Introduction
With the increasing affinity of patients and consumers to natural treatment options, well proven herbal medicinal products gain increased attention also in functional gastrointestinal diseases. One of these is STW 5 (Iberogast), for which more than 55 years of therapeutic experience in more than 73 Mio patients are available. For answering the question, whether its efficacy is comparable in patients of different age groups, respective sub-group analyses were conducted.
Methods
After meta-analyses of randomized placebo-controlled double blind trials have shown compliance to modern standards for a proof of efficacy, in a second step, sub-group analyses were conducted. The analyses were based on the original patient data from the trials, including demografic data and primary endpoints (ANCOVA).
Results
As the primary outcome variable, the validated gastrointestinal symptom score (GIS) [1] were identical in all trials. Also the therapeutic dose (3 x 20drops/day) was the same, so that a uniform evaluation was possible. The full analysis set (FAS) included 557 patients (272 resp. 285 for placebo resp. verum). For the GIS the difference between placebo and verum after 28 days of treatment showed a highly significant (p< 0.0001) difference between placebo and verum (6.7 resp. 4.7points). The analyses in different age groups (adults up to 30, 30-40, 40-50, 50-60, above 60) did show a comparable efficacy.
Conclusion
After meta-analyses have clearly shown the efficacy of STW 5 (Iberogast), now also its therapeutic usefulness in elderly patients was demonstrated. Given also the very good tolerability shown by the study and by pharmacovigilance data, STW 5 is very well suitable also in self-medication. Additional insights can be expected from additional sub group analyses, as e.g. the evaluation of subgroups with specific predominant symptoms.
References
[1] Adam et al. Aliment Pharmacol Ther 2005; 22: 357-363