[A plant extract and its modified preparation in functional dyspepsia. Results of a double-blind placebo controlled comparative study].
OBJECTIVE
To assess the efficacy and safety of the commercially available herbal preparation (Iberogast, STW-5*) containing extracts from bitter candy tuft, chamomile flower, peppermint leaves, caraway fruit, licorice root, lemon balm leaves, angelica root, celandine herbs, milk thistle fruit and its research preparation STW-5-S (without bitter candy tuft) in patients with functional dyspepsia.


METHODS
After a standardized diagnostic work-up and at least 7 days free of medication, 60 patients, diagnosed with functional dyspepsia, were recruited in a multicenter trial and randomly assigned to one of 3 treatment groups (STW-5, STW-5-S or placebo). Each patient received the treatment for 4 weeks. The main outcome variables were the improvement of a gastrointestinal symptom score (GIS), a sumscore consisted of 10 dyspeptic symptoms rated on a Likert scale. Dyspeptic symptoms were assessed at baseline, 2 and 4 weeks after treatment.


RESULTS
60 patients completed the trial (mean age 46.8 years, range 25-70, female 38 patients). Compared with placebo-group both herbal preparations STW-5 and STW-5-S showed a clinically significant improvement of GIS after 2 and 4 weeks of treatment (p < 0.001). No statistically significant difference could be observed between the efficacy of STW-5 and STW-5 S (p > 0.05), but a solid improvement of gastrointestinal symptoms could be achieved earlier with STW-5 than with its research preparation STW-5-S without bitter candy tuft (p = 0.023).


CONCLUSIONS
In patients with functional dyspepsia, the commercially available herbal preparation STW-5 and its modified dispense STW-5-S tested improved dyspeptic symptoms significantly better than placebo. The extract bitter candy tuft appeared to have an additive effect on dyspeptic symptoms.
Madisch
A
A
Klinik für Gastroenterologie, Allgemeines Krankenhaus Celle. gastroenterologie@akh-celle.de
Melderis
H
H
Mayr
G
G
Sassin
I
I
Hotz
J
J
D000328:Adult; D000368:Aged; D004415:Dyspepsia / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D013329:Structure-Activity Relationship; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D010936:Plant Extracts; C039964:iberogast
Ein Phytotherapeutikum und seine modifizierte Rezeptur bei funktioneller Dyspepsie. Ergebnisse einer doppelblinden plazebokontrollierten Vergleichsstudie.