Functional Nausea Clinical Trial
Official title:
Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea - a Randomized Clinical Trial With Sham-conditions
Functional gastrointestinal disorders are common disorders that are characterized by
persistent and recurring GI symptoms. These occur as a result of abnormal functioning of the
GI tract and are not caused by structural or biochemical abnormalities. As a result, medical
tests- such as blood tests and endoscopic exams- have essentially normal/negative
(non-disease) results. More than 20 functional GI disorders have been identified. They can
affect any part of the GI tract. One of the most common functional disorders is nausea and
dyspepsia (pain or discomfort in the upper abdominal area, feeling of fullness, bloating).
Any chronic illness, including functional nausea, will affect a person's health-related
quality of life (general well-being, ability to carry out everyday activities), additional
psychosocial disturbances and amplify the experienced illness.
The majority of children suffering from functional nausea in Europe are treated with
Iberogast®. a herbal mixture, whose effect was demonstrated in several studies. Since
Iberogast® is not available in the United States of America, children there receive an
acupressure therapy. The American gastroenterologists refer hereby to several studies, which
have shown, that the positive effect of such therapies in patients with chemotherapy-induced
nausea is even greater than a therapy with ondansetron. Since acupressure is able to reduce
somatic nausea, it is also believed to decrease functional nausea, but it has never been
investigated. Therefore, there are no data. That's why Investigators want to compare the
efficacy of these two therapies, that is, Iberogast® and acupressure
Functional gastrointestinal disorders are common disorders that are characterized by
persistent and recurring GI symptoms. These occur as a result of abnormal functioning of the
GI tract and are not caused by structural or biochemical abnormalities. As a result, medical
tests- such as blood tests and endoscopic exams- have essentially normal/negative
(non-disease) results. More than 20 functional GI disorders have been identified. They can
affect any part of the GI tract. One of the most common functional disorders is nausea and
dyspepsia (pain or discomfort in the upper abdominal area, feeling of fullness, bloating).
Any chronic illness, including functional nausea, will affect a person's health-related
quality of life (general well-being, ability to carry out everyday activities), additional
psychosocial disturbances and amplify the experienced illness.
However, the majority of children suffering from functional Nausea in Europe get treated with
Iberogast®: A herbal mixture, whose effect was demonstrated in several studies [10, 11].
Since Iberogast® is not available in the United States of America, children receive there an
acupressure therapy. The American gastroenterologists refer hereby to several studies, which
have shown, that the effect of such therapies in patient with chemotherapy-induced nausea is
even greater than the taking of ondansetron [12,13 ]. Since acupressure is capable to reduce
somatic nausea, it is also believed to decrease functional nausea, but it has never been
investigated, therefore no data are available. That's why Investigators plan to compare the
efficiency of these two therapies.
Furthermore Investigators want to measure the cognitive performance before and after the
intervention to proof a possible effect on the 'gut-brain-axis'. For this purpose the
participants have to do the 'Flanker Task', a standardised test on the computer.
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