Perceived Changes in Anxiety Symptom Burden During Treatment With Bryophyllum Pinnatum and Tolerability: a Prospective, Single-Group Pre-post Observational Study as Investigator-Initiated Trial (IIT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change of anxiety symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Wheat allergies
- •Acute life-threatening conditions
- •Withdrawal of informed consent
研究组 & 干预措施
Bryophyllum pinnatum 50% chewing tablets
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.
干预措施: Bryophyllum 50 % Chewing Tablets (Drug)
结局指标
主要结局
Change of anxiety symptoms
时间窗: 2 weeks
Assessed with the Beck Anxiety Inventory (BAI, Beckler 2010) score between before treatment and after 2 weeks of treatment. BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. The questions ask about common symptoms of anxiety that the subject has had during the past week (including the day you take it) (such as numbness and tingling, sweating not due to heat, and fear of the worst happening). Each answer to a BAI-question is scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cut-offs are: 0-7, minimal anxiety; 8-15, mild anxiety; 16-25, moderate anxiety; 26-63, severe anxiety.
次要结局
- Change of anxiety symptoms(2 and 3 weeks)
- Change in the Sense of Coherence(2 and 3 weeks)
- Change of depression symptoms(2 and 3 weeks)
- Change of stress symptoms(2 and 3 weeks)
- Change in sleep quality(2 and 3 weeks)
- Change in health-related quality of life questionnaire(2 and 3 weeks)
- Brophyllum Prescription report(3 weeks)
研究者
Markus Schlemmer
Dr. med.
Klinik Arlesheim