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The Cochrane Database of Systematic... Aug 2023Gastro-oesophageal reflux (GOR) is characterised by the regurgitation of gastric contents into the oesophagus. GOR is a common presentation in infancy, both in primary... (Review)
Review
BACKGROUND
Gastro-oesophageal reflux (GOR) is characterised by the regurgitation of gastric contents into the oesophagus. GOR is a common presentation in infancy, both in primary and secondary care, affecting approximately 50% of infants under three months old. The natural history of GOR in infancy is generally of a self-limiting condition that improves with age, but older children and children with co-existing medical conditions can have more protracted symptoms. The distinction between gastro-oesophageal reflux disease (GORD) and GOR is debated. Current National Institute of Health and Care Excellence (NICE) guidelines define GORD as GOR causing symptoms severe enough to merit treatment. This is an update of a review first published in 2014.
OBJECTIVES
To assess the effects of pharmacological treatments for GOR in infants and children.
SEARCH METHODS
For this update, we searched CENTRAL, MEDLINE, Embase, and Web of Science up to 17 September 2022. We also searched for ongoing trials in clinical trials registries, contacted experts in the field, and searched the reference lists of trials and reviews for any additional trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that compared any currently-available pharmacological treatment for GOR in children with placebo or another medication. We excluded studies assessing dietary management of GORD and studies of thickened feeds. We included studies in infants and children up to 16 years old.
DATA COLLECTION AND ANALYSIS
We used standard methodology expected by Cochrane.
MAIN RESULTS
We included 36 RCTs involving 2251 children and infants. We were able to extract summary data from 14 RCTs; the remaining trials had insufficient data for extraction. We were unable to pool results in a meta-analysis due to methodological differences in the included studies (including heterogeneous outcomes, study populations, and study design). We present the results in two groups by age: infants up to 12 months old, and children aged 12 months to 16 years old. Infants Omeprazole versus placebo: there is no clear effect on symptoms from omeprazole. One study (30 infants; very low-certainty evidence) showed cry/fuss time in infants aged three to 12 months had altered from 246 ± 105 minutes/day at baseline (mean +/- standard deviation (SD)) to 191 ± 120 minutes/day in the omeprazole group and from 287 ± 132 minutes/day to 201 ± 100 minutes/day in the placebo group (mean difference (MD) 10 minutes/day lower (95% confidence interval (CI) -89.1 to 69.1)). The reflux index changed in the omeprazole group from 9.9 ± 5.8% in 24 hours to 1.0 ± 1.3% and in the placebo group from 7.2 ± 6.0% to 5.3 ± 4.9% in 24 hours (MD 7% lower, 95% CI -4.7 to -9.3). Omeprazole versus ranitidine: one study (76 infants; very low-certainty evidence) showed omeprazole may or may not provide symptomatic benefit equivalent to ranitidine. Symptom scores in the omeprazole group changed from 51.9 ± 5.4 to 2.4 ± 1.2, and in the ranitidine group from 47 ± 5.6 to 2.5 ± 0.6 after two weeks: MD -4.97 (95% CI -7.33 to -2.61). Esomeprazole versus placebo: esomeprazole appeared to show no additional reduction in the number of GORD symptoms compared to placebo (1 study, 52 neonates; very low-certainty evidence): both the esomeprazole group (184.7 ± 78.5 to 156.7 ± 75.1) and placebo group (183.1 ± 77.5 to 158.3 ± 75.9) improved: MD -3.2 (95% CI -4.6 to -1.8). Children Proton pump inhibitors (PPIs) at different doses may provide little to no symptomatic and endoscopic benefit. Rabeprazole given at different doses (0.5 mg/kg and 1 mg/kg) may provide similar symptom improvement (127 children in total; very low-certainty evidence). In the lower-dose group (0.5 mg/kg), symptom scores improved in both a low-weight group of children (< 15 kg) (mean -10.6 ± SD 11.13) and a high-weight group of children (> 15 kg) (mean -13.6 ± 13.1). In the higher-dose groups (1 mg/kg), scores improved in the low-weight (-9 ± 11.2) and higher-weight groups (-8.3 ± 9.2). For the higher-weight group, symptom score mean difference between the two different dosing regimens was 2.3 (95% CI -2 to 6.6), and for the lower-weight group, symptom score MD was 4.6 (95% CI -2.9 to 12). Pantoprazole: pantoprazole may or may not improve symptom scores at 0.3 mg/kg, 0.6 mg/kg, and 1.2 mg/kg pantoprazole in children aged one to five years by week eight, with no difference between 0.3 mg/kg and 1.2 mg/kg dosing (0.3 mg/kg mean -2.4 ± 1.7; 1.2 mg/kg -1.7 ± 1.2: MD 0.7 (95% CI -0.4 to 1.8)) (one study, 60 children; very low-certainty evidence). There were insufficient summary data to assess other medications.
AUTHORS' CONCLUSIONS
There is very low-certainty evidence about symptom improvements and changes in pH indices for infants. There are no summary data for endoscopic changes. Medications may or may not provide a benefit (based on very low-certainty evidence) for infants whose symptoms remain bothersome, despite nonmedical interventions or parental reassurance. If a medication is required, there is no clear evidence based on summary data for omeprazole, esomeprazole (in neonates), H₂antagonists, and alginates for symptom improvements (very low-certainty evidence). Further studies with longer follow-up are needed. In older children with GORD, in studies with summary data extracted, there is very low-certainty evidence that PPIs (rabeprazole and pantoprazole) may or may not improve GORD outcomes. No robust data exist for other medications. Further RCT evidence is required in all areas, including subgroups (preterm babies and children with neurodisabilities).
Topics: Adolescent; Child; Humans; Infant; Infant, Newborn; Esomeprazole; Gastroesophageal Reflux; Omeprazole; Pantoprazole; Proton Pump Inhibitors; Rabeprazole; Ranitidine
PubMed: 37635269
DOI: 10.1002/14651858.CD008550.pub3 -
PloS One 2022Cerebral palsy is an extremely severe brain injury associated with multiple nutritional and clinical issues, such as underweight, gastroesophageal reflux, constipation,...
BACKGROUND
Cerebral palsy is an extremely severe brain injury associated with multiple nutritional and clinical issues, such as underweight, gastroesophageal reflux, constipation, and nutrient deficiency. Evidence-based dietary and nutritional interventions may improve the quality of life of children with cerebral palsy.
AIM
Systematically review randomized clinical trials evaluating nutritional and dietary interventions in the clinical, nutritional, and neurodevelopmental aspects of children with cerebral palsy.
METHODS
A search was performed in electronic databases (LILACS, Medline, Web of Science, Embase, Scopus, Cochrane Library, ClinicalTrials.gov, Brazilian Digital Library of Theses and Dissertations, ProQuest Dissertations and Theses Database, OpenGrey) using keywords. The search was firstly performed in May 2020 and updated on June 18th, 2021. Eligible studies were randomized clinical trials, that included children between 2 and 12 years old, and evaluated the effect of nutritional or dietetic interventions on clinical, nutritional or neurodevelopmental outcomes. Risk of bias was investigated using the RoB-2 tool. The study was registered on PROSPERO (CRD42020181284).
RESULTS
Fifteen studies were selected. Positive results included the use of whey-based or pectin-enriched enteral formulas for gastroesophageal reflux (n = 6); 25-hydroxy-vitamin D supplementation for hypovitaminosis D (n = 2); supplementation with lipid mixture or diet with high-density energy for improvements in anthropometric measures (n = 2); supplementation with probiotics, prebiotics, symbiotics or magnesium for constipation (n = 2); nutritional support system for gross motor function (n = 1); lactoferrin and iron hydroxide polymaltose for iron deficiency anemia (n = 1); and educational intervention to improve feeding skills (n = 1). The overall risk of bias was high for 60% of the studies, and some concerns were raised for the remaining 40%.
CONCLUSION
Some promising dietary and nutritional interventions may promote important clinical improvements for patients with cerebral palsy. However, evidence is weak, as few clinical trials have been published with many methodological errors, leading to a high risk of bias.
Topics: Cerebral Palsy; Child; Child, Preschool; Constipation; Diet; Gastroesophageal Reflux; Humans; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 35867728
DOI: 10.1371/journal.pone.0271993 -
Clinical Nutrition ESPEN Dec 2022Treatments for Gastroesophageal Reflux Disease (GERD) symptoms include pharmaceutical, surgical, dietary, and lifestyle behaviors; however, dietary interventions lack... (Meta-Analysis)
Meta-Analysis
What is the efficacy of dietary, nutraceutical, and probiotic interventions for the management of gastroesophageal reflux disease symptoms? A systematic literature review and meta-analysis.
BACKGROUND
Treatments for Gastroesophageal Reflux Disease (GERD) symptoms include pharmaceutical, surgical, dietary, and lifestyle behaviors; however, dietary interventions lack evidence synthesis.
RESEARCH QUESTION
What is the effect of dietary, probiotic, and nutraceutical interventions on GERD symptoms, with or without pharmaceutical therapy, in adults with a history of GERD or functional dyspepsia compared to no intervention, placebo, or usual care?
METHOD
A systematic review and meta-analysis was performed according to PRISMA. The search strategy was implemented in MEDLINE, CINAHL, CENTRAL, and Embase on the 28th October 2020 and updated to 27th July 2021. Intervention studies were eligible if they evaluated the effect of a dietary, nutraceutical, or probiotic intervention on GERD symptoms in adults with a history of GERD or functional dyspepsia. The internal validity of studies was assessed using the Academy Quality Criteria Checklist; Review Manager software was used to perform meta-analysis; and certainty in the body of evidence was assessed using GRADE.
RESULTS
6,608 study records were retrieved from the search, with 21 studies (n = 24 highly heterogenous intervention groups) included (n = 10 restrictive dietary interventions; n = 3 non-restrictive dietary interventions; n = 8 nutraceutical interventions; and n = 3 probiotic interventions). GERD symptoms were clinically and statistically improved by a test-based elimination diet (n = 1 study), low nickel diet (n = 1 study), probiotic yoghurt (n = 1 study), psyllium husk (n = 1 study), prickly pear and olive leaf extract supplement (n = 1 study), and melatonin, amino acid and b-group vitamin supplement (n = 1 study) according to qualitative synthesis. Ginger-containing supplements could be meta-analyzed, and improved incidence of GERD symptom alleviation (n = 2 studies, OR: 7.50 [95%CI: 3.62-15.54], GRADE: high). No clinically and/or statistically significant effects were found for the remaining n = 16 highly heterogenous interventions.
CONCLUSION
Evidence to guide the dietary management of GERD symptoms is limited in scope, quality, and feasibility. Based on the limited evidence available, dietary GERD management should be long-term, individualized, and consider both dietary restrictions and/or additions.
PROSPERO ID
CRD42021224082.
Topics: Adult; Humans; Dyspepsia; Probiotics; Gastroesophageal Reflux; Dietary Supplements; Diet; Pharmaceutical Preparations
PubMed: 36513474
DOI: 10.1016/j.clnesp.2022.09.015 -
Gastrointestinal Endoscopy Feb 2020Achalasia is a primary esophageal motor disorder of unknown etiology characterized by degeneration of the myenteric plexus, which results in impaired relaxation of the...
Achalasia is a primary esophageal motor disorder of unknown etiology characterized by degeneration of the myenteric plexus, which results in impaired relaxation of the esophagogastric junction (EGJ), along with the loss of organized peristalsis in the esophageal body. The criterion standard for diagnosing achalasia is high-resolution esophageal manometry showing incomplete relaxation of the EGJ coupled with the absence of organized peristalsis. Three achalasia subtypes have been defined based on high-resolution manometry findings in the esophageal body. Treatment of patients with achalasia has evolved in recent years with the introduction of peroral endoscopic myotomy. Other treatment options include botulinum toxin injection, pneumatic dilation, and Heller myotomy. This American Society for Gastrointestinal Endoscopy Standards of Practice Guideline provides evidence-based recommendations for the treatment of achalasia, based on an updated assessment of the individual and comparative effectiveness, adverse effects, and cost of the 4 aforementioned achalasia therapies.
Topics: Acetylcholine Release Inhibitors; Botulinum Toxins; Dilatation; Disease Management; Endoscopy, Digestive System; Esophageal Achalasia; Esophageal Sphincter, Lower; Heller Myotomy; Humans; Injections, Intramuscular; Manometry; Myotomy; Societies, Medical; United States
PubMed: 31839408
DOI: 10.1016/j.gie.2019.04.231 -
Clinical Interventions in Aging 2020The purpose of this review was to summarize the latest best scientific evidence on the efficacy of neuromuscular electrical stimulation on swallowing function in...
The purpose of this review was to summarize the latest best scientific evidence on the efficacy of neuromuscular electrical stimulation on swallowing function in dysphagic stroke patients. A comprehensive systematic search of literature published between November 2014 and May 2020 was performed using the following electronic databases: PubMed/Medline, CINAHL, PEDro, Science Direct, Google Scholar, EMBASE, and Scopus. Only randomized controlled trials (RCT) evaluating the effect of neuromuscular electrical stimulation on swallowing function in dysphagic stroke patients were included. Physiotherapy Evidence Database (PEDro) has been used to evaluate the risk of bias of included trials. This review was reported in accordance with PRISMA statement guideline. The methodological quality of the studies was determined using PEDro scale and GRADE approach. Evidence of overall quality was graded from moderate to high. Eleven RCTs involving 784 patients were analyzed. The primary outcome measures of this review were functional dysphagia scale (FDS) and standard swallowing assessment. This review found neuromuscular electrical stimulation (NMES) coupled with traditional swallowing therapy could be an optional intervention to improve swallowing function after stroke in rehabilitation department.
Topics: Deglutition Disorders; Electric Stimulation; Electric Stimulation Therapy; Humans; Male; Physical Therapy Modalities; Randomized Controlled Trials as Topic; Stroke; Stroke Rehabilitation; Treatment Outcome
PubMed: 32943855
DOI: 10.2147/CIA.S262596 -
Developmental Medicine and Child... Nov 2019To determine the prevalence of drooling, swallowing, and feeding problems in persons with cerebral palsy (CP) across the lifespan. (Meta-Analysis)
Meta-Analysis
AIM
To determine the prevalence of drooling, swallowing, and feeding problems in persons with cerebral palsy (CP) across the lifespan.
METHOD
A systematic review was conducted using five different databases (AMED, CINAHL, Embase, MEDLINE, and PubMed). The selection process was completed by two independent researchers and the methodological quality of included studies was assessed using the STROBE and AXIS guidelines. Meta-analyses were conducted to determine pooled prevalence estimates of drooling, swallowing, and feeding problems with stratified group analyses by type of assessment and Gross Motor Function Classification System level.
RESULTS
A total of 42 studies were included. Substantial variations in selected outcome measures and variables were observed, and data on adults were limited. Pooled prevalence estimates determined by meta-analyses were as high as 44.0% (95% confidence interval [CI] 35.6-52.7) for drooling, 50.4% (95% CI 36.0-64.8) for swallowing problems, and 53.5% (95% CI 40.7-65.9) for feeding problems. Group analyses for type of assessments were non-significant; however, more severely impaired functioning in CP was associated with concomitant problems of increased drooling, swallowing, and feeding.
INTERPRETATION
Drooling, swallowing, and feeding problems are very common in people with CP. Consequently, they experience increased risks of malnutrition and dehydration, aspiration pneumonia, and poor quality of life.
WHAT THIS PAPER ADDS
Drooling, swallowing, and feeding problems are very common in persons with cerebral palsy (CP). The prevalence of drooling, swallowing, and feeding problems is 44.0%, 50.4%, and 53.5% respectively. There are limited data on the prevalence of drooling, swallowing, and feeding problems in adults. Higher Gross Motor Function Classification System levels are associated with higher prevalence of drooling, swallowing, and feeding problems. There is increased risk for malnutrition, dehydration, aspiration pneumonia, and poor quality of life in CP.
Topics: Cerebral Palsy; Deglutition Disorders; Feeding and Eating Disorders; Humans; Longevity; Prevalence; Quality of Life; Sialorrhea
PubMed: 31328797
DOI: 10.1111/dmcn.14316 -
Annals of Surgery Feb 2020The aim of this study was to appraise the prevalence of gastroesophageal reflux disease (GERD), esophagitis, and Barrett's esophagus (BE) after sleeve gastrectomy (SG)... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The aim of this study was to appraise the prevalence of gastroesophageal reflux disease (GERD), esophagitis, and Barrett's esophagus (BE) after sleeve gastrectomy (SG) through a systematic review and meta-analysis.
BACKGROUND
The precise prevalence of new-onset or worsening GERD after SG is controversial. Subsequent esophagitis and BE can be a serious unintended sequalae. Their postoperative prevalence remains unclear.
METHODS
A systematic literature search was performed to identify studies evaluating postoperative outcomes in primary SG for morbid obesity. The primary outcome was prevalence of GERD, esophagitis, and BE after SG. Meta-analysis was performed to calculate combined prevalence.
RESULTS
A total of 46 studies totaling 10,718 patients were included. Meta-analysis found that the increase of postoperative GERD after sleeve (POGAS) was 19% and de novo reflux was 23%. The long-term prevalence of esophagitis was 28% and BE was 8%. Four percent of all patients required conversion to RYGB for severe reflux.
CONCLUSIONS
The postoperative prevalence of GERD, esophagitis, and BE following SG is significant. Symptoms do not always correlate with the presence of pathology. As the surgical uptake of SG continues to increase, there is a need to ensure that surgical decision-making and the consent process for this procedure consider these long-term complications while also ensuring their postoperative surveillance through endoscopic and physiological approaches. The long-term outcomes of this commonly performed bariatric procedure should be considered alongside its weight loss and metabolic effects.
Topics: Barrett Esophagus; Esophagitis; Gastrectomy; Gastroesophageal Reflux; Humans; Postoperative Complications
PubMed: 30921053
DOI: 10.1097/SLA.0000000000003275 -
Pediatric Research Jan 2024Symptoms related to infant ankyloglossia/tongue-tie may deter mothers from breastfeeding, yet frenotomy is controversial. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Symptoms related to infant ankyloglossia/tongue-tie may deter mothers from breastfeeding, yet frenotomy is controversial.
METHODS
Databases included PubMed, Embase, CINAHL, PsycINFO, Web of Science, and Google Scholar from 1961-2023. Controlled trials and cohort studies with validated measures of surgical efficacy for breastfeeding outcomes were eligible. Meta-analyses synthesized data with inverse-variance weighting to determine standardized mean differences (SMD) between pre-/postoperative scores.
RESULTS
Twenty-one of 1568 screened studies were included. Breastfeeding self-efficacy improved significantly post-frenotomy: medium effect after 5-10 days (SMD 0.60 [95% CI: 0.48, 0.71; P < 0.001]), large effect after 1 month (SMD 0.91 [CI: 0.79, 1.04; P < 0.001]). Nipple pain decreased significantly post-frenotomy: large effect after 5-15 days (SMD -1.10 [CI: -1.49, -0.70; P < 0.001]) and 1 month (SMD -1.23 [CI: -1.79, -0.67; P = 0.002]). Frenotomy had a medium effect on infant gastroesophageal reflux severity at 1-week follow-up (SMD -0.63 [CI: -0.95, -0.31; P = 0.008]), with continued improvement at 1 month (SMD -0.41 [CI: -0.78, -0.05; P = 0.04]). From LATCH scores, breastfeeding quality improved after 5-7 days by a large SMD of 1.28 (CI: 0.56, 2.00; P = 0.01).
CONCLUSIONS
Providers should offer frenotomy to improve outcomes in dyads with ankyloglossia-associated breastfeeding difficulties.
PROTOCOL REGISTRATION
PROSPERO identifier CRD42022303838 .
IMPACT
This systematic review and meta-analysis showed that breastfeeding self-efficacy, maternal pain, infant latch, and infant gastroesophageal reflux significantly improve after frenotomy in mother-infant dyads with breastfeeding difficulties and ankyloglossia. Providers should offer frenotomy to improve breastfeeding outcomes in symptomatic mother-infant dyads who face challenges associated with ankyloglossia.
Topics: Female; Humans; Infant; Ankyloglossia; Breast Feeding; Gastroesophageal Reflux; Lingual Frenum; Pain; Treatment Outcome
PubMed: 37608056
DOI: 10.1038/s41390-023-02784-y -
Journal of Gastroenterology and... Aug 2019Gastroesophageal reflux disease (GERD) is a common disease caused by reflux of gastric contents to the esophagus. Proton-pump inhibitors (PPIs) are recommended as a... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND AIM
Gastroesophageal reflux disease (GERD) is a common disease caused by reflux of gastric contents to the esophagus. Proton-pump inhibitors (PPIs) are recommended as a first-line therapy to treat GERD. Recently, a new potassium-competitive acid blocker, vonoprazan, was launched in Japan. We aimed to evaluate the comparative efficacy of vonoprazan and other PPIs in healing GERD.
METHODS
We used MEDLINE and the Cochrane Central Register of Controlled Trials to search the literature. Double-blind randomized controlled trials for PPIs and/or vonoprazan that were published in English or Japanese and assessed healing effects in adult GERD patients were included. To estimate the comparative efficacy of treatments, we performed a Bayesian network meta-analysis to assess the consistency assumption.
RESULTS
Of 4001 articles identified in the database, 42 studies were eligible. One study was hand-searched and added to the analysis. For the main analysis of healing effects at 8 weeks, odds ratios (ORs) of vonoprazan (20 mg daily) to esomeprazole (20 mg), rabeprazole (20 mg), lansoprazole (30 mg), and omeprazole (20 mg) were 2.29 (95% credible interval, 0.79-7.06), 3.94 (1.15-14.03), 2.40 (0.90-6.77), and 2.71 (0.98-7.90), respectively. Subgroup analysis for patients with severe esophagitis at baseline showed significantly higher ORs for vonoprazan versus most of the comparator PPIs.
CONCLUSIONS
This analysis shows that the GERD healing effect of vonoprazan is higher than that of rabeprazole (20 mg) but not higher than other PPIs. Subgroup analysis indicated that vonoprazan is more effective than most PPIs for patients with severe erosive esophagitis.
Topics: Bayes Theorem; Esophagitis, Peptic; Gastroesophageal Reflux; Humans; Network Meta-Analysis; Patient Selection; Proton Pump Inhibitors; Pyrroles; Randomized Controlled Trials as Topic; Remission Induction; Severity of Illness Index; Sulfonamides; Time Factors; Treatment Outcome; Wound Healing
PubMed: 30883868
DOI: 10.1111/jgh.14664 -
Rheumatology (Oxford, England) Oct 2023Dysphagia is a common debilitating clinical feature of IBM. However, the impact of dysphagia in IBM has been historically overlooked. This study aimed to identify,...
OBJECTIVES
Dysphagia is a common debilitating clinical feature of IBM. However, the impact of dysphagia in IBM has been historically overlooked. This study aimed to identify, evaluate and summarize the evidence regarding the assessment and management of dysphagia in persons with IBM undergoing treatment.
METHODS
A systematic review was conducted using a multiengine search following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. Eligible studies had to employ an intervention for persons with IBM, report a swallowing outcome and be published in English. Quality assessments of the eligible studies were performed.
RESULTS
Of 239 studies found, 19 met the inclusion criteria. One study was rated as 'fair' and the rest as 'poor' quality, particularly due to the lack of published and validated swallowing assessment procedures and outcome measures. Cricopharyngeal (CP) dysfunction (12/19) was the most commonly reported swallowing abnormality. Interventions for disease management included pharmacological agents (10/19), followed by surgical (3/19), behavioral (1/19) and combined approaches (5/19). Interventions with immunosuppressants, botulinum toxin injection, balloon dilation and/or CP myotomy led to mixed and transient benefits. Few studies examining statins or behavioral therapies (primarily focused on respiratory function) showed no effects for dysphagia.
CONCLUSION
Various interventions have been reported to temporarily improve dysphagia in persons with IBM. However, these findings are based on limited and overall low-quality evidence. This study cautions against the generalization of these findings and emphasizes the need for further systematic research to improve the diagnosis and management of dysphagia in IBM.
Topics: Humans; Deglutition Disorders; Myositis, Inclusion Body; Pharyngeal Muscles; Endoscopy
PubMed: 37115631
DOI: 10.1093/rheumatology/kead194