In recent years there has been an increase in the use of complementary and alternative medicines (CAM) in the general population, in paediatrics and also during pregnancy and lactation. This phenomenon is largely due to the fact that complementary medicine practices and even more natural products are mistakenly perceived as safer than conventional drugs.
In breastfeeding the women very often resort to CAM independently, without consulting their doctor, because of problems related to breastfeeding itself, such as poor milk production, breast rash, mastitis, or to deal with specific clinical conditions, from the common cold to depression. Many studies have focused on the use of drugs in breastfeeding, with particular reference to the passage of active ingredients in breast milk and the possible onset of adverse effects not only in the mother, but also in the baby. Little is known about the safety of products of natural origin during pregnancy and breastfeeding.
The Italian situation
The HaBIT (Herbal Supplements in Breastfeeding InvesTigation) study was conducted with the aim of expanding the scientific evidence available in Italy on the attitudes of breastfeeding women towards CAM, which is still scarce today.1 A very important aspect addressed by the HaBIT study was to assess the awareness of these women about the nature of the products they were taking and their perception of safety with respect to these products.
For a period of 6 years a web interview was conducted involving a total of 388 women resident in Tuscany who were breastfeeding or who had stopped breastfeeding in the six months preceding the interview. The majority of the sample was primiparous (60%), with an average age of 35 and a high level of education. Of the 388 women included in the study, 204 stated that they used CAM during breastfeeding and 61% and 48% respectively that they used it before and during pregnancy. Two hundred and forty-one women reported some complications during breastfeeding. The most frequent were: breast rash (33.5%), breast blockage (31%), low milk production (10%) and mastitis (10%). In particular, breast engorgement (36% compared to 26%) and inverted nipple (11% compared to 4%) were more frequent among CAM users than among non-users. 35% of respondents reported two or more complications and 40% of them were CAM users.
Which substances and which effects?
In a specific section of the interview women were asked to list and classify all complementary medicine products they had used or were using. The same products were then re-classified by a group of experts on the basis of the European Pharmacopoeia. The results showed that phytotherapy products are the most widely used product category (38%), followed by dietary supplements (32%) and herbal products (31%). The surprising fact concerns the degree of agreement between the classification made by CAM users and that made by experts: only 9% of users were able to correctly classify phytotherapeutic products, while the other patients were convinced of using dietary supplements. Only in the case of herbal products did the agreement between the two classifications reach a high level (Cohen's kappa = 0.92).
The adverse effects reported by some of the women interviewed included 3 cases of diarrhoea, 2 cases of skin rash, 2 cases of tachycardia and individual cases of anxiety, confusion, hypotension, insomnia and stomach pain. In addition, 50% of women responded that they consider CAM equally or more effective than traditional drugs, and the percentage of participants who consider these products equally or safer than traditional drugs rises to 73%. This figure is even more relevant when one considers that 79% of the participants stated that they were well informed about the importance of breastfeeding, mainly by midwives and paediatricians, and that 65% did not receive any information about the potential risks of using CAM in breastfeeding.
The role of the health professional
The health professional's advice should be as open and respectful as possible of the needs of pregnant or lactating women, and should provide comprehensive and reliable information. An improvement in the knowledge of CAM among health professionals is in fact essential to guide pregnant and breastfeeding women through the conscious use of these products, which are very often administered under self-medication, especially after the onset of complications that can be resolved with the support of well-trained professionals.
Future studies may clarify the benefit/risk ratio of CAM and their results may provide new information to expand our knowledge, and in particular that of health professionals. In this way, CAM can be used consciously, without underestimating its possible adverse effects.
Alessandra Bettiol1, Niccolò Lombardi1, Ettore Marconi1, Giada Crescioli1, Roberto Bonaiuti1, Valentina Maggini2,3, Eugenia Gallo2,3, Alessandro Mugelli1, Fabio Firenzuoli3, Claudia Ravaldi4, Alfredo Vannacci1,4
1 Department of Neuroscience, Psychology, Area of Medicine and Child Health, University of Florence, Regional Centre for Pharmacovigilance and Phyto-vigilance, Florence
2 Department of Experimental and Clinical Medicine, University of Florence
3 Centre for Integrative Medicine, Careggi University Hospital, University of Florence
- Br J Clin Pharmacol 2018;84(9):2040-7. CDI