[A plant extract and its modified preparation in functional dyspepsia. Results of a double-blind placebo controlled comparative study].

Abstract

AIMS:

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.

PATIENTS AND 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.

• Authors: A Madisch, H Melderis, G Mayr, I Sassin, J Hotz
• Journal: Zeitschrift fur Gastroenterologie (Z Gastroenterol) Vol. 39 Issue 7 Pg. 511-7 (Jul 2001) ISSN: 0044-2771 [Print] Germany
• Vernacular Title: Ein Phytotherapeutikum und seine modifizierte Rezeptur bei funktioneller Dyspepsie. Ergebnisse einer doppelblinden plazebokontrollierten Vergleichsstudie.
• PMID: 11505331 (Publication Type: Clinical Trial, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Gastrointestinal Agents
• Plant Extracts
• iberogast

Topics

• Adult
• Aged
• Dyspepsia (diagnosis, drug therapy)
• Female
• Gastrointestinal Agents (adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Phytotherapy
• Plant Extracts (adverse effects, therapeutic use)
• Structure-Activity Relationship
• Treatment Outcome