Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea

Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea - a Randomized Clinical Trial With Sham-conditions

Sponsors

Lead Sponsor: University Hospital, Basel, Switzerland

Source University Hospital, Basel, Switzerland
Brief Summary

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

Detailed Description

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.

Overall Status Completed
Start Date January 2016
Completion Date September 16, 2020
Primary Completion Date September 16, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
comparison in the levels of nausea as assessed by visual analog scales (VAS) 4 weeks
Enrollment 56
Condition
Intervention

Intervention Type: Other

Intervention Name: Acupressure

Description: Children will have to wear a 'seasickness-band', which has the effect of acupressure

Arm Group Label: Acupressure

Other Name: Seasickness-Band

Intervention Type: Other

Intervention Name: Placebo-band

Description: Children will have to wear a 'placebo-wristband'

Arm Group Label: Placebo-band

Intervention Type: Drug

Intervention Name: Iberogast

Description: Children will have to take Iberogast drops

Arm Group Label: Iberogast

Intervention Type: Other

Intervention Name: Placebo-drops

Description: Children will have to take placebo-drops

Arm Group Label: Placebo-drops

Eligibility

Criteria:

Inclusion Criteria: - Functional nausea (normal endoscopy findings) Exclusion Criteria: - Gastrointestinal infection less than 2 weeks ago - Known chronic gastrointestinal disease - Use of drugs 2 weeks prior to starting the study

Gender: All

Minimum Age: 6 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Raoul Furlano, MD, Dr Principal Investigator University Children's Hospital
Location
Facility: Department of Pedriatric Gastroenterology, University Children's Hospital Basel
Location Countries

Switzerland

Verification Date

October 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Acupressure

Type: Active Comparator

Description: Children will have to wear a 'seasickness-band', which has the effect of acupressure

Label: Placebo-band

Type: Placebo Comparator

Description: Children will have to wear a 'placebo-wristband'

Label: Iberogast

Type: Active Comparator

Description: Children will have to take Iberogast drops

Label: Placebo-drops

Type: Placebo Comparator

Description: Children will have to take placebo-drops

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov