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The Cochrane Database of Systematic... Nov 2022Hereditary angioedema (HAE) is a serious and potentially life-threatening condition that causes acute attacks of swelling, pain and reduced quality of life. People with... (Review)
Review
BACKGROUND
Hereditary angioedema (HAE) is a serious and potentially life-threatening condition that causes acute attacks of swelling, pain and reduced quality of life. People with Type I HAE (approximately 80% of all HAE cases) have insufficient amounts of C1 esterase inhibitor (C1-INH) protein; people with Type II HAE (approximately 20% of all cases) may have normal C1-INH concentrations, but, due to genetic mutations, these do not function properly. A few people, predominantly females, experience HAE despite having normal C1-INH levels and C1-INH function (rare Type III HAE). Several new drugs have been developed to treat acute attacks and prevent recurrence of attacks. There is currently no systematic review and meta-analysis that included all preventive medications for HAE.
OBJECTIVES
To assess the benefits and harms of interventions for the long-term prevention of HAE attacks in people with Type I, Type II or Type III HAE.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search date was 3 August 2021.
SELECTION CRITERIA
We included randomised controlled trials in children or adults with HAE that used medications to prevent HAE attacks. The comparators could be placebo or active comparator, or both; approved and experimental drug trials were eligible for inclusion. There were no restrictions on dose, frequency or intensity of treatment. The minimum length of four weeks of treatment was required for inclusion; this criterion excluded the acute treatment of HAE attacks.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were 1. HAE attacks (number of attacks per person, per population) and change in number of HAE attacks; 2. mortality and 3. serious adverse events (e.g. hepatic dysfunction, hepatic toxicity and deleterious changes in blood tests). Our secondary outcomes were 4. quality of life; 5. severity of breakthrough attacks; 6. disability and 7. adverse events (e.g. weight gain, mild psychological changes and body hair). We used GRADE to assess certainty of evidence for each outcome.
MAIN RESULTS
We identified 15 studies (912 participants) that met the inclusion criteria. The studies included people with Type I and II HAE. The studies investigated avoralstat, berotralstat, subcutaneous C1-INH, plasma-derived C1-INH, nanofiltered C1-INH, recombinant human C1-INH, danazol, and lanadelumab for the prevention of HAE attacks. We did not find any studies on the use of tranexamic acid for prevention of HAE attacks. All drugs except avoralstat reduced the number of HAE attacks compared with placebo. For breakthrough attacks that occurred despite prophylactic treatment, intravenous and subcutaneous forms of C1-INH and lanadelumab reduced attack severity. It is not known whether other drugs have a similar effect, as the severity of breakthrough attacks in people taking drugs other than C1-INH and lanadelumab was not reported. For quality of life, avoralstat, berotralstat, C1-INH (all forms) and lanadelumab increased quality of life compared with placebo; there were no data for danazol. Four studies reported on changes in disability during treatment with C1-INH, berotralstat and lanadelumab; all three drugs decreased disability compared with placebo. Adverse events, including serious adverse events, did not occur at a rate higher than placebo. However, serious adverse event data and other adverse event data were not available for danazol, which prevented us from drawing conclusions about the absolute or relative safety of this drug. No deaths were reported in the included studies. The analysis was limited by the small number of studies, the small number of participants in each study and the lack of data on older drugs, therefore the certainty of the evidence is low. Given the rarity of HAE, it is not surprising that drugs were rarely directly compared, which does not allow conclusions on the comparative efficacy of the various drugs for people with HAE. Finally, we did not identify any studies that included people with Type III HAE. Therefore, we cannot draw any conclusions about the efficacy or safety of any drug in people with this form of HAE.
AUTHORS' CONCLUSIONS
The available data suggest that berotralstat, C1-INH (subcutaneous, plasma-derived, nanofiltered and recombinant), danazol and lanadelumab are effective in lowering the risk or incidence (or both) of HAE attacks. In addition, C1-INH and lanadelumab decrease the severity of breakthrough attacks (data for other drugs were not available). Avoralstat, berotralstat, C1-INH (all forms) and lanadelumab increase quality of life and do not increase the risk of adverse events, including serious adverse events. It is possible that danazol, subcutaneous C1-INH and recombinant human C1-INH are more effective than berotralstat and lanadelumab in reducing the risk of breakthrough attacks, but the small number of studies and the small size of the studies means that the certainty of the evidence is low. This and the lack of head-to-head trials prevented us from drawing firm conclusions on the relative efficacy of the drugs.
Topics: Adult; Child; Female; Humans; Male; Angioedemas, Hereditary; Quality of Life; Danazol; Complement C1 Inhibitor Protein; Administration, Intravenous; Treatment Outcome
PubMed: 36326435
DOI: 10.1002/14651858.CD013403.pub2 -
Annals of the Rheumatic Diseases Jun 2020The past decades have seen rapid advances in the treatment of rheumatoid arthritis (RA). In particular, the introduction of biologic and targeted synthetic...
BACKGROUND
The past decades have seen rapid advances in the treatment of rheumatoid arthritis (RA). In particular, the introduction of biologic and targeted synthetic disease-modifying antirheumatic drugs have improved clinical outcomes and reconfigured traditional RA cost compositions.
OBJECTIVES
To map the existing evidence concerning cost of illness of RA, as the treatment pathway evolves in the biologic era, and examine how costs have been measured and estimated, in order to assemble and appropriately interpret available data.
METHODS
Systematic review of studies that estimated the costs of patients with RA. Multiple electronic databases were searched to identify studies published between 2000 and 2019. The reported total costs and cost components were evaluated according to the study and population characteristics. The Cochran-Armitage test was used to determine statistically significant trends in increasing or decreasing proportions over time.
RESULTS
Overall, 72 studies were included. Drug costs compromised the main component (up to 87%) of direct costs with an increasing trajectory over time, although not statistically significant. The proportion of costs for hospitalisation showed a statistically significant decrease chronologically (p=0.044). Indirect costs, primarily associated with absenteeism and work disability accounted for 39% to 86% of total costs. The reported indirect costs are highly sensitive to the approach to estimation.
CONCLUSIONS
A decreasing trend in inpatient costs chronologically suggested a cost shift in other components of direct costs. Indirect costs still contributed a considerable proportion of total costs, with work disability being the main cost component. Economic analyses that do not incorporate or appropriately measure indirect costs will underestimate the full economic impact of RA.
Topics: Absenteeism; Arthritis, Rheumatoid; Biological Products; Cost of Illness; Disabled Persons; Drug Costs; Employment; Health Care Costs; Humans
PubMed: 32245893
DOI: 10.1136/annrheumdis-2019-216243 -
Pain Apr 2022Yoga is frequently used for back pain relief. However, the evidence was judged to be of only low to moderate certainty. To assess the efficacy and safety of yoga in... (Meta-Analysis)
Meta-Analysis
Yoga is frequently used for back pain relief. However, the evidence was judged to be of only low to moderate certainty. To assess the efficacy and safety of yoga in patients with low back pain, a meta-analysis was performed. Therefore, MEDLINE/PubMed, Scopus, and the Cochrane Library were searched to May 26, 2020. Only randomized controlled trials comparing Yoga with passive control (usual care or wait list), or an active comparator, for patients with low back pain and that assessed pain intensity or pain-related disability as a primary outcome were considered to be eligible. Two reviewers independently extracted data on study characteristics, outcome measures, and results at short-term and long-term follow-up. Risk of bias was assessed using the Cochrane risk of bias tool. Thirty articles on 27 individual studies (2702 participants in total) proved eligible for review. Compared with passive control, yoga was associated with short-term improvements in pain intensity (15 RCTs; mean difference [MD] = -0.74 points on a numeric rating scale; 95% confidence interval [CI] = -1.04 to -0.44; standardized mean difference [SMD] = -0.37 95% CI = -0.52 to -0.22), pain-related disability (15 RCTs; MD = -2.28; 95% CI = -3.30 to -1.26; SMD = -0.38 95% CI = -0.55 to -0.21), mental health (7 RCTs; MD = 1.70; 95% CI = 0.20-3.20; SMD = 0.17 95% CI = 0.02-0.32), and physical functioning (9 RCTs; MD = 2.80; 95% CI = 1.00-4.70; SMD = 0.28 95% CI = 0.10-0.47). Except for mental health, all effects were sustained long-term. Compared with an active comparator, yoga was not associated with any significant differences in short-term or long-term outcomes.
Topics: Disabled Persons; Humans; Low Back Pain; Pain Measurement; Quality of Life; Yoga
PubMed: 34326296
DOI: 10.1097/j.pain.0000000000002416 -
Brain, Behavior, and Immunity Oct 2020During the COVID-19 pandemic general medical complications have received the most attention, whereas only few studies address the potential direct effect on mental...
BACKGROUND
During the COVID-19 pandemic general medical complications have received the most attention, whereas only few studies address the potential direct effect on mental health of SARS-CoV-2 and the neurotropic potential. Furthermore, the indirect effects of the pandemic on general mental health are of increasing concern, particularly since the SARS-CoV-1 epidemic (2002-2003) was associated with psychiatric complications.
METHODS
We systematically searched the database Pubmed including studies measuring psychiatric symptoms or morbidities associated with COVID-19 among infected patients and among none infected groups the latter divided in psychiatric patients, health care workers and non-health care workers.
RESULTS
A total of 43 studies were included. Out of these, only two studies evaluated patients with confirmed COVID-19 infection, whereas 41 evaluated the indirect effect of the pandemic (2 on patients with preexisting psychiatric disorders, 20 on medical health care workers, and 19 on the general public). 18 of the studies were case-control studies/compared to norm, while 25 of the studies had no control groups. The two studies investigating COVID-19 patients found a high level of post-traumatic stress symptoms (PTSS) (96.2%) and significantly higher level of depressive symptoms (p = 0.016). Patients with preexisting psychiatric disorders reported worsening of psychiatric symptoms. Studies investigating health care workers found increased depression/depressive symptoms, anxiety, psychological distress and poor sleep quality. Studies of the general public revealed lower psychological well-being and higher scores of anxiety and depression compared to before COVID-19, while no difference when comparing these symptoms in the initial phase of the outbreak to four weeks later. A variety of factors were associated with higher risk of psychiatric symptoms and/or low psychological well-being including female gender, poor-self-related health and relatives with COVID-19.
CONCLUSION
Research evaluating the direct neuropsychiatric consequences and the indirect effects on mental health is highly needed to improve treatment, mental health care planning and for preventive measures during potential subsequent pandemics.
Topics: Anxiety; Betacoronavirus; COVID-19; Coronavirus Infections; Depression; Disease Progression; Health Personnel; Humans; Mental Disorders; Mental Health; Mentally Ill Persons; Pandemics; Pneumonia, Viral; Psychological Distress; SARS-CoV-2; Stress Disorders, Post-Traumatic
PubMed: 32485289
DOI: 10.1016/j.bbi.2020.05.048 -
Chiropractic & Manual Therapies 2019Headache is the most common neurological symptoms worldwide, as over 90% of people have noted at least one headache during their lifetime. Tension-type headaches,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Headache is the most common neurological symptoms worldwide, as over 90% of people have noted at least one headache during their lifetime. Tension-type headaches, cervicogenic headaches, and migraines are common types of headache which can have a significant impact on social, physical, and occupational functioning. Therapeutic management of headaches mainly includes physical therapy and pharmacological interventions. Dry needling is a relatively new therapeutic approach that uses a thin filiform needle without injectate to penetrate the skin and stimulate underlying tissues for the management of neuromusculoskeletal pain and movement impairments.The main objective of this systematic review and meta-analysis is to evaluate the effectiveness of dry needling in comparison to other interventions on pain and disability in patients with tension-type headache, cervicogenic headache, and migraine.
METHODS/DESIGN
We will focus on clinical trials with concurrent control group(s) and comparative observational studies assessing the effect of dry needling in patients with tension-type headache, cervicogenic headache, and migraine. Electronic databases from relevant fields of research (PubMed/ Medline, Scopus, Embase®, PEDro, Web of Science, Ovid, AMED, CENTRAL, and Google Scholar) will be searched from inception to June 2019 using defined search terms. No restrictions for language of publication or geographic location will be applied. Moreover, grey literature, citation tracking, and reference lists scanning of the selected studies will be searched manually. Primary outcomes of this study are pain intensity and disability, and secondary outcomes are cervical spine ROM, frequency of headaches, health-related quality of life, and TrPs tenderness. Studies will be selected by three independent reviewers based on prespecified eligibility criteria. Three reviewers will independently extract data in each eligible study using a pre-piloted Microsoft Excel data extraction form. The assessment of risk of bias will be implemented using the Cochrane Back and Neck Review Group 13-item criteria and NOS. Direct meta-analysis will be performed using a fixed or random effects model to estimate effect size such as standardized mean difference (Morris's ) and 95% confidence intervals. Statistical heterogeneity will also be evaluated using the statistic and the χ test. All meta-analyses will be performed using Stata V.11 and V.14 softwares. The overall quality of the evidence for the primary outcomes will be assessed using GRADE.
DISCUSSION
All analyses in this study will be based on the previous published papers. Therefore, ethical approval and patient consent are not required. The findings of this study will provide important information on the value of dry needling for the management of tension-type headache, cervicogenic headache, and migraine.
TRIAL REGISTRATION
PROSPERO registration number: CRD42019124125.
Topics: Acupuncture Therapy; Adult; Disabled Persons; Dry Needling; Female; Humans; Male; Migraine Disorders; Post-Traumatic Headache; Randomized Controlled Trials as Topic; Research Design; Tension-Type Headache
PubMed: 31572570
DOI: 10.1186/s12998-019-0266-7 -
International Journal of Molecular... Oct 2022Dapsone (DDS), Rifampicin (RIF) and Ofloxacin (OFL) are drugs recommended by the World Health Organization (WHO) for the treatment of leprosy. In the context of leprosy,... (Meta-Analysis)
Meta-Analysis Review
Dapsone (DDS), Rifampicin (RIF) and Ofloxacin (OFL) are drugs recommended by the World Health Organization (WHO) for the treatment of leprosy. In the context of leprosy, resistance to these drugs occurs mainly due to mutations in the target genes (Folp1, RpoB and GyrA). It is important to monitor antimicrobial resistance in patients with leprosy. Therefore, we performed a meta-analysis of drug resistance in Mycobacterium leprae and the mutational profile of the target genes. In this paper, we limited the study period to May 2022 and searched PubMed, Web of Science (WOS), Scopus, and Embase databases for identified studies. Two independent reviewers extracted the study data. Mutation and drug-resistance rates were estimated in Stata 16.0. The results demonstrated that the drug-resistance rate was 10.18% (95% CI: 7.85-12.51). Subgroup analysis showed the highest resistance rate was in the Western Pacific region (17.05%, 95% CI:1.80 to 13.78), and it was higher after 2009 than before [(11.39%, 7.46-15.33) vs. 6.59% (3.66-9.53)]. We can conclude that the rate among new cases (7.25%, 95% CI: 4.65-9.84) was lower than the relapsed (14.26%, 95 CI%: 9.82-18.71). Mutation rates of Folp1, RpoB and GyrA were 4.40% (95% CI: 3.02-5.77), 3.66% (95% CI: 2.41-4.90) and 1.28% (95% CI: 0.87-1.71) respectively, while the rate for polygenes mutation was 1.73% (0.83-2.63). For further analysis, we used 368 drug-resistant strains as research subjects and found that codons (Ser, Pro, Ala) on RpoB, Folp1 and GyrA are the most common mutation sites in the determining region (DRDR). In addition, the most common substitution patterns of Folp1, RpoB, and GyrA are Pro→Leu, Ser→Leu, and Ala→Val. This study found that a higher proportion of patients has developed resistance to these drugs, and the rate has increased since 2009, which continue to pose a challenge to clinicians. In addition, the amino acid alterations in the sequence of the DRDR regions and the substitution patterns mentioned in the study also provide new ideas for clinical treatment options.
Topics: Humans; Rifampin; Dapsone; Leprostatic Agents; Ofloxacin; Drug Resistance, Bacterial; Mycobacterium leprae; Leprosy; Mutation; Amino Acids; Microbial Sensitivity Tests
PubMed: 36293307
DOI: 10.3390/ijms232012443 -
Issues in Mental Health Nursing Feb 2021One in four people in the world will be affected by mental illness in their lifetime, placing mental disorders as the leading cause of disability worldwide. This...
One in four people in the world will be affected by mental illness in their lifetime, placing mental disorders as the leading cause of disability worldwide. This qualitative systematic review was to explore perceived stigma and discrimination experienced by individuals seeking care for physical or mental health concerns. Specifically, it sought to uncover the level of perceived stigma and discrimination experienced by mentally ill patients seeking care for physical or mental health concerns. Seven databases were searched between January 1, 2007 to November 1, 2018. Selected studies met the following inclusion criteria: 1) English language and published within North America, Australia, or United Kingdom; 2) studies and articles that consider individuals with mental illness seeking help for either mental or physical conditions in the hospital setting except for within mental health wards; and 3) research in which the phenomenon of interest examined how stigma and discrimination influences the perception of nursing care received by the mentally ill patient and the perception of nurses who provide care to the mentally ill patient. Eight studies met the inclusion criteria. Studies reported that both patients and nurses perceive similar barriers to person-centered care resulting from stigma toward mental illness. This significantly compromised quality person-centered care, and negatively affected the nurse-client relationship. Results indicate the need for further research to determine how health care and educational institutions play a role in perpetuating stigma against mental illness through the prioritization of physical illness over mental illness.
Topics: Australia; Humans; Mental Disorders; Nursing Care; Social Stigma; United Kingdom
PubMed: 32762576
DOI: 10.1080/01612840.2020.1789788 -
BMJ Military Health Apr 2022Amputations result from trauma, war, conflict, vascular diseases and cancer. Phantom limb pain (PLP) is a potentially debilitating form of chronic pain affecting around... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Amputations result from trauma, war, conflict, vascular diseases and cancer. Phantom limb pain (PLP) is a potentially debilitating form of chronic pain affecting around 100 million amputees across the world. Mirror therapy and virtual reality (VR) are two commonly used treatments, and we evaluated their respective success rates.
METHODS
A meta-analysis and systematic review was undertaken to investigate mirror therapy and VR in their ability to reduce pain levels. A mean difference (MD) model to compare group pain levels pretreatment and post-treatment via aggregating these results from numerous similar studies was employed. Meta-analysis was conducted using RevMan (V.5.4) and expressed in MD for visual analogue scale (VAS) score.
RESULTS
A total of 15 studies met our search criteria; they consisted of eight mirror therapy with 214 participants and seven VR including 86 participants, totalling 300 participants. Mean age ranged from 36 to 63 years, 77% male, of which 61% were lower body amputees. Both led to a VAS reduction (mirror therapy mean reduction VAS score was 2.54, 95% CI 1.42 to 3.66; p<0.001; VR 2.24, 95% CI 1.28 to 3.20; p<0.001). There was no statistically significant difference in pain alleviation between mirror therapy and VR (p=0.69).
CONCLUSIONS
Mirror therapy and VR are both equally efficacious in alleviating PLP, but neither is more effective than the other. However, due to small sample size and limited number of studies, factors such as gender, cause of amputation, site of limb loss or length of time from amputation, which may influence treatment success, could not be explored.
Topics: Adult; Amputees; Female; Humans; Male; Middle Aged; Mirror Movement Therapy; Phantom Limb; Virtual Reality; Virtual Reality Exposure Therapy
PubMed: 35042760
DOI: 10.1136/bmjmilitary-2021-002018 -
The Lancet. Infectious Diseases Dec 2019Non-typhoidal salmonella invasive disease is a major cause of global morbidity and mortality. Malnourished children, those with recent malaria or sickle-cell anaemia,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Non-typhoidal salmonella invasive disease is a major cause of global morbidity and mortality. Malnourished children, those with recent malaria or sickle-cell anaemia, and adults with HIV infection are at particularly high risk of disease. We sought to estimate the burden of disease attributable to non-typhoidal salmonella invasive disease for the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2017.
METHODS
We did a systematic review of scientific databases and grey literature, and estimated non-typhoidal salmonella invasive disease incidence and mortality for the years 1990 to 2017, by age, sex, and geographical location using DisMod-MR, a Bayesian meta-regression tool. We estimated case fatality by age, HIV status, and sociodemographic development. We also calculated the HIV-attributable fraction and estimated health gap metrics, including disability-adjusted life-years (DALYs).
FINDINGS
We estimated that 535 000 (95% uncertainty interval 409 000-705 000) cases of non-typhoidal salmonella invasive disease occurred in 2017, with the highest incidence in sub-Saharan Africa (34·5 [26·6-45·0] cases per 100 000 person-years) and in children younger than 5 years (34·3 [23·2-54·7] cases per 100 000 person-years). 77 500 (46 400-123 000) deaths were estimated in 2017, of which 18 400 (12 000-27 700) were attributable to HIV. The remaining 59 100 (33 300-98 100) deaths not attributable to HIV accounted for 4·26 million (2·38-7·38) DALYs in 2017. Mean all-age case fatality was 14·5% (9·2-21·1), with higher estimates among children younger than 5 years (13·5% [8·4-19·8]) and elderly people (51·2% [30·2-72·9] among those aged ≥70 years), people with HIV infection (41·8% [30·0-54·0]), and in areas of low sociodemographic development (eg, 15·8% [10·0-22·9] in sub-Saharan Africa).
INTERPRETATION
We present the first global estimates of non-typhoidal salmonella invasive disease that have been produced as part of GBD 2017. Given the high disease burden, particularly in children, elderly people, and people with HIV infection, investigating the sources and transmission pathways of non-typhoidal salmonella invasive disease is crucial to implement effective preventive and control measures.
FUNDING
Bill & Melinda Gates Foundation.
Topics: Female; Geography, Medical; Global Burden of Disease; Humans; Incidence; Male; Prevalence; Risk Factors; Salmonella; Salmonella Infections; Socioeconomic Factors
PubMed: 31562022
DOI: 10.1016/S1473-3099(19)30418-9 -
Clinical Rehabilitation Dec 2021This systematic review and meta-analysis aimed to evaluate the effects of mirror therapy on phantom limb sensation and phantom limb pain in amputees. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This systematic review and meta-analysis aimed to evaluate the effects of mirror therapy on phantom limb sensation and phantom limb pain in amputees.
DATA SOURCES
Nine electronic databases (PubMed, EMBASE, MEDLINE, Web of Science, the Cochrane Library, CINAHL, PsycInfo, PreQuest, PEDro) were searched from their inception to May 10th, 2021.
METHODS
Two authors independently selected relevant studies and extracted the data. The effect sizes were calculated under a random-effects model meta-analysis, and heterogeneity was assessed using the test. The risk of bias was evaluated by the Cochrane risk of bias tool, and the methodological quality was appraised by the PEDro scale. The GRADE approach was applied to assess the confidence of the effect.
RESULTS
A total of 11 RCTs involving 491 participants were included in this review and nine RCTs involving 372 participants were included in meta-analysis. The quality of these studies was from poor to good with scores ranging from 2 to 8 points according to PEDro scale. The pooled SMD showed that mirror therapy reduced the pain with a large effect size (-0.81; 95% CI = -1.36 to -0.25; = 0.005; = 82%; = 372) compared with other methods (four covered mirror, one phantom exercise, three mental visualization, one sensorimotor exercise, one transcutaneous electrical nerve stimulation, one tactile stimuli). The quality of evidence for the outcome pain intensity was determined to be fair according to GRADE approach.
CONCLUSION
There is fair-quality evidence that MT is beneficial for reducing phantom limb pain.
Topics: Amputees; Humans; Phantom Limb; Randomized Controlled Trials as Topic; Sensation; Transcutaneous Electric Nerve Stimulation
PubMed: 34308686
DOI: 10.1177/02692155211027332