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The Cochrane Database of Systematic... Apr 2023Vestibular migraine is a form of migraine where one of the main features is recurrent attacks of vertigo. These episodes are often associated with other features of... (Review)
Review
BACKGROUND
Vestibular migraine is a form of migraine where one of the main features is recurrent attacks of vertigo. These episodes are often associated with other features of migraine, including headache and sensitivity to light or sound. The unpredictable and severe attacks of vertigo can lead to a considerable reduction in quality of life. The condition is estimated to affect just under 1% of the population, although many people remain undiagnosed. A number of pharmacological interventions have been used, or proposed to be used, at the time of a vestibular migraine attack to help reduce the severity or resolve the symptoms. These are predominantly based on treatments that are in use for headache migraine, with the belief that the underlying pathophysiology of these conditions is similar. OBJECTIVES: To assess the benefits and harms of pharmacological interventions used to relieve acute attacks of vestibular migraine.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 September 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-RCTs in adults with definite or probable vestibular migraine comparing triptans, ergot alkaloids, dopamine antagonists, antihistamines, 5-HT3 receptor antagonists, gepants (CGRP receptor antagonists), magnesium, paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) with either placebo or no treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) improvement in headache, 6) improvement in other migrainous symptoms and 7) other adverse effects. We considered outcomes reported at three time points: < 2 hours, 2 to 12 hours, > 12 to 72 hours. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We included two RCTs with a total of 133 participants, both of which compared the use of triptans to placebo for an acute attack of vestibular migraine. One study was a parallel-group RCT (of 114 participants, 75% female). This compared the use of 10 mg rizatriptan to placebo. The second study was a smaller, cross-over RCT (of 19 participants, 70% female). This compared the use of 2.5 mg zolmitriptan to placebo. Triptans may result in little or no difference in the proportion of people whose vertigo improves at up to two hours after taking the medication. However, the evidence was very uncertain (risk ratio 0.84, 95% confidence interval 0.66 to 1.07; 2 studies; based on 262 attacks of vestibular migraine treated in 124 participants; very low-certainty evidence). We did not identify any evidence on the change in vertigo using a continuous scale. Only one of the studies assessed serious adverse events. No events were noted in either group, but as the sample size was small we cannot be sure if there are risks associated with taking triptans for this condition (0/75 receiving triptans, 0/39 receiving placebo; 1 study; 114 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS: The evidence for interventions used to treat acute attacks of vestibular migraine is very sparse. We identified only two studies, both of which assessed the use of triptans. We rated all the evidence as very low-certainty, meaning that we have little confidence in the effect estimates and cannot be sure if triptans have any effect on the symptoms of vestibular migraine. Although we identified sparse information on potential harms of treatment in this review, the use of triptans for other conditions (such as headache migraine) is known to be associated with some adverse effects. We did not identify any placebo-controlled randomised trials for other interventions that may be used for this condition. Further research is needed to identify whether any interventions help to improve the symptoms of vestibular migraine attacks and to determine if there are side effects associated with their use.
Topics: Adult; Female; Humans; Male; Migraine Disorders; Anti-Inflammatory Agents, Non-Steroidal; Vertigo; Headache; Tryptamines
PubMed: 37042545
DOI: 10.1002/14651858.CD015322.pub2 -
The Cochrane Database of Systematic... May 2014Antidepressants are widely used to treat chronic neuropathic pain (pain due to nerve damage), usually in doses below those at which they exert antidepressant effects. An... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Antidepressants are widely used to treat chronic neuropathic pain (pain due to nerve damage), usually in doses below those at which they exert antidepressant effects. An earlier review that included all antidepressants for neuropathic pain is being replaced by new reviews of individual drugs examining individual neuropathic pain conditions.Imipramine is a tricyclic antidepressant that is occasionally used to treat neuropathic pain.
OBJECTIVES
To assess the analgesic efficacy of imipramine for chronic neuropathic pain in adults, and to assess the associated adverse events.
SEARCH METHODS
We searched CENTRAL, MEDLINE, and EMBASE on 18 November 2013, as well as the reference lists of retrieved papers and other reviews. We also used our own handsearched database for older studies, and two clinical trials databases.
SELECTION CRITERIA
We included randomised, double-blind studies of at least two weeks' duration comparing imipramine with placebo or another active treatment in chronic neuropathic pain. Participants were adults aged 18 and over. We included only articles with full journal publication and extended trial abstracts and summaries.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted efficacy and adverse event data, and examined issues of study quality. We performed analysis using three tiers of evidence. First tier evidence was derived from data meeting current best standards and subject to minimal risk of bias (outcome equivalent to substantial pain intensity reduction, intention-to-treat analysis without imputation for dropouts; at least 200 participants in the comparison, 8 to 12 weeks duration, parallel design); second tier from data that failed to meet one or more of these criteria and were considered at some risk of bias but with adequate numbers in the comparison; and third tier from data involving small numbers of participants which was considered very likely to be biased or used outcomes of limited clinical utility, or both.
MAIN RESULTS
Five studies treated 168 participants with painful diabetic neuropathy or polyneuropathy. The mean age in individual studies was between 47 and 56 years. Four studies used a cross-over, and one a parallel group design; 126 participants were randomised to receive imipramine 25 mg to 350 mg daily (most took 100 mg to 150 mg daily). Comparators were placebo (an active placebo in one study), paroxetine, mianserin, venlafaxine, and amitriptyline, and treatment was given for 2 to 12 weeks. All studies had one or more sources of potential major bias.No study provided first or second tier evidence for any outcome. No data were available on the proportion of people with at least 50% or 30% reduction in pain or equivalent, and data were available from only one study for our other primary outcome of Patient Global Impression of Change, reported as patient evaluation of pain relief of complete or good. No pooling of data was possible, but third tier evidence in individual studies indicated some improvement in pain relief with imipramine compared with placebo, although this is was very low quality evidence, derived mainly from group mean data and completer analyses, in small, short duration studies where major bias is possible.Four studies reported some information about adverse events, but reporting was inconsistent and fragmented, and the quality of evidence was very low. Participants taking imipramine generally experienced more adverse events, notably dry mouth, and a higher rate of withdrawal due to adverse events, than did participants taking placebo.
AUTHORS' CONCLUSIONS
This review found little evidence to support the use of imipramine to treat neuropathic pain. There was very low quality evidence of benefit but this came from studies that were methodologically flawed and potentially subject to major bias. Effective medicines with much greater supportive evidence are available.
Topics: Adult; Analgesics; Antidepressive Agents, Tricyclic; Diabetic Neuropathies; Humans; Imipramine; Middle Aged; Neuralgia; Randomized Controlled Trials as Topic
PubMed: 24838845
DOI: 10.1002/14651858.CD010769.pub2 -
Spinal Cord Apr 2022Systematic review. (Review)
Review
STUDY DESIGN
Systematic review.
OBJECTIVES
To investigate the changes in the microbiome among human and animal populations with spinal cord injury (SCI).
METHODS
Four databases (EMBASE, Medline (Ovid), Web of Science, Cochrane Central Register of Trials (CENTRAL)) and Google Scholar were searched. No language restrictions were applied. Data extraction was done in parallel and independently by two reviewers. The search was last conducted on 07 April 2021.
RESULTS
There were 6869 studies retrieved, 43 full-text studies reviewed, and 19 studies included. There were seven animal gut studies, six human gut studies, and six urinary tract studies identified. There were no publications found on other body sites. Among the included studies, we observed a consistent and significant difference in gut microbiome composition between populations with SCI and able-bodied populations. This is characterized by a decrease in beneficial butyrate-producing bacteria (Faecalbacterium, Megamonas, Roseburia) and an increase in inflammation-associated bacteria (Alistipes, Anaerotruncus, and Lachnoclostridium). On the other hand, the urine of individuals with SCI was polymicrobial and members of Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) were frequently observed. Probiotics were shown to induce a significant but transient shift in the urinary tract microbiome. The studies had low to moderate risks of bias.
CONCLUSIONS
There are limited studies on the changes in microbiome among SCI populations. The gut microbiome was characterized by bacterial profiles associated with chronic inflammation and metabolic disorder while the studies of the urinary tract microbiome show the dominance of bacterial genera associated with urinary tract infection.
Topics: Animals; Bacteria; Gastrointestinal Microbiome; Humans; Inflammation; Metabolic Diseases; Probiotics; Spinal Cord Injuries
PubMed: 34992210
DOI: 10.1038/s41393-021-00737-y -
The Cochrane Database of Systematic... Aug 2016This is an updated version of the original Cochrane review published in Issue 6, 2012.Epilepsy is one of the most common chronic neurological disorders. Despite the... (Review)
Review
BACKGROUND
This is an updated version of the original Cochrane review published in Issue 6, 2012.Epilepsy is one of the most common chronic neurological disorders. Despite the plethora of antiepileptic drugs (AEDs) currently available, 30% of people continue having seizures. This group of people requires a more aggressive treatment, since monotherapy, the first choice scheme, fails to control seizures. Nevertheless, polytherapy often results in a number of unwanted effects, including neurological disturbances (somnolence, ataxia, dizziness), psychiatric and behavioural symptoms, and metabolic alteration (osteoporosis, inducement or inhibition of hepatic enzymes, etc.). The need for better tolerated AEDs is even more urgent in this group of people. Reports have suggested an antiepileptic role of melatonin with a good safety profile.
OBJECTIVES
To assess the efficacy and tolerability of melatonin as add-on treatment for epilepsy.
SEARCH METHODS
For the latest update, we searched the Cochrane Epilepsy Group's Specialized Register (12 January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO, 12 January 2016), and MEDLINE (Ovid, 11 January 2016). We searched the bibliographies of any identified study for further references. We handsearched selected journals and conference proceedings. We applied no language restrictions. In addition, we contacted melatonin manufacturers (i.e. Nathura) and original investigators to identify any unpublished studies.
SELECTION CRITERIA
Randomized controlled trials; double, single, or unblinded trials; parallel group or cross-over studies. People with epilepsy regardless of age and gender, including children and adults with disabilities. Administration of melatonin as add-on treatment to any AED(s) compared to add-on placebo or no add-on treatment.
DATA COLLECTION AND ANALYSIS
Review authors independently selected trials for inclusion according to pre-defined criteria, extracted relevant data, and evaluated the methodological quality of trials. We assessed the following outcomes: at least 50% seizure reduction, seizure freedom, adverse events, and quality of life.
MAIN RESULTS
We included six publications, with 125 participants (106 aged under 18 years). Two different comparisons were available: melatonin versus placebo and melatonin 5 mg versus melatonin 10 mg. Despite our primary intention, due to insufficient information on outcomes, we were unable to perform any meta-analyses, but summarized data narratively. Four studies were randomized, double-blind, cross-over, placebo-controlled trials and two were randomized, double-blind, parallel, placebo-controlled trials. Only two studies provided the exact number of seizures during the trial compared to the baseline: none of the participants with seizures during the trial had a change in seizure frequency compared with the baseline. Two studies systematically evaluated adverse effects (worsening of headache was reported in a child with migraine under melatonin treatment). Only one study systematically evaluated quality of life, showing no statistically significant improvement in quality of life in the add-on melatonin group.
AUTHORS' CONCLUSIONS
Included studies were of poor methodological quality, and did not systematically evaluate seizure frequency and adverse events, so that it was impossible to summarize data in a meta-analysis. It is not possible to draw any conclusion about the role of melatonin in reducing seizure frequency or improving quality of life in people with epilepsy.
Topics: Adolescent; Adult; Anticonvulsants; Child; Child, Preschool; Drug Therapy, Combination; Epilepsy; Humans; Infant; Melatonin; Randomized Controlled Trials as Topic; Young Adult
PubMed: 27513702
DOI: 10.1002/14651858.CD006967.pub4 -
Experimental and Therapeutic Medicine Nov 2023Vortioxetine is a novel drug for the treatment of major depressive disorder (MDD). It has been reported that vortioxetine exhibits positive effect on the acute stage of...
Εfficacy and safety of vortioxetine (Lu AA21004) in the treatment of adult patients with major depressive disorder: A systematic review and a meta‑analysis of randomized controlled trials.
Vortioxetine is a novel drug for the treatment of major depressive disorder (MDD). It has been reported that vortioxetine exhibits positive effect on the acute stage of MDD, while it can effectively prevent the recurrence of MDD during the maintenance period. Currently, the results of systematic reviews on vortioxetine are insufficient since several efficacy measures, such as the 24-Items Hamilton Rating Scale for Depression (HADRS-24) total score and other safety factors have not been evaluated. Therefore, the present study aimed to evaluate the efficacy and safety of different doses of vortioxetine on the treatment of adult patients with MDD via assessing more efficacy and safety indicators. The clinical, double-blind, parallel and randomized controlled trials (RCTs) on the effect of vortioxetine on MDD were retrieved from PubMed\Medline, EBSCO, Embase, Cochrane Library, OVID, Web of Science and clinical trial registration websites from database inception to November 2022. A total of two investigators independently screened the included references and independently evaluated their quality. The meta-analysis was performed using Revman 5.0 software. The present systematic review was registered in PROSPERO (registration no. CRD42018106343). In the present study 11 RCTs were included, with a total of 4,908 adult patients with MDD. More specifically, 1,158 patients were included in the 5-mg vortioxetine group, 736 in the 10-mg group, 298 in the 15-mg group, 864 in the 20-mg group and 1,852 in the placebo group. All 11 studies were randomized, double-blinded and parallel control trials, and all publications were evaluated as high quality. The meta-analysis results showed that patients in the 5-, 10- and 20-mg vortioxetine groups exhibited significantly higher Montgomery-Asberg Depression Rating Scale (MADRS) response (≥50%) and remission (≤10%) rates compared with the placebo group (P<0.05). The pooled analysis also revealed a statistically significant change in the total score of HADRS-24, MADRS, Sheehan Disability Scale (SDS), Clinical Global Impression Scale-Improvement (CGI-I) and HADRS-24 response rate in the 10- and 20-mg vortioxetine groups compared with the placebo group (P<0.05). However, no statistically significant changes in the total score of HADRS-24, MADRS, SDS, CGI-I and HADRS-24 response rate were obtained in the 5-mg group compared with the placebo group (P>0.05). Furthermore, the most common adverse events were nausea, hyperhidrosis, insomnia and vomiting, the incidence of which was increased with higher doses of vortioxetine. Overall, the results suggested that vortioxetine administration at doses of 5-20 mg was significantly effective and safe compared with placebo in the treatment of MDD. However, 5 mg vortioxetine displayed no difference in the HADRS-24, MADRS, SDS and CGI-I total scores, and HADRS-24 response rate. Furthermore, patient treatment with increasing vortioxetine doses was associated with good tolerance and high safety. Nevertheless, more multi-center, high-quality and long-term RCTs are still needed to support the aforementioned findings.
PubMed: 37840562
DOI: 10.3892/etm.2023.12214 -
Medicine Dec 2017Spironolactone, a nonselective mineralocorticoid receptor antagonist (MRA), may have a deleterious effect on glycemia. The objective of this review was to assess current... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Spironolactone, a nonselective mineralocorticoid receptor antagonist (MRA), may have a deleterious effect on glycemia. The objective of this review was to assess current knowledge on MRAs' influence (spironolactone, eplerenone, and canrenone) on glucose homeostasis and the risk of diabetes.
METHOD
A systematic review was conducted using the Medline database on articles published from 1946 to January 2017 that studied the effects of MRAs on any glucose-related endpoints, without any restrictions regarding the participants' characteristics.Study design, patient population, dose and duration of intervention, and the quantitative results on glycemic markers were extracted, interpreted for result synthesis, and evaluated for sources of bias. From the articles included in the qualitative analysis, a select number were used in a meta-analysis on studies having measured glycated hemoglobin (HbA1c) or risk of diabetes.
RESULTS
Seventy-two articles were selected from the Medline database and references of articles. Results on spironolactone were heterogeneous, but seemed to be disease-specific. A potential negative effect on glucose regulation was mainly observed in heart failure and diabetes trials, while a neutral or positive effect was detected in diseases characterized by hyperandrogenism, and inconclusive for hypertension. Interpretation of data from heart failure trials was limited by the small number of studies. From a meta-analysis of 12 randomized controlled studies evaluating spironolactone's impact on HbA1c in diabetic patients, spironolactone had a nonsignificant effect in parallel-group studies (mean difference 0.03 [-0.20;0.26]), but significantly increased HbA1c in crossover studies (mean difference 0.24 [0.18;0.31]). Finally, eplerenone did not seem to influence glycemia, while limited data indicated that canrenone may exert a neutral or beneficial effect.The studies had important limitations regarding study design, sample size, duration of follow-up, and choice of glycemic markers.
CONCLUSION
Spironolactone may induce disease-specific and modest alterations on glycemia. It is uncertain whether these effects are transient or not. Data from the most extensively studied population, individuals with diabetes, do not support a long-term glycemic impact in these patients. Further prospective studies are necessary to establish spironolactone's true biological effects and their clinical implications.
Topics: Blood Glucose; Canrenone; Eplerenone; Glycated Hemoglobin; Homeostasis; Humans; Mineralocorticoid Receptor Antagonists; Spironolactone
PubMed: 29310346
DOI: 10.1097/MD.0000000000008719 -
Frontiers in Global Women's Health 2023Episiotomy at the time of vaginal birth is a common lifesaving surgical procedure. In Ethiopia, several studies have been conducted concerning the proportion of... (Review)
Review
BACKGROUND
Episiotomy at the time of vaginal birth is a common lifesaving surgical procedure. In Ethiopia, several studies have been conducted concerning the proportion of episiotomy. However, its prevalence varies across these series of studies. Thus, this systematic review and meta-analysis aimed to estimate the level of episiotomy practice and its disparity among primiparous and multiparous women in Ethiopia.
METHODS
This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guideline. We systematically searched the PubMed/MEDLINE, EMBASE, Google Scholar, and Science Direct databases for studies conducted in Ethiopia focusing on episiotomy. We included all cross-sectional studies published until October 5,2022. Data were analyzed using R version 4.2.1 software. The pooled estimates with 95% confidence intervals (CIs) were presented using forest plots. A random-effects meta-analysis was conducted on extracted crude rates to calculate the national and regional pooled estimates for the country. The -squared test and Egger's regression test were used to assess heterogeneity and publication bias, respectively.
RESULTS
Our search yielded 390 articles. A total of 13 studies covering five administrative regions and 6,404 women who delivered vaginally were involved. The mean age of the study participants ranged from 22 to 27.7 years. The estimated overall pooled prevalence rate of episiotomy in Ethiopian women was 42.75% (95% CI: 34.97%-50.54%). In the subgroup analysis, the pooled prevalence rate of episiotomy was 61.45% (95% CI: 51.11%-71.80%) among primiparous women. Meanwhile, the pooled estimate appears to be approximately 30.47% (95% CI: 22.08%-38.85%) among multiparous women.
CONCLUSION
Our findings concluded that the pooled prevalence rate of episiotomy was higher than the evidence-based WHO recommendations for optimal patient care. Parallel to this, nulliparous women had a higher episiotomy rate than multiparous women. These findings highlight the importance of continued training for labor ward staff, particularly healthcare providers who often perform the majority of deliveries.
PubMed: 38025985
DOI: 10.3389/fgwh.2023.1153640 -
Journal of Dentistry May 2016Bone grafts are often used to enhance bone volume/quality prior to implantation insertion. This systematic review compares the histomorphometric effectiveness of bone... (Meta-Analysis)
Meta-Analysis Review
Comparative effectiveness of natural and synthetic bone grafts in oral and maxillofacial surgery prior to insertion of dental implants: Systematic review and network meta-analysis of parallel and cluster randomized controlled trials.
OBJECTIVES
Bone grafts are often used to enhance bone volume/quality prior to implantation insertion. This systematic review compares the histomorphometric effectiveness of bone grafts in an evidence-based manner.
DATA
Randomized clinical trials comparing histomorphometrically the % of newly-formed bone between two grafts were included. Risk of bias within and across studies was assessed with the Cochrane tool and the GRADE approach, respectively. Random-effects pairwise meta-analyses were conducted, followed by network meta-analysis, network meta-regression and sensitivity analyses.
SOURCES
Four electronic databases were searched from inception to June 2015 without limitations.
STUDY SELECTION
A total of 12 trials (5 parallel; 7 cluster) with a total of 231 patients (302 grafted sites) were included. No statistically significant differences were found in the % of new bone from pairwise comparisons between any two bone grafts. Treatment ranking based on the evidence network indicated that autografts presented the highest percentage of new bone, followed by synthetic grafts, xenografts, and allografts. No differences according to patient age, sex, healing time, membrane used or kind of surgical graft use were identified. Our confidence on pairwise comparisons was moderate to very low due to study limitations, inconsistency, and imprecision; our confidence on graft ranking was moderate due to study limitations.
CONCLUSIONS
No significant differences were found in the percentage of new bone between any two grafts.
CLINICAL SIGNIFICANCE
Synthetic bone substitutes or xenologous bone grafts can be used as an alternative to autologous graft in order to overcome problems of additional surgeries or limited graft availability.
Topics: Alveolar Ridge Augmentation; Bone Substitutes; Bone Transplantation; Dental Implantation, Endosseous; Dental Implants; Humans; Randomized Controlled Trials as Topic; Sinus Floor Augmentation; Surgery, Oral; Tooth Extraction; Treatment Outcome
PubMed: 27012858
DOI: 10.1016/j.jdent.2016.03.010 -
The Cochrane Database of Systematic... May 2018Cystic fibrosis is the most common autosomal recessive disease in white populations, and causes respiratory dysfunction in the majority of individuals. Numerous types of... (Review)
Review
BACKGROUND
Cystic fibrosis is the most common autosomal recessive disease in white populations, and causes respiratory dysfunction in the majority of individuals. Numerous types of respiratory muscle training to improve respiratory function and health-related quality of life in people with cystic fibrosis have been reported in the literature. Hence a systematic review of the literature is needed to establish the effectiveness of respiratory muscle training (either inspiratory or expiratory muscle training) on clinical outcomes in cystic fibrosis. This is an update of a previously published review.
OBJECTIVES
To determine the effectiveness of respiratory muscle training on clinical outcomes in people with cystic fibrosis.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials register comprising of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Date of most recent search: 17 April 2018.A hand search of the Journal of Cystic Fibrosis and Pediatric Pulmonology was performed, along with an electronic search of online trial databases up until 07 May 2018.
SELECTION CRITERIA
Randomised controlled studies comparing respiratory muscle training with a control group in people with cystic fibrosis.
DATA COLLECTION AND ANALYSIS
Review authors independently selected articles for inclusion, evaluated the methodological quality of the studies, and extracted data. Additional information was sought from trial authors where necessary. The quality of the evidence was assessed using the GRADE system MAIN RESULTS: Authors identified 19 studies, of which nine studies with 202 participants met the review's inclusion criteria. There was wide variation in the methodological and written quality of the included studies. Four of the nine included studies were published as abstracts only and lacking concise details, thus limiting the information available. Seven studies were parallel studies and two of a cross-over design. Respiratory muscle training interventions varied dramatically, with frequency, intensity and duration ranging from thrice weekly to twice daily, 20% to 80% of maximal effort, and 10 to 30 minutes, respectively. Participant numbers ranged from 11 to 39 participants in the included studies; five studies were in adults only and four in a combination of children and adults.No significant improvement was reported in the primary outcome of pulmonary function (forced expiratory volume in one second and forced vital capacity) (very low-quality evidence). Although no change was reported in exercise capacity as assessed by the maximum rate of oxygen use, a 10% improvement in exercise duration was found when working at 60% of maximal effort in one study (n = 20) (very low-quality evidence). In a further study (n = 18), when working at 80% of maximal effort, health-related quality of life improved in the mastery and emotion domains (very low-quality evidence). With regards to the review's secondary outcomes, one study (n = 11) found a significant change in intramural pressure, functional residual capacity and maximal inspiratory pressure following training (low-quality evidence). A further study (n = 22) reported that respiratory muscle endurance was significantly longer in the training group (P < 0.01). No studies reported on any other secondary outcomes. Meta-analyses could not be performed due to a lack of consistency and insufficient detail in reported outcome measures.
AUTHORS' CONCLUSIONS
There is insufficient evidence to suggest whether this intervention is beneficial or not. Healthcare practitioners should consider the use of respiratory muscle training on a case-by-case basis. Further research of reputable methodological quality is needed to determine the effectiveness of respiratory muscle training in people with cystic fibrosis. Researchers should consider the following clinical outcomes in future studies; respiratory muscle function, pulmonary function, exercise capacity, hospital admissions, and health-related quality of life. Sensory-perceptual changes, such as respiratory effort sensation (e.g. rating of perceived breathlessness) and peripheral effort sensation (e.g. rating of perceived exertion) may also help to elucidate mechanisms underpinning the effectiveness of respiratory muscle training.
Topics: Adult; Breathing Exercises; Child; Cystic Fibrosis; Humans; Inhalation; Randomized Controlled Trials as Topic; Respiratory Muscles
PubMed: 29797578
DOI: 10.1002/14651858.CD006112.pub4 -
The Cochrane Database of Systematic... Apr 2023Cystic fibrosis (CF) is an inherited progressive life-limiting disease characterised by the build-up of abnormally thick, sticky mucus affecting mostly the lungs,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cystic fibrosis (CF) is an inherited progressive life-limiting disease characterised by the build-up of abnormally thick, sticky mucus affecting mostly the lungs, pancreas, and digestive system. Airway clearance techniques (ACTs), traditionally referred to as chest physiotherapy, are recommended as part of a complex treatment programme for people with CF. The aim of an ACTs is to enhance mucociliary clearance and remove viscous secretions from the airways within the lung to prevent distal airway obstruction. This reduces the infective burden and associated inflammatory effects on the airway epithelia. There are a number of recognised ACTs, none of which have shown superiority in improving short-term outcomes related to mucus transport. This systematic review, which has been updated regularly since it was first published in 2000, considers the efficacy of ACTs compared to not performing any ACT in adults and children with CF. It is important to continue to review this evidence, particularly the long-term outcomes, given the recent introduction of highly effective modulator therapies and the improved health outcomes and potential changes to CF management associated with these drugs.
OBJECTIVES
To determine the effectiveness and acceptability of airway clearance techniques compared to no airway clearance techniques or cough alone in people with cystic fibrosis.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings, to 17 October 2022. We searched ongoing trials registers (Clinicaltrials.gov and the WHO International Clinical Trials Registry Platform) to 7 November 2022.
SELECTION CRITERIA
We included randomised or quasi-randomised studies that compared airway clearance techniques (chest physiotherapy) with no airway clearance techniques or spontaneous cough alone in people with CF.
DATA COLLECTION AND ANALYSIS
Both review authors independently assessed study eligibility, extracted data, and assessed the risk of bias of the included studies. We used GRADE methodology to assess the certainty of the evidence.
MAIN RESULTS
We included 11 cross-over studies (153 participants) and one parallel study (41 participants). There were differences between studies in how the interventions were delivered, with several intervention groups combining more than one ACT. One study used autogenic drainage; five used conventional chest physiotherapy; nine used positive expiratory pressure (PEP), with one study varying the water pressure between arms; three studies used oscillating PEP; two used exercise; and two used high-frequency chest wall oscillation (HFCWO). Of the 12 included studies, 10 were single-treatment studies, and two delivered the intervention over two consecutive days (once daily in one study, twice daily in the second). This substantial heterogeneity in the treatment interventions precluded pooling of data for meta-analysis. Blinding of participants, caregivers, and clinicians is impossible in airway clearance studies; we therefore judged all studies at unclear risk of performance bias. Lack of information in eight studies made assessment of risk of bias unclear for most other domains. We rated the certainty of evidence as low or very low due to the short-term cross-over trial design, small numbers of participants, and uncertain risk of bias across most or all domains. Six studies (84 participants) reported no effect on pulmonary function variables following intervention; but one study (14 participants) reported an improvement in pulmonary function following the intervention in some of the treatment groups. Two studies reported lung clearance index: one (41 participants) found a variable response to treatment with HFCWO, whilst another (15 participants) found no effect on lung clearance index with PEP therapy (low-certainty evidence). Five studies (55 participants) reported that ACTs, including coughing, increased radioactive tracer clearance compared to control, while a further study (eight participants) reported no improvement in radioactive tracer clearance when comparing PEP to control, although coughing was discouraged during the PEP intervention. We rated the certainty of evidence on the effect of ACTs on radioactive tracer clearance as very low. Four studies (46 participants) investigated the weight of mucus cleared from the lungs and reported greater secretions during chest physiotherapy compared to a control. One study (18 participants) reported no differences in sputum weight (very low-certainty evidence).
AUTHORS' CONCLUSIONS
The evidence from this review shows that ACTs may have short-term effects on increasing mucus transport in people with CF. All included studies had short-term follow-up; consequently, we were unable to draw any conclusions on the long-term effects of ACTs compared to no ACTs in people with CF. The evidence in this review represents the use of airway clearance techniques in a CF population before widespread use of cystic fibrosis transmembrane conductance regulator (CFTR) modulators. Further research is needed to determine the effectiveness and acceptability of airway clearance in those treated with highly effective CFTR modulators.
Topics: Adult; Child; Humans; Cystic Fibrosis; Cystic Fibrosis Transmembrane Conductance Regulator; Cough; Radioactive Tracers; Forced Expiratory Volume
PubMed: 37042825
DOI: 10.1002/14651858.CD001401.pub4