THE EFFICACY OF METHYLPREDNISOLONE IN THE TREATMENT OF HYPEREMESIS GRAVIDARUM - A RANDOMIZED, DOUBLE-BLIND, CONTROLLED-STUDY

OBJECTIVE: The study compared the efficacy of methylprednisolone with that of promethazine for the treatment of hyperemesis gravidarum. STUD Y DESIGN: Patients with a normal-appearing intrauterine pregnancy of l ess than or equal to 16 weeks' gestation with hyperemesis gravidarum ( persistent vomiting and large ketonuria despite outpatient therapy) we re admitted to the hospital for continuous intravenous hydration and o ffered participation in the study. Patients meeting study criteria wer e randomly assigned to receive (from identical-appearing dispensers pa ckaged in advance with a 2-week supply) oral methylprednisolone, 16 mg 3 times daily, or oral promethazine, 25 mg 3 times daily. After 3 day s the methylprednisolone was tapered completely during the course of 2 weeks whereas the promethazine was continued without change for 2 wee ks. For patients who continued to vomit after 2 days the study medicat ion was discontinued. Patients receiving study medication at discharge continued to take the remainder of the assigned medication from the p ackaged pill dispensers. Patients were followed up weekly. The study o utcomes, as established in advance, were (1) improvement of symptoms w ithin 2 days of starting therapy and (2) readmission for hyperemesis w ithin 2 weeks of starting the study. RESULTS: Forty patients were enro lled in the course of 11 months (20 per group). There were no signific ant differences between the groups with respect to maternal age, gravi dity, parity, gestational age at entry, number of previous admissions, or >5% body weight loss. Three patients in the methylprednisolone gro up and 2 in the promethazine group failed to stop vomiting within 2 da ys. One patient from the promethazine group was unavailable for follow -up. No patient from the methylprednisolone group but 5 of the 17 pati ents receiving promethazine were readmitted for hyperemesis within 2 w eeks of discharge (P = .0001). There were no adverse effects noted for either drug. CONCLUSION: A short course of methylprednisolone is more effective than promethazine for the treatment of hyperemesis.