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International Journal of Clinical Pharmacy

https://doi.org/10.1007/s11096-018-0608-x

RESEARCH ARTICLE

Complementary medicines in pregnancy: recommendations


and information sources of healthcare professionals in Australia
Christine E. Gilmartin1   · To‑Hao Vo‑Tran1 · Laura Leung1

Received: 1 October 2017 / Accepted: 15 February 2018


© Springer International Publishing AG, part of Springer Nature 2018

Abstract
Background The use of oral complementary and alternative medicines, including herbal supplements, has been increasing in
pregnant women worldwide despite limited safety data. The decision of healthcare professionals to recommend these products
to pregnant patients is controversial and not well documented. Objective To explore the recommendations and information
sources that healthcare professionals use to determine the safety of oral non-prescribed supplements during pregnancy.
Setting An Australian metropolitan maternity hospital. Method An electronic survey was distributed to doctors, midwives,
pharmacists, dietitians, lactation consultants and physiotherapists. Main outcome measure The nature of recommendations
and information sources that healthcare professionals use to determine the safety of oral non-prescribed supplements during
pregnancy. Results Responses were received from 54 healthcare professionals. Forty of 54 (74.1%) were concerned about the
safety of their patients’ supplements, while 35 of 54 (64.8%) felt that they had access to trustworthy safety information. Sup-
plements most commonly recommended as safe to use were ginger (40.7%), probiotics (29.6%) and raspberry leaf (22.2%).
Participants specifically requested further safety information for raspberry leaf, evening primrose oil, fish oil, probiotics,
ginger, vitamin C, valerian, turmeric, blue cohosh and colloidal silver. Written resources most frequently consulted included
­MIMS® (61.1%) and ‘Google Searches’ (29.6%), and healthcare professionals most referred to were pharmacists (74.1%),
doctors (22.2%), and naturopaths or herbalists (3.7%). Conclusion The recommendations of maternity heath care profession-
als and quality of information sources used varied. Further education and access to unbiased safety information is required
to empower healthcare professionals to provide informed recommendations to pregnant patients.

Keywords  Australia · Complementary medicines · Herbal medicines · Information · Pregnancy

Impacts on practice

• This study demonstrates the need to empower mater-


nity healthcare professionals to seek appropriate safety
information regarding complementary and alternative
Electronic supplementary material  The online version of this medicine use during pregnancy so that they can provide
article (https​://doi.org/10.1007/s1109​6-018-0608-x) contains informed recommendations to patients.
supplementary material, which is available to authorized users. • The findings of this study reveal the requirement for
maintaining access and awareness of up-to-date resources
* Christine E. Gilmartin
christine.gilmartin@thewomens.org.au and local protocols, so that healthcare managers and clin-
ical teachers can support and train the current and next
To‑Hao Vo‑Tran
tohao.votran@thewomens.org.au generation of healthcare providers accordingly.
• This study also highlights to health researchers the need
Laura Leung
laura.leung@thewomens.org.au to address the paucity of safety information for comple-
mentary and alternative medicines in the pregnant patient
1
The Royal Women’s Hospital Pharmacy Department, The cohort, so that future patients may be prevented from
Royal Women’s Hospital, Cnr. Grattan St. & Flemington Rd, taking contraindicated supplements.
Parkville, VIC 3052, Australia

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International Journal of Clinical Pharmacy

• The trends of information queries regarding the use of com- Aim of the study
plementary and alternative medicines in this study may
guide the direction and focus of future safety information The aim of this study was to investigate the recommenda-
research. tions and information sources of maternity healthcare pro-
fessionals regarding the use of oral non-prescribed herbal
Introduction medicines and complementary supplements at an Australian
metropolitan tertiary hospital.
Complementary or alternative medicines (CAMs) can be
defined as health care practices or therapies which are not
integrated into the dominant health care system, and can Ethics approval
include traditional or herbal supplements [1]. Australia has
experienced an increase in the awareness and use of CAMs, The Human Research and Ethics Committee of the site was
and has some of the highest utilisation rates in the world [2]. notified of this project and approval was granted to conduct
The use of these oral non-prescribed supplements, includ- the investigation as a quality-assurance audit.
ing some non-prescribed vitamins, is significantly higher
in women and those with a higher education and higher
income [2]. Reported rates of herbal medicine use in preg- Method
nant women may vary according to Australian geographical
area but has been reported to be as high as 36% of pregnant An electronic survey (see electronic supplementary mate-
women in a previous Victorian study [3]. The perception of rial) was sent to maternity healthcare professionals in Octo-
control over health, and the beliefs that herbal supplements ber 2016. The recipients of the survey included all doc-
are natural, holistic, “non-chemical”, free of side-effects, and tors, pharmacists, midwives, nurses, lactation consultants,
accessible, have all been cited as major factors in women’s dietitians, and physiotherapists currently practicing at the
decisions to use these products [4]. Despite their popularity, study site and expected to provide frequent care to mater-
there is limited robust safety evidence available for many nity patients. Email lists of recipients were obtained from
commonly-used products for use during pregnancy [3, 5]. the heads of relevant departments, with nurse/midwives
Some products requiring caution have been found to not pro- representing the largest profession group at the site. The
vide clear safety information, and some patients choose to survey was composed of 13 questions which explored par-
import products for personal use from countries outside Aus- ticipant demographics, the frequency and nature of patient
tralian jurisdiction, potentially making safety information queries about CAM safety, their opinion of CAM safety in
even more difficult to locate [6]. Explicit safety information pregnancy, and information sources they use. Survey ques-
is important as cases of poor outcomes of prenatal exposure tions were mostly multiple-choice in design, closed-ended,
to CAM products have been reported, including intrauterine and phrased in plain language. Where appropriate, survey
growth restriction, preterm labour, gestational hypertensive responses were accepted in the form of single-selection only,
disorders, fetal distress, and renal, cardiac and neural tube multiple-selection enabled (“select all that apply”), and free
defects [7–12]. It is of additional concern that a 2016 mul- text for responses that did not conform to a provided option.
tinational study of herbal medicine use in pregnancy found Participants were instructed to consider only oral formu-
that while many women used products considered only low lations of non-prescription dietary or herbal supplements
risk, those using a contraindicated preparation were more which are not routinely initiated to correct or prevent a medi-
likely to have done so with consultation of a healthcare prac- cally diagnosed disorder in pregnant patients. The survey
titioner than an informal source [13]. As such, combined requested that the following supplements were specifically
with the potential for harm to the fetus and scarcity of large not to be referred to in responses: pregnancy multivitamins,
clinical studies, healthcare professionals providing care to vitamin D (colecalciferol), vitamin B1 (thiamine), vitamin
pregnant women must ensure that their advice pertaining to B6 (pyridoxine), vitamin B9 (folic acid), vitamin B12 (cya-
supplement use is based on the most robust evidence avail- nocobalamin), magnesium, calcium, iron, and meal replace-
able [13]. The opinions and practices of healthcare profes- ment products such as ­Sustagen®. Survey responses were
sionals regarding CAMs in a maternity healthcare setting are anonymous and resulting data was pooled. Responses were
however not well documented. entered into a Microsoft E ­ xcel® spreadsheet and analysed
descriptively. Data analysis was performed using the statisti-
cal software program SPSS Statistics 22 (IBM).

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International Journal of Clinical Pharmacy

Results (9 of 29; 31.0%), fish oil (4 of 29; 13.8%), evening primrose


oil (oenothera biennis, 4 of 29; 13.8%), probiotics (3 of 29;
The electronic survey (see supplementary electronic mate- 10.3%), followed by ginger, vitamin C, valerian (valeriana
rial) was sent to 219 maternity healthcare professionals officinalis), turmeric (curcuma longa), blue cohosh (caulo-
(Table 1), of whom 54 (24.7%) responded. Over half the phyllum thalictroides), and colloidal silver (each accounting
respondents (33 of 54, 61.1%) reported to have been prac- for 1 of 29; 3.4%).
tising for greater than 5 years. No participants declared that When searching written information sources for safety
they had a potential conflict of interest pertaining to their data of CAMs use in pregnancy, most participants favoured
recommendations of CAM use in pregnancy. the medicine database ­MIMS® (33 of 54; 61.1%) (Table 3),
Thirty-five of 54 (64.8%) participants reported being which features a compilation of manufacturer-provided prod-
asked by their pregnant patients about the safety of CAMs uct information. The minimum level of evidence required by
at least once a month, while 40 of 54 (74.1%) expressed participants before recommending a supplement as safe to
that they are sometimes concerned about the safety of their use in pregnancy was most commonly an online database
patients’ supplements. Thirty-four of 54 (63.0%) partici- such as M­ icromedex® or M ­ IMS® (21 of 54; 38.9%), with
pants disclosed that they do not feel knowledgeable about no participants willing to accept case studies or anecdotal
the safety of CAMs in pregnancy. However, a similar propor- evidence as their sole source of safety information. In the
tion (35 of 54 (64.8%)) felt that they have ready access to event of uncertainty requiring referral to another healthcare
quality safety information about CAMs. professional or other personnel, participants most frequently
Twenty-four of 54 (44.4%) participants did not recom- sought the advice of pharmacists (40 of 54; 74.1%), followed
mend any CAMs to their patients as safe to use during preg- by doctors (12 of 54; 22.2%), then naturopaths or herbalists
nancy [14] (Table 2). Ginger (zingiber officinale) was most (2 of 54; 3.7%). Four participants specified that they sought
commonly recommended (22 of 31; 71.0%) as safe, followed the advice of the pharmacists operating the medicines infor-
by raspberry leaf, (rubus idaeus, 12 of 31; 38.7%) and fish mation service (MIS) provided by the hospital.
oil (9 of 31; 29.0%). A majority of these participants typi-
cally recommended greater than 2 different supplements (20
of 31; 64.5%). Discussion
The indications described for the CAMs that were recom-
mended as safe to use were consistent for ginger (nausea), The safety recommendations and information sources
chamomile (matricaria chamomilla, sleeping difficulty), regarding supplement use in pregnancy used by healthcare
and raspberry leaf (uterine tone and induction or efficiency professionals were varied in this study. An important finding
of labour). Participants who listed the use of cranberry for was the high variability of indications for which supplements
urinary tract infections did not specify if they recommended were recommended, as well as the frequent responses of
it for use in treatment or prevention of infection. Described “general health” and “general well-being.” This may be a
indications varied significantly for vitamin C (ascorbic acid), result of a perceived faith in the supplements’ value in treat-
probiotics, and fish oil (Table 2). ing multiple non-specific ailments, or possibly a reflection of
More than half of the participants (29 of 54; 53.7%) stated what some critics believe is a tendency of manufacturers to
a preference for more pregnancy-specific safety information suggest ambiguous or unproven benefits [15, 16].
about CAMs. Ten of 29 (34.5%) participants wanted access Existing safety data for the three supplements most fre-
to further information about all commonly used CAMs, but quently recommended in this study (ginger, probiotics, and
specifically mentioned supplements included raspberry leaf raspberry leaf) can be considered neither alarming nor hav-
ing the robustness to suggest an absolute recommendation
as safe to use in pregnancy [17]. While multiple studies
observing oral ginger use in pregnancy report no increased
Table 1  Participant response rate by profession risks of harm to the mother or fetus, some concerns persist
Profession Survey respondents Survey recipients regarding ginger’s potential to increase risk of bleeding and
postpartum haemorrhage [17–20]. Current published stud-
Midwife and/or nurse, n (%) 19 (13.2) 144 (65.8)
ies suggest that probiotics generally appear safe and well
Doctor, n (%) 16 (39.0) 41 (20.1)
tolerated in healthy pregnant individuals, possibly due in
Pharmacist, n (%) 11 (73.3) 15 (7.4)
part to limited systemic absorption [21]. However, safety
Dietitian, n (%) 6 (60.0) 10 (4.6)
data for probiotics may depend on the strains within the pro-
Physiotherapist, n (%) 1 (20.0) 5 (2.3)
prietary product, which usually contain one or more vari-
Lactation consultant, n (%) 1 (25.0) 4 (1.8)
eties of bifidobacterium, lactobacillus and saccharomyces
Total, n (%) 54 (24.7) 219 (100)
strains, as well as occasionally streptococcus thermophilus

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Table 2  Dietary and herbal supplements recommended to pregnant women


Supplements Frequencya Indications
(n = 54)

NIL—does not recommend any 24 –


Ginger 22 Nausea
Probiotics 16 General well-being
Diarrhoea or gastrointestinal symptoms secondary to antibiotics
Indigestion
For concurrent use with antibiotics
Gastro-intestinal complaints
Immune system enhancement
Thrush
Raspberry leaf 12 After 36/40 weeks
Uterine tone
Uterine irritability
Induction of labour
Improved efficiency of labour
Fish oil 9 Joint pain
Mental health
Cardiac health
General well-being
For women with low dietary fish intake
For women who are breastfeeding while pregnant
Support for foetal neurodevelopment
Prolonged gestation
Inflammatory complaints
High cholesterol
Cranberry 9 Urinary tract infections
Recurrent urinary tract infections
Evening primrose oil 4 Induction of labour
Uterine health
Vitamin C 5 Prevention and/or treatment of cold & flu/upper respiratory tract infections
‘General health’
To take with iron supplements to improve absorption
‘Collagen booster’/skin repair in 2nd & 3rd trimester
Floradix® formula liquid herbal iron 3 Iron deficiency
­extractb Iron supplementation for women intolerant to other formulas due to consti-
pation, inability to swallow tablets
Chamomile 1 Difficulty sleeping
Blue cohosh 1 (indication not specified)
Garlic 1 (indication not specified)
a
 Some participants recommended more than one supplement
b
 Floradix® formula liquid herbal iron extract ingredients include Iron (from ferrous gluconate), Vitamin B1, Vitamin B2, Vitamin B6, Vitamin
B12, Vitamin C, rosehip, carrot, nettle wort, spinach, couch grass, angelica, fennel, ocean kelp, African Mallow Blossom, orange peel, wheat
germ powder, yeast extract, honey, and juices from pear, grape, black currant, orange, blackberry, cherry and beetroot [14]

[17, 22]. Safety evidence in pregnancy cannot be located for important to note that there is still potential for pregnant
some strains, for example, saccharomyces and streptococcus patients to come to harm from untreated or sub-optimally
thermophilus [21, 23–25]. In addition to blue cohosh and treated conditions by using ineffective complementary or
evening primrose oil, raspberry leaf has been a CAM sup- alternative treatments in lieu of conventional medicine. For
plement favoured in the past by some healthcare providers example, the use of cranberry for the treatment of urinary
for use in labour augmentation [26]. While the consumption tract infections in pregnancy in place of antibiotics may
of medicinal products containing raspberry leaf is possibly result in dire consequences for mother and fetus should an
safe in late pregnancy under healthcare professional supervi- infection be allowed to advance untreated.
sion, the lack of efficacy evidence may not justify even the Information sources for deriving safety data pertaining
low perceived risk of use [17, 27, 28]. Although the efficacy to herbal or complementary supplement use in pregnancy
of supplements was not strictly the focus of this study, it is should ideally be evidence-based, practical, up-to-date,

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International Journal of Clinical Pharmacy

Table 3  Information sources used for pregnancy-specific safety data of complementary and herbal supplements
Information sources most frequently u­ seda
Information source Frequency (n = 54) Percentage (%)

MIMS 33 61.1
Google search 15 27.8
Journal articles 15 27.8
Manufacturer product information 12 22.2
Micromedex 11 20.4
Books 8 14.8
Natural medicines database 6 11.1
Internal hospital guidelines 3 5.6
Australian dietary guidelines 1 1.9
Minimum acceptable level of safety information required before recommending a supplement as safe to use in pregnancy
Information source Frequency (n = 54) Percentage (%)

Medicine databases (e.g. ­Micromedex®, ­MIMS®) 21 38.9


Randomised controlled trials 15 27.8
Expert opinion 7 13.0
Observational or epidemiological studies 6 11.1
Past experience 4 7.4
Case studies or anecdotal evidence 0 0
Would not recommend any non-prescribed supplements or herbal medicines as safe 1 1.8
to use in pregnancy
Total: 54 100
a
 Some participants mostly consulted more than one information source for data regarding safety in pregnancy

easily accessible, and unbiased. The database ­MIMS®, too is an essential consideration when assessing safety of use
preferred by some study participants, has the advantages in pregnancy. Reputable online information resources are
of having electronically accessible and propriety product- also available for this purpose, such as for example, Stock-
specific information. Unfortunately, due to the scarcity of ley’s Drug Interactions on Medicines ­Complete®. Overall,
safety studies of their product in pregnancy, many manufac- due to the low number of participants in this study favouring
turers conservatively advise women who are or may become preferred information sources, education may be pertinent
pregnant to not use their product. While this is certainly a to clarify to health professionals what constitutes a quality
safe recommendation to adhere to, clinicians often require information source.
further information to compare the benefits and risks for The integration of herbal or alternative medicines into
some patients. Many healthcare professionals prefer the conventional medical care remains controversial, with some
accessibility and speed of the internet when faced with such maternity healthcare professionals often recommending
a query. However, despite the merits of search engines like herbal medicine products for pregnancy-related conditions
Google, the largely unregulated nature of this information and others considering them entirely contraindicated dur-
source means that clinicians would need to navigate some ing pregnancy [26, 31]. The uncertainty regarding CAM
amount of poor quality and possibly biased information that safety observed in this investigation has also been described
their search terms may retrieve [29]. The electronic data- in previous studies. Many respondents (71.8%) to a 2010
bases ­Micromedex® and Natural Medicines ­Database® were online survey of mostly UK-based healthcare professionals
not highly favoured by the participants, but they both contain believed that the public has a misplaced trust in herbal treat-
broadly sourced and unbiased information in a relatively eas- ments, but that they themselves had a “quite poor” (36.2%)
ily accessible format. Natural Medicines D ­ atabase® particu- or “very poor” (10.4%) knowledge of these supplements
larly was recommended by a 2016 review of drug informa- [32]. The survey found that a large proportion of respond-
tion sources conducted by the National Prescribing Service ents (50%) also preferred general internet searches such as
[30]. While the topic of drug interactions between medicines Google for further information, and that 21.3% of health-
and herbal or complementary supplements were not specifi- care professionals would not attempt seeking further safety
cally explored in this study, it is important to note that this data about a patients’ herbal supplement before initiating a

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International Journal of Clinical Pharmacy

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