Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome.

BACKGROUND & AIMS: Peppermint oil is frequently used to treat irritable bowel syndrome (IBS), despite a lack of evidence for efficacy from high-quality controlled trials. We studied the efficacy and safety of small-intestinal-release peppermint oil in patients with IBS and explored the effects of targeted ileocolonic-release peppermint oil. METHODS: We performed a double-blind trial of 190 patients with IBS (according to Rome IV criteria) at 4 hospitals in The Netherlands from August 2016 through March 2018; 189 patients were included in the intent-to-treat analysis (mean age, 34.0 years; 77.8% female; 57.7% in primary care), and 178 completed the study. Patients were randomly assigned to groups given 182 mg small-intestinal-release peppermint oil, 182 mg ileocolonic-release peppermint oil, or placebo for 8 weeks. The primary endpoint was abdominal pain response, as defined by the US Food and Drug Administration: at least a 30% decrease in the weekly average of worst daily abdominal pain compared with baseline in at least 4 weeks. The co-primary endpoint was overall relief of IBS symptoms, as defined by the European Medicines Agency. Secondary endpoints included abdominal pain, discomfort, symptom severity, and adverse events. RESULTS: Abdominal pain response did not differ significantly between the peppermint oil and placebo groups: 29 of 62 patients in the small-intestinal-release peppermint oil group had a response (46.8%, P = .170 vs placebo), 26 of 63 patients in the ileocolonic-release peppermint oil group had a response (41.3%, P = .385 vs placebo), and 22 of 64 patients in the placebo group had a response (34.4%). We did not find differences among the groups in overall relief (9.7%, P = .317 and 1.6%, P = .351 vs 4.7% for placebo). The small intestinal peppermint oil did, however, produce greater improvements than placebo in secondary outcomes of abdominal pain (P = .016), discomfort (P = .020), and IBS severity (P = .020). Adverse events, although mild, were more common in both peppermint oil groups (P < .005). CONCLUSIONS: In a randomized trial of patients with IBS, we found that neither small-intestinal-release nor ileocolonic-release peppermint oil (8 weeks) produced statistically significant reductions in abdominal pain response or overall symptom relief, when using US Food and Drug Administration/European Medicines Agency recommended endpoints. The small-intestinal-release peppermint oil did, however, significantly reduce abdominal pain, discomfort, and IBS severity. These findings do not support further development of ileocolonic-release peppermint oil for treatment of IBS. Clinicaltrials.gov, Number: NCT02716285.

Efficacy of a physical exercise training programme COPD in primary care: study protocol of a randomized controlled trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is recognized as a systemic illness with significant extra-pulmonary features, such as exercise intolerance and muscle weakness. Pulmonary rehabilitation has been shown to be very effective in counteracting these consequences in patients with more advanced COPD. However, limited data is available on the efficacy of a physical exercise training programme in patients with mild to moderate COPD in primary care. Furthermore, it is unknown if improved exercise capacity translates into enhanced daily physical activities. The aim of this paper is to describe the design of a randomized controlled trial to assess the efficacy of a physical exercise training programme in patients with mild to moderate COPD. METHODS/DESIGN: In this randomized controlled trial situated in the primary care setting, 102 patients with mild to moderate airflow obstruction (FEV1 ≥ 50% of predicted), dyspnoea and a physically inactive lifestyle will be randomized to an intervention or control group. The intervention group receives a 4-month physical exercise training programme at a local physiotherapy practice, which includes exercise training, resistance training, breathing exercises and advises on how to increase the level of physical activity. The control group receives usual care, i.e. advises on how to increase the level of physical activity and a sham treatment at a local physiotherapy practice of which no physiological training stimulus can be expected. Primary outcome is functional exercise capacity at 4-months measured on the six-minute walk distance. Secondary outcomes include peripheral muscle strength, physical activity in daily life, health related quality of life, Medical Research Council (MRC) dyspnoea score and patients' perceived effectiveness. Follow-up measurement will take place at 6 months after baseline. DISCUSSION: This will be one of the first studies to evaluate the efficacy of a physical exercise training programme in patients with mild to moderate COPD completely recruited and assessed in primary care. The results of this trial may give a unique insight into the potential of the implementation of an easy, close-to-home rehabilitation programme. TRIAL REGISTRATION: The Netherlands National Trial Register NTR1471.

Do clinical findings in lower respiratory tract infection help general practitioners prescribe antibiotics appropriately? An observational cohort study in general practice.

BACKGROUND: Antibiotics are over-prescribed for lower respiratory tract infection (LRTI). The influence of clinicians' history and examination findings on antibiotic prescribing for LRTI has not been directly assessed, and the extent to which these clinical findings predict appropriate antibiotic prescribing is unknown. A clearer understanding is crucial to achieving evidence-based prescribing. OBJECTIVES: To directly assess the influence of general practitioners' history and examination findings on antibiotic prescribing for LRTI, and to explore the extent to which these clinical findings predict appropriate antibiotic prescribing. METHODS: In this observational cohort study 25 GPs in The Netherlands were recruited during routine consultations and 247 adult patients with a clinical diagnosis of LRTI. The GPs recorded clinical information. Odds ratios (ORs) with 95% confidence intervals (CIs) for clinical variables predicting a prescription for an antibiotic were calculated. The relationship between antibiotic prescription and radiographic evidence of pneumonia was explored in order to gauge appropriateness of antibiotic prescribing. RESULTS: Auscultation abnormalities (OR 11.5; 95% CI 5.4-24.7), and diarrhoea (OR>11) were strongly associated with antibiotic prescribing. An antibiotic was prescribed for 195 (79%) patients. Assuming that an antibiotic definitely needs to be prescribed only for patients with pneumonia, antibiotics may have been inappropriately prescribed for 166/193 (86%) of the patients. Antibiotics were not prescribed for 5 of the 32 (16%) patients with a radiographic diagnosis of pneumonia. CONCLUSIONS: Abnormal findings on auscultation in patients with LRTI strongly predict antibiotic prescribing and this is probably inappropriate for most patients. These results should prompt GPs to consider the extent to which finding 'crackles/rhonchi on auscultation' influences their decisions to prescribe antibiotics for their patients with LRTI, and to consider the predictive value of individual clinical signs in reaching evidence-based prescribing decisions.