In this study we sought consensus on a list of important potential harms and benefits of using ginger for the management of NVP that should be addressed during the clinical consultation in the Palestinian clinical practice by a panel of physicians and a panel of women. To the best of our knowledge, this is the first attempt to achieve consensus on such list of potential harms and benefits of ginger in NVP using formal consensus techniques.
In this study, we used a purpose sampling technique to recruit the panel of physicians and a snowball sampling technique to recruit the panel of women. In conservative views, these sampling techniques has long been considered biased [44, 45]. However, using other randomized sampling techniques was not possible in this study as these techniques are not suitable for the type of this study. Using these sampling techniques allowed the inclusion of panel members who had prior knowledge of the subject being investigated. In this study, we recruited physicians the majority of which were gynecologists and the rest were physicians who are frequently consulted by pregnant women suffering from NVP. Currently, there is no consensus on the ideal number of panelists in a Delphi panel. Previous studies used panels ranging in size from 10 to 1000 . The number of panelists in this study was larger or similar to those previously used in Delphi consensus studies on issues in healthcare [40, 41, 46]. The advantages of the Delphi technique includes maintaining anonymity of the panelists, possibility of including panelists from different geographic locations, reduces costs and efforts to bring the panelists together compared to focus groups, and ensures immunity against individual domination of the decision compared to nominal or focused groups [44, 47].
The aim of this study was to achieve consensus on a list of the important potential harms and benefits of using ginger for the management of NVP that should be addressed during the clinical consultation. This list would be used by clinicians as a guidance on what potential harms and benefits to address during the clinical consultation. Guidelines on what clinicians should address during the clinical consultation when ginger is advised for NVP do not exist. We, therefore, believe that such lists developed through consensual methods might be beneficial in changing the behavior of physicians during the clinical consultation [14, 40, 43, 46, 48–50].
Prior studies reported high usage of herbal therapies in the Palestinian population including women who were pregnant [51–53]. In this study, 70% of the women reported being quite often recommended to use herbal therapies for their NVP. Similarly, 62% of the physicians admitted recommending quite often herbal therapies for pregnant women suffering NVP. It was reported that about 50% of the users of herbal therapies would not inform their physicians of such use . Similarly, another study reported that physicians seldom ask if the patient was using herbal therapies . Therefore, many patients end up using herbal and conventional therapies concurrently . This has been attributed to poor communication and the insufficient time allocated to the clinical consultation . The panel of women included women who had previous pregnancies, suffered NVP, and used ginger to manage their NVP. Women included in the panel were expected to provide the concerns that pregnant women suffering NVP would like their physicians to address during the clinical consultation. Interestingly, 76% of the women wanted their physicians to address the potential harms and benefits of the herbal therapies during the clinical consultation.
High response rates in both Delphi iterative rounds from physicians and women is a major strength that adds to the validity of this study. Previous studies used panels that greatly varied in size ranging from 10 to more than 1000 participants [44, 57]. Studies using the Delphi technique to achieve consensus on issues in healthcare used panels of 50 participants or less [36, 46, 50]. In this study, both panels were composed of 50 members. The panel size used in this study was either comparable to or more than those used in previous studies [36, 40, 43, 46, 50]. The panel of physicians included participants of both genders, from different geographical locations, clinical practice settings, age groups, and experience periods. The panel of women also included participants from different geographical locations, age groups, number of pregnancies, history of miscarriage, employment, and educational levels. This diversity adds to the validity and suitability of addressing the potential harms and benefits that the participants agreed upon in this study. It has been argued that in absence of gold standards, consensual methods provide means of reducing bias, promoting transparency, and validity of judgmental methods when developing certain criteria . Therefore, we believe that addressing these potential harms and benefits of using ginger for NVP during a clinical consultation approached using formal consensus method might be more appealing to clinical practitioners advising pregnant women to use ginger for their NVP.
Interestingly in this study, consensus was achieved on six potential harms associated with the potential anticoagulant effects of ginger that should be addressed during the clinical consultation by both women and physicians (Table 3). These findings are not surprising, as previous studies showed that patients wanted to hear more from their healthcare providers on the medications they are taking . The American Society of Anesthesiologists has advised that patients should discontinue all herbal therapies 2 to 3 weeks before an elective surgical procedure to avoid any potential intraoperative adverse events . Recently, Marx et al. systematically reviewed eight clinical trials and two observational studies on the anticoagulant effects of ginger . Considering the risks of bias, methodological variation, timeframe studied, dose of ginger used, and characteristics of the participants, Marx et al. concluded that the evidence that ginger affects platelet aggregation and coagulation is still equivocal and further studies are needed to illustrate a definite conclusion. However, a previous study showed that gingerols, which are compounds found in ginger, and the related compounds were able to inhibit arachidonic acid-induced human platelet serotonin release and aggregation in vitro . The potency of these compounds were comparable to aspirin. Another study showed that 8-paradol, which is a component of ginger, was a relatively potent COX-1 inhibitor and antiplatelet aggregation agent compared to four other components of ginger with antiplatelet activities . In spite of the fact that the anticoagulant effects of ginger are still inconclusive. Bleeding in the first trimester of pregnancy can have detrimental effects on the mother and her fetus. Hasan et al. reported association between heavy bleeding in the first trimester, especially when accompanied with pain, and higher risk of miscarriage in a study with 4539 women . In this study, panelists were of the opinion that physician should address the potential anticoagulant effects of ginger with pregnant women who are at higher risk of bleeding to make a better informed decision whether to use ginger or not.
Both physicians and women agreed that the risks associated with abortion should also be addressed during the clinical consultation when pregnant women are advised to take ginger for their NVP (Table 3, items 7–9). Today, there is no conclusive evidence of the adverse effects of ginger on the developing fetus. Therefore, ginger and ginger containing products are labeled differently across the globe. In the United States, ginger is “generally regarded as safe”. However, in Germany, the German E Commission on herbal medicines (does not exist anymore) recommended that ginger to be avoided in pregnancy . Moreover, the Finnish Food Safety Authority Evira recommended that ginger products, ginger tea, and food supplements containing ginger should bear a warning label as not recommended during pregnancy . Previous studies showed that ginger might be associated with spontaneous abortion and impairment of fetal development [21–23, 30]. Portnoi et al. conducted a study in Canada in which the birth outcomes of 187 women who were exposed to ginger in their first trimester of pregnancy were prospectively compared to the birth outcomes of 187 women who were exposed to other nonteratogenic medications that were not antiemetics . The comparison showed that there was no statistically significant difference in terms of live births, spontaneous abortions, therapeutic abortions, birth weight, and/or gestational age between both groups. More recently, Heitmann et al. reported on the safety of using ginger during pregnancy in terms of congenital malformations and selected pregnancy outcomes in a large cohort of 68,522 women in Norway . The study showed that 1020 women which represented 1.5% of the study population used ginger during their pregnancies. The study concluded that there was no increased risk of stillbirth/perinatal death, preterm birth, low birth weight, or low Appearance, Pulse, Grimace, Activity, Respiration (Apgar) score for the women who were exposed and those who were not exposed to ginger. Taking a conservative approach, women should be warned of the still inconclusive association between exposure to ginger and risk on the fetus and continuity of the pregnancy.
Ginger could be associated with or could worsen symptoms of other co-morbidities [19, 20, 28, 31]. Ginger might be associated with reducing blood pressure and blood sugar. Ginger can cause dehydration and allergic reactions. In this study, both physicians and women agreed that such possibilities should be addressed during the clinical consultation. Pregnant women should be warned that ginger might precipitate cardiac arrhythmias, stimulate irritable bowel syndrome, duodenal ulcer, secretion of bile, and heartburn. Physicians should address these potential harms during the clinical consultation. For example, pregnant women at risk of cardiac arrhythmias or those taking antiarrhythmic medications might be advised not to take ginger and a suitable alternative might be recommended. Similar measures should be applied to avoid the potential harm of ginger in worsen other conditions.
The views of both physicians and women were divisive whether to address the potentials of ginger inducing diarrhea, mild headache, fever, sweating, thirst, mild skin itching, and belching. It is noteworthy to mention that in many studies the seriousness of the reported adverse effects depends on the subjective judgements of the research team taking into account the possibility of these events in normal pregnancies without any interventions . Classifying the potential harms of ginger into major and minor goes beyond the scope of this study, however in general, researchers often classify harms as major when the consequence was serious or detrimental to the mother and/or fetus. When the harm was a merely discomfort and manageable it was considered minor.
Both physicians and women agreed that pregnant women suffering NVP might be informed of the potential benefits of ginger for NVP, nausea and vomiting in motion sickness, cough, flu, chronic pulmonary disease, milk production, joint pain, skin health, appetite in eating disorders, weight loss, hypercholesterolemia, diuresis, and dyspepsia. Physicians and women were divisive whether to address that ginger might induce somnolence.
When pregnant women need treatment, more care should be exerted when prescribing medications to this vulnerable group of patients. The risks should be weighed against the benefits of using a specific treatment considering the available alternatives and consequences of using or not using these treatments. The same measures should be applied when advising them to take herbal therapies.