Randomized Controlled Trial

. 2023 Jul;176(7):922-933.

doi: 10.7326/M22-2974. Epub 2023 Jun 20.

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

Xiao-Ke Wu¹, Jing-Shu Gao², Hong-Li Ma³, Yu Wang³, Bei Zhang⁴, Zhao-Lan Liu⁵, Jian Li⁶, Jing Cong³, Hui-Chao Qin⁷, Xin-Ming Yang³, Qi Wu⁸, Xiao-Yong Chen⁹, Zong-Lin Lu¹⁰, Ya-Hong Feng¹¹, Xue Qi¹², Yan-Xiang Wang¹³, Lan Yu¹⁴, Ying-Mei Cui¹⁵, Chun-Mei An¹⁶, Li-Li Zhou⁷, Yu-Hong Hu¹⁷, Lu Li¹⁸, Yi-Juan Cao¹⁹, Ying Yan²⁰, Li Liu³, Yu-Xiu Liu²¹, Zhi-Shun Liu²², Rebecca C Painter²³, Ernest H Y Ng²⁴, Jian-Ping Liu²⁵, Ben Willem J Mol²⁶, Chi Chiu Wang²⁷

Affiliations

¹ First Affiliated Hospital, Heilongjiang University of Chinese Medicine, and Heilongjiang Provincial Hospital, Harbin, China (X.-K.W.).
² First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China, and College of Pharmacy, The Department of Medicine, Hangzhou Normal University, Hangzhou, China (J.-S.G.).
³ First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China (H.-L.M., Y.W., J.C., X.-M.Y., L. Liu).
⁴ Department of Obstetrics and Gynecology, Xuzhou Central Hospital, Xuzhou, China (B.Z.).
⁵ Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China (Z.-L. Liu).
⁶ Department of Obstetrics & Gynaecology, Affiliated Hospital, Guizhou Medical University, Guiyang, China; First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China; and Department of Obstetrics & Gynecology, The Chinese University of Hong Kong, Hong Kong, China (J.L.).
⁷ Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin, China (H.-C.Q., L.-L.Z.).
⁸ Heilongjiang Province "TouYan" Innovation Team, Heilongjiang University of Chinese Medicine, Harbin, China, and Department of Obstetrics & Gynaecology, The Chinese University of Hong Kong, Hong Kong, China (Q.W.).
⁹ Jiangxi Maternal and Child Health Hospital, Nanchang, China (X.-Y.C.).
¹⁰ Luoyang Hospital of Chinese Medicine, Luoyang, China (Z.-L. Lu).
¹¹ Ningxia Hui Autonomous Region Hospital of Chinese Medicine, Yinchuan, China (Y.-H.F.).
¹² Jixi Maternal and Child Health Hospital, Jixi, China (X.Q.).
¹³ Jiamusi Maternal and Child Health Hospital, Jiamusi, China (Y.-X.W.).
¹⁴ Hegang Maternal and Child Health Hospital, Hegang, China (L.Y.).
¹⁵ Mudanjiang Maternal and Child Health Hospital, Mudanjiang, China (Y.-M.C.).
¹⁶ Shuangyashan Maternal and Child Health Hospital, Shuangyashan, China (C.-M.A.).
¹⁷ First Affiliated Hospital of Jiamusi University, Jiamusi, China (Y.-H.H.).
¹⁸ Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, China, and Department of Obstetrics & Gynaecology, The Chinese University of Hong Kong, Hong Kong, China (L. Li).
¹⁹ Centre of Reproductive Medicine, Xuzhou Central Hospital, Xuzhou, China (Y.-J.C.).
²⁰ Department of Gynecology, First Affiliated Hospital, Tianjin University of Chinese Medicine, Tianjin, China (Y.Y.).
²¹ Data and Statistics Division, Department of Critical Care Medicine, Jinling Hospital, and Department of Biostatistics, Public Health School, Nanjing Medical University, Nanjing, China (Y.-X.L.).
²² Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Z.-S.L.).
²³ Amsterdam University Medical Center, Reproduction and Development, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (R.C.P.).
²⁴ Department of Obstetrics & Gynaecology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China (E.H.Y.N.).
²⁵ Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China, and National Research Center in Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, Faculty of Health Science, UiT The Arctic University of Norway, Tromsø, Norway (J.-P.L.).
²⁶ Monash Medical Centre, Monash University, Melbourne, Victoria, Australia (B.W.J.M.).
²⁷ Department of Obstetrics & Gynaecology, Li Ka Shing Institute of Health Sciences; School of Biomedical Sciences; and The Chinese University of Hong Kong-Sichuan University Joint Laboratory in Reproductive Medicine, The Chinese University of Hong Kong, Hong Kong, China (C.C.W.).

PMID: 37335994
DOI: 10.7326/M22-2974

Randomized Controlled Trial

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

Xiao-Ke Wu et al. Ann Intern Med. 2023 Jul.

. 2023 Jul;176(7):922-933.

doi: 10.7326/M22-2974. Epub 2023 Jun 20.

Authors

Affiliations

¹ First Affiliated Hospital, Heilongjiang University of Chinese Medicine, and Heilongjiang Provincial Hospital, Harbin, China (X.-K.W.).
² First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China, and College of Pharmacy, The Department of Medicine, Hangzhou Normal University, Hangzhou, China (J.-S.G.).
³ First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China (H.-L.M., Y.W., J.C., X.-M.Y., L. Liu).
⁴ Department of Obstetrics and Gynecology, Xuzhou Central Hospital, Xuzhou, China (B.Z.).
⁵ Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China (Z.-L. Liu).
⁶ Department of Obstetrics & Gynaecology, Affiliated Hospital, Guizhou Medical University, Guiyang, China; First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China; and Department of Obstetrics & Gynecology, The Chinese University of Hong Kong, Hong Kong, China (J.L.).
⁷ Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin, China (H.-C.Q., L.-L.Z.).
⁸ Heilongjiang Province "TouYan" Innovation Team, Heilongjiang University of Chinese Medicine, Harbin, China, and Department of Obstetrics & Gynaecology, The Chinese University of Hong Kong, Hong Kong, China (Q.W.).
⁹ Jiangxi Maternal and Child Health Hospital, Nanchang, China (X.-Y.C.).
¹⁰ Luoyang Hospital of Chinese Medicine, Luoyang, China (Z.-L. Lu).
¹¹ Ningxia Hui Autonomous Region Hospital of Chinese Medicine, Yinchuan, China (Y.-H.F.).
¹² Jixi Maternal and Child Health Hospital, Jixi, China (X.Q.).
¹³ Jiamusi Maternal and Child Health Hospital, Jiamusi, China (Y.-X.W.).
¹⁴ Hegang Maternal and Child Health Hospital, Hegang, China (L.Y.).
¹⁵ Mudanjiang Maternal and Child Health Hospital, Mudanjiang, China (Y.-M.C.).
¹⁶ Shuangyashan Maternal and Child Health Hospital, Shuangyashan, China (C.-M.A.).
¹⁷ First Affiliated Hospital of Jiamusi University, Jiamusi, China (Y.-H.H.).
¹⁸ Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, China, and Department of Obstetrics & Gynaecology, The Chinese University of Hong Kong, Hong Kong, China (L. Li).
¹⁹ Centre of Reproductive Medicine, Xuzhou Central Hospital, Xuzhou, China (Y.-J.C.).
²⁰ Department of Gynecology, First Affiliated Hospital, Tianjin University of Chinese Medicine, Tianjin, China (Y.Y.).
²¹ Data and Statistics Division, Department of Critical Care Medicine, Jinling Hospital, and Department of Biostatistics, Public Health School, Nanjing Medical University, Nanjing, China (Y.-X.L.).
²² Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Z.-S.L.).
²³ Amsterdam University Medical Center, Reproduction and Development, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (R.C.P.).
²⁴ Department of Obstetrics & Gynaecology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China (E.H.Y.N.).
²⁵ Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China, and National Research Center in Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, Faculty of Health Science, UiT The Arctic University of Norway, Tromsø, Norway (J.-P.L.).
²⁶ Monash Medical Centre, Monash University, Melbourne, Victoria, Australia (B.W.J.M.).
²⁷ Department of Obstetrics & Gynaecology, Li Ka Shing Institute of Health Sciences; School of Biomedical Sciences; and The Chinese University of Hong Kong-Sichuan University Joint Laboratory in Reproductive Medicine, The Chinese University of Hong Kong, Hong Kong, China (C.C.W.).

PMID: 37335994
DOI: 10.7326/M22-2974

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.

PubMed Disclaimer

Conflict of interest statement

Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-2974.

Comment in

Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy.
Fan AY, Gu S. Fan AY, et al. Ann Intern Med. 2024 Feb;177(2):eL230425. doi: 10.7326/L23-0425. Ann Intern Med. 2024. PMID: 38373317 No abstract available.
Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy.
Wang Q. Wang Q. Ann Intern Med. 2024 Feb;177(2):eL230426. doi: 10.7326/L23-0426. Ann Intern Med. 2024. PMID: 38373321 No abstract available.

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Comment in

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Associated data

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Medical