A trial-based economic evaluation of peppermint oil for the treatment of irritable bowel syndrome.

BACKGROUND: Irritable Bowel Syndrome (IBS) is a prevalent, chronic gastrointestinal disorder that imposes a substantial socioeconomic burden. Peppermint oil is a frequently used treatment for IBS, but evidence about cost-effectiveness is lacking. OBJECTIVE: We aimed to assess cost-effectiveness of small-intestinal release peppermint oil versus placebo in IBS patients. METHODS: In a multicenter randomized placebo-controlled trial, cost-effectiveness was evaluated from a societal perspective. The incremental cost-effectiveness ratios (ICERs) were expressed as (1) incremental costs per Quality Adjusted Life Years (QALY), and (2) incremental costs per successfully treated patient, that is per abdominal pain responder (according to FDA definitions), both after an eight-week treatment period with placebo versus peppermint oil. Cost-utility and uncertainty were estimated using non-parametric bootstrapping. Sensitivity analyses were performed. RESULTS: The analysis comprised 126 patients (N = 64 placebo, N = 62 small-intestinal release peppermint oil). Peppermint oil was a dominant treatment compared to placebo in 46% of bootstrap replications. Peppermint oil was also more effective but at higher cost in 31% of replications. The net-benefit acceptability curve showed that peppermint oil has a 56% probability of being cost-effective at a conservative willingness-to-pay threshold of €10.000/QALY. Peppermint oil was also a dominant treatment per additional successfully treated patient according to FDA definitions, that is in 51% of replications. In this case, the acceptability curve showed an 89% probability of being cost-effective. CONCLUSIONS: In patients with IBS, small-intestinal release peppermint oil appears to be a cost-effective treatment although there is uncertainty surrounding the ICER. When using abdominal pain responder as outcome measure for the ICER, peppermint oil has a high probability of being cost-effective. The use of peppermint oil, which is a low-cost treatment, can be justified by the modest QALY gains and slightly higher proportion of abdominal pain responders. More research and long-term data are necessary to confirm the cost-effectiveness of peppermint oil. NCT02716285.

Microorganisms and complaints in outpatients with a percutaneous endoscopic gastrostomy catheter.

BACKGROUND: We analyzed the presence of microorganisms at the insertion site of percutaneous endoscopic gastrostomy (PEG) catheters of 100 patients to investigate the microbiologic flora and its possible relation with complaints. MATERIALS AND METHODS: Outpatients visiting our hospital PEG-catheter team were included. Symptoms and the local aspect of the skin at the insertion site were described systematically and swabs were taken to analyze the presence of pathogenic microorganisms. RESULTS: The mean age of these 100 patients (55 men) was 62 ± 14 years (range, 3-89 years). Oropharyngeal carcinoma (n = 59) and neurologic disorders (n = 27) were the most frequent indications for a PEG catheter. The mean insertion time was 17 ± 20 months (range, 3-99 months). In 15 patients no microorganisms were found. In 85 patients we found Candida albicans (n = 37; 44%), Staphylococcus aureus (n = 28; 33%), Escherichia coli, Klebsiella, Enterobacter, and enterococci (5%-20%). None of the patients reported discomfort. Pain or itching was reported by 24 patients. We did not find any statistically significant relationship between colonization, microorganisms, complaints, and aspect of skin. CONCLUSIONS: The insertion sites of PEG catheters in outpatients are frequently colonized, especially with C albicans, S aureus, and E coli, without clinical consequences. We did not find a relationship between microorganisms at the insertion sites of PEG catheters and signs and symptoms.