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Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy : A Randomized, Controlled, 2 × 2 Factorial Trial.

AbstractBACKGROUND:
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.
AuthorsXiao-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, Ernest H Y Ng, Jian-Ping Liu, Ben Willem J Mol, Chi Chiu Wang
JournalAnnals of internal medicine (Ann Intern Med) Vol. 176 Issue 7 Pg. 922-933 (07 2023) ISSN: 1539-3704 [Electronic] United States
PMID37335994 (Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Doxylamine
  • Pyridoxine
  • Antiemetics
Topics
  • Pregnancy
  • Child
  • Female
  • Humans
  • Doxylamine (adverse effects)
  • Pyridoxine (therapeutic use, adverse effects)
  • Antiemetics (therapeutic use)
  • Quality of Life
  • Vomiting (drug therapy, chemically induced)
  • Nausea (drug therapy)
  • Pregnancy Complications (drug therapy)
  • Acupuncture Therapy (adverse effects)

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