Medline ® Abstracts for References 32,51,60,69-71
of 'Treatment and outcome of nausea and vomiting of pregnancy'
Evidence-based view of safety and effectiveness of pharmacologic therapy for nausea and vomiting of pregnancy (NVP).
Magee LA, Mazzotta P, Koren G
Am J Obstet Gynecol. 2002;186(5 Suppl Understanding):S256.
OBJECTIVE: Our goal was to review the safety and effectiveness of available antiemetics for treatment of nausea and vomiting of pregnancy.
STUDY DESIGN: We performed a quantitative and qualitative overview of observational controlled studies for drug safety in pregnancy and randomized controlled trials for drug effectiveness for nausea and vomiting in pregnancy.
RESULTS: All of the following are safe and effective for treatment of varying degrees of nausea and vomiting in pregnancy: Bendectin/Diclectin (doxylamine, pyridoxine, dicyclomine), antihistamine (H(1)) blockers, and phenothiazines; however, the magnitude of effect, particularly for phenothiazines, is in question and may differ among individual agents. Pyridoxine and vitamin B(12)are safe and may be effective. Metoclopramide, droperidol, and ondansetron may be effective, but safety data are insufficient to recommend them as first-line agents. Corticosteroids may not be as beneficial as first thought, and there may be a small teratogenic risk. The relative effectiveness of various agents is largely unknown.
CONCLUSION: Many medications, particularly H(1)-antagonists and phenothiazines, are safe and effective for treatment of varying degrees of NVP.
Department of Specialized Women's Health, BC Women's Hospital and Health Centre, Vancouver, Canada. email@example.com
Pregnancy outcome following first trimester exposure to antihistamines: meta-analysis.
Seto A, Einarson T, Koren G
Am J Perinatol. 1997;14(3):119.
To determine the relative risk for major malformations associated with antihistamine (H1 blockers) exposure in the first trimester of pregnancy, a literature search of all studies examining the association between antihistamines and major malformations for the period 1960 to 1991 was conducted, followed by meta-analysis. Odds ratio was calculated using the Mantel-Haenszel method. Twenty-four controlled studies met the inclusion criteria with more than 200,000 participating women. The summary odds ratio of major malformations associated with antihistamines taken during the first trimester was 0.76 (95% CI: 0.60-0.94). This analysis indicates that H1 blockers used mainly for morning sickness during the first trimester do not increase the teratogenic risk in humans and may, in fact, be associated with a protective effect. More study is needed to verify the possibility that by preventing vomiting, antihistamines may ensure better metabolic conditions to the fetus and thus may reduce some birth defects. Alternatively, it is possible that pregnancies characterized by vomiting are associated with better outcome due to other reasons, such as hormonal status or placental function. Women suffering from morning sickness which is not controlled by nonpharmacological methods can safely use antihistamines.
Department of Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.
Promethazine compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial.
Tan PC, Khine PP, Vallikkannu N, Omar SZ
Obstet Gynecol. 2010;115(5):975.
OBJECTIVE: To compare the effects of promethazine with those of metoclopramide for hyperemesis gravidarum.
METHODS: Women at their first hospitalization for hyperemesis gravidarum were approached when intravenous antiemetic therapy was needed. They were randomly assigned to receive 25 mg promethazine or 10 mg metoclopramide every 8 hours for 24 hours in a double-blind study. Primary outcomes were vomiting episodes by diary and well-being visual numerical rating scale score (10-point scale) in the 24-hour main study period. Participants also filled out an adverse-effects questionnaire at 24 hours and a nausea visual numerical rating scale score at recruitment and at 8, 16, and 24 hours.
RESULTS: A total of 73 and 76 women, randomized to metoclopramide and promethazine, respectively, were analyzed. Median vomiting episodes were one (range 0-26) compared with two (range 0-26) (P=.81), and well-being visual numerical rating scale scores were 8 (range 1-10) compared with 7 (range 2-10) (P=.24) for metoclopramide and promethazine, respectively. Repeat-measures analysis of variance of the nausea visual numerical rating scale scores showed no significant difference between study drugs (F score=0.842, P=.47). Reported drowsiness (58.6% compared with 83.6%, P=.001, number needed to treat to benefit [NNTb]5), dizziness (34.3% compared with 71.2%, P<.001, NNTb 3), dystonia (5.7% compared with 19.2%, P=.02, NNTb 8), and therapy curtailment owing to adverse events (0 of 73 [0%]compared with 7 of 76 [9.2%], P=.014) were encountered less frequently with metoclopramide.
CONCLUSION: Promethazine and metoclopramide have similar therapeutic effects in patients who are hospitalized for hyperemesis gravidarum. The adverse effects profile was better with metoclopramide.
Department of Obstetrics and Gynecology, University of Malaya, Lembah Pantai, Kuala Lumpur, Malaysia. firstname.lastname@example.org
Kallen B. Hyperemesis gravidarum during pregnancy and delivery: A registry study. In: Nausea and Vomiting of Pregnancy: State of the Art 2000, Koren G, Bishai R (Eds), Motherisk, Toronto 2000. p.36.
no abstract available
Ondansetron versus promethazine to treat acute undifferentiated nausea in the emergency department: a randomized, double-blind, noninferiority trial.
Braude D, Crandall C
Acad Emerg Med. 2008;15(3):209.
OBJECTIVES: The authors sought to compare ondansetron and promethazine among emergency department (ED) patients with undifferentiated nausea. The hypothesis was that ondansetron was not inferior to promethazine and that rates of adverse effects were similar.
METHODS: This was a randomized double-blind noninferiority clinical trial conducted in an urban academic ED. A convenience sample of nonpregnant adults with at least 40 mm of self-reported nausea measured on a 100-mm visual analog scale (VAS) were enrolled. Patients who had already received more than 1 L of intravenous fluid or an antiemetic agent were excluded. Subjects were block-randomized in groups of 10 to either 4 mg of ondansetron or 25 mg of promethazine delivered intravenously. The primary outcome was change in nausea over 30 minutes. The authors used a 15-mm margin of noninferiority. Secondary endpoints included changes in anxiety, sedation, and other adverse effects. Analyses included t-tests, tests for proportions, and 95% confidence intervals (CIs).
RESULTS: A total of 120 subjects completed the study, 60 in each arm. Baseline nausea, anxiety, and sedation scores were similar. Ondansetron and promethazine reduced nausea similarly (ondansetron -34 mm, promethazine -36 mm; difference -2 mm; 95% CI = -13 to 8 mm). The reduction in anxiety was similar (ondansetron -13 mm, promethazine -14 mm; difference -1 mm; 95% CI = -10 to 10 mm). Promethazine was associated with significantly more sedation than ondansetron (ondansetron 5 mm, promethazine 19 mm; difference 14 mm; 95% CI = 5 to 24 mm). There were no cases of akathisia in the ondansetron group and 2 cases in the promethazine group.
CONCLUSIONS: Promethazine and ondansetron have similar efficacy in reducing nausea among ED patients. Change in anxiety was similar, but promethazine was associated with greater sedation.
Department of Emergency Medicine, University of New Mexico, Albuquerque, NM, USA. email@example.com
The effect of promethazine in nausea and vomiting of pregnancy.
N Z Med J. 1955;54(300):215.