Perceived Changes in Anxiety Symptom Burden During Treatment With Bryophyllum Pinnatum and Tolerability

Markus Schlemmer

Status and phase: Completed; Phase 4

Conditions: Anxiety Symptoms

Treatments: Drug: Bryophyllum 50 % Chewing Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04825171

Bryo-KLA-02

Details and patient eligibility

About

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.

Full description

The present IIT (Investigator-Initiated Trial) study is a prospective, single-group, pre-post study (phase IV).

A past study showed that among Anthroposophical physicians the most frequent diagnosis group where BP preparations are prescribed are mental and behavioural disorders such as anxiety and sleep disorders. In the present study, we, therefore, want to investigate the effectiveness of Bryophyllum tablets in patients with anxiety symptoms.

Study participants will be recruited among the patients on the waiting list of the Department of Psychiatry and Psychosomatics at the Clinic Arlesheim.

• Participant recruitment will continue until 60 patients have concluded the study.
• Recruitment period will probably last 15 months.
• Duration of the drug administration is 3 weeks.

Participants will fill in a questionnaire three times. At baseline, after two and after three weeks of Bryophyllum intake.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients referred by their treating physician to the Department of Psychiatry and Psychosomatic of the Clinic Arlesheim waiting for the in-stay
• Expected waiting time until in-stay is at least two weeks
• Patients having anxiety symptoms as measured by the GAD-2 questionnaire (cut-off of 3 points)
• Patients'state of health allows them to complete the questionnaire on their own
• Signed informed consent
• No treatment with BP during the last two months
• No planned doses increase of (conventional) anxiolytics or antidepressants for the duration of the period until in-stay
• Age over 18 years
• Good German knowledge (at least level B2 from Common European Framework of Reference for Languages)

Exclusion criteria

• Wheat allergies
• Acute life-threatening conditions
• Withdrawal of informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

51 participants in 1 patient group

Bryophyllum pinnatum 50% chewing tablets

Experimental group

Description:

Bryophyllum is administered for 3 weeks. Bryophyllum is given in form of chewing tablets, 350mg per tablet, 0-2-2-2/d: 2 tablets at midday, 2 tablets in the evening, 2 tablets before bedtime.

Treatment:

Drug: Bryophyllum 50 % Chewing Tablets