Overview

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

Status:
Completed
Trial end date:
2021-07-21
Target enrollment:
0
Participant gender:
Female
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) Sham acupuncture and diclectin (Arm B) have similar treatment effects with active acupuncture and placebo (Arm C); (4) There is no interaction (either synergistic or antagonistic effects) between the two interventions of active acupuncture and Diclectin in patients with NVP.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xiaoke Wu
Collaborators:
Affiliated Hospital of Jiamusi Medical University
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Hegang Maternal and Child Health Hospital
Heilongjiang provincial hospital
Jiamusi Maternal and Child Health Hospital
Jiangxi Maternal and Child Health Hospital
Jixi Maternal and Child Health Hospital
Luoyang Hospital of TCM
Mudanjaing Maternal and Child Health Hospital
Ningxia Hui Autonomous Region Hospital of TCM
Shuangyashan Maternal and Child Health Hospital
Suihua Maternal and Child Health Hospital
Xuzhou Central Hospital
Treatments:
Dicyclomine
Dicyclomine, doxylamine, pyridoxine drug combination
Doxylamine
Pyridoxine
Criteria
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 by
ultrasound dating;

4. Less than 20% weight loss.

Exclusion Criteria:

1. Having major medical problems such as malignant tumor, acute or subacute severe
hepatitis, severe aplastic anemia, idiopathic thrombocytopenic purpura, acute
appendicitis, acute pancreatitis, TORCH syndrome, etc

2. Having chronic medical conditions such as poorly controlled diabetes, coronary heart
disease, 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 peptic
ulcer, 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 laboratory
tests due to pregnancy vomiting, such as liver function and ions, are acceptable for
inclusion)

8. Having mental handicaps or psychological disorders

9. Allergic to doxylamine, other ethanolamine-derived antihistamines, pyridoxine
hydrochloride, 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