EFFICACY OF CARAWAY OIL/L-MENTHOL PLUS USUAL CARE VS PLACEBO PLUS USUAL CARE, IN FUNCTIONAL DYSPEPSIA PATIENTS WITH POST-PRANDIAL DISTRESS (PDS) OR EPIGASTRIC PAIN (EPS) SYNDROMES: RESULTS FROM A US RCT
William D. Chey, Brian E. Lacy, Brooks D. Cash, Michael Epstein, Syed M. Shah
Background: There are no FDA-approved pharmaceuticals for Functional Dyspepsia (FD). By the Rome criteria, FD patients can be sub-grouped into PDS or EPS. Prior work suggested that a combination of caraway oil & peppermint oil (L-menthol) may benefit FD. The FD Reduction Evaluation and Safety Trial (FDREST) assessed capsules containing caraway oil and L-menthol (COLM) with site specific technology vs placebo in FD patients taking usual FD medications.
Methods: FDREST was a post-marketing, parallel group study which compared the efficacy and safety of COLM plus usual medications vs placebo plus usual medications. Reduction of Global Overall Symptoms (GOS) and Clinical Global Impressions (CGI) were measured over a treatment period of 28 days. Eligible patients met Rome III criteria for FD. PDS patients had to report a GOS score of ≥5 for a sensation of pressure, heaviness, or fullness, while EPS patients had to report a GOS score of ≥4.5 for epigastric pain or discomfort. Eligible patients took COLM (50 mg CO and 41.5 mg LM) or placebo in the morning and at dinner time as well as patient’s ongoing FD medications (PPIs, H2RAs, anticonvulsants, beta blockers, antihistamines, SSRIs/TCAs, pain modulators, and antacids). Patients using prohibited medicines, such as antiemetics, prokinetics, cholinergics, antidiarrheals, sedative hypnotics, NSAIDs, narcotic analgesics, oral heartburn and gas relief agents, probiotics, and antispasmodics, had to complete a 14-day washout. 48 hours after the first dose, they were allowed use of prohibited medicines after discussion and approval by the medical monitor. Results: 34 FD patients met criteria for PDS. 39 FD patients met criteria for EPS. At the end of treatment, 78% of PDS patients and 72% of EPS patients given COLM reported either a “much” or “very much” improved assessment of CGI, compared to 50% (P=0.09) and 40% (P=0.046) in the control groups, respectively (Figure 1). PDS patients on COLM had a statistically significant reduction in sensations of pressure, heaviness, or fullness compared with the control group at 24 hours and were objectively better, although measures did not reach statistical significance, compared to the control group, in all measures at 2-14 days and 15-28 days (Figure 2). EPS patients on COLM had a statistically significant reduction in epigastric pain or discomfort symptoms at 24 hours and were objectively better, although measures did not reach statistical significance, compared to the control group in all measures at 2-14 days and 15-28 days.
Conclusion: COLM provides an effective treatment option for patients with PDS and EPS taking usual FD medications. Approximately threequarters of PDS and EPS patients reported substantial symptom improvement after 4 weeks of treatment.
