Objective
In 2010 we published in the Journal a primary paper examining the effectiveness of the pyridoxine-doxylamine delayed-release combination in treating symptoms of morning sickness. We were asked by readers to report on other endpoints that were listed online in the study plan ( clinicaltrials.gov – NCT00614445 ) but were not reported in the primary paper. The objective of this letter is to report these additional data.
Study Design
This was a blinded randomized controlled trial comparing the pyridoxine-doxylamine delayed-release combination to placebo over 14 days of treatment. One hundred and forty subjects per arm were to be enrolled to achieve 200 evaluable subjects for a power of 0.9 and beta of 0.01. An estimated dropout rate of 25% and a noncompliance rate of approximately 5% were expected.
Study Design
This was a blinded randomized controlled trial comparing the pyridoxine-doxylamine delayed-release combination to placebo over 14 days of treatment. One hundred and forty subjects per arm were to be enrolled to achieve 200 evaluable subjects for a power of 0.9 and beta of 0.01. An estimated dropout rate of 25% and a noncompliance rate of approximately 5% were expected.
Results
The active combination was superior to placebo in the prespecified primary outcomes of change in the Pregnancy-Unique Quantification of Emesis (PUQE) score ( P = .006) and in the measurement of quality of life ( P = .005). All of the data from this trial (including unpublished data) were submitted to the US Food and Drug Administration in support of a new drug application (NDA 021876).
There were no significant differences between the active drug and placebo in the number of tablets used, in the rates of calls or visits to healthcare providers, or in time lost from household tasks. In time lost from employment, women on the active drug lost 0.92 ± 3.86 hours vs 2.37 ± 10.23 in the placebo group ( P = .064). There were nonsignificant trends between the 2 arms in 2 of the 3 individual components of the PUQE score (vomiting and retching) ( Table ).
