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A randomized comparison of vitamin B6 and dimenhydrinate in the treatment of nausea and vomiting in early pregnancy
Abstract and Figures
Nausea and vomiting are the common symptoms of early pregnancy. Without treatment, vomiting can complicate the pregnancy, so it must be reduced. Wide varieties of treatment have been used for nausea and vomiting in pregnancy. This study compared the effectiveness of vitamin B6 and dimenhydrinate for gestational nausea and vomiting.
One hundred and forty pregnant women with a gestational age of <16 weeks who had symptoms of nausea and vomiting were selected. They were randomly allocated into group A (n = 70) and group B (n = 70). The patients in group A received a vitamin B6 tablet, while the patients in group B received a dimenhydrinate tablet daily; the tablets were identical in appearance. The degree of nausea and vomiting was assessed by physical symptoms of Rhodes score.
One hundred and thirty-five women returned to follow-up. Dimenhydrinate and vitamin B6 significantly reduced nausea and vomiting scores from 8.3 (7.4) to 2.8 (2.0) and from 8.6 (2.9) to 3.8 (2.3), respectively. The mean score change after treatment with dimenhydrinate was greater than with vitamin B6.
Both dimenhydrinate and vitamin B6 were effective in the treatment of nausea and vomiting in early pregnancy. Dimenhydrinate was more effective than vitamin B6.
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... Another study demonstrated that promethazine and metoclopramide have similar therapeutic effects in patients who are hospitalised for HG, but metoclopramide had less adverse effects [61]. In a study of 140 pregnant women, dimenhydrinate was more effective than vitamin B6 in the treatment of nausea and vomiting in early pregnancy [13]. ...
Although, nausea and vomiting in early pregnancy is very common, affecting approximately 80% of pregnancies, hyperemesis gravidarum (HG) is a severe form that complicates up to 2.2% of pregnancies. HG is one of the most common indications for hospitalization during pregnancy. In addition to the insufficient nutrition both for the mother and fetus, the severity of HG symptoms causes a serious psychosocial stress, which leads to depression, anxiety and even the development of perinatal pathology. The aim of this meta-analysis was to study available randomized controlled trials about therapeutic strategies by HG, their evaluation based on both subjective and objective measures of efficacy, maternal and fetal/neonatal safety, and economic costs.A systematic data search was conducted using the databases MEDLINE, ISI Web of Science, PubMed, Scopus, Google Scholar, Cochrane Database of Systematic Reviews and publications in professional editions of Ukraine for 2013–2023. The search was conducted using the following keywords: pregnancy, nausea and vomiting of pregnant women, excessive vomiting of pregnancy, hyperemesis, antiemetic therapy during pregnancy, infusion therapy and the safety profile of medications prescribed during pregnancy in various combinations.The main outcome was: the effectiveness of therapeutic strategies (reduction or stopping nausea/vomiting); detailing by safety profile of antiemetic drugs; optimization of infusion therapy; additional clinical strategies that help to improve the quality of care for pregnant women; adverse effects and side effects of drugs for HG for the mother/fetus/newborn.The results presented in this meta-analysis can be used in the creation of a national clinical guideline, protocol, consensus or clinical recommendations regarding the clinical management of hyperemesis gravidarum.
... Another study showed that promethazine and metoclopramide have a similar therapeutic outcome in pregnant women with HG; of note, promethazine has less adverse effects (144). Strikingly, dimenhydrinate was found to be more effective than vitamin B6 in the treatment of nausea and vomiting in early pregnancy based on 140 pregnant women (145). In a 2021 clinical trial, gabapentin was revealed to be more effective than standard-of-care treatment for reducing NVP scores and increasing overall satisfaction and oral nutrition in pregnant women with HG (146). ...
Nausea and vomiting of pregnancy (NVP) is a common condition that affects up to 70% of pregnant women. Hyperemesis gravidarum (HG) is considered the serious form of NVP, which is reported in 0.3–10.8% of pregnant women. NVP has a relatively benign course, but HG can be linked with some poor maternal, fetal, and offspring outcomes. The exact causes of NVP and HG are unknown, but various factors have been hypothesized to be associated with pathogenesis. With the advance of precision medicine and molecular biology, some genetic factors such as growth/differentiation factor 15 (GDF15) have become therapeutic targets. In our review, we summarize the historical hypotheses of the pathogenesis of NVP and HG including hormonal factors, Helicobacter pylori , gastrointestinal dysmotility, placenta-related factors, psychosocial factors, and new factors identified by genetics. We also highlight some approaches to the management of NVP and HG, including pharmacological treatment, complementary treatment, and some supporting treatments. Looking to the future, progress in understanding NVP and HG may reduce the adverse outcomes and improve the maternal quality of life during pregnancy.
... [16] Different types of treatment are used for NVP. [17] Treatment of NVP depends on the severity of symptoms. [18] In addition to diet, therapy, and lifestyle modification, complementary medicine is an interesting complementary for many women [19] so that more than 87% of women use at least one method of complementary and alternative medicine during pregnancy. ...
Nausea and vomiting of pregnancy (NVP) is a common problem for pregnant women. Researchers have recently paid special attention to complementary medicine methods for the treatment of NVP. Regarding the high prevalence of NVP as well as maternal and fetal adverse effects of chemical drugs, the present study, focusing on clinical trials carried out in Iran, was conducted to assess safety and efficacy of different nonpharmacological methods in relieving NVP. This systematic review focused on randomized controlled trials (RCTs) and assessed complementary medicine on NVP for which databases including MedLib, Magiran, Iran Medex, SID, PubMed, Scopus, and Google Scholar search engines from 2000 to 2015 were searched. Those articles that gained score 3 or higher, according to Jadad criteria, were recruited for the study. In this study, 31 clinical trials assessing NVP were conducted on Iranian pregnant women. After removing ten articles, 21 articles with scores 3 and higher, according to Jedad criteria, were assessed. Out of 21 papers, 10 papers were about ginger, one was about cardamom, one was about lemon, two were about peppermint aromatherapy, six were about pericardium 6 (P6) acupressure, and one article about KID21 acupressure. Most studies have demonstrated a positive effect on reducing NVP; however, no adverse effect was reported. According to the results of this review, the majority of methods employed were effective in reducing the incidence of NVP, among which ginger and P6 acupressure can be recommended with more reliability.
Zusammenfassung
Die Hyperemesis gravidarum (HG) ist eine multifaktorielle Erkrankung, charakterisiert durch persistierende Übelkeit/Erbrechen, Dehydratation, Gewichtsverlust von mindestens 5%, Elektrolytstörungen und Ketoazidose. Die Prävalenz liegt weltweit zwischen 0,3 und 10%. Die Diagnose wird anhand der Anamnese, der klinischen Symptome, der körperlichen Untersuchung und der typischen Laborveränderungen gestellt. Grundpfeiler der Therapie sind Ernährungsberatung, Beratung zum Lebensstil, psychologische/psychosoziale Unterstützung der Schwangeren und die Gabe von Antiemetika im Sinne eines sich an dem Schweregrad der Symptome orientierenden Stufenkonzepts. Ein häufiger Wechsel von Antiemetika ist zu vermeiden. Die Behandlung der HG erfordert eine enge interprofessionelle und interdisziplinäre Zusammenarbeit.
Purpose: The aim of this study was to investigate the effects of dimenhydrinate on neural tube development in an early chick embryo model.
Materials and Methods: 32 fertile, specific pathogen free eggs were used in the study. All eggs were divided into four groups with 8 eggs in each group. At the 28th hour of the incubation, three different doses of dimenhydrinate (0.7, 1.4, 2.1 mg/kg) were injected into the experimental groups and physiological saline was injected into the control group. At 48th hour of incubation, all embryos were dissected and evaluated histologically under the light microscope.
Results: When the control, low, medium and high dose group embryos were evaluated morphologically, their mean craniocaudal lengths were 8493.73±1342.90 μm, 5743.61±770.3 μm, 5572.62±315.32 μm, 5306.55±1135.99 μm respectively, mean of somite numbers were 15.91±1.62, 15.38±1.19, 15.13±0.83, 10.63±5.15 respectively. Craniocaudal lengths and somite numbers decreased depending on the increase in the dimenhydrinate dose. The incidence of open neural tube increased due to the increase in dimenhydrinate dose.
Conclusion: Neurogenesis and morphological development were negatively affected due to the increase in dose in the groups treated with dimenhydrinate in the early chick embryo model.
Drug use during pregnancy is a process that may cause adverse effects on both pregnant women and fetuses, but the risk can be reduced by certain precautions. During pregnancy, women can use drugs for various acute or chronic reasons. Although the frequency of drug use during pregnancy may differ between countries, recent studies have shown that the rate of pregnant women using at least one drug during pregnancy is over 50% [1–4]. In a retrospective study (between the years 2008 and 2012), it has been shown that a considerable number of pregnant women used more than one drug, an average of 4,6 medications, in their pregnancy period, excluding vitamins and minerals. [1]. In a multinational study, the frequency of different drug types used in pregnancy has been investigated. While the frequency of drug use for the treatment of acute/short-term illnesses occurred is 68.4%, the frequency of drug use for the treatment of chronic/long-term illnesses occurred is 17%. Over-the-counter (OTC) drug use had a similar frequency with short-term drug use [2]. In another cohort study, it has been demonstrated that the prescription rate for drugs used for pregnancy-related symptoms increased, whereas the prescription rate for drugs used for chronic diseases and for short-time use declined during pregnancy [3]. Physiological variations during pregnancy alter the pharmacokinetics (absorption, distribution, metabolism, elimination) and pharmacodynamics of drugs [5]. Many pharmaceutical clinical experiments are performed on men or non-pregnant women due to ethical considerations and fetal risk. Prediction of the effect, side effect, and fetal risks of drug use in pregnancy is quite complicated due to both maternal pharmacokinetic/pharmacodynamic alterations and limited clinical data.KeywordsDrug therapyPharmaceutical preparationsPregnancyPostpartum period
The diagnosis of leukemia during pregnancy is a rare event. The low incidence of leukemia that occurs during pregnancy generates few reports of management, which makes it difficult to search for updated information. Considering that strategies for chemotherapy treatment of leukemia in this population are the same as those used for non-pregnant patients, it is necessary to make an adequate assessment if the chosen medication can bring more risks than benefits during pregnancy, for both the mother and the fetus. Supportive drugs are used to manage adverse events that must be well stabilized, as some of them may be contraindicated or inadvisable during pregnancy. This chapter aims to gather information from the literature on the main drugs involved in the supportive therapy of symptoms presented during chemotherapy treatment of leukemia in pregnancy, as well as safety and risk data in the stages of pregnancy.
A atenção farmacêutica é um serviço relevante na promoção do uso racional de medicamentos e sucesso farmacoterapêutico, devido ao conhecimento e acessibilidade existente por parte do farmacêutico. Logo, denota-se grande importância da prestação desse serviço às gestantes, em razão dos possíveis riscos materno-fetais associados ao medicamento. Bem como a doenças pré-existentes e condições durante este período que requerem a medicalização, como hipertensão arterial e diabetes mellitus gestacional, que apresentam grande relevância na saúde pública brasileira, em virtude da incidência que exibem e das complicações que podem provocar, consistindo em cenários oportunos para o acompanhamento farmacêutico visando auxiliar a adesão ao tratamento e promoção de saúde. Nesse contexto, objetivou-se compreender a importância do farmacêutico clínico na orientação farmacológica durante a gestação. Foi realizada uma pesquisa nas bases de dados Scielo, PubMed, Google Scholar e ScienceDirect, usando os descritores: categorias de risco; hipertensão; diabetes mellitus; automedicação; gravidez; náuseas; vômitos; eclampsia e assistência farmacêutica, todos selecionados dos DeCS nos idiomas: Português e Inglês. Evidenciou-se nesse estudo, a importância da atenção farmacêutica na gravidez, relacionado à orientação segura e adequada de terapias medicamentosas, reduzindo a automedicação, como também no processo de adesão terapêutica, através do acompanhamento contínuo e regular, destacando a importância da realização correta do tratamento e sugerindo intervenções terapêuticas necessárias, contribuindo assim para a melhora da qualidade de vida materno-fetal. Portanto, essa pesquisa assume relevância ímpar, uma vez que explanou a atenção farmacêutica para gestantes, colaborando para o desenvolvimento de ações e campanhas visando mostrar e conscientizar a importância do farmacêutico clínico durante a gestação.
Background: Nausea and vomiting are the common side-effects of chemotherapy in children with malignancy. In this study, the effectiveness of vitamin B6 in reducing the chemo-induced nausea and vomiting (CINV) in children was tested. Material and methods: A triple-blind clinical trials was performed on 100 children with malignancy referring to the pediatric clinic of Amir Kabir Hospital, Arak, Iran. Besides the infusion of granisetron (3mg/3ml) half an hour before each chemotherapy cycle, an intravenous dose of vitamin B6 (100 mg for children from 2 to 5 years old, 200 mg for children from 5 to 10 years old, and 300 mg for children older than 10) was given 6 hours before the first chemotherapy cycle and placebo was injected (2-5 years old: 100 mg, 5-10 years old: 200 mg, age≥ 10 years old: 300mg) 6 hours before the second cycle. Then the severity of nausea and the frequency of vomiting episodes in each cycle were recorded to be compared. Results: The mean age of children was 7.98 ± 3.133 years old. The most common and rare malignancy were acute lymphocytic leukemia (ALL) (46%) and ependymoma (0.5%), respectively. Vincristin was the most commonly used chemotherapy agent (28%). A positive correlation between the severity of nausea(R=0.313, P-value=0.0016) and frequency of vomiting with age was found (R=0.319, P-value=0.0012). However, no noticeable association was observed between N/V and gender (P-value.0.05). There was a considerable correlation between the frequency of vomiting and different tumor types in this study (P-value=0.0006).In comparison with placebo, Vitamin B6 significantly reduced the severity of nausea (P = 0.0001) as well as the frequency of vomiting (P-value = 0.0005). It was also more effective in ALL compared to rhabdomyosarcoma (P-value=0.001). Conclusion: This study suggested that vitamin B6 can be considered as an appropriate alternative to treat CINV in children with malignancy.
Introduction:
Several drugs were explored for their utility in treating nausea and vomiting in pregnancy. The present study is a network meta-analysis of such drugs.
Methods:
Electronic databases were searched for randomized clinical trials that have compared active interventions (with placebo or other active interventions) for treating nausea and vomiting in pregnancy. Nausea scores was the primary outcome and change in nausea scores, emetic episodes, adverse events and vomiting control were the key secondary outcomes. Weighted mean difference (WMD) was the effect estimate for continuous variable and odds ratio for the numerical variable. Random-effects model was used and the strength of the evidence was graded.
Results:
Fifty studies were included in the systematic review and 42 in the meta-analysis. Acupuncture, chamomile, dimenhydrinate, doxylamine/vitamin B6, ginger, quince, metoclopramide and vitamin B6 were associated with reduced nausea scores compared to placebo. Of these interventions, ginger and vitamin B6 were also associated with better vomiting control and less incidence of adverse events. Adequate evidence supporting the use exists only for ginger and the quality of evidence for this comparison is moderate. Strength of evidence for all other comparisons is very low.
Conclusion:
Present evidence is conclusive on the therapeutic benefits of ginger in treating nausea and vomiting in pregnancy. Although favourable results were obtained for several other interventions, the strength of evidence is very low. The results of this network meta-analysis should be interpreted with extreme caution as it might change with the advent of data from future head-to-head clinical trials.
Know the risk versus the benefit, before you prescribe: the authoritative, updated 10th edition of Drugs in Pregnancy and Lactation remains the leading drug reference for treatment of pregnant or breastfeeding patients. Listing nearly 1,200 commonly prescribed drugs taken during pregnancy and lactation, each detailed, in-depth drug monograph offers a summary of known or possible effects on mother, embryo, fetus and nursing infant. Features: • Enhanced eBook with searchable text and frequent updates integrating important new evidence • NEW over 120 new drugs including drug reviews • NEW drugs contraindicated during breastfeeding and pregnancy • Each monograph contains: generic name (in US); risk factor; pharmacologic class; fetal risk summary; breastfeeding summary; and updated references • List of drugs known to cause human developmental toxicity Now with the print edition, enjoy the bundled interactive eBook edition, offering tablet, smartphone, or online access to: • Complete content with enhanced navigation • A powerful search tool that pulls results from content in the book, your notes, and even the web • Cross-linked pages, references, and more for easy navigation • Highlighting tool for easier reference of key content throughout the text • Ability to take and share notes with friends and colleagues • Quick reference tabbing to save your favorite content for future use.
PURPOSE:: Symptoms of nausea and vomiting are commonly experienced during early pregnancy (nausea and vomiting of pregnancy or NVP) and have been associated with stress, anxiety, and depression in pregnancy. However, nausea and vomiting in late pregnancy is a little-studied phenomenon. The purpose of our study was to examine the prevalence, severity, and psychosocial determinants of NVP during early and late pregnancy. STUDY DESIGN AND METHODS:: Data were originally from a longitudinal and epidemiological study of depression in pregnancy and postpartum in a cohort of 648 Canadian women conducted from 2005 to 2008. Measures included the Nausea and Vomiting in Pregnancy Instrument (NVPI), the Cambridge Worry Scale (CWS), and the Edinburgh Postnatal Depression Scale (EPDS). Demographic, maternal/obstetrical, psychological, and behavioral variables related to NVP were also examined. Odds ratios and 95% confidence intervals were calculated for all risk factors investigated using multiple logistic regression, controlling for potential confounders. RESULTS:: The prevalence of NVP was 63.3% (n = 551) at Time 1 (early pregnancy) and 45.4% (n = 575) at Time 2 (late pregnancy). Severity of symptoms was associated with earlier gestation, antiemetic medication use, employment status, and symptoms of major depression. Maternal smoking and having the support of three or more persons were protective for NVP. CLINICAL IMPLICATIONS:: This study suggests that screening for NVP should be ongoing throughout pregnancy and measures that address NVP, poor social support, and depression are warranted. Further research is needed in regard to effective management of this very common and distressing condition.
Pregnancy sickness is a universal phenomenon, affecting 70% to 85% of all pregnant women. The primary symptoms of pregnancy sickness are nausea, vomiting, and food aversions. In the past, pregnancy sickness was attributed to psychological disturbances of the pregnant woman. However, recent evolutionary psychological and biopsychological studies have reconsidered pregnancy sickness as an embryo-protective mechanism, an evolutionary adaptation to protect the embryo from phytotoxins and other environmental hazards. The biopsychological perspective of pregnancy sickness as an embryo-protective mechanism is presented. TARGET AUDIENCEObstetricians and gynecologists, family physicians. LEARNING OBJECTIVES
After completing this CME activity, physicians should be better able to compare the biopsychological and nonbiopsychological theories of pregnancy sickness, and to examine the role that hormones play in pregnancy sickness.
This study assesses the effects of ginger on nausea and vomiting caused by pregnancy and compares it with metoclopramide medicine. This study was a randomized double-blind controlled trial. Metoclopramide, Ginger and placebo were putted in similar capsules. The medicines were administered three times a day. Then the Rhodes questionnaire was completed and its score were calculated. Data were analyzed by Chi square test, ANOVA and Repeated measurement. The intensity of changes in nausea, vomiting and Rhodes during study were statistically different in two groups of ginger and metoclopramide compared with placebo (p < 0.05), but it was not statistically significant between two groups of ginger and metoclopramide. According to our study, ginger is less effective than metoclopramide in reducing nausea and vomiting but it could be a good alternative for metoclopramide.
Nausea and vomiting in pregnancy is a continuum that ranges from mild discomfort to significant morbidity. Systematic assessment with the use of the Pregnancy-Unique Quantification of Emesis/Nausea (PUQE) index and timely treatment using evidence-based protocols can decrease the time that many women spend using treatment recommendations that are inadequate. This article reviews the epidemiology of nausea and vomiting in pregnancy, use of the PUQE index, and the evidence for specific nonpharmacologic and pharmacologic treatment regimens. A protocol for clinical management is presented.
Cyclic vomiting syndrome is a condition that consists of recurrent episodes of vomiting occurring between periods of normal health, with no apparent organic cause of vomiting. We report the sentinel case of pregnancy complicated by preexisting cyclic vomiting syndrome.
A primigravida presented at 8 weeks of gestation with a complaint of protracted vomiting. She had been diagnosed previously with cyclic vomiting syndrome. An extensive workup was performed, and she was admitted for therapy numerous times during her pregnancy. She underwent an indicated preterm delivery for fetal growth restriction, oligohydramnios, and nonreassuring fetal testing. The neonate was discharged to home in stable condition.
Cyclic vomiting syndrome can complicate pregnancy, and the gravida with cyclic vomiting syndrome may be at risk for pregnancy complications. Increased surveillance may be warranted.
The over-the-counter anti-emetic dimenhydrinate (DMH) (Gravol or Dramamine) has been reported to be abused for non-medicinal purposes. Street drug users abuse DMH for the acute effects of euphoric sensations and hallucinations, while psychiatric patients abuse DMH for its anxiolytic or anti-cholinergic effects. DMH is an H(1) histamine receptor antagonist, but it interacts either directly or indirectly with other neurotransimitter systems, including those using acetylcholine, serotonin, norepinephrine, dopamine, opioids or adenosine. Animal behavioural studies, such as self-administration, conditioned place preference, drug discrimination, and modulation of operant responding, show that anti-histamines have abuse potential. Further support comes from reports of acute and chronic abuse of DMH by humans. Collectively, results confirm the abuse liability of DMH.
To compare the efficacy of ginger to vitamin B6 in the treatment of nausea and vomiting of pregnancy.
A randomized double-blind controlled trial.
The Department of Obstetrics and Gynecology, Bangkok Metropolitan Administration Medical College and Vajira Hospital.
Women with nausea and vomiting of pregnancy at or before 16 weeks of gestation, who attended the antenatal care clinic. The subjects requested anti-emetics, had no medical complications, non-hospitalized and were able to attend a one week follow-up visit. From November, 1999 to November 2000, 138 women participated and gave consent for the study.
The subjects were randomly allocated into two groups to take either 500 mg of ginger orally or an identical 10 mg of vitamin B6 one capsule three times daily for three days. Subjects graded the severity of their nausea using visual analogue scales before treatment and recorded the number of vomiting episodes in the previous 24 hours and again during three consecutive days of treatment.
The change of nausea scores and the number of vomiting episodes during three days of treatment.
The 64 subjects in each group remained in the study. The demographic data were comparable in both groups. The ginger and vitamin B6 significantly reduced the nausea scores from 5.0 (SD, 1.99) to 3.6 (SD, 2.48) and 5.3 (SD, 2.08) to 3.3 (SD, 2.07) respectively, with p < 0.001. The mean score change after treatment with ginger was 1.4 (2.21), less than with vitamin B6, which was 2.0 (2.19) but with no statistically significant difference (95% CI -1.4 to 0.2, p = 0.136). The ginger and vitamin B6 also significantly reduced the number of vomiting episodes from 1.9 (2.06) to 1.2 (1.75) and 1.7 (1.81) to 1.2 (1.50) respectively, with p < 0.01. The mean number change after treatment with ginger was 0.7 (2.18), more than with vitamin B6, which was 0.5 (1.44) but with no statistically significant difference, (p = 0.498). There were some minor side effects in both groups such as sedation (26.6% vs 32.8%, p = 0.439), and heartburn (9.4% vs 6.3%, p = 0.510), a non-significant difference.
The nausea score and the number of vomiting episodes were significantly reduced following ginger and vitamin B6 therapy. Comparing the efficacy, there was no significant difference between ginger and vitamin B6 for the treatment of nausea and vomiting during pregnancy.
The Index of Nausea and Vomiting (INV), developed by Rhodes and others in 1984, measures three dimensions of upper gastrointestinal distress: nausea, vomiting and retching (NVR). While the revised version has been tested with a variety of high-risk populations, there are no data suggesting that it can be used to assess upper gastrointestinal distress among the growing numbers of ambulatory or day surgery patients.
The aim of this study was to evaluate a modified version of the INV for use with ambulatory surgery patients.
A secondary analysis was conducted using data obtained from a descriptive study designed to identify risk factors for postdischarge nausea and vomiting (PDNV) among adult ambulatory surgery patients. Patients who reported PDNV (n = 190) participated via phone interview 24 hours after discharge by completing a modified Rhodes INV.
Reliability analysis (alpha = 0.897) indicated that the modified Rhodes INV measured upper gastrointestinal distress as a single concept in the postdischarge ambulatory surgical sample. One item of the 8-item scale was dropped. Principal component analysis extracted one factor that accounted for 67% of the variance with all items loading.
Upper gastrointestinal distress following ambulatory surgery discharge comprises a different symptom mix than during other high-risk events such as pregnancy or chemotherapy. Further research on the differences in assessing NVR among different populations is indicated.