Comparison of Clinical Characteristics of Patients With Gastroesophageal Reflux Disease Who Failed Proton Pump Inhibitor Therapy Versus Those Who Fully Responded

( Ram Dickman ),( Mona Boaz ),( Shoshanna Aizic ),( Zaza Beniashvili ),( Ronnie Fass ),( Yaron Niv ) 대한소화기기능성질환·운동학회(구 대한소화관운동학회) 2011 Journal of Neurogastroenterology and Motility (JNM Vol.17 No.4

Background/Aims Refractory gastroesophageal reflux disease (GERD) is very common, affecting up to 40% of the patients receiving proton pump inhibitor (PPI) therapy. However, there is not much information about the clinical characteristics of these patients. The aim of the study is to compare the clinical characteristics of PPI responders vs non-responders. Methods Consecutive GERD patients receiving PPI once or twice daily were evaluated by a questionnaire and a personal interview regarding their demographics, habits, clinical characteristics and endoscopic findings. The patients were divided into 3 groups: Patients who fully responded to PPI once daily (Group A, n = 111), patients who failed PPI once daily (Group B, n = 78) and patients who failed PPI twice daily (Group C, n = 56). Results A total of 245 patients (59.3% females, 52 ± 17.2 years of age) were included in this study. Cross-group differences (A vs B vs C) were detected for hiatal hernia (33% vs 51% vs 52%, P = 0.011); erosive esophagitis (19% vs 51% vs 30%, P < 0.0001); cough (24% vs 44% vs 43%, P = 0.007); sleep disturbances (19% vs 30% vs 38%, P = 0.033); chest symptoms (21% vs 35% vs 41%, P = 0.010); Helicobacter pylori status (25% vs 33% vs 48%, P < 0.0001), disease duration (1.6 ± 0.8 vs 1.9 ± 1.0 vs 2.0 ± 1.1 years, P = 0.007), performed lifestyle interventions (68.5% vs 46.7% vs 69.6%, P = 0.043) and compliance (84% vs 55% vs 46%, P < 0.0001). Conclusions PPI failure (either once or twice daily) appears to be significantly associated with atypical GERD symptoms, disease duration and severity, H. pylori status, obesity, performed lifestyle interventions and compliance as compared with PPI responders. (J Neurogastroenterol Motil 2011;17:387-394)

Olive Leaf Extract as a Hypoglycemic Agent in Both Human Diabetic Subjects and in Rats

Julio Wainstein,Tali Ganz,Mona Boaz,Yosefa Bar Dayan,Eran Dolev,Zohar Kerem,Zecharia Madar 한국식품영양과학회 2012 Journal of medicinal food Vol.15 No.7

Olive tree (Olea europaea L.) leaves have been widely used in traditional remedies in European and Mediterranean countries as extracts, herbal teas, and powder. They contain several potentially bioactive compounds that may have hypoglycemic properties. To examine the efficacy of 500 mg oral olive leaf extract taken once daily in tablet form versus matching placebo in improving glucose homeostasis in adults with type 2 diabetes (T2DM). In this controlled clinical trial, 79 adults with T2DM were randomized to treatment with 500 mg olive leaf extract tablet taken orally once daily or matching placebo. The study duration was 14 weeks. Measures of glucose homeostasis including Hba1c and plasma insulin were measured and compared by treatment assignment. In a series of animal models, normal, streptozotocin (STZ) diabetic, and sand rats were used in the inverted sac model to determine the mechanism through which olive leaf extract affected starch digestion and absorption. In the randomized clinical trial, the subjects treated with olive leaf extract exhibited significantly lower HbA1c and fasting plasma insulin levels; however, postprandial plasma insulin levels did not differ significantly by treatment group. In the animal models, normal and STZ diabetic rats exhibited significantly reduced starch digestion and absorption after treatment with olive leaf extract compared with intestine without olive leaf treatment. Reduced digestion and absorption was observed in both the mucosal and serosal sides of the intestine. Though reduced, the decline in starch digestion and absorption did not reach statistical significance in the sand rats. Olive leaf extract is associated with improved glucose homeostasis in humans. Animal models indicate that this may be facilitated through the reduction of starch digestion and absorption. Olive leaf extract may represent an effective adjunct therapy that normalizes glucose homeostasis in individuals with diabetes.

Dietary Cinnamon Supplementation and Changes in Systolic Blood Pressure in Subjects with Type 2 Diabetes

Julio Wainstein,Naftali Stern,Shimrit Heller,Mona Boaz 한국식품영양과학회 2011 Journal of medicinal food Vol.14 No.12

Experimental and some clinical evidence suggests that ingestion of cinnamon may improve metabolic measures in individuals with diabetes; however, few human studies have been designed to examine this association as their primary objective. In this study adult subjects 30 years of age or older with type 2 diabetes were randomized to treatment with 1,200 mg/day cinnamon or matched placebo. Blood pressure, hemoglobin A1c, fasting blood glucose, lipid profile, physical examination, and blood and urine chemistry were measured at baseline and at the 12-week follow-up end-of-treatment visit. In total, 59 subjects (40.7% female; mean age, 63.05±10.85 years) were recruited. Systolic blood pressure (SBP) declined from baseline values by 3.4±11.4mm Hg in the cinnamon group and increased by 1.9±10.2mm Hg in the placebo group (P = .06). In repeated-measures analysis, a significant by-treatment difference over time was detected (P = .02). However, when baseline SBP was included in the model as a covariate, change from baseline SBP was no longer associated with treatment. Although cinnamon added to the diets of spontaneously hypertensive rats has been shown to decrease SBP in a dose-dependent manner,results of the present study in humans suggest that the by-treatment difference in change-from-baseline SBP was a function of regression to the mean rather than a treatment-associated change.

Alcohol Drinks Induce Acute Lowering in Circulating l-Arginine in Obese and Type 2 Diabetic Subjects

Assaf Buch,Tali Ganz,Julio Wainstein,Suzan Gilad,Rona Limor,Gabi Shefer,Mona Boaz,Naftali Stern 한국식품영양과학회 2022 Journal of medicinal food Vol.25 No.6

Since low serum l-arginine (Arg) and high asymmetric dimethylarginine (ADMA) can predict microvascular complications in type 2 diabetes mellitus (T2DM), we tested whether Arg and ADMA are affected by diet and physical activity in overweight/obese and T2DM subjects. We tested the effects on serum Arg and ADMA of single loads of dextrose, protein, fat, or alcohol (∼300 calories each); one episode of physical exercise; and 12 weeks of standard lifestyle modification (dietary and physical activity counseling). Alcohol drink was followed by ∼30% lowering in Arg. Arg and ADMA increased after a protein load but remained stable after glucose or fat load or 30 min of treadmill walk. Following 12 weeks of lifestyle modification, ADMA declined only in subjects achieving weight loss >5%. In conclusion, alcohol is a previously unrecognized acute suppressor of serum Arg. Lifestyle modification lowers ADMA in subjects who achieve weight loss >5%. Clinical Trial Registration Number: NCT04406402.

Purslane Extract and Glucose Homeostasis in Adults with Type 2 Diabetes: A Double-Blind, Placebo-Controlled Clinical Trial of Efficacy and Safety

Julio Wainstein,Zohar Landau,Yosefa Bar Dayan,Daniela Jakubowicz,Torsten Grothe,Tania Perrinjaquet-Moccetti,Mona Boaz 한국식품영양과학회 2016 Journal of medicinal food Vol.19 No.2

Purslane extract (PE) is derived from Portulaca oleracea L., a medicinal plant used in traditional medicine for its antidiabetic properties. This randomized, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of PE in improving glucose control, blood pressure, and lipid profile in adults with type 2 diabetes mellitus (T2DM) treated with a single oral hypoglycemic agent at baseline. Subjects were randomized to treatment with three capsules of PE/day or a matched placebo. Change from baseline to the week 12 end-of-follow-up visit measures of glucose homeostasis, hemodynamics, and lipid profile was compared by treatment assignment. In addition, these measures were evaluated in a subgroup of ‘‘responders,’’ defined as patients whose week 12 HbA1c was lower than baseline values, regardless of treatment assignment. This group was further assessed in subgroups of baseline oral hypoglycemic treatment. A total of 63 participants were treated with either PE (n = 31, 11 females, mean age 52.4 ± 7.9 years) or matched placebo (n = 32, 11 females, mean age 58.3 ± 10.8 years). In the total cohort, systolic blood pressure declined significantly more in the PE group than the placebo group: -7.5 ± 5.0 versus -0.01 ± 0.3 mmHg, P < .0001. In the responders’ subgroup, HbA1c declined significantly more in the PE group than the placebo group: -0.8% ± 0.4% versus -0.6% ± 0.5%, P = .03. Few adverse events were reported. These were mild and did not differ by treatment assignment. PE appears to be a safe, adjunct treatment for T2DM, significantly reducing systolic blood pressure in the total cohort and HbA1c in the subgroup of responders.