Efficacy and safety of STW 5-II in patients with functional dyspepsia according RomeIV criteria: Results from a post-hoc analysis of a double-blind, randomized, placebo-controlled, 8-week multicenter trial

Background We previously reported the results of a multicenter, placebo-controlled, double-blind study showing efficacy with no safety signals of the herbal drug STW 5-II in functional dyspepsia (FD) patients meeting Rome-II criteria [1]. This post-hoc analysis was performed to re-assess the efficacy of STW 5-II for FD patients meeting the current Rome-IV criteria in an eight-week study.

Material and methods 272 FD patients meeting theRome-II criteria comprised the original ITT population of this randomized placebo-controlled trial. 266 met the Rome-IV criteria (97.8%) with at least a) one moderate key symptom ("fullness", "early satiety", and "epigastric/ upper abdominal pain") at baseline and b) one efficacy assessment post-baseline. Severity of GI symptoms was assessed utilizing the validated Gastrointestinal Symptom Score (GIS) and responder rates were calculated using 50% improvement from baseline of GIS in at least 3 out of 4 assessments as response criterion. An additional analysis evaluated the efficacy within four independent symptom clusters defining the change in symptom sum score from baseline to Week 8 as endpoint.

Results Baseline characteristics of both groups (STW 5-II: n=134, placebo: n=132) were comparable for demography and baseline symptom severity (p>0.3 for all tests). The post-hoc analysis revealed superiority of STW-II over placebo (65% vs 48.7%, p= 0.010) regarding the responder rate and confirmed the original results (response rate 61.2% vs 45.1%, p=0.008) of the study. Significant better improvement of the meal related symptom cluster (“early satiety”, “fullness” and “loss of appetite”) with a mean difference of 0.6 (95%-CI 0.02, 1.18; p=0.042) was shown, comparing STW5-II to placebo group.

Conclusion STW 5-II is an efficacious treatment option for FD patients meeting Rome IV criteria during an eight week treatment study.

Publication History

Article published online:
19 August 2022