Ondansetron compared with metoclopramide for hyperemesis gravidarum: a randomized
controlled trial.
Author(s): Abas MN(1), Tan PC, Azmi N, Omar SZ.
Affiliation(s): Author information:
(1)Department of Obstetrics and Gynecology, Faculty of Medicine, University of
Malaya, Lembah Pantai, Kuala Lumpur, Malaysia.
Publication date & source: 2014, Obstet Gynecol. , 123(6):1272-9
OBJECTIVE: To compare ondansetron with metoclopramide in the treatment of
hyperemesis gravidarum.
METHODS: We enrolled 160 women with hyperemesis gravidarum in a double-blind
randomized trial. Participants were randomized to intravenous 4 mg ondansetron or
10 mg metoclopramide every 8 hours for 24 hours. Participants kept an emesis
diary for 24 hours; at 24 hours, they expressed their well-being using a 10-point
visual numeric rating scale and answered an adverse effects questionnaire. Nausea
intensity was evaluated using a 10-point visual numeric rating scale at
enrollment and at 8, 16, and 24 hours. Primary analysis was on an
intention-to-treat basis.
RESULTS: Eighty women each were randomized to ondansetron or metoclopramide.
Median well-being visual numeric rating scale scores were 9 (range, 5-10)
compared with 9 (range, 4-10) (P=.33) and vomiting episodes in the first 24 hours
were 1 (range, 0-9) compared with 2 (range, 0-23) (P=.38) for ondansetron
compared with metoclopramide, respectively. Repeat-measures analysis of variance
of nausea visual numeric rating scale showed no difference between study drugs
(P=.22). Reported rates of drowsiness (12.5% compared with 30%; P=.01; number
needed to treat to benefit, 6), xerostomia (10.0% compared with 23.8%; P<.01;
number needed to treat to benefit, 8), and persistent ketonuria at 24 hours
(12.5% compared with 30%; P=.01; number needed to treat to benefit, 6) were less
frequent with ondansetron. Length of hospital stay was similar.
CONCLUSION: Ondansetron and metoclopramide demonstrated similar antiemetic and
antinauseant effects in hyperemesis gravidarum. However, the overall profile,
particularly regarding adverse effects, was better with ondansetron. In our
setting, metoclopramide was significantly less expensive than ondansetron and
remained a reasonable antiemetic choice.
CLINICAL TRIAL REGISTRATION: ISRCN Register, www.isrctn.org, ISRCTN00592566.
LEVEL OF EVIDENCE: I.
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