Efficacy of Olanzapine in Addition to Standard Triplet Antiemetic Therapy for Cisplatin-Based Chemotherapy: A Secondary Analysis of the J-FORCE Randomized Clinical Trial.

Importance: It is unknown whether olanzapine combined with triplet antemetic therapy is effective for all patients undergoing highly emetogenic chemotherapy. A secondary analysis of randomized clinical trials using olanzapine may provide insight into the effectiveness of olanzapine for chemotherapy-induced nausea and vomiting (CINV), including cisplatin. Objective: To examine the add-on effect of olanzapine according to risk factors for CINV. Design, Setting, and Participants: This preplanned secondary analysis evaluated results of the J-FORCE trial, a large double-blind, placebo-controlled phase 3 randomized clinical trial conducted in Japan from February 9, 2017, to July 18, 2018. Participants were enrolled from 26 participating hospitals across Japan and included patients aged 20 to 75 years who had a malignant tumor and were cisplatin-naive. The efficacy analysis population of the J-FORCE trial was analyzed according to allocation adjustment factors (sex [male or female], age [≥55 years or <55 years], and cisplatin dose [≥70 mg/m2 or <70 mg/m2]) and patient-related risk factors (history of motion sickness, drinking habit [defined as alcoholic drinks consumption in excess of occasional drinking], and history of morning sickness during pregnancy). Statistical analysis was performed from February 18 to April 18, 2020. Interventions: Patients were randomized 1:1 to receive 5 mg of olanzapine or placebo combined with standard triplet antiemetic therapy. Main Outcomes and Measures: The primary end point was complete response (CR, defined as no vomiting and no use of rescue medication) in the delayed phase (24-120 hours after cisplatin-based chemotherapy administration). Secondary end points were CR, complete control, and total control in the acute, delayed, and overall phases for 6 CINV risk factors as well as time to treatment failure. The CR point estimates and 95% CIs of the differences between groups were calculated, and a Mantel-Haenszel test was performed. Results: Of the 705 patients (mean [SD] age, 63.0 [9.2] years; 471 males [66.8%]) included in the efficacy analysis population; 581 patients (82.4%) were 55 years or older, and 526 (74.6%) were treated with a cisplatin dose of 70 mg/m2 or more. Risk difference (RD) for a CR in the delayed phase was significantly greater in the olanzapine group than the placebo group in males (RD, 12.6% [95% CI, 5.0%-20.1%]; P = .001); in females (RD, 14.5% [95% CI, 2.2%-26.3%]; P = .02); in those 55 years or older (RD, 11.1% [95% CI, 3.9%-18.2%]; P = .003) or younger than 55 years (RD, 23.6% [95% CI, 7.3%-38.3%]; P = .005); for a cisplatin dose of 70 mg/m2 or more (RD, 13.5% [95% CI, 5.9%-21.0%]; P < .001); for those without a history of motion sickness (RD, 13.9% [95% CI, 6.9%-20.6%]; P < .001); for those with a drinking habit (RD, 14.9% [95% CI, 6.1%-23.4%]; P = .001) or without a drinking habit (RD, 12.0% [95% CI, 2.5%-21.3%]; P = .01); and for those with a history of morning sickness during pregnancy (RD, 27.2% [9.7%-42.6%]; P = .002). In other subgroups, a delayed CR was higher in the olanzapine group than the placebo group, although not significantly higher. Conclusions and Relevance: Results of this study suggest a benefit of using 5 mg of olanzapine plus triplet antiemetic therapy to counter CINV regardless of the presence or absence of risk factors. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry Identifier: UMIN000024676.

Self-medication practice and contributing factors among pregnant women.

BACKGROUND: The practice of self-medication during pregnancy is a global challenge that necessitates high attention as it poses a potential threat to the pregnant mother and fetus. However, little is known regarding self-medication practice and its contributors among pregnant women in our setting. OBJECTIVE: The main aim of this study was to investigate the practice of self-medication and its contributing factors among pregnant women. METHODOLOGY: A cross sectional study was conducted among pregnant women at antenatal care follow-up of Ayder comprehensive specialized hospital, Tigray, Ethiopia. Written informed consent was obtained from each participant before interview. Simple random sampling technique was employed to recruit participants in to the study. Data were collected by interviewing participants using the structured questionnaire. Binary logistic regressions analysis was performed to determine the contributing factors of self-medication practice during pregnancy. A p value of less than 0.05 was considered as significant. RESULTS: A total of 250 pregnant women were included in the study. Of the total, 40.8% practiced self-medication during the current pregnancy. Morning sickness (39.2%), headache (34.3%), and upper respiratory tract infections (29.4%) were the leading indications for self-medication. According to participant report, ease of access to medicines (25.5%), feelings that the disease is minor (21.6%) and timesaving (19.6%) were the most commonly reported reasons for self-medication practice. Absence of health insurance (AOR: 2.75, 95%CI: 1.29-5.89) and being on first trimester of pregnancy (AOR: 2.44, 95%CI: 1.02-5.86) were significant contributors of self-medication practice among pregnant women. CONCLUSION: In our study, high prevalence of self-medication was reported among pregnant women. Self-medication practice during pregnancy was higher among pregnant women on first trimester and those who were not having health insurance. Therefore, intervention programs should be designed to minimize the practice of self-medication during pregnancy.

Comparison of Pregnancy Outcomes of Patients Treated With Ondansetron vs Alternative Antiemetic Medications in a Multinational, Population-Based Cohort.

Importance: Ondansetron is frequently used to treat nausea and vomiting during pregnancy. Although some studies reported important safety signals, few studies have been sufficiently large to assess rare pregnancy outcomes. Objective: To study the association between ondansetron exposure during pregnancy and the risks of spontaneous abortion, stillbirth, and major congenital malformations. Design, Setting, and Participants: This is a cohort study conducted in 3 countries, with a meta-analysis. Participants included women and girls aged 12 to 55 years who experienced spontaneous abortion, induced abortion, stillbirth, or live birth between April 2002 and March 2016, as recorded in administrative data from 5 Canadian provinces (British Columbia, Alberta, Saskatchewan, Manitoba, and Ontario), the US IBM MarketScan Research Databases, and the UK Clinical Practice Research Datalink. The statistical analysis was completed in October 2020. Exposures: Exposure to ondansetron during pregnancy was compared with exposure to other commonly used antiemetics to minimize confounding by indication. Main Outcomes and Measures: The primary outcome was fetal death, defined as either spontaneous abortion or stillbirth. Secondary outcomes were the 2 components of the primary outcome and major congenital malformations identified during the year after a live birth. Adjusted hazard ratios were estimated using Cox proportional hazards models with time-dependent drug exposures and were adjusted using high-dimensional propensity scores. For major congenital malformations, adjusted odds ratios were estimated from logistic models. Site-level results were pooled using random-effects meta-analysis. Sensitivity analyses considered second-line antiemetic exposure and exposure specifically during 4 to 10 weeks of gestation. Results: Data from 456 963 pregnancies were included in this study of fetal death (249 787 [54.7%] in Canada, 197 913 [43.3%] in the US, and 9263 [2.0%] in the UK; maternal age, ≤24 years, 93 201 patients [20.4%]; 25-29 years, 149 117 patients [32.6%]; 30-34 years, 142 442 patients [31.2%]; and ≥35 years, 72 203 patients [15.8%]). Fetal death occurred in 12 907 (7.9%) of 163 810 pregnancies exposed to ondansetron, and 17 476 (5.7%) of 306 766 pregnancies exposed to other antiemetics. The adjusted hazard ratios were 0.91 (95% CI, 0.67-1.23) for fetal death with time-dependent ondansetron exposure during pregnancy, 0.82 (95% CI, 0.64-1.04) for spontaneous abortion, and 0.97 (95% CI, 0.79-1.20) for stillbirth. For major congenital malformations, the estimated odds ratio was 1.06 (95% CI, 0.91-1.22). Results of sensitivity analyses were generally consistent with those of the primary analyses. Conclusions and Relevance: In this large, multicenter cohort study, there was no association between ondansetron exposure during pregnancy and increased risk of fetal death, spontaneous abortion, stillbirth, or major congenital malformations compared with exposure to other antiemetic drugs.

Considerations and Implications of Cannabidiol Use During Pregnancy.

PURPOSE OF REVIEW: Cannabis is a naturally occurring plant that is composed of over sixty phytocannabinoids, of which cannabidiol (CBD) has been recently identified as having therapeutic potential. RECENT FINDINGS: Although not clearly understood in its mechanism of action, CBD contains potent anti-inflammatory, anti-hyperalgesia, and analgesic qualities now being further analyzed for its use in the treatment of a plethora of diseases. Related to its large safety profile and lack of psychoactive effects typically associated with cannabis and tetrahydrocannabinol (THC), CBD is being used more frequently for self-treatment of chronic pain, anxiety, and depression. With the help of broad marketing, CBD is being used by numerous people, including pregnant women who use CBD as an anti-emetic. Since marijuana is legalized in many states in the USA, the use of CBD has increased not only in the general population but also in specific groups such as pregnant women with chronic pain. Despite CBD's accessibility, there are limited studies showing its safety during pregnancy. While the use of cannabis has been well explored in terms of the effects on pregnancy, the use of CBD during pregnancy thus far has limited literature. The goal of this investigation is to impart the current understanding of CBD and its effects of pregnancy.

Major Congenital Malformation Risk After First Trimester Gestational Exposure to Oral or Intravenous Ondansetron.

Ondansetron is a 5-HT3 receptor antagonist that has been approved for the prevention of nausea and vomiting associated with cancer chemotherapy, radiotherapy, and surgery. Ondansetron has also been studied in the treatment of many neuropsychiatric and medical conditions. The drug is commonly used off-label to treat nausea and vomiting of pregnancy (NVP) and hyperemesis gravidarum (HG). Ondansetron crosses the placental barrier, and concerns have been expressed that using ondansetron for NVP/HG during the first trimester of pregnancy may increase the risk of major congenital malformations (MCMs) in the offspring. In this context, findings from a meta-analysis of 6 cohort and 2 case-control studies, read along with the results of subsequently published cohort (n = 3) and case-control (n = 1) studies, suggest that a signal does exist to associate early gestational exposure to ondansetron with an increased risk of heart defects and orofacial defects. Arguments both for and against confounding by indication have been proposed to explain these findings. Nevertheless, even if ondansetron is causally implicated in MCM risk, the absolute increase in risk, such as for orofacial clefts (by 0.03%) and ventricular septal defect (by 0.3%), is small. These small risks should be balanced against the risks associated with inadequately treated NVP/HG, and decision-making must be shared between clinician and patient. Repeated fetal scanning during the second trimester can help in the early detection of malformations, if present.

Safe Management of Nausea and Vomiting During Pregnancy in the Emergency Department.

Nausea and vomiting during pregnancy are a frequent complaint in the emergency department, with a significant economic burden on the patient and health care system. The American College of Obstetricians and Gynecologists (ACOG) in January 2018 released an updated practice bulletin discussing the latest guidelines to managing nausea and vomiting during pregnancy. This article discusses the incidence, prevalence, and economic costs regarding medical visits for pregnancy-associated nausea and vomiting. It also discusses ACOG guidelines and furthermore outlines special considerations, management, admission, and discharge criteria for pregnant patients presenting to the emergency department for nausea and vomiting.

Medications that Cause Fetal Anomalies and Possible Prevention Strategies.

Many conditions that require frequent medication use are common during pregnancy. The purpose of this article is to list some of the most common of these disorders and to discuss the risk to the developing fetus of the medications used most frequently to treat them. Included are drugs used for the treatment of asthma, nausea and vomiting, hyperthyroidism, pain and fever, and depression during pregnancy.

Use of alternative medicine, ginger and licorice among Danish pregnant women - a prospective cohort study.

BACKGROUND: The use of alternative medicines and dietary supplements is constantly changing, as are dietary habits. One example of this phenomenon is the current popularity of ginger products as an everyday health boost. Ginger and licorice has also been shown to ameliorate nausea a common complaint in early pregnancy. Alternative medicines are often regarded as safe. However, they might affect fetal development, such as through alterations of hormone metabolism and cytochrome P450 function. Health care professionals may be unaware of the supplementation habits of pregnant women, which may allow adverse exposures to go unnoticed, especially if the rates of use in pregnancy are not known. We therefore investigated the use of alternative medicines and licorice among pregnant Danish women. METHODS: A total of 225 pregnant women were included in a prospective cohort when attending the national prenatal screening program at gestational weeks 10-16. Participants were asked to complete a questionnaire regarding their socio-economic status and lifestyle habits, including their intake of alternative medicine and licorice. RESULTS: We found that 22.7% of women reported taking alternative medicines, with 14.7% reporting daily consumption. Ginger supplements were consumed by 11.1%, mainly as health boost and 87.1% reported consumption of licorice. Regular or daily licorice consumption was reported by 38.2 and 7.1%, respectively. Notably, the use of licorice was reflected by an increase in blood pressure of the pregnant women. CONCLUSIONS: The use of licorice and alternative medicines appears to be common in pregnant Danish women, supporting the need for further investigations into the safety of alternative medicine use during pregnancy and the importance of up-to-date personalized counseling regarding popular health trends and lifestyle habits.

The health and quality of life of Thalidomide survivors as they age - Evidence from a UK survey.

BACKGROUND: In the late 1950s and early 1960s the drug Thalidomide was marketed across the world as a non-addictive tranquilizer. Despite being given to pregnant women as a safe treatment for morning sickness, Thalidomide caused serious damage to the unborn child. Much has been written about the drug and the birth defects it caused but evidence about the health of Thalidomide survivors as they age is limited. AIM: The aim of this study was to: explore the health and wellbeing UK Thalidomide survivors; document the health problems experienced by them as they reach their mid-50s; and examine the impacts on their health-related quality of life and employment. METHODS: A health and wellbeing survey of 351 UK Thalidomide survivors, which gathered information about home and employment circumstances, recent health problems, and health related quality of life (using SF12 Health Survey). Overall analysis focused on descriptive statistics; the association between respondents' health related quality of life and original impairment was examined using Pearson Correlation; and a three step Hierarchical Regression was used to explore the influence of five factors which narrative responses suggested might be important. RESULTS: As Thalidomide survivors reach their mid-50's they are experiencing a wide range of secondary health problems, in particular musculoskeletal problems, and depression and anxiety, with multimorbidity a growing issue. These health problems are having a negative impact on their employment (two fifths are unable to work) and their physical health related quality of life, which is significantly poorer than the general population. DISCUSSION: Having lived relatively independent lives, many Thalidomide survivors are now having to adjust to growing disability. The study provides further evidence of the accumulative impact of disability over peoples' lifetimes and highlights the value of a life course perspective in understanding the complex experience of growing older with a disability.

Getting through the day: a pilot qualitative study of U.S. women's experiences making decisions about anti-nausea medication during pregnancy.

BACKGROUND: Nausea during pregnancy affects 80% of pregnant women and can severely affect women's functioning and quality of life. Women often have difficulty deciding whether to take anti-nausea medications due to concern about medication risks. This paper foregrounds U.S. women's voices as they share their experiences making decisions about anti-nausea medication use. METHODS: As a pilot study, we conducted two focus groups including 20 women who had filled at least one prescription for an anti-nausea medication during pregnancy. Topics included deciding about and taking anti-nausea medications. Transcripts were analyzed by two medical anthropologists using an inductive or open coding approach. RESULTS: Women in our pilot study carefully considered whether to take anti-nausea medications. Most women preferred not to take medications, in general, but were willing to do so for severe symptoms. When considering medications, they expressed concerns about risks to fetal health. They considered information from internet research, their health care provider, and the experiences of friends and family. While some women in our study decided against taking medications, many did take a prescription medication, and they reported substantial improvement in their symptoms and sense of well-being. CONCLUSIONS: Women weighed various sources of evidence to assess the risks and benefits of taking anti-nausea medication and ultimately made a range of choices. More research is needed about the effectiveness and risks of anti-nausea medication, to help support women in their decision-making process, and also about the best methods to communicate scientific evidence to women.

Ondansetron for Treatment of Nausea and Vomiting of Pregnancy and the Risk of Specific Birth Defects.

OBJECTIVE: To use data from two large studies of birth defects to describe time trends in ondansetron use for the treatment of first-trimester nausea and vomiting of pregnancy and to investigate associations, either previously reported or undescribed, between first-trimester ondansetron use and major birth defects. METHODS: We used data from two case-control studies, the National Birth Defects Prevention Study (1997-2011) and the Slone Birth Defects Study (1997-2014). The prevalence of ondansetron use for the treatment of first-trimester nausea and vomiting of pregnancy among control patients was calculated in 2-year intervals. Using women with untreated first-trimester nausea and vomiting of pregnancy as the reference, we calculated adjusted odds ratios (ORs) and 95% CIs for associations between first-trimester ondansetron use for treatment of nausea and vomiting of pregnancy and specific birth defects. A secondary exposure group of other prescription antiemetics was used to address confounding by indication. RESULTS: In the National Birth Defects Prevention Study and Slone Birth Defects Study, respectively, 6,751 and 5,873 control mothers and 14,667 and 8,533 case mothers who reported first-trimester nausea and vomiting of pregnancy were included in the analysis. Among women in the control group, ondansetron exposure increased from less than 1% before 2000 to 13% in 2013-2014. Ondansetron use was not associated with an increased risk for most of the 51 defect groups analyzed. Modest increases in risk were observed for cleft palate (adjusted OR 1.6, 95% CI 1.1-2.3) in the National Birth Defects Prevention Study and renal agenesis-dysgenesis (adjusted OR 1.8, 95% CI 1.1-3.0) in the Birth Defects Study, although these findings may be the result of chance. CONCLUSION: Off-label use of ondansetron for the treatment of nausea and vomiting of pregnancy increased to 13% by the end of the study period. For the majority of specific birth defects investigated, there was no increased risk associated with first-trimester use of ondansetron for treatment of nausea and vomiting of pregnancy compared with no treatment, although modest associations with cleft palate and renal agenesis-dysgenesis warrant further study.

Recommendations From Cannabis Dispensaries About First-Trimester Cannabis Use.

OBJECTIVE: To characterize recommendations given to pregnant women by Colorado cannabis dispensaries regarding use of cannabis products for nausea during the first trimester of pregnancy. METHODS: This was a statewide cross-sectional study in which advice about cannabis product use was requested using a mystery caller approach. The caller stated she was 8 weeks pregnant and experiencing morning sickness. Dispensaries were randomly selected from the Colorado Department of Revenue Enforcement Division website. The primary outcome was the proportion of marijuana dispensaries that recommended a cannabis product for use during pregnancy. We hypothesized that 50% of dispensaries would recommend use. A sample size of 400 was targeted to yield a two-sided 95% CI width of 10%. Secondary outcomes included the proportion endorsing cannabis use as safe during pregnancy, specific product recommendations, and encouraging discussion with a health care provider. Recommendations were compared by licensure type (medical, retail, or both) and location (rural vs urban). RESULTS: Of the 400 dispensaries contacted, 37% were licensed for medical sale (n=148), 28% for retail (n=111), and 35% for both (n=141). The majority, 69% (277/400), recommended treatment of morning sickness with cannabis products (95% CI 64-74%). Frequency of recommendations differed by license type (medical 83.1%, retail 60.4%, both 61.7%, P<.001). Recommendations for use were similar for dispensary location (urban 71% vs nonurban 63%, P=.18). The majority (65%) based their recommendation for use in pregnancy on personal opinion and 36% stated cannabis use is safe in pregnancy. Ultimately, 81.5% of dispensaries recommended discussion with a health care provider; however, only 31.8% made this recommendation without prompting. CONCLUSION: Nearly 70% of Colorado cannabis dispensaries contacted recommended cannabis products to treat nausea in the first trimester. Few dispensaries encouraged discussion with a health care provider without prompting. As cannabis legalization expands, policy and education efforts should involve dispensaries.

Self-medication among pregnant women attending antenatal clinic at Makongoro health centre in Mwanza, Tanzania: a challenge to health systems.

BACKGROUND: Self-medication is a universal challenge that requires attention because of the potential threat not only to the pregnant women but also to unborn child. Data on self-medication practice and predictors among pregnant women is lacking in Tanzania. Information on the effects of this practice to the pregnant woman and the foetus globally is also scanty. METHODS: This was a cross sectional study which was conducted using face to face interview with 372 pregnant women at Makongoro health centre. Semi-structured questionnaires were used. Data were analysed using STATA 13 (Statistical Corporation, College Station, Texas, US). RESULTS: A total of 372 pregnant women participated in the study. The prevalence of self-medication among pregnant women was 172 (46.24%). There was a significant statistical association between self-medication and occupation (P value =0.01), gestation age (P < 0.01) and education (P < 0.01). Age, marital status and gravidity were not associated with self-medication (P = 0.809, P = 0.243 and P = 0.922) respectively. When bivariate logistic regression was performed, occupation and education were the only determining factors for self-medication. Pregnant women who were unemployed, doing business and house wife were most likely to practice self-medication than employed pregnant women (P = 0.03; OR = 2.33; 95% CI, 1.06-5.31, P = 0.01; OR = 2.31; CI 1.21-4.41, P = <0.01, OR = 2.73, 95% CI 0.52-2.43) respectively. Pregnant women with no formal education, incomplete primary education, primary education and secondary education were most likely to practice self-medication than pregnant women with college or university education (P < 0.01, OR = 6.37 95% CI 2.37-19.03, P < 0.01, OR = 6.58, 95% CI 2.36-18.25, P < 0.01, OR = 3.78, 95% CI 1.89-7.56, P < 0.01, OR = 2.59 95% CI = 1.30-5.17). The leading illness/symptoms which led to self-medication among pregnant women attending clinic were malaria 56 (32.56%, morning sickness 44 (25.55%) and headache 33(19.19%). Drugs commonly used in self-medication among pregnant women were ant malarial 42 (24.42%), antiemetics 59 (34.30%) and analgesics 33 (19.19%). CONCLUSION: Prevalence of self-medication among pregnant women is high in Tanzania. This is a threat to the safety of the developing foetus and the pregnant woman. Therefore there is a need of interventions to minimize the practice among pregnant women.

ACOG Practice Bulletin No. 189 Summary: Nausea And Vomiting Of Pregnancy.

Nausea and vomiting of pregnancy is a common condition that affects the health of a pregnant woman and her fetus. It can diminish a woman's quality of life and also significantly contributes to health care costs and time lost from work (1, 2). Because morning sickness is common in early pregnancy, the presence of nausea and vomiting of pregnancy may be minimized by obstetricians, other obstetric care providers, and pregnant women and, thus, undertreated (1). Furthermore, some women do not seek treatment because of concerns about the safety of medications (3). Once nausea and vomiting of pregnancy progresses, it can become more difficult to control symptoms. Treatment in the early stages may prevent more serious complications, including hospitalization (4). Safe and effective treatments are available for more severe cases, and mild cases of nausea and vomiting of pregnancy may be resolved with lifestyle and dietary changes. The woman's perception of the severity of her symptoms plays a critical role in the decision of whether, when, and how to treat nausea and vomiting of pregnancy. Nausea and vomiting of pregnancy should be distinguished from nausea and vomiting related to other causes. The purpose of this document is to review the best available evidence about the diagnosis and management of nausea and vomiting of pregnancy.

ACOG Practice Bulletin No. 189: Nausea And Vomiting Of Pregnancy.

Nausea and vomiting of pregnancy is a common condition that affects the health of a pregnant woman and her fetus. It can diminish a woman's quality of life and also significantly contributes to health care costs and time lost from work (1, 2). Because morning sickness is common in early pregnancy, the presence of nausea and vomiting of pregnancy may be minimized by obstetricians, other obstetric care providers, and pregnant women and, thus, undertreated (1). Furthermore, some women do not seek treatment because of concerns about the safety of medications (3). Once nausea and vomiting of pregnancy progresses, it can become more difficult to control symptoms. Treatment in the early stages may prevent more serious complications, including hospitalization (4). Safe and effective treatments are available for more severe cases, and mild cases of nausea and vomiting of pregnancy may be resolved with lifestyle and dietary changes. The woman's perception of the severity of her symptoms plays a critical role in the decision of whether, when, and how to treat nausea and vomiting of pregnancy. Nausea and vomiting of pregnancy should be distinguished from nausea and vomiting related to other causes. The purpose of this document is to review the best available evidence about the diagnosis and management of nausea and vomiting of pregnancy.

Comparison of quince with vitamin B6 for treatment of nausea and vomiting in pregnancy: a randomised clinical trial.

This trial was performed to compare quince (Cydonia oblonga) fruit with vitamin B6 on 76 pregnant women with a gestational age of 6-14 weeks and mild-to-moderate nausea and vomiting (NVP) (40 in the quince and 36 in the B6 group). The 'Pregnancy-Unique Quantification of Emesis' (PUQE-24) scale was used to examine the severity of NVP. The quince syrup (1 tablespoon/TDS) or vitamin B6 tablets (20 mg/TDS) were used as intervention for 1 week. The mean (±SD) age was 27.5 (±5.2) years. The score of the PUQE was decreased from 9.5 (± 2) at baseline to 5.2 (±2.3) on the 7th day and 5.3 (±2.6) on the 14th day (p < .001) in the quince group. In the other group, the scores were 8.4 (±1.8), 7.3 (±2.4) and 7.7 (±3.8), respectively (p = .001). The change in symptoms were more marked in the quince group (p < .001). Quince syrup seems to be a suitable treatment for NVP. Impact statement What is already known on this subject: Pregnancy-induced nausea and vomiting (NVP) is one of the most common problems during gestation. Treatment is mainly symptomatic, ranging from dietary changes and oral pharmacological treatment to hospitalization in severe forms. In early pregnancy, the use of chemical drugs is avoided, so there is an increasing tendency to use alternative therapies. According to the literature review in Iranian Traditional Medicine (ITM), the quince fruit (Cydonia oblonga) can be useful in NVP. Quince has a wide range of pharmacological activities including antioxidant, antibacterial, antifungal, anti-inflammatory, hepatoprotective and antidepressant effects. ITM literature suggests some therapeutic effects of the quince fruit on important organs like brain, heart, liver and stomach. What the results of this study add: The results of this study demonstrated the significant efficacy of quince in comparison with vitamin B6. What the implications are of these findings for clinical practice and/or further research: This fruit is also safe to be administered in pregnant women suffering from NVP.

Observational Case Series Evaluation of the Granisetron Transdermal Patch System (Sancuso) for the Management of Nausea/Vomiting of Pregnancy.

Objective The objective of this study was to observe the efficacy of antiemetic therapy (no emesis/retching episodes and no rescue medication use) when granisetron is administered via a transdermal patch system (TDS) in women who are 6 to 14 weeks pregnant when compared with oral ondansetron by evaluating the frequency of the use of rescue medications for control of nausea/vomiting of pregnancy (NVP). Methods This was an observational case series study to observe the potential benefits of granisetron TDS compared with oral ondansetron for management of NVP in pregnant patients during the first trimester. Dates of data collection were September 1, 2014, through December 31, 2015. There was no direct contact with patient. The oral ondansetron and granisetron TDS patients were matched by age, 4:1. The proportion of patients who received rescue antiemetics was calculated from those patients who continued to experience NVP. Risk factors for NVP were identified and compared between groups. Descriptive statistics were used to describe study results. Results Patients were prescribed rescue antiemetics in 0/3 patients in the granisetron TDS group compared with 2/12 patients in the oral ondansetron group. Conclusion Prospective efficacy studies on the use of granisetron TDS for management of NVP are needed to confirm this clinical observation.

Antiemetic use among pregnant women in the United States: the escalating use of ondansetron.

PURPOSE: To examine ondansetron use in pregnancy in the context of other antiemetic use among a large insured United States population of women delivering live births. METHODS: We assessed ondansetron and other antiemetic use among pregnant women delivering live births between 2001 and 2015 in 15 data partners contributing data to the Mini-Sentinel Distributed Database. We identified live birth pregnancies using a validated algorithm, and all forms of ondansetron and other available antiemetics were identified using National Drug Codes or procedure codes. We assessed the prevalence of antiemetic use by trimester, calendar year, and formulation. RESULTS: In over 2.3 million pregnancies, the prevalence of ondansetron, promethazine, metoclopramide, or doxylamine/pyridoxine use anytime in pregnancy was 15.2, 10.3, 4.0, and 0.4%, respectively. Ondansetron use increased from <1% of pregnancies in 2001 to 22.2% in 2014, with much of the increase attributable to oral ondansetron beginning in 2006. Promethazine and metoclopramide use increased modestly between 2001 (13.8%, 3.2%) and 2006 (16.0%, 6.0%) but decreased annually through 2014 (8.0%, 3.2%). Doxylamine/pyridoxine, approved for management of nausea and vomiting in pregnancy in 2013, was used in 1.8% of pregnancies in 2014. For all antiemetics, use was highest in the first trimester. CONCLUSIONS: We observed a marked increase in ondansetron use by study year, prescribed to nearly one-quarter of insured pregnant women in 2014, occurring in conjunction with decreased use of promethazine and metoclopramide. Given the widespread use of ondansetron in pregnancy, data establishing product efficacy and methodologically rigorous evaluation of post-marketing safety are needed. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.