STW 5-II significantly improves bothersome symptoms and overall symptom scores in patients with functional dyspepsia as defined by the latest ROME IV criteria: a systematic review and meta-analysis

Background Functional dyspepsia (FD) is a chronic disorder with high prevalence worldwide. Effective therapeutic options are limited.

Objective STW 5-II, an herbal combination with 6 components is indicated for treatment of functional gastrointestinal disorders incl. FD and irritable bowel syndrome (IBS). We performed a systematic review and meta-analysis of efficacy of STW 5-II in improving FD symptoms according Rome IV.

Methods MEDLINE, EMBASE, Current Contents and Cochrane Controlled Trials Register were searched for randomized controlled clinical trials with FD patients treated with STW5-II. Inclusion criteria were:

1. course of FD, assessed by the validated gastrointestinal symptom score (GIS),

2. data of GIS at baseline and after 28 days of therapy,

3. used dosage of STW 5-II is 3x20 drops/day,

4. adult patients.

5. safety reporting.

For statistical analysis, data of patients with at least one moderate symptom of FD according ROME IV (fullness, early satiety, epigastric pain/burning) (score ≥ 2) at baseline and on Day 14 or Day 28 were used for pooled efficacy and meta-analyses. For single symptom analysis, changes in scores (baseline minus Day 28) were evaluated for each symptom with an analysis of covariance (ANCOVA) model. Meta-analysis was based on adjusted means and standard errors (95 % confidence interval).

Results Three of four FD trials were eligible. The analysis set comprised 527 patients (STW 5-II: 262, placebo: 265). Baseline characteristics of both therapy groups were comparable. ANCOVA showed statistically significant results in favor of STW 5-II for the GIS (Mean difference (MD) 2.44; 95 % CI 1.57; 3.30; p < .0001) and the main symptoms fullness (MD 0.38; CI 0.21; 0.55; p < .0001; early satiety (MD 0.35; CI 0.19; 0.52; p < .0001) and epigastric pain/burning (MD 0.38; CI 0.22; 0.53; p < .0001;), which are main FD symptoms according ROME IV. Also, improvement of abdominal cramps (MD 0.27; CI 0.11; 0.42; p = 0.0006) and retrosternal discomfort (MD 0.23; CI 0.11; 0.34; p < .0001) showed significant superiority of STW5-II. The safety of STW5-II within all studies was comparable to placebo.

Conclusions This meta-analysis indicates STW 5-II as an effective and safe treatment for the most bothersome symptoms of FD according current ROME IV.

Publication History

Article published online:
08 September 2020