Effectiveness of Acupuncture and Doxylamine/Pyridoxine for Moderate to Severe Nausea and Vomiting in Pregnancy

Last updated: March 31, 2022
Sponsor: Xiaoke Wu
Overall Status: Completed

Phase

3

Condition

Lactose Intolerance

Colic

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT04401384
NVPAct
  • Ages 20-45
  • Female

Study Summary

Nausea and vomiting in pregnancy (NVP) is one of the most common symptoms of pregnancy affecting 50-85% of women during the first half of pregnancy. Maternal morbidity is common and includes psychological effects, financial burden, clinical complications from nutritional deficiencies, gastrointestinal trauma, and in rare cases, neurological damage. As the main means of alternative treatment, economical and easy to obtain; the clinical efficacy of acupuncture treatment of this disease has low level of evidence and needs to be reconfirmed. Doxylamine vitamin B6 sustained release tablets (Diclectin, combination of doxylamine succinate (10mg) and pyridoxine hydrochloride (10mg) are The American College of Obstetricians and Gynecologists recommends with Level A evidence the use of vitamin B6 in combination with doxylamine as first-line pharmacotherapy for treatment of NVP. The efficacy and safety of Diclectin has been confirmed in many years of research, but there is no evidence of high-level evidence-based medicine for the Chinese population. The purpose of this multicenter, randomized, double-blind, placebo-controlled trial was to investigate the efficacy and safety of acupuncture versus Diclectin in the treatment of NVP. We hypothesis that: (1)Sham acupuncture and Diclectin (Arm B) is more effective than sham acupuncture and placebo (Arm D); (2)Active acupuncture and placebo (Arm C) is more effective than sham acupuncture and placebo (Arm D); (3) There is no interaction (either synergistic or antagonistic effects) between the two interventions of active acupuncture and Diclectin in patients with NVP.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women with 20-45 years of age;
  2. PUQE score ≥6;
  3. 7-14 weeks of gestation with viable fetus inside the uterine cavity confirmed byultrasound dating;
  4. Less than 20% weight loss.

Exclusion

Exclusion Criteria:

  1. Having major medical problems such as malignant tumor, acute or subacute severehepatitis, severe aplastic anemia, idiopathic thrombocytopenic purpura, acuteappendicitis, acute pancreatitis, TORCH syndrome, etc
  2. Having chronic medical conditions such as poorly controlled diabetes, coronary heartdisease, uncontrolled hypertension, etc
  3. Coexistence of other diseases that cause vomiting such as infectious disease,gestational trophoblastic disease, etc
  4. Having asthma, increased intraocular pressure, narrow-angle glaucoma, narrow pepticulcer, pyloric obstruction, bladder neck obstruction, etc
  5. Taking antiemetics such as vitamin B6, ondansetron, metoclopramide, prednisone,anti-vomiting Chinese medicine, etc., within the past week
  6. Receiving conservative treatment such as dietary and lifestyle modification
  7. Abnormal physical examination and laboratory tests (minor abnormalities in laboratorytests due to pregnancy vomiting, such as liver function and ions, are acceptable forinclusion)
  8. Having mental handicaps or psychological disorders
  9. Allergic to doxylamine, other ethanolamine-derived antihistamines, pyridoxinehydrochloride, or any inactive ingredient in diclectin
  10. Using monoamine oxidase inhibitors
  11. Driving or operating heavy machinery
  12. Using alcohol or other central nervous system inhibitors

Study Design

Total Participants: 352
Study Start date:
June 21, 2020
Estimated Completion Date:
January 31, 2022

Study Description

Subjects will be randomized into one of the four treatment arms: A) active acupuncture (30 min /every day) + Diclectin (combination of doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg) , 2-4 tablets/day); B) sham acupuncture (30 min /every day) + Diclectin (2-4 tablets/day); C) active acupuncture (30 min / every day) + Diclectin placebo (2-4 tablets/day); D) sham acupuncture (30 min /every day) + Diclectin placebo (2-4 tablets/day). Participants will receive active acupuncture or sham acupuncture treatment daily, 14 times in total, and receive Diclectin or placebo treatment every day (2 tablets at bedtime for the first two days, if the symptoms are unrelieved, add one tablet in the morning, if the symptoms are still unrelieved, add another one tablet at three o 'clock in the afternoon) for 2 consecutive weeks, 28-56 tablets in total. Daily measurement PUQE score, Visual analog scale (VAS), Adverse events and concomitant medications. Weekly visits will include global assessment of well being, adverse events and concomitant medications. The visit after treatment will assess NVP quality of life (NVPQoL), SAS, SDS and so on. Participants will be followed up 30 days after treatment. Primary outcomes is difference of the mean change in PUQE score from baseline to the last visit. Secondary outcomes were some core outcome set for hyperemesis gravidarum, including weight difference, quality of life (change in Global assessment of well-being, NVPQOL, VAS, SDS and SAS), pregnancy complication, treatment compliance, neonatal outcomes; area under the curve of PUQE score, effect of intervention on PUQE score reduction over treatment period and adverse events.

Connect with a study center

  • First Affiliated Hospital of Heilongjiang Chinese Medicine University

    Harbin, Heilongjiang
    China

    Site Not Available

  • Heilongjiang provincial hospital

    Harbin, Heilongjiang
    China

    Site Not Available

  • Hegang Maternal and Child Health Hospital

    Hegang, Heilongjiang
    China

    Site Not Available

  • Affiliated Hospital of Jiamusi Medical University

    Jiamusi, Heilongjiang
    China

    Site Not Available

  • Jiamusi Maternal and Child Health Hospital

    Jiamusi, Heilongjiang
    China

    Site Not Available

  • Jixi Maternal and Child Health Hospital

    Jixi, Heilongjiang
    China

    Site Not Available

  • Mudanjaing Maternal and Child Health Hospital

    Mudanjiang, Heilongjiang
    China

    Site Not Available

  • Shuangyashan Maternal and Child Health Hospital

    Shuangyashan, Heilongjiang
    China

    Site Not Available

  • Suihua Maternal and Child Health Hospital

    Suihua, Heilongjing
    China

    Site Not Available

  • Luoyang Hospital of TCM

    Luoyang, Henan
    China

    Site Not Available

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu
    China

    Site Not Available

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi
    China

    Site Not Available

  • Ningxia Hui Autonomous Region Hospital of TCM

    Yinchuan, Ningxia Hui Autonomous Region
    China

    Site Not Available

  • First Affiliated Hospital of Tianjin Chinese Medicine University

    Tianjin,
    China

    Site Not Available

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