A randomized double-blind controlled trial.
SETTING: The Department of Obstetrics and Gynecology, Bangkok Metropolitan Administration Medical College and Vajira Hospital.
SUBJECTS: Women with
nausea and
vomiting of pregnancy at or before 16 weeks of gestation, who attended the
antenatal care clinic. The subjects requested
anti-emetics, had no medical complications, non-hospitalized and were able to attend a one week follow-up visit. From November, 1999 to November 2000, 138 women participated and gave consent for the study.
METHOD: The subjects were randomly allocated into two groups to take either 500 mg of ginger orally or an identical 10 mg of
vitamin B6 one
capsule three times daily for three days. Subjects graded the severity of their
nausea using visual analogue scales before treatment and recorded the number of
vomiting episodes in the previous 24 hours and again during three consecutive days of treatment.
MAIN OUTCOME MEASURES: The 64 subjects in each group remained in the study. The demographic data were comparable in both groups. The ginger and
vitamin B6 significantly reduced the
nausea scores from 5.0 (SD, 1.99) to 3.6 (SD, 2.48) and 5.3 (SD, 2.08) to 3.3 (SD, 2.07) respectively, with p < 0.001. The mean score change
after treatment with ginger was 1.4 (2.21), less than with
vitamin B6, which was 2.0 (2.19) but with no statistically significant difference (95% CI -1.4 to 0.2, p = 0.136). The ginger and
vitamin B6 also significantly reduced the number of
vomiting episodes from 1.9 (2.06) to 1.2 (1.75) and 1.7 (1.81) to 1.2 (1.50) respectively, with p < 0.01. The mean number change
after treatment with ginger was 0.7 (2.18), more than with
vitamin B6, which was 0.5 (1.44) but with no statistically significant difference, (p = 0.498). There were some minor side effects in both groups such as sedation (26.6% vs 32.8%, p = 0.439), and
heartburn (9.4% vs 6.3%, p = 0.510), a non-significant difference.
CONCLUSION: