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Aloe barbadensis Mill. extract improves symptoms in IBS patients with diarrhoea: post hoc analysis of two randomized double-blind controlled studies

Ahluwalia, Bani, Magnusson, Maria K., Böhn, Lena, Störsrud, Stine, Larsson, Fredrik, Öhman, Lena, Simrén, Magnus·2021·Therapeutic Advances in Gastroenterology

Abstract

Background: Aloe barbadensis Mill. (Aloe) extract was found to be well-tolerated, safe and showed beneficial effects in subsets of irritable bowel syndrome (IBS) patients in two randomized, double-blind, controlled studies. However, the individual studies were underpowered to perform subgroup analyses. We therefore determined the effect of Aloe extract in IBS subgroups in a post hoc analysis combining the results from the two studies. Methods: Data from the two controlled studies comparing Aloe and control treatment taken orally for 4 weeks, were pooled. Both studies included IBS patients fulfilling the ROME III criteria and IBS Symptom Severity Score (IBS-SSS) was assessed. We analysed the effect of Aloe extract on IBS symptom severity and the proportion of responders (IBS-SSS reduction ⩾ 50) in IBS subgroups. Results: In total, 213 IBS patients were included in the post hoc subgroup analyses. A reduction in overall symptom severity, primarily driven by effect on pain severity and frequency, comparing baseline versus end of treatment, was recorded in IBS patients with diarrhoea (IBS-D) receiving Aloe ( n = 38, p < 0.001) but not control treatment ( n = 33, p = 0.33), with difference between the treatment groups ( p = 0.01). Moreover, the frequency of responders was higher in IBS-D patients receiving Aloe ( n = 22, 58%) compared to control treatment ( n = 10, 30%) ( p = 0.02). The effect of Aloe extract treatment on IBS symptom severity was not superior to control treatment in the other IBS subtypes. Conclusion: Aloe extract improves symptom severity in IBS-D patients and can be regarded as a safe and effective treatment option for this patient group.

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Metadata

Authors
Ahluwalia, B., Magnusson, M. K., Böhn, L., Störsrud, S., Larsson, F., Öhman, L., & Simrén, M.
Affiliations
  • Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden
  • Research and Development, Calmino Group AB, Gothenburg, Sweden
  • Department of Molecular and Clinical Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden
  • Department of Microbiology and Immunology, Institute of Biomedicine, University of Gothenburg, Box 435, 405 30 Gothenburg, Sweden
Venue
Therapeutic Advances in Gastroenterology
Published
2021-01
Volume
14
ISSN
1756-2848
Cited by
11
References
5
Language
en
Funders
  • Calmino group AB, Sweden
  • sahlgrenska akademin
  • AFA Försäkring
  • Swedish Medical Research Council (13409, 2015-02317, 2019-01052, 21691, 21692)
  • Regional Executive Board, Region Västra Götaland (VGFOUREG-931919)

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