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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 -
British Journal of Anaesthesia Nov 2006Postoperative vomiting (POV) remains one of the commonest causes of significant morbidity after tonsillectomy in children. A variety of prophylactic anti-emetic... (Meta-Analysis)
Meta-Analysis Review
Postoperative vomiting (POV) remains one of the commonest causes of significant morbidity after tonsillectomy in children. A variety of prophylactic anti-emetic interventions have been reported, but there has only been a limited systematic review in this patient group. A systematic search was performed by using Cochrane Controlled Trials Register, MEDLINE and EMBASE to identify double-blind, randomized, placebo-controlled trials of prophylactic anti-emetic interventions in children undergoing tonsillectomy, with or without adenoidectomy. The outcome of interest was POV in the first 24 h. Summary estimates of the effect of each prophylactic anti-emetic strategy were derived using fixed effect meta-analysis. Where appropriate, dose-response effects were estimated using logistic regression and 22 articles were identified. Good evidence was found for the prophylactic anti-emetic effect of dexamethasone [odds ratio (OR) 0.23, 95% CI 0.16-0.33], and the serotinergic antagonists ondansetron (OR 0.36, 95% CI 0.29-0.46), granisetron (OR 0.11, 95% CI 0.06-0.19), tropisetron (OR 0.15, 95% CI 0.06-0.35) and dolasetron (OR 0.25, 95% CI 0.1-0.59). Metoclopramide was also found to be efficacious (OR 0.51, 95% CI 0.34-0.77). There is not sufficient evidence to suggest that dimenhydrinate, perphenazine or droperidol, in the doses studied, are efficacious, nor were gastric aspiration or acupuncture. In conclusion, dexamethasone and the anti-serotinergic agents appear to be the most effective agents for the prophylaxis for POV in children undergoing tonsillectomy.
Topics: Antiemetics; Child; Double-Blind Method; Humans; Postoperative Nausea and Vomiting; Randomized Controlled Trials as Topic; Serotonin Antagonists; Tonsillectomy
PubMed: 17005507
DOI: 10.1093/bja/ael256 -
The Cochrane Database of Systematic... Jul 2006Drugs can prevent postoperative nausea and vomiting, but their relative efficacies and side effects have not been compared within one systematic review. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Drugs can prevent postoperative nausea and vomiting, but their relative efficacies and side effects have not been compared within one systematic review.
OBJECTIVES
The objective of this review was to assess the prevention of postoperative nausea and vomiting by drugs and the development of any side effects.
SEARCH STRATEGY
We searched The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 2, 2004), MEDLINE (January 1966 to May 2004), EMBASE (January 1985 to May 2004), CINAHL (1982 to May 2004), AMED (1985 to May 2004), SIGLE (to May 2004), ISI WOS (to May 2004), LILAC (to May 2004) and INGENTA bibliographies.
SELECTION CRITERIA
We included randomized controlled trials that compared a drug with placebo or another drug, or compared doses or timing of administration, that reported postoperative nausea or vomiting as an outcome.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trial quality and extracted outcome data.
MAIN RESULTS
We included 737 studies involving 103,237 people. Compared to placebo, eight drugs prevented postoperative nausea and vomiting: droperidol, metoclopramide, ondansetron, tropisetron, dolasetron, dexamethasone, cyclizine and granisetron. Publication bias makes evidence for differences among these drugs unreliable. The relative risks (RR) versus placebo varied between 0.60 and 0.80, depending upon the drug and outcome. Evidence for side effects was sparse: droperidol was sedative (RR 1.32) and headache was more common after ondansetron (RR 1.16).
AUTHORS' CONCLUSIONS
Either nausea or vomiting is reported to affect, at most, 80 out of 100 people after surgery. If all 100 of these people are given one of the listed drugs, about 28 would benefit and 72 would not. Nausea and vomiting are usually less common and, therefore, drugs are less useful. For 100 people, of whom 30 would vomit or feel sick after surgery if given placebo, 10 people would benefit from a drug and 90 would not. Between one to five patients out of every 100 people may experience a mild side effect, such as sedation or headache, when given an antiemetic drug. Collaborative research should focus on determining whether antiemetic drugs cause more severe, probably rare, side effects. Further comparison of the antiemetic effect of one drug versus another is not a research priority.
Topics: Antiemetics; Humans; Postoperative Nausea and Vomiting; Randomized Controlled Trials as Topic
PubMed: 16856030
DOI: 10.1002/14651858.CD004125.pub2 -
British Journal of Clinical Pharmacology Jun 2005To determine whether there is robust evidence of efficacy for domperidone in reducing the symptoms of gastro-oesophageal reflux (GOR) and gastro-oesophageal reflux... (Review)
Review
Should domperidone be used for the treatment of gastro-oesophageal reflux in children? Systematic review of randomized controlled trials in children aged 1 month to 11 years old.
AIM
To determine whether there is robust evidence of efficacy for domperidone in reducing the symptoms of gastro-oesophageal reflux (GOR) and gastro-oesophageal reflux disease (GORD) in children.
METHODS
Systematic review of randomized controlled trials (RCTs). A search was made of the Cochrane Library Issue 2004 (Central Register of Controlled Trials and Database of Systematic Reviews), Medline (Pub-med) 1966 to present and Embase from 1974 to 2004, and reference citations of the RCTs that had been found electronically.
RESULTS
Four RCTs were identified. Only the two older trials showed any benefits of domperidone on clinical symptoms of GORD in older children, which were the primary outcome measures. In the trial undertaken by Clara, a good or excellent result was obtained in 93% of the domperidone group compared with 33% of the controls (P < 0.05). In the trial undertaken by de Loore, after 2 weeks of treatment 75% of patients treated with domperidone were found not to be vomiting, compared with 43% in the metoclopramide group and 7% in the placebo group. The trial by Corraccio gave no detailed results regarding the primary outcomes of effect of domperidone on symptoms but simply reported 'cured', 'improved' or 'unchanged'. The secondary pH-metric outcome of the number of reflux episodes, was reduced with domperidone.
CONCLUSION
From the limited evidence available, there was no robust evidence of efficacy for the treatment of GOR with domperidone in young children. Given the usually benign nature of the condition, the widespread use of unlicensed medicines for GOR is not warranted.
Topics: Antiemetics; Child; Child, Preschool; Domperidone; Dopamine Antagonists; Evidence-Based Medicine; Gastroesophageal Reflux; Humans; Infant; Randomized Controlled Trials as Topic; Research Design; Treatment Outcome
PubMed: 15948939
DOI: 10.1111/j.1365-2125.2005.02422.x -
Yakugaku Zasshi : Journal of the... Jan 2004We performed a systematic review of the effectiveness of anti-emetics for prophylaxis of cisplatin-induced delayed emesis using meta-analysis. We selected 12 reports of... (Meta-Analysis)
Meta-Analysis Review
We performed a systematic review of the effectiveness of anti-emetics for prophylaxis of cisplatin-induced delayed emesis using meta-analysis. We selected 12 reports of randomized controlled trials from MEDLINE (1966-2003. 4) and The Cochrane Library Issue 1, 2003. Nine of these reports were evaluated as high quality and the others as low quality according to the evaluation criteria of Jadad et al., and only the high-quality reports were subjected to meta-analysis. The statistical results obtained from all 12 reports were also compared with those obtained from the 9 reports of high quality. Corticosteroids significantly reduced the occurrence of delayed emesis. Metoclopramide tended to reduce the occurrence of delayed emesis, although not to a significant extent. In contrast, 5-HT3 receptor antagonists did not show a significant prophylactic effect on delayed emesis. Combination treatments using corticosteroids with metoclopramide or 5-HT3 receptor antagonists did not show significant additional benefits over corticosteroids alone. In conclusion, treatment with corticosteroids without additional metoclopramide or 5-HT3 receptor antagonists appears to be preferable for the prevention of delayed emesis induced by cisplatin.
Topics: Adrenal Cortex Hormones; Antiemetics; Antineoplastic Agents; Cisplatin; Drug Therapy, Combination; Humans; MEDLINE; Metoclopramide; Nausea; Randomized Controlled Trials as Topic; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Vomiting
PubMed: 14768349
DOI: 10.1248/yakushi.124.1 -
BMC Anesthesiology 2001BACKGROUND: The relative efficacy of antiemetics for the treatment of postoperative nausea and vomiting (PONV) is poorly understood. METHODS: Systematic search (MEDLINE,...
BACKGROUND: The relative efficacy of antiemetics for the treatment of postoperative nausea and vomiting (PONV) is poorly understood. METHODS: Systematic search (MEDLINE, Embase, Cochrane Library, bibliographies, any language, to 8.2000) for randomised comparisons of antiemetics with any comparator for the treatment of established PONV. Dichotomous data on prevention of further nausea and vomiting, and on side effects were combined using a fixed effect model. RESULTS: In seven trials (1,267 patients), 11 different antiemetics were tested without placebos; these data were not further analysed. Eighteen trials (3,809) had placebo controls. Dolasetron 12.5-100 mg, granisetron 0.1-3 mg, tropisetron 0.5-5 mg, and ondansetron 1-8 mg prevented further vomiting with little evidence of dose-responsiveness; with all regimens, absolute risk reductions compared with placebo were 20%-30%. The anti-nausea effect was less pronounced. Headache was dose-dependent. Results on propofol were contradictory. The NK1 antagonist GR205171, isopropyl alcohol vapor, metoclopramide, domperidone, and midazolam were tested in one trial each with a limited number of patients. CONCLUSIONS: Of 100 vomiting surgical patients receiving a 5-HT3 receptor antagonist, 20 to 30 will stop vomiting who would not have done so had they received a placebo; less will profit from the anti-nausea effect. There is a lack of evidence for a clinically relevant dose-response; minimal effective doses may be used. There is a discrepancy between the plethora of trials on prevention of PONV and the paucity of trials on treatment of established symptoms. Valid data on the therapeutic efficacy of classic antiemetics, which have been used for decades, are needed.
PubMed: 11734064
DOI: 10.1186/1471-2253-1-2 -
BMJ (Clinical Research Ed.) Jul 2001To quantify the antiemetic efficacy and adverse effects of cannabis used for sickness induced by chemotherapy. (Review)
Review
OBJECTIVE
To quantify the antiemetic efficacy and adverse effects of cannabis used for sickness induced by chemotherapy.
DESIGN
Systematic review.
DATA SOURCES
Systematic search (Medline, Embase, Cochrane library, bibliographies), any language, to August 2000.
STUDIES
30 randomised comparisons of cannabis with placebo or antiemetics from which dichotomous data on efficacy and harm were available (1366 patients). Oral nabilone, oral dronabinol (tetrahydrocannabinol), and intramuscular levonantradol were tested. No cannabis was smoked. Follow up lasted 24 hours.
RESULTS
Cannabinoids were more effective antiemetics than prochlorperazine, metoclopramide, chlorpromazine, thiethylperazine, haloperidol, domperidone, or alizapride: relative risk 1.38 (95% confidence interval 1.18 to 1.62), number needed to treat 6 for complete control of nausea; 1.28 (1.08 to 1.51), NNT 8 for complete control of vomiting. Cannabinoids were not more effective in patients receiving very low or very high emetogenic chemotherapy. In crossover trials, patients preferred cannabinoids for future chemotherapy cycles: 2.39 (2.05 to 2.78), NNT 3. Some potentially beneficial side effects occurred more often with cannabinoids: "high" 10.6 (6.86 to 16.5), NNT 3; sedation or drowsiness 1.66 (1.46 to 1.89), NNT 5; euphoria 12.5 (3.00 to 52.1), NNT 7. Harmful side effects also occurred more often with cannabinoids: dizziness 2.97 (2.31 to 3.83), NNT 3; dysphoria or depression 8.06 (3.38 to 19.2), NNT 8; hallucinations 6.10 (2.41 to 15.4), NNT 17; paranoia 8.58 (6.38 to 11.5), NNT 20; and arterial hypotension 2.23 (1.75 to 2.83), NNT 7. Patients given cannabinoids were more likely to withdraw due to side effects 4.67 (3.07 to 7.09), NNT 11.
CONCLUSIONS
In selected patients, the cannabinoids tested in these trials may be useful as mood enhancing adjuvants for controlling chemotherapy related sickness. Potentially serious adverse effects, even when taken short term orally or intramuscularly, are likely to limit their widespread use.
Topics: Antiemetics; Antineoplastic Agents; Cannabinoids; Humans; Nausea; Patient Satisfaction; Randomized Controlled Trials as Topic; Treatment Outcome; Vomiting
PubMed: 11440936
DOI: 10.1136/bmj.323.7303.16 -
Yakugaku Zasshi : Journal of the... Feb 2001Postoperative nausea and vomiting (PONV) with morphine therapy develops in more than 60% of patients after surgery, markedly reducing patient QOL. The prophylactic... (Meta-Analysis)
Meta-Analysis
Postoperative nausea and vomiting (PONV) with morphine therapy develops in more than 60% of patients after surgery, markedly reducing patient QOL. The prophylactic effect of several antiemetics has already been studied, but evaluations, and even those using the same drug, are not uniform. The present research involved a meta-analysis of randomized controlled trials on prophylactic drug therapy for PONV in patients receiving morphine for the treatment of postoperative pain. The efficacy of the prophylactic administration of the drugs was examined. As a result, meta-analysis of five drugs was possible and the evidence of efficacy was shown for three drugs ranked in order of an increasing odds ratio (OR) and confidence interval (CI): dexamethasone (OR: 0.23, 95% CI: 0.15-0.35, p < 0.00001), droperidol (OR: 0.27, 95% CI: 0.21-0.34, p < 0.00001), and metoclopramide (OR: 0.48, 95% CI: 0.30-0.75, p < 0.001). These results suggest that the three drugs are effective in prophylactic treatment for PONV. Of them, dexamethasone used as a prophylactic drug for PONV provided the best results. Dexamethasone was shown to reduce the incidence of PONV from 66-80% to 16-50% with a dose of 1.25 to 10 mg and to be suitable as a first drug of choice.
Topics: Antiemetics; Dexamethasone; Droperidol; Humans; Metoclopramide; Morphine; Ondansetron; Pain, Postoperative; Postoperative Nausea and Vomiting; Propofol; Randomized Controlled Trials as Topic
PubMed: 11218733
DOI: 10.1248/yakushi.121.179 -
British Journal of Anaesthesia Mar 2000Ginger (Zingiber officinale) is often advocated as beneficial for nausea and vomiting. Whether the herb is truly efficacious for this condition is, however, still a... (Review)
Review
Ginger (Zingiber officinale) is often advocated as beneficial for nausea and vomiting. Whether the herb is truly efficacious for this condition is, however, still a matter of debate. We have performed a systematic review of the evidence from randomized controlled trials for or against the efficacy of ginger for nausea and vomiting. Six studies met all inclusion criteria and were reviewed. Three on postoperative nausea and vomiting were identified and two of these suggested that ginger was superior to placebo and equally effective as metoclopramide. The pooled absolute risk reduction for the incidence of postoperative nausea, however, indicated a non-significant difference between the ginger and placebo groups for ginger 1 g taken before operation (absolute risk reduction 0.052 (95% confidence interval -0.082 to 0.186)). One study was found for each of the following conditions: seasickness, morning sickness and chemotherapy-induced nausea. These studies collectively favoured ginger over placebo.
Topics: Double-Blind Method; Female; Zingiber officinale; Humans; Nausea; Plants, Medicinal; Postoperative Nausea and Vomiting; Randomized Controlled Trials as Topic; Vomiting
PubMed: 10793599
DOI: 10.1093/oxfordjournals.bja.a013442 -
British Journal of Anaesthesia Nov 1999Metoclopramide has been used for almost 40 yr to prevent postoperative nausea and vomiting (PONV). We have reviewed the efficacy and safety of metoclopramide for the... (Meta-Analysis)
Meta-Analysis
Metoclopramide has been used for almost 40 yr to prevent postoperative nausea and vomiting (PONV). We have reviewed the efficacy and safety of metoclopramide for the prevention of PONV. A systematic search (MEDLINE, EMBASE, manufacturers' databases, hand searching, bibliographies, all languages, up to June 1998) was performed for full reports of randomized comparisons of metoclopramide with placebo in surgical patients. Relevant end-points were prevention of early PONV (within 6 h after operation), late PONV (48 h) and adverse effects. Combined data were analysed using relative benefit/risk and number-needed-to-treat/harm. In 66 studies, 3260 patients received 18 different regimens of metoclopramide, and 3006 controls received placebo or no treatment. There was no evidence of dose-responsiveness with oral, i.m., intranasal or i.v. metoclopramide in children and adults. In adults, the best documented regimen was 10 mg i.v. There was no significant anti-nausea effect. The numbers-needed-to-treat to prevent early and late vomiting were 9.1 (95% confidence intervals 5.5-27) and 10 (6-41), respectively. In children, the best documented regimen was 0.25 mg kg-1 i.v. The number-needed-to-treat to prevent early vomiting was 5.8 (3.9-11). There was no significant late anti-vomiting effect. Minor drug-related adverse effects (sedation, dizziness, drowsiness) were not significantly associated with metoclopramide. There was one adult who experienced extrapyramidal symptoms with metoclopramide.
Topics: Adult; Antiemetics; Child, Preschool; Dose-Response Relationship, Drug; Humans; Metoclopramide; Postoperative Nausea and Vomiting; Randomized Controlled Trials as Topic
PubMed: 10690140
DOI: 10.1093/bja/83.5.761