Safety profile of herbal medicines submitted for marketing authorization in Tanzania: a cross-sectional retrospective study.

BACKGROUND: The popular use of herbal medicines necessitates national regulatory authorities to have efficient mechanisms for the control of these products including marketing authorization (MA) and safety follow-up. Herbal medicines like conventional medicines require assessment of efficacy, safety and quality information before MA can be granted. However, the complete proof of safety is mainly based on the history of the long-term traditional use. Herbal medicines can cause adverse reactions due to various factors and thus require clinical trials to ensure their safety. Herbal medicines treatment practices involve combinations of different plants to achieve the desired effect while multiple herbal components have been known to cause herbal-herbal toxicity and interactions due to variety of complex active ingredients in plants. Compliance with regulatory requirements on herbal medicines has been shown to be difficult for manufacturers since different countries have different regulatory requirements with wide variations which results in the MA of very few herbal medicines. Limited studies on dossiers of marketing authorization of herbal medicines have been performed in other countries, with no studies in African regulatory system settings. The aim of this study is to determine the type of safety documentation that is submitted on herbal medicines application dossiers to support MA in Tanzania. METHODS: A cross-sectional retrospective study of herbal medicines dossiers submitted at the Tanzania Medicines and Medical Devices Authority from 2009 to 2020 was conducted. RESULTS: As many as 75% of the herbal products applications were combination products made by more than one herbal substance or plant. Out of 84 dossiers subjected to analysis the majority did not provide evidence of preclinical (55%) and clinical safety data (68%). Evidence of safety data in humans was mostly from the literature (70%) and not manufacturers' clinical studies. Quality parameters with safety implications were not included in 48% and 23% of the active herbal substance and finished product specifications, respectively. CONCLUSION: Analysis of the herbal medicine dossiers submitted showed major deficiencies of safety data to support MA. Manufactures need to provide evidence to support the safety of their products for evidence-based regulatory decisions and to avoid multiple reviews of the applications.

Antiemetic treatment of hyperemesis gravidarum in 1,064 Norwegian women and the impact of European warning on metoclopramide: a retrospective cohort study 2002-2019.

BACKGROUND: Women suffering from severe nausea and vomiting during pregnancy, hyperemesis gravidarum, have poor quality of life and increased risk of potentially fatal maternal and fetal complications. There is increasing and reassuring knowledge about safety of antiemetics in pregnancy. In 2013, the European Medical Agency (EMA) issued a warning on metoclopramide limiting treatment to maximum five days. Metoclopramide was the most used antiemetic in pregnancy at the time the warning was implemented in the Norwegian hyperemesis guidelines (2014). We aimed at describing changes in the treatment of hyperemesis over time, including changes associated with the EMA warning. METHODS: Retrospective chart review of all women hospitalized for hyperemesis gravidarum with metabolic disturbances between 01/Jan/2002 and 31/Dec/2019 at a university hospital serving nearly 10% of the pregnant population in Norway. Time-series analysis described changes over time and interrupted time series analysis quantified changes in treatment and clinical outcomes related to the EMA warning. RESULTS: In total, 1,064 women (1.2% of the birthing population) were included. The use of meclizine, prochlorperazine, and ondansetron increased during 2002-2019. This led to a yearly increase in the percentage of women using any antiemetic of 1.5% (95%CI 0.6; 2.4) pre-hospital, 0.6% (95%CI 0.2; 1.1) during hospitalization, and 2.6% (95%CI 1.3; 3.8) at discharge. Overall, only 50% of the women received antiemetics pre-hospital. Following the EMA warning, prehospital use of metoclopramide dropped by 30% (95%CI 25; 36), while use of any antiemetic pre-hospital dropped by 20% (95%CI 5.7; 34). In timely association, we observed a decrease in gestational age (-3.8 days, 98.75%CI 0.6; 7.1) at first admission, as well as indication of increased rate of termination of pregnancy with an absolute increase of 4.8% (98.75%CI 0.9; 8.7) in 2014. CONCLUSION: During 2002-2019, the overall use of antiemetics in treatment of hyperemesis increased. The EMA-warning on metoclopramide in 2013 temporarily limited pre-hospital antiemetic provision associated with hospitalization at lower gestational length and indication of an increase in termination of pregnancy.

Medication Prescription, Common Side-effects, and Nutritional Status are Associated in Patients With Chronic Kidney Disease.

OBJECTIVE: Chronic kidney disease (CKD) is associated with metabolic, nutritional, and extra-renal changes, as well as a high rate of comorbidities, which necessitates the prescription of numerous medications. Patients with CKD often experience poor nutritional status related to disease severity and prescribed medication; however, this association has not been investigated in depth. Therefore, this study aimed at investigating the association between prescribed medication and nutritional status in patients with CKD. METHODS: Assessment of nutritional status was performed using anthropometric and functional measurements and by biochemical measures. Patient history and the number and type of currently prescribed medications were collected from patients' records. We evaluated the total number and the number of specific medicines with common or very common side-effects of nausea or xerostomia. RESULTS: Two hundred seventeen patients with CKD were included in this cross-sectional study (n = 112 with pre-dialysis CKD stages 3-5, n = 33 with hemodialysis, and n = 72 with kidney transplant). On average, patients were prescribed nine medications concurrently. The number of prescribed medications was inversely associated with mid-upper arm circumference, skinfold thickness triceps, handgrip strength, serum albumin, and hemoglobin after adjustment for age, sex, and kidney function. Prescription of medications with nausea as a side-effect showed similar associations, whereas prescription of medications with xerostomia as a side-effect was associated with lower handgrip strength. CONCLUSION: Medication prescription was associated with poor nutritional status in patients with CKD, and monitoring of nutritional status in patients with CKD with long medication lists is warranted to identify and treat patients with poor nutritional status.

Home management by remote self-monitoring in intermediate- and high-risk pregnancies: A retrospective study of 400 consecutive women.

INTRODUCTION: Home management in general is considered to improve patient well-being, patient involvement and cost-effectiveness, for obstetric patients as well. But concerns regarding inclusion of intermediate- and high-risk pregnant women are an issue and a limitation for clinical implementation. This retrospective study evaluated the outcome and safety of extended remote self-monitoring of maternal and fetal health in intermediate- and high-risk pregnancies. MATERIAL AND METHODS: The study reports on 400 singleton pregnancies complicated by preterm premature rupture of membranes (PPROM), fetal growth restriction, preeclampsia, gestational diabetes mellitus, high-risk of preeclampsia, or a history of previous fetal or neonatal loss. Remote self-monitoring was performed by pregnant women and included C-reactive protein, non-stress test by cardiotocography, temperature, blood pressure, heart rate, and a questionnaire concerning maternal and fetal wellbeing. Data were transferred to the hospital using a mobile device platform and evaluated by healthcare professionals. In case of non-reassuring registrations, the pregnant women were invited for assessment at the hospital. Primary outcome was perinatal death. Secondary outcomes were other maternal and perinatal complications. RESULTS: No severe maternal complications were observed. Nine fetal or neonatal deaths occurred, all secondary to malformations, severe fetal growth restriction, extreme prematurity or lung hypoplasia in cases of PPROM before 24 weeks. Even in the latter group, fetal and neonatal survival was 78% (18/23) and rose to 97% (60/62) when PPROM occurred after a gestational age 23+6 weeks. None of the fetal or neonatal deaths were attributable to the home-management setting. CONCLUSIONS: Home-monitoring including remote self-monitoring of fetal and maternal well-being in intermediate- and high-risk pregnancies seems to be a safe alternative to inpatient or frequent outpatient care, which sets the stage for a new way of thinking of hospital care. The implementation process included staff training workshops and development of patient enrollment practice with clarification of expectations and responsibilities, which can be crucial to the results.

Herbal medicine use among pregnant women attending antenatal clinics in Lusaka Province, Zambia: A cross-sectional, multicentre study.

BACKGROUND AND PURPOSE: The study of herbal medicine (HM) use which is related to maternal health, a public health priority in many sub-Saharan African countries including Zambia, has been limited. Accordingly, we aimed to determine the prevalence and patterns of HM use during pregnancy in Lusaka Province, Zambia. MATERIALS AND METHODS: A survey-based (interviewer-administered), cross-sectional, multicentre study was conducted in 446 adult pregnant women attending antenatal clinics in June/July 2019. RESULTS: Overall, 57.8% of participants reported using HM during their current pregnancy, with a mean of 2.0 ± 1.5 remedies/woman. Logistic regression analysis showed that HM use was significantly associated with HM use in prior pregnancies (p < 0.001) and willingness to use HM in the future (p < 0.001). The most commonly used herbs were lemon for nausea/vomiting and common cold, soybean to boost energy, ginger for common cold and nausea/vomiting, and Aloe vera for skin care. The perceived safety of HM (37.6%) and its complementary action with conventional medicines (35.3%) were the main reasons for HM use. CONCLUSION: HM use among pregnant women attending antenatal clinics in Lusaka Province, Zambia is common, and a wide range of herbs is used.

"Back to Eden": An explorative qualitative study on traditional medicine use during pregnancy among selected women in Lusaka Province, Zambia.

BACKGROUND AND PURPOSE: No qualitative study on traditional medicine use among Zambian pregnant women has ever been conducted. Accordingly, this study was performed to explore the perceptions, motivations and experiences of Zambian women with regard to traditional medicine use during pregnancy. MATERIALS AND METHODS: In-depth, semi-structured interviews were conducted in June/July 2019 with 8 adult women residing in Lusaka, Zambia, who used traditional remedies during their pregnancies, and who were recruited through purposive and snowball sampling. RESULTS: Reported reasons behind traditional medicine use during pregnancy included labour induction, prevention of childbirth complications in case of sexual infidelity by either spouse, and prevention and/or treatment of anaemia. In addition, family members and faith leaders played an important role in influencing traditional medicine use. CONCLUSION: Multiple, interconnecting factors influence traditional medicine use among pregnant women in Lusaka, Zambia. Traditional medicine use during pregnancy will likely continue to be widespread across Zambia.

Herbal Medicine Use During Pregnancy: A Review of the Literature With a Special Focus on Sub-Saharan Africa.

Herbal medicine use has grown considerably worldwide among pregnant women, and is particularly widespread in sub-Saharan Africa. However, herbal medicines used across sub-Saharan Africa are associated with important research gaps and a lack of regulatory framework. This is particularly problematic, as herbal medicine use during pregnancy raises several concerns attributed to the herbal ingredient itself, conventional drug-herbal medicine interactions, and contamination or adulteration of herbal remedies. Moreover, several local herbal remedies used by sub-Saharan African pregnant women have never been botanically identified. In this review, an overview of the practice of herbal medicine, including the regulations, challenges and overall safety, is provided. Then, we discuss the prevalence of herbal medicine use during pregnancy across different sub-Saharan African countries, as well as the indications, adverse outcomes, and effectiveness of the most commonly used herbal medicines during pregnancy in that region.

Women's perspectives on the management and consequences of hyperemesis gravidarum - a descriptive interview study.

OBJECTIVE: Hyperemesis gravidarum (HG) affects 0.3-3% of pregnant women and is a leading cause of hospitalization in early pregnancy. The aim of the study was to investigate women's treatment and management of HG, as well as the consequences of HG on women's daily life. DESIGN AND SETTING: A cross-sectional study based on a structured telephone interview and an online questionnaire. Participants were recruited by social media and by the Norwegian patient's organization for HG. SUBJECTS: Norwegian women that experienced HG. MAIN OUTCOME MEASURE: Women's perspectives on management and consequences of HG. RESULTS: The study included 107 women. Maternal morbidity was profound; about 3/4 of participants were hospitalized due to HG, and the majority showed clinical signs of dehydration (79%), ketonuria (75%), and >5% weight loss (84%). Antiemetics were used by >90% and frequently prescribed "as needed". Metoclopramide (71%) and meclozine (51%) were most commonly used. Participants described HG as having severe psychosocial consequences and profound impact on daily activities. Almost two out of five reported thoughts of elective abortion, and 8 women had at least one elective pregnancy termination due to HG. Overall, 20 women (19%) changed GPs due to dissatisfaction with HG management. CONCLUSION: Despite the high psychosocial burden and major impact on daily activities, many women with HG reported a lack of support from healthcare professionals and suboptimal management. Greater awareness and knowledge among healthcare professionals is needed to improve care for women with HG. Key Points There is a paucity of studies on management and the consequences of HG on women's daily lives and psychosocial burden. We found that: • Many women described HG as one of their worst life experiences with profound morbidity. • Many women reported suboptimal management of HG and lack of support from healthcare professionals. • Greater understanding of patient perspectives among healthcare professionals is important to improve care and management for HG patients.

Knowledge of antibiotics and antibiotic resistance among Norwegian pharmacy customers - a cross-sectional study.

BACKGROUND: Antibiotic resistance is a global health threat. Public knowledge is considered a prerequisite for appropriate use of antibiotics and limited spread of antibiotic resistance. Our aim was to examine the level of knowledge of antibiotics and antibiotic resistance among Norwegian pharmacy customers, and to assess to which degree beliefs, attitudes and sociodemographic factors are associated with this knowledge. METHODS: A questionnaire based, cross-sectional study was conducted among pharmacy customers in three Norwegian cities. The questionnaire covered 1) knowledge of antibiotics (13 statements) and antibiotic resistance (10 statements), 2) the general beliefs about medicines questionnaire (BMQ general) (three subdomains, four statements each), 3) attitudes toward antibiotic use (four statements), and 4) sociodemographic factors, life style and health. High knowledge level was defined as > 66% of maximum score. Factors associated with knowledge of antibiotics and antibiotic resistance were investigated through univariate and multiple linear regression. Hierarchical model regression was used to estimate a population average knowledge score weighted for age, gender and level of education. RESULTS: Among 877 participants, 57% had high knowledge of antibiotics in general and 71% had high knowledge of antibiotic resistance. More than 90% knew that bacteria can become resistant against antibiotics and that unnecessary use of antibiotics can make them less effective. Simultaneously, more than 30% erroneously stated that antibiotics are effective against viruses, colds or influenza. Factors positively associated with antibiotic knowledge were health professional background, high education level, and a positive view on the value of medications in general. Male gender, a less restrictive attitude toward antibiotic use, and young age were negatively associated with antibiotic knowledge. The mean overall antibiotic knowledge score was relatively high (15.6 out of maximum 23 with estimated weighted population score at 14.8). CONCLUSIONS: Despite a high level of knowledge of antibiotics and antibiotic resistance among Norwegian pharmacy customers, there are obvious knowledge gaps. We suggest that action is taken to increase the knowledge level, and particularly target people in vocational, male dominated occupations outside the health service, and primary/secondary school curricula.

The burden of nausea and vomiting during pregnancy: severe impacts on quality of life, daily life functioning and willingness to become pregnant again - results from a cross-sectional study.

BACKGROUND: Though nausea and vomiting is very common during pregnancy, no studies have investigated the impact of this condition on the women's daily lives in a Scandinavian population. The aim of this study was to describe the burden of nausea and vomiting during pregnancy (NVP) on global quality of life, daily life functioning and willingness to become pregnant again according to the severity of NVP symptoms. METHODS: This study is a cross-sectional population-based study conducted in Norway. Pregnant women and mothers with children <1 year of age with current or prior NVP were eligible to participate. Data were collected through an anonymous on-line questionnaire accessible from November 10th, 2014 to January 31st, 2015. Severity of NVP was measured using the 24-h Pregnancy Unique Quantification of Emesis Scale (PUQE). Associations between severity of NVP, daily life functioning and willingness to become pregnant again were tested using chi-square tests. Associations with global quality of life measured in terms of the Quality of Life Scale (QOLS) were estimated using generalized linear models and reported as unstandardized regression coefficients (ß) with 95% confidence intervals (CI). RESULTS: 712 women with NVP were included in the study. NVP was significantly associated with several characteristics, including daily life functioning, quality of life and willingness to become pregnant again. The negative impact was greater the more severe the symptoms were, although considerable adverse effects were also seen among women with mild and moderate NVP symptoms. Over one fourth of the women with severe NVP considered terminating the pregnancy due to NVP, and three in four considered not to get pregnant again. Severity of NVP remained significantly associated with reduced global quality of life when adjusting for maternal characteristics and illnesses with ß (95% CI) = -10.9 (-16.9, -4.9) for severe versus mild NVP. CONCLUSIONS: NVP as measured by PUQE had a major impact on various aspects of the women's lives, including global quality of life and willingness to become pregnant again.

Pharmacists counselling of pregnant women: Web-based, comparative study between Serbia and Norway.

OBJECTIVES: To describe, compare and evaluate whether pharmacists in two European countries, Serbia and Norway, give appropriate counselling for common ailments in pregnancy. DESIGN: A cross sectional, web-based study. PARTICIPANTS AND SETTINGS: A study was conducted among Serbian and Norwegian pharmacists during two four-month study periods in 2012 respectively 2014. Participants were recruited through postal and electronic invitation facilitated by several pharmacy chains. Participation in the study was anonymous and voluntary. MEASUREMENT INSTRUMENT: Pharmacists were presented with the questionnaire that included five scenarios (back pain, heavy legs, nausea, cold and constipation in pregnancy) and were asked to give their advice about use of medicines, supplements (e.g. herbal products, vitamins, minerals), non-pharmacological treatment and referral to physician in each condition. FINDINGS: In total, 276 pharmacists, 119 in Serbia and 157 in Norway, accepted to participate in the study. Recommendation about medicines use ranged from 32% (heavy legs) to 71% (back pain) in Serbia and from 3% (heavy legs) to 92% (constipation) in Norway. Several pharmacists' recommendations on medicines and supplements use were inappropriate. Recommendation about non-pharmacological treatments ranged from 11% (nausea) to 50% (heavy legs) in Serbia and from 12% (constipation) to 63% (cold) in Norway. Approximately 12% of the Norwegian and Serbian pharmacists offered referral to a physician as only advice for nausea in pregnancy, indicating a lack of confidence in or knowledge about this common ailment in pregnancy. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Large differences in counselling of pregnant women by pharmacists in Serbia and Norway were observed. Enhancement of pharmacists' knowledge about treatment of common ailments in pregnancy is needed and will enhance pharmacists' role in improving maternal health.

Nausea in pregnancy: attitudes among pregnant women and general practitioners on treatment and pregnancy care.

OBJECTIVE: Nausea and vomiting during pregnancy (NVP) is very common, and may have great impact on a woman's life. The aim of this study was to explore thoughts and attitudes among Norwegian pregnant women and GPs on treatment of NVP and pregnancy care. DESIGN: Focus-group study. SETTING AND SUBJECTS: Separate focus-group discussions were conducted with pregnant women and GPs. RESULTS: Two focus-group discussions were conducted with pregnant women and two with GPs. The GPs thought it was important to normalize NVP symptoms. However, the women felt their distress due to NVP was trivialized by the GPs. The women were sceptical towards the use of medicines while pregnant, and avoidance was sought despite being ill. The GPs appeared uncertain with respect to medical treatment of NVP, which was stated to be considered only after progression to quite severe symptoms. Sick leave seemed to be an important part of the treatment regime applied by the GPs. The women had good experiences with graded sick leave. CONCLUSION: This Norwegian study identifies attitudes among GPs and pregnant women that may act as obstacles to appropriate care for women with NVP. The pregnant women and the GPs seemed to talk at cross-purposes; GPs' normalization of the symptoms made the women feel that their distress due to NVP was trivialized by the GPs. Our results indicate that pregnant women with NVP requiring medical treatment probably need comprehensive and reassuring information about treatment options before considering using any medicines. KEY POINTS: Nausea and vomiting during pregnancy (NVP) is very common, and considered to be of clinical significance for 35% of women. While the GPs agreed on the importance of normalizing the symptoms, the women felt their distress was trivialized, and missed being properly evaluated. Both the GPs and the women showed a reluctant attitude to medical treatment of NVP. The GPs gave the impression of considering medical treatment only after progression of symptoms to becoming quite severe.

Treatment of nausea and vomiting during pregnancy -a cross-sectional study among 712 Norwegian women.

PURPOSE: The purposes of this study were to investigate the treatments used for nausea and vomiting of pregnancy (NVP) according to NVP severity among Norwegian women and to assess whether maternal characteristics and attitudes were related to the use of pharmacological treatment of NVP. METHODS: This is a cross-sectional Web-based study. Pregnant women and mothers with children ≤1 year of age were eligible to participate. Data were collected through an anonymous online questionnaire accessible from November 10th, 2014 to January 31st, 2015. RESULTS: In total, 712 women were included in the study, of which 62 (8.7 %), 439 (61.7 %) and 210 (29.5 %) had mild, moderate and severe NVP, respectively, according to the Pregnancy-Unique Quantification of Emesis (PUQE) classification. A total of 277 (38.9 %) women had used one or more antiemetics, of which meclizine, closely followed by metoclopramide, was the most commonly used. Different drug utilisation patterns were found between the groups of women with mild, moderate and severe NVP. Many with moderate or severe symptoms did not use any pharmacological treatment (70.2 and 32.9 %, respectively). Sick leave was given without initiating medical treatment in 266 (62.1 %) women. The women's beliefs about medicines had an important impact on their use of medicines for NVP. CONCLUSIONS: A large proportion of women suffered from moderate to severe symptoms of NVP, many of whom did not receive any pharmacological treatment. Many women, who had been on sick leave due to NVP, were not prescribed medicines.

Treatment of nausea in pregnancy: a cross-sectional multinational web-based study of pregnant women and new mothers.

BACKGROUND: The factors related to the treatment of nausea during pregnancy have not yet been investigated in several countries simultaneously. The present study aimed to describe differences in self-reported nausea during pregnancy and the patterns of use for both conventional and herbal medicines across countries. The factors related to nausea and its treatment and the relationships between different self-reported co-morbidities and nausea were also investigated. METHODS: This cross-sectional study used data collected by a web-based questionnaire distributed between October 2011 and February 2012 in several countries within five regions: Western, Northern, and Eastern Europe, North America, and Australia. Women who were pregnant or had a child less than one year old were eligible to participate. RESULTS: A total of 9113 women were included in the study, whereof 6701 (73.5%) had experienced nausea during pregnancy. Among respondents with nausea, conventional medicines were used by 1201 (17.9%) women and herbal medicines by 556 (8.3%) women. The extent of self-reported nausea and its treatment varied by country. Education, working status, and folic acid use were significantly associated with the use of conventional medicines against nausea. Respondents who had nausea also had a high burden of co-morbidity. CONCLUSION: The prevalence of nausea was high across all participating countries but its treatment varied, possibly due to cultural differences and differences in attitudes towards medicines. A high degree of co-morbidity was found among respondents with nausea.

Use of renal risk drugs in patients with renal impairment.

BACKGROUND: Renal impairment often goes unrecognised until the most advanced stages. Patients with renal impairment use a variety of drugs and the pharmacokinetics and drug effects are prone to change. OBJECTIVE: Describe drug related problems in a population of patients with renal impairment, investigate possible risk factors, and investigate whether the clinical pharmacist can propose relevant measures to solve the problems. SETTING: The internal medicine department at Innlandet Hospital Trust Gjøvik, Norway. METHOD: A prospective study enrolling patients (≥18 years) with moderate and severe renal impairment, i.e. with glomerular filtration rate of 30-59 and 15-29 ml/min/1.73 m(2), respectively, and using at least one drug. The clinical pharmacist reviewed the patients' drug regimen with focus on drug related problems, related to renal function. Problems identified were discussed with the multidisciplinary team, or directly with the physician. MAIN OUTCOME MEASURE: The number of drug related problems. RESULTS: The results are based on data from 79 patients, 21 with severe and 58 with moderate renal impairment. Most patients, 92.4 %, used 5 or more drugs; in average 10.2 (range 2-27). In total, 88 drug related problems were identified in 49 patients, i.e. in 62 %. The most frequently occurring problems were incorrect dose (45.5 %) and inappropriate drug (41.0 %). There was a significant correlation between both the degree of renal impairment and the number of drugs, and the number of drug related problems. The acceptance rate of the clinical pharmacist's interventions was 95.7 %. The drugs most frequently associated with drug related problems were metformin, benzylpenicillin and furosemide. CONCLUSION: Drug related problems often occur in patients with renal impairment. Incorrect drug dose and inappropriate drug choice according to the patients' renal function were the most common problems. Patients with the most complex drug treatment, i.e. with increasing degree of renal impairment and increasing number of drugs, are at greater risk of drug related problems. The high acceptance rate for the pharmacist's interventions supports the inclusion of a clinical pharmacist in the multidisciplinary treatment team to increase awareness and optimisation of the drug treatment in this patient group.

Echinacea and elderberry-should they be used against upper respiratory tract infections during pregnancy?

This review evaluates the safety of echinacea and elderberry in pregnancy. Both herbs are commonly used to prevent or treat upper respiratory tract infections (URTIs) and surveys have shown that they are also used by pregnant women. The electronic databases PubMed, ISI Web of Science, AMED, EMBASE, Natural Medicines Comprehensive Database, and Cochrane Library were searched from inception to November 2013. Relevant references from the acquired articles were included. No clinical trials concerning safety of either herb in pregnancy were identified. One prospective human study and two small animal studies of safety of echinacea in pregnancy were identified. No animal- or human studies of safety of elderberry in pregnancy were identified. Twenty clinical trials concerning efficacy of various echinacea preparations in various groups of the population were identified between 1995 and 2013. Three clinical trials concerning efficacy of two different elderberry preparations were identified between 1995 and 2013. The results from the human and animal studies of Echinacea sp. are not sufficient to conclude on the safety in pregnancy. The prospective, controlled study in humans found no increase in risk of major malformations. The efficacy of Echinacea sp. is dubious based on the identified studies. Over 2000 persons were given the treatment, but equal amounts of studies of good quality found positive and negative results. All three clinical trials of Elderberry concluded that it is effective against influenza, but only 77 persons were given the treatment. Due to lack of evidence of efficacy and safety, health care personnel should not advice pregnant women to use echinacea or elderberry against upper respiratory tract infection.

Pregnancy outcome after use of cranberry in pregnancy--the Norwegian Mother and Child Cohort Study.

BACKGROUND: Cranberry is one of the most commonly used herbs during pregnancy. The herb has been used traditionally against urinary tract infections. No studies are found that specifically address the risk of malformations after use of cranberry during pregnancy. The aim of the study was to investigate the safety of cranberry use during pregnancy, including any effects on congenital malformations and selected pregnancy outcomes. METHODS: The study is based on data from The Norwegian Mother and Child Cohort Study including more than 100,000 pregnancies from 1999 to 2008. Information on use of cranberry and socio-demographic factors was retrieved from three self-administered questionnaires completed by the women in pregnancy weeks 17 and 30, and 6 months after birth. Information on pregnancy outcomes was retrieved from the Medical Birth Registry of Norway. RESULTS: Among the 68,522 women in the study, 919 (1.3%) women had used cranberry while pregnant. We did not detect any increased risk of congenital malformations after use of cranberry. Furthermore, the use of cranberry was also not associated with increased risk for stillbirth/neonatal death, low birth weight, small for gestational age, preterm birth, low Apgar score (<7), neonatal infections or maternal vaginal bleeding in early pregnancy. Although an association was found between use of cranberry in late pregnancy and vaginal bleeding after pregnancy week 17, further sub-analyses of more severe bleeding outcomes did not support a significant risk. CONCLUSIONS: The findings of this study, revealing no increased risk of malformations nor any of the following pregnancy outcomes; stillbirth/neonatal death, preterm delivery, low birth weight, small for gestational age, low Apgar score and neonatal infections are reassuring. However, maternal vaginal bleeding should be investigated further before any firm conclusion can be drawn. Treatment guidelines on asymptomatic bacteriuria in pregnancy recommend antimicrobial therapy as the first line treatment. According to our data and the outcomes studied, cranberry does not appear to be a harmful adjunctive self-treatment.

Safety of ginger use in pregnancy: results from a large population-based cohort study.

PURPOSE: The objective of the study was to examine the safety of ginger use during pregnancy on congenital malformations and selected pregnancy outcomes. METHODS: The Norwegian Mother and Child Cohort study, a large population-based cohort, provided the data used in this study. Our study population consisted of 68,522 women. Data on ginger use and socio-demographic factors were retrieved from three self-administered questionnaires completed by the women during weeks 17 and 30 of the pregnancy and when their child was 6 months old. Data on pregnancy outcomes were provided by the Medical Birth Registry of Norway. RESULTS: Among the 68,522 women in the study, 1,020 (1.5 %) women reported using ginger during pregnancy. The use of ginger during pregnancy was not associated with any increased risk of congenital malformations. No increased risk for stillbirth/perinatal death, preterm birth, low birth weight, or low Apgar score was detected for the women exposed to ginger during pregnancy compared to women who had not been exposed. CONCLUSION: Use of ginger during pregnancy does not seem to increase the risk of congenital malformations, stillbirth/perinatal death, preterm birth, low birth weight, or low Apgar score. This finding is clinically important for health care professionals giving advice to pregnant women with NPV.

Safety and efficacy of herbal remedies in obstetrics-review and clinical implications.

OBJECTIVE: to review the literature on safety and efficacy of the most commonly used herbs to enable midwives to give evidence-based information to pregnant women. DESIGN: survey and review of the scientific literature. SETTING: the survey was performed at the antenatal clinic at Norfolk and Norwich University Hospital between 26 November 2007 and 15 February 2008. PARTICIPANTS: a total of 578 expectant mothers at least 20-weeks pregnant. MEASUREMENTS AND FINDINGS: 57.8% of the participants used one or more herbal remedies. The most commonly used herbal preparations during pregnancy were ginger, cranberry, raspberry leaf, chamomile, peppermint and echinacea. Altogether, 14 studies focusing on the safety and/or efficacy of these herbals in human pregnancy were identified. Ten studies of ginger, one of cranberry, two of raspberry leaf and one of echinacea were located. KEY CONCLUSIONS: there is limited documentation on the safety and efficacy of many herbs commonly used during pregnancy. IMPLICATIONS FOR PRACTICE: midwives are important caregivers for pregnant women and should strive to give evidence-based advice on herbal use in pregnancy. If 'traditional use' is the only available information, the pregnant woman should be made aware of this to enable her to make an informed decision about the eventual use.