What research do you want to see?
I’m feeling a huge weight of responsibility at the moment. You see we have finally got so key funders interested in researching treatments for hyperemesis gravidarum… woohoo I hear you say! Except that it’s not quite as simple as that.
The problem is, I don’t believe the research they are proposing is clinically relevant or helpful to women with HG in the UK at the moment. And I have concerns over the ethics of the trial they are proposing (the ONLY trial they are proposing). The good news is that I'm involved as an "expert patient" advisor to the funders on which team of researchers proposals they will fund to go ahead.
I have three responsibilities…
- As the chairperson for Pregnancy Sickness Support it is my duty to ensure the reputation of the organisation is maintained and enhanced as a reputable patient representative organisation which women, health care providers and the public can trust and rely on.
- As Spewing Mummy I feel a weight of responsibility to give a representative voice to UK women affected by hyperemesis gravidarum and ensure that their voices are heard through me.
- As a registered nurse (and ethically motivated member of society and tax payer) I have a duty to encourage public money to be used wisely and purposefully and to that end that ensure research is purposeful and meaningful.
However, I am concerned that I don’t truly know what you, my audience, want from research in the UK and so I would like a conversation with as many of you as possible. Please get involved, comment below and give me your thoughts so that I may represent them accurately and loudly with the people in power.
The current research suggestion is for a Randomised Control Trial of Metocloprimide verses Ondansetron. The argument in favour is that we don’t ‘know’ which is better as a second-line treatment for those women whose symptoms aren’t controlled with cyclizine. Is this a research project you would like to have a huge amount of money invested in? Do you think that the answers we can get from it will make a big difference to you? Do you think we already know the answer of which drug is better and therefore don’t need a trial like this? Would you be willing to take part knowing that you might get a placebo drug (ie. A fake drug with no effect) for a period of time?
If this is not the sort of research you feel is of clinical importance at the moment then what would you prefer to see? Some ideas are:
- Ondansetron verse Steroids
- High does Ondansetron (ie. Up to 32mg) verse current doses (up to 16mg)
- Omeprazole (the strong antacid) combined with antiemetics verses placebo (I think omeprazole is massively under-utilised and can improve not just the symptoms themselves but the trauma of the symptoms, because let’s face it puking pure acid out of your nose is traumatic! And it’s the acid that hurts our oesophagus and wrecks our teeth)
- Rapid rehydration verses standard rehydration protocols
- Early pre-emptive treatment verse waiting until symptoms are severe
Bear in mind that the potential funders in question only fund clinical trials of this nature (like drug X verses Drug Y or verses placebo) rather than exploratory research such as causes of HG, but, that getting such research funded would allow money for qualitative aspects of the trial also.
My concerns are thus:
- We know Ondansetron is better and there’s no need to do a long clinical trial to prove it, we know this from the use of anti-emetics in other, non-pregnant, conditions and from clinical experience.
- The reason doctors are reluctant to prescribe ondansetron is not because they don’t know it works but because they are not convinced it’s safe because they haven’t read papers like Pasternak (2013). A trial of this size won’t have enough power (ie. It’s not big enough) to show the safety of the drugs, it would only be about which is more effective. Therefore it is education that is needed rather than research.
- A placebo arm and delaying ondansetron is ethically unacceptable
However, I want to know your thoughts on it… Do you want to know definitively which is better, metoclopramide or ondansetron and would you be willing to take part in a drug trial where you might get a placebo (dummy) drug instead of a real one, even if just for a couple of days to find out the answer?
If not then what do you think the top priorities for HG research are? How would you like to see research money spent to improve the lives of women affected by hyperemesis gravidarum? What research can we do now that will ensure our daughters don’t suffer the way we have?
Pasternak, B. (2013) 'Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes (vol 368, pg 814, 2013)', New England Journal of Medicine, 368(22), pp. 2146-2146.