Iberogast® for Healthcare Professionals
Iberogast is registered as an OTC medicine for the treatment of functional gastrointestinal symptoms including those of Functional Dyspepsia and Irritable Bowel Syndrome (IBS).8 There are a multitude of double-blind and randomised studies versus placebo or active control, as well as some meta-analyses. In these clinical trials, the efficacy and safety profile of Iberogast was demonstrated.13,14,17,20,24
The efficacy and safety of Iberogast for the treatment of functional digestive symptoms have been proven in a large number of studies with more than 50,000 participants in total.17 Using quantifiable criteria, the excellent efficacy and tolerability of Iberogast was verified at the highest level of scientific evidence.24
|Study||Disorders||No. of patients treated with Iberogast® in the studies||Results|
6 controlled, randomised, doubleblind studies
|FD and IBS||413||
2 non-interventional studies in FD and IBS
|FGIDs, FD, IBS||4815||
Efficacy in improving various GI symptoms:
Retrospective cohort study
Efficacy comparable to prokinetics:
Retrospective surveillances with children up to 12 years
Non-interventional study in children
Patients treated with Iberogast since market launch
|Functional GI symptoms||> 25,000,000 (estimated)||
Effective for common use:
FD: Functional Dyspepsia
IBS: Irritable Bowel Syndrome
FGIDs: Functional Gastrointestinal Disorders
Table modified from Ottillinger et al. (2013)17
In summary, the Iberogast studies showed:
In a clinical trial of 208 patients with Irritable Bowel Syndrome (IBS), digestive symptoms and abdominal pain, those using Iberogast were shown to have their symptoms significantly reduced after 2 and 4 weeks treatment.13
Iberogast is significantly better than placebo in reducing the total abdominal pain score. (Madisch A et al. 2004)
Change of the abdominal pain score during 4 weeks of therapy with Iberogast® or placebo
In a combined analysis of three separate trials in FD with 273 individuals, 60% of patients in the Iberogast group reported their most bothersome symptom as mild or absent vs. only 24% of patients in the placebo group.
Pooled data showed Iberogast to be more effective than placebo with regard to the severity of the most bothersome gastrointestinal symptom.14 (Melzer J et al. 2004).
Clinical evidence of fast onset of action. Major onset of therapeutic effects was observed between 15 and 30 minutes after taking Iberogast. In a clinical study of 272 patients, Iberogast began to relieve functional digestive symptoms within minutes of administration.25 (Vinson BR et al. 2013 poster)
In a placebo-controlled clinical trial of 208 patients with functional digestive symptoms, an assessment of tolerability was conducted.
94% of the patients assessed tolerability of Iberogast to be ‘good‘ or ‘very good‘. Again, no safety-relevant changes of laboratory parameters were observed. (Madisch A et al. 2004)
In a number of different studies the acute, chronic, subchronic and reproductive toxicity, mutagenic effects and cytotoxicity of Iberogast were tested. All toxicological studies were carried out with Iberogast that are required in accordance with the current international guidelines (ICH, OECD, FDAJap. MHW) for new marketing authorisation of a medicine (NCE). These studies did not show any toxic or mutagenic effects, thus further confirming the established safety profile of Iberogast.
The ROME Foundation is an independent not-for-profit organisation with the mission: "Improving the lives of people with functional GI disorders". Over the last 17 years, this organisation developed global recommendations for diagnosing and treating FGIDs. Their directives are updated regularly and represent eminently respected guidance. In the recent “ROME IV” publications, issued by special working groups of renowned gastroenterologists, Iberogast (STW 5) is recommended for the treatment of patients with Functional Dyspepsia.28