STW 5 (Iberogast) Therapy in Gastrointestinal Functional Disorders

Abstract

Background: Functional gastrointestinal disorders (FGIDs) are very common and affect populations worldwide. A majority of patients are affected by a variety of heterogenous gastrointestinal symptoms (GIS) related to the upper and lower digestive system with frequent overlap and mostly of mild to moderate degree. The herbal medicinal preparation STW 5 is documented as an effective therapeutic option for treating FGID. Studies Conducted in Summary: STW 5 has been in use for more than 50 years in clinical practice and proven to be effective and safe in the management of FGID. The high efficacy of STW 5 on symptoms clustered in functional dyspepsia (FD) and irritable bowel syndrome (IBS) as well as on individual abdominal symptoms is demonstrated in 5 controlled, randomized double-blind studies in FD and in one trial conducted in patients with IBS. In addition the beneficial therapeutic effect of STW 5 on FGD as well as safety issues have been reported in a series of non interventional studies conducted in several thousands of adult patients and including 980 children. An additional study has been performed addressing the question as to how quickly the therapeutic effect is obtained after STW 5 administration. Key Messages from These Studies: STW 5 is an effective phyto-medication for treating patients with FD and IBS. STW 5 acts beneficially on abdominal symptom clusters as well as on individual GIS in adults and children. The time to onset of action is rapid, well tolerated and safe. The repetitive use of STW 5 is an appropriate option in clinical practice for patients with FGID.

Non-pharmacological Approach in the Management of Functional Dyspepsia

“…STW 5 has been used to treat a variety of functional digestive symptoms. 45 In a meta-analysis of 3 RCTs evaluating STW 5 in the treatment of FD, Melzer et al 46 found treatment with STW 5 (n = 138) to be more effective than placebo (n = 135) with regard to the severity of the most bothersome gastrointestinal symptom (P = 0.001; OR, 0.22; 95% CI, 0.11-0.47). An RCT by von Arnim et al 47 found a similarly favor-able result: statistically significant improvement in Gastrointestinal Symptom Score in the STW 5 arm (n = 158) as compared to the placebo arm (n = 157) (6.9 ± 4.8 vs 5.9 ± 4.3 at 56 days, P < 0.05).…”

“…It has been suggested that the therapeutic mechanism of STW 5 includes a decrease in muscle tone within the gastric fundus that enhances antral contractility. 45 However, Braden et al 48 found that the clinical effects of STW 5 in FD patients with FD and gastroparesis were not directly mediated by an acceleration of gastric emptying. No serious adverse events have been reported in the RCTs evaluating STW 5 for FD.…”

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

“…been tested in a variety of pharmacologic models on specific GI functions [53]. In addition, the efficacy of this herbal combination has been tested and confirmed in prospective, controlled clinical trials [26,54,55], and tolerability has also been monitored and established in clinical studies as well as post-marketing studies. Available toxicology data for specific ingredients of STW5 do not provide evidence for relevant toxicity, neither in rodents such as rats [56,57] nor mammalians such as pigs [58].…”

“…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.…”

“…For some herbals such as STW5, comprehensive documentation is available addressing different targets important for the treatment of functional GI diseases [50]. Clinical trials suggest efficacy in relation to FGID symptoms [54] and confirmed safety from toxicological studies as well as from randomized clinical trials and post-marketing surveys [89]. Thus, while the exposure of patients with a nonlife-threatening condition needs to be minimized, there are appropriate ways to achieve this and for some of the herbal preparations the available data are far more robust as compared to products that have been introduced only recently after clinical trials with at best several thousand study patients.…”