Iberogast-Induced Severe Hepatotoxicity Leading to Liver Transplantation

Saéz-González, Esteban; Conde, Isabel; Díaz-Jaime, Francia Carolina; Benlloch, Salvador; Prieto, M.; Berenguer, Marina

doi:10.1038/ajg.2016.260

Cited by 19 publications

(18 citation statements)

References 5 publications

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“…[46][47][48] Though STW 5 is thought to be a safe remedy and available without doctor's prescription in many countries including the United States, STW 5 is linked with drug-induced liver injury in recent 2 case reports, which might be the results from an idiosyncratic reaction. 49,50 Another non-pharmacological avenue for the treatment of FD is probiotics. Probiotics are living microorganisms that (when consumed) have the potential to confer a beneficial health effect; they can be marketed as a medical food.…”

Section: Dietary Management and Medical Foodmentioning

confidence: 99%

Non-pharmacological Approach in the Management of Functional Dyspepsia

Wang

Herndon²,

2020

J Neurogastroenterol Motil

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Functional dyspepsia (FD) is a common functional gastrointestinal disease which bears a significant burden on society and individuals. Despite the high prevalence of FD, its pathophysiology remains poorly understood and the treatment options are limited and unsatisfactory. In the absence of effective pharmacological treatments for FD, non-pharmacological approaches, including: reassurance, lifestyle modification, psychotherapy, dietary interventions, medical food, acupuncture, and electrical stimulation and modulation are sought after by many physicians and FD patients. In this article, we review clinical studies which investigate nonpharmacological therapies for FD. We will also discuss potential mechanisms involved in the therapeutic effects of these nonpharmacological approaches. Though the evidences to support the routine use of the non-pharmacological management is still lacking, the non-invasive nature and potentially minimal side-effects of these therapies may be attractive in the FD management. In order to confirm the clinical effectiveness of these non-pharmacological approaches, more well-conducted, methodologically rigorous, and large-scaled clinical trials are required. (J Neurogastroenterol Motil 2020;26:6-15)

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Section: Dietary Management and Medical Foodmentioning

confidence: 99%

Non-pharmacological Approach in the Management of Functional Dyspepsia

Wang

Herndon²,

2020

J Neurogastroenterol Motil

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“…For the combination product STW5, containing Chelidonium majus extract in a low concentration, toxicological studies utilizing even high doses did not provide evidence for any appreciable toxicity. Nevertheless, 1 case with a positive temporal relationship between exposure to STW5 and hepatic toxicity was recently published [68]. The authors suspected a probable causal relationship to STW5 based upon the chronological association and the assumption that one of the ingredients (greater celandine) was potentially could have caused a drug-induced liver injury and the available information regarding the chronological exposure.…”

Section: Safety Assessment Of Herbal Treatmentsmentioning

confidence: 99%

“…It is estimated that during a time-span of 5 decades, approxi-DOI: 10.1159/000504570 mately 80,000,000 patients have been treated with this preparation [55]. In spite of the widespread use and safety monitoring requirements that are in many jurisdictions identical to chemically defined medications, only very few cases of adverse events have been observed and reported [75] and very recently a 2 cases of a liver failure after treatment with STW5 has been reported [68,76]. In these 2 cases, causality was supported by a positive Roussel Uclaf Causality Assessment Method score [77] that suggested a highly probable link.…”

Section: Adverse Event Pattern Of Herbal Medicinesmentioning

confidence: 99%

Use of Evidence-Based Herbal Medicines for Patients with Functional Gastrointestinal Disorders: A Conceptional Framework for Risk-Benefit Assessment and Regulatory Approaches

Holtmann

Schrenk

Madisch

et al. 2019

Dig Dis

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Background: Herbal or complementary medicines are frequently used for the treatment of patients with functional gastrointestinal disorders (FGID). Regulatory requirements for herbal therapies are inconsistent and, in many jurisdictions, herbal therapies are either self-, minimally-or unregulated. Aim: To provide guidance for the appropriate and safe use of herbal medicines in patients with FGID patients with special consideration of the regulatory frameworks. Methods: A PubMed search of the literature was performed; relevant articles were included. Results: Similar to chemically defined therapies herbal medicines can cause adverse events. Thus, a risk-benefit appraisal should be undertaken for these therapies. While there is no disease specific mortality in FGID public and policy makers. However, the frequently chronic or relapsing nature of FGIDs cause disabilities in predominately young people and are a considerable burden to society even though life expectancy is not affected.

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“…Some clinical data also support its use, and it is a popular over-the-counter remedy for FD in several European countries. However, a recent report of severe hepatotoxicity leading to liver transplantation potentially associated with the use of Iberogast suggests some caution in prescribing this medication 33 . Finally, rikkunshito, another herbal medicine, which is thought to accelerate gastric emptying, has been shown to improve symptoms of epigastric pain and postprandial fullness in patients with FD in a randomized clinical trial 34 .…”

Section: Managementmentioning

confidence: 99%