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.publishedVersio

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.publishedVersio

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.publishedVersio

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.publishedVersio

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 chisquare 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 (β) 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 β (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.publishedVersio