Fifty-nine women completed a randomized, double-blind placebo-controlled study of
pyridoxine hydrochloride (
vitamin B6) for the treatment of
nausea and
vomiting of pregnancy. Thirty-one patients received
vitamin B6, 25-mg
tablets orally every 8 hours for 72 hours, and 28 patients received placebo in the same regimen. Patients were categorized according to the presence of
vomiting: severe
nausea (score greater than 7) or mild to moderate
nausea (score of 7 or less). The severity of
nausea (as graded on a visual analogue scale of 1-10 cm) and the number of patients with
vomiting over a 72-hour period were used to evaluate response to
therapy. Twelve of 31 patients in the
vitamin B6 group had a pre-treatment
nausea score greater than 7 (severe) (mean 8.2 +/- 0.8), as did ten of 28 patients in the placebo group (mean 8.7 +/- 0.9) (not significant). Following
therapy, there was a significant difference in the mean "difference in
nausea" score (ie, baseline - post-
therapy nausea) between patients with severe
nausea receiving
vitamin B6 (mean 4.3 +/- 2.1) and placebo (mean 1.8 +/- 2.2) (P less than .01). In patients with mild to moderate
nausea and in the group as a whole, no significant difference between treatment and placebo was observed. Fifteen of 31
vitamin B6-treated patients had
vomiting before
therapy, compared with ten of 28 in the placebo group (not significant). At the completion of 3 days of
therapy, only eight of 31 patients in the
vitamin B6 group had any
vomiting, compared with 15 of 28 patients in the placebo group (P less than .05).(ABSTRACT TRUNCATED AT 250 WORDS)