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:
Participant gender:
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
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