A randomized placebo-controlled trial on the effects of Menthacarin, a proprietary peppermint- and caraway-oil-preparation, on symptoms and quality of life in patients with functional dyspepsia.

BACKGROUND: Functional dyspepsia (FD) is a very common condition affecting more than 10% of the population. While there is no cure, a few drugs have been found to be effective for the relief of symptoms, although most are only effective in a subgroup of patients. We assess and compare the efficacy of a fixed peppermint/caraway-oil-combination (Menthacarin) on symptoms and quality of life (QoL) in patients with FD symptoms consistent with epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS). METHODS: In a prospective, double-blind, multicenter trial, 114 outpatients with chronic or recurrent FD were randomized and treated for 4 weeks with the proprietary peppermint- and caraway-oil-preparation Menthacarin or placebo (2×1 capsule/day). Improvement of abdominal pain and discomfort were used as co-primary efficacy measures (scores measured with the validated Nepean Dyspepsia Index). KEY RESULTS: After 2 and 4 weeks, active treatment was superior to placebo in alleviating symptoms consistent with PDS and EPS (P all <.001). After 4 weeks of treatment, pain and discomfort scores improved by 7.6±4.8 and 3.6±2.5 points (full analysis set; mean±SD) for Menthacarin and by 3.4±4.3 and 1.3±2.1 points for placebo, respectively. All secondary efficacy measures showed advantages for Menthacarin. CONCLUSIONS & INFERENCES: Menthacarin is an effective therapy for the relief of pain and discomfort and improvement of disease-specific QoL in patients with FD and significantly improves symptoms consistent with EPS and PDS.

Forces on cardiac implantable electronic devices during remote magnetic navigation.

BACKGROUND: Remote magnetic navigation systems are used for catheter navigation in cardiac electrophysiological ablation procedures. In this setting, ferromagnetic particles will be moved by changes in the magnetic field. It is unknown to what extent cardiac implantable electronic devices (CIED) are affected by the magnetic field when using magnetic navigation, and whether these forces may exceed the limit of 5 N that is set forth by German and European norms for implanted electrodes. METHODS: A total of 121 rhythm devices were examined in a magnetic field of 0.1 T using the NIOBE II(®) Magnetic Navigation System (Stereotaxis, St. Louis, USA). Forces acting on the devices were measured with the force measurement tool Futek LRF 400 (Futek Advanced Sensor Technology Inc., Irvine, CA, USA). A standardized protocol of different movements of the magnetic field including all three dimensions was performed and maximal forces on the CIED were assessed. RESULTS: Out of 121 devices, 78 different pacemakers (54 different model families from 11 manufacturers) and 43 different cardioverter-defibrillators (26 different model families from 6) were examined. The mean force that could be observed was 0.33 ± 0.13 N for pacemakers (range 0.16-1.12 N) and 1.05 ± 0.11 N for cardioverter-defibrillators (range 0.86-1.38 N) when exposed to the magnetic field. CONCLUSION: Exposure of pacemakers or implantable cardioverter-defibrillators to a magnetic field of 0.1 T does not result in a force exceeding the regulatory demanded 5 N that could damage the connected leads.