Patient-reported therapeutic benefits of herbal medicinal products in the treatment of gynecological ailments.

Background: Gynecological ailments have a negative impact on quality of life and productivity. Standard treatment is associated with poor tolerability and other issues related to public health and environment. Herbal Medicinal Products (HMPs) are used traditionally for the treatment of menstrual and menopausal ailments as well as uncomplicated urinary tract infections (uUTIs) for centuries and constitute a suitable addition to current treatment options. HMPs are well tolerated, non-polluting and therapeutically efficacious as evidenced by various clinical studies. Aim of this study was to expand the evidence regarding therapeutic effectiveness of HMPs for the treatment of gynecological complaints by complementing knowledge from clinical studies with real-world evidence from patient-reported outcomes.

Methods: A data set consisting of patient-reported outcomes regarding the treatment of gynecological ailments (n = 1658) with HMPs was taken from the pharmaco-epidemiological database PhytoVIS. After data preparation excluding all cases of herbal supplements, homeopathic preparations, or non-herbal medicinal products the remaining data (n = 1363) was grouped into the three indications menstrual complaints (n = 222), menopausal complaints (n = 301), and uUTIs (n = 840). We applied descriptive statistical methods (frequency and percentage) with regard to the variables "age", "treatment duration", "severity of symptoms", "therapeutic benefits", and "adverse drug reactions". Thereafter we evaluated the therapeutic benefit of HMPs as well as adverse events.

Results: The majority of the patients (82.2%) in the sample assessed the overall therapeutic effect of HMPs for the treatment of gynecological complaints as beneficial and 90.8% of them perceived no or no significant adverse events. Treatment habits differed depending on the type of complaint. In this context the majority of women with menstrual or menopausal ailments preferred to treat for time period of 1 month or longer, while those affected by uUTIs reduced the application of HMPs to the length of their symptoms. Interestingly women with even strong symptoms relied on the therapeutic benefit of HMPs.

Conclusion: Real-world outcome data are an important supplement to clinical data. Our results reveal a favorable benefit-risk ratio of HMPs and help to implement them into novel therapeutic strategies to treat gynecological complaints.