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Biomedical subjects

G P Ravelli

Publications and source records attributed to G P Ravelli.

8 recordsLinked to original sources

Sucralfate gel versus placebo in patients with non-erosive gastro-oesophageal reflux disease.

BACKGROUND: Gastro-oesophageal reflux disease, a term used to refer to chest symptoms that result from reflux of gastric acid into the oesophagus, occur at least daily in 7% and every 3 days in 33% of the population. METHODS: One hundred and forty-one patients with moderate to severe gastro-oesophageal reflux symptoms occurring at least three times per week (but no oesophageal erosions or ulcers at endoscopy) were treated in this randomized, double-blind, placebo-controlled study at six trial centres. Treatment was given for 6 weeks and consisted of daily doses of either 1 g sucralfate gel b.d. or placebo. The evaluation of efficacy was based on data of 139 patients. RESULTS: The responder rate at Day 42 was statistically significantly higher for the patients treated with sucralfate (71%) than for the placebo patients (29%) (P < 0.0001, Fisher's exact test). The overall response of the non-ulcer dyspepsia and gastro-oesophageal reflux disease symptoms was better for sucralfate gel than for placebo with 45% of patients treated with sucralfate gel being considered as having a 'good' or 'excellent' overall response compared with 22% of the patients who received placebo (P < 0.0001, Wilcoxon test). Only a few adverse experiences were reported by 10% of sucralfate patients and 7% of placebo patients. CONCLUSION: In this trial, we demonstrated a statistically significant superiority of sucralfate gel at a dosage of 1 g b.d. compared to placebo in the treatment of patients with gastro-oesophageal reflux disease. Sucralfate gel was well tolerated.

Adolescent↗

Zaldaride maleate (a new calmodulin antagonist) versus loperamide in the treatment of traveler's diarrhea: randomized, placebo-controlled trial.

The present study was undertaken to compare the efficacy of a new calmodulin antagonist, zaldaride maleate, with that of placebo or loperamide in persons with traveler's diarrhea. One hundred seventy-nine patients were randomized to receive loperamide (4 mg followed by 2 mg after each unformed stool), zaldaride maleate (20 mg four times per day), or placebo. During the initial 48 hours of therapy, zaldaride maleate decreased the number of unformed stools by 30% and the duration of illness by 23% when compared with placebo. Loperamide was superior to both zaldaride maleate and placebo during the initial hours of treatment. However, after 48 hours of treatment, loperamide and zaldaride maleate were equally efficacious, decreasing by > 50% the number of unformed stools passed in a 24-hour interval (P, not significant), and were both superior when compared with placebo (P < .0001 and P = .0048, respectively). The apparent superiority of loperamide early in the course of therapy appeared to be related to a loading-dose effect and not to any differences in antidiarrheal properties.

Acute Disease↗

Lactitol, a second-generation disaccharide for treatment of chronic portal-systemic encephalopathy. A double-blind, crossover, randomized clinical trial.

A double-blind crossover trial was performed to test the therapeutic usefulness and safety of lactitol, a beta-galactoside sorbitol, against lactose in 18 patients with chronic portal-systemic encephalopathy (PSE). The study included four periods: two for washout and two for lactitol and lactose administration. During washout periods, which lasted two weeks each, patients were stabilized with neomycin plus milk of magnesia. Lactitol and lactose were administered during four weeks each. Ten patients were randomly assigned to receive lactose (group A) and eight patients to receive lactitol (group B) first. PSE parameters, ie, mental state, number connection test performance, asterixis and blood ammonia levels were assessed fortnightly. Electroencephalographic tracings and stool pHs were evaluated at the end of each study period. After the first administration of lactose and lactitol, no statistically significant differences in PSE parameters were found. At the same stage, a significant stool acidification (P less than 0.05) was detected. It is concluded that lactitol seems to be safe and efficacious in treating patients with chronic PSE.

Clinical Trials as Topic↗

[Nestlé Foundation studies of nutritional problems in the 3d world].

An outline is given of the aims and activities of the Nestlé Foundation, notably the inquiries performed at the Study center at Adiopodoumé (Ivory Coast) about the nutrition situation, and the efforts made there to improve the protein intake by introducing new food-stuffs of high protein content.

Child↗

Obesity in nineteen-year-old men: family size and birth order associations.

The authors analyzed the prevalence of obesity by family size and birth order for a total population of over 280,000 19-year-old Dutch males, who were born between 1944 and 1947 and who were from one- to five-child families. Obesity was defined by a relative weight index, 120% or more of the standard of weight for height. Overall obesity prevalence was 1.83%; sons of manual workers were more prone to obesity than sons of non-manual workers. Individuals from one-child families (only children) were uniquely at risk for obesity, particularly in the non-manual social class. This result was similar to reported findings for childhood obesity.

Adult↗

Obesity in young men after famine exposure in utero and early infancy.

In a historical cohort study of 300,000 19-year-old men exposed to the Dutch famine of 1944-45 and examined at military induction, we tested the hypothesis that prenatal and early postnatal nutrition determines subsequent obesity. Outcomes were opposite depending on the time of exposure. During the last trimester of pregnancy and the first months of life, exposure produced significantly lower obesity rates (P less than 0.005). This result is consistent with the inference that nutritional deprivation affected a critical period of development for adipose-tissue cellularity. During the first half of pregnancy, however, exposure resulted in significantly higher obesity rates (P less than 0.0005). This observation is consistent with the inference that nutritional deprivation affected the differentiation of hypothalamic centers regulating food intake and growth, and that subsequent increased food availability produced an accumulation of excess fat in an organism growing to its predetermined maximum size.

Adipose Tissue↗

Acidifying enemas (lactitol and lactose) vs. nonacidifying enemas (tap water) to treat acute portal-systemic encephalopathy: a double-blind, randomized clinical trial.

A double-blind, controlled trial to study the efficacy of acidifying enemas of lactitol, a new galactoside-sorbitol disaccharide, and lactose vs. nonacidifying tap-water enemas was performed in 45 episodes of acute portal-systemic encephalopathy. At the time of randomization, all patients had encephalopathy of at least Grade 2+ severity, delay in the performance of number connection tests and hyperammonemia. A sequential analysis was performed which revealed after the inclusion of the first 20 patients, a significant failure of the nonacidifying enemas as compared to the lactitol enemas (p less than 0.004). The tap-water enema group was, therefore, suspended but the rest of the study continued after rerandomization for lactose and lactitol groups. A favorable response to treatment was obtained in 19 (86%) of the patients receiving lactitol enemas and in 14 (78%) of those receiving lactose enemas. A similar significant improvement in portal-systemic encephalopathy parameters and index was observed after both treatments. Both types of acidifying enemas induced a significant pH decrease in stool (p less than 0.05). These data suggest that acidifying agents like lactose and lactitol are effective and superior to tap-water enemas for the treatment of acute nitrogenous portal-systemic encephalopathy.

Ammonia↗