Ondansetron Compared With Doxylamine and Pyridoxine for Treatment of Nausea in Pregnancy

Oliveira, Lauren G.; Shannon, Michael; You, Whitney; Riffenburgh, Robert H.; Carstairs, Shaun D.

doi:10.1097/aog.0000000000000479

Cited by 58 publications

(46 citation statements)

References 17 publications

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“…However to the best of the authors' knowledge, no study was previously published on neonatal outcomes following the use of ondansetron compared to that of vitamin B6. In a study by Oliveira et al (13) and in contrary to the current study observations, patients in the ondansetron group were more likely to have an improvement in their nausea compared with the ones in the vitamin B6 group, in the five-day treatment course. Females using ondansetron reported less vomiting, although the neonatal outcomes were not compared between the two groups.…”

Section: Discussioncontrasting

confidence: 99%

Comparing Neonatal Outcome Following the Use of Ondansetron versus Vitamin B6 in Pregnant Females with Morning Sickness: A Randomized Clinical Trial

et al. 2016

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Background: Pregnancy-related nausea and vomiting or morning sickness with an overall prevalence rate of 80% is commonly appeared at the eighth week and frequently disappeared in most pregnant females at the 16th week of gestation. The severe form of the condition named hyperemesis occurs in one per 200 to 300 pregnancies; it is accompanied by dehydration, electrolyte instability and nutritional deficits and needs medical interventions. Limited data are available on harmful effects of common antiemetic medications used within pregnancy on human neonates. Objectives: The current study aimed to compare the effects of ondansetron and vitamin B6 on neonatal outcome in pregnant females with pregnancy-related nausea and vomiting. Neonatal outcome included the probable difference in neonates' gestational age, weight, height, head circumference and frequency of apparent congenital anomalies. Methods: This randomized double-blinded clinical trial was conducted on 188 primipara singleton pregnant females with pregnancy-related nausea and vomiting who referred to state healthcare centers of Zabol, Iran, in 2014. The pregnant females were randomly assigned to receive drug packages including ondansetron tablets (4 mg) or vitamin B6 tablets (40 mg) and patients were instructed to take one tablet twice daily. Females were followed up until delivery and neonatal outcomes including any congenital anomaly, weight, height and head circumference at birth were assessed. Results: There was no difference between the groups in the mean age of mother and the mean age of gestation. No differences were

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Section: Discussioncontrasting

confidence: 99%

Comparing Neonatal Outcome Following the Use of Ondansetron versus Vitamin B6 in Pregnant Females with Morning Sickness: A Randomized Clinical Trial

et al. 2016

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“…The remaining 16 studies did not provide sufficient information to permit a judgement of low or high bias, often due to imprecise, poor reporting, and were thus classed as unclear. 42,43,65,69,70,73,76,94,95,97,98,104,107,109,111,114 Incomplete outcome data Most studies (n = 50) were judged as carrying low risk of bias in relation to this component. 13,41,42,57,59-61, 63-65,67,70-72,74-76,78,80-85,87-89,91-94,96-99,102-108,110,112-118 Although published protocols were rarely available, all data for the primary outcomes pre-specified in the paper were reported for all randomised participants, or rates of drop-out were either sufficiently low (< 20%), or proportionately comparable between groups, so that it was not considered likely to result in a clinically relevant bias.…”

Section: Allocation Concealmentmentioning

confidence: 99%

“…62,68,111 The remainder (11 studies in total) were judged as unclear due to lack of sufficient information. 43,58,66,69,73,77,79,90,95,100,109 Selective outcome reporting Six studies were judged as having high risk of bias in terms of selective outcome reporting, due to either not reporting data for pre-specified outcomes, or for reporting data in the results that were not pre-specified in either the original study protocol or methods section. 87,90,94,[113][114][115] Forty-five studies were classed as having low risk of bias, with all outcomes specified and subsequently reported.…”

Section: Allocation Concealmentmentioning

confidence: 99%

“…57,60,61,63,64,66,67,73,76,78,[80][81][82][83][84][85]88,89,93,98,99,102,103,[105][106][107][108]112,118 Thirty studies did not provide sufficient information to allow a judgement of low or high risk and were therefore classed as unclear. 13,[41][42][43]58,59,62,65,[68][69][70][71]74,75,77,79,90,91,[94][95][96][97]100,…”

Section: Allocation Concealmentmentioning

confidence: 99%

“…111 It was categorised as unclear in the remaining 24 RCTs due to insufficient information provided by the authors to permit judgement either way. 42,43,58,59,65,68,[71][72][73][74][75][77][78][79]84,90,92,[95][96][97]104,105,109,116 …”

Section: Random Sequence Generationmentioning

confidence: 99%

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Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment

O’Donnell

McParlin

Robson

et al. 2016

Health Technol Assess

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BackgroundNausea and vomiting in pregnancy (NVP) affects up to 85% of all women during pregnancy, but for the majority self-management suffices. For the remainder, symptoms are more severe and the most severe form of NVP – hyperemesis gravidarum (HG) – affects 0.3–1.0% of pregnant women. There is no widely accepted point at which NVP becomes HG.ObjectivesThis study aimed to determine the relative clinical effectiveness and cost-effectiveness of treatments for NVP and HG.Data sourcesMEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, PsycINFO, Commonwealth Agricultural Bureaux (CAB) Abstracts, Latin American and Caribbean Health Sciences Literature, Allied and Complementary Medicine Database, British Nursing Index, Science Citation Index, Social Sciences Citation Index, Scopus, Conference Proceedings Index, NHS Economic Evaluation Database, Health Economic Evaluations Database, China National Knowledge Infrastructure, Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effects were searched from inception to September 2014. References from studies and literature reviews identified were also examined.Obstetric Medicinewas hand-searched, as were websites of relevant organisations. Costs came from NHS sources.Review methodsA systematic review of randomised and non-randomised controlled trials (RCTs) for effectiveness, and population-based case series for adverse events and fetal outcomes. Treatments: vitamins B6 and B12, ginger, acupressure/acupuncture, hypnotherapy, antiemetics, dopamine antagonists, 5-hydroxytryptamine receptor antagonists, intravenous (i.v.) fluids, corticosteroids, enteral and parenteral feeding or other novel treatment. Two reviewers extracted data and quality assessed studies. Results were narratively synthesised; planned meta-analysis was not possible due to heterogeneity and incomplete reporting. A simple economic evaluation considered the implied values of treatments.ResultsSeventy-three studies (75 reports) met the inclusion criteria. For RCTs, 33 and 11 studies had a low and high risk of bias respectively. For the remainder (n = 20) it was unclear. The non-randomised studies (n = 9) were low quality. There were 33 separate comparators. The most common were acupressure versus placebo (n = 12); steroid versus usual treatment (n = 7); ginger versus placebo (n = 6); ginger versus vitamin B6 (n = 6); and vitamin B6 versus placebo (n = 4). There was evidence that ginger, antihistamines, metoclopramide (mild disease) and vitamin B6 (mild to severe disease) are better than placebo. Diclectin®[Duchesnay Inc.; doxylamine succinate (10 mg) plus pyridoxine hydrochloride (10 mg) slow release tablet] is more effective than placebo and ondansetron is more effective at reducing nausea than pyridoxine plus doxylamine. Diclectin before symptoms of NVP begin for women at high risk of severe NVP recurrence reduces risk of moderate/severe NVP compared with taking Diclectin once symptoms begin. Promethazine is as, and ondansetron is more, effective than metoclopramide for severe NVP/HG. I.v. fluids help correct dehydration and improve symptoms. Dextrose saline may be more effective at reducing nausea than normal saline. Transdermal clonidine patches may be effective for severe HG. Enteral feeding is effective but extreme method treatment for very severe symptoms. Day case management for moderate/severe symptoms is feasible, acceptable and as effective as inpatient care. For all other interventions and comparisons, evidence is unclear. The economic analysis was limited by lack of effectiveness data, but comparison of costs between treatments highlights the implications of different choices.LimitationsThe main limitations were the quantity and quality of the data available.ConclusionThere was evidence of some improvement in symptoms for some treatments, but these data may not be transferable across disease severities. Methodologically sound and larger trials of the main therapies considered within the UK NHS are needed.Study registrationThis study is registered as PROSPERO CRD42013006642.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy

McParlin

O’Donnell

Robson

et al. 2016

JAMA

141

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Ondansetron Compared With Doxylamine and Pyridoxine for Treatment of Nausea in Pregnancy

Abstract: : I.

Cited by 58 publications

References 17 publications

Comparing Neonatal Outcome Following the Use of Ondansetron versus Vitamin B6 in Pregnant Females with Morning Sickness: A Randomized Clinical Trial

Comparing Neonatal Outcome Following the Use of Ondansetron versus Vitamin B6 in Pregnant Females with Morning Sickness: A Randomized Clinical Trial

Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment

Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy

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