Preemptive treatment of nausea and vomiting of pregnancy: results of a randomized controlled trial.
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ABSTRACT:
SUBMITTER: Maltepe C
PROVIDER: S-EPMC3588181 | biostudies-literature | 2013
REPOSITORIES: biostudies-literature
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Project description:BackgroundDoxylamine-pyridoxine is recommended as a first line treatment for nausea and vomiting during pregnancy and it is commonly prescribed. We re-analysed the findings of a previously reported superiority trial of doxylamine-pyridoxine for the treatment of nausea and vomiting during pregnancy using the clinical study report obtained from Health Canada.Methods and findingsWe re-analysed individual level data for a parallel arm randomized controlled trial that was conducted in six outpatient obstetrical practices in the United States. Pregnant women between 7 and 14 weeks of gestation with moderate nausea and vomiting of pregnancy symptoms. The active treatment was a tablet containing both doxylamine 10 mg and pyridoxine 10 mg taken between 2 and 4 times per day for 14 days depending on symptoms. The control was an identical placebo tablet taken using the same instructions. The primary outcome measure was improvement in nausea and vomiting of symptoms scores using the 13-point pregnancy unique quantification of emesis scale between baseline and 14 days using an ANCOVA. 140 participants were randomized into each group. Data for 131 active treatment participants and 125 control participants were analysed. On the final day of the trial, 101 active treatment participants and 86 control participants provided primary outcome measures. There was greater improvement in symptoms scores with doxylamine-pyridoxine compared with placebo (0.73 points; 95% CI 0.21 to 1.25) when last observation carried forward imputation was used for missing data but the difference is not statistically significant using other approaches to missing data (e.g. 0.38; 95% CI -0.08 to 0.84 using complete data).ConclusionsThere is a trend towards efficacy for nausea and vomiting symptoms with doxylamine-pyridoxine compared with placebo but the statistical significance of the difference depends on the method of handling missing data and the magnitude of the difference suggests that there is no clinically important benefit employing the prespecified minimal clinically important difference or "expected difference" of 3 points.Trial registrationClinical Trial NCT00614445.
| S-EPMC5771578 | biostudies-literature
Project description:There is empirical evidence that smokers are less likely to suffer from postoperative nausea and vomiting (PONV). We sought to investigate whether transcutaneus nicotine prevents PONV.Non-smokers receiving general anaesthesia for surgery were randomly allocated to Nicotinell Patch 10cm(2) (TTS 10), containing 17.5mg of nicotine (average delivery rate, 7mg?24h(-1) ) or matching placebo patch. Patches were applied 1h before surgery and were left in situ until 24h after surgery (or until the first PONV symptoms occurred).We randomized 90 patients (45 nicotine, 45 placebo). In the post-anaesthetic care unit, the incidence of nausea was 22.2% with nicotine and 24.4% with placebo (P= 0.80), and the incidence of vomiting was 20.0% with nicotine and 17.8% with placebo (P= 0.78). Cumulative 24h incidence of nausea was 42.2% with nicotine and 40.0% with placebo (P= 0.83), and of vomiting was 31.1% with nicotine and 28.9% with placebo (P= 0.81). PONV episodes tended to occur earlier in the nicotine group. Postoperative headache occurred in 17.8% of patients treated with nicotine and in 15.6% with placebo (P= 0.49). More patients receiving nicotine reported a low quality of sleep during the first postoperative night (26.7% vs. 6.8% with placebo; P= 0.01).Non-smokers receiving a prophylactic nicotine patch had a similar incidence of PONV during the first 24h and tended to develop PONV symptoms earlier compared with controls. They had a significantly increased risk of insomnia during the first postoperative night.
| S-EPMC3045547 | biostudies-literature
Project description:ObjectivesWe report information about an unpublished 1970s study ("8-way" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published.DesignDouble blinded, multi-centred, randomized placebo-controlled study.Setting14 clinics in the United States.Participants2308 patients in the first 12 weeks of pregnancy with complaints of nausea or vomiting were enrolled.InterventionsEach patient was randomized to one of eight arms: placebo, doxylamine/pyridoxine/dicylcomine, doxylamine/pyridoxine, dicylomine/pyridoxine, doxylamine, dicyclomine/pyridoxine, pyridoxine and dicyclomine. Each patient was instructed to take 2 tablets at bedtime and 1 additional tablet in the afternoon or morning if needed, for 7 nights.OutcomesReported outcomes included the number of hours of nausea reported by patients, the frequency of vomiting reported by patients and the overall efficacy of medication as judged by physicians.ResultsData from 1599 (69% of those randomized) participants were analyzed. Based on the available summary data of physician evaluation of symptoms and ignoring missing data and data integrity issues, the proportion of participants who were "evaluated moderate or excellent" was greater in each of the seven active treatment groups when compared with placebo (57%): doxylamine/pyridoxine/dicylcomine (14% absolute difference versus placebo; 95% CI: 4 to 24), doxylamine/pyridoxine (21; 95% CI 11 to 30), dicylomine/pyridoxine (21; 95% CI 11 to 30), doxylamine (20; 95% CI 10 to 29), dicyclomine/pyridoxine (4; 95% CI -6 to 14), pyridoxine (9; 95% CI -1 to 19) and dicyclomine (4; 95% CI -6 to 14). Based on incomplete information, the most common adverse events were apparently drowsiness and fatigue. There is a high risk of bias in these previously unpublished results given the high attrition rate in a 7 day trial, the lack of prespecified outcomes or analyses, and the exclusion of some data because of questionable data integrity.ConclusionThe available information about this "8-way Bendectin" trial indicates it should not be used to support the efficacy of doxylamine, pyridoxine or dicyclomine for the treatment of nausea and vomiting during pregnancy because of a high risk of bias.Trial registrationNot registered.
| S-EPMC5215753 | biostudies-literature
Project description:Importance:Nausea and vomiting during pregnancy have been associated with a reduced risk for pregnancy loss. However, most prior studies enrolled women with clinically recognized pregnancies, thereby missing early losses. Objective:To examine the association of nausea and vomiting during pregnancy with pregnancy loss. Design, Setting, and Participants:A randomized clinical trial, Effects of Aspirin in Gestation and Reproduction, enrolled women with 1 or 2 prior pregnancy losses at 4 US clinical centers from June 15, 2007, to July 15, 2011. This secondary analysis was limited to women with a pregnancy confirmed by positive results of a human chorionic gonadotropin (hCG) test. Nausea symptoms were ascertained from daily preconception and pregnancy diaries for gestational weeks 2 to 8. From weeks 12 to 36, participants completed monthly questionnaires summarizing symptoms for the preceding 4 weeks. A week-level variable included nausea only, nausea with vomiting, or neither. Main Outcomes and Measures:Peri-implantation (hCG-detected pregnancy without ultrasonographic evidence) and clinically recognized pregnancy losses. Results:A total of 797 women (mean [SD] age, 28.7 [4.6] years) had an hCG-confirmed pregnancy. Of these, 188 pregnancies (23.6%) ended in loss. At gestational week 2, 73 of 409 women (17.8%) reported nausea without vomiting and 11 of 409 women (2.7%), nausea with vomiting. By week 8, the proportions increased to 254 of 443 women (57.3%) and 118 of 443 women (26.6%), respectively. Hazard ratios (HRs) for nausea (0.50; 95% CI, 0.32-0.80) and nausea with vomiting (0.25; 95% CI, 0.12-0.51) were inversely associated with pregnancy loss. The associations of nausea (HR, 0.59; 95% CI, 0.29-1.20) and nausea with vomiting (HR, 0.51; 95% CI, 0.11-2.25) were similar for peri-implantation losses but were not statistically significant. Nausea (HR, 0.44; 95% CI, 0.26-0.74) and nausea with vomiting (HR, 0.20; 95% CI, 0.09-0.44) were associated with a reduced risk for clinical pregnancy loss. Conclusions and Relevance:Among women with 1 or 2 prior pregnancy losses, nausea and vomiting were common very early in pregnancy and were associated with a reduced risk for pregnancy loss. These findings overcome prior analytic and design limitations and represent the most definitive data available to date indicating the protective association of nausea and vomiting in early pregnancy and the risk for pregnancy loss. Trial Registration:clinicaltrials.gov Identifier: NCT00467363.
| S-EPMC6191846 | biostudies-literature
Project description:BackgroundNausea and vomiting of pregnancy (NVP) is the most common medical condition in pregnancy, affecting up to 80% of expecting mothers. In April 2013 the FDA approved the delayed release combination of doxylamine succinate and -pyridoxine hydrochloride (Diclegis®) for NVP, following a phase 3 randomized trial in pregnant women. The fetal safety of this medication has been proven by numerous studies. However, because it is the only FDA-approved medication for NVP that is likely to be used by a large number of pregnant women, its maternal safety is an important public health question. The Objective is to evaluate the maternal safety of doxylamine succinate -pyridoxine hydrochloride delayed-release preparation (Diclegis® as compared to placebo.MethodsWe randomized women suffering from NVP to receive Diclegis® (n = 131) or placebo (n = 125) for 14 days at doses ranging from 2-4 tablets a day, based on a pre-specified titration protocol response to symptoms. Adverse events were collected through patient diaries, clinical examination and laboratory testing.ResultsDoxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg use was not associated with an increased rate of any adverse event over placebo, including CNS depression, gastrointestinal or cardiovascular involvement.ConclusionsDoxylamine succinate-pyridoxine hydrochloride delayed release combination is safe and well tolerated by pregnant women when used in the recommended dose of up to 4 tablets daily in treating nausea and vomiting of pregnancy.Trial registrationClinical Trial Registration No: NCT00614445 .
| S-EPMC4391332 | biostudies-literature
Project description:IntroductionThis study aimed to assess the impact of wearing compression stockings on women's quality of life (QoL) associated with nausea and vomiting in early pregnancy (NVP).MethodsIn this randomized, open, single-center, crossover study, 74 women were assigned 1:1 to 2 weeks with compression stockings followed by 2 weeks without or vice versa. The main outcomes were NVP-associated QoL, leg-related QoL, and dizziness, as assessed by the Nausea and Vomiting in Pregnancy Quality of Life (NVPQOL) questionnaire, Chronic Venous Disease Quality of Life (CIVIQ) questionnaire, and questions on dizziness at baseline and after each 2-week period, respectively. Daily NVP was assessed using the modified Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) questionnaire. Data were analyzed using Pearson's chi-square and independent t-tests.ResultsFifty-eight women completed the study. QoL scores improved with compression treatment; changes in mean total scores were as follows: NVPQOL, -36.7 with compression vs -21.7 without (P<0.0001); and CIVIQ, -4.5 with compression vs +1.4 without (P=0.001). Mean dizziness scores were -3.2 with compression vs -0.4 without (P<0.0001). PUQE mean total score (standard deviation) was 4.9 (2.3) with compression vs 5.5 (2.2) without (P=0.042).DiscussionWearing of compression stockings in early pregnancy may improve nausea and vomiting-associated symptoms in addition to improving QoL factors.
| S-EPMC5328137 | biostudies-literature
Project description:Nausea and vomiting in pregnancy (NVP) is a condition that commonly affects women in the first trimester of pregnancy. Despite frequently leading to emergency department (ED) visits, little evidence exists to characterize the nature of ED visits or to guide its treatment in the ED. Our objectives were to evaluate the treatment of NVP in the ED and to identify factors that predict return visits to the ED for NVP.We conducted a retrospective database analysis using the electronic medical record from a single, large academic hospital. Demographic and treatment variables were collected using a chart review of 113 ED patient visits with a billing diagnosis of "nausea and vomiting in pregnancy" or "hyperemesis gravidarum." Logistic regression analysis was used with a primary outcome of return visit to the ED for the same diagnoses.There was wide treatment variability of nausea and vomiting in pregnancy patients in the ED. Of the 113 patient visits, 38 (33.6%) had a return ED visit for NVP. High gravidity (OR 1.31, 95% CI [1.06-1.61]), high parity (OR 1.50 95% CI [1.12-2.00]), and early gestational age (OR 0.74 95% CI [0.60-0.90]) were associated with an increase in return ED visits in univariate logistic regression models, while only early gestational age (OR 0.74 95% CI [0.59-0.91]) was associated with increased return ED visits in a multiple regression model. Admission to the hospital was found to decrease the likelihood of return ED visits (p=0.002).NVP can be difficult to manage and has a high ED return visit rate. Optimizing care with aggressive, standardized treatment in the ED and upon discharge, particularly if factors predictive of return ED visits are present, may improve quality of care and reduce ED utilization for this condition.
| S-EPMC5017843 | biostudies-other
Project description:Objectives To determine whether preoperative dexamethasone reduces postoperative vomiting in patients undergoing elective bowel surgery and whether it is associated with other measurable benefits during recovery from surgery, including quicker return to oral diet and reduced length of stay.Design Pragmatic two arm parallel group randomised trial with blinded postoperative care and outcome assessment.Setting 45 UK hospitals.Participants 1350 patients aged 18 or over undergoing elective open or laparoscopic bowel surgery for malignant or benign pathology.Interventions Addition of a single dose of 8 mg intravenous dexamethasone at induction of anaesthesia compared with standard care.Main outcome measures Primary outcome: reported vomiting within 24 hours reported by patient or clinician.Secondary outcomesvomiting with 72 and 120 hours reported by patient or clinician; use of antiemetics and postoperative nausea and vomiting at 24, 72, and 120 hours rated by patient; fatigue and quality of life at 120 hours or discharge and at 30 days; time to return to fluid and food intake; length of hospital stay; adverse events.Results 1350 participants were recruited and randomly allocated to additional dexamethasone (n=674) or standard care (n=676) at induction of anaesthesia. Vomiting within 24 hours of surgery occurred in 172 (25.5%) participants in the dexamethasone arm and 223 (33.0%) allocated standard care (number needed to treat (NNT) 13, 95% confidence interval 5 to 22; P=0.003). Additional postoperative antiemetics were given (on demand) to 265 (39.3%) participants allocated dexamethasone and 351 (51.9%) allocated standard care (NNT 8, 5 to 11; P<0.001). Reduction in on demand antiemetics remained up to 72 hours. There was no increase in complications.Conclusions Addition of a single dose of 8 mg intravenous dexamethasone at induction of anaesthesia significantly reduces both the incidence of postoperative nausea and vomiting at 24 hours and the need for rescue antiemetics for up to 72 hours in patients undergoing large and small bowel surgery, with no increase in adverse events.Trial registration EudraCT (2010-022894-32) and ISRCTN (ISRCTN21973627).
| S-EPMC5482348 | biostudies-literature
Project description:Dexamethasone is widely used for postoperative nausea and vomiting (PONV) prophylaxis, but its effect on PONV prevention in paediatric patients is validated only in short minor surgical procedures. In this study, we aimed to determine whether a single dose of dexamethasone reduces PONV in highly invasive surgeries that require opioid-based postoperative analgesia. One hundred adolescents undergoing scoliosis correction surgery were randomized to receive intravenous dexamethasone 0.15 mg/kg (dexamethasone group) or saline (control group) at induction of anaesthesia. The primary outcome was the incidence of PONV in the 72 h postoperatively. Data for 98 patients were available for analysis. The 72-h incidence of PONV was significantly lower in the dexamethasone group than in the control group (62.5% vs 84.0%; RR 0.74, 95% CI 0.58-0.96, P = 0.02). During the first and second 24-h postoperative intervals, fewer patients in the dexamethasone group received rescue antiemetics. Visual analogue scale scores for nausea and pain were lower in the dexamethasone group than in the control group during the first 24 h postoperatively. Dexamethasone did not increase the number of adverse events. The results of this study showed that a single dose of dexamethasone was effective for reducing PONV after paediatric scoliosis correction surgery.
| S-EPMC6376007 | biostudies-other
Project description:ImportanceNausea and vomiting, unrelated to chemotherapy, can be substantial symptoms in patients with advanced cancer.ObjectiveTo evaluate the utility of olanzapine for treating chronic nausea/vomiting, unrelated to chemotherapy, in patients with advanced cancer.Design, setting, and participantsThis study is a double-line, placebo-controlled, randomized clinical trial conducted from July 2017 through April 2019, with analysis conducted in 2019. Eligible participants were outpatients with advanced cancer who had persistent nausea/vomiting without having had chemotherapy or radiotherapy in the prior 14 days. Chronic nausea was present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).InterventionsPatients received olanzapine (5 mg) or a placebo, orally, daily for 7 days.Main outcomes and measuresPatient-reported outcomes were used for study end points. Data were collected at baseline and daily for 7 more days. The primary study end point (the change in nausea numeric rating scores from baseline to the last treatment day) and the study hypothesis were both identified prior to data collection.ResultsA total of 30 patients (15 per arm) were enrolled; these included 16 women and 14 men who had a mean (range) age of 63 (39-79) years. Baseline median nausea scores, in all patients, were 9 out of 10 (range, 8-10). After 1 day and 1 week, the median nausea scores in the placebo arm were 9 out of 10 (range, 8-10) on both days, compared with the olanzapine arm scores of 2 out of 10 (range, 2-3) after day 1 and 1 out of 10 (range, 0-3) after 1 week. After 1 week of treatment, the reduction in nausea scores in the olanzapine arm was 8 points (95% CI, 7-8) higher than that of the placebo arm. The primary 2-sided end point P value was <.001. Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being. One patient, on the placebo, stopped treatment early owing to lack of perceived benefit. No patients receiving olanzapine reported excess sedation or any other adverse event.Conclusions and relevanceOlanzapine, at 5 mg/d, appeared to be effective in controlling nausea and emesis and in improving other symptoms and quality-of-life parameters in the study population.Trial registrationClinicalTrials.gov Identifier: NCT03137121.
| S-EPMC7206532 | biostudies-literature