- Title
- Double-blind, randomized, 8-week multicenter study of the efficacy and safety of STW 5-II versus placebo in functional dyspepsia
- Creator
- Vinson, Bettina; Fink, Careen; Wargenau, Manfred; Talley, Nicholas J.; Holtmann, Gerald
- Relation
- JGH Open: An Open Access Journal of Gastroenterology and Hepatology Vol. 8, Issue 5, no. e13054
- Publisher Link
- http://dx.doi.org/10.1002/jgh3.13054
- Publisher
- John Wiley & Sons
- Resource Type
- journal article
- Date
- 2024
- Description
- Background and Aim: Herbal products are widely used to treat patients with disorders of gut brain interaction but clinical efficacy and safety data for treatments lasting >4 weeks are widely lacking. We evaluated the efficacy and safety of 8 weeks of treatment with the herbal combination product STW 5-II for patients with functional dyspepsia (FD) meeting Rome II criteria. We also conducted a post hoc analysis including patients meeting Rome IV criteria for FD and evaluated the effect of the G-protein beta 3 (GNB3) subunit polymorphism (C825T) on therapeutic response. Methods: This multicenter, placebo-controlled, double-blind study included 272 FD patients meeting Rome II criteria in the intention-to-treat cohort and 266 meeting Rome IV criteria. We used the validated Gastrointestinal Symptom Score (GIS) to assess GI symptoms, defining response rate as the proportion of patients with ≥50% GIS improvement in at least three of four assessments. Results: After 8 weeks, the response rate was significantly higher in the STW 5-II group versus placebo (61.2% vs 45.1%, P = 0.008). Mean GIS non-significantly improved with STW 5-II treatment (7.9 ± 4.41 vs 6.7 ± 4.91 with placebo; P = 0.07). In the Rome IV subgroup analysis, STW 5-II yielded a better response rate (P = 0.01) versus placebo and greater postprandial distress symptom improvement (P = 0.04) versus placebo. Safety parameters did not differ between groups, and GNB3 status was not linked with therapeutic response. Conclusion: STW 5-II is efficacious, with no observed safety signals at up to 8 weeks of treatment in patients with FD meeting Rome II or IV criteria.
- Subject
- efficacy; functional dyspepsia; Rome criteria; safety; STW 5-11
- Identifier
- http://hdl.handle.net/1959.13/1504123
- Identifier
- uon:55452
- Identifier
- ISSN:2397-9070
- Rights
- x
- Language
- eng
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