Two hundred and seventy patients over 65 years were included in a placebo-controlled randomized double-blind trial to determine whether a small dose of a low molecular weight (LMW) heparin prevents the occurrence of deep vein leg thrombosis (DVT) diagnosed by ¹²⁵I fibrinogen scanning. LMW heparin (60 mg daily) significantly reduced the frequency of DVT from 9 to 3 percent (p = 0.03). Adverse drug reactions did not differ significantly between the 2 groups, except for the injection site hematomas that were more frequent in the LMW heparin group. In conclusion, LMW heparin appears of value in preventing the occurrence of DVT in an unselected elderly in-patient population.

The correlation between ultrasonographic gastric emptying and appetite was studied. Echographic evaluation of gastric emptying by measurement of the antral vertical diameter and assessment of sensations of hunger and satiety using analogue visual scales were performed simultaneously in 12 healthy volunteers. Measurements were carried out after the intake of 10O8 g psyilium or placebo in a randomised, crossover, double blind trial. The correlation between echographic gastric emptying and sensations of hunger and satiety was excellent (p<0.001) after the intake of either psyllium or placebo. Psyllium significantly delayed gastric emptying from the third hour after a meal. It increased the sensation of satiety and decreased hunger at the sixth hour after the meal. The association between echographic measurement and visual scales is a simple method of evaluating the relationship between the stomach and appetite. The pharmacodynamic effect of psyilium should be confirmed by longterm therapeutic trials. (Gut 1992; 33: 1042-1043 Real time ultrasound is a simple method of measuring gastric emptying which has been validated by previous studies.' Correlated with scintigraphic measurements, it could become the method of choice in evaluating the role of gastric distention in the regulation of appetite and assessing the efficacy of drugs on sensations of hunger and satiety. The Before and after eating the meal and every hour for six hours, the subjects were asked to record hunger sensations on a 100 mm vertical visual analogue scale,24 placing crosses on lines representing ranges from 'not hungry at all' = 0 to 'as hungry as possible'= 100. The satiety sensation was recorded after the meal and every hour for six hours using the same kind of visual analogue scale with 'empty stomach'=0 and 'full'= 100. They were also asked to record the time at which hunger returned. After a seven day washout period, the same measurements were taken under the same conditions after intake of the other treatment being studied. For the six hours after the test meal, the subjects were instructed to remain quiet.Data are expressed as mean (SEM) analysis of variance (ANOVA), a bilateral paired t test and linear correlation coefficients using X-Y pairs were performed for statistical analysis. ResultsThe trial was conducted in nine women and three men with a mean age of 43.2 (4.3) years and a mean weight of 73-3 (1.8) kg (68-85). All weighed at least 10% more than their ideal reference weight (63.0 (1-3) kg).As shown in the Figure, the correlation between the echographic measurements of gastric emptying and the visual analogue scale was excellent. This correlation was observed between gastric emptying and hunger during psyllium intake (R=0.989, p=0.0001) or after placebo (R=0.957, p=0 0007). It was also observed between gastric emptying and satiety during psyllium intake (R=0.987, p=0Q0001) or after placebo (R=0-961, p=0 0006). This study confirmed that the decrease of the sensation of satiety is correlated with the increase of hunger.Comp...

To examine whether written informed consent might influence the results of clinical trials the effect of placebo when given with or without informed consent to patients suffering from insomnia was studied. The study was a single blind observer blinded trial, and patients were paired according to sex, age, and hospital environment. Randomisation assigned the first patient of each pair to the control group (without informed consent) or the group to give informed consent. Of the 56 patients, 26 refused to give informed consent, and the age and sex distribution of these differed significantly (p<002) from the 30 pairs of patients ultimately enrolled into the study. In this "biased" sample, the hypnotic activity of placebo was significantly higher in the control group (p<005).It is concluded that the informed consent procedure biases the results of clinical trials and might affect their general applicability.

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