gms | German Medical Science

Background: Gynecological ailments can affect more than half of the world’s population and have a negative impact on quality of life and economic productivity. Standard treatments comprise hormone preparations, analgetic drugs and antibiotics, however they are related to issues concerning tolerability and public health. In this context Herbal Medicinal Products (HMPs) can be an additional treatment option. Clinical data suggest a certain efficacy and good safety, and there is a trend towards an increased demand of Herbal Medicines (HMs, i.e. herbal extracts in solid dosage forms). Nevertheless, HMs are only sporadically integrated into the conventional medical treatments. Therefore, the aim of this study was to add knowledge from the real-world of medical practice regarding preferences of use as well as effectiveness and adverse events of preferred HMPs.

Materials and Methods: A data sample (n=1658) was taken from the pharmaco-epidemiological database PhytoVIS consisting of outcomes reported by women treating their gynecological complaints with HMPs. We excluded all cases regarding herbal supplements, homeopathic preparations, non-herbal medicinal products, or products of unclear origin and women aged under 12 years. After plausibility check, we excluded five more patients, due to implausible information. Totally 1.363 data entries remained for analysis. Data was then grouped into the three indications menstrual complaints (n=222), menopausal complaints (n=301) and uncomplicated urinary tract infections (uUTIs) (n=840). We applied descriptive statistical (IBM SPSS for Windows, 29.0) methods to evaluate the perceived therapeutic effectiveness and tolerability of HMs as well as treatment habits.

Results: In general, participants applied both herbal medicines (HMs) (n=935) as well as herbal teas (HTs) (n=428) to treat symptoms of gynecological complaints with a clear tendency to prefer HMs. However, looking more into detail there were differences concerning age or type of ailment. Comparing the three complaints, the trend to apply preferably herbal teas was highest for the treatment of uUTIs (43%) compared to menstrual (21%) or menopausal (only 7%) complaints. Comparing women of different age with menstrual complaints the trend to prefer HTs was higher (43%) for girls or young women (12-17 years), although the majority used HMs (57%). With increasing age, the tendency to prefer HMs was more pronounced and the majority of women were more likely to favour HMs (77% - 85.7%). Likewise, the vast majority of women with menopausal complaints in the age groups 31-50 years (95.7%) or 51-65 years (93.2%) prefer HMs for the treatment of their symptoms. However, the tendency to prefer HTs is growing with increasing age. Accordingly, less women over 66 years were using HMs (66.7%). The remaining one third in this age group preferred HTs. Among women aged between 12 and 65 years suffering from uUTIs there was a clear trend towards the use of HMs (approx. 50.0%-62.0%). However, herbal teas were still used quite often (approx. 38.0%-49.0%), comparing uUTIs to menstrual or menopausal complaints.

Women predominantly preferred a particular medicinal plant to treat menstrual and menopausal symptoms, namely Vitex agnus-castus L. (97,1%; n = 170) for the treatment of menstrual complaints and Actaea racemosa L. (79,1%; n = 220) for menopausal complaints. In contrast, two different mono- and three combination drugs were most commonly used to treat uUTIs, namely Arctostaphylos uva-ursi (L.) Spreng., Solidago virgaurea L., a combination of Centaurium erythraea Rafn, Levisticum officinale W.D.J.Koch and Salvia rosmarinus Spenn, a combination of Tropaeolum majus L. and Cochlearia armoracia L. or a combination of Betula pendula Roth, Arctostaphylos uva-ursi (L.) Spreng. and Achillea L..

Overall, the tolerability of HMPs was very good. The vast majority of women with gynecological complaints (82%, n=1120) rated the effectiveness of treatment with HMPS as very positive. Adverse events (AEs) that were perceived to be more serious than the therapeutic effectiveness only occurred in 0.4% (n=6) of cases. Examples of this included diarrhea, palpitations, itching, abdominal pain or stomach problems. None of the AEs experienced were life-threatening.

Conclusion: Our data suggest that HMPs have an excellent benefit-risk ratio under everyday conditions and are well suited for the treatment of gynecological conditions. There were differences in preferences regarding pharmaceutical form (HM versus HT) depending on age and type of complaint. Overall, the results presented here represent an important addition to existing clinical data and contribute to the implementation of HMPs in novel therapeutic strategies.