gms | German Medical Science

Background: Herbal Medicines have traditionally been used for a variety of diseases, but their use in recent therapeutic strategies is limited due to a lack of clinical evidence. The aim of this study was to analyze Patient-Reported Outcomes (PRO) in order to generate more evidence for the effects of Herbal Medicines in menstrual, menopausal, and bladder and urinary symptoms in addition to clinical trials. Therefore, a respective data set was taken from PhytoVIS, a large pharmacoepidemiological database on the use of Herbal Medicines. These Real-world data were analyzed statistically, and the results were evaluated to assess the clinical benefits of medicinal plants in gynecological complaints.

Materials and methods: The PhytoVIS questionnaire was developed by ‘Kooperation Phytopharmaka’ together with the University of Cologne. For data collection, patients in pharmacies and medical practices have been interviewed anonymously about their personal experiences with Herbal Medicines. Information on indication, gender, age, therapeutic benefit, and side effects was collected. A data subset concerning gynecological complaints was extracted from PhytoVIS. After data cleaning, 941 patient data entries were descriptively analyzed and Spearman correlations, Kruskal-Wallis tests, and Mann-Whitney U test were applied.

Results: The most frequent gynecological complaint in the data set was uncomplicated cystitis (51%), followed by menopausal (30%) and menstrual (30%) complaints. For the treatment of menstrual complaints, predominantly (97%) Herbal Medicines containing Agni casti fructus (engl. agnus castus fruit) were used. About half of the patients (49%) reported that they experienced a moderate-distinct therapeutic effect and about a third (35%) reported even a very good effect. Overall, patients under 18 years perceived a lower therapeutic benefit (Spearman Correlation p=0.003, Mann-Whitney U test).

For complaints during menopause the majority (79%) of women used Cimicifugae rhizoma (engl. black cohosh), but also Agni casti fructus (10%) and a combination of Cimicifugae rhizoma with Hypericum perforatum (6%) (engl. St. John’s wort) have been applied. Cimicifugae rhizoma showed a very good (34%) to moderate (46%) therapeutic benefit. Nevertheless, in case of menopausal complaints with high severity, Herbal Medicines with Agni casti fructus had a better therapeutic efficacy (Spearman Correlation: p=0.010).

The picture of used plant drugs for uncomplicated cystitis was diverse. Uvae ursi folium (engl. bearberry leaf) (44%) and a combination of Centaurii herba (engl. centaury), Levistici radix (engl. lovage root), Rosmarini folium (engl. rosemary leaf) (26%) are the most commonly used. Both are described in literature as being very efficacious. Well in line, in this data set, patients predominantly reported a positive therapeutic effect: almost half of the patients perceived for Uvae ursi folium (47%) and the combination preparation (46%) the therapeutic effect as very good. Although the number of patients underline the popularity of Uvae ursi folium and the combination preparation, a small number of patients (7%) used Solidaginis virgaureae herba (engl. goldenrod herb) and was perceived as being therapeutically even superior: 62% reported a very good therapeutic benefit.

Conclusion: In general, patients perceived the efficacy of Herbal Medicines as very good for the treatment of gynecological complaints. Therefore, we propose the above-mentioned plant drugs as an effective alternative or additional therapy option to conventional drugs for patients with menstrual, menopausal, urinary symptoms. The evaluation of Real-world outcome parameters from the patient’s perspective, as carried out in the present study, is a scientifically valuable and important add-on to the data from clinical (randomized controlled) studies. This source of information represents an important measuring tool for the routine application of Rational Phytotherapy.