Background: A recent randomized clinical trial (RCT) of a novel peppermint oil preparation (PO-SST) demonstrated significant relief of irritable bowel syndrome (IBS) symptoms versus placebo. In addition to efficacy, patient satisfaction and post-marketing utilization are also important to assess.
Methods: The RCT included an end-of-study questionnaire for subjects in the active arm to evaluate overall satisfaction with IBS symptom relief. A separate post-marketing study was conducted in the general population to assess real world satisfaction and dosing frequency of open label PO-SST in patients with IBS. The dosing frequency in the RCT was fixed at 2 capsules three times daily (TID), while the post-marketing patient population was allowed flexible dosing.
Results: Thirty-five subjects randomized to PO-SST in the RCT and 285 patients in the post-marketing study were included in this analysis. There was a high satisfaction rate (>80%) with PO-SST in both studies. Most patients in the postmarketing population (60.8%) used 1 to 2 capsules per day, and 75.6% reported IBS symptom reduction within 1-2 hours of ingestion. Patients in the RCT reported significant reduction in IBS symptoms 24 hours after the first dose of PO-SST.
Discussion: PO-SST showed a high rate of satisfaction among patients participating in an RCT and the general patient population. Symptom improvement was rapid and remarkably similar in both groups, despite the lower daily capsule intake by patients in the general population.
Cash BD, Epstein MS and Shah SM