Efficacy and safety of STW 5 II in patients with functional dyspepsia: results from a double-blind, randomized, multicenter trial

BSTW5-II is an herbal combination with 6 components and proven clinical evidence for treatment of functional digestive disorders like functional dyspepsia (FD) and irritable bowel syndrome (IBS). This multicenter, placebo-controlled, double-blind study evaluated efficacy and tolerability of STW 5-II for 8 week treatment in FD patients in Germany.

Methods 272 Patients with FD according ROME criteria were treated with 3 × 20 drops/day of either STW 5-II or placebo. Symptom intensity was assessed with the validated Gastrointestinal Symptom Score (GIS) comprising epigastric pain/upper abdominal pain, abdominal cramps, fullness, early satiety, loss of appetite, sickness, nausea, vomiting, retrostemal discomfort and acid eructation/heartburn. The primary criterion was therapy response defined as 50% improvement of GIS at least in 3 out of 4 assessments. Secondary criteria were the change of GIS from baseline to end of treatment and the patients and investigators assessment of efficacy and tolerability.

Results The ITT population (n = 272) comprised 139 patients in the STW 5-II and 133 in the placebo-group. Baseline values were comparable with regards to demography and GIS score (11.9 ± 3.66 STW5-II vs. 12.1 ± 4.0 placebo). For primary criterion the number of responders was significantly higher in the STW 5 II group vs. Placebo (61.2% vs. 45.1 %, p <  0.0079). Values for the PP population were similar (63.3% vs. 46.1%) and confirmed the results. GIS score of the STW 5 II group improved by 7.9 ± 4.41 in the STW 5 II group vs. 6.7 ± 4.91 in Placebo group. 64,7% of the patients assessed efficacy of STW5-II as very good and good vs. 54,9% of the placebo group. Investigators assessed efficacy of STW5-II for 64% as very good and good vs for 52,6% of Placebo group. Logistic regression model showed significant differences in therapy judgements in favor to STW 5 II (patients p = 0.0205; investigators p = 0.0238). All safety parameters showed no significant difference between treatments. Of three reported serious adverse events (1 in STW5-II, cardiovascular disorder; 2 in placebo, mental disorder and anaemia) none was assessed as related to study medication.

Conclusion This placebo-controlled trial confirms long-term efficacy and safety of STW 5-II in treatment of FD.

Publication History

Article published online:
08 September 2020