differences in HRQoL, adverse events, muscular strength, or death (any cause). Pulmonary function and pathological bone fractures were not reported. Two studies comparing multimodal exercise training with no exercise reported improvement in 6MWT at 3 months (P = 0.008) and at 12-months post-transplant (P = 0.002) and muscular strength (quadriceps force (P = 0.001); maximum leg press (P = 0.047)) with multimodal exercise, but no improvement in HRQoL, adverse events, pulmonary function, pathological bone fractures (lumbar T-score), or death (any cause). One study comparing the same multimodal exercise programs given over 7 and 14 weeks reported no differences in 6MWT, HRQoL, adverse events, pulmonary function, muscle strength, or death (any cause). Pathological bone fractures were not reported. According to GRADE criteria, we rated the certainty of the evidence as very low, mainly due to the high risk of bias and serious imprecision.
AUTHORS' CONCLUSIONS
In adults undergoing lung transplantation the evidence about the effects of exercise training is very uncertain in terms of maximal and functional exercise capacity, HRQoL and safety, due to very imprecise estimates of effects and high risk of bias.
Topics: Bias; Bone Density; Cause of Death; Exercise; Exercise Tolerance; Female; Forced Expiratory Volume; Humans; Lung Transplantation; Male; Middle Aged; Muscle Strength; Program Evaluation; Quality of Life; Randomized Controlled Trials as Topic; Resistance Training; Time Factors; Transplant Recipients; Walk Test
PubMed: 34282853
DOI: 10.1002/14651858.CD012307.pub2 -
The Cochrane Database of Systematic... Jun 2023Chronic venous insufficiency (CVI) is a condition related to chronic venous disease that may progress to venous leg ulceration and impair quality of life of those... (Review)
Review
BACKGROUND
Chronic venous insufficiency (CVI) is a condition related to chronic venous disease that may progress to venous leg ulceration and impair quality of life of those affected. Treatments such as physical exercise may be useful to reduce CVI symptoms. This is an update of an earlier Cochrane Review.
OBJECTIVES
To evaluate the benefits and harms of physical exercise programmes for the treatment of individuals with non-ulcerated CVI.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 28 March 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing exercise programmes with no exercise in people with non-ulcerated CVI.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were intensity of disease signs and symptoms, ejection fraction, venous refilling time, and incidence of venous leg ulcer. Our secondary outcomes were quality of life, exercise capacity, muscle strength, incidence of surgical intervention, and ankle joint mobility. We used GRADE to assess the certainty of the evidence for each outcome.
MAIN RESULTS
We included five RCTs involving 146 participants. The studies compared a physical exercise group with a control group that did not perform a structured exercise programme. The exercise protocols differed between studies. We assessed three studies to be at an overall unclear risk of bias, one study at overall high risk of bias, and one study at overall low risk of bias. We were not able to combine data in meta-analysis as studies did not report all outcomes, and different methods were used to measure and report outcomes. Two studies reported intensity of CVI disease signs and symptoms using a validated scale. There was no clear difference in signs and symptoms between groups in baseline to six months after treatment (Venous Clinical Severity Score mean difference (MD) -0.38, 95% confidence interval (CI) -3.02 to 2.26; 28 participants, 1 study; very low-certainty evidence), and we are uncertain if exercise alters the intensity of signs and symptoms eight weeks after treatment (MD -4.07, 95% CI -6.53 to -1.61; 21 participants, 1 study; very low-certainty evidence). There was no clear difference in ejection fraction between groups from baseline to six months follow-up (MD 4.88, 95% CI -1.82 to 11.58; 28 participants, 1 study; very low-certainty evidence). Three studies reported on venous refilling time. We are uncertain if there is an improvement in venous refilling time between groups for baseline to six-month changes (MD 10.70 seconds, 95% CI 8.86 to 12.54; 23 participants, 1 study; very low-certainty evidence) or baseline to eight-week change (MD 9.15 seconds, 95% CI 5.53 to 12.77 for right side; MD 7.25 seconds, 95% CI 5.23 to 9.27 for left side; 21 participants, 1 study; very low-certainty evidence). There was no clear difference in venous refilling index for baseline to six-month changes (MD 0.57 mL/min, 95% CI -0.96 to 2.10; 28 participants, 1 study; very low-certainty evidence). No included studies reported the incidence of venous leg ulcers. One study reported health-related quality of life using validated instruments (Venous Insufficiency Epidemiological and Economic Study (VEINES) and 36-item Short Form Health Survey (SF-36), physical component score (PCS) and mental component score (MCS)). We are uncertain if exercise alters baseline to six-month changes in health-related quality of life between groups (VEINES-QOL: MD 4.60, 95% CI 0.78 to 8.42; SF-36 PCS: MD 5.40, 95% CI 0.63 to 10.17; SF-36 MCS: MD 0.40, 95% CI -3.85 to 4.65; 40 participants, 1 study; all very low-certainty evidence). Another study used the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20), and we are uncertain if exercise alters baseline to eight-week changes in health-related quality of life between groups (MD 39.36, 95% CI 30.18 to 48.54; 21 participants, 1 study; very low-certainty evidence). One study reported no differences between groups without presenting data. There was no clear difference between groups in exercise capacity measured as time on treadmill (baseline to six-month changes) (MD -0.53 minutes, 95% CI -5.25 to 4.19; 35 participants, 1 study; very low-certainty evidence). We are uncertain if exercise improves exercise capacity as assessed by the 6-minute walking test (MD 77.74 metres, 95% CI 58.93 to 96.55; 21 participants, 1 study; very low-certainty evidence). Muscle strength was measured using dynamometry or using heel lifts counts. We are uncertain if exercise increases peak torque/body weight (120 revolutions per minute) (changes from baseline to six months MD 3.10 ft-lb, 95% CI 0.98 to 5.22; 29 participants, 1 study; very low-certainty evidence). There was no clear difference between groups in baseline to eight-week change in strength measured by a hand dynamometer (MD 12.24 lb, 95% CI -7.61 to 32.09 for the right side; MD 11.25, 95% CI -14.10 to 36.60 for the left side; 21 participants, 1 study; very low-certainty evidence). We are uncertain if there is an increase in heel lifts (n) (baseline to six-month changes) between groups (MD 7.70, 95% CI 0.94 to 14.46; 39 participants, 1 study; very low-certainty evidence). There was no clear difference between groups in ankle mobility measured during dynamometry (baseline to six-month change MD -1.40 degrees, 95% CI -4.77 to 1.97; 29 participants, 1 study; very low-certainty evidence). We are uncertain if exercise increases plantar flexion measured by a goniometer (baseline to eight-week change MD 12.13 degrees, 95% CI 8.28 to 15.98 for right leg; MD 10.95 degrees, 95% CI 7.93 to 13.97 for left leg; 21 participants, 1 study; very low-certainty evidence). In all cases, we downgraded the certainty of evidence due to risk of bias and imprecision.
AUTHORS' CONCLUSIONS
There is currently insufficient evidence to assess the benefits and harms of physical exercise in people with chronic venous disease. Future research into the effect of physical exercise should consider types of exercise protocols (intensity, frequency, and time), sample size, blinding, and homogeneity according to the severity of disease.
Topics: Humans; Body Weight; Evidence Gaps; Exercise; Veins; Venous Insufficiency
PubMed: 37314059
DOI: 10.1002/14651858.CD010637.pub3 -
Therapeutic Advances in Respiratory... 2019Dual bronchodilation with a long-acting muscarinic antagonist (LAMA)/long-acting β-agonist (LABA) fixed-dose combination (FDC) is an established treatment strategy for... (Comparative Study)
Comparative Study Meta-Analysis
Systematic review and network meta-analysis of the efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler in comparison with other long-acting muscarinic antagonist/long-acting β-agonist fixed-dose combinations in COPD.
BACKGROUND
Dual bronchodilation with a long-acting muscarinic antagonist (LAMA)/long-acting β-agonist (LABA) fixed-dose combination (FDC) is an established treatment strategy for chronic obstructive pulmonary disease (COPD). The relative efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI 18/9.6 μg) in patients with moderate-to-very severe COPD, compared with other licensed LAMA/LABA FDCs, was investigated using an integrated Bayesian network meta-analysis (NMA).
METHODS
A systematic literature review and subsequent screening process identified randomized controlled trials of ⩾10 weeks' duration that enrolled patients aged ⩾40 years with moderate-to-very severe COPD and included at least one LAMA/LABA FDC or open LAMA + LABA treatment arm. NMAs were conducted for outcomes including change from baseline in forced expiratory volume in 1 s (FEV), St George's Respiratory Questionnaire (SGRQ), and transition dyspnea index (TDI) parameters, annualized rate of exacerbations, use of rescue medication, adverse events, and all-cause withdrawals. Meta-regression and sensitivity analyses accounted for heterogeneity across studies.
RESULTS
In total, 29 studies including 34,617 patients contributed to the NMA for efficacy or safety outcomes at week 24 or exacerbations. For all LAMA/LABA FDCs with data available, significantly greater improvements in FEV [trough, peak, and area under the curve (AUC)], SGRQ total score and TDI focal score at week 24, and annualized rate of moderate-to-severe exacerbations, were observed placebo. Where indirect comparisons were possible, differences between GFF MDI and other LAMA/LABA FDCs were small relative to established margins of clinical relevance, and not statistically significant. The safety and tolerability profile of GFF MDI was consistent with other LAMA/LABA FDCs and placebo. The results of the meta-regression were generally similar to the base case.
CONCLUSIONS
GFF MDI demonstrated comparable efficacy and safety outcomes to other LAMA/LABA FDCs. Personalization of treatment choice within the class on the basis of other factors such as patient preference may be appropriate.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Drug Combinations; Formoterol Fumarate; Glycopyrrolate; Humans; Metered Dose Inhalers; Muscarinic Antagonists; Network Meta-Analysis; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic
PubMed: 31868101
DOI: 10.1177/1753466619894502 -
The Cochrane Database of Systematic... Oct 2016Serum monoclonal anti-myelin-associated glycoprotein (anti-MAG) antibodies may be pathogenic in some people with immunoglobulin M (IgM) paraprotein and demyelinating... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Serum monoclonal anti-myelin-associated glycoprotein (anti-MAG) antibodies may be pathogenic in some people with immunoglobulin M (IgM) paraprotein and demyelinating neuropathy. Immunotherapies aimed at reducing the level of these antibodies might be expected to be beneficial. This is an update of a review first published in 2003 and previously updated in 2006 and 2012.
OBJECTIVES
To assess the effects of immunotherapy for IgM anti-MAG paraprotein-associated demyelinating peripheral neuropathy.
SEARCH METHODS
On 1 February 2016 we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase for randomised controlled trials (RCTs). We also checked trials registers and bibliographies, and contacted authors and experts in the field.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) or quasi-RCTs involving participants of any age treated with any type of immunotherapy for anti-MAG antibody-associated demyelinating peripheral neuropathy with monoclonal gammopathy of undetermined significance and of any severity.Our primary outcome measures were numbers of participants improved in disability assessed with either or both of the Neuropathy Impairment Scale (NIS) or the modified Rankin Scale (mRS) at six months after randomisation. Secondary outcome measures were: mean improvement in disability, assessed with either the NIS or the mRS, 12 months after randomisation; change in impairment as measured by improvement in the 10-metre walk time, change in a validated linear disability measure such as the Rasch-built Overall Disability Scale (R-ODS) at six and 12 months after randomisation, change in subjective clinical scores and electrophysiological parameters at six and 12 months after randomisation; change in serum IgM paraprotein concentration or anti-MAG antibody titre at six months after randomisation; and adverse effects of treatments.
DATA COLLECTION AND ANALYSIS
We followed standard methodological procedures expected by Cochrane.
MAIN RESULTS
We identified eight eligible trials (236 participants), which tested intravenous immunoglobulin (IVIg), interferon alfa-2a, plasma exchange, cyclophosphamide and steroids, and rituximab. Two trials of IVIg (22 and 11 participants, including 20 with antibodies against MAG), had comparable interventions and outcomes, but both were short-term trials. We also included two trials of rituximab with comparable interventions and outcomes.There were very few clinical or statistically significant benefits of the treatments used on the outcomes predefined for this review, but not all the predefined outcomes were used in every included trial and more responsive outcomes are being developed. A well-performed trial of IVIg, which was at low risk of bias, showed a statistical benefit in terms of improvement in mRS at two weeks and 10-metre walk time at four weeks, but these short-term outcomes are of questionable clinical significance. Cyclophosphamide failed to show any benefit in the single trial's primary outcome, and showed a barely significant benefit in the primary outcome specified here, but some toxic adverse events were identified.Two trials of rituximab (80 participants) have been published, one of which (26 participants) was at high risk of bias. In the meta-analysis, although the data are of low quality, rituximab is beneficial in improving disability scales (Inflammatory Neuropathy Cause and Treatment (INCAT) improved at eight to 12 months (risk ratio (RR) 3.51, 95% confidence interval (CI) 1.30 to 9.45; 73 participants)) and significantly more participants improve in the global impression of change score (RR 1.86, 95% CI 1.27 to 2.71; 70 participants). Other measures did not improve significantly, but wide CIs do not preclude some effect. Reported adverse effects of rituximab were few, and mostly minor.There were few serious adverse events in the other trials.
AUTHORS' CONCLUSIONS
There is inadequate reliable evidence from trials of immunotherapies in anti-MAG paraproteinaemic neuropathy to form an evidence base supporting any particular immunotherapy treatment. IVIg has a statistically but probably not clinically significant benefit in the short term. The meta-analysis of two trials of rituximab provides, however, low-quality evidence of a benefit from this agent. The conclusions of this meta-analysis await confirmation, as one of the two included studies is of very low quality. We require large well-designed randomised trials of at least 12 months' duration to assess existing or novel therapies, preferably employing unified, consistent, well-designed, responsive, and valid outcome measures.
Topics: Demyelinating Diseases; Humans; Immunoglobulin M; Immunoglobulins, Intravenous; Immunosuppressive Agents; Immunotherapy; Myelin-Associated Glycoprotein; Paraproteinemias; Paraproteins; Peripheral Nervous System Diseases; Plasma Exchange; Randomized Controlled Trials as Topic; Rituximab
PubMed: 27701752
DOI: 10.1002/14651858.CD002827.pub4 -
Journal of Thoracic Disease Dec 2020Indigenous peoples in Australia, New Zealand, Canada, and the United States of America (USA) have a higher burden of chronic lung disease than non-Indigenous people.... (Review)
Review
Indigenous peoples in Australia, New Zealand, Canada, and the United States of America (USA) have a higher burden of chronic lung disease than non-Indigenous people. Exercised-based interventions, such as pulmonary rehabilitation, are highly effective to manage chronic lung disease. The outcomes of these interventions for Indigenous people require evaluation. The aim of this review was to critically appraise the literature on the impact of exercise-based interventions on quality of life, exercise capacity and health care utilisation in Indigenous adults with chronic lung disease in Australia, New Zealand, Canada, and USA. The Cochrane Library, Medline, Embase, CINAHL, Scopus, Psychinfo, APAIS-Aboriginal Health and PEDro databases were searched for peer-reviewed and grey literature that evaluated exercise-based interventions, such as pulmonary rehabilitation for Indigenous adults with chronic lung disease in Australia, New Zealand, Canada, and USA. Two authors independently screened and reviewed titles and abstract and full texts of potentially eligible studies for inclusion. An Indigenous decolonisation methodological framework was also applied to evaluate Indigenous governance, involvement, and engagement in the studies. A total of 3,598 records were screened, nine full papers were reviewed, and one was study included, which was a cardiopulmonary rehabilitation program for Indigenous people in Australia. Participants with chronic respiratory or heart disease significantly improved functional exercise capacity and quality of life [six-minute walk distance mean change (95% CI) 79 metres (47 to 111); Chronic Respiratory Questionnaire Dyspnoea 0.9 points (0.2 to 1.5)]. Several items of the decolonisation framework were addressed. Only one study was able to be included in the review, highlighting the paucity of research about culturally safe exercise-based interventions for Indigenous adults with chronic lung disease. There is a need for further research with strong Indigenous governance, involvement, and engagement.
PubMed: 33447432
DOI: 10.21037/jtd-20-1904 -
The Cochrane Database of Systematic... Aug 2016Pulmonary hypertension is a condition of complex aetiology that culminates in right heart failure and early death. Soluble guanylate cyclase (sGC) stimulators are a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pulmonary hypertension is a condition of complex aetiology that culminates in right heart failure and early death. Soluble guanylate cyclase (sGC) stimulators are a promising class of agents that have recently gained approval for use.
OBJECTIVES
To evaluate the efficacy of sGC stimulators in pulmonary hypertension.
SEARCH METHODS
We searched CENTRAL (Cochrane Central Register of Controlled Trials), MEDLINE, EMBASE and the reference lists of articles. Searches are current as of 12 February 2016.
SELECTION CRITERIA
We selected randomised controlled trials (RCTs) involving participants with pulmonary hypertension of all ages, severities and durations of treatment.
DATA COLLECTION AND ANALYSIS
AW, MS and RW independently selected studies, assessed evidence quality and extracted data. This process was overseen by RT and SG. All included studies were sponsored by the drug manufacturer.
MAIN RESULTS
Five trials involving 962 participants are included in this review. All trials were of relatively short duration (< 16 weeks). Due to the heterogenous aetiology of pulmonary hypertension in participants, results are best considered according to each pulmonary hypertension subtype.Pooled analysis shows a mean difference (MD) increase in six-minute walking distance (6MWD) of 30.13 metres (95% CI 5.29 to 54.96; participants = 659; studies = 3). On subgroup analysis, for pulmonary arterial hypertension (PAH) there was no effect noted (6MWD; MD 11.91 metres, 95% CI -44.92 to 68.75; participants = 398; studies = 2), and in chronic thromboembolic pulmonary hypertension (CTEPH) sGC stimulators improved 6MWD by an MD of 45 metres (95% CI 23.87 to 66.13; participants = 261; studies = 1). Data for left heart disease-associated PH was not available for pooling. Importantly, when participants receiving phosphodiesterase inhibitors were excluded, sGC stimulators increased 6MWD by a MD of 36 metres in PAH. The second primary outcome, mortality, showed no change on pooled analysis against placebo (Peto odds ratio (OR) 0.57, 95% CI 0.18 to 1.80).Pooled secondary outcomes include an increase in World Health Organization (WHO) functional class (OR 1.53, 95% CI 0.87 to 2.72; participants = 858; studies = 4), no effect on clinical worsening (OR 0.45, 95% CI 0.17 to 1.14; participants = 842; studies = 3), and a reduction in mean pulmonary artery pressure (MD -2.77 mmHg, 95% CI -4.96 to -0.58; participants = 744; studies = 5). There was no significant difference in serious adverse events on pooled analysis (OR 1.12, 95% CI 0.66 to 1.90; participants = 818; studies = 5) or when analysed at PAH (MD -3.50, 95% CI -5.54 to -1.46; participants = 344; studies = 1), left heart disease associated subgroups (OR 1.56, 95% CI 0.78 to 3.13; participants = 159; studies = 2) or CTEPH subgroups (OR 1.29, 95% CI 0.65 to 2.56; participants = 261; studies = 1).It is important to consider the results for PAH in the context of a person who is not also receiving a phosphodiesterase-V inhibitor, a contra-indication to sGC stimulator use. It should also be noted that CTEPH results are applicable to inoperable or recurrent CTEPH only.Evidence was rated according to the GRADE scoring system. One outcome was considered high quality, two were moderate, and eight were of low or very low quality, meaning that for many of the outcomes the true effect could differ substantially from our estimate. There were only minor concerns regarding the risk of bias in these trials, all being RCTs largely following the original protocol. Most trials employed an intention-to-treat analysis.
AUTHORS' CONCLUSIONS
sGC stimulators improve pulmonary artery pressures in people with PAH (who are treatment naive or receiving a prostanoid or endothelin antagonist) or those with recurrent or inoperable CTEPH. In these settings this can be achieved without notable complication. However, sGC stimulators should not be taken by people also receiving phosphodiestase-V inhibitors or nitrates due to the risks of hypotension, and there is currently no evidence supporting their use in pulmonary hypertension associated with left heart disease. There is no evidence supporting their use in children. These conclusions are based on data with limitations, including unavailable data from two of the trials.
Topics: Adult; Female; Guanylate Cyclase; Humans; Hypertension, Pulmonary; Male; Pyrazoles; Pyrimidines; Randomized Controlled Trials as Topic; Time Factors; Walking
PubMed: 27482837
DOI: 10.1002/14651858.CD011205.pub2 -
Frontiers in Cardiovascular Medicine 2021Exercise-based, multimodal rehabilitation programming similar to that used in the existing models of cardiac or pulmonary rehabilitation or prehabilitation is a holistic...
Evaluation of the Structure and Health Impacts of Exercise-Based Cardiac and Pulmonary Rehabilitation and Prehabilitation for Individuals With Cancer: A Systematic Review and Meta-Analysis.
Exercise-based, multimodal rehabilitation programming similar to that used in the existing models of cardiac or pulmonary rehabilitation or prehabilitation is a holistic potential solution to address the range of physical, psychological, and existential (e.g., as their diagnosis relates to potential death) stressors associated with a cancer diagnosis and subsequent treatment. The purpose of this study was to systematically evaluate the structure and format of any type of exercise-based, multimodal rehabilitation programs used in individuals with cancer and the evidence base for their real-world effectiveness on metrics of physical (e.g., cardiorespiratory fitness, blood pressure) and psychological (e.g., health-related quality of life) health. Very few of the 33 included exercise-based, multimodal rehabilitation programs employed intervention components, education topics, and program support staff that were multi-disciplinary or cancer-specific. In particular, a greater emphasis on nutrition care, and the evaluation and management of psychosocial distress and CVD risk factors, with cancer-specific adaptations, would broaden and maximize the holistic health benefits of exercise-based rehabilitation. Despite these opportunities for improvement, exercise-based, multimodal rehabilitation programs utilized under real-world settings in individuals with cancer produced clinically meaningful and large effect sizes for cardiorespiratory fitness (VOpeak, ±2.9 mL/kg/min, 95% CI = 2.6 to 3.3) and 6-minute walk distance (+47 meters, 95% CI = 23 to 71), and medium effect sizes for various measures of cancer-specific, health-related quality of life. However, there were no changes to blood pressure, body mass index, or lung function. Overall, these findings suggest that exercise-based, multimodal rehabilitation is a real-world therapy that improves physical and psychological health among individuals with cancer, but the holistic health benefits of this intervention would likely be enhanced by addressing nutrition, psychosocial concerns, and risk factor management through education and counselling with consideration of the needs of an individual with cancer.
PubMed: 34631836
DOI: 10.3389/fcvm.2021.739473