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Anaesthesia Jul 2021Postoperative nausea and vomiting is a common adverse effect of anaesthesia. Although dozens of different anti-emetics are available for clinical practice, there is... (Meta-Analysis)
Meta-Analysis
Postoperative nausea and vomiting is a common adverse effect of anaesthesia. Although dozens of different anti-emetics are available for clinical practice, there is currently no comparative ranking of efficacy and safety of these drugs to inform clinical practice. We performed a systematic review with network meta-analyses to compare, and rank in terms of efficacy and safety, single anti-emetic drugs and their combinations, including 5-hydroxytryptamine , dopamine-2 and neurokinin-1 receptor antagonists; corticosteroids; antihistamines; and anticholinergics used to prevent postoperative nausea and vomiting in adults after general anaesthesia. We systematically searched for placebo-controlled and head-to-head randomised controlled trials up to November 2017 (updated in April 2020). We assessed how trustworthy the evidence was using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) and Confidence In Network Meta-Analysis (CINeMA) approaches for vomiting within 24 h postoperatively, serious adverse events, any adverse event and drug class-specific side-effects. We included 585 trials (97,516 participants, 83% women) testing 44 single drugs and 51 drug combinations. The studies' overall risk of bias was assessed as low in only 27% of the studies. In 282 trials, 29 out of 36 drug combinations and 10 out of 28 single drugs lowered the risk of vomiting at least 20% compared with placebo. In the ranking of treatments, combinations of drugs were generally more effective than single drugs. Single neurokinin-1 receptor antagonists were as effective as other drug combinations. Out of the 10 effective single drugs, certainty of evidence was high for aprepitant, with risk ratio (95%CI) 0.26 (0.18-0.38); ramosetron, 0.44 (0.32-0.59); granisetron, 0.45 (0.38-0.54); dexamethasone, 0.51 (0.44-0.57); and ondansetron, 0.55 (0.51-0.60). It was moderate for fosaprepitant, 0.06 (0.02-0.21) and droperidol, 0.61 (0.54-0.69). Granisetron and amisulpride are likely to have little or no increase in any adverse event compared with placebo, while dimenhydrinate and scopolamine may increase the number of patients with any adverse event compared with placebo. So far, there is no convincing evidence that other single drugs effect the incidence of serious, or any, adverse events when compared with placebo. Among drug class specific side-effects, evidence for single drugs is mostly not convincing. There is convincing evidence regarding the prophylactic effect of at least seven single drugs for postoperative vomiting such that future studies investigating these drugs will probably not change the estimated beneficial effect. However, there is still considerable lack of evidence regarding safety aspects that does warrant investigation.
Topics: Adult; Anesthesia, General; Antiemetics; Female; Humans; Male; Network Meta-Analysis; Postoperative Nausea and Vomiting; Treatment Outcome
PubMed: 33170514
DOI: 10.1111/anae.15295 -
The British Journal of General Practice... Oct 2021Acute gastroenteritis (AGE) affects almost all children aged ≤5 years. In secondary care, ondansetron was found to be effective at reducing vomiting. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Acute gastroenteritis (AGE) affects almost all children aged ≤5 years. In secondary care, ondansetron was found to be effective at reducing vomiting.
AIM
To determine the effectiveness of adding oral ondansetron to care as usual (CAU) to treat vomiting in children with AGE attending out-ofhours primary care (OOH-PC).
DESIGN AND SETTING
A pragmatic randomised controlled trial at three OOH-PC centres in the north of the Netherlands (Groningen, Zwolle, and Assen), with a follow-up of 7 days.
METHOD
Children were included if they were: aged 6 months-6 years; AGE diagnosed by a GP; ≥4 reported episodes of vomiting in the 24 hours before presentation; ≥1 reported episode of vomiting in the 4 hours before presentation; and written informed consent from both parents. Children were randomly allocated to either the control group or the intervention group. The control group received CAU, namely oral rehydration therapy. The intervention group received CAU plus one dose of oral ondansetron (0.1 mg/kg).
RESULTS
In total, 194 children were included for randomisation. One dose of oral ondansetron decreased the proportion of children who continued vomiting within 4 hours from 42.9% to 19.5%, with an odds ratio of 0.37 (95% confidence interval [CI] = 0.20 to 0.72, number needed to treat: four). Ondansetron also decreased the number of vomiting episodes within 4 hours (incidence rate ratio 0.51 [95% CI = 0.29 to 0.88]) and improved overall parental satisfaction with treatment ( = 0.027).
CONCLUSION
Children with AGE and increased risk of dehydration due to vomiting could be treated with ondansetron in primary care to stop vomiting more quickly and increase parental satisfaction with treatment. These results could be used to improve the quality and efficacy of general practice medicine.
Topics: Administration, Oral; Antiemetics; Child; Child, Preschool; Double-Blind Method; Gastroenteritis; Humans; Infant; Ondansetron; Primary Health Care; Treatment Outcome; Vomiting
PubMed: 34426397
DOI: 10.3399/BJGP.2021.0211 -
JAMA Jan 2020This pharmacoepidemiology study uses Medicaid data to estimate associations between first-trimester use of intravenous ondansetron and risk of cardiac malformations and...
This pharmacoepidemiology study uses Medicaid data to estimate associations between first-trimester use of intravenous ondansetron and risk of cardiac malformations and oral cleft in children of exposed mothers.
Topics: Abnormalities, Drug-Induced; Administration, Oral; Adult; Antiemetics; Cleft Lip; Cleft Palate; Female; Follow-Up Studies; Heart Defects, Congenital; Humans; Injections, Intravenous; Nausea; Ondansetron; Pregnancy; Pregnancy Complications; Pregnancy Trimester, First; Risk
PubMed: 31730152
DOI: 10.1001/jama.2019.18587 -
International Journal of Molecular... Sep 2022Cancer is one of the leading causes of death in the world, with breast cancer being the most prevalent cancer. Chemotherapy-induced nausea and vomiting (CINV) is one of... (Meta-Analysis)
Meta-Analysis Review
Cancer is one of the leading causes of death in the world, with breast cancer being the most prevalent cancer. Chemotherapy-induced nausea and vomiting (CINV) is one of the most serious side effects of chemotherapy. Because the current CINV treatment option has several flaws, alternative treatment options are required. Ginger has traditionally been used to treat nausea and vomiting, and it also has anticancer properties in breast cancer cells. Based on these findings, researchers investigated whether using ginger to treat CINV in breast cancer patients is both effective and safe. We searched PubMed, Embase, Cochrane Library, CNKI, and Wanfang from inception to June 2022. Outcomes included Rhodes Index Scores of Nausea, Vomiting, and Retching, severity and frequency of CINV. Five RCTs were included. We pooled all included data and performed subgroup analysis by types of CINV. Overall, authors found that ginger was associated with a reduction in CINV. Subgroup and sensitivity analysis revealed that managing severity of acute CINV in breast cancer patients with ginger was efficient. In terms of managing delayed CINV in breast cancer patients, ginger was also statistically significant. The authors concluded that ginger may be helpful in lowering both acute and delayed CINV in breast cancer patients. Since there were no serious side effects, ginger is thought to be safe.
Topics: Antiemetics; Antineoplastic Agents; Breast Neoplasms; Drug-Related Side Effects and Adverse Reactions; Female; Zingiber officinale; Humans; Nausea; Vomiting
PubMed: 36232567
DOI: 10.3390/ijms231911267 -
Seminars in Perinatology Apr 2020Pregnant women frequently take prescription and over the counter medications. The efficacy of medications is affected by the many physiological changes during pregnancy,... (Review)
Review
Pregnant women frequently take prescription and over the counter medications. The efficacy of medications is affected by the many physiological changes during pregnancy, and these events may be further impacted by genetic factors. Research on pharmacogenomic and pharmacokinetic influences on drug disposition during pregnancy has lagged behind other fields. Clinical investigators have demonstrated altered activity of several drug metabolizing enzymes during pregnancy. Emerging evidence also supports the influence of pharmacogenomic variability in drug response for many important classes of drugs commonly used in pregnancy. Prescribing medications during pregnancy requires an understanding of the substantial dynamic physiologic and metabolic changes that occur during gestation. Pharmacogenomics also contributes to the inter-individual variability in response to many medications, and more research is needed to understand how best to manage drug therapy in pregnant women.
Topics: Analgesics, Opioid; Antidepressive Agents; Antiemetics; Antihypertensive Agents; Cytochrome P-450 Enzyme System; Drug Elimination Routes; Female; Humans; Pharmaceutical Preparations; Pharmacogenetics; Pharmacogenomic Variants; Pharmacokinetics; Pregnancy
PubMed: 32081407
DOI: 10.1016/j.semperi.2020.151222 -
Journal of Clinical Oncology : Official... Jan 2022We evaluated the efficacy and safety of fosnetupitant (FosNTP) versus fosaprepitant (FosAPR) for preventing highly emetogenic chemotherapy-induced nausea and vomiting.... (Comparative Study)
Comparative Study
PURPOSE
We evaluated the efficacy and safety of fosnetupitant (FosNTP) versus fosaprepitant (FosAPR) for preventing highly emetogenic chemotherapy-induced nausea and vomiting. This phase III study was the first head-to-head comparison between two different neurokinin-1 receptor antagonists in combination with palonosetron and dexamethasone.
PATIENTS AND METHODS
Patients scheduled to receive cisplatin-based chemotherapy were randomly assigned 1:1 to FosNTP 235 mg or FosAPR 150 mg in combination with palonosetron 0.75 mg and dexamethasone. The primary end point was overall (0-120 hours) complete response (CR; no emetic event and no rescue medication) rate, stratified by sex and age category, to show the noninferiority of FosNTP to FosAPR (noninferiority margin, -10% for the difference in the overall CR rate).
RESULTS
Overall, 795 patients were randomly assigned, of whom 785 received the study drug (FosNTP [N = 392] FosAPR [N = 393]) and were evaluated for efficacy and safety. The overall CR rate was 75.2% versus 71.0%, respectively (Mantel-Haenszel common risk difference, 4.1%; 95% CI, -2.1% to 10.3%), demonstrating noninferiority of FosNTP to FosAPR. The CR rates in the acute (0-24 hours), delayed (24-120 hours), and beyond delayed (120-168 hours) phases, and at 0-168 hours were 93.9% versus 92.6%, 76.8% versus 72.8%, 86.5% versus 81.4%, and 73.2% versus 66.9%, respectively. The incidence rates of treatment-related adverse events with FosNTP versus FosAPR were 22.2% versus 25.4%, whereas adverse events or treatment-related adverse events relevant to injection site reactions were 11.0% versus 20.6% ( < .001) and 0.3% versus 3.6% ( < .001), respectively.
CONCLUSION
FosNTP demonstrated noninferiority to FosAPR, with a favorable safety profile and lower risk for injection site reactions. Thus, FosNTP is valuable in the prophylaxis of acute, delayed, and beyond delayed chemotherapy-induced nausea and vomiting.
Topics: Adult; Aged; Aged, 80 and over; Antiemetics; Antineoplastic Agents; Cisplatin; Dexamethasone; Double-Blind Method; Drug Combinations; Female; Humans; Isoquinolines; Japan; Male; Middle Aged; Morpholines; Nausea; Neurokinin-1 Receptor Antagonists; Pyridines; Quinuclidines; Time Factors; Treatment Outcome; Vomiting
PubMed: 34793245
DOI: 10.1200/JCO.21.01315 -
International Journal of Environmental... Sep 2022Hyperemesis gravidarum is characterized by severe nausea and vomiting. This study aims to illustrate the efficacy of acupressure at P6 in treating nausea and vomiting in... (Randomized Controlled Trial)
Randomized Controlled Trial
Hyperemesis gravidarum is characterized by severe nausea and vomiting. This study aims to illustrate the efficacy of acupressure at P6 in treating nausea and vomiting in hyperemesis gravidarum. This parallel randomized controlled trial was conducted from 2016-2017 in a tertiary hospital. Hospitalized women with ≤16 weeks of gestation and moderate to severe nausea and vomiting classified using a modified PUQE score were randomly assigned in a 1:1 ratio to either apply an acupressure wristband at the P6 point three times daily or to receive regular doses of intravenous antiemetics. The primary outcome was differences in modified PUQE scores among the groups. The secondary outcomes were differences in the rate of urine ketone clearance and the frequency of requiring rescue antiemetics. Ninety women were equally randomized into two groups, with no dropout. There was a statistically significant difference in the degrees of nausea and vomiting between the groups at 8, 16, and 24 hours post-admission (p= 0.001, p = 0.006, and p = 0.001). The requirement of antiemetics and the rate of urine ketone clearance between the two groups were also statistically significant, at = 0.001 and = 0.02 respectively. There were no side effects in either group. The P6 acupressure was efficacious in alleviating nausea and vomiting among hyperemesis gravidarum women. The trial was retrospectively registered on ClinicalTrials.gov (NCT05175079).
Topics: Acupressure; Antiemetics; Female; Humans; Hyperemesis Gravidarum; Ketones; Nausea; Pregnancy
PubMed: 36078602
DOI: 10.3390/ijerph191710886 -
Ugeskrift For Laeger Apr 2024Evidence suggests that available antiemetics are equal to intravenous fluid treatment against acute nausea of other causes than motion sickness, pregnancy, anaesthesia,... (Review)
Review
Evidence suggests that available antiemetics are equal to intravenous fluid treatment against acute nausea of other causes than motion sickness, pregnancy, anaesthesia, chemo- or radiation therapy. Each antiemetic is associated with adverse effects, which include movement disorders, sedation, and QT prolongation. Intravenous fluid and treatment directed against underlying pathology is recommended as a first-line treatment against nausea in these patients. If an antiemetic is clinically warranted, ondansetron has the most favourable ratio between side effects and price, as argued in this review.
Topics: Humans; Antiemetics; Nausea; Acute Disease; Ondansetron; Fluid Therapy; Hospitalization; Female; Pregnancy
PubMed: 38704720
DOI: 10.61409/V11230735 -
Medicine Jun 2022Uterine cervix tumors have an invasive nature, with the capacity to proliferate to surrounding organs such as the vagina, bladder, and rectum, as well as the capacity... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Uterine cervix tumors have an invasive nature, with the capacity to proliferate to surrounding organs such as the vagina, bladder, and rectum, as well as the capacity for dissemination and involvement of structures distant from its place of origin. According to the International Federation of Gynecology and Obstetrics, patients with stages IB I, IB I microscopic (small dimension <4 cm) are indicated for radiotherapy or adjuvant chemoradiotherapy with cisplatin (40 mg/m2). However, cisplatin has side effects such as hematological implications (anemia, neutropenia, and thrombocytopenia), gastrointestinal disorders (nausea, vomiting, diarrhea, constipation), and fatigue. Zingiber officinale contains bioactive compounds that act on pregnancy and postoperative nausea, chemotherapy-induced nausea and vomiting, and also in the management of fatigue, myalgia, and insomnia. This study aimed to evaluate the effects of ginger on chemotherapy-induced nausea and vomiting in patients with cervical cancer undergoing treatment with cisplatin and radiotherapy.
METHODS AND ANALYSES
A randomized intervention clinical and controlled trial with a triple-blind design is described, comparing the effects of institutional antiemetic therapy alone, as well as in combination with 2 different ginger concentrations.
ETHICS AND DISSEMINATION
Due to the nature of the study, we obtained approval from the Division Ethics Committee of Liga Contra o Câncer. All participants signed an informed consent form prior to randomization. The results of this study will be published in peer-reviewed journals. The data collected will also be available in a public repository of data.
TRIAL REGISTRATION NUMBER
This study is registered in the Brazilian Registry of Clinical Trials under number RBR-47yx6p9. This study was approved by the Division Ethics Committee of Liga Contra o Câncer under CAAE 40602320.0.0000.5293.
Topics: Antiemetics; Antineoplastic Agents; Cisplatin; Fatigue; Female; Zingiber officinale; Humans; Postoperative Nausea and Vomiting; Pregnancy; Uterine Cervical Neoplasms; Vomiting
PubMed: 35713447
DOI: 10.1097/MD.0000000000029403 -
JAMA Oncology Jun 2020Nausea and vomiting, unrelated to chemotherapy, can be substantial symptoms in patients with advanced cancer. (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Nausea and vomiting, unrelated to chemotherapy, can be substantial symptoms in patients with advanced cancer.
OBJECTIVE
To evaluate the utility of olanzapine for treating chronic nausea/vomiting, unrelated to chemotherapy, in patients with advanced cancer.
DESIGN, SETTING, AND PARTICIPANTS
This study is a double-line, placebo-controlled, randomized clinical trial conducted from July 2017 through April 2019, with analysis conducted in 2019. Eligible participants were outpatients with advanced cancer who had persistent nausea/vomiting without having had chemotherapy or radiotherapy in the prior 14 days. Chronic nausea was present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).
INTERVENTIONS
Patients received olanzapine (5 mg) or a placebo, orally, daily for 7 days.
MAIN OUTCOMES AND MEASURES
Patient-reported outcomes were used for study end points. Data were collected at baseline and daily for 7 more days. The primary study end point (the change in nausea numeric rating scores from baseline to the last treatment day) and the study hypothesis were both identified prior to data collection.
RESULTS
A total of 30 patients (15 per arm) were enrolled; these included 16 women and 14 men who had a mean (range) age of 63 (39-79) years. Baseline median nausea scores, in all patients, were 9 out of 10 (range, 8-10). After 1 day and 1 week, the median nausea scores in the placebo arm were 9 out of 10 (range, 8-10) on both days, compared with the olanzapine arm scores of 2 out of 10 (range, 2-3) after day 1 and 1 out of 10 (range, 0-3) after 1 week. After 1 week of treatment, the reduction in nausea scores in the olanzapine arm was 8 points (95% CI, 7-8) higher than that of the placebo arm. The primary 2-sided end point P value was <.001. Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being. One patient, on the placebo, stopped treatment early owing to lack of perceived benefit. No patients receiving olanzapine reported excess sedation or any other adverse event.
CONCLUSIONS AND RELEVANCE
Olanzapine, at 5 mg/d, appeared to be effective in controlling nausea and emesis and in improving other symptoms and quality-of-life parameters in the study population.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03137121.
Topics: Adult; Aged; Antiemetics; Double-Blind Method; Female; Humans; Male; Middle Aged; Nausea; Neoplasms; Olanzapine; Pilot Projects; Vomiting
PubMed: 32379269
DOI: 10.1001/jamaoncol.2020.1052