Functional gastrointestinal disorders in children: Effectivity, safety, and tolerability of the herbal preparation STW-5 (Iberogast®) in general practice
Background: Functional gastrointestinal disorders (FGIDs) of the upper and lower digestive system in children and adolescents present with heterogeneous gastrointestinal symptoms and are a common reason for specialist consultations. The herbal medicinal preparation STW-5 has already shown efficacy a...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | Complementary Therapies in Medicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0965229922000759 |
| _version_ | 1811295245069975552 |
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| author | Radke Michael Vinson Bettina Lehmann Eckehard |
| author_facet | Radke Michael Vinson Bettina Lehmann Eckehard |
| author_sort | Radke Michael |
| collection | DOAJ |
| description | Background: Functional gastrointestinal disorders (FGIDs) of the upper and lower digestive system in children and adolescents present with heterogeneous gastrointestinal symptoms and are a common reason for specialist consultations. The herbal medicinal preparation STW-5 has already shown efficacy and safety in clinical studies with more than 7000 adult participants suffering from functional dyspepsia (FD) or irritable bowel syndrome (IBS). Here, we evaluate with a prospective observational study the effectivity and safety of STW-5 in children with FGID under real-life conditions and interpret these data versus the background of controlled clinical studies in a predominantly adult population. Methods: This prospective observational study included 980 children (age 3–14 years) with FGID. For inclusion, Rome III criteria were recommended to apply. The inclusion of the patients for treatment with STW-5 followed routine clinical practice. Patients were treated for approximately 1 week. The presence and severity of symptoms was documented at the study start and at the end of treatment period utilizing the adapted gastrointestinal symptom score (GIS). Other target parameters included global effectivity and tolerability assessments as well as adverse events. Results: The average patient age was 7.6 ± 2.9 years. Most of the patients were treated for IBS (n = 418; 43 %) or FD (n = 259; 26 %), with a mean baseline GIS of 16.1 ± 8.9. During the treatment period, the GIS decreased 76 % to 3.8 ± 4.2. The decrease in symptoms was similar for different age groups, gender, and indications. Patients with a shorter duration of complaints had a lower GIS at study end (p < 0.0001. The global treatment effect was assessed as good or very good by 87–89 % of patients/parents and physicians. Physicians rated the global tolerability as good or very good for 95 % of the patients. Seven patients (0.7 %) reported adverse events. Conclusions: The treatment effect of STW-5 in this study was in its range comparable to according data from controlled clinical trials with predominantly adult participants.Thus, supporting robustness of these data generated in an uncontrolled observational setting. The results of this observational study indicate that STW-5 may be an effective and well tolerated treatment option also for children with FGIDs. |
| first_indexed | 2024-04-13T05:30:32Z |
| format | Article |
| id | doaj.art-b9ccbd580ac94a0da0e7a80e303de915 |
| institution | Directory Open Access Journal |
| issn | 0965-2299 |
| language | English |
| last_indexed | 2024-04-13T05:30:32Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Complementary Therapies in Medicine |
| spelling | doaj.art-b9ccbd580ac94a0da0e7a80e303de9152022-12-22T03:00:28ZengElsevierComplementary Therapies in Medicine0965-22992022-12-0171102873Functional gastrointestinal disorders in children: Effectivity, safety, and tolerability of the herbal preparation STW-5 (Iberogast®) in general practiceRadke Michael0Vinson Bettina1Lehmann Eckehard2Hospital for Paediatrics and Adolescents' Medicine, Hospital for Paediatrics and Youth Medicine, Klinikum Westbrandenburg GmbH, Potsdam, Germany Klinikum Ernst von Bergmann gemeinnützige GmbH, Potsdam, GermanySteigerwald Arzneimittelwerk GmbH, Darmstadt, Germany; Correspondence to: Steigerwald Arzneimittelwerk GmbH, Havelstraße 5, 64295 Darmstadt, Germany.Joint Practice for General Medicine Dr. med. Eckehard Lehmann und Dipl.-Med. Ilona Lehmann, Michendorf, GermanyBackground: Functional gastrointestinal disorders (FGIDs) of the upper and lower digestive system in children and adolescents present with heterogeneous gastrointestinal symptoms and are a common reason for specialist consultations. The herbal medicinal preparation STW-5 has already shown efficacy and safety in clinical studies with more than 7000 adult participants suffering from functional dyspepsia (FD) or irritable bowel syndrome (IBS). Here, we evaluate with a prospective observational study the effectivity and safety of STW-5 in children with FGID under real-life conditions and interpret these data versus the background of controlled clinical studies in a predominantly adult population. Methods: This prospective observational study included 980 children (age 3–14 years) with FGID. For inclusion, Rome III criteria were recommended to apply. The inclusion of the patients for treatment with STW-5 followed routine clinical practice. Patients were treated for approximately 1 week. The presence and severity of symptoms was documented at the study start and at the end of treatment period utilizing the adapted gastrointestinal symptom score (GIS). Other target parameters included global effectivity and tolerability assessments as well as adverse events. Results: The average patient age was 7.6 ± 2.9 years. Most of the patients were treated for IBS (n = 418; 43 %) or FD (n = 259; 26 %), with a mean baseline GIS of 16.1 ± 8.9. During the treatment period, the GIS decreased 76 % to 3.8 ± 4.2. The decrease in symptoms was similar for different age groups, gender, and indications. Patients with a shorter duration of complaints had a lower GIS at study end (p < 0.0001. The global treatment effect was assessed as good or very good by 87–89 % of patients/parents and physicians. Physicians rated the global tolerability as good or very good for 95 % of the patients. Seven patients (0.7 %) reported adverse events. Conclusions: The treatment effect of STW-5 in this study was in its range comparable to according data from controlled clinical trials with predominantly adult participants.Thus, supporting robustness of these data generated in an uncontrolled observational setting. The results of this observational study indicate that STW-5 may be an effective and well tolerated treatment option also for children with FGIDs.http://www.sciencedirect.com/science/article/pii/S0965229922000759ChildrenFunctional gastrointestinal disorderGastrointestinal symptom scoreNon-interventional studyIberogastSTW-5 |
| spellingShingle | Radke Michael Vinson Bettina Lehmann Eckehard Functional gastrointestinal disorders in children: Effectivity, safety, and tolerability of the herbal preparation STW-5 (Iberogast®) in general practice Complementary Therapies in Medicine Children Functional gastrointestinal disorder Gastrointestinal symptom score Non-interventional study Iberogast STW-5 |
| title | Functional gastrointestinal disorders in children: Effectivity, safety, and tolerability of the herbal preparation STW-5 (Iberogast®) in general practice |
| title_full | Functional gastrointestinal disorders in children: Effectivity, safety, and tolerability of the herbal preparation STW-5 (Iberogast®) in general practice |
| title_fullStr | Functional gastrointestinal disorders in children: Effectivity, safety, and tolerability of the herbal preparation STW-5 (Iberogast®) in general practice |
| title_full_unstemmed | Functional gastrointestinal disorders in children: Effectivity, safety, and tolerability of the herbal preparation STW-5 (Iberogast®) in general practice |
| title_short | Functional gastrointestinal disorders in children: Effectivity, safety, and tolerability of the herbal preparation STW-5 (Iberogast®) in general practice |
| title_sort | functional gastrointestinal disorders in children effectivity safety and tolerability of the herbal preparation stw 5 iberogast r in general practice |
| topic | Children Functional gastrointestinal disorder Gastrointestinal symptom score Non-interventional study Iberogast STW-5 |
| url | http://www.sciencedirect.com/science/article/pii/S0965229922000759 |
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