Among 352 women in early pregnancy with moderate-to-severe nausea and vomiting, acupuncture and doxylamine–pyridoxine individually were efficacious but with modest effects of uncertain clinical importance. Combination therapy “may yield a potentially larger benefit than each treatment alone,” the investigators conclude.
Conducted at 13 tertiary hospitals in China, participants were randomized to daily active or sham acupuncture for 30 minutes and doxylamine-pyridoxine or placebo for 14 days. Based on a primary outcome of reduction in Pregnancy-Unique Quantification of Emesis (PUQE) score at the end of the intervention at day 15 relative to baseline, the study yielded these results: “No significant interaction was detected between the interventions (P = 0.69). Participants receiving acupuncture (mean difference [MD], −0.7 [95% CI, −1.3 to −0.1]), doxylamine–pyridoxine (MD, −1.0 [CI, −1.6 to −0.4]), and the combination of both (MD, −1.6 [CI, −2.2 to −0.9]) had a larger reduction in PUQE score over the treatment course than their respective control groups (sham acupuncture, placebo, and sham acupuncture plus placebo). Compared with placebo, a higher risk for births with children who were small for gestational age was observed with doxylamine–pyridoxine (odds ratio, 3.8 [CI, 1.0 to 14.1]).”