Doxylamine-Pyridoxine May Not Ease Morning Sickness

By Kelly Young

Edited by Susan Sadoughi, MD

Doxylamine-pyridoxine, recommended to treat nausea and vomiting in pregnancy, may not be as effective as previously reported, according to a reanalysis published in PLOS One. (Doxylamine-pyridoxine is marketed as Diclegis in the U.S.)

Briefly, roughly 250 women at 7 to 14 weeks' gestation reporting pregnancy-related nausea and vomiting were randomized to receive doxylamine-pyridoxine or placebo for 2 weeks. The treatment group had a statistically significant improvement of 0.73 points on the 13-point PUQE symptom scale, researchers reported in 2010. However, in this reanalysis, a separate group of researchers point out that a 3-point difference is required to be considered clinically significant. In addition, another analysis of the data found no statistical difference between the groups,

The authors conclude: "Clinical practice and guidelines should be updated. This reanalysis underscores the importance of public access to individual participant level data from clinical trials and the verification of their findings."