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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Lacy, Brian E. Chey, William D. Epstein, Michael S. Shah, Syed M. Corsino, Patrick Zeitzoff, Linda R. Cash, Brooks D. |
| Abstract | Background A randomized, placebo-controlled clinical trial (FDREST) of a novel formulation of caraway oil and L-menthol (COLM-SST) demonstrated symptom relief in patients with functional dyspepsia (FD). Two follow-up studies were conducted to evaluate patient satisfaction, self-regulated dosing, and long-term safety data: FDACT, Functional Dyspepsia Adherence and Compliance Trial, and FDSU36, Functional Dyspepsia Safety Update at 36 months. Methods A patient reported outcomes (PRO) questionnaire was designed and distributed online to assess real-world satisfaction and dosing frequency of open-label COLM-SST in patients with FD. A separate study analyzing voluntary safety surveillance data evaluated the frequency and severity of reported adverse events (AEs). Results A total of 600 FD patients were enrolled in the PRO study. Ninety five percent of respondents reported a major or moderate improvement in their FD symptoms and 91.7% indicated a major or moderate improvement in quality of life (QOL) using COLM-SST. Between 1 and 4 capsules were consumed daily by 91.2% of respondents, with 56.2% taking them before meals. Symptom relief was rapid, with 86.4% of respondents indicating relief within 2 h of taking COLM-SST. Few adverse events (AEs) were reported (0.0187%) by patients using COLM-SST. No serious AEs were identified. Conclusion COLM-SST is safe, well tolerated, and provides rapid relief of FD symptoms. These findings, demonstrated in the FDREST trial, were further supported by a large prospective PRO study evaluating self-regulated dosing frequency, symptom improvement, and QOL. COLM-SST was well-tolerated based on review of AE data at 36 months. |
| Related Links | https://bmcgastroenterol.biomedcentral.com/counter/pdf/10.1186/s12876-022-02181-5.pdf |
| Ending Page | 9 |
| Page Count | 9 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| DOI | 10.1186/s12876-022-02181-5 |
| Journal | BMC Gastroenterology |
| Issue Number | 1 |
| Volume Number | 22 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2022-03-07 |
| Access Restriction | Open |
| Subject Keyword | Gastroenterology Internal Medicine Hepatology Abdominal pain Caraway oil Dyspepsia Functional dyspepsia L-menthol |
| Content Type | Text |
| Resource Type | Article |
| Subject | Gastroenterology |
| Journal Impact Factor | 2.5/2023 |
| 5-Year Journal Impact Factor | 2.7/2023 |
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