Evaluation of Treatment of Hyperemesis gravidarum Using Parenteral Fluid with or without Diazepam

Ditto, Antonino; Morgante, Giuseppe; Marca, Antonio La; Leo, Vincenzo De

doi:10.1159/000010189

Cited by 36 publications

(24 citation statements)

References 25 publications

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“…13,41,57,60,[62][63][64]66,67,69,70,76,[80][81][82][83][85][86][87][88][89]91,93,94,[98][99][100][101][102][103][104][106][107][108]110,[112][113][114][115] Methods employed included random number tables, computer-generated sequence generation 61,63,64,[81][82][83]88,93,94,98,99,106,108,…”

Section: Random Sequence Generationmentioning

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%

“…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%

“…13,41,43,57,59-67,70-72, 74-76,78,80,81,83-85,88,89,91-93,96-99,101-104,106-108,110,112,116,117 Risk of bias was judged as unclear for the final 13 studies. 42,58,68,69,73,77,79,82,95,100,105,109,111 Other sources of bias Twenty of the included RCT studies were judged as having low risk of bias in this area. 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.…”

Section: Allocation Concealmentmentioning

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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