It’s enough to make you PUQE.
Hyperemesis Gravidarum (HG) is a debilitating condition in pregnancy.
It should be taken seriously in research, right?
Apparently, the Danes disagree.
A research team in Denmark recruited 59 pregnant women to participate in the VOMIT trial, an acronym for Validating the effect of Ondansetron and Mirtazapine In Treating hyperemesis gravidarum, with the findings published in the American Journal of Obstetrics and Gynecology .
The choice of which letters to use in the acronym is extremely questionable – who includes filler words like “in” while completely skipping over the actual condition?
But it begs the question: is this highly insensitive to the immense suffering of women with HG and the increased risk of adverse foetal outcomes, or is it just too good an opportunity to waste?
And look, credit where credit is due; they are doing incredibly valuable work.
Women need expanded and better pharmaceutical options in pregnancy and, according to the authors, there are no placebo-controlled trials with oral ondansetron in pregnancy and no controlled trials with mirtazapine in pregnancy.
Although a small trial, it focused on those severely affected – participants either had a Pregnancy Unique Quantification of Emesis 24 (PUQE-24) score of 13 or higher, or a score of at least seven accompanied by a 5% or greater weight loss or a need for hospitalisation.
Ok, this is getting ridiculous now. Is the acronym for the severity of HG seriously “puke”??
But I digress.
The multicentre, double-blinded RCT assigned participants 1:1:1 to oral treatment with either mirtazapine, ondansetron or placebo for 14 days.
The mirtazapine group experienced a mean 1.86-point greater reduction in puke score than placebo after two days, while ondansetron was only a 0.51 greater reduction than placebo.
After one week, the reduction in score change from baseline was 2.11 points greater for mirtazapine than ondansetron (-2.93 mirtazapine vs placebo, -0.81 ondansetron vs placebo).
At day 14, the improvements dipped somewhat, but mirtazapine still appeared superior to ondansetron. There was a 2.43-point greater reduction in the mirtazapine group than placebo and a -0.64 difference between ondansetron and placebo (-1.79 mirtazapine vs ondansetron).
Tablets were administered twice a day for the first week – ondansetron 8mg in the morning and evening, and mirtazapine 15mg in the evening and placebo in the morning.
Participants could request to increase their dose for the second week, with four tablets spread across the day – three placebos and a bedtime 30mg mirtazapine, or four 8mg ondansetron tablets.
All groups were allowed oral metoclopramide 10mg (rescue medication) up to three times daily and intravenous rehydration as necessary.
Participants filled out baseline and daily questionnaires, which were more extensive on days seven and 14, which covered adherence to trial medication, PUQE-24 score, adverse events and more.
The difference in use of rescue medication, days of sick leave, amount of fluid treatments and hospitalisations were not significantly different between the groups, but patient satisfaction was higher with mirtazapine than ondansetron (28.9 points greater on a 100-point scale).
Adverse events were more common in the mirtazapine group, with 86% experiencing any compared to 72% of ondansetron and 40% of placebo groups.
Most effects were mild to moderate and resolved on their own. For mirtazapine, common adverse events were fatigue (48%), dizziness (24%) and headache (24%), while the ondansetron group experienced mostly constipation (44%) and headache (33%).
Only three participants discontinued from mirtazapine, all due to excessive fatigue, and one serious adverse event was reported in each of the mirtazapine and ondansetron groups, compared to two in placebo.
One participant in the mirtazapine gave birth to a child with congenital malformations – unilateral membranous choanal atresia and stenosis of the pulmonary valve. At two-year follow-up, no pulmonary stenosis was detected and the child developed normally.
This certainly isn’t the first study with a comical name, and it won’t be the last.
But as far as this author is concerned, as long as they’re contributing meaningfully to women’s health, they can call it whatever they like.
If you’ve got a story tip gurgling inside you, let it out by emailing holly@medicalrepublic.com.au.
