59: Ondansetron versus doxylamine/pyridoxine for treatment of nausea and vomiting in pregnancy: a prospective randomized double-blind trial

Capp, Shannon; Oliveira, Lauren G.; Carstairs, Shaun D.; You, Whitney

doi:10.1016/j.ajog.2013.10.092

Cited by 5 publications

(13 citation statements)

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“…Another trial 117 examined pre-emptive treatment with Diclectin and this trial appeared to be at low risk of bias but some items were unclear. Capp and colleagues 65 was at unclear risk of bias due to lack of provided details across a number of measures.…”

Section: Discussionmentioning

confidence: 99%

“…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%

“…13,41,42,61,62,64,67,70,71,74,81,83,88,96,[101][102][103]106,110,112 However, a substantial number (n = 44) were classed as unclear, due to lack of sufficient information in the paper to permit detailed assessment of whether or not an important risk of bias existed, or due to insufficient rationale or evidence that an identified problem had introduced serious levels of bias to the study. 43,[57][58][59][60]65,66,68,69,72,73,[75][76][77][78][79][80]82,84,85,87,[89][90][91][92][93][94][95][97]…”

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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Section: Discussionmentioning

confidence: 99%

Section: Allocation Concealmentmentioning

confidence: 99%

Section: Allocation Concealmentmentioning

confidence: 99%

Section: Allocation Concealmentmentioning

confidence: 99%

Section: Random Sequence Generationmentioning

confidence: 99%

See 3 more Smart Citations

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

View full text Add to dashboard Cite

show abstract

Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy

McParlin

O’Donnell

Robson

et al. 2016

JAMA

141

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Interventions for nausea and vomiting in early pregnancy

Matthews

Haas

O’Mathúna

et al. 2015

Cochrane Database of Systematic Reviews

211

124

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Given the high prevalence of nausea and vomiting in early pregnancy, women and health professionals need clear guidance about effective and safe interventions, based on systematically reviewed evidence. There is a lack of high-quality evidence to support any particular intervention. This is not the same as saying that the interventions studied are ineffective, but that there is insufficient strong evidence for any one intervention. The difficulties in interpreting and pooling the results of the studies included in this review highlight the need for specific, consistent and clearly justified outcomes and approaches to measurement in research studies.

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59: Ondansetron versus doxylamine/pyridoxine for treatment of nausea and vomiting in pregnancy: a prospective randomized double-blind trial

Cited by 5 publications

References 0 publications

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: a systematic review and economic assessment

Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy

Interventions for nausea and vomiting in early pregnancy

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