A Randomized Controlled Trial of Ginger

to Treat
Nausea and Vomiting in Pregnancy
SHINTYA FELLA ADLINA
01.210.6278
1. Tujuan Klinik
To estimate whether the use of ginger to treat nausea or
vomiting in pregnancy is equivalent to pyridoxine
hydrochloride (vitamin B6).
2. Rancangan Uji Klinik
A randomized, controlled equivalence trial involving 291
women less than 16 weeks pregnant was undertaken at a
teaching hospital in Australia. The trial took place at The
Womens and ChildrensHospital in Adelaide, Australia,
between July 2000 and March 2002
3. Kriteria Pasien
Women with nausea or vomiting were
eligible for the trial if they were between 8 and 16 weeks
pregnant, with dates confirmed by ultrasound. Women
were excluded if they had any signs of clinical dehydration,if
there were reasons to suspect their symptoms were not the
result of pregnancy, or if they had any known allergy to
ginger or vitamin B6. T he previous use of antiemetics,
ginger, or vitamin B6 did not exclude entry to the trial.
4. Obat dan Pembandingnya
OBAT
Ginger
Pembanding
Vit B6
5. Alokasi Perlakuan Terapi
6. Kriteria Penilaian, ada Blind?
7. Analisa Statistik
 Analysis was by intention to treat using SPSS for Windows
(SSPSS, Chicago,IL) and SAS 8.2 (SAS Institute, Cary, NC)
Equivalence of these mean changes was assessed using one-
sided t tests with 90% confidence intervals (CIs). The 2 or
Fisher exact test was used for comparing binary variables,
and 95% CIs were reported. A P value of less than .05 was used
to demonstrate statistical significance.
8. Makna Klinik Hasil Uji

LEVEL OF EVIDENCE: I
9. Etika
10. Kesimpulan Uji Klinik