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The Cochrane Database of Systematic... Aug 2014Angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) are widely prescribed for primary hypertension (systolic blood... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) are widely prescribed for primary hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg). However, while ACE inhibitors have been shown to reduce mortality and morbidity in placebo-controlled trials, ARBs have not. Therefore, a comparison of the efficacies of these two drug classes in primary hypertension for preventing total mortality and cardiovascular events is important.
OBJECTIVES
To compare the effects of ACE inhibitors and ARBs on total mortality and cardiovascular events, and their rates of withdrawals due to adverse effects (WDAEs), in people with primary hypertension.
SEARCH METHODS
We searched the Cochrane Hypertension Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the World Health Organization (WHO) International Clinical Trials Registry Platform, and the ISI Web of Science up to July 2014. We contacted study authors for missing and unpublished information, and also searched the reference lists of relevant reviews for eligible studies.
SELECTION CRITERIA
We included randomized controlled trials enrolling people with uncontrolled or controlled primary hypertension with or without other risk factors. Included trials must have compared an ACE inhibitor and an ARB in a head-to-head manner, and lasted for a duration of at least one year. If background blood pressure lowering agents were continued or added during the study, the protocol to do so must have been the same in both study arms.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by The Cochrane Collaboration.
MAIN RESULTS
Nine studies with 11,007 participants were included. Of the included studies, five reported data on total mortality, three reported data on total cardiovascular events, and four reported data on cardiovascular mortality. No study separately reported cardiovascular morbidity. In contrast, eight studies contributed data on WDAE. Included studies were of good to moderate quality. There was no evidence of a difference between ACE inhibitors and ARBs for total mortality (risk ratio (RR) 0.98; 95% confidence interval (CI) 0.88 to 1.10), total cardiovascular events (RR 1.07; 95% CI 0.96 to 1.19), or cardiovascular mortality (RR 0.98; 95% CI 0.85 to 1.13). Conversely, a high level of evidence indicated a slightly lower incidence of WDAE for ARBs as compared with ACE inhibitors (RR 0.83; 95% CI 0.74 to 0.93; absolute risk reduction (ARR) 1.8%, number needed to treat for an additional beneficial outcome (NNTB) 55 over 4.1 years), mainly attributable to a higher incidence of dry cough with ACE inhibitors. The quality of the evidence for mortality and cardiovascular outcomes was limited by possible publication bias, in that several studies were initially eligible for inclusion in this review, but had no extractable data available for the hypertension subgroup. To this end, the evidence for total mortality was judged to be moderate, while the evidence for total cardiovascular events was judged to be low by the GRADE approach.
AUTHORS' CONCLUSIONS
Our analyses found no evidence of a difference in total mortality or cardiovascular outcomes for ARBs as compared with ACE inhibitors, while ARBs caused slightly fewer WDAEs than ACE inhibitors. Although ACE inhibitors have shown efficacy in these outcomes over placebo, our results cannot be used to extrapolate the same conclusion for ARBs directly, which have not been studied in placebo-controlled trials for hypertension. Thus, the substitution of an ARB for an ACE inhibitor, while supported by evidence on grounds of tolerability, must be made in consideration of the weaker evidence for the efficacy of ARBs regarding mortality and morbidity outcomes compared with ACE inhibitors. Additionally, our data mostly derives from participants with existing clinical sequelae of hypertension, and it would be useful to have data from asymptomatic people to increase the generalizability of this review. Unpublished subgroup data of hypertensive participants in existing trials comparing ACE inhibitors and ARBs needs to be made available for this purpose.
Topics: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Essential Hypertension; Heart Diseases; Humans; Hypertension; Hypotension; Randomized Controlled Trials as Topic; Stroke
PubMed: 25148386
DOI: 10.1002/14651858.CD009096.pub2 -
Journal of Ethnopharmacology Jun 2020Withania somnifera popularly known as Aswagandha or Indian Ginseng/Poison Gooseberry have thousands years of history of use in Indian traditional medicine. Besides,...
ETHNOPHARMACOLOGICAL RELEVANCE
Withania somnifera popularly known as Aswagandha or Indian Ginseng/Poison Gooseberry have thousands years of history of use in Indian traditional medicine. Besides, finding place root of the plant as Indian Ginseng, Ayurveda also uses root of this plant as general health tonic, adaptogenic, nootropic, immunomodulatory etc. With its widespread and growing use, it becomes prudent to scientifically evaluate and document both the efficacy and safety of this plant in humans.
AIM OF THE STUDY
Aswagnadha root is rapidly gaining popularity abroad for use as medicine. Current article attempts to primarily review the human efficacy and safety of Aswagandha generated through clinical trials.
METHODS
A systematic search both for indexed and non-indexed literature was made for W. somnifera using various search engines and databases and the details of research articles pertaining to all clinical trials/human studies, animal studies addressing safety issues of CNS, CVS, general toxicity, mutagenicity, genotoxicity, reproductive safety and herb-drug interactions were reviewed and compiled comprehensively from full texts.
RESULTS
A total of 69 (39 pre-clinical and 30 clinical) studies documenting efficacy and safety aspects were identified and the desired information of these studies is comprehensively presented in this review. Retrieved thirty(30) human studies demonstrated reasonable efficacy of root preparations in subclinical hypothyroidism (1), schizophrenia (3), chronic stress (2), insomnia (2), anxiety (1), memory and cognitive improvement (2), obsessive-compulsive disorder (1), rheumatoid arthritis (2), type-2 diabetes (2), male infertility (6), fertility promotion activity in females (1), adaptogenic (3), growth promoter in children (3) and chemotherapy adjuvant (1). Reasonable safety of root preparations of Aswagandha has been established by these retrieved 30 human trials. No serious adverse events or any changes in haematological, biochemical or vital parameters were reported in these human studies. Only mild and mainly transient type adverse events of somnolence, epigastric pain/discomfort and loose stools were reported as most common (>5%); and giddiness, drowsiness, hallucinogenic, vertigo, nasal congestion (rhinitis), cough, cold, decreased appetite, nausea, constipation, dry mouth, hyperactivity, nocturnal cramps, blurring of vision, hyperacidity, skin rash and weight gain were reported as less common adverse events. Pre-clinical chronic toxicity studies conducted up to 8 months also found root extracts to be safe. No mutagenicity or genotoxicity was reported for the root; only mild CNS depression and increase in thyroxine (T4) levels were reported with rootby some studies. Further, there was no in vitro and in vivo inhibition seen for CYP3A4 and CYP2D6, the two major hepatic drug metabolizing enzymes.
CONCLUSION
Root of the Ayurvedic drug W. somnifera (Aswagandha) appears a promising safe and effective traditional medicine for management of schizophrenia, chronic stress, insomnia, anxiety, memory/cognitive enhancement, obsessive-compulsive disorder, rheumatoid arthritis, type-2 diabetes and male infertility, and bears fertility promotion activity in females adaptogenic, growth promoter activity in children and as adjuvant for reduction of fatigue and improvement in quality of life among cancer patients undergoing chemotherapy. Properly designed, randomized-controlled, large-size, prospective trials with standardized preparations are needed to ascertain efficacy of Aswagandha root in previously studied and other new indications.
Topics: Herb-Drug Interactions; Humans; Patient Safety; Plant Extracts; Plant Roots; Risk Assessment; Risk Factors; Withania
PubMed: 32201301
DOI: 10.1016/j.jep.2020.112768 -
The Cochrane Database of Systematic... May 2023Cystic fibrosis (CF) is an inherited life-limiting disorder. Over time persistent infection and inflammation within the lungs contribute to severe airway damage and loss... (Review)
Review
BACKGROUND
Cystic fibrosis (CF) is an inherited life-limiting disorder. Over time persistent infection and inflammation within the lungs contribute to severe airway damage and loss of respiratory function. Chest physiotherapy, or airway clearance techniques (ACTs), are integral in removing airway secretions and initiated shortly after CF diagnosis. Conventional chest physiotherapy (CCPT) generally requires assistance, while alternative ACTs can be self-administered, facilitating independence and flexibility. This is an updated review.
OBJECTIVES
To evaluate the effectiveness (in terms of respiratory function, respiratory exacerbations, exercise capacity) and acceptability (in terms of individual preference, adherence, quality of life) of CCPT for people with CF compared to alternative ACTs.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search was 26 June 2022.
SELECTION CRITERIA
We included randomised or quasi-randomised controlled trials (including cross-over design) lasting at least seven days and comparing CCPT with alternative ACTs in people with CF.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were 1. pulmonary function tests and 2. number of respiratory exacerbations per year. Our secondary outcomes were 3. quality of life, 4. adherence to therapy, 5. cost-benefit analysis, 6. objective change in exercise capacity, 7. additional lung function tests, 8. ventilation scanning, 9. blood oxygen levels, 10. nutritional status, 11. mortality, 12. mucus transport rate and 13. mucus wet or dry weight. We reported outcomes as short-term (seven to 20 days), medium-term (more than 20 days to up to one year) and long-term (over one year).
MAIN RESULTS
We included 21 studies (778 participants) comprising seven short-term, eight medium-term and six long-term studies. Studies were conducted in the USA (10), Canada (five), Australia (two), the UK (two), Denmark (one) and Italy (one) with a median of 23 participants per study (range 13 to 166). Participant ages ranged from newborns to 45 years; most studies only recruited children and young people. Sixteen studies reported the sex of participants (375 males; 296 females). Most studies compared modifications of CCPT with a single comparator, but two studies compared three interventions and another compared four interventions. The interventions varied in the duration of treatments, times per day and periods of comparison making meta-analysis challenging. All evidence was very low certainty. Nineteen studies reported the primary outcomes forced expiratory volume in one second (FEV)and forced vital capacity (FVC), and found no difference in change from baseline in FEV % predicted or rate of decline between groups for either measure. Most studies suggested equivalence between CCPT and alternative ACTs, including positive expiratory pressure (PEP), extrapulmonary mechanical percussion, active cycle of breathing technique (ACBT), oscillating PEP devices (O-PEP), autogenic drainage (AD) and exercise. Where single studies suggested superiority of one ACT, these findings were not corroborated in similar studies; pooled data generally concluded that effects of CCPT were comparable to those of alternative ACTs. CCPT versus PEP We are uncertain whether CCPT improves lung function or has an impact on the number of respiratory exacerbations per year compared with PEP (both very low-certainty evidence). There were no analysable data for our secondary outcomes, but many studies provided favourable narrative reports on the independence achieved with PEP mask therapy. CCPT versus extrapulmonary mechanical percussion We are uncertain whether CCPT improves lung function compared with extrapulmonary mechanical percussions (very low-certainty evidence). The annual rate of decline in average forced expiratory flow between 25% and 75% of FVC (FEF) was greater with high-frequency chest compression compared to CCPT in medium- to long-term studies, but there was no difference in any other outcome. CCPT versus ACBT We are uncertain whether CCPT improves lung function compared to ACBT (very low-certainty evidence). Annual decline in FEF was worse in participants using the FET component of ACBT only (mean difference (MD) 6.00, 95% confidence interval (CI) 0.55 to 11.45; 1 study, 63 participants; very low-certainty evidence). One short-term study reported that directed coughing was as effective as CCPT for all lung function outcomes, but with no analysable data. One study found no difference in hospital admissions and days in hospital for exacerbations. CCPT versus O-PEP We are uncertain whether CCPT improves lung function compared to O-PEP devices (Flutter device and intrapulmonary percussive ventilation); however, only one study provided analysable data (very low-certainty evidence). No study reported data for number of exacerbations. There was no difference in results for number of days in hospital for an exacerbation, number of hospital admissions and number of days of intravenous antibiotics; this was also true for other secondary outcomes. CCPT versus AD We are uncertain whether CCPT improves lung function compared to AD (very low-certainty evidence). No studies reported the number of exacerbations per year; however, one study reported more hospital admissions for exacerbations in the CCPT group (MD 0.24, 95% CI 0.06 to 0.42; 33 participants). One study provided a narrative report of a preference for AD. CCPT versus exercise We are uncertain whether CCPT improves lung function compared to exercise (very low-certainty evidence). Analysis of original data from one study demonstrated a higher FEV % predicted (MD 7.05, 95% CI 3.15 to 10.95; P = 0.0004), FVC (MD 7.83, 95% CI 2.48 to 13.18; P = 0.004) and FEF (MD 7.05, 95% CI 3.15 to 10.95; P = 0.0004) in the CCPT group; however, the study reported no difference between groups (likely because the original analysis accounted for baseline differences).
AUTHORS' CONCLUSIONS
We are uncertain whether CCPT has a more positive impact on respiratory function, respiratory exacerbations, individual preference, adherence, quality of life, exercise capacity and other outcomes when compared to alternative ACTs as the certainty of the evidence is very low. There was no advantage in respiratory function of CCPT over alternative ACTs, but this may reflect insufficient evidence rather than real equivalence. Narrative reports indicated that participants prefer self-administered ACTs. This review is limited by a paucity of well-designed, adequately powered, long-term studies. This review cannot yet recommend any single ACT above others; physiotherapists and people with CF may wish to try different ACTs until they find an ACT that suits them best.
Topics: Adolescent; Child; Humans; Infant, Newborn; Middle Aged; Cystic Fibrosis; Drainage, Postural; Physical Therapy Modalities; Quality of Life; Respiratory Therapy
PubMed: 37144842
DOI: 10.1002/14651858.CD002011.pub3 -
Journal of Clinical Hypertension... Aug 2023Studies have shown that angiotensin converting enzyme inhibitors (ACEIs) are superior in primary and secondary prevention for cardiac mortality and morbidity to... (Meta-Analysis)
Meta-Analysis
Studies have shown that angiotensin converting enzyme inhibitors (ACEIs) are superior in primary and secondary prevention for cardiac mortality and morbidity to angiotensin receptor blocker (ARBs). One of the common side effects from ACEI is dry cough. The aims of this systematic review, and network meta-analysis are to rank the risk of cough induced by different ACEIs and between ACEI and placebo, ARB or calcium channel blockers (CCB). We performed a systematic review, and network meta-analysis of randomized controlled trials to rank the risk of cough induced by each ACEI and between ACEI and placebo, ARB or CCB. A total of 135 RCTs with 45,420 patients treated with eleven ACEIs were included in the analyses. The pooled estimated relative risk (RR) between ACEI and placebo was 2.21 (95% CI: 2.05-2.39). ACEI had more incidences of cough than ARB (RR 3.2; 95% CI: 2.91, 3.51), and pooled estimated of RR between ACEI and CCB was 5.30 (95% CI: 4.32-6.50) Moexipril ranked as number one for inducing cough (SUCRA 80.4%) and spirapril ranked the least (SUCRA 12.3%). The order for the rest of the ACEIs are as follows: ramipril (SUCRA 76.4%), fosinopril (SUCRA 72.5%), lisinopril (SUCRA 64.7%), benazepril (SUCRA 58.6%), quinapril (SUCRA 56.5%), perindopril (SUCRA 54.1%), enalapril (SUCRA 49.7%), trandolapril (SUCRA 44.6%) and, captopril (SUCRA 13.7%). All ACEI has the similar risk of developing a cough. ACEI should be avoided in patients who have risk of developing cough, and an ARB or CCB is an alternative based on the patient's comorbidity.
Topics: Humans; Antihypertensive Agents; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Network Meta-Analysis; Cough; Hypertension; Calcium Channel Blockers
PubMed: 37417783
DOI: 10.1111/jch.14695 -
European Review For Medical and... Jun 2022The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), also known as COVID-19, a viral outbreak that started in December 2019, eventually lead to a worldwide...
OBJECTIVE
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), also known as COVID-19, a viral outbreak that started in December 2019, eventually lead to a worldwide pandemic. COVID-19 usually presents with flu-like symptoms, such as headaches, dry cough, fever, fatigue, myalgia, shortness of breath, diarrhea and loss of smell or taste. However, it can also have major effects on the cardiovascular system. Based on the available relevant literature, we aimed to elaborate the possible mechanisms influencing cardiovascular damage, myocardial injury and thromboembolic disease process in particular.
MATERIALS AND METHODS
After considering our inclusion and exclusion criteria, the systematic review included 8 studies in total.
RESULTS
In general, underlying cardiovascular diseases were associated with poorer clinical outcomes. This may be due to immunological dysregulation. The disease outcomes were also positively correlated with the severity of the disease, especially with myocardial injury. Thus, cardiac biomarkers, such as Troponin T, CK-MB and myoglobin could be utilized in prediction algorithms for deciphering the clinical outcome in COVID-19 patients.
CONCLUSIONS
Venous thromboembolisms were commonly encountered complications despite the administration of thromboprophylaxis, and they mostly presented as pulmonary embolisms, warranting the need for relevant investigations in hemodynamically unstable patients. However, more studies need to be conducted to better understand the mechanisms at play and the ensuing complications, to better treat COVID-19 patients.
Topics: Anticoagulants; COVID-19; Humans; SARS-CoV-2; Troponin T; Venous Thromboembolism
PubMed: 35776052
DOI: 10.26355/eurrev_202206_29090 -
Presse Medicale (Paris, France : 1983) Mar 2017In France, cocaine is the second most commonly used illicit drug after cannabis. It can be responsible for many respiratory disorders among which pneumomediastinum. (Review)
Review
INTRODUCTION
In France, cocaine is the second most commonly used illicit drug after cannabis. It can be responsible for many respiratory disorders among which pneumomediastinum.
OBJECTIVES
Systematic literature review of data on pneumediastinum in cocaine users. Documentary sources. Medline, on the period 1980-2016 with the keywords "pneumomediastinum" and "cocaine" or "free-base" or "freebasing" or "crack"; limits "title/abstract"; the selected languages were English or French. Among 72 articles, 48 abstracts have given use to a dual reading to select 37 studies.
RESULTS
Thirty-five selected articles related 44 subjects (sex-ratio: 5.2) whose age ranged from 15 to 36 years. Fourteen subjects used cocaine nasally and 30 others smoked it (12 as free-base and 18 in the form of crack). Thirty-two subjects had an isolated pneumomediastinum and 12 others had a pneumomediastinum combined with other gaseous effusions (pneumothorax, pneumopericardium, pneumoperitoneum or pneumorachis). Chest pain of sudden onset in the most common symptom which is often associated with tightness or swelling of the neck; more rarely there are dyspnea and/or a dry cough. The time between taking cocaine and the onset of the symptoms varies from a few minutes to 3 days. The course is usually good with healing in 1 to 4 days.
CONCLUSION
Cocaine use may be responsible for spontaneous pneumomediastinum. Practitioners must seek cocaine use in case of pneumomediastinum in a young person and consider the diagnosis in the case of sudden chest pain in cocaine users; they must help them to stop their consumption.
Topics: Cocaine-Related Disorders; Humans; Mediastinal Emphysema
PubMed: 28189373
DOI: 10.1016/j.lpm.2017.01.002 -
BMC Ophthalmology Jul 2023Dry eye disease (DED) is caused by a persistently unstable tear film leading to ocular discomfort and is treated mainly with tear supplementation. There is emerging... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Dry eye disease (DED) is caused by a persistently unstable tear film leading to ocular discomfort and is treated mainly with tear supplementation. There is emerging evidence that nicotinic acetylcholine receptor (nAChR) agonists (e.g., varenicline and simpinicline) nasal sprays are effective for DED. Our systematic review and meta-analysis assessed the efficacy and safety of varenicline nasal spray (VNS) for DED treatment.
METHODS
The Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched. Only randomized controlled trials (RCTs) that evaluated the efficacy of VNS versus placebo were included. The efficacy endpoint was the mean change in the anesthetized Schirmer test score (STS), a measure of basal tear production, from baseline. The safety endpoints were serious adverse events (SAEs) and adverse events (AEs). The standardized mean difference (SMD) was used for continuous outcomes, while the risk ratio (RR) was used to demonstrate dichotomous variables. The certainty of the evidence was rated utilizing the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The risk of bias assessment was conducted using the Revised Cochrane risk of bias tool for randomized trials.
RESULTS
Three RCTs (n = 1063) met the eligibility criteria. All RCTs had a low risk of bias. The meta-analysis found a statistically significant increase in the mean STS change from baseline on day 28. The pooled analysis found no significant difference between VNS and placebo in the frequency of SAEs and ocular AEs. However, VNS had a significant effect on developing nasal cavity-related AEs.
CONCLUSION
VNS caused a highly significant improvement regarding the efficacy endpoint but caused an increased frequency of some nasal cavity-related AEs (i.e., cough and throat irritation). However, it caused neither SAEs nor ocular AEs. Included studies had a low risk of bias.
Topics: Humans; Nasal Sprays; Varenicline; Dry Eye Syndromes
PubMed: 37452334
DOI: 10.1186/s12886-023-03069-y -
Evidence-based Complementary and... 2019Fr. Schmidt ex Miq, the sole species in the genus (Apiaceae), has long been used in traditional Chinese medicine to treat fatigue, weakness, stomach-yin deficiency,... (Review)
Review
Fr. Schmidt ex Miq, the sole species in the genus (Apiaceae), has long been used in traditional Chinese medicine to treat fatigue, weakness, stomach-yin deficiency, lung heat, cough, dry throat, and thirst. Recently, has also been incorporated into a wide range of Chinese vegetarian cuisines. Based on the comprehensive information, advances in botany, known uses, phytochemistry, pharmacology, and toxicity of , we aim to highlight research gaps and challenges in studying as well as to explore its potential use in plant biotechnology. This may provide more efficient therapeutic agents and health products from . A literature search of SciFinder, ScienceDirect, Scopus, TPL, Google Scholar, Baidu Scholar, and Web of Science, books, PhD and MSc dissertations, and peer-reviewed papers on research was conducted and comprehensively analyzed. We confirmed that the ethnomedical uses of have been recorded in China, Japan, and Korea for thousands of years. A phytochemical investigation revealed that the primary active compounds were phenylpropanoids, coumarins, lignanoids, and flavonoids, organic acids and derivatives, terpenoids, polyacetylenes, steroids, nitrogen compounds, and others. Our analysis also confirmed that the extracts of possess immunoregulatory, antitumor, anti-inflammatory, hepatoprotective, antioxidant, neuroprotective, antibacterial, antifungal, and analgesic properties. Although further studies are required, there is strong evidence of the antitumor and immunoregulatory potential of . Also, more studies are needed to elucidate the mechanisms of action of its active compounds (e.g., falcarinol and panaxydiol) before any clinical studies can be carried out.
PubMed: 31915441
DOI: 10.1155/2019/1253493 -
The Cochrane Database of Systematic... Feb 2018Several agents are used to clear secretions from the airways of people with cystic fibrosis. Mannitol increases mucociliary clearance, but its exact mechanism of action... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Several agents are used to clear secretions from the airways of people with cystic fibrosis. Mannitol increases mucociliary clearance, but its exact mechanism of action is unknown. The dry powder formulation of mannitol may be more convenient and easier to use compared with established agents which require delivery via a nebuliser. Phase III trials of inhaled dry powder mannitol for the treatment of cystic fibrosis have been completed and it is now available in Australia and some countries in Europe. This is an update of a previous review.
OBJECTIVES
To assess whether inhaled dry powder mannitol is well tolerated, whether it improves the quality of life and respiratory function in people with cystic fibrosis and which adverse events are associated with the treatment.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic databases, handsearching relevant journals and abstracts from conferences.Date of last search: 28 September 2017.
SELECTION CRITERIA
All randomised controlled studies comparing mannitol with placebo, active inhaled comparators (for example, hypertonic saline or dornase alfa) or with no treatment.
DATA COLLECTION AND ANALYSIS
Authors independently assessed studies for inclusion, carried out data extraction and assessed the risk of bias in included studies. The quality of the evidence was assessed using GRADE.
MAIN RESULTS
Six studies (reported in 50 publications) were included with a total of 784 participants.Duration of treatment in the included studies ranged from 12 days to six months, with open-label treatment for an additional six months in two of the studies. Five studies compared mannitol with control (a very low dose of mannitol or non-respirable mannitol) and the final study compared mannitol to dornase alfa alone and to mannitol plus dornase alfa. Two large studies had a similar parallel design and provided data for 600 participants, which could be pooled where data for a particular outcome and time point were available. The remaining studies had much smaller sample sizes (ranging from 22 to 95) and data could not be pooled due to differences in design, interventions and population.Pooled evidence from the two large parallel studies was judged to be of low to moderate quality and from the smaller studies was judged to be of low to very low quality. In all studies, there was an initial test to see if participants tolerated mannitol, with only those who could tolerate the drug being randomised; therefore, the study results are not applicable to the cystic fibrosis population as a whole.While the published papers did not provide all the data required for our analysis, additional unpublished data were provided by the drug's manufacturer and the author of one of the studies.Pooling the large parallel studies comparing mannitol to control, up to and including six months, lung function (forced expiratory volume at one second) measured in both mL and % predicted was significantly improved in the mannitol group compared to the control group (moderate-quality evidence). Beneficial results were observed in these studies in adults and in both concomitant dornase alfa users and non-users in these studies. In the smaller studies, statistically significant improvements in lung function were also observed in the mannitol groups compared to the non-respirable mannitol groups; however, we judged this evidence to be of low to very low quality.For the comparisons of mannitol and control, we found no consistent differences in health-related quality of life in any of the domains except for burden of treatment, which was less for mannitol up to four months in the two pooled studies of a similar design; this difference was not maintained at six months. It should be noted that the tool used to measure health-related quality of life was not designed to assess mucolytics and pooling of the age-appropriate tools (as done in some of the included studies) may not be valid so results were judged to be low to very low quality and should be interpreted with caution. Cough, haemoptysis, bronchospasm, pharyngolaryngeal pain and post-tussive vomiting were the most commonly reported side effects in both treatment groups. Where rates of adverse events could be compared, statistically no significant differences were found between mannitol and control groups; although some of these events may have clinical relevance for people with CF.For the comparisons of mannitol to dornase alfa alone and to mannitol plus dornase alfa, very low-quality evidence from a 12-week cross-over study of 28 participants showed no statistically significant differences in the recorded domains of health-related quality of life or measures of lung function. Cough was the most common side effect in the mannitol alone arm but there was no occurrence of cough in the dornase alfa alone arm and the most commonly reported reason of withdrawal from the mannitol plus dornase alfa arm was pulmonary exacerbations.In terms of secondary outcomes of the review (pulmonary exacerbations, hospitalisations, symptoms, sputum microbiology), evidence provided by the included studies was more limited. For all comparisons, no consistent statistically significant and clinically meaningful differences were observed between mannitol and control treatments (including dornase alfa).
AUTHORS' CONCLUSIONS
There is moderate-quality evidence to show that treatment with mannitol over a six-month period is associated with an improvement in some measures of lung function in people with cystic fibrosis compared to control. There is low to very low-quality evidence suggesting no difference in quality of life for participants taking mannitol compared to control. This review provides very low-quality evidence suggesting no difference in lung function or quality of life comparing mannitol to dornase alfa alone and to mannitol plus dornase alfa.The clinical implications from this review suggest that mannitol could be considered as a treatment in cystic fibrosis; but further research is required in order to establish who may benefit most and whether this benefit is sustained in the longer term. Furthermore, studies comparing its efficacy against other (established) mucolytic therapies need to be undertaken before it can be considered for mainstream practice.
Topics: Administration, Inhalation; Adult; Child; Cystic Fibrosis; Deoxyribonuclease I; Humans; Mannitol; Mucociliary Clearance; Powders; Randomized Controlled Trials as Topic; Recombinant Proteins; Respiratory Function Tests
PubMed: 29424930
DOI: 10.1002/14651858.CD008649.pub3 -
JMIR MHealth and UHealth Jun 2022Mobile health (mHealth) apps have facilitated symptom monitoring of COVID-19 symptoms globally and have been used to share data with health care professionals and...
BACKGROUND
Mobile health (mHealth) apps have facilitated symptom monitoring of COVID-19 symptoms globally and have been used to share data with health care professionals and support disease prediction, prevention, management, diagnostics, and improvements in treatments and patient education.
OBJECTIVE
The aim of this review is to evaluate the quality and functionality of COVID-19 mHealth apps that support tracking acute and long-term symptoms of COVID-19.
METHODS
We systematically reviewed commercially available mHealth apps for COVID-19 symptom monitoring by searching Google Play and Apple iTunes using search terms such as "COVID-19," "Coronavirus," and "COVID-19 and symptoms." All apps underwent three rounds of screening. The final apps were independently assessed using the Mobile Application Rating Scale (MARS), an informatics functionality scoring system, and the Center for Disease Control and World Health Organization symptom guidelines. The MARS is a 19-item standardized tool to evaluate the quality of mHealth apps on engagement, functionality, aesthetics, and information quality. Functionality was quantified across the following criteria: inform, instruct, record (collect, share, evaluate, and intervene), display, guide, remind or alert, and communicate. Interrater reliability between the reviewers was calculated.
RESULTS
A total of 1017 mobile apps were reviewed, and 20 (2%) met the inclusion criteria. The majority of the 20 included apps (n=18, 90%) were designed to track acute COVID-19 symptoms, and only 2 (10%) addressed long-term symptoms. Overall, the apps scored high on quality, with an overall MARS rating of 3.89 out of 5, and the highest domain score for functionality (4.2). The most common functionality among all apps was the instruct function (n=19, 95%). The most common symptoms included in the apps for tracking were fever and dry cough (n=18, 90%), aches and pains (n=17, 85%), difficulty breathing (n=17, 85%), tiredness, sore throat, headache, loss of taste or smell (n=16, 80%), and diarrhea (n=15, 75%). Only 2 (10%) apps specifically tracked long-term symptoms of COVID-19. The top 4 rated apps overall were state-specific apps developed and deployed for public use.
CONCLUSIONS
Overall, mHealth apps designed to monitor symptoms of COVID-19 were of high quality, but the majority of apps focused almost exclusively on acute symptoms. Future apps should also incorporate monitoring long-term symptoms of COVID-19 and evidence-based educational materials; they should also include a feature that would allow patients to communicate their symptoms to specific caregivers or their own health care team. App developers should also follow updated technical and clinical guidelines from the Center for Disease Control and the World Health Organization.
Topics: COVID-19; Health Personnel; Humans; Mobile Applications; Reproducibility of Results; Telemedicine
PubMed: 35609313
DOI: 10.2196/36065