Randomised, double-blind, placebo-controlled trial of corticosteroids for the treatment of hyperemesis gravidarum

Objective To assess the efficacy of corticosteroids in the treatment of sev ere hyperemesis gravidarum refractory to conventional management. Design Multicentre, double-blind, randomised, placebo-controlled trial. Setting Inpatient gynaecology wards in eight collaborating centres. Population Twenty-five women with severe hyperemesis of which 24 completed the one- week study period. Methods Twenty-five women were randomised to receive either 40 mg prednisol one daily in two divided oral doses, or equivalent placebo tablets. If, aft er three days, a woman was still vomiting, medication was changed to the eq uivalent intravenous alternative (hydrocortisone 100mg twice daily or norma l saline injections) Main outcome measures Frequency of vomiting and the dependence on intraveno us fluid replacement therapy after one week of treatment. Results There was a non-significant trend towards improved nausea and vomit ing and reduced dependence on intravenous fluids. However, steroid therapy led to an improved sense of wellbeing (P = 0.021), improved appetite (P = 0 .039) and increased weight gain (P = 0.025) compared with placebo. There wa s no difference in pregnancy outcome between the treatment and placebo grou ps. Conclusions This study supports a beneficial role for steroids in severe hy peremesis, but did not validate the hypothesis that they lead to rapid and complete remission of symptoms. The study was not large enough to demonstra te a significant improvement in the primary outcome measures.