TY - JOUR
T1 - Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy
T2 - A Randomized, Controlled, 2 × 2 Factorial Trial
AU - Wu, Xiao-Ke
AU - Gao, Jing-Shu
AU - Ma, Hong-Li
AU - Wang, Yu
AU - Zhang, Bei
AU - Liu, Zhao-Lan
AU - Li, Jian
AU - Cong, Jing
AU - Qin, Hui-Chao
AU - Yang, Xin-Ming
AU - Wu, Qi
AU - Chen, Xiao-Yong
AU - Lu, Zong-Lin
AU - Feng, Ya-Hong
AU - Qi, Xue
AU - Wang, Yan-Xiang
AU - Yu, Lan
AU - Cui, Ying-Mei
AU - An, Chun-Mei
AU - Zhou, Li-Li
AU - Hu, Yu-Hong
AU - Li, Lu
AU - Cao, Yi-Juan
AU - Yan, Ying
AU - Liu, Li
AU - Liu, Yu-Xiu
AU - Liu, Zhi-Shun
AU - Painter, Rebecca C.
AU - Ng, Ernest H. Y.
AU - Liu, Jian-Ping
AU - Mol, Ben Willem J.
AU - Wang, Chi Chiu
N1 - Funding Information: Primary Funding Source: The National Key R&D Program of China and the Project of Heilongjiang Province “TouYan” Innovation Team. Funding Information: Grant Support: By the National Key R&D Program of China (2019YFC1709500), the Project of Heilongjiang Province “TouYan” Innovation Team, the National Clinical Research Base of Chinese Medicine, the Heilongjiang Provincial Clinical Research Centre for Ovary Diseases, and the 2023 Capability Improvement Project for Evidence-based Assessment of Traditional Chinese Medicine (2023–2024). Publisher Copyright: © 2023 American College of Physicians.
PY - 2023/7/1
Y1 - 2023/7/1
N2 - BACKGROUND: An effective and safe treatment for nausea and vomiting of pregnancy (NVP) is lacking. OBJECTIVE: To assess the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in women with moderate to severe NVP. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. (ClinicalTrials.gov: NCT04401384). SETTING: 13 tertiary hospitals in mainland China from 21 June 2020 to 2 February 2022. PARTICIPANTS: 352 women in early pregnancy with moderate to severe NVP. INTERVENTION: Participants received daily active or sham acupuncture for 30 minutes and doxylamine-pyridoxine or placebo for 14 days. MEASUREMENTS: The 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. 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]). LIMITATION: The placebo effects of the interventions and natural regression of the disease were not evaluated. CONCLUSION: Both 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 SOURCE: The National Key R&D Program of China and the Project of Heilongjiang Province "TouYan" Innovation Team.
AB - BACKGROUND: An effective and safe treatment for nausea and vomiting of pregnancy (NVP) is lacking. OBJECTIVE: To assess the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in women with moderate to severe NVP. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. (ClinicalTrials.gov: NCT04401384). SETTING: 13 tertiary hospitals in mainland China from 21 June 2020 to 2 February 2022. PARTICIPANTS: 352 women in early pregnancy with moderate to severe NVP. INTERVENTION: Participants received daily active or sham acupuncture for 30 minutes and doxylamine-pyridoxine or placebo for 14 days. MEASUREMENTS: The 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. 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]). LIMITATION: The placebo effects of the interventions and natural regression of the disease were not evaluated. CONCLUSION: Both 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 SOURCE: The National Key R&D Program of China and the Project of Heilongjiang Province "TouYan" Innovation Team.
UR - http://www.scopus.com/inward/record.url?scp=85165220841&partnerID=8YFLogxK
U2 - https://doi.org/10.7326/M22-2974
DO - https://doi.org/10.7326/M22-2974
M3 - Article
C2 - 37335994
SN - 0003-4819
VL - 176
SP - 922
EP - 934
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 7
ER -