• Xiao-Ke Wu, Jing-Shu Gao, Hong-Li Ma, Yu Wang, Bei Zhang, Zhao-Lan Liu, Jian Li, Jing Cong, Hui-Chao Qin, Xin-Ming Yang, Qi Wu, Xiao-Yong Chen, Zong-Lin Lu, Ya-Hong Feng, Xue Qi, Yan-Xiang Wang, Lan Yu, Ying-Mei Cui, Chun-Mei An, Li-Li Zhou, Yu-Hong Hu, Lu Li, Yi-Juan Cao, Ying Yan, Li Liu, Yu-Xiu Liu, Zhi-Shun Liu, Rebecca C Painter, NgErnest H YEHY0000-0002-7688-4557Department of Obstetrics & Gynaecology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China (E.H.Y.N.)., Jian-Ping Liu, MolBen Willem JBWJ0000-0001-8337-550XMonash Medical Centre, Monash University, Melbourne, Victoria, Australia (B.W.J.M.)., and Chi Chiu Wang.
• First Affiliated Hospital, Heilongjiang University of Chinese Medicine, and Heilongjiang Provincial Hospital, Harbin, China (X.-K.W.).
• Ann. Intern. Med. 2023 Jul 1; 176 (7): 922933922-933.

BackgroundAn effective and safe treatment for nausea and vomiting of pregnancy (NVP) is lacking.ObjectiveTo assess the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in women with moderate to severe NVP.DesignMulticenter, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. (ClinicalTrials.gov: NCT04401384).Setting13 tertiary hospitals in mainland China from 21 June 2020 to 2 February 2022.Participants352 women in early pregnancy with moderate to severe NVP.InterventionParticipants received daily active or sham acupuncture for 30 minutes and doxylamine-pyridoxine or placebo for 14 days.MeasurementsThe primary outcome was the reduction in Pregnancy-Unique Quantification of Emesis (PUQE) score at the end of the intervention at day 15 relative to baseline. Secondary outcomes included quality of life, adverse events, and maternal and perinatal complications.ResultsNo 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]).LimitationThe placebo effects of the interventions and natural regression of the disease were not evaluated.ConclusionBoth acupuncture and doxylamine-pyridoxine alone are efficacious for moderate and severe NVP. However, the clinical importance of this effect is uncertain because of its modest magnitude. The combination of acupuncture and doxylamine-pyridoxine may yield a potentially larger benefit than each treatment alone.Primary Funding SourceThe National Key R&D Program of China and the Project of Heilongjiang Province "TouYan" Innovation Team.

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