Greater improvement in symptom scores versus placebo, but clinical relevance unclear
THURSDAY, Jan. 18, 2018 (HealthDay News) — Doxylamine-pyridoxine may be beneficial for nausea and vomiting symptoms in early pregnancy, but the magnitude of the difference is very small and may indicate no clinically important benefit, according to a study published online Jan. 17 in PLOS ONE.
Navindra Persaud, M.D., from St. Michael’s Hospital in Toronto, and colleagues re-analyzed individual level data from a randomized trial conducted in six outpatient obstetrical practices in the United States. Pregnant women between 7 and 14 weeks of gestation with moderate nausea and vomiting of pregnancy were randomized to an active treatment (tablet containing doxylamine and pyridoxine) or placebo. Data were analyzed for 131 active treatment participants and 125 control participants. Primary outcome measures were provided for 101 active treatment participants and 86 control participants.
The researchers found that the improvement in symptom scores was greater with doxylamine-pyridoxine versus placebo (0.73 points; 95 percent confidence interval, 0.21 to 1.25) when the last observation carried forward imputation was used for missing data. Using other approaches to missing data, the difference was not statistically significant (0.38; 95 percent confidence interval, −0.08 to 0.84).
“There is a trend towards efficacy for nausea and vomiting symptoms with doxylamine-pyridoxine compared with placebo but the statistical significance of the difference depends on the method of handling missing data and the magnitude of the difference suggests that there is no clinically important benefit,” the authors write.
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