Interventions for nausea and vomiting in early pregnancy: a Cochrane Review

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Interventions for nausea and vomiting in early
pregnancy a Cochrane Review

• Clinical

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Background

• Can occur at any time of day
• Most common in first trimester 6-12/40, but can
  continue up to 20/40.
• Persists beyond 20/40 in up to 20
• Associated with rising hCG,
• Hyperemesis gravidarum is severe and persistent
  vomiting, with weight loss gt5, dehydration and
  electrolyte imbalance, and affects 0.3-3
• Nausea and vomiting experienced by 50-80.

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What Interventions?
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Nice Guidelines

• Women should be informed that most cases of
  nausea and
• vomiting in pregnancy will resolve spontaneously
  within 16
• to 20 weeks of gestation and that nausea and
  vomiting are
• not usually associated with a poor pregnancy
  outcome. If a
• woman requests or would like to consider
  treatment, the
• following interventions appear to be effective in
  reducing
• symptoms
• non-pharmacological
• ginger
• P6 acupressure
• pharmacological
• antihistamines (no specific drug )

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BWH Guidelines

• Reassurance the condition is generally
  self-limiting and associated with a good
  prognosis
• Dietary advice - adequate oral fluid intake to
  prevent dehydration, frequent small meals with
  high-carbohydrate or high-protein content (avoid
  offensive odours, fatty foods, spicy foods, iron
  supplements)
• Oral anti-emetics if the patient's condition is
  unresponsive to oral fluids and dietary
  restrictions alone. Recommended first line drug
  is cyclizine 50mg po tds and second line drugs
  include prochlorperazine 5mg po tds, 3-6mg buccal
  bd or 25mg od rectally, metoclopramide 10mg po
  tds.

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Clinical question

• What interventions are effective and safe for
  treating nausea and vomiting in early pregnancy?

Source Matthews A, Dowswell T, Haas DM, Doyle M,
OMathúna DP. Interventions for nausea and
vomiting in early pregnancy. Cochrane Database of
Systematic Reviews 2010, Issue 9. Art. No.
CD007575. DOI 10.1002/14651858.CD007575.pub2.
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Context

• This builds on a Cochrane review of interventions
  for nausea and vomiting in early pregnancy from
  2003.

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Methods

• The Cochrane Pregnancy and Childbirth Groups
  Trials Register was searched by the Trials Search
  Co-ordinator in May 2010. This Register contains
  reports of trials identified from
• quarterly searches of the Cochrane Central
  Register of Controlled Trials (CENTRAL) weekly
  searches of MEDLINE hand searches of 30 journals
  and the proceedings of major conferences weekly
  current awareness alerts for a further 44
  journals and monthly BioMed Central email
  alerts.
• The search identified 55 studies (in 66 reports).
  27 of these studies were included and 22 were
  excluded. Four trials are awaiting further
  assessment and two trials are ongoing.
• Outcomes are described approximately 3 days after
  the start of treatment.

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PICO(S) to assess eligible studies

• Participants Women experiencing nausea, vomiting
  or retching in pregnancy, where recruitment to a
  trial took place up to 20 weeks gestation.
  (Women with the severe illness, hyperemesis
  gravidarum are excluded and covered in another
  review.)
• Intervention All interventions for nausea,
  vomiting or retching.
• Comparison Any other intervention, including
  placebo and usual care.
• Outcomes Primary outcomes symptomatic relief
  (measured as reduction or cessation of nausea,
  vomiting or retching), and adverse maternal and
  fetal/neonatal outcomes. Secondary outcomes
  quality of life, and costs.
• Studies Randomized trials. (Cross-over and
  quasi-randomised studies were excluded.)

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Description of eligible studies

• Twenty-seven trials were included, with a total
  of 4041 women.
• Studies were found of the following comparisons
• Acupressure (P6 point, including acustimulation
  and auricular) versus placebo or vitamin B6 (7
  studies, 795 women)
• Acupuncture versus sham treatment and no
  treatment (2 studies, 648 women)
• Moxibustion (Traditional Chinese Medicine) versus
  Chinese drugs (1 study, 302 women)
• Ginger versus placebo, vitamin B6 or drugs (9
  studies, 1077 women)
• Vitamin B6 versus placebo (2 studies, 416 women)
• Anti-emetic medications (6) versus placebo (6
  studies with 803 women)

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Results symptom relief

• No statistically significant difference between
  P6 acupressure and placebo or vitamin B6.
• Results for auricular acupuncture difficult to
  interpret, and no statistically significant
  differences in the acupuncture study.
• Improvements with both moxibustion and Chinese
  drugs, but this study is poorly reported.
• Two studies favoured ginger over placebo
• Some studies favoured ginger over vitamin B6 and
  some favoured vitamin B6 over ginger.
• Vitamin B6 was better than placebo.
• Of the anti-emetic medications studied, the
  combination of dicyclomine (anti-cholinergic),
  doxylamine and pyridoxine was better than placebo.

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Results adverse effects and secondary outcomes

• Adverse effects on the mother or baby
• Maternal effects
• Side-effects from acupressure bands (both placebo
  and treatment groups)
• Heartburn from ginger
• Fetal/neonatal effects
• No studies found significant differences in
  adverse neonatal outcomes, but all were too small
  to detect any likely differences
• Secondary outcomes
• Quality of life was reported in few studies (and
  results were difficult to interpret)
• No studies reported on economic costs

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Conclusions current evidence

• There is little strong or consistent evidence for
  any intervention, and it is not possible to be
  confident in the effectiveness or safety of any
  of the interventions.
• The methodological quality of studies was mixed,
  with inadequate information on randomisation
  procedures and blinding in many studies and the
  results were difficult to interpret and pool
  because of differences in participants,
  interventions, comparisons and outcomes.
• Some commonly recommended interventions, such as
  dietary and other behavioural advice, have not
  been studied.
• No studies had the statistical power to provide
  convincing evidence of the effects on relatively
  rare adverse outcomes.
• There was very little information on the
  psychological, social or economic effects of
  nausea and how these were affected by different
  interventions.

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Limitations

• No research into cyclizine included
• Limited research into prochlorperazine and
  metoclopramide ( Bsat 2003)

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Conclusions future research

• There is a need for specific and justified
  outcomes in research on interventions for nausea
  and vomiting in pregnancy.
• Several instruments have been used to measure
  outcomes and some of these might help address
  this (for example, the Pregnancy Unique
  Quantification of Emesis and Nausea (PUQE)
  scale).
• Adherence to dietary and other advice should be
  measured consistently, because this may also
  affect symptom relief.
• Adverse effects, quality of life and cost
  outcomes need to be collected and reported.

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Useful links

• Cochrane Journal Club discussion points
• Interventions for nausea and vomiting in early
  pregnancy

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