A novel duodenal-release formulation of caraway oil and L-menthol is a safe, effective and well tolerated therapy for functional dyspepsia

• Published in: BMC gastroenterology 2022-03, Vol.22 (1), p.105-105, Article 105
• Main Authors: Lacy, Brian E, Chey, William D, Epstein, Michael S, Shah, Syed M, Corsino, Patrick, Zeitzoff, Linda R, Cash, Brooks D
• Format: Article
• Language: English
• Subjects: Abdominal pain; Caraway; Caraway oil; Care and treatment; Chemical properties; Dyspepsia; Dyspepsia - diagnosis; Dyspepsia - drug therapy; Essences and essential oils; Functional dyspepsia; Health aspects; Humans; L-menthol; Menthol; Menthol - therapeutic use; Plant Oils; Prospective Studies; Quality of Life; Testing; Treatment Outcome
• ISSN: 1471-230X; 1471-230X
• DOI: 10.1186/s12876-022-02181-5

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. 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). 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. 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.