The impact of the prophylactic or therapeutic application of Bryophyllum (Bryophyllum calycinum) on preterm delivery—A prospective study

Introduction Preterm delivery is still the leading cause of perinatal mortality and morbidity in the western countries. Despite intensive efforts in the field of preventive care, screening and therapeutic interventions, the incidence of preterm deliveries has remained stable for over two decades. For inhibiting preterm labor, beta-mimetics have been used for over 20 years. Other medicaments with tocolytic properties include calcium antagonists, prostaglandin inhibitors, and, currently, antagonists of the oxytocic receptor. However, many of them show considerable side effects. Due to the stagnant long-term results of the tocolytical drugs, alternative medicaments, especially with a lower side effect, profile are needed. Material and methods A prospective double-blind trial with orally applied Bryophyllum versus placebo was initiated in June 2004. The patients were divided into three different groups according to the indication of Bryophyllum: twin pregnancies (group A), shortened cervix (less than 25 mm) or preterm contractions (group B), or positive history of preterm contractions and/or preterm delivery (group C). Thirty-two patients were enrolled between February 2004 and August 2005. Primary outcome consists of the extension of pregnancy. Secondary outcomes include rate of preterm delivery, rate of side effects, number of days of hospitalization, and rate of lung maturation. Results Thirty-two patients were recruited. The mean randomization time was the 23 week of gestation. Fifteen patients received Bryophyllum and 17 received the placebo. The time of delivery did not differ among the groups. In both groups the mean time of birth was in the 35 week of gestation. The mean birth weight was slightly higher in the placebo group (2192 g) compared to the Verum group (1948 g). A transition to the intensive care unit was slightly higher in the placebo group (13) compared to the Bryophyllum group (11). Discussion Bryophyllum has been implemented in clinical practice not only in anthroposophical but also in tertiary obstetrical units. This double-blind study was designed to determine its effectiveness in preventing preterm deliveries in a tertiary setting. However, the recruitment was difficult because many patients have already had Bryophyllum before they consult their doctor. Our data do not show statistically significant differences between the groups; however, larger groups are needed to detect potential differences. Side effects of Bryophyllum were not detected. Since a placebo-controlled recruitment is not possible we added an observational arm to our study to investigate the outcome of a larger group of patients.