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Annals of Internal Medicine Jul 2023An effective and safe treatment for nausea and vomiting of pregnancy (NVP) is lacking. (Randomized Controlled Trial)
Randomized Controlled Trial
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 ( = 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.
Topics: Pregnancy; Child; Female; Humans; Doxylamine; Pyridoxine; Antiemetics; Quality of Life; Vomiting; Nausea; Pregnancy Complications; Acupuncture Therapy
PubMed: 37335994
DOI: 10.7326/M22-2974 -
Drug and Therapeutics Bulletin Mar 2019
Review
Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Nausea; Practice Guidelines as Topic; Pregnancy; Pregnancy Complications; Pyridoxine; Vomiting
PubMed: 30705026
DOI: 10.1136/dtb.2018.000053 -
Turk Psikiyatri Dergisi = Turkish... 2022Doxylamine succinate, one of the antihistamines available without a prescription for patients suffering from insomnia, is also an antihistamine with the potential for...
Doxylamine succinate, one of the antihistamines available without a prescription for patients suffering from insomnia, is also an antihistamine with the potential for abuse. Although there are case reports about the addictive potential of antihistamines, there are not many studies on doxylamine succinate addiction in the literature. To our knowledge, there have been no case reports on doxylamine succinate addiction in Turkey. This case report presents a patient (43, M), who started using over-the-counter doxylamine succinate at 25 mg/day due to insomnia, gradually increased to 125 mg/day for the last 3 years continuing his doxylamine succinate intake for 5 years uninterrupted, as well as his treatment process. In addition, possible causes and consequences of doxylamine succinate and the potential for abuse of antihistaminic drugs are discussed through the case. Keywords: Antihistamines, drug dependence, doxylamine.
Topics: Doxylamine; Histamine H1 Antagonists; Humans; Sleep Initiation and Maintenance Disorders; Turkey
PubMed: 36148572
DOI: 10.5080/u26340 -
Zhurnal Nevrologii I Psikhiatrii Imeni... 2018Symptoms of sleep disruption are widely prevalent in general population, but they are not necessarily form the full clinical presentation of insomnia. Diagnostic process... (Review)
Review
Symptoms of sleep disruption are widely prevalent in general population, but they are not necessarily form the full clinical presentation of insomnia. Diagnostic process should consider somatic diseases usually accompanied by sleep disruption. This review presents the data on insomnia symptoms in gynecological diseases: menstrual cycle related disorders, endometriosis, peri- and postmenopausal symptoms.
Topics: Doxylamine; Endometriosis; Female; Histamine H1 Antagonists; Humans; Melatonin; Menopause; Menstrual Cycle; Prevalence; Sleep; Sleep Initiation and Maintenance Disorders
PubMed: 30059054
DOI: 10.17116/jnevro20181184267 -
International Journal of Women's Health 2014Nausea and vomiting in pregnancy (NVP) is common and often undertreated, in part due to fears of adverse effects of medications on the fetus during early pregnancy. In... (Review)
Review
Nausea and vomiting in pregnancy (NVP) is common and often undertreated, in part due to fears of adverse effects of medications on the fetus during early pregnancy. In April 2013, the US Food and Drug Administration (FDA) approved doxylamine succinate 10 mg and pyridoxine hydrochloride (a vitamin B6 analog) 10 mg as a delayed-release combination pill called Diclegis for the treatment of NVP. Diclegis is currently the only medication that is FDA-approved for the indication of NVP. This review addresses the historical context, safety, efficacy, pharmacology, and practical role of doxylamine and pyridoxine for the management of NVP. The reintroduction of this doxylamine-pyridoxine combination pill into the American market fills a therapeutic gap in the management of NVP left by the removal of the same active drugs marketed over 30 years ago in the form of Bendectin. The substantial amount of safety data accumulated over the years makes it one of the few drugs that qualify for FDA Pregnancy Category A status. In the hierarchical approach to pharmacological treatment of NVP, the combination of doxylamine and pyridoxine should thus be first-tier.
PubMed: 24748822
DOI: 10.2147/IJWH.S46653 -
Archives of Women's Mental Health Jun 2017Hyperemesis gravidarum (HG) is a severe and prolonged form of nausea and/or vomiting during pregnancy. HG affects 0.3-2% of pregnancies and is defined by dehydration,... (Comparative Study)
Comparative Study Review
Hyperemesis gravidarum (HG) is a severe and prolonged form of nausea and/or vomiting during pregnancy. HG affects 0.3-2% of pregnancies and is defined by dehydration, ketonuria, and more than 5% body weight loss. Initial pharmacologic treatment for HG includes a combination of doxylamine and pyridoxine. Additional interventions include ondansetron or dopamine antagonists such as metoclopramide or promethazine. The options are limited for women who are not adequately treated with these medications. We suggest that mirtazapine is a useful drug in this context and its efficacy has been described in case studies. Mirtazapine acts on noradrenergic, serotonergic, histaminergic, and muscarinic receptors to produce antidepressant, anxiolytic, antiemetic, sedative, and appetite-stimulating effects. Mirtazapine is not associated with an independent increased risk of birth defects. Further investigation of mirtazapine as a treatment for HG holds promise to expand treatment options for women suffering from HG.
Topics: Adrenergic alpha-Antagonists; Adult; Antiemetics; Dopamine Agonists; Female; Humans; Hyperemesis Gravidarum; Mianserin; Mirtazapine; Pregnancy
PubMed: 28070660
DOI: 10.1007/s00737-016-0707-4