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Article: Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy

TitleAcupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy
Other TitlesA Randomized, Controlled, 2 × 2 Factorial Trial
Authors
Issue Date20-Jun-2023
PublisherAmerican College of Physicians
Citation
Annals of Internal Medicine, 2023, v. 176, n. 7, p. 922-933 How to Cite?
Abstract

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.


Persistent Identifierhttp://hdl.handle.net/10722/329079
ISSN
2023 Impact Factor: 19.6
2023 SCImago Journal Rankings: 3.337
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorWu, Xiao Ke-
dc.contributor.authorGao, Jing Shu-
dc.contributor.authorMa, Hong Li-
dc.contributor.authorWang, Yu-
dc.contributor.authorZhang, Bei-
dc.contributor.authorLiu, Zhao Lan-
dc.contributor.authorLi, Jian-
dc.contributor.authorCong, Jing-
dc.contributor.authorQin, Hui Chao-
dc.contributor.authorYang, Xin Ming-
dc.contributor.authorWu, Qi-
dc.contributor.authorChen, Xiao Yong-
dc.contributor.authorLu, Zong Lin-
dc.contributor.authorFeng, Ya Hong-
dc.contributor.authorQi, Xue-
dc.contributor.authorWang, Yan Xiang-
dc.contributor.authorYu, Lan-
dc.contributor.authorCui, Ying Mei-
dc.contributor.authorAn, Chun Mei-
dc.contributor.authorZhou, Li Li-
dc.contributor.authorHu, Yu Hong-
dc.contributor.authorLi, Lu-
dc.contributor.authorCao, Yi Juan-
dc.contributor.authorYan, Ying-
dc.contributor.authorLiu, Li-
dc.contributor.authorLiu, Yu Xiu-
dc.contributor.authorLiu, Zhi Shun-
dc.contributor.authorPainter, Rebecca-
dc.contributor.authorNg, Ernest-
dc.contributor.authorLiu, Jian Ping-
dc.contributor.authorMol, Ben Willem-
dc.contributor.authorWang, Chi Chiu-
dc.date.accessioned2023-08-05T07:55:07Z-
dc.date.available2023-08-05T07:55:07Z-
dc.date.issued2023-06-20-
dc.identifier.citationAnnals of Internal Medicine, 2023, v. 176, n. 7, p. 922-933-
dc.identifier.issn0003-4819-
dc.identifier.urihttp://hdl.handle.net/10722/329079-
dc.description.abstract<p><strong>Background: </strong>An effective and safe treatment for nausea and vomiting of pregnancy (NVP) is lacking.</p><p><strong>Objective: </strong>To assess the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in women with moderate to severe NVP.</p><p><strong>Design: </strong>Multicenter, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. (ClinicalTrials.gov: <a href="http://clinicaltrials.gov/show/NCT04401384" title="See in ClinicalTrials.gov">NCT04401384</a>).</p><p><strong>Setting: </strong>13 tertiary hospitals in mainland China from 21 June 2020 to 2 February 2022.</p><p><strong>Participants: </strong>352 women in early pregnancy with moderate to severe NVP.</p><p><strong>Intervention: </strong>Participants received daily active or sham acupuncture for 30 minutes and doxylamine-pyridoxine or placebo for 14 days.</p><p><strong>Measurements: </strong>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.</p><p><strong>Results: </strong>No significant interaction was detected between the interventions (<em>P</em> = 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]).</p><p><strong>Limitation: </strong>The placebo effects of the interventions and natural regression of the disease were not evaluated.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Primary funding source: </strong>The National Key R&D Program of China and the Project of Heilongjiang Province "TouYan" Innovation Team.</p>-
dc.languageeng-
dc.publisherAmerican College of Physicians-
dc.relation.ispartofAnnals of Internal Medicine-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.titleAcupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy-
dc.title.alternativeA Randomized, Controlled, 2 × 2 Factorial Trial-
dc.typeArticle-
dc.identifier.doi10.7326/M22-2974-
dc.identifier.scopuseid_2-s2.0-85165220841-
dc.identifier.volume176-
dc.identifier.issue7-
dc.identifier.spage922-
dc.identifier.epage933-
dc.identifier.eissn1539-3704-
dc.identifier.isiWOS:001019670300001-
dc.identifier.issnl0003-4819-

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