[Gastroplasty versus very low calorie diet in morbid obesity. Short-term results of a randomized clinical trial].
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Biomedical subjects
Publications and source records attributed to F Quaade.
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Blood pressure (BP) was followed simultaneously with body weight in 134 morbidly obese patients randomized to either jejunoileal bypass (101 patients) or dietary treatment (33 patients). After a median observation time of 24 months (range 12-48 months) body weight fell significantly from a median of 124.0 kg to 81.2 kg in the jejunoileal bypass patients whilst median BP decreased significantly from 140/85 mmHg to 120/80 mmHg. In the patients treated with diet, body weight decreased significantly from a median of 129.0 kg to 119.0 kg after a median observation time of 18 months (range 9-36 months) whereas the median BP of 140/90 mmHg was unaffected. The fall in BP after weight loss was significantly positively correlated with the height of BP before the weight loss. The correlation could not be explained by a greater weight loss in the patients with initially high BP. Furthermore, a significantly positive correlation between BP changes and body weight changes was demonstrated, but this correlation was lesser than the above-mentioned. The study shows that the beneficial effect of a weight loss upon BP in obese patients is greater the higher the initial BP is, but also that a normal BP is only little affected and explained mainly by cuff artifact.
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A review of all literature on jejunoileal bypass for obesity disclosed 282 deaths, corresponding to a mortality rate of 4.2 percent. This rate has been fairly constant through the last 8 years. The causes of death and the postoperative duration are quantified. Pulmonary embolism, mostly early, and liver disease, sometimes late, dominate among the numerous causes of death. Details are too scarcely reported to allow guidance to better results.
Consecutive patients, between 18 and 54 years, suffering from morbid obesity (greater than or equal to 60 per cent overweight) are being randomized to either gastroplasty a.m. Gomez or to a very-low-calorie diet (341 kcal, 1.43 MJ) based on a high-value protein powder with an admixture of calcium, phosphate, sodium, chloride, and magnesium. Through a supplementary daily vitamin-mineral capsule and three tablets of potassium chloride the total regime complies with the 1980 RDA. After initial hospitalization, both groups are seen as out-patients. Twenty-eight patients have so far been studied and none has dropped out. Preliminary results show a substantial weight lose without significant differences between the groups.
A randomized clinical trial concerning treatment of moderate obesity is described. The study compares: (a) conventional 1000 kcal (4.19 MJ) diet with diethylpropion permitted: (b) isocaloric partial meal replacement with protein powder, and diethylpropion permitted; and (c) pre-meal satiation with protein powder. Preliminary results indicate equally good weight losses by the three methods.
Self-reported height and weight were compared with directly-measured controlled height and weight in 158 women with a median age of 34 years (16-62 years) and in 594 men with a median age of 37 (16-66 years). A model of two one-dimensional linear regressions with two independent variables was used in order to describe the combined influence of both controlled height and controlled weight on self-reported height and on self-reported weight. For both sexes there was a systematic tendency for tall and heavy persons to underestimate their height and weight and conversely for small and thin persons to overestimate these measurements. The influence of controlled weight on self-reported height was statistically significant (women: P less than 0.05; men: P approximately 0.05,) and so was the influence of controlled height on self-reported weight (women: P less than 0.002; men: P less than 0.001). The reported heights and weights of women and men converged towards a pair of desired measures for each sex, ie the values of height and weight for which the reported and the controlled values were identical. For women the desired measures were 159.6 cm and 45.2 kg, for men 176.7 cm and 68.9 kg. The demonstrated differences between self-reported and controlled body measures may invalidate data and conclusions of insurance studies and population surveys based on self-reported measures.
Obese patients, age 18-60 years, overweight 20-80 per cent, entered a controlled, clinical study comparing the effects of two anorectic drugs, ie a prescription containing ephedrine and caffein ('Elsinore pills') and diethylpropion, with placebo. All 132 patients were instructed in a 1200-kcal diet, and 108 patients completed 12 weeks' treatment. There was a significantly better effect on body weight of diethylpropion (39 patients, median weight loss 8.4 kg, P less than 0.01) as well as of 'Elsinore pills' (38 patients, median weight loss 8.1 kg, P less than 0.01) compared to the effect of placebo treatment ( 31 patients, median weight loss 4.1 kg). Four patients treated with diethylpropion, and four patients treated with 'Elsionore pills' were withdrawn because of complaints of exaltation, tremor and insomnia. Tremor, in some cases only transient, was significantly more frequent in the 'Elsinore pill' group, but no serious side effects were observed.
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A computerized search was made of all publications on jejunoileal bypass for obesity, recorded in Index Medicus during 1963 to 1977. A total of 171 references, dealing with 6319 patients were usable for the purpose. Fifty-three variables were registered. The great majority of publications is American and published since 1972. Only 20% are joint publications from collaborating surgical and medical departments. The study draws attention to a number of quantitative and qualitative deficiencies in the data and to the less expedient way they are sometimes presented. Principally, this applies to patient number and description, length of observation time, and frequency of complications. Lack of specified criteria for surgical eligibility is common, as is ambiguity in conclusion. It is suggested that recommendations, positive or negative, reflect the authors' subjective attitude, as they are apparently made from the same objective data.
Twenty-two consecutive obese patients were given very-low-calorie diet (VLCD) in the form of a casein and lactose preparation dissolved in orange juice containing 43.0 g protein, 30.4 g carbohydrate and 1.1 g lipid in a total of 317 kcal (1.3 MJ) daily. VLCD was given intermittently in eight-week periods alternating with three-week periods of conventional diet (900-1200 kcal, 3.8-5.0 MJ) to ensure recuperation of lean body mass and to establish a therapy which may facilitate indefinite patient compliance. In case of persisting hunger, diethyl-propion was given in small doses. The median observation time was nine weeks (range 1-37 weeks). The median weight loss was 15.5 kg (range 3.8-39.2 kg), and the median overweight decreased from 85.5 per cent (range 43-135 per cent) to 61.0 per cent (range 19-100 per cent). Blood glucose and cholesterol fell significantly (P < 0.01), and no major side-effects were observed.
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For 2 years, 12 Danish hospitals have conducted a randomized clinical trial to evaluate the hazards and benefits of jejunoileal bypass operations for severe obesity. At present (January, 1976), there are 92 operated and 46 unoperated patients. There has been no mortality in the operated group. One control patient has died. Weight loss is significantly better in the operated group, but not always satisfactory. The well-known postoperative complications have not been deterring in frequency or seriousness. On the whole, but not invariably, the operation has been followed by an improvement in psychosocial status.