Perceived Changes in Anxiety Symptom Burden During Treatment With Bryophyllum Pinnatum and Tolerability
Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Bryophyllum pinnatum (BP) is a succulent perennial plant from the family Crassulacea (for
reviews see Fürer 2016 and Hamburger 2017). Leaf extracts from BP have been used in
traditional medicine to treat wounds and ulcers, skin diseases, infections, inflammations,
pain, diabetes, hypertension, and cancer. In Europe, BP started to be used at the beginning
of the 20th century in Anthroposophic medicine, a form of holistic medicine with an
integrative approach. Almost a hundred years later, BP preparations are still often
prescribed in Anthroposophic medicine, where it is used in the treatment of a broad spectrum
of diagnoses, most often of mental and behavioural disorders (ICD-10 F00-F99), including
anxiety, depressive, and sleep disorders (Simões-Wüst 2012).
In Switzerland, during the last decade, BP (50 % tablets) started to be used in conventional
settings mainly in the treatment of preterm labour (Simões-Wüst 2018, Plangger 2006),
overactive bladder (Betschart 2013), sleep disorders (Simões-Wüst 2015), and restless legs
syndrome (Von Manitius 2019).
Whereas the good effectiveness of BP preparations in the treatment of preterm contractions
and overactive bladder is well supported by data obtained using a variety of in vitro models
(see e.g. Santos 2018, Bachmann 2017, Simões-Wüst 2010), less is known about possible
mechanisms of action that would support their use in the treatment of mental and behavioural
disorders.
Nevertheless, the observed improvements of sleep disorders are corroborated by animal
experiments showing that different fractions of the leaf extract of BP can prolong the
pentobarbitone-induced sleeping time (Yemitan 2005 and Pal 1999), indicating a CNS depressant
action. Some of the bufadienolides present in Bryophyllum species are thought to be
responsible for the sedative effects (Wagner 1986).
The aim of the present study is to find out if patients suffering from anxiety symptoms
perceive improvements of these symptoms during treatment with Bryophyllum 50% tablets. Since
anxiety symptoms are often related to depression, reduced sleep quality, stress, reduced
health-related quality of life and the feeling of not being able to control owns life
(internal coherence), these aspects will be assessed as well.