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To re-evaluate the effectiveness of STW 5-II for functional dyspepsia (FD) patients satisfying the most recent Rome-IV criteria in an 8-week study, a post-hoc study was carried out.
STW 5-II was an effective therapeutic choice for people with functional dyspepsia who met the Rome IV criteria during an 8-week trial period.
To re-evaluate the effectiveness of STW 5-II for functional dyspepsia (FD) patients satisfying the most recent Rome-IV criteria in an 8-week study, a post-hoc study was carried out.
Out of 272 FD patients who met Rome-II criteria, 266 satisfied the Rome-IV criteria (97.8%) with at least 1 moderate key symptom (such as "fullness," "early satiety," or "epigastric/upper stomach pain") at baseline and one effectiveness evaluation after baseline. Using the validated Gastrointestinal Symptom Score (GIS), the severity of gastrointestinal symptoms was evaluated.
The responder rates were computed utilizing the 50% improvement from the baseline of GIS in at least three out of four evaluations as the response criterion. An additional study used the alteration in the symptom sum score between the baseline and Week 8 as the outcome to assess the effectiveness across four distinct symptom clusters.
Demographics and baseline symptom severity for the two groups (STW 5-II: n=134, placebo: n=132) were comparable at baseline. The post-hoc evaluation corroborated the study's initial findings (response rate 61.2% vs. 45.1%) and showed that STW-II was better than placebo in terms of responder rate (65% vs. 48.7%). Early satiety, fullness, and loss of appetite were the meal-associated symptom clusters that showed a mean difference of 0.6 when contrasting STW5-II to the placebo group.
In terms of responder rate, STW-II demonstrated superiority over placebo in individuals with functional dyspepsia. Also, STW-II use was associated with better improvement of meal-linked symptom clusters.
Thieme
Efficacy and safety of STW 5-II in patients with functional dyspepsia according Rome IV criteria: Results from a post-hoc analysis of a double-blind, randomized, placebo-controlled, 8-week multicenter trial
B Vinson et al.
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