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BMJ Clinical Evidence Oct 2008Gastro-oesophageal regurgitation is considered a problem if it is frequent, persistent, and associated with other symptoms such as increased crying, discomfort with... (Review)
Review
INTRODUCTION
Gastro-oesophageal regurgitation is considered a problem if it is frequent, persistent, and associated with other symptoms such as increased crying, discomfort with regurgitation, and frequent back arching. A cross-sectional survey of parents of 948 infants attending 19 primary care paediatric practices found that regurgitation of at least one episode a day was reported in 51% of infants aged 0-3 months.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatment for symptomatic gastro-oesophageal reflux? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2007 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 27 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: domperidone, feed thickeners in infants, H(2) antagonists, head elevated sleep positioning, left lateral or prone sleep positioning, metoclopramide, proton pump inhibitors, sodium alginate, surgery, soy formula with added fibre, and weight loss.
Topics: Acute Disease; Administration, Oral; Child; Cross-Sectional Studies; Domperidone; Gastroesophageal Reflux; Humans; Incidence; Infant; Metoclopramide; Proton Pump Inhibitors
PubMed: 19445794
DOI: No ID Found -
Annals of Palliative Medicine Apr 2017The aim of this article was to systematically review the efficacy and safety of various antiemetics in prophylaxis of radiation-induced nausea and vomiting (RINV). (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The aim of this article was to systematically review the efficacy and safety of various antiemetics in prophylaxis of radiation-induced nausea and vomiting (RINV).
METHODS
A literature search of Ovid MEDLINE, EMBASE and Cochrane CENTRAL was performed to identify randomized controlled trials (RCTs) that evaluated the efficacy of prophylaxis for RINV in patients receiving radiotherapy to abdomen/pelvis, including total body irradiation (TBI). Primary endpoints were complete control of nausea and complete control of vomiting during acute and delayed phases. Secondary endpoints included use of rescue medication, quality of life (QoL) and incidence of adverse events.
RESULTS
Seventeen RCTs were identified. Among patients receiving radiotherapy to abdomen/pelvis, our meta-analysis showed that prophylaxis with a 5-hydroxytryptamine-3 receptor antagonist (5HT3 RA) was significantly more efficacious than placebo and dopamine receptor antagonists in both complete control of vomiting [OR 0.49; 95% confidence interval (CI): 0.33-0.72 and OR 0.17; 95% CI: 0.05-0.58 respectively] and complete control of nausea (OR 0.43; 95% CI: 0.26-0.70 and OR 0.46; 95% CI: 0.24-0.88 respectively). 5HT3 RAs were also more efficacious than rescue therapy and dopamine receptor antagonists plus dexamethasone. The addition of dexamethasone to 5HT3 RA compared to 5HT3 RA alone provides a modest improvement in prophylaxis of RINV. Among patients receiving TBI, 5HT3 RA was more effective than other agents (placebo, combination of metoclopramide, dexamethasone and lorazepam).
CONCLUSIONS
5HT3 RAs are more effective than other antiemetics for prophylaxis of RINV in patients receiving radiotherapy to abdomen/pelvis and TBI. Future RCTs should investigate the efficacy of newer agents such as substance P neurokinin 1 receptor antagonists in addition to 5HT3 RAs in prophylaxis of RINV during both acute and delayed phases.
Topics: Antiemetics; Humans; Nausea; Radiotherapy; Randomized Controlled Trials as Topic; Vomiting
PubMed: 28249542
DOI: 10.21037/apm.2016.12.01 -
PloS One 2021Nausea and vomiting of pregnancy affects up to 80% of pregnant women, it typically occurs during the first trimester which is the most sensitive time for environmental... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Nausea and vomiting of pregnancy affects up to 80% of pregnant women, it typically occurs during the first trimester which is the most sensitive time for environmental exposures given organogenesis. Metoclopramide is an antiemetic drug used widely during NVP, but the findings of studies evaluating its safety of use in pregnancy is inconsistent. Therefore, we conducted a systematic review and meta-analysis to assess whether metoclopramide use during first trimester of pregnancy is associated with the risk of major congenital malformations.
METHODS
The systematic search using database included Pubmed, Embase, Web of science, and Cochrane library. Studies written in English, comprising with an exposed group and a control group, reporting major congenital malformation as an outcome were included.
RESULTS
Six studies assessing a total number of 33374 metoclopramide-exposed and 373498 controls infants were included in this meta-analysis. No significant increase in the rate of major congenital malformation was detected following metoclopramide use during first trimester (OR, 1.14; 95% CI, 0.93-1.38).
CONCLUSIONS
Metoclopramide use during first trimester of pregnancy was not associated with the risk of major congenital malformations.
Topics: Antiemetics; Congenital Abnormalities; Female; Humans; Metoclopramide; Nausea; Odds Ratio; Pregnancy; Pregnancy Trimester, First; Vomiting
PubMed: 34543335
DOI: 10.1371/journal.pone.0257584 -
Journal of Pain and Symptom Management Apr 2010A systematic review of antiemetics for emesis in cancer unrelated to chemotherapy and radiation is an important step in establishing treatment recommendations and... (Meta-Analysis)
Meta-Analysis Review
CONTEXT
A systematic review of antiemetics for emesis in cancer unrelated to chemotherapy and radiation is an important step in establishing treatment recommendations and guiding future research. Therefore, a systematic review based on the question "What is the evidence that supports antiemetic choices in advanced cancer?" guided this review.
OBJECTIVES
To determine the level of evidence for antiemtrics in the management of nausea and vomiting in advanced cancer unrelated to chemotherapy and radiation, and to discover gaps in the evidence, which would provide important areas for future research.
METHODS
Three databases and independent searches using different MeSH terms were performed. Related links were searched and hand searches of related articles were made. Eligible studies included randomized controlled trials (RCTs), prospective single-drug studies, studies that used guidelines based on the etiology of emesis, cohort studies, retrospective studies, and case series or single-patient reports. Studies that involved treatment of chemotherapy, radiation, or postoperation-related emesis were excluded. Studies that involved the treatment of emesis related to bowel obstruction were included. The strength of evidence was graded as follows: 1) RCTs, A; 2) single-drug prospective studies, B1; 3) studies based on multiple drug choices for etiology of emesis, B2; and 4) cohort, case series, retrospective, and single-patient reports, E. Level of evidence was determined by the Oxford Centre for Evidence-Based Medicine Levels of Evidence (May 2001) (A, B, C, D).
RESULTS
Ninety-three articles were found. Fourteen were RCTs, most of them of low quality, based either on lack of blinding, lack of description of the method of randomization, concealment, and/or attrition. Metoclopramide had modest evidence (B) based on RCTs and prospective cohort studies. Octreotide, dexamethasone, and hyoscine butylbromide are effective in reducing symptoms of bowel obstruction, based on prospective studies and/or one RCT. There was no evidence that either multiple antiemetics or antiemetic choices based on the etiology of emesis were any better than a single antiemetic. There is poor evidence for dose response, intraclass or interclass drug switch, or antiemetic combinations in those individuals failing to respond to the initial antiemetic.
CONCLUSION
There are discrepancies between antiemetic studies and published antiemetic guidelines, which are largely based on expert opinion. Antiemetic recommendations have moderate to weak evidence at best. Prospective randomized trials of single antiemetics are needed to properly establish evidence-based guidelines.
Topics: Comorbidity; Drug Therapy; Humans; Nausea; Neoplasms; Practice Patterns, Physicians'; Prevalence; Radiation Injuries; Vomiting
PubMed: 20413062
DOI: 10.1016/j.jpainsymman.2009.08.010 -
Clinical Gastroenterology and... Jun 2023Multiple drugs have been used to treat gastroparesis symptoms, yet their therapeutic benefits are poorly understood partly due to lack of insight into response and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND & AIMS
Multiple drugs have been used to treat gastroparesis symptoms, yet their therapeutic benefits are poorly understood partly due to lack of insight into response and adverse event rates with placebo in randomized controlled trials (RCTs). We evaluated these issues systematically in drug trials for gastroparesis.
METHODS
We searched the medical literature through August 2, 2022 to identify RCTs comparing active drug with placebo in patients with gastroparesis. We assessed placebo response rates according to at least one of the following endpoints: improvement according to a composite outcome, nausea, vomiting, abdominal pain, bloating, or fullness, as well as total adverse events, and adverse events leading to withdrawal. We extracted data as intention-to-treat analyses with dropouts assumed to be treatment failures. We pooled placebo response and adverse event rates using a random effects model and expressed as proportions with 95% confidence intervals (CIs).
RESULTS
Thirty-five studies were eligible. Among 23 trials reporting a composite endpoint of improvement, the pooled placebo response rate was 29.3% (95% CI, 23.7%-35.2%). Pooled placebo response rates were higher in idiopathic compared with diabetic gastroparesis (34.2% vs 28.1%), among trials that did not use validated symptom questionnaires (31.2% vs 27.4%), and in RCTs of shorter duration (<4 weeks, 32.6% vs ≥9 weeks, 23.2%). Adverse events occurred in 33.8% (95% CI, 26.4%-41.8%) of patients with placebo, in 27 trials, and were less common in idiopathic compared with diabetic gastroparesis (17.9% vs 43.4%), trials of shorter duration (<4 weeks, 33.7% vs ≥9 weeks, 40.7%), and trials with lower randomization ratios of active drug to placebo (1:1, 26.7% vs 3:1, 50.5%).
CONCLUSIONS
This meta-analysis assessed placebo response and adverse event rates in gastroparesis. To accurately assess therapeutic gain, future trials should be a minimum of 8 weeks duration, use validated questionnaires, and distinguish gastroparesis subtypes.
Topics: Humans; Gastroparesis; Vomiting; Nausea
PubMed: 36270614
DOI: 10.1016/j.cgh.2022.09.033 -
The Cochrane Database of Systematic... May 2010Gastro-esophageal reflux (GER) is the refluxing of gastric contents into the esophagus. Fifty per cent of all infants 0 to 3 months regurgitate at least once a day. This... (Review)
Review
BACKGROUND
Gastro-esophageal reflux (GER) is the refluxing of gastric contents into the esophagus. Fifty per cent of all infants 0 to 3 months regurgitate at least once a day. This drops to 5% once infants are 10 to 12 months old. Three per cent of parents of 10 to 12 month old infants view this as a problem.
OBJECTIVES
To investigate the effectiveness of thickened feeds, positioning, and metoclopramide as compared to placebo in improving the outcome of GER in developmentally normal infants aged one month to two years.
SEARCH STRATEGY
Trials were identified by searching Cochrane Central Register of Controlled Trials (The Cochrane Library 2003), MEDLINE (January 1966 to 23 January 2003), EMBASE (January 1985 to 27 January 2003), and reference lists of articles. Searches in all databases were updated in April 2009.
SELECTION CRITERIA
Randomised studies (parallel or cross over) which evaluated thickened feeds, positional alternations or metoclopramide for the treatment of GER in children between the age of one month and two years who were developmentally normal.
DATA COLLECTION AND ANALYSIS
All three reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials.
MAIN RESULTS
Twenty trials involving 771 children met the inclusion criteria: eight dealt with thickened feeds, five with positioning, and seven with metoclopramide. Few comparisons could be made, and so summary measures were often made with two or three studies. Thickened feeds reduce the regurgitation severity score (standardized mean difference (SMD) -0.94;95% confidence interval -1.35 to -0.52), as well as the frequency of emesis (SMD -0.91; confidence interval -1.22 to -0.61). The reflux index was not reduced (weighted mean difference (WMD) 0.48%; 95% confidence interval -3.27 to 4.23). All five positioning studies utilized esophageal pH monitoring as their outcome measure. Elevating the head of the crib for treating reflux in the supine position is not justifiable. The seven metoclopramide studies used a variety of outcomes. Compared to placebo, metoclopramide appears to reduce daily symptoms ( SMD -0.73; 95% confidence interval -1.16 to -0.30), and reduce the reflux index (WMD -2.80%; 95% confidence interval -5.58 to -0.01). It does increase side effects.
AUTHORS' CONCLUSIONS
Thickened feeds are helpful in reducing the symptoms of GER. Elevating the head of the crib in the supine position does not have any effect. Metoclopramide may have some benefit in comparison to placebo in the symptomatic treatment for GER, but that must be weighed against possible side effects. .
Topics: Dopamine Antagonists; Gastroesophageal Reflux; Humans; Infant; Infant Food; Metoclopramide; Posture; Randomized Controlled Trials as Topic
PubMed: 20464724
DOI: 10.1002/14651858.CD003502.pub3 -
World Journal of Methodology Jul 2022Metoclopramide may be used to treat people suffering from acute migraine. However, no comprehensive investigation on this issue has been recorded. This review will...
BACKGROUND
Metoclopramide may be used to treat people suffering from acute migraine. However, no comprehensive investigation on this issue has been recorded. This review will provide more solid evidence for the use of metoclopramide in treating acute migraine.
AIM
To compare the efficacy of intravenous metoclopramide with other therapies in migraine attack treatment in an emergency department (ED).
METHODS
We included randomized controlled trials of participants older than 18 years with acute migraine headaches, which included at least one arm that received intravenous (IV) metoclopramide at the ED. A literature search of PubMed, Web of Science, Cochrane Collaboration, and Reference Citation Analysis on December 31, 2021 retrieved other drugs or placebo-controlled studies without language limitation. The risk of bias was assessed using the Cochrane risk of bias tool. The primary endpoint was pain reduction at 60 min or closest to 1 h after treatment, as measured by the pain scale. Secondary endpoints included adverse effects or reactions resulting from metoclopramide or comparisons.
RESULTS
Fourteen trials with a total of 1661 individuals were eligible for review. The risk of bias ranged from low to intermediate. IV metoclopramide administration was not associated with higher pain reduction at 1 h (Standard mean difference [SMD] = -0.03, 95% confidence interval [CI]: -0.33-0.28, = 0.87). However, metoclopramide was associated with better pain reduction than placebo (SMD = 1.04, 95%CI: 0.50-1.58, = 0.0002). In addition, side effects were not significantly different between IV metoclopramide and other drugs or placebo (odds ratio [OR] = 0.76, 95%CI: 0.48-1.19, = 0.09 and OR = 0.92, 95%CI: 0.31-2.74, = 0.54, respectively).
CONCLUSION
Metoclopramide is more effective than placebo in treating migraine in the ED. Despite the observed tendency of decreased side effects, its effectiveness compared to other regimens is poorly understood. More research on this area is needed to treat migraine in acute care settings effectively.
PubMed: 36159095
DOI: 10.5662/wjm.v12.i4.319 -
The Cochrane Database of Systematic... Oct 2004Gastro-esophageal reflux (GER) is the refluxing of gastric contents into the esophagus. Fifty per cent of all infants 0 to 3 months regurgitate at least once a day. This... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Gastro-esophageal reflux (GER) is the refluxing of gastric contents into the esophagus. Fifty per cent of all infants 0 to 3 months regurgitate at least once a day. This drops to 5% once infants are 10 to 12 months old. Three per cent of parents of 10 to 12 month old infants view this as a problem.
OBJECTIVES
To investigate the effectiveness of thickened feeds, positioning, and metoclopramide as compared to placebo in improving the outcome of GER in developmentally normal infants aged one month to two years.
SEARCH STRATEGY
We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2003), MEDLINE (January 1966 to 23 January 2003), EMBASE (January 1985 to 27 January 2003), and reference lists of articles.
SELECTION CRITERIA
Randomised studies (parallel or cross over) which evaluated thickened feeds, positional alternations or metoclopramide for the treatment of GER in children between the age of one month and two years who were developmentally normal.
DATA COLLECTION AND ANALYSIS
All three reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials.
MAIN RESULTS
Twenty trials involving 771 children met the inclusion criteria: eight dealt with thickened feeds, five with positioning, and seven with metoclopramide. Few comparisons could be made, and so summary measures were often made with two or three studies. Thickened feeds reduce the regurgitation severity score (standardized mean difference (SMD) -0.94;95% confidence interval -1.35 to -0.52), as well as the frequency of emesis (SMD -0.91; confidence interval -1.22 to -0.61). The reflux index was not reduced (weighted mean difference (WMD) 0.48%; 95% confidence interval-3.27 to 4.23). All five positioning studies utilized esophageal pH monitoring as their outcome measure. Elevating the head of the crib for treating reflux in the supine position is not justifiable. The seven metoclopramide studies used a variety of outcomes. Compared to placebo, metoclopramide appears to reduce daily symptoms ( SMD -0.73; 95% confidence interval -1.16 to -0.30), and reduce the reflux index (WMD -2.80%; 95% confidence interval -5.58 to -0.01). It does increase side effects.
REVIEWERS' CONCLUSIONS
Thickened feeds are helpful in reducing the symptoms of GER. Elevating the head of the crib in the supine position does not have any effect. Metoclopramide may have some benefit in comparison to placebo in the symptomatic treatment for GER, but that must be weighed against possible side effects. .
Topics: Dopamine Antagonists; Gastroesophageal Reflux; Humans; Infant; Infant Food; Metoclopramide; Posture; Randomized Controlled Trials as Topic
PubMed: 15495056
DOI: 10.1002/14651858.CD003502.pub2 -
Journal of Cardiothoracic and Vascular... Nov 2022TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) is carried out in various clinical settings, with an increasing importance, and sedation usually is required to perform it.... (Meta-Analysis)
Meta-Analysis Review
TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) is carried out in various clinical settings, with an increasing importance, and sedation usually is required to perform it. Several sedative agents are available, and the authors aimed to compare the cardiovascular and respiratory safety of the strategies used for sedation in TEE through a systematic review with network meta-analysis (NMA). The MEDLINE, CENTRAL, EMBASE, and PsycInfo databases were searched in December 2020 for randomized clinical trials (RCTs) comparing sedation strategies for patients undergoing TEE. The authors assessed variations in systolic blood pressure (SBP), heart rate (HR), and peripheral oxygen saturation (SpO), along with the incidences of hypotension, bradycardia, and desaturation. A random-effect meta-analysis was performed. Nine RCTs (N = 881 patients) with 20 active arms (5 dexmedetomidine; 4 propofol; 4 midazolam; 3 midazolam + opioid; 2 ketamine + propofol; 1 midazolam + ondansetron; 1 midazolam + metoclopramide) and 1 placebo arm were included. Dexmedetomidine was associated with decreases in SBP (mean difference [MD] = -18.78 mmHg; 95% CI [-26.27 to -11.28]) and HR (MD = -11.15 beats/min; 95% CI [-16.15 to -6.15]). Dexmedetomidine significantly reduced the HR compared with ketamine + propofol (-16.90 beats/min; 95% CI: -33.21 to -0.58]) and midazolam + opioid (-24.15 beats/min; 95% CI: -42.67 to -5.63). Midazolam was found to reduce SBP (-12.09 mmHg; 95% CI: -20.43 to -3.74) and was shown to reduce SpO compared with the placebo (-1.00%; 95% CI -1.74 to -0.26). Based on the NMA, the drugs with a higher likelihood of decreasing both SBP and HR were dexmedetomidine and midazolam. All of the drugs led to a small decrease (only statistically significant for midazolam) in SpO, with the systematic use of supplemental O in some trials. The risks of hypotension, bradycardia, or desaturation were not significantly different among the evaluated drugs.
Topics: Analgesics, Opioid; Bradycardia; Dexmedetomidine; Echocardiography, Transesophageal; Humans; Hypnotics and Sedatives; Hypotension; Ketamine; Metoclopramide; Midazolam; Network Meta-Analysis; Ondansetron; Propofol
PubMed: 36028379
DOI: 10.1053/j.jvca.2022.07.003 -
Wiener Medizinische Wochenschrift (1946) May 2017The prokinetic cisapride, an important therapeutic option in functional gastrointestinal (GI) disorders, was withdrawn from the market 15 years ago due to rare severe... (Comparative Study)
Comparative Study Review
Modulation of gastrointestinal motility beyond metoclopramide and domperidone : Pharmacological and clinical evidence for phytotherapy in functional gastrointestinal disorders.
The prokinetic cisapride, an important therapeutic option in functional gastrointestinal (GI) disorders, was withdrawn from the market 15 years ago due to rare severe side effects. Likewise in 2014, the use of metoclopramide (MCP) and domperidone in functional GI disorders (FGID) was restricted, consequently leaving a therapeutic gap in clinical practice. A systematic review revealed that the herbal medicinal product (HMP) STW 5 presents a therapeutic option equivalent to MCP and cisapride. STW 5 is the only HMP for which efficacy has been shown in randomized controlled clinical trials (RCTs) in functional dyspepsia and irritable bowel syndrome, based on its multitarget effect on numerous etiological factors. Due to an outstanding favorable safety profile, STW 5 allows an effective and safe use in FGID without a limitation of the duration of the treatment.
Topics: Domperidone; Gastrointestinal Diseases; Gastrointestinal Motility; Humans; Irritable Bowel Syndrome; Metoclopramide; Phytotherapy; Plant Extracts; Randomized Controlled Trials as Topic
PubMed: 28424994
DOI: 10.1007/s10354-017-0557-3