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Abstract: Objectives: To evaluate usage pattern, effectiveness and safety of Black cohosh alone or in fixed combination with St. John''s wort on menopausal symptoms in general clinical practice. Method: Prospective, controlled open-label observational study of 6141 women at 1287 outpatient gynecologists in Germany. Subjects were treated with recommended doses of study therapies, with treatment chosen by the participating physicians. Patients were followed up for 6 months, optionally 12 months. The primary effectiveness variable was Menopause Rating Scale (MRS) subscore PSYCHE at Month 3 evaluated by ANCOVA. Results: The treatment groups were comparable at baseline, excepting the main MRS score and the PSYCHE score (monotherapy: 0.31±0.22; combination therapy: 0.42±0.23). Reductions from baseline were seen with both regimens for all variables. The changes in the primary variable remained significantly different between groups (p <0.001) when adjusted for differences at baseline with the combination therapy being superior: from 0.37 (adjusted) to 0.25 (95% CI: 0.24–0.25) and 0.23 (95% CI: 0.22–0.23) at Month 3 in the monotherapy and combination-therapy groups, respectively. The improvement by both therapies was maintained at 6 and 12 months. The rate of possibly treatment-related adverse events was 0.16%, all non-serious. Conclusion: The results support the effectiveness and tolerability profiles of two Black cohosh-based therapies for menopausal symptoms in general practice. They were used differentially: the monotherapy for neurovegetative symptoms, the combination for patients with more pronounced mood complaints. The fixed combination of Black cohosh and St. John''s wort was superior to Black cohosh alone in alleviating climacteric mood symptoms. [Copyright &y& Elsevier]

Little is known about the utilization of St. John's wort (Hypericum perforatum L.) during pregnancy. In Germany, certain preparations of St. John's wort can be reimbursed by statutory health insurances, facilitating to investigate exposure to St. John's wort based on claims data. We therefore aimed to characterize pregnancies exposed to St. John's wort and to explore potential malformations in the babies. Using claims data from the German Pharmacoepidemiological Research Database (GePaRD), pregnancies exposed to St. John's wort during at least one trimester between 2006 and 2016 and the corresponding babies were identified. Exposure was identified via outpatient dispensations. Pregnancies were characterized regarding timing of exposure, use of other antidepressants, pregnancy outcomes and the occurrence of major malformations in the babies (not considering codes for musculoskeletal and other malformations due to low data quality in this regard). Out of 496 pregnancies with a dispensation of St. John's wort during pregnancy, 420 (85 %) had a dispensation during the first trimester. There was a dispensation of other antidepressants before pregnancy in 21 % (during pregnancy: 12 %). Eleven percent of pregnancies ended in non-live births. In 312 babies linked to 305 pregnancies, major malformations were coded in 18 babies (5.8 %), of which 17 were exposed in the first trimester. The crude relative risk of major malformations for babies exposed during the first vs. the second or third trimester only was 3.56 (0.48-26.17). Our results suggest that only in a minority of pregnancies, St. John's wort is used as an alternative to other antidepressants. Even though the relatively high rates of non-live births and major malformations after exposure to St. John's wort during the first trimester need to be interpreted with caution, the findings are striking and generate hypotheses that merit further investigation., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: In Germany herbal medicines are traditionally frequently used. They represent an important therapeutic option, especially in self-medication., Methods: Current systematic review articles and meta-analyses were evaluated and summarized with respect to the evidence of phytotherapeutic drugs for selected psychiatric indications., Results: Apart from the use of St. John's wort for depression, no other herb has so far shown convincing evidence., Conclusion: Due to the promising effects and the low side effect potential within the existing studies, further randomized controlled trials (e. g. for Passiflora incarnata, Rhodiola rosea and Lavendula officinalis) are definitely indicated.