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