Bryophyllum pinnatum Treatment of Anxiety Related to Preterm Labor: A Randomized, Double-Blind, Placebo-Controlled Study as Investigator-Initiated Trial IIT

Objectives Bryophyllum pinnatum is a medicinal plant frequently used in the treatment of anxiety and of preterm labor; however, placebo-controlled studies evaluating its efficacy are currently lacking. Our goal was to characterize clinical outcomes needed to investigate the efficacy of Bryophyllum 50% chewable tablets (à 350 mg; made from leaf press juice of Bryophyllum pinnatum plants grown in Brazil; Weleda AG Arlesheim, Switzerland) on the treatment of preterm labor-related anxiety. Here, data collected at study discontinuation (n = 16) and learnings are described. Methods Patients (pregnancy week 22 to 34) suffering from signs of preterm birth, after 48-h standard tocolysis, without indications for imminent delivery were recruited for this placebo-controlled double blinded study. Primary endpoint was anxiety (at day 1, 7 and 14, assessed with standard questionnaires). Sleep quality, gestational age at birth and hospitalization days were secondary outcomes. Results Study was discontinued after 16 patients had been randomized with 10 of them completing the study (5 per group). At day 1, anxiety level was intermediate, and sleep quality was good; corresponding scores changed minimally in time, no tendencies for differences between the two groups were detected. Nine out of the 10 patients delivered at term, ie, after completing 37 weeks of pregnancy. In the verum (herbal medication) and placebo groups, delivery occurred after median 2 (range 2-6) and median 12 (range 2-56) days in an in-patient facility, respectively. Conclusion Our approach did not seem to capture anxiety related to preterm labor, due to either selection bias or inappropriateness of the questionnaires used. However, the pragmatic approach of counting the days spent in an in-patient facility as a proxy for successful preterm labor treatment appears promising for future studies. Study registration at clinicaltrials.gov NCT05110599, November fourth 2021