The effect of an apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers on brachial artery flow-mediated vasodilatory function in volunteers with elevated blood pressure.

BACKGROUND: The primary aim of this study was to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves endothelium-dependent brachial artery flow-mediated vasodilatation (FMD) in volunteers with borderline hypertension. The secondary aim of the study was to test whether the investigational product would improve endothelium-independent nitrate-mediated vasodilatation (NMD). METHODS: This was a single centre, repeated-dose, double-blind, placebo-controlled, crossover study in 60 otherwise healthy subjects (26 men, 34 women; aged 40-65 years) with borderline hypertension (blood pressure 130-139/85-89 mmHg) or unmedicated mild hypertension (blood pressure 140-165/90-95 mmHg). The subjects were randomised to receive placebo or the apple polyphenol extract to provide a daily dose of 100 mg epicatechin for 4 weeks, followed by a four to five-week wash-out period, and then 4 weeks intake of the product that they did not receive during the first treatment period. FMD and NMD of the left brachial artery were investigated with ultrasonography at the start and end of both treatment periods, and the per cent increase of the arterial diameter (FMD% and NMD%) was calculated. RESULTS: With the apple extract treatment, a significant acute improvement was detected in the mean change of maximum FMD% at the first visit 1.16 (p = 0.04, 95% CI: 0.04; 2.28), last visit 1.37 (p = 0.02, 95% CI: 0.22; 2.52) and for both visits combined 1.29 (p < 0.01, 95% CI: 0.40; 2.18). However, such improvement was not statistically significant when apple extract was compared with placebo. The overall long-term effect of apple extract on FMD% was not different from placebo. No statistically significant differences between the apple extract and placebo treatments were observed for endothelium-independent NMD. CONCLUSIONS: A significant acute improvement in maximum FMD% with apple extract administration was found. However, superiority of apple extract over placebo was not statistically significant in our study subjects with borderline hypertension or mild hypertension. The study raised no safety concerns regarding the daily administration of an apple polyphenol extract rich in epicatechin. TRIAL REGISTRATION: The trial is registered at http://clinicaltrials.gov (identifier: NCT01690676 ). Registered 25th May 2012.

Irritable bowel syndrome symptom severity improves equally with probiotic and placebo.

AIM: To determine the effects of Lactobacillus acidophilus NCFM on irritable bowel syndrome (IBS) symptoms and quality of life (QoL). METHODS: In this randomized triple-blind trial, adult IBS volunteers who were recruited according to Rome III criteria received 109 or 1010 colony-forming units of NCFM or placebo daily for 12 wk. IBS Symptom Severity Score (IBS-SSS), which constituted the primary outcome, and secondary outcomes, including individual IBS symptoms, IBS-related QoL questionnaire, anxiety and depression, defecation frequency, and stool consistency, were assessed at baseline at the end of the 8-wk run-in period, after 4 and 12 wk of intervention, and after a 4-wk washout. RESULTS: A total of 340 of 391 randomized volunteers completed the trial. IBS-SSS improved over 12 wk of treatment in all treatment groups, decreasing by a mean ± SD of 44.0 ± 80.2, 50.8 ± 82.4, and 48.3 ± 72.2 in the placebo, active low-dose, and active high-dose groups, respectively. Similarly, secondary outcomes did not differ between treatment groups. However, in a post hoc analysis of volunteers with moderate to severe abdominal pain at baseline (VAS > 35/100), the treatment significantly reduced the sensation of abdominal pain. Pain scores fell by 20.8 ± 22.8, 29.4 ± 17.9, and 31.2 ± 21.9 in the placebo, active low-dose, and active high-dose groups, respectively (P value for placebo vs combined active doses = 0.0460). CONCLUSION: NCFM alleviates moderate to severe abdominal pain, consistent with earlier observations of this strain mitigating visceral pain through increased analgesic receptor expression.

Magnesium hydroxide in ibuprofen tablet reduces the gastric mucosal tolerability of ibuprofen.

GOAL: The study was designed to compare the gastrointestinal tolerability of a magnesium hydroxide-containing ibuprofen tablet (buffered ibuprofen) and the conventional ibuprofen tablet in healthy volunteers. BACKGROUND: Magnesium hydroxide has been shown to increase the rate of absorption of ibuprofen. METHODS: A double blind, randomized, 2-period crossover study design was used. Twenty healthy men ingested 800 mg ibuprofen 3 times daily either in conventional tablets (2 doses of 400 mg) or in tablets containing magnesium hydroxide (2 doses of 400 mg ibuprofen and 200 mg magnesium hydroxide). On the 5th day only the morning dose was administered. Endoscopy was performed at baseline and on the 5th day in both treatments 2 hours after the last dose, and gastric pH was determined. In addition, plasma concentrations of ibuprofen were determined up to 90 minutes. RESULTS: The magnesium hydroxide-containing formulation increased the number of subjects evincing erosions in gastric corpus and antrum. In the gastric corpus 2 and 7 volunteers had erosions after conventional and buffered ibuprofen, respectively (P = 0.08). In the gastric antrum 5 and 13 volunteers showed erosions after conventional and buffered ibuprofen, respectively (P = 0.02). There was a trend toward faster absorption of ibuprofen when given together with magnesium hydroxide. The difference was not however statistically significant. CONCLUSIONS: Prolonged use of magnesium hydroxide together with high doses of ibuprofen should be avoided, because the combination may incur a higher risk of gastrointestinal irritation.