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The Cochrane Database of Systematic... Sep 2018Acute rhinosinusitis is an acute infection of the nasal passages and paranasal sinuses that lasts less than four weeks. Diagnosis of acute rhinosinusitis is generally... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Acute rhinosinusitis is an acute infection of the nasal passages and paranasal sinuses that lasts less than four weeks. Diagnosis of acute rhinosinusitis is generally based on clinical signs and symptoms in ambulatory care settings. Technical investigations are not routinely performed, nor are they recommended in most countries. Some trials show a trend in favour of antibiotics, but the balance of benefit versus harm is unclear.We merged two Cochrane Reviews for this update, which comprised different approaches with overlapping populations, resulting in different conclusions. For this review update, we maintained the distinction between populations diagnosed by clinical signs and symptoms, or imaging.
OBJECTIVES
To assess the effects of antibiotics versus placebo or no treatment in adults with acute rhinosinusitis in ambulatory care settings.
SEARCH METHODS
We searched CENTRAL (2017, Issue 12), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (January 1950 to January 2018), Embase (January 1974 to January 2018), and two trials registers (January 2018). We also checked references from identified trials, systematic reviews, and relevant guidelines.
SELECTION CRITERIA
Randomised controlled trials of antibiotics versus placebo or no treatment in people with rhinosinusitis-like signs or symptoms or sinusitis confirmed by imaging.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data about cure and side effects and assessed the risk of bias. We contacted trial authors for additional information as required.
MAIN RESULTS
We included 15 trials involving 3057 participants. Of the 15 included trials, 10 appeared in our 2012 review, and five (631 participants) are legacy trials from merging two reviews. No new studies were included from searches for this update. Overall, risk of bias was low. Without antibiotics, 46% of participants with rhinosinusitis, whether or not confirmed by radiography, were cured after 1 week and 64% after 14 days. Antibiotics can shorten time to cure, but only 5 to 11 more people per 100 will be cured faster if they receive antibiotics instead of placebo or no treatment: clinical diagnosis (odds ratio (OR) 1.25, 95% confidence interval (CI) 1.02 to 1.54; number needed to treat for an additional beneficial outcome (NNTB) 19, 95% CI 10 to 205; I² = 0%; 8 trials; high-quality evidence) and diagnosis confirmed by radiography (OR 1.57, 95% CI 1.03 to 2.39; NNTB 10, 95% CI 5 to 136; I² = 0%; 3 trials; moderate-quality evidence). Cure rates with antibiotics were higher when a fluid level or total opacification in any sinus was found on computed tomography (OR 4.89, 95% CI 1.75 to 13.72; NNTB 4, 95% CI 2 to 15; 1 trial; moderate-quality evidence). Purulent secretion resolved faster with antibiotics (OR 1.58, 95% CI 1.13 to 2.22; NNTB 10, 95% CI 6 to 35; I² = 0%; 3 trials; high-quality evidence). However, 13 more people experienced side effects with antibiotics compared to placebo or no treatment (OR 2.21, 95% CI 1.74 to 2.82; number needed to treat for an additional harmful outcome (NNTH) 8, 95% CI 6 to 12; I² = 16%; 10 trials; high-quality evidence). Five fewer people per 100 will experience clinical failure if they receive antibiotics instead of placebo or no treatment (Peto OR 0.48, 95% CI 0.36 to 0.63; NNTH 19, 95% CI 15 to 27; I² = 21%; 12 trials; high-quality evidence). A disease-related complication (brain abscess) occurred in one participant (of 3057) one week after receiving open antibiotic therapy (clinical failure, control group).
AUTHORS' CONCLUSIONS
The potential benefit of antibiotics to treat acute rhinosinusitis diagnosed either clinically (low risk of bias, high-quality evidence) or confirmed by imaging (low to unclear risk of bias, moderate-quality evidence) is marginal and needs to be seen in the context of the risk of adverse effects. Considering antibiotic resistance, and the very low incidence of serious complications, we conclude there is no place for antibiotics for people with uncomplicated acute rhinosinusitis. We could not draw conclusions about children, people with suppressed immune systems, and those with severe sinusitis, because these populations were not included in the available trials.
Topics: Acute Disease; Adult; Anti-Bacterial Agents; Humans; Radiography; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Time Factors
PubMed: 30198548
DOI: 10.1002/14651858.CD006089.pub5 -
Annals of Medicine Dec 2022The present systematic review and meta-analysis of randomized clinical trials (RCTs) aimed to investigate the effects of pulmonary rehabilitation in individuals with... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The present systematic review and meta-analysis of randomized clinical trials (RCTs) aimed to investigate the effects of pulmonary rehabilitation in individuals with chronic obstructive pulmonary disease (COPD).
METHODS
The RCTs of pulmonary rehabilitation programs published between 1999 and 2021 were retrieved from electronic databases (PubMed, Cochrane Library, and Embase). Two reviewers independently assessed the topical relevance and trial quality and extracted data for meta-analysis using the Stata software version 14.0.
RESULTS
A total of 39 trials involving 2,397 participants with COPD were evaluated. We found that patients who received pulmonary rehabilitation program had significant improvement in the 6-min walk test (6MWT), St. George Respiratory Questionnaire score, and the modified British Medical Research Council score as compared to those who received usual care. Yoga and Tai Chi showed significant improvement in the forced expiratory volume (FEV1)% in 1 s predicted value. However, no significant difference was detected in the modified Borg score, forced vital capacity (FVC), and FEV1/FVC predicted value between the pulmonary rehabilitation and usual care groups.
CONCLUSION
Yoga and Tai Chi showed a significant improvement in the FEV1% predicted value. Also, pulmonary rehabilitation program improved the exercise capacity, the quality of life, and dyspnoea in patients with COPD.Key messagesA total of 39 trials involving 2,397 participants with COPD were evaluated.We found that patients who received pulmonary rehabilitation program had significant improvement in the 6MWT, St. George Respiratory Questionnaire score, and the modified British Medical Research Council score as compared to those who received usual care.Yoga and Tai Chi showed significant improvement in the FEV1% predicted value.No significant difference was detected in the modified Borg score, FVC, and FEV1/FVC predicted value between the pulmonary rehabilitation and usual care groups.
Topics: Dyspnea; Exercise Tolerance; Humans; Pulmonary Disease, Chronic Obstructive; Quality of Life; Randomized Controlled Trials as Topic; Respiratory Function Tests
PubMed: 35037535
DOI: 10.1080/07853890.2021.1999494 -
Critical Care (London, England) Apr 2015Despite recommendations from professional societies and patient safety organizations, the majority of ICU patients worldwide are not routinely monitored for delirium,... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Despite recommendations from professional societies and patient safety organizations, the majority of ICU patients worldwide are not routinely monitored for delirium, thus preventing timely prevention and management. The purpose of this systematic review is to summarize what types of implementation strategies have been tested to improve ICU clinicians' ability to effectively assess, prevent and treat delirium and to evaluate the effect of these strategies on clinical outcomes.
METHOD
We searched PubMed, Embase, PsychINFO, Cochrane and CINAHL (January 2000 and April 2014) for studies on implementation strategies that included delirium-oriented interventions in adult ICU patients. Studies were suitable for inclusion if implementation strategies' efficacy, in terms of a clinical outcome, or process outcome was described.
RESULTS
We included 21 studies, all including process measures, while 9 reported both process measures and clinical outcomes. Some individual strategies such as "audit and feedback" and "tailored interventions" may be important to establish clinical outcome improvements, but otherwise robust data on effectiveness of specific implementation strategies were scarce. Successful implementation interventions were frequently reported to change process measures, such as improvements in adherence to delirium screening with up to 92%, but relating process measures to outcome changes was generally not possible. In meta-analyses, reduced mortality and ICU length of stay reduction were statistically more likely with implementation programs that employed more (six or more) rather than less implementation strategies and when a framework was used that either integrated current evidence on pain, agitation and delirium management (PAD) or when a strategy of early awakening, breathing, delirium screening and early exercise (ABCDE bundle) was employed. Using implementation strategies aimed at organizational change, next to behavioral change, was also associated with reduced mortality.
CONCLUSION
Our findings may indicate that multi-component implementation programs with a higher number of strategies targeting ICU delirium assessment, prevention and treatment and integrated within PAD or ABCDE bundle have the potential to improve clinical outcomes. However, prospective confirmation of these findings is needed to inform the most effective implementation practice with regard to integrated delirium management and such research should clearly delineate effective practice change from improvements in clinical outcomes.
Topics: Clinical Trials as Topic; Critical Care; Delirium; Disease Management; Humans; Intensive Care Units; Treatment Outcome
PubMed: 25888230
DOI: 10.1186/s13054-015-0886-9 -
The Cochrane Database of Systematic... Dec 2017Patellofemoral pain syndrome, now generally referred to as patellofemoral pain (PFP), is one of the most common orthopaedic disorders, characterised by pain in the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Patellofemoral pain syndrome, now generally referred to as patellofemoral pain (PFP), is one of the most common orthopaedic disorders, characterised by pain in the anterior or retropatellar knee region. Neuromuscular electrical stimulation (NMES) has been proposed generally as a complementary treatment, associated with other interventions such as exercise, or as a single treatment to increase muscle force, reduce knee pain, and improve function.
OBJECTIVES
To assess the effects (benefits and harms) of neuromuscular electrical stimulation for people with patellofemoral pain.
SEARCH METHODS
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PEDro, CINAHL, SPORTDiscus, AMED, LILACS, trial registers, conference abstracts, and reference lists. We carried out the search in May 2017.
SELECTION CRITERIA
We included randomised controlled clinical trials that evaluated the use of NMES for people with PFP.
DATA COLLECTION AND ANALYSIS
Two review authors independently performed the process of study selection, data extraction, and 'Risk of bias' assessment in duplicate. The primary outcomes were knee pain, knee function, and adverse events. The timing of outcome measurements was up to three months (short term), three to 12 months (medium term), and 12 months and above from trial entry (long term). We calculated risk ratios for dichotomous data and mean differences or standardised mean differences for continuous data. Where appropriate, we pooled data using the fixed-effect model.
MAIN RESULTS
We included eight randomised clinical trials, reporting results for 345 participants with PFP. The mean ages of trial populations ranged from 25 to 43 years, and the majority (53% to 100%) of participants were female. There was a wide duration of symptoms, with the minimum duration of symptoms for trial inclusion ranging from one to six months. In addition to the study inclusion criteria, studies varied widely in the characteristics of the NMES and its application, and associated co-interventions. We assessed all trials as at high risk of bias in at least one domain, particularly blinding and incomplete outcome data. The results of a laboratory-based trial reporting knee pain immediately after a single 15-minute session of NMES are not reported here as these are of questionable clinical relevance. The seven remaining trials provided evidence for three comparisons. We assessed the overall quality of the evidence, using GRADE, for all primary outcomes for all comparisons as very low, thus we are very unsure of the findings.Four studies compared NMES plus exercise versus exercise alone. Patellar taping was applied as well as exercise to all participants of one study, and patellar taping and ice were also applied in another study. Each trial tested a different multiple-session NMES programme. Pooled data from three studies (118 participants) provided very low-quality evidence that NMES is associated with reduced pain at the end of treatment (ranging from 3 to 12 weeks): mean difference -1.63, 95% confidence interval (CI) -2.23 to -1.02; visual analogue scale (VAS) 0 to 10; higher scores = worse pain. However, this result may not be clinically relevant since the minimal clinically important difference for VAS during activities (1.5 to 2.0, out of 10 points) lies within the 95% CI. We found very low-quality evidence from pooled data from two trials of little effect of NMES on knee function, as measured by two knee function rating systems. We found inconclusive and very low-quality evidence from one trial (29 participants) of little effect of NMES on pain and function at one-year follow-up. None of the four trials reported on adverse effects of treatment.One study (94 participants) compared NMES, applied four hours per day on a daily basis for four weeks, with two types of exercises (isometric and isokinetic). The study did not report on knee pain or adverse events. The study provided very low-quality evidence of no important difference between the two groups in knee function at the end of the four-week treatment. Of note is the potentially onerous NMES schedule in this study, which does not correspond to that typically used in clinical practice.Two studies compared different types of NMES. Simultaneously delivered high-low frequencies NMES was compared with sequentially delivered high-low frequencies NMES in one trial (14 participants) and with fixed frequency NMES in the second trial (64 participants). The studies provided very low-quality evidence of no important differences at the end of the six-week treatment programme between the simultaneous frequencies NMES and the two other NMES programmes in overall knee pain, knee function, or in quadriceps fatigue (an adverse event).
AUTHORS' CONCLUSIONS
This review found insufficient and inconclusive evidence from randomised controlled trials to inform on the role of NMES for treating people with PFP in current clinical practice. The very low-quality evidence available means that we are uncertain whether or not a multiple-session programme of NMES combined with exercise over several weeks versus exercise alone results in clinically important differences in knee pain and function at the end of the treatment period or at one year. There were no data on adverse effects such as muscle fatigue and discomfort. High-quality randomised clinical trials are needed to inform on the use of NMES for people with PFP. However, professional and stakeholder consensus is required on prioritisation of the research questions for interventions for treating people with PFP, including on the NMES treatment protocol for trials testing NMES.
Topics: Adult; Electric Stimulation Therapy; Female; Humans; Male; Pain Measurement; Patellofemoral Pain Syndrome; Randomized Controlled Trials as Topic; Time Factors
PubMed: 29231243
DOI: 10.1002/14651858.CD011289.pub2 -
The Lancet. Public Health Feb 2017Although it is well established that heavy alcohol consumption increases the risk of hypertension, little is known about the effect of a reduction of alcohol intake on... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Although it is well established that heavy alcohol consumption increases the risk of hypertension, little is known about the effect of a reduction of alcohol intake on blood pressure. We aimed to assess the effect of a reduction in alcohol consumption on change in blood pressure stratified by initial amount of alcohol consumption and sex in adults.
METHODS
In this systematic review and meta-analysis, we searched MedLine, Embase, CENTRAL, and ClinicalTrials.gov from database inception up to July 13, 2016, for trials investigating the effect of a change of alcohol consumption on blood pressure in adults using keywords and MeSH terms related to alcohol consumption, blood pressure, and clinical trials, with no language restrictions. We also searched reference lists of identified articles and published meta-analyses and reviews. We included full-text articles with original human trial data for the effect of a change of alcohol consumption on blood pressure in adults, which reported a quantifiable change in average alcohol consumption that lasted at least 7 days and a corresponding change in blood pressure. We extracted data from published reports. We did random-effects meta-analyses stratified by amount of alcohol intake at baseline. All meta-analyses were done with Stata (version 14.1). For the UK, we modelled the effect of a reduction of alcohol consumption for 50% of the population drinking more than two standard drinks per day (ie, 12 g pure alcohol per drink).
FINDINGS
36 trials with 2865 participants (2464 men and 401 women) were included. In people who drank two or fewer drinks per day, a reduction in alcohol was not associated with a significant reduction in blood pressure; however, in people who drank more than two drinks per day, a reduction in alcohol intake was associated with increased blood pressure reduction. Reduction in systolic blood pressure (mean difference -5·50 mm Hg, 95% CI -6·70 to -4·30) and diastolic blood pressure (-3·97, -4·70 to -3·25) was strongest in participants who drank six or more drinks per day if they reduced their intake by about 50%. For the UK, the results would translate into more than 7000 inpatient hospitalisations and 678 cardiovascular deaths prevented every year.
INTERPRETATION
Reducing alcohol intake lowers blood pressure in a dose-dependent manner with an apparent threshold effect. Implementation of effective alcohol interventions in people who drink more than two drinks per day would reduce the disease burden from both alcohol consumption and hypertension, and should be prioritised in countries with substantial alcohol-attributable risk.
FUNDING
National Institute on Alcohol Abuse and Alcoholism of the National Institutes of Health (NIH).
Topics: Alcohol Drinking; Blood Pressure; Humans; Hypertension; Randomized Controlled Trials as Topic
PubMed: 29253389
DOI: 10.1016/S2468-2667(17)30003-8 -
Daru : Journal of Faculty of Pharmacy,... Dec 2019This review aims to evaluate the efficacy and safety of complementary and alternative medicine methods for constipation in the pediatric population. (Review)
Review
OBJECTIVES
This review aims to evaluate the efficacy and safety of complementary and alternative medicine methods for constipation in the pediatric population.
EVIDENCE ACQUISITION
Medical literature search was performed in several databases for a variety of Traditional, Complementary and Alternative Medicine in childhood constipation. Databases included Web of Science, Scopus, Embase, Cochrane Library, PubMed, ScienceDirect, Google scholar and a number of Persian databases including IranDoc, Magiran and SID. No time limitation was determined. Clinical trials or case series that had evaluated the effectiveness of CAM therapies in functional constipation of 1-18 year old children were included. Papers not in English or Persian language were excluded. Related articles were screened independently by two reviewers according to their titles and abstracts. A data extraction form was filled in for each eligible paper. Quality assessment of eligible documents was also performed.
RESULTS
30 studies were included, comprising 27 clinical trials and 3 case series. Ten documents were on herbal medicine, nine on traditional medicine, ten on manual therapies and one on homeopathy. Except for two herbal and one reflexology interventions, all studies reported positive effects on childhood constipation, with the majority being statistically significant. As the number of studies in each method was limited, we could not perform a meta-analysis.
CONCLUSION
The scarcity of research on the efficacy and safety of different types of complementary and alternative medicine methods in children with constipation necessitates conducting more studies in each field. Graphical abstract.
Topics: Adolescent; Child; Child, Preschool; Clinical Trials as Topic; Complementary Therapies; Constipation; Humans; Infant; Medicine, Traditional; Phytotherapy; Treatment Outcome
PubMed: 31734825
DOI: 10.1007/s40199-019-00297-w -
The Cochrane Database of Systematic... Nov 2018Eczema is a common chronic skin condition. Probiotics have been proposed as an effective treatment for eczema; their use is increasing, as numerous clinical trials are... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Eczema is a common chronic skin condition. Probiotics have been proposed as an effective treatment for eczema; their use is increasing, as numerous clinical trials are under way. This is an update of a Cochrane Review first published in 2008, which suggested that probiotics may not be an effective treatment for eczema but identified areas in which evidence was lacking.
OBJECTIVES
To assess the effects of probiotics for treating patients of all ages with eczema.
SEARCH METHODS
We updated our searches of the following databases to January 2017: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, the Global Resource of Eczema Trials (GREAT) database, MEDLINE, Embase, PsycINFO, the Allied and Complementary Medicine Database (AMED), and Latin American Caribbean Health Sciences Literature (LILACS). We searched five trials registers and checked the reference lists of included studies and relevant reviews for further references to relevant randomised controlled trials (RCTs). We also handsearched a number of conference proceedings. We updated the searches of the main databases in January 2018 and of trials registries in March 2018, but we have not yet incorporated these results into the review.
SELECTION CRITERIA
Randomised controlled trials of probiotics (live orally ingested micro-organisms) compared with no treatment, placebo, or other active intervention with no probiotics for the treatment of eczema diagnosed by a doctor.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures as expected by Cochrane. We recorded adverse events from the included studies and from a separate adverse events search conducted for the first review. We formally assessed reporting bias by preparing funnel plots, and we performed trial sequential analysis for the first primary outcome - eczema symptoms at the end of active treatment.We used GRADE to assess the quality of the evidence for each outcome (in italic font).
MAIN RESULTS
We included 39 randomised controlled trials involving 2599 randomised participants. We included participants of either gender, aged from the first year of life through to 55 years (only six studies assessed adults), who had mild to severe eczema. Trials were undertaken in primary and secondary healthcare settings, mainly in Europe or Asia. Duration of treatment ranged from four weeks to six months, and duration of follow-up after end of treatment ranged from zero to 36 months. We selected no standard dose: researchers used a variety of doses and concentrations of probiotics. The probiotics used were bacteria of the Lactobacillus and Bifidobacteria species, which were taken alone or combined with other probiotics, and were given with or without prebiotics. Comparators were no treatment, placebo, and other treatments with no probiotics.For all results described in this abstract, the comparator was no probiotics. Active treatment ranged from six weeks to three months for all of the following results, apart from the investigator-rated eczema severity outcome, for which the upper limit of active treatment was 16 weeks. With regard to score, the higher the score, the more severe were the symptoms. All key results reported in this abstract were measured at the end of active treatment, except for adverse events, which were measured during the active treatment period.Probiotics probably make little or no difference in participant- or parent-rated symptoms of eczema (13 trials; 754 participants): symptom severity on a scale from 0 to 20 was 0.44 points lower after probiotic treatment (95% confidence interval (CI) -1.22 to 0.33; moderate-quality evidence). Trial sequential analysis shows that target sample sizes of 258 and 456, which are necessary to demonstrate a minimum mean difference of -2 and -1.5, respectively, with 90% power, have been exceeded, suggesting that further trials with similar probiotic strains for this outcome at the end of active treatment may be futile.We found no evidence suggesting that probiotics make a difference in QoL for patients with eczema (six studies; 552 participants; standardised mean difference (SMD) 0.03, 95% CI -0.36 to 0.42; low-quality evidence) when measured by the participant or the parent using validated disease-specific QoL instruments.Probiotics may slightly reduce investigator-rated eczema severity scores (24 trials; 1596 participants). On a scale of 0 to 103 for total Severity Scoring of Atopic Dermatitis (SCORAD), a score combining investigator-rated eczema severity score and participant scoring for eczema symptoms of itch and sleep loss was 3.91 points lower after probiotic treatment than after no probiotic treatment (95% CI -5.86 to -1.96; low-quality evidence). The minimum clinically important difference for SCORAD has been estimated to be 8.7 points.We noted significant to extreme levels of unexplainable heterogeneity between the results of individual studies. We judged most studies to be at unclear risk of bias; six studies had high attrition bias, and nine were at low risk of bias overall.We found no evidence to show that probiotics make a difference in the risk of adverse events during active treatment (risk ratio (RR) 1.54, 95% CI 0.90 to 2.63; seven trials; 402 participants; low-quality evidence). Studies in our review that reported adverse effects described gastrointestinal symptoms.
AUTHORS' CONCLUSIONS
Evidence suggests that, compared with no probiotic, currently available probiotic strains probably make little or no difference in improving patient-rated eczema symptoms. Probiotics may make little or no difference in QoL for people with eczema nor in investigator-rated eczema severity score (combined with participant scoring for eczema symptoms of itch and sleep loss); for the latter, the observed effect was small and of uncertain clinical significance. Therefore, use of probiotics for the treatment of eczema is currently not evidence-based. This update found no evidence of increased adverse effects with probiotic use during studies, but a separate adverse events search from the first review revealed that probiotic treatment carries a small risk of adverse events.Results show significant, unexplainable heterogeneity between individual trial results. Only a small number of studies measured some outcomes.Future studies should better measure QoL scores and adverse events, and should report on new probiotics. Researchers should also consider studying subgroups of patients (e.g. patients with atopy or food allergies, adults) and standardising doses/concentrations of probiotics given.
Topics: Adolescent; Adult; Child; Child, Preschool; Eczema; Female; Humans; Infant; Male; Middle Aged; Probiotics; Randomized Controlled Trials as Topic; Symptom Assessment; Treatment Outcome; Young Adult
PubMed: 30480774
DOI: 10.1002/14651858.CD006135.pub3 -
The Cochrane Database of Systematic... Sep 2019Neuromuscular diseases (NMDs) are a heterogeneous group of diseases affecting the anterior horn cell of spinal cord, neuromuscular junction, peripheral nerves and...
BACKGROUND
Neuromuscular diseases (NMDs) are a heterogeneous group of diseases affecting the anterior horn cell of spinal cord, neuromuscular junction, peripheral nerves and muscles. NMDs cause physical disability usually due to progressive loss of strength in limb muscles, and some NMDs also cause respiratory muscle weakness. Respiratory muscle training (RMT) might be expected to improve respiratory muscle weakness; however, the effects of RMT are still uncertain. This systematic review will synthesize the available trial evidence on the effectiveness and safety of RMT in people with NMD, to inform clinical practice.
OBJECTIVES
To assess the effects of respiratory muscle training (RMT) for neuromuscular disease (NMD) in adults and children, in comparison to sham training, no training, standard treatment, breathing exercises, or other intensities or types of RMT.
SEARCH METHODS
On 19 November 2018, we searched the Cochrane Neuromuscular Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase. On 23 December 2018, we searched the US National Institutes for Health Clinical Trials Registry (ClinicalTrials.gov), the World Health Organization International Clinical Trials Registry Platform, and reference lists of the included studies.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and quasi-RCTs, including cross-over trials, of RMT in adults and children with a diagnosis of NMD of any degree of severity, who were living in the community, and who did not need mechanical ventilation. We compared trials of RMT (inspiratory muscle training (IMT) or expiratory muscle training (EMT), or both), with sham training, no training, standard treatment, different intensities of RMT, different types of RMT, or breathing exercises.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methodological procedures.
MAIN RESULTS
We included 11 studies involving 250 randomized participants with NMDs: three trials (N = 88) in people with amyotrophic lateral sclerosis (ALS; motor neuron disease), six trials (N = 112) in Duchenne muscular dystrophy (DMD), one trial (N = 23) in people with Becker muscular dystrophy (BMD) or limb-girdle muscular dystrophy, and one trial (N = 27) in people with myasthenia gravis.Nine of the trials were at high risk of bias in at least one domain and many reported insufficient information for accurate assessment of the risk of bias. Populations, interventions, control interventions, and outcome measures were often different, which largely ruled out meta-analysis. All included studies assessed lung capacity, our primary outcome, but four did not provide data for analysis (1 in people with ALS and three cross-over studies in DMD). None provided long-term data (over a year) and only one trial, in ALS, provided information on adverse events. Unscheduled hospitalisations for chest infection or acute exacerbation of chronic respiratory failure were not reported and physical function and quality of life were reported in one (ALS) trial.Amyotrophic lateral sclerosis (ALS)Three trials compared RMT versus sham training in ALS. Short-term (8 weeks) effects of RMT on lung capacity in ALS showed no clear difference in the change of the per cent predicted forced vital capacity (FVC%) between EMT and sham EMT groups (mean difference (MD) 0.70, 95% confidence interval (CI) -8.48 to 9.88; N = 46; low-certainty evidence). The mean difference (MD) in FVC% after four months' treatment was 10.86% in favour of IMT (95% CI -4.25 to 25.97; 1 trial, N = 24; low-certainty evidence), which is larger than the minimal clinically important difference (MCID, as estimated in people with idiopathic pulmonary fibrosis). There was no clear difference between IMT and sham IMT groups, measured on the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALFRS; range of possible scores 0 = best to 40 = worst) (MD 0.85, 95% CI -2.16 to 3.85; 1 trial, N = 24; low-certainty evidence) or quality of life, measured on the EuroQol-5D (0 = worst to 100 = best) (MD 0.77, 95% CI -17.09 to 18.62; 1 trial, N = 24; low-certainty evidence) over the medium term (4 months). One trial report stated that the IMT protocol had no adverse effect (very low-certainty evidence).Duchenne muscular dystrophy (DMD)Two DMD trials compared RMT versus sham training in young males with DMD. In one study, the mean post-intervention (6-week) total lung capacity (TLC) favoured RMT (MD 0.45 L, 95% CI -0.24 to 1.14; 1 trial, N = 16; low-certainty evidence). In the other trial there was no clear difference in post-intervention (18 days) FVC between RMT and sham RMT (MD 0.16 L, 95% CI -0.31 to 0.63; 1 trial, N = 20; low-certainty evidence). One RCT and three cross-over trials compared a form of RMT with no training in males with DMD; the cross-over trials did not provide suitable data. Post-intervention (6-month) values showed no clear difference between the RMT and no training groups in per cent predicted vital capacity (VC%) (MD 3.50, 95% CI -14.35 to 21.35; 1 trial, N = 30; low-certainty evidence).Becker or limb-girdle muscular dystrophyOne RCT (N = 21) compared 12 weeks of IMT with breathing exercises in people with Becker or limb-girdle muscular dystrophy. The evidence was of very low certainty and conclusions could not be drawn.Myasthenia gravisIn myasthenia gravis, there may be no clear difference between RMT and breathing exercises on measures of lung capacity, in the short term (TLC MD -0.20 L, 95% CI -1.07 to 0.67; 1 trial, N = 27; low-certainty evidence). Effects of RMT on quality of life are uncertain (1 trial; N = 27).Some trials reported effects of RMT on inspiratory and/or expiratory muscle strength; this evidence was also of low or very low certainty.
AUTHORS' CONCLUSIONS
RMT may improve lung capacity and respiratory muscle strength in some NMDs. In ALS there may not be any clinically meaningful effect of RMT on physical functioning or quality of life and it is uncertain whether it causes adverse effects. Due to clinical heterogeneity between the trials and the small number of participants included in the analysis, together with the risk of bias, these results must be interpreted very cautiously.
Topics: Adult; Breathing Exercises; Child; Exhalation; Humans; Muscle Weakness; Neuromuscular Diseases; Quality of Life; Randomized Controlled Trials as Topic; Vital Capacity
PubMed: 31487757
DOI: 10.1002/14651858.CD011711.pub2 -
Clinical Infectious Diseases : An... Apr 2018We sought to determine if clinical data validate the dogma that bactericidal antibiotics are more clinically effective than bacteriostatic agents. We performed a...
We sought to determine if clinical data validate the dogma that bactericidal antibiotics are more clinically effective than bacteriostatic agents. We performed a systematic literature review of published, randomized, controlled trials (RCTs) that compared a bacteriostatic agent to a bactericidal agent in the treatment of clinical, bacterial infections. Of 56 identified trials published since 1985, 49 found no significant difference in efficacy between bacteriostatic and bactericidal agents. In 6 trials it was found that the bacteriostatic agent was superior to the bactericidal agent in efficacy. Only 1 trial found that the bactericidal agent was superior; in that case, the inferiority of the static agent was explainable by underdosing of the drug based on pharmacokinetic-pharmacodynamic analysis. Thus, virtually all available data from high-quality, RCTs demonstrate no intrinsic superiority of bactericidal compared to bacteriostatic agents. Other drug characteristics such as optimal dosing, pharmacokinetics, and tissue penetration may be more important efficacy drivers.
Topics: Anti-Bacterial Agents; Bacteria; Bacterial Infections; Humans; Microbial Sensitivity Tests; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 29293890
DOI: 10.1093/cid/cix1127 -
Progress in Orthodontics Dec 2016In the view of the widespread acceptance of indefinite retention, it is important to determine the effects of fixed and removable orthodontic retainers on periodontal... (Review)
Review
OBJECTIVE
In the view of the widespread acceptance of indefinite retention, it is important to determine the effects of fixed and removable orthodontic retainers on periodontal health, survival and failure rates of retainers, cost-effectiveness, and impact of orthodontic retainers on patient-reported outcomes.
METHODS
A comprehensive literature search was undertaken based on a defined electronic and gray literature search strategy (
PROSPERO
CRD42015029169). The following databases were searched (up to October 2015); MEDLINE via OVID, PubMed, the Cochrane Central Register of Controlled Trials, LILACS, BBO, ClinicalTrials.gov, the National Research Register, and ProQuest Dissertation and Thesis database. Randomized and non-randomized controlled clinical trials, prospective cohort studies, and case series (minimum sample size of 20) with minimum follow-up periods of 6 months reporting periodontal health, survival and failure rates of retainers, cost-effectiveness, and impact of orthodontic retainers on patient-reported outcomes were identified. The Cochrane Collaboration's Risk of Bias tool and Newcastle-Ottawa Scale were used to assess the quality of included trials.
RESULTS
Twenty-four studies were identified, 18 randomized controlled trials and 6 prospective cohort studies. Of these, only 16 were deemed to be of high quality. Meta-analysis was unfeasible due to considerable clinical heterogeneity and variations in outcome measures. The mean failure risk for mandibular stainless steel fixed retainers bonded from canine to canine was 0.29 (95 % confidence interval [CI] 0.26, 0.33) and for those bonded to canines only was 0.25 (95 % CI: 0.16, 0.33). A meta-regression suggested that failure of fixed stainless steel mandibular retainers was not directly related to the period elapsed since placement (P = 0.938).
CONCLUSION
Further well-designed prospective studies are needed to elucidate the benefits and potential harms associated with orthodontic retainers.
Topics: Cost-Benefit Analysis; Humans; Mandible; Meta-Analysis as Topic; Non-Randomized Controlled Trials as Topic; Orthodontic Retainers; Orthodontics, Corrective; Periodontal Diseases; Randomized Controlled Trials as Topic; Stainless Steel; Treatment Outcome
PubMed: 27459974
DOI: 10.1186/s40510-016-0137-x